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Book - 5

SDS Book

A collection of printed SDS for Clinical Chemistry

Printed on: 01/07/2013
Product Page
QUANTIA ASO Calibrator Kit  --  6K46-02 4
QUANTIA ASO Calibrator Kit  --  6K46-01 11
QUANTIA ASO Control I Kit  --  6K54-21 18
QUANTIA ASO Control I Kit  --  6K54-01 25
QUANTIA ASO Control II Kit  --  6K55-22 32
QUANTIA ASO Control II Kit  --  6K55-01 39
QUANTIA ASO Reagent Kit  --  6K38-01 46
QUANTIA ASO Reagent Kit  --  6K38-50 57
QUANTIA ASO Reagent Kit  --  6K38-40 57
QUANTIA Beta-2 Microglobulin Calibrator Kit  --  6K47-02 68
QUANTIA Beta-2 Microglobulin Calibrator Kit  --  6K47-01 75
QUANTIA Beta-2 Microglobulin Reagent Kit  --  6K39-40 82
QUANTIA Beta-2 Microglobulin Reagent Kit  --  6K39-01 95
QUANTIA Ferritin Calibrator Kit  --  6K49-02 107
QUANTIA Ferritin Calibrator Kit  --  6K49-01 114
QUANTIA Ferritin Reagent Kit  --  6K41-50 121
QUANTIA Ferritin Reagent Kit  --  6K41-40 121
QUANTIA Ferritin Reagent Kit  --  6K41-01 132
QUANTIA Ferritin/Myoglobin/IgE Control Kit  --  6K56-21 143
QUANTIA Ferritin/Myoglobin/IgE Control Kit  --  6K56-01 158
QUANTIA IgE Calibrator Kit  --  6K50-02 173
QUANTIA IgE Calibrator Kit  --  6K50-01 180
QUANTIA IgE Reagent Kit  --  6K42-40 187
QUANTIA Lp(a) Control Kit  --  7K00-21 199
QUANTIA Lp(a) Control Kit  --  7K00-20 212
QUANTIA Lp(a) Reagent Kit  --  7K00-40 225
QUANTIA Lp(a) Reagent Kit  --  7K00-01 238
QUANTIA Lp(a) Standard Kit  --  7K00-02 250
QUANTIA Lp(a) Standard Kit  --  7K00-10 257
Quantia Myoglobin  --  6L32-42 264
Quantia Myoglobin Standard  --  6L33-04 271
QUANTIA Proteins Calibrator Kit  --  6K45-01 276
QUANTIA Proteins Calibrators  --  6K45-02 283
QUANTIA Proteins Control Kit  --  6K53-01 290
QUANTIA Proteins Controls  --  6K53-21 301
SENTINEL Bile Acids Controls  --  6K90-20 312
SENTINEL Bile Acids TBA  --  6K90-01 318
SENTINEL Cholesterol HDL Liquid  --  17201M 340
SENTINEL Cholesterol HDL Liquid  --  3K28-02 340
SENTINEL Cholesterol LDL Liquid  --  6K28-02 351
SENTINEL Cholinesterase Liquid  --  6K24-01 362
SENTINEL CK-MB Liquid  --  6K25-03 369
SENTINEL Clin Chem Control 1  --  6K30-20 376
SENTINEL Clin Chem Control 2  --  6K30-21 380
SENTINEL Copper  --  6K93-01 384
SENTINEL CRP Ultra  --  6K26-01 405
SENTINEL Fructosamine  --  6K94-01 412
SENTINEL Fructosamine Control 1  --  6K98-10 430
SENTINEL Fructosamine Control 2  --  6K98-20 436
SENTINEL HBDH Liquid  --  6K23-01 442
Product Page
SENTINEL HDL/LDL Calibrator  --  3K28-10 455
SENTINEL Lipids Controls  --  3K28-11 461
Release Date: 6/7/11

ADD List Number Product Name

6K46-02 QUANTIA ASO Calibrator Kit

Components:
6K46 QUANTIA ASO Calibrator

Book 5 - Page 4
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA ASO Calibrator
· Article number: 6K46
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
CAS: 30007-47-7 5-Bromo-5-nitro-1,3-dioxane 14,50%
EINECS: 250-001-7 Xn R21/22; Xi R36/38
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
(Contd. on page 2)
ENG

Book 5 - Page 5

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Calibrator

(Contd. of page 1)

· After eye contact:


Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling
Avoid contact with skin.
Handle as potentially infectious material.
Avoid contact with eyes.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
(Contd. on page 3)
ENG

Book 5 - Page 6

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Calibrator

(Contd. of page 2)

· Conditions for safe storage, including any incompatibilities


· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
Avoid contact with the skin.
Avoid contact with the eyes.
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.
ENG
(Contd. on page 4)

Book 5 - Page 7

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Calibrator

(Contd. of page 3)

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: Clear
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

* 10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
30007-47-7 5-Bromo-5-nitro-1,3-dioxane
Oral LD50 2000 mg/kg (rat)
· Primary irritant effect:
· on the skin: Irritant to skin and mucous membranes.
· on the eye: Irritant effect.
· Sensitisation: No sensitizing effect known.
ENG
(Contd. on page 5)

Book 5 - Page 8

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Calibrator

(Contd. of page 4)

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R21/22 Harmful in contact with skin and if swallowed.
(Contd. on page 6)
ENG

Book 5 - Page 9

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Calibrator

(Contd. of page 5)
R36/38 Irritating to eyes and skin.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 10

DR
Release Date: 6/7/11

ADD List Number Product Name

6K46-01 QUANTIA ASO Calibrator Kit

Components:
6K46 QUANTIA ASO Calibrator

Book 5 - Page 11
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA ASO Calibrator
· Article number: 6K46
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
CAS: 30007-47-7 5-Bromo-5-nitro-1,3-dioxane 14,50%
EINECS: 250-001-7 Xn R21/22; Xi R36/38
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
(Contd. on page 2)
ENG

Book 5 - Page 12

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Calibrator

(Contd. of page 1)

· After eye contact:


Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling
Avoid contact with skin.
Handle as potentially infectious material.
Avoid contact with eyes.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
(Contd. on page 3)
ENG

Book 5 - Page 13

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Calibrator

(Contd. of page 2)

· Conditions for safe storage, including any incompatibilities


· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
Avoid contact with the skin.
Avoid contact with the eyes.
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.
ENG
(Contd. on page 4)

Book 5 - Page 14

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Calibrator

(Contd. of page 3)

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: Clear
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

* 10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
30007-47-7 5-Bromo-5-nitro-1,3-dioxane
Oral LD50 2000 mg/kg (rat)
· Primary irritant effect:
· on the skin: Irritant to skin and mucous membranes.
· on the eye: Irritant effect.
· Sensitisation: No sensitizing effect known.
ENG
(Contd. on page 5)

Book 5 - Page 15

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Calibrator

(Contd. of page 4)

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R21/22 Harmful in contact with skin and if swallowed.
(Contd. on page 6)
ENG

Book 5 - Page 16

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Calibrator

(Contd. of page 5)
R36/38 Irritating to eyes and skin.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 17

DR
Release Date: 6/7/11

ADD List Number Product Name

6K54-21 QUANTIA ASO Control I Kit

Components:
6K54/I QUANTIA ASO Control I

Book 5 - Page 18
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA ASO Control I
· Article number: 6K54/I
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
(Contd. on page 2)
ENG

Book 5 - Page 19

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control I

(Contd. of page 1)

· After swallowing: Seek medical attention and appropriate follow up.


· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.
ENG
(Contd. on page 3)

Book 5 - Page 20

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control I

(Contd. of page 2)

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,079%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
(Contd. on page 4)
ENG

Book 5 - Page 21

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control I

(Contd. of page 3)

· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Amber
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 79,2 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.
ENG
(Contd. on page 5)

Book 5 - Page 22

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control I

(Contd. of page 4)

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
(Contd. on page 6)
ENG

Book 5 - Page 23

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control I

(Contd. of page 5)
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 24

DR
Release Date: 6/7/11

ADD List Number Product Name

6K54-01 QUANTIA ASO Control I Kit

Components:
6K54/I QUANTIA ASO Control I

Book 5 - Page 25
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA ASO Control I
· Article number: 6K54/I
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
(Contd. on page 2)
ENG

Book 5 - Page 26

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control I

(Contd. of page 1)

· After swallowing: Seek medical attention and appropriate follow up.


· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.
ENG
(Contd. on page 3)

Book 5 - Page 27

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control I

(Contd. of page 2)

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,079%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
(Contd. on page 4)
ENG

Book 5 - Page 28

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control I

(Contd. of page 3)

· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Amber
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 79,2 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.
ENG
(Contd. on page 5)

Book 5 - Page 29

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control I

(Contd. of page 4)

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
(Contd. on page 6)
ENG

Book 5 - Page 30

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control I

(Contd. of page 5)
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 31

DR
Release Date: 6/7/11

ADD List Number Product Name

6K55-22 QUANTIA ASO Control II Kit

Components:
6K55/ II QUANTIA ASO Control II

Book 5 - Page 32
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA ASO Control II
· Article number: 6K55/ II
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
(Contd. on page 2)
ENG

Book 5 - Page 33

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control II

(Contd. of page 1)

· After swallowing: Seek medical attention and appropriate follow up.


· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.
ENG
(Contd. on page 3)

Book 5 - Page 34

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control II

(Contd. of page 2)

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,079%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
(Contd. on page 4)
ENG

Book 5 - Page 35

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control II

(Contd. of page 3)

· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Amber
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,1
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 79,2 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.
ENG
(Contd. on page 5)

Book 5 - Page 36

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control II

(Contd. of page 4)

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
(Contd. on page 6)
ENG

Book 5 - Page 37

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control II

(Contd. of page 5)
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 38

DR
Release Date: 6/7/11

ADD List Number Product Name

6K55-01 QUANTIA ASO Control II Kit

Components:
6K55/ II QUANTIA ASO Control II

Book 5 - Page 39
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA ASO Control II
· Article number: 6K55/ II
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
(Contd. on page 2)
ENG

Book 5 - Page 40

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control II

(Contd. of page 1)

· After swallowing: Seek medical attention and appropriate follow up.


· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.
ENG
(Contd. on page 3)

Book 5 - Page 41

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control II

(Contd. of page 2)

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,079%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
(Contd. on page 4)
ENG

Book 5 - Page 42

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control II

(Contd. of page 3)

· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Amber
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,1
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 79,2 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.
ENG
(Contd. on page 5)

Book 5 - Page 43

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control II

(Contd. of page 4)

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
(Contd. on page 6)
ENG

Book 5 - Page 44

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO Control II

(Contd. of page 5)
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 45

DR
Release Date: 6/7/11

ADD List Number Product Name

6K38-01 QUANTIA ASO Reagent Kit

Components:
6K38/R1 QUANTIA ASO R1 (Buffer)
6K38/R2 QUANTIA ASO R2 (Reagent)

Book 5 - Page 46
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA ASO R1 (Buffer)
· Article number: 6K38/R1
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.
ENG
(Contd. on page 2)

Book 5 - Page 47

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R1 (Buffer)

(Contd. of page 1)

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
(Contd. on page 3)
ENG

Book 5 - Page 48

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R1 (Buffer)

(Contd. of page 2)
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,097%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7
· Change in condition
Melting point/Melting range: Not determined
(Contd. on page 4)
ENG

Book 5 - Page 49

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R1 (Buffer)

(Contd. of page 3)
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 97,7 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 50

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R1 (Buffer)

(Contd. of page 4)
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 51

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA ASO R2 (Reagent)
· Article number: 6K38/R2
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.
ENG
(Contd. on page 2)

Book 5 - Page 52

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R2 (Reagent)

(Contd. of page 1)

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
(Contd. on page 3)
ENG

Book 5 - Page 53

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R2 (Reagent)

(Contd. of page 2)
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,098%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
57-55-6 1,2-propylene glycol (0,009%)
WEL (Great Britain) 474* 10** mg/m³, 150* ppm
*total vapour and particulates **particulates
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
(Contd. on page 4)
ENG

Book 5 - Page 54

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R2 (Reagent)

(Contd. of page 3)

· pH-value at 20°C: 7
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 98,4 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
(Contd. on page 5)
ENG

Book 5 - Page 55

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R2 (Reagent)

(Contd. of page 4)
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 56

DR
Release Date: 6/7/11

ADD List Number Product Name

6K38-40 QUANTIA ASO Reagent Kit


6K38-50

Components:
6K38/R1 QUANTIA ASO R1 (Buffer)
6K38/R2 QUANTIA ASO R2 (Reagent)

Book 5 - Page 57
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA ASO R1 (Buffer)
· Article number: 6K38/R1
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.
ENG
(Contd. on page 2)

Book 5 - Page 58

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R1 (Buffer)

(Contd. of page 1)

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
(Contd. on page 3)
ENG

Book 5 - Page 59

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R1 (Buffer)

(Contd. of page 2)
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,097%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7
· Change in condition
Melting point/Melting range: Not determined
(Contd. on page 4)
ENG

Book 5 - Page 60

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R1 (Buffer)

(Contd. of page 3)
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 97,7 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 61

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R1 (Buffer)

(Contd. of page 4)
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 62

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA ASO R2 (Reagent)
· Article number: 6K38/R2
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.
ENG
(Contd. on page 2)

Book 5 - Page 63

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R2 (Reagent)

(Contd. of page 1)

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
(Contd. on page 3)
ENG

Book 5 - Page 64

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R2 (Reagent)

(Contd. of page 2)
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,098%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
57-55-6 1,2-propylene glycol (0,009%)
WEL (Great Britain) 474* 10** mg/m³, 150* ppm
*total vapour and particulates **particulates
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
(Contd. on page 4)
ENG

Book 5 - Page 65

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R2 (Reagent)

(Contd. of page 3)

· pH-value at 20°C: 7
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 98,4 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
(Contd. on page 5)
ENG

Book 5 - Page 66

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA ASO R2 (Reagent)

(Contd. of page 4)
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 67

DR
Release Date: 6/7/11

ADD List Number Product Name

6K47-02 QUANTIA Beta-2 Microglobulin Calibrator Kit

Components:
6K47 QUANTIA Beta-2 Microglobulin Calibrator

Book 5 - Page 68
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Beta-2 Microglobulin Calibrator
· Article number: 6K47
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
(Contd. on page 2)
ENG

Book 5 - Page 69

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin Calibrator

(Contd. of page 1)

· After swallowing: Seek medical attention and appropriate follow up.


· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.
ENG
(Contd. on page 3)

Book 5 - Page 70

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin Calibrator

(Contd. of page 2)

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,0966%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
(Contd. on page 4)
ENG

Book 5 - Page 71

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin Calibrator

(Contd. of page 3)

· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Clear
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 96,8 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.
ENG
(Contd. on page 5)

Book 5 - Page 72

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin Calibrator

(Contd. of page 4)

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
(Contd. on page 6)
ENG

Book 5 - Page 73

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin Calibrator

(Contd. of page 5)
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 74

DR
Release Date: 6/7/11

ADD List Number Product Name

6K47-01 QUANTIA Beta-2 Microglobulin Calibrator Kit

Components:
6K47 QUANTIA Beta-2 Microglobulin Calibrator

Book 5 - Page 75
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Beta-2 Microglobulin Calibrator
· Article number: 6K47
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
(Contd. on page 2)
ENG

Book 5 - Page 76

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin Calibrator

(Contd. of page 1)

· After swallowing: Seek medical attention and appropriate follow up.


· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.
ENG
(Contd. on page 3)

Book 5 - Page 77

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin Calibrator

(Contd. of page 2)

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,0966%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
(Contd. on page 4)
ENG

Book 5 - Page 78

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin Calibrator

(Contd. of page 3)

· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Clear
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 96,8 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.
ENG
(Contd. on page 5)

Book 5 - Page 79

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin Calibrator

(Contd. of page 4)

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
(Contd. on page 6)
ENG

Book 5 - Page 80

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin Calibrator

(Contd. of page 5)
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 81

DR
Release Date: 6/7/11

ADD List Number Product Name

6K39-40 QUANTIA Beta-2 Microglobulin Reagent Kit

Components:
6K39/R1 QUANTIA Beta-2 Microglobulin R1 (Buffer)
6K39/R2 QUANTIA Beta-2 Microglobulin R2 (Reagent)

Book 5 - Page 82
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Beta-2 Microglobulin R1 (Buffer)
· Article number: 6K39/R1
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008
This product has been evaluated per the classification criteria in Regulation (EC) No 1272/2008 (CLP) and the Globally
Harmonized System of Classification and Labelling of Chemicals (GHS). This product does not meet the criteria for
classification in accordance with either CLP or GHS.
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to Regulation (EC) No 1272/2008 None
· Hazard pictograms None
· Signal word None
· Hazard statements
EUH032 Contact with acids liberates very toxic gas.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
(Contd. on page 2)
ENG

Book 5 - Page 83

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R1 (Buffer)

(Contd. of page 1)

· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
(Contd. on page 3)
ENG

Book 5 - Page 84

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R1 (Buffer)

(Contd. of page 2)

· Conditions for safe storage, including any incompatibilities


· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,096%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
(Contd. on page 4)
ENG

Book 5 - Page 85

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R1 (Buffer)

(Contd. of page 3)
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 6,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 95,3 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
(Contd. on page 5)
ENG

Book 5 - Page 86

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R1 (Buffer)

(Contd. of page 4)
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· UN "Model Regulation": -
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous
Goods by Road)
(Contd. on page 6)
ENG

Book 5 - Page 87

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R1 (Buffer)

(Contd. of page 5)
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of
Dangerous Goods by Rail)
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)
ICAO: International Civil Aviation Organization
ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
PBT: persistent, bioaccumulative and toxic
vPvB: very persistent and very bioaccumulative
ENG

Book 5 - Page 88

DR
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Beta-2 Microglobulin R2 (Reagent)
· Article number: 6K39/R2
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008

GHS08 health hazard

Repr. 1B H360 May damage fertility or the unborn child.


· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to Regulation (EC) No 1272/2008
The product is classified and labelled according to the CLP regulation.
· Hazard pictograms

GHS08

· Signal word Danger


· Hazard-determining components of labelling:
Sodium borate decahydrate
· Hazard statements
H360 May damage fertility or the unborn child.
EUH032 Contact with acids liberates very toxic gas.
· Precautionary statements
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been read and understood.
P281 Use personal protective equipment as required.
P308+P313 IF exposed or concerned: Get medical advice/attention.
P405 Store locked up.
P501 This material and its container must be disposed of in a safe way.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
(Contd. on page 2)
ENG

Book 5 - Page 89

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R2 (Reagent)

(Contd. of page 1)
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
CAS: 1303-96-4 Sodium borate decahydrate 1,4571%
EINECS: 215-540-4 T Repr. Cat. 2 R60-61
Repr. 1B, H360
· SVHC
1303-96-4 Sodium borate decahydrate
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
(Contd. on page 3)
ENG

Book 5 - Page 90

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R2 (Reagent)

(Contd. of page 2)
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Provide local exhaust ventilation if dust or vapor is formed.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,0958%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures: Take off immediately all contaminated clothing.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.
(Contd. on page 4)
ENG

Book 5 - Page 91

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R2 (Reagent)

(Contd. of page 3)

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 8,1
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 95,6 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used and stored according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
(Contd. on page 5)
ENG

Book 5 - Page 92

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R2 (Reagent)

(Contd. of page 4)
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
1303-96-4 Sodium borate decahydrate
Oral LD50 400 mg/kg (human)
Approximate LD50 for adults.
2660 mg/kg (rat)
Target Organ Effects Clinical (human)
Workers exposed to visible amounts of borax dust reported to have nose bleeds, upper respiratory
tract irritation, and shortness of breath. Direct contact with dust could cause skin and eye irritation.
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.
· Additional toxicological information: Product is suspected to cause birth defects.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.
ENG
(Contd. on page 6)

Book 5 - Page 93

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R2 (Reagent)

(Contd. of page 5)

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· UN "Model Regulation": -
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
H360 May damage fertility or the unborn child.
R60 May impair fertility.
R61 May cause harm to the unborn child.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous
Goods by Road)
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of
Dangerous Goods by Rail)
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)
ICAO: International Civil Aviation Organization
ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
LC50: Lethal concentration, 50 percent
LD50: Lethal dose, 50 percent
PBT: persistent, bioaccumulative and toxic
vPvB: very persistent and very bioaccumulative
ENG

Book 5 - Page 94

DR
Release Date: 6/7/11

ADD List Number Product Name

6K39-01 QUANTIA Beta-2 Microglobulin Reagent Kit

Components:
6K39/R1 QUANTIA Beta-2 Microglobulin R1 (Buffer)
6K39/R2 QUANTIA Beta-2 Microglobulin R2 (Reagent)

Book 5 - Page 95
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Beta-2 Microglobulin R1 (Buffer)
· Article number: 6K39/R1
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.
ENG
(Contd. on page 2)

Book 5 - Page 96

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R1 (Buffer)

(Contd. of page 1)

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
(Contd. on page 3)
ENG

Book 5 - Page 97

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R1 (Buffer)

(Contd. of page 2)
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,096%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 6,5
· Change in condition
Melting point/Melting range: Not determined
(Contd. on page 4)
ENG

Book 5 - Page 98

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R1 (Buffer)

(Contd. of page 3)
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 95,3 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 99

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R1 (Buffer)

(Contd. of page 4)
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 100

DR
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Beta-2 Microglobulin R2 (Reagent)
· Article number: 6K39/R2
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
CAS: 1303-96-4 Sodium borate decahydrate 1,4571%
EINECS: 215-540-4 T Repr. Cat. 2 R60-61
· SVHC
1303-96-4 Sodium borate decahydrate
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
(Contd. on page 2)
ENG

Book 5 - Page 101

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R2 (Reagent)

(Contd. of page 1)

· Information for doctor:


· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Provide local exhaust ventilation if dust or vapor is formed.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
(Contd. on page 3)
ENG

Book 5 - Page 102

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R2 (Reagent)

(Contd. of page 2)
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,0958%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures: Take off immediately all contaminated clothing.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 8,1
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
(Contd. on page 4)
ENG

Book 5 - Page 103

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R2 (Reagent)

(Contd. of page 3)
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 95,6 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used and stored according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
1303-96-4 Sodium borate decahydrate
Oral LD50 400 mg/kg (human)
Approximate LD50 for adults.
2660 mg/kg (rat)
Target Organ Effects Clinical (human)
Workers exposed to visible amounts of borax dust reported to have nose bleeds, upper respiratory
tract irritation, and shortness of breath. Direct contact with dust could cause skin and eye irritation.
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.
· Additional toxicological information: Product is suspected to cause birth defects.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
(Contd. on page 5)
ENG

Book 5 - Page 104

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R2 (Reagent)

(Contd. of page 4)
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
(Contd. on page 6)
ENG

Book 5 - Page 105

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Beta-2 Microglobulin R2 (Reagent)

(Contd. of page 5)
· Relevant phrases
R60 May impair fertility.
R61 May cause harm to the unborn child.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 106

DR
Release Date: 6/7/11

ADD List Number Product Name

6K49-02 QUANTIA Ferritin Calibrator Kit

Components:
6K49/1 QUANTIA Ferritin Calibrator 1-4
6K49/2
6K49/3
6K49/4

Book 5 - Page 107
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Ferritin Calibrator 1-4
· Article number:
6K49/1
6K49/2
6K49/3
6K49/4
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008
This product has been evaluated per the classification criteria in Regulation (EC) No 1272/2008 (CLP) and the Globally
Harmonized System of Classification and Labelling of Chemicals (GHS). This product does not meet the criteria for
classification in accordance with either CLP or GHS.
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to Regulation (EC) No 1272/2008 None
· Hazard pictograms None
· Signal word None
· Hazard statements None
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.
ENG
(Contd. on page 2)

Book 5 - Page 108

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Ferritin Calibrator 1-4

(Contd. of page 1)

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
(Contd. on page 3)
ENG

Book 5 - Page 109

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Ferritin Calibrator 1-4

(Contd. of page 2)
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,098%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

(Contd. on page 4)
ENG

Book 5 - Page 110

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Ferritin Calibrator 1-4

(Contd. of page 3)
This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Clear
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 97,8 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
(Contd. on page 5)
ENG

Book 5 - Page 111

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Ferritin Calibrator 1-4

(Contd. of page 4)
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Generally not hazardous for water.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
(Contd. on page 6)
ENG

Book 5 - Page 112

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Ferritin Calibrator 1-4

(Contd. of page 5)
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· UN "Model Regulation": -
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous
Goods by Road)
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of
Dangerous Goods by Rail)
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)
ICAO: International Civil Aviation Organization
ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
PBT: persistent, bioaccumulative and toxic
vPvB: very persistent and very bioaccumulative
ENG

Book 5 - Page 113

DR
Release Date: 6/7/11

ADD List Number Product Name

6K49-01 QUANTIA Ferritin Calibrator Kit

Components:
6K49/1 QUANTIA Ferritin Calibrator 1-4
6K49/2
6K49/3
6K49/4

Book 5 - Page 114
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Ferritin Calibrator 1-4
· Article number:
6K49/1
6K49/2
6K49/3
6K49/4
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
(Contd. on page 2)
ENG

Book 5 - Page 115

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Ferritin Calibrator 1-4

(Contd. of page 1)

· After eye contact:


Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
(Contd. on page 3)
ENG

Book 5 - Page 116

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Ferritin Calibrator 1-4

(Contd. of page 2)
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,098%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
(Contd. on page 4)
ENG

Book 5 - Page 117

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Ferritin Calibrator 1-4

(Contd. of page 3)
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Clear
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 97,8 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
(Contd. on page 5)
ENG

Book 5 - Page 118

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Ferritin Calibrator 1-4

(Contd. of page 4)
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Generally not hazardous for water.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
(Contd. on page 6)
ENG

Book 5 - Page 119

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 06.06.2011

Trade name: QUANTIA Ferritin Calibrator 1-4

(Contd. of page 5)
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 120

DR
Release Date: 6/7/11

ADD List Number Product Name

6K41-40 QUANTIA Ferritin Reagent Kit


6K41-50

Components:
6K41/R1 QUANTIA Ferritin R1 (Buffer)
6K41/R2 QUANTIA Ferritin R2 (Reagent)

Book 5 - Page 121
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 5 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Ferritin R1 (Buffer)
· Article number: 6K41/R1
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.
ENG
(Contd. on page 2)

Book 5 - Page 122

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 5 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R1 (Buffer)

(Contd. of page 1)

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
(Contd. on page 3)
ENG

Book 5 - Page 123

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 5 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R1 (Buffer)

(Contd. of page 2)
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,094%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7
· Change in condition
Melting point/Melting range: Not determined
(Contd. on page 4)
ENG

Book 5 - Page 124

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 5 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R1 (Buffer)

(Contd. of page 3)
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 93,1 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 125

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 5 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R1 (Buffer)

(Contd. of page 4)
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 126

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Ferritin R2 (Reagent)
· Article number: 6K41/R2
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.
ENG
(Contd. on page 2)

Book 5 - Page 127

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R2 (Reagent)

(Contd. of page 1)

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
(Contd. on page 3)
ENG

Book 5 - Page 128

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R2 (Reagent)

(Contd. of page 2)
· Specific end use(s) No additional relevant information available.

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,096%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 8,3
· Change in condition
Melting point/Melting range: Not determined
(Contd. on page 4)
ENG

Book 5 - Page 129

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R2 (Reagent)

(Contd. of page 3)
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 93,5 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 130

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R2 (Reagent)

(Contd. of page 4)
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 131

DR
Release Date: 6/7/11

ADD List Number Product Name

6K41-01 QUANTIA Ferritin Reagent Kit

Components:
6K41/R1 QUANTIA Ferritin R1 (Buffer)
6K41/R2 QUANTIA Ferritin R2 (Reagent)

Book 5 - Page 132
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 5 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Ferritin R1 (Buffer)
· Article number: 6K41/R1
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.
ENG
(Contd. on page 2)

Book 5 - Page 133

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 5 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R1 (Buffer)

(Contd. of page 1)

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
(Contd. on page 3)
ENG

Book 5 - Page 134

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 5 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R1 (Buffer)

(Contd. of page 2)
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,094%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7
· Change in condition
Melting point/Melting range: Not determined
(Contd. on page 4)
ENG

Book 5 - Page 135

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 5 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R1 (Buffer)

(Contd. of page 3)
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 93,1 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 136

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 5 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R1 (Buffer)

(Contd. of page 4)
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 137

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Ferritin R2 (Reagent)
· Article number: 6K41/R2
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.
ENG
(Contd. on page 2)

Book 5 - Page 138

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R2 (Reagent)

(Contd. of page 1)

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
(Contd. on page 3)
ENG

Book 5 - Page 139

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R2 (Reagent)

(Contd. of page 2)
· Specific end use(s) No additional relevant information available.

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,096%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 8,3
· Change in condition
Melting point/Melting range: Not determined
(Contd. on page 4)
ENG

Book 5 - Page 140

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R2 (Reagent)

(Contd. of page 3)
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 93,5 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 141

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin R2 (Reagent)

(Contd. of page 4)
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 142

DR
Release Date: 6/7/11

ADD List Number Product Name

6K56-21 QUANTIA Ferritin/Myoglobin/IgE Control Kit

Components:
6K56/I QUANTIA Ferritin/Myoglobin/IgE Control I
6K56/II QUANTIA Ferritin/Myoglobin/IgE Control II

Book 5 - Page 143
Page 1/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I
· Article number: 6K56/I
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC
Xn; Harmful
R22: Harmful if swallowed.
R32: Contact with acids liberates very toxic gas.
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
· Code letter and hazard designation of product:

Xn Harmful

· Hazard-determining components of labelling:


Sodium azide
· Risk phrases:
22 Harmful if swallowed.
32 Contact with acids liberates very toxic gas.
· Safety phrases:
35 This material and its container must be disposed of in a safe way.
36 Wear suitable protective clothing.
46 If swallowed, seek medical advice immediately and show this container or label.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
ENG
(Contd. on page 2)

Book 5 - Page 144

DR
Page 2/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I

(Contd. of page 1)

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
CAS: 26628-22-8 Sodium azide 0,2123%
EINECS: 247-852-1 T+ R28; N R50/53
R32
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· General information:
Symptoms of poisoning may even occur after several hours; therefore medical observation for at least 48 hours after the
accident is recommended.
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
(Contd. on page 3)
ENG

Book 5 - Page 145

DR
Page 3/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I

(Contd. of page 2)
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,2123%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
(Contd. on page 4)
ENG

Book 5 - Page 146

DR
Page 4/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I

(Contd. of page 3)

· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
Keep away from foodstuffs, beverages and food.
Wash hands at the start of breaks and at the end of the work.
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: Amber
White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
(Contd. on page 5)
ENG

Book 5 - Page 147

DR
Page 5/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I

(Contd. of page 4)
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions Contact with acids liberates very toxic gas.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
26628-22-8 Sodium azide
Oral LD50 27-46 mg/kg (mammal)
LD50 = 27-46 mg/kg in rats and mice.
27 mg/kg (rat)
Dermal LD50 20 mg/kg (rabbit)
Inhalation LC50 1 h 1000 ppm (Rat)
47 ppm (rat)
LD50 (Intratracheal) = 47 mg/kg in rats. Signs of toxicity included spastic paralysis with and
without sensory change. LC50 estimated at 1,000 ppm 1 hour with LC zero of 849-976
ppm/1 hour in rats for hydrazoic acid. Hydrazoic acid vapor or mist irritating to eyes and
respiratory tract.
Mutagenicity Positive (Ames Assay)
Positive in the Ames test.
Negative (mammalian cells)
Human lymphocytes: No evidence of chromosomal damage. Sperm morphology assay in
mice: No adverse effects on sperm morphology. Chinese hamster ovary cells: Increase in
sister chromosome exchanges but no evidence of chromosomal damage.
Target Organ Effects See Comment (human)
Sodium azide acts on smooth muscles of the blood vessels producing a rapid decrease in
blood pressure. It also interferes with cellular respiration. In animal studies, sodium azide
has produced demyelination of nerve fibers in the central nervous system, damage to the
thalamus and cerebrum, damage to the optic nerves, testicular injury and fetotoxicity at
maternally toxic dosages.
See comment (rat)
Negative in a NTP bioassay in rats by gavage at dosages of 5 or 10 mg/kg/day but did produce
a possible increase in pituitary and mammary tumors at dietary concentrations of 100 ppm or
more in a feeding study in rats.
(Contd. on page 6)
ENG

Book 5 - Page 148

DR
Page 6/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I

(Contd. of page 5)

· Primary irritant effect:


· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation:
Non contaminated packagings can be used for recycling.
For disposal of contaminated packaging, please refer to applicable local regulations.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.
ENG
(Contd. on page 7)

Book 5 - Page 149

DR
Page 7/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I

(Contd. of page 6)

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
· Code letter and hazard designation of product:

Xn Harmful

· Hazard-determining components of labelling:


Sodium azide
· Risk phrases:
22 Harmful if swallowed.
32 Contact with acids liberates very toxic gas.
· Safety phrases:
35 This material and its container must be disposed of in a safe way.
36 Wear suitable protective clothing.
46 If swallowed, seek medical advice immediately and show this container or label.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R28 Very toxic if swallowed.
R32 Contact with acids liberates very toxic gas.
R50/53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 150

DR
Page 1/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II
· Article number: 6K56/II
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC
Xn; Harmful
R22: Harmful if swallowed.
R32: Contact with acids liberates very toxic gas.
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
· Code letter and hazard designation of product:

Xn Harmful

· Hazard-determining components of labelling:


Sodium azide
· Risk phrases:
22 Harmful if swallowed.
32 Contact with acids liberates very toxic gas.
· Safety phrases:
35 This material and its container must be disposed of in a safe way.
36 Wear suitable protective clothing.
46 If swallowed, seek medical advice immediately and show this container or label.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
ENG
(Contd. on page 2)

Book 5 - Page 151

DR
Page 2/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II

(Contd. of page 1)

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
CAS: 26628-22-8 Sodium azide 0,2123%
EINECS: 247-852-1 T+ R28; N R50/53
R32
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· General information:
Symptoms of poisoning may even occur after several hours; therefore medical observation for at least 48 hours after the
accident is recommended.
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
(Contd. on page 3)
ENG

Book 5 - Page 152

DR
Page 3/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II

(Contd. of page 2)
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,2123%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
(Contd. on page 4)
ENG

Book 5 - Page 153

DR
Page 4/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II

(Contd. of page 3)

· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
Keep away from foodstuffs, beverages and food.
Wash hands at the start of breaks and at the end of the work.
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: Amber
White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
(Contd. on page 5)
ENG

Book 5 - Page 154

DR
Page 5/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II

(Contd. of page 4)
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions Contact with acids liberates very toxic gas.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
26628-22-8 Sodium azide
Oral LD50 27-46 mg/kg (mammal)
LD50 = 27-46 mg/kg in rats and mice.
27 mg/kg (rat)
Dermal LD50 20 mg/kg (rabbit)
Inhalation LC50 1 h 1000 ppm (Rat)
47 ppm (rat)
LD50 (Intratracheal) = 47 mg/kg in rats. Signs of toxicity included spastic paralysis with and
without sensory change. LC50 estimated at 1,000 ppm 1 hour with LC zero of 849-976
ppm/1 hour in rats for hydrazoic acid. Hydrazoic acid vapor or mist irritating to eyes and
respiratory tract.
Mutagenicity Positive (Ames Assay)
Positive in the Ames test.
Negative (mammalian cells)
Human lymphocytes: No evidence of chromosomal damage. Sperm morphology assay in
mice: No adverse effects on sperm morphology. Chinese hamster ovary cells: Increase in
sister chromosome exchanges but no evidence of chromosomal damage.
Target Organ Effects See Comment (human)
Sodium azide acts on smooth muscles of the blood vessels producing a rapid decrease in
blood pressure. It also interferes with cellular respiration. In animal studies, sodium azide
has produced demyelination of nerve fibers in the central nervous system, damage to the
thalamus and cerebrum, damage to the optic nerves, testicular injury and fetotoxicity at
maternally toxic dosages.
See comment (rat)
Negative in a NTP bioassay in rats by gavage at dosages of 5 or 10 mg/kg/day but did produce
a possible increase in pituitary and mammary tumors at dietary concentrations of 100 ppm or
more in a feeding study in rats.
(Contd. on page 6)
ENG

Book 5 - Page 155

DR
Page 6/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II

(Contd. of page 5)

· Primary irritant effect:


· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation:
Non contaminated packagings can be used for recycling.
For disposal of contaminated packaging, please refer to applicable local regulations.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.
ENG
(Contd. on page 7)

Book 5 - Page 156

DR
Page 7/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II

(Contd. of page 6)

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
· Code letter and hazard designation of product:

Xn Harmful

· Hazard-determining components of labelling:


Sodium azide
· Risk phrases:
22 Harmful if swallowed.
32 Contact with acids liberates very toxic gas.
· Safety phrases:
35 This material and its container must be disposed of in a safe way.
36 Wear suitable protective clothing.
46 If swallowed, seek medical advice immediately and show this container or label.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R28 Very toxic if swallowed.
R32 Contact with acids liberates very toxic gas.
R50/53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 157

DR
Release Date: 6/7/11

ADD List Number Product Name

6K56-01 QUANTIA Ferritin/Myoglobin/IgE Control Kit

Components:
6K56/I QUANTIA Ferritin/Myoglobin/IgE Control I
6K56/II QUANTIA Ferritin/Myoglobin/IgE Control II

Book 5 - Page 158
Page 1/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I
· Article number: 6K56/I
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC
Xn; Harmful
R22: Harmful if swallowed.
R32: Contact with acids liberates very toxic gas.
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
· Code letter and hazard designation of product:

Xn Harmful

· Hazard-determining components of labelling:


Sodium azide
· Risk phrases:
22 Harmful if swallowed.
32 Contact with acids liberates very toxic gas.
· Safety phrases:
35 This material and its container must be disposed of in a safe way.
36 Wear suitable protective clothing.
46 If swallowed, seek medical advice immediately and show this container or label.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
ENG
(Contd. on page 2)

Book 5 - Page 159

DR
Page 2/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I

(Contd. of page 1)

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
CAS: 26628-22-8 Sodium azide 0,2123%
EINECS: 247-852-1 T+ R28; N R50/53
R32
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· General information:
Symptoms of poisoning may even occur after several hours; therefore medical observation for at least 48 hours after the
accident is recommended.
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
(Contd. on page 3)
ENG

Book 5 - Page 160

DR
Page 3/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I

(Contd. of page 2)
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,2123%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
(Contd. on page 4)
ENG

Book 5 - Page 161

DR
Page 4/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I

(Contd. of page 3)

· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
Keep away from foodstuffs, beverages and food.
Wash hands at the start of breaks and at the end of the work.
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: Amber
White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
(Contd. on page 5)
ENG

Book 5 - Page 162

DR
Page 5/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I

(Contd. of page 4)
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions Contact with acids liberates very toxic gas.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
26628-22-8 Sodium azide
Oral LD50 27-46 mg/kg (mammal)
LD50 = 27-46 mg/kg in rats and mice.
27 mg/kg (rat)
Dermal LD50 20 mg/kg (rabbit)
Inhalation LC50 1 h 1000 ppm (Rat)
47 ppm (rat)
LD50 (Intratracheal) = 47 mg/kg in rats. Signs of toxicity included spastic paralysis with and
without sensory change. LC50 estimated at 1,000 ppm 1 hour with LC zero of 849-976
ppm/1 hour in rats for hydrazoic acid. Hydrazoic acid vapor or mist irritating to eyes and
respiratory tract.
Mutagenicity Positive (Ames Assay)
Positive in the Ames test.
Negative (mammalian cells)
Human lymphocytes: No evidence of chromosomal damage. Sperm morphology assay in
mice: No adverse effects on sperm morphology. Chinese hamster ovary cells: Increase in
sister chromosome exchanges but no evidence of chromosomal damage.
Target Organ Effects See Comment (human)
Sodium azide acts on smooth muscles of the blood vessels producing a rapid decrease in
blood pressure. It also interferes with cellular respiration. In animal studies, sodium azide
has produced demyelination of nerve fibers in the central nervous system, damage to the
thalamus and cerebrum, damage to the optic nerves, testicular injury and fetotoxicity at
maternally toxic dosages.
See comment (rat)
Negative in a NTP bioassay in rats by gavage at dosages of 5 or 10 mg/kg/day but did produce
a possible increase in pituitary and mammary tumors at dietary concentrations of 100 ppm or
more in a feeding study in rats.
(Contd. on page 6)
ENG

Book 5 - Page 163

DR
Page 6/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I

(Contd. of page 5)

· Primary irritant effect:


· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation:
Non contaminated packagings can be used for recycling.
For disposal of contaminated packaging, please refer to applicable local regulations.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.
ENG
(Contd. on page 7)

Book 5 - Page 164

DR
Page 7/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 4 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control I

(Contd. of page 6)

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
· Code letter and hazard designation of product:

Xn Harmful

· Hazard-determining components of labelling:


Sodium azide
· Risk phrases:
22 Harmful if swallowed.
32 Contact with acids liberates very toxic gas.
· Safety phrases:
35 This material and its container must be disposed of in a safe way.
36 Wear suitable protective clothing.
46 If swallowed, seek medical advice immediately and show this container or label.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R28 Very toxic if swallowed.
R32 Contact with acids liberates very toxic gas.
R50/53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 165

DR
Page 1/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II
· Article number: 6K56/II
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC
Xn; Harmful
R22: Harmful if swallowed.
R32: Contact with acids liberates very toxic gas.
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
· Code letter and hazard designation of product:

Xn Harmful

· Hazard-determining components of labelling:


Sodium azide
· Risk phrases:
22 Harmful if swallowed.
32 Contact with acids liberates very toxic gas.
· Safety phrases:
35 This material and its container must be disposed of in a safe way.
36 Wear suitable protective clothing.
46 If swallowed, seek medical advice immediately and show this container or label.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
ENG
(Contd. on page 2)

Book 5 - Page 166

DR
Page 2/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II

(Contd. of page 1)

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
CAS: 26628-22-8 Sodium azide 0,2123%
EINECS: 247-852-1 T+ R28; N R50/53
R32
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· General information:
Symptoms of poisoning may even occur after several hours; therefore medical observation for at least 48 hours after the
accident is recommended.
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
(Contd. on page 3)
ENG

Book 5 - Page 167

DR
Page 3/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II

(Contd. of page 2)
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,2123%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
(Contd. on page 4)
ENG

Book 5 - Page 168

DR
Page 4/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II

(Contd. of page 3)

· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
Keep away from foodstuffs, beverages and food.
Wash hands at the start of breaks and at the end of the work.
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: Amber
White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
(Contd. on page 5)
ENG

Book 5 - Page 169

DR
Page 5/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II

(Contd. of page 4)
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions Contact with acids liberates very toxic gas.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
26628-22-8 Sodium azide
Oral LD50 27-46 mg/kg (mammal)
LD50 = 27-46 mg/kg in rats and mice.
27 mg/kg (rat)
Dermal LD50 20 mg/kg (rabbit)
Inhalation LC50 1 h 1000 ppm (Rat)
47 ppm (rat)
LD50 (Intratracheal) = 47 mg/kg in rats. Signs of toxicity included spastic paralysis with and
without sensory change. LC50 estimated at 1,000 ppm 1 hour with LC zero of 849-976
ppm/1 hour in rats for hydrazoic acid. Hydrazoic acid vapor or mist irritating to eyes and
respiratory tract.
Mutagenicity Positive (Ames Assay)
Positive in the Ames test.
Negative (mammalian cells)
Human lymphocytes: No evidence of chromosomal damage. Sperm morphology assay in
mice: No adverse effects on sperm morphology. Chinese hamster ovary cells: Increase in
sister chromosome exchanges but no evidence of chromosomal damage.
Target Organ Effects See Comment (human)
Sodium azide acts on smooth muscles of the blood vessels producing a rapid decrease in
blood pressure. It also interferes with cellular respiration. In animal studies, sodium azide
has produced demyelination of nerve fibers in the central nervous system, damage to the
thalamus and cerebrum, damage to the optic nerves, testicular injury and fetotoxicity at
maternally toxic dosages.
See comment (rat)
Negative in a NTP bioassay in rats by gavage at dosages of 5 or 10 mg/kg/day but did produce
a possible increase in pituitary and mammary tumors at dietary concentrations of 100 ppm or
more in a feeding study in rats.
(Contd. on page 6)
ENG

Book 5 - Page 170

DR
Page 6/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II

(Contd. of page 5)

· Primary irritant effect:


· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation:
Non contaminated packagings can be used for recycling.
For disposal of contaminated packaging, please refer to applicable local regulations.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.
ENG
(Contd. on page 7)

Book 5 - Page 171

DR
Page 7/7
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Ferritin/Myoglobin/IgE Control II

(Contd. of page 6)

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
· Code letter and hazard designation of product:

Xn Harmful

· Hazard-determining components of labelling:


Sodium azide
· Risk phrases:
22 Harmful if swallowed.
32 Contact with acids liberates very toxic gas.
· Safety phrases:
35 This material and its container must be disposed of in a safe way.
36 Wear suitable protective clothing.
46 If swallowed, seek medical advice immediately and show this container or label.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R28 Very toxic if swallowed.
R32 Contact with acids liberates very toxic gas.
R50/53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 172

DR
Release Date: 6/7/11

ADD List Number Product Name

6K50-02 QUANTIA IgE Calibrator Kit

Components:
6K50/1 QUANTIA IgE Calibrators
6K50/2
6K50/3
6K50/4
6K50/5

Book 5 - Page 173
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA IgE Calibrators
· Article number:
6K50/1
6K50/2
6K50/3
6K50/4
6K50/5
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 174

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE Calibrators

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
(Contd. on page 3)
ENG

Book 5 - Page 175

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE Calibrators

(Contd. of page 2)
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,088%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
(Contd. on page 4)
ENG

Book 5 - Page 176

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE Calibrators

(Contd. of page 3)
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Clear
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 97,8 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
(Contd. on page 5)
ENG

Book 5 - Page 177

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE Calibrators

(Contd. of page 4)
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
(Contd. on page 6)
ENG

Book 5 - Page 178

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE Calibrators

(Contd. of page 5)
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 179

DR
Release Date: 6/7/11

ADD List Number Product Name

6K50-01 QUANTIA IgE Calibrator Kit

Components:
6K50/1 QUANTIA IgE Calibrators
6K50/2
6K50/3
6K50/4
6K50/5

Book 5 - Page 180
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA IgE Calibrators
· Article number:
6K50/1
6K50/2
6K50/3
6K50/4
6K50/5
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 181

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE Calibrators

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
(Contd. on page 3)
ENG

Book 5 - Page 182

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE Calibrators

(Contd. of page 2)
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,088%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
(Contd. on page 4)
ENG

Book 5 - Page 183

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE Calibrators

(Contd. of page 3)
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Clear
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 97,8 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
(Contd. on page 5)
ENG

Book 5 - Page 184

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE Calibrators

(Contd. of page 4)
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
(Contd. on page 6)
ENG

Book 5 - Page 185

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE Calibrators

(Contd. of page 5)
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 186

DR
Release Date: 6/7/11

ADD List Number Product Name

6K42-40 QUANTIA IgE Reagent Kit

Components:
6K42/R1 QUANTIA IgE R1 (Buffer)
6K42/R2 QUANTIA IgE R2 (Reagent)

Book 5 - Page 187
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA IgE R1 (Buffer)
· Article number: 6K42/R1
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
CAS: 139-33-3 EDTA, Disodium Salt 1,775%
EINECS: 205-358-3 Xn R22; Xi R36
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
(Contd. on page 2)
ENG

Book 5 - Page 188

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE R1 (Buffer)

(Contd. of page 1)

· Information for doctor:


· Most important symptoms and effects, both acute and delayed
Cramps
Gastric or intestinal disorders
Nausea
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
(Contd. on page 3)
ENG

Book 5 - Page 189

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE R1 (Buffer)

(Contd. of page 2)

· Conditions for safe storage, including any incompatibilities


· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,086%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
(Contd. on page 4)
ENG

Book 5 - Page 190

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE R1 (Buffer)

(Contd. of page 3)
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 8,8
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 95,4 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
139-33-3 EDTA, Disodium Salt
Oral LD50 2000-2300 mg/kg (mouse)
2000-2300 mg/kg (rabbit)
2000-2300 mg/kg (rat)
Mutagenicity Negative (Ames Assay)
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
(Contd. on page 5)
ENG

Book 5 - Page 191

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE R1 (Buffer)

(Contd. of page 4)
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
(Contd. on page 6)
ENG

Book 5 - Page 192

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE R1 (Buffer)

(Contd. of page 5)
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R22 Harmful if swallowed.
R36 Irritating to eyes.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 193

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA IgE R2 (Reagent)
· Article number: 6K42/R2
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.
ENG
(Contd. on page 2)

Book 5 - Page 194

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE R2 (Reagent)

(Contd. of page 1)

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
(Contd. on page 3)
ENG

Book 5 - Page 195

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE R2 (Reagent)

(Contd. of page 2)
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,0879%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,3
· Change in condition
Melting point/Melting range: Not determined
(Contd. on page 4)
ENG

Book 5 - Page 196

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE R2 (Reagent)

(Contd. of page 3)
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 98,0 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 197

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA IgE R2 (Reagent)

(Contd. of page 4)
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 198

DR
Release Date: 6/7/11

ADD List Number Product Name

7K00-21 QUANTIA Lp(a) Control Kit

Components:
7K00/ I QUANTIA Lp(a) Control I
7K00/ II QUANTIA Lp(a) Control II

Book 5 - Page 199
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Lp(a) Control I
· Article number: 7K00/ I
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008
This product has been evaluated per the classification criteria in Regulation (EC) No 1272/2008 (CLP) and the Globally
Harmonized System of Classification and Labelling of Chemicals (GHS). This product does not meet the criteria for
classification in accordance with either CLP or GHS.
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to Regulation (EC) No 1272/2008 None
· Hazard pictograms None
· Signal word None
· Hazard statements None
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 200

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control I

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.
(Contd. on page 3)
ENG

Book 5 - Page 201

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control I

(Contd. of page 2)

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,09%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
(Contd. on page 4)
ENG

Book 5 - Page 202

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control I

(Contd. of page 3)

· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value: Not applicable.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 203

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control I

(Contd. of page 4)
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
(Contd. on page 6)
ENG

Book 5 - Page 204

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control I

(Contd. of page 5)
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· UN "Model Regulation": -
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous
Goods by Road)
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of
Dangerous Goods by Rail)
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)
ICAO: International Civil Aviation Organization
ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
PBT: persistent, bioaccumulative and toxic
vPvB: very persistent and very bioaccumulative
ENG

Book 5 - Page 205

DR
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Lp(a) Control II
· Article number: 7K00/ II
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008
This product has been evaluated per the classification criteria in Regulation (EC) No 1272/2008 (CLP) and the Globally
Harmonized System of Classification and Labelling of Chemicals (GHS). This product does not meet the criteria for
classification in accordance with either CLP or GHS.
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to Regulation (EC) No 1272/2008 None
· Hazard pictograms None
· Signal word None
· Hazard statements None
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 206

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control II

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.
(Contd. on page 3)
ENG

Book 5 - Page 207

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control II

(Contd. of page 2)

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,09%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
(Contd. on page 4)
ENG

Book 5 - Page 208

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control II

(Contd. of page 3)

· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value: Not applicable.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 209

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control II

(Contd. of page 4)
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
(Contd. on page 6)
ENG

Book 5 - Page 210

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control II

(Contd. of page 5)
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· UN "Model Regulation": -
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous
Goods by Road)
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of
Dangerous Goods by Rail)
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)
ICAO: International Civil Aviation Organization
ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
PBT: persistent, bioaccumulative and toxic
vPvB: very persistent and very bioaccumulative
ENG

Book 5 - Page 211

DR
Release Date: 6/7/11

ADD List Number Product Name

7K00-20 QUANTIA Lp(a) Control Kit

Components:
7K00/ I QUANTIA Lp(a) Control I
7K00/ II QUANTIA Lp(a) Control II

Book 5 - Page 212
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Lp(a) Control I
· Article number: 7K00/ I
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
(Contd. on page 2)
ENG

Book 5 - Page 213

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control I

(Contd. of page 1)

· After swallowing: Seek medical attention and appropriate follow up.


· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
(Contd. on page 3)
ENG

Book 5 - Page 214

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control I

(Contd. of page 2)
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,09%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
(Contd. on page 4)
ENG

Book 5 - Page 215

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control I

(Contd. of page 3)

· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value: Not applicable.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.
ENG
(Contd. on page 5)

Book 5 - Page 216

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control I

(Contd. of page 4)

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
(Contd. on page 6)
ENG

Book 5 - Page 217

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control I

(Contd. of page 5)
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 218

DR
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Lp(a) Control II
· Article number: 7K00/ II
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
(Contd. on page 2)
ENG

Book 5 - Page 219

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control II

(Contd. of page 1)

· After swallowing: Seek medical attention and appropriate follow up.


· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
(Contd. on page 3)
ENG

Book 5 - Page 220

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control II

(Contd. of page 2)
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,09%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
(Contd. on page 4)
ENG

Book 5 - Page 221

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control II

(Contd. of page 3)

· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value: Not applicable.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.
ENG
(Contd. on page 5)

Book 5 - Page 222

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control II

(Contd. of page 4)

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
(Contd. on page 6)
ENG

Book 5 - Page 223

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Control II

(Contd. of page 5)
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 224

DR
Release Date: 6/7/11

ADD List Number Product Name

7K00-40 QUANTIA Lp(a) Reagent Kit

Components:
7K00/R1 QUANTIA Lp(a) R1 (Buffer)
7K00/R2 QUANTIA Lp(a) R2 (Reagent)

Book 5 - Page 225
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Lp(a) R1 (Buffer)
· Article number: 7K00/R1
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008
This product has been evaluated per the classification criteria in Regulation (EC) No 1272/2008 (CLP) and the Globally
Harmonized System of Classification and Labelling of Chemicals (GHS). This product does not meet the criteria for
classification in accordance with either CLP or GHS.
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to Regulation (EC) No 1272/2008 None
· Hazard pictograms None
· Signal word None
· Hazard statements None
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
6381-92-6 EDTA disodium salt, dihydrate 1,7333%
Xn R22; Xi R36
Acute Tox. 4, H302; Eye Irrit. 2, H319
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 226

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R1 (Buffer)

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Most important symptoms and effects, both acute and delayed
Cramps
Gastric or intestinal disorders
Nausea
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
(Contd. on page 3)
ENG

Book 5 - Page 227

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R1 (Buffer)

(Contd. of page 2)
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,0839%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
(Contd. on page 4)
ENG

Book 5 - Page 228

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R1 (Buffer)

(Contd. of page 3)

· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 9
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 93,2 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.
ENG
(Contd. on page 5)

Book 5 - Page 229

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R1 (Buffer)

(Contd. of page 4)

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
6381-92-6 EDTA disodium salt, dihydrate
Oral LD50 2000-2300 mg/kg (mouse)
2000-2300 mg/kg (rabbit)
2000-2300 mg/kg (rat)
Mutagenicity Negative (Ames Assay)
Target Organ Effects (other)
Possible adverse effects from pharmacological use include fever and effects on the: kidneys, gastro
intestinal system, CNS, cardiovascular system, skin, blood, metabolism.
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
(Contd. on page 6)
ENG

Book 5 - Page 230

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R1 (Buffer)

(Contd. of page 5)
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· UN "Model Regulation": -
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
H302 Harmful if swallowed.
H319 Causes serious eye irritation.
R22 Harmful if swallowed.
R36 Irritating to eyes.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous
Goods by Road)
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of
Dangerous Goods by Rail)
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)
ICAO: International Civil Aviation Organization
ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
LC50: Lethal concentration, 50 percent
LD50: Lethal dose, 50 percent
PBT: persistent, bioaccumulative and toxic
vPvB: very persistent and very bioaccumulative
ENG

Book 5 - Page 231

DR
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Lp(a) R2 (Reagent)
· Article number: 7K00/R2
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008
This product has been evaluated per the classification criteria in Regulation (EC) No 1272/2008 (CLP) and the Globally
Harmonized System of Classification and Labelling of Chemicals (GHS). This product does not meet the criteria for
classification in accordance with either CLP or GHS.
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to Regulation (EC) No 1272/2008 None
· Hazard pictograms None
· Signal word None
· Hazard statements None
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
(Contd. on page 2)
ENG

Book 5 - Page 232

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R2 (Reagent)

(Contd. of page 1)

· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
(Contd. on page 3)
ENG

Book 5 - Page 233

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R2 (Reagent)

(Contd. of page 2)

· Conditions for safe storage, including any incompatibilities


· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,0878%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
(Contd. on page 4)
ENG

Book 5 - Page 234

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R2 (Reagent)

(Contd. of page 3)
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,3
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 97,6 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
(Contd. on page 5)
ENG

Book 5 - Page 235

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R2 (Reagent)

(Contd. of page 4)
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· UN "Model Regulation": -
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous
Goods by Road)
(Contd. on page 6)
ENG

Book 5 - Page 236

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R2 (Reagent)

(Contd. of page 5)
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of
Dangerous Goods by Rail)
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)
ICAO: International Civil Aviation Organization
ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
PBT: persistent, bioaccumulative and toxic
vPvB: very persistent and very bioaccumulative
ENG

Book 5 - Page 237

DR
Release Date: 6/7/11

ADD List Number Product Name

7K00-01 QUANTIA Lp(a) Reagent Kit

Components:
7K00/R1 QUANTIA Lp(a) R1 (Buffer)
7K00/R2 QUANTIA Lp(a) R2 (Reagent)

Book 5 - Page 238
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Lp(a) R1 (Buffer)
· Article number: 7K00/R1
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
6381-92-6 EDTA disodium salt, dihydrate 1,7333%
Xn R22; Xi R36
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
(Contd. on page 2)
ENG

Book 5 - Page 239

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R1 (Buffer)

(Contd. of page 1)

· Information for doctor:


· Most important symptoms and effects, both acute and delayed
Cramps
Gastric or intestinal disorders
Nausea
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
(Contd. on page 3)
ENG

Book 5 - Page 240

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R1 (Buffer)

(Contd. of page 2)

· Conditions for safe storage, including any incompatibilities


· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,0839%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
(Contd. on page 4)
ENG

Book 5 - Page 241

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R1 (Buffer)

(Contd. of page 3)
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 9
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 93,2 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
6381-92-6 EDTA disodium salt, dihydrate
Oral LD50 2000-2300 mg/kg (mouse)
2000-2300 mg/kg (rabbit)
2000-2300 mg/kg (rat)
Mutagenicity Negative (Ames Assay)
Target Organ Effects (other)
Possible adverse effects from pharmacological use include fever and effects on the: kidneys, gastro
intestinal system, CNS, cardiovascular system, skin, blood, metabolism.
(Contd. on page 5)
ENG

Book 5 - Page 242

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R1 (Buffer)

(Contd. of page 4)

· Primary irritant effect:


· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.
ENG
(Contd. on page 6)

Book 5 - Page 243

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R1 (Buffer)

(Contd. of page 5)

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R22 Harmful if swallowed.
R36 Irritating to eyes.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 244

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Lp(a) R2 (Reagent)
· Article number: 7K00/R2
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.
ENG
(Contd. on page 2)

Book 5 - Page 245

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R2 (Reagent)

(Contd. of page 1)

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
(Contd. on page 3)
ENG

Book 5 - Page 246

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R2 (Reagent)

(Contd. of page 2)
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,0878%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,3
· Change in condition
Melting point/Melting range: Not determined
(Contd. on page 4)
ENG

Book 5 - Page 247

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R2 (Reagent)

(Contd. of page 3)
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 97,6 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 248

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) R2 (Reagent)

(Contd. of page 4)
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 249

DR
Release Date: 6/7/11

ADD List Number Product Name

7K00-02 QUANTIA Lp(a) Standard Kit

Components:
7K00/1-5 QUANTIA Lp(a) Calibrator

Book 5 - Page 250
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Lp(a) Calibrator
· Article number: 7K00/1-5
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008
This product has been evaluated per the classification criteria in Regulation (EC) No 1272/2008 (CLP) and the Globally
Harmonized System of Classification and Labelling of Chemicals (GHS). This product does not meet the criteria for
classification in accordance with either CLP or GHS.
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to Regulation (EC) No 1272/2008 None
· Hazard pictograms None
· Signal word None
· Hazard statements
EUH032 Contact with acids liberates very toxic gas.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 251

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Calibrator

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.
(Contd. on page 3)
ENG

Book 5 - Page 252

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Calibrator

(Contd. of page 2)

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,09%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
(Contd. on page 4)
ENG

Book 5 - Page 253

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Calibrator

(Contd. of page 3)

· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value: Not applicable.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 254

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Calibrator

(Contd. of page 4)
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
(Contd. on page 6)
ENG

Book 5 - Page 255

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Calibrator

(Contd. of page 5)
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· UN "Model Regulation": -
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous
Goods by Road)
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of
Dangerous Goods by Rail)
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)
ICAO: International Civil Aviation Organization
ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
PBT: persistent, bioaccumulative and toxic
vPvB: very persistent and very bioaccumulative
ENG

Book 5 - Page 256

DR
Release Date: 6/7/11

ADD List Number Product Name

7K00-10 QUANTIA Lp(a) Standard Kit

Components:
7K00/1-5 QUANTIA Lp(a) Calibrator

Book 5 - Page 257
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Lp(a) Calibrator
· Article number: 7K00/1-5
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
(Contd. on page 2)
ENG

Book 5 - Page 258

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Calibrator

(Contd. of page 1)

· After swallowing: Seek medical attention and appropriate follow up.


· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
(Contd. on page 3)
ENG

Book 5 - Page 259

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Calibrator

(Contd. of page 2)
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,09%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
(Contd. on page 4)
ENG

Book 5 - Page 260

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Calibrator

(Contd. of page 3)

· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value: Not applicable.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.
ENG
(Contd. on page 5)

Book 5 - Page 261

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Calibrator

(Contd. of page 4)

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
(Contd. on page 6)
ENG

Book 5 - Page 262

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 06.06.2011

Trade name: QUANTIA Lp(a) Calibrator

(Contd. of page 5)
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 263

DR
25.06.2008 Kit components
Product Quantia Myoglobin
Product code 6L32-42
Substance number Description Amount Symbols
6L32-42/R1 Quantia Myoglobin R1 (Buffer) 1 -
6K43-01/R1
6L32-42/R2 Quantia Myoglobin R2 (Reagent) 1 -
6K43/R2

Book 5 - Page 264
Page 1/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

* 1 Identification of substance:
· Trade name: Quantia Myoglobin R1 (Buffer)
· Article number:
6L32-42/R1
6K43-01/R1
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0
· Manufacturer:
BIOKIT S.A.
Can Malé s/n 08186, Lliçà d’Amunt, Barcelona, Spain
Tel:(++34)-93-860 9000
Fax:(++34)-93-860 9009
· Emergency information: MSDS-Support@Abbott.com

* 2 Hazards identification
· Hazard designation: Void
· Information pertaining to particular dangers for man and environment:
The product does not have to be labelled due to the calculation procedure of the "General Classification
guideline for preparations of the EU" in the latest valid version.
· Classification system
The classification is in line with current EC (European Community)-directives. It is expanded, however, by
information from technical literature and by information furnished by supplier companies.

* 3 Composition/information on ingredients
· Chemical characterization
· Dangerous components according to EC-criteria: Void
· Additional information For the wording of the listed risk phrases refer to section 16.

* 4 First aid measures


· General information: If signs of infection occur, seek medical attention.
· After inhalation Supply fresh air; consult doctor in case of symptoms.
· After skin contact: Rinse with water.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: In case of persistent symptoms consult doctor.

* 5 Fire fighting measures


· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Protective equipment: No special measures required.

* 6 Accidental release measures:


· Person-related safety precautions: See point 8.
· Measures for environmental protection: Dilute with much water.
· Measures for cleaning/collecting:
Absorb with liquid-binding material (sand,diatomite,acid binders,
universal binders,sawdust).

7 Handling and storage


· Handling
· Information for safe handling: No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
(Contd. on page 2)
ENG

Book 5 - Page 265

DR
Page 2/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: Quantia Myoglobin R1 (Buffer)

(Contd. of page 1)
· Storage:
· Requirements to be met by storerooms and containers:
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Not required.
· Further information about storage conditions: Protect from heat and direct sunlight.

* 8 Exposure controls and personal protection


· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be
monitored at the workplace.
· Additional information: The lists that were valid during the compilation were used as basis.
· Personal protective equipment:
· General protective and hygienic measures:
The usual precautionary measures should be adhered to general rules for handling chemicals.
· Breathing equipment:
Not necessary, if room is well-ventilated.
Take precautions, if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
The gloves serve to protect the user against splashes. For safety reasons they should be changed immediately
after wetting.
Since the product is in fact a preparation out of several substances, no specific information can be given on
the permeation breakthrough time. The choice of suitable gloves depends not only on the material, but also
on other quality features and must, therefore, be checked with the respective manufacturer. As far as we
know, disposable gloves, among other things out of nitriles, are suitable. Nevertheless, this recommendation
is not intended to replace a suitability test, which is essential and must be carried out under the respective
conditions of use.
· Eye protection: Safety glasses recommended during refilling.

* 9 Physical and chemical properties:


· General Information
Form: Fluid
Colour: Colourless
Odour: Odourless
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Self-inflammability: Product is not selfigniting.
· Danger of explosion: Product is not explosive.
· Density at 20°C 1 g/cm³
· Solubility in / Miscibility with
Water: Fully miscible
· pH-value at 20°C: 8,2

* 10 Stability and reactivity


· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Dangerous reactions Contact with acids releases toxic gases.
· Dangerous products of decomposition: No dangerous decomposition products known.

* 11 Toxicological information
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitization: No sensitizing effect known.
(Contd. on page 3)
ENG

Book 5 - Page 266

DR
Page 3/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: Quantia Myoglobin R1 (Buffer)

(Contd. of page 2)
· Additional toxicological information:
The product is not subject to classification according to the calculation method of the General EC
Classification Guidelines for Preparations as issued in the latest version.
When used and handled according to specifications, the product does not have any harmful effects according
to our experience and the information provided to us.

12 Ecological information:
· General notes:
Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage
system.

* 13 Disposal considerations
· Product:
· General notes:
In general laboratory waste is under the special supervision of the authorities. Refer to applicable local
regulations.
· European waste catalogue:
Please consult the responsible regulatory body for the assignment of disposal codes according to European
Waste Catalogue.
· Following waste disposal key number are possible:
180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC-regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: not restricted
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: not restricted

* 15 Regulatory information
· Designation according to EC guidelines:
Observe the normal safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.

* 16 Other information:
These data are based on our present knowledge. However, they shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Tel: (++34)-93-860 9000
· * Data compared to the previous version altered.
ENG

Book 5 - Page 267

DR
Page 1/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

* 1 Identification of substance:
· Trade name: Quantia Myoglobin R2 (Reagent)
· Article number:
6L32-42/R2
6K43/R2
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0
· Manufacturer:
BIOKIT S.A.
Can Malé s/n 08186, Lliçà d’Amunt, Barcelona, Spain
Tel:(++34)-93-860 9000
Fax:(++34)-93-860 9009
· Emergency information: MSDS-Support@Abbott.com

* 2 Hazards identification
· Hazard designation: Void
· Information pertaining to particular dangers for man and environment:
The product does not have to be labelled due to the calculation procedure of the "General Classification
guideline for preparations of the EU" in the latest valid version.
· Classification system
The classification is in line with current EC (European Community)-directives. It is expanded, however, by
information from technical literature and by information furnished by supplier companies.

3 Composition/information on ingredients
· Chemical characterization
· Dangerous components according to EC-criteria: Void
· Additional information For the wording of the listed risk phrases refer to section 16.

* 4 First aid measures


· General information: If signs of infection occur, seek medical attention.
· After inhalation Supply fresh air; consult doctor in case of symptoms.
· After skin contact: Rinse with water.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: In case of persistent symptoms consult doctor.

5 Fire fighting measures


· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Protective equipment: No special measures required.

6 Accidental release measures:


· Person-related safety precautions: See point 8.
· Measures for environmental protection: Dilute with much water.
· Measures for cleaning/collecting:
Absorb with liquid-binding material (sand,diatomite,acid binders,
universal binders,sawdust).

7 Handling and storage


· Handling
· Information for safe handling: No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
(Contd. on page 2)
ENG

Book 5 - Page 268

DR
Page 2/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: Quantia Myoglobin R2 (Reagent)

(Contd. of page 1)
· Storage:
· Requirements to be met by storerooms and containers:
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Not required.
· Further information about storage conditions: Protect from heat and direct sunlight.

* 8 Exposure controls and personal protection


· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be
monitored at the workplace.
· Additional information: The lists that were valid during the compilation were used as basis.
· Personal protective equipment:
· General protective and hygienic measures:
The usual precautionary measures should be adhered to general rules for handling chemicals.
· Breathing equipment:
Not necessary, if room is well-ventilated.
Take precautions, if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
The gloves serve to protect the user against splashes. For safety reasons they should be changed immediately
after wetting.
Since the product is in fact a preparation out of several substances, no specific information can be given on
the permeation breakthrough time. The choice of suitable gloves depends not only on the material, but also
on other quality features and must, therefore, be checked with the respective manufacturer. As far as we
know, disposable gloves, among other things out of nitriles, are suitable. Nevertheless, this recommendation
is not intended to replace a suitability test, which is essential and must be carried out under the respective
conditions of use.
· Eye protection: Safety glasses recommended during refilling.

* 9 Physical and chemical properties:


· General Information
Form: Fluid
Colour: Whitish
Odour: Odourless
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Self-inflammability: Product is not selfigniting.
· Danger of explosion: Product is not explosive.
· Density at 20°C 1 g/cm³
· Solubility in / Miscibility with
Water: Fully miscible
· pH-value at 20°C: 8,2

10 Stability and reactivity


· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Dangerous reactions Contact with acids releases toxic gases.
· Dangerous products of decomposition: No dangerous decomposition products known.

11 Toxicological information
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitization: No sensitizing effect known.
(Contd. on page 3)
ENG

Book 5 - Page 269

DR
Page 3/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: Quantia Myoglobin R2 (Reagent)

(Contd. of page 2)
· Additional toxicological information:
The product is not subject to classification according to the calculation method of the General EC
Classification Guidelines for Preparations as issued in the latest version.
When used and handled according to specifications, the product does not have any harmful effects according
to our experience and the information provided to us.

12 Ecological information:
· General notes:
Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage
system.

13 Disposal considerations
· Product:
· General notes:
In general laboratory waste is under the special supervision of the authorities. Refer to applicable local
regulations.
· European waste catalogue:
Please consult the responsible regulatory body for the assignment of disposal codes according to European
Waste Catalogue.
· Following waste disposal key number are possible:
180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC-regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: not restricted
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: not restricted

* 15 Regulatory information
· Designation according to EC guidelines:
Observe the normal safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.

* 16 Other information:
These data are based on our present knowledge. However, they shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Tel: (++34)-93-860 9000
· * Data compared to the previous version altered.
ENG

Book 5 - Page 270

DR
25.06.2008 Kit components
Product Quantia Myoglobin Standard
Product code 6L33-04
Substance number Description Amount Symbols
6L33-04/Std quantia Myoglobin Standard 5 -
6K51-01/Std

Book 5 - Page 271
Page 1/4
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

* 1 Identification of substance:
· Trade name: quantia Myoglobin Standard
· Article number:
6L33-04/Std
6K51-01/Std
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0
· Manufacturer:
BIOKIT S.A.
Can Malé s/n 08186, Lliçà d’Amunt, Barcelona, Spain
Tel:(++34)-93-860 9000
Fax:(++34)-93-860 9009
· Emergency information: MSDS-Support@Abbott.com

2 Hazards identification
· Hazard designation: Void
· Information pertaining to particular dangers for man and environment:
The product does not have to be labelled due to the calculation procedure of the "General Classification
guideline for preparations of the EU" in the latest valid version.
· Classification system
The classification is in line with current EC (European Community)-directives. It is expanded, however, by
information from technical literature and by information furnished by supplier companies.
· Additional information:
This preparation contains human sourced components. No known test method can offer complete assurance
that products derived from human sources will not transmit infection. Therefore, all human sourced materials
should be considered potentially infectious.

3 Composition/information on ingredients
· Chemical characterization
· Dangerous components according to EC-criteria: Void
· Additional information For the wording of the listed risk phrases refer to section 16.

4 First aid measures


· General information: If signs of infection occur, seek medical attention.
· After inhalation Supply fresh air; consult doctor in case of symptoms.
· After skin contact: Rinse with water.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: Seek medical treatment.

5 Fire fighting measures


· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Protective equipment: No special measures required.

6 Accidental release measures:


· Person-related safety precautions: See point 8.
· Measures for environmental protection: Dilute with much water.
· Measures for cleaning/collecting:
Absorb with liquid-binding material (sand,diatomite,acid binders,
universal binders,sawdust).
ENG
(Contd. on page 2)

Book 5 - Page 272

DR
Page 2/4
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: quantia Myoglobin Standard


(Contd. of page 1)

7 Handling and storage


· Handling
· Information for safe handling: No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Storage:
· Requirements to be met by storerooms and containers:
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Not required.
· Further information about storage conditions: Protect from heat and direct sunlight.

8 Exposure controls and personal protection


· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be
monitored at the workplace.
· Additional information: The lists that were valid during the compilation were used as basis.
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human sourced materials should be handled according to good laboratory practices
and safe handling procedures.
· Breathing equipment:
Not necessary, if room is well-ventilated.
Take precautions, if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
The gloves serve to protect the user against splashes. For safety reasons they should be changed immediately
after wetting.
Since the product is in fact a preparation out of several substances, no specific information can be given on
the permeation breakthrough time. The choice of suitable gloves depends not only on the material, but also
on other quality features and must, therefore, be checked with the respective manufacturer. As far as we
know, disposable gloves, among other things out of nitriles, are suitable. Nevertheless, this recommendation
is not intended to replace a suitability test, which is essential and must be carried out under the respective
conditions of use.
· Eye protection: Safety glasses recommended during refilling.

9 Physical and chemical properties:


· General Information
Form: Fluid
Colour: Colourless
Odour: Odourless
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Self-inflammability: Product is not selfigniting.
· Danger of explosion: Product is not explosive.
· Density Not determined
· Solubility in / Miscibility with
Water: Fully miscible

10 Stability and reactivity


· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Dangerous reactions Contact with acids releases toxic gases.
· Dangerous products of decomposition: No dangerous decomposition products known.
ENG
(Contd. on page 3)

Book 5 - Page 273

DR
Page 3/4
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: quantia Myoglobin Standard


(Contd. of page 2)

11 Toxicological information
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitization: No sensitizing effect known.
· Additional toxicological information:
The product is not subject to classification according to the calculation method of the General EC
Classification Guidelines for Preparations as issued in the latest version.
When used and handled according to specifications, the product does not have any harmful effects according
to our experience and the information provided to us.

12 Ecological information:
· General notes:
Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage
system.

13 Disposal considerations
· Product:
· General notes:
In general laboratory waste is under the special supervision of the authorities. Refer to applicable local
regulations.
· European waste catalogue:
Please consult the responsible regulatory body for the assignment of disposal codes according to European
Waste Catalogue.
· Following waste disposal key number are possible:
180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC-regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.

14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: not restricted
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: not restricted
not restricted

* 15 Regulatory information
· Designation according to EC guidelines:
Observe the normal safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.

* 16 Other information:
These data are based on our present knowledge. However, they shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
(Contd. on page 4)
ENG

Book 5 - Page 274

DR
Page 4/4
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: quantia Myoglobin Standard

(Contd. of page 3)
· Contact manufacturer: Tel: (++34)-93-860 9000
· * Data compared to the previous version altered.
ENG

Book 5 - Page 275

DR
Release Date: 6/7/11

ADD List Number Product Name

6K45-01 QUANTIA Proteins Calibrator Kit

Components:
6K45/1 QUANTIA Proteins Calibrator 1-5
6K45/2
6K45/3
6K45/4
6K45/5

Book 5 - Page 276
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Proteins Calibrator 1-5
· Article number:
6K45/1
6K45/2
6K45/3
6K45/4
6K45/5
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 277

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Proteins Calibrator 1-5

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
(Contd. on page 3)
ENG

Book 5 - Page 278

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Proteins Calibrator 1-5

(Contd. of page 2)
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,094%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
(Contd. on page 4)
ENG

Book 5 - Page 279

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Proteins Calibrator 1-5

(Contd. of page 3)
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Light yellow
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,1
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 89,4 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
(Contd. on page 5)
ENG

Book 5 - Page 280

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Proteins Calibrator 1-5

(Contd. of page 4)
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
(Contd. on page 6)
ENG

Book 5 - Page 281

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Proteins Calibrator 1-5

(Contd. of page 5)
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 282

DR
Release Date: 6/7/11

ADD List Number Product Name

6K45-02 QUANTIA Proteins Calibrators

Components:
6K45/1 QUANTIA Proteins Calibrator 1-5
6K45/2
6K45/3
6K45/4
6K45/5

Book 5 - Page 283
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Proteins Calibrator 1-5
· Article number:
6K45/1
6K45/2
6K45/3
6K45/4
6K45/5
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008
This product has been evaluated per the classification criteria in Regulation (EC) No 1272/2008 (CLP) and the Globally
Harmonized System of Classification and Labelling of Chemicals (GHS). This product does not meet the criteria for
classification in accordance with either CLP or GHS.
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to Regulation (EC) No 1272/2008 None
· Hazard pictograms None
· Signal word None
· Hazard statements None
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.
ENG
(Contd. on page 2)

Book 5 - Page 284

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Proteins Calibrator 1-5

(Contd. of page 1)

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
(Contd. on page 3)
ENG

Book 5 - Page 285

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Proteins Calibrator 1-5

(Contd. of page 2)
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,094%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

(Contd. on page 4)
ENG

Book 5 - Page 286

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Proteins Calibrator 1-5

(Contd. of page 3)
This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Light yellow
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,1
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density at 20°C 1 g/cm³
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 89,4 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
(Contd. on page 5)
ENG

Book 5 - Page 287

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Proteins Calibrator 1-5

(Contd. of page 4)
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
(Contd. on page 6)
ENG

Book 5 - Page 288

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 1 Revision: 06.06.2011

Trade name: QUANTIA Proteins Calibrator 1-5

(Contd. of page 5)
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· UN "Model Regulation": -
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous
Goods by Road)
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of
Dangerous Goods by Rail)
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)
ICAO: International Civil Aviation Organization
ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
PBT: persistent, bioaccumulative and toxic
vPvB: very persistent and very bioaccumulative
ENG

Book 5 - Page 289

DR
Release Date: 6/7/11

ADD List Number Product Name

6K53-01 QUANTIA Proteins Control Kit

Components:
6K53/ I QUANTIA Proteins Control I
6K53/ II QUANTIA Proteins Control II

Book 5 - Page 290
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Proteins Control I
· Article number: 6K53/ I
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
(Contd. on page 2)
ENG

Book 5 - Page 291

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control I

(Contd. of page 1)

· After swallowing: Seek medical attention and appropriate follow up.


· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.
ENG
(Contd. on page 3)

Book 5 - Page 292

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control I

(Contd. of page 2)

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 8,3
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
(Contd. on page 4)
ENG

Book 5 - Page 293

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control I

(Contd. of page 3)
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
(Contd. on page 5)
ENG

Book 5 - Page 294

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control I

(Contd. of page 4)
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 295

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Proteins Control II
· Article number: 6K53/ II
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
(Contd. on page 2)
ENG

Book 5 - Page 296

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control II

(Contd. of page 1)

· After swallowing: Seek medical attention and appropriate follow up.


· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.
ENG
(Contd. on page 3)

Book 5 - Page 297

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control II

(Contd. of page 2)

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,7
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
(Contd. on page 4)
ENG

Book 5 - Page 298

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control II

(Contd. of page 3)
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
(Contd. on page 5)
ENG

Book 5 - Page 299

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control II

(Contd. of page 4)
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
ENG

Book 5 - Page 300

DR
Release Date: 6/7/11

ADD List Number Product Name

6K53-21 QUANTIA Proteins Controls

Components:
6K53/ I QUANTIA Proteins Control I
6K53/ II QUANTIA Proteins Control II

Book 5 - Page 301
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Proteins Control I
· Article number: 6K53/ I
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008
This product has been evaluated per the classification criteria in Regulation (EC) No 1272/2008 (CLP) and the Globally
Harmonized System of Classification and Labelling of Chemicals (GHS). This product does not meet the criteria for
classification in accordance with either CLP or GHS.
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to Regulation (EC) No 1272/2008 None
· Hazard pictograms None
· Signal word None
· Hazard statements None
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 302

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control I

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
(Contd. on page 3)
ENG

Book 5 - Page 303

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control I

(Contd. of page 2)

· Conditions for safe storage, including any incompatibilities


· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: White
(Contd. on page 4)
ENG

Book 5 - Page 304

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control I

(Contd. of page 3)
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 8,3
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 305

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control I

(Contd. of page 4)
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· UN "Model Regulation": -
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous
Goods by Road)
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of
Dangerous Goods by Rail)
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)
ICAO: International Civil Aviation Organization
ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
PBT: persistent, bioaccumulative and toxic
vPvB: very persistent and very bioaccumulative
ENG

Book 5 - Page 306

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: QUANTIA Proteins Control II
· Article number: 6K53/ II
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008
This product has been evaluated per the classification criteria in Regulation (EC) No 1272/2008 (CLP) and the Globally
Harmonized System of Classification and Labelling of Chemicals (GHS). This product does not meet the criteria for
classification in accordance with either CLP or GHS.
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to Regulation (EC) No 1272/2008 None
· Hazard pictograms None
· Signal word None
· Hazard statements None
· Additional information: Potentially infectious
· Other hazards
This preparation contains human-sourced components. No known test method can offer complete assurance that products
derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered
potentially infectious.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Supply fresh air and seek immediate medical attention.
In case of unconsciousness bring patient into stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 307

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control II

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue
rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Seek medical attention and appropriate follow up.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as other
microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is suitable for
most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically hazardous
chemicals that react with many chemicals, materials and living tissues. Obtain and review the manufacturer’s safety
information before using the disinfectant.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling Handle as potentially infectious material.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
(Contd. on page 3)
ENG

Book 5 - Page 308

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control II

(Contd. of page 2)

· Conditions for safe storage, including any incompatibilities


· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human-sourced materials should be handled according to good laboratory practices and safe handling
procedures.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Material of gloves
The selection of suitable gloves depends not only on the material, but also on further marks of quality, and varies from
manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot
be calculated in advance and has, therefore, to be checked prior to the application.
· Penetration time of glove material
The exact breakthrough time has to be determined by the manufacturer of the protective gloves and has to be observed.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: White
(Contd. on page 4)
ENG

Book 5 - Page 309

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control II

(Contd. of page 3)
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,7
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 310

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 06.06.2011

Trade name: QUANTIA Proteins Control II

(Contd. of page 4)
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· UN "Model Regulation": -
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Abbreviations and acronyms:
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous
Goods by Road)
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of
Dangerous Goods by Rail)
IMDG: International Maritime Code for Dangerous Goods
IATA: International Air Transport Association
IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA)
ICAO: International Civil Aviation Organization
ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO)
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
PBT: persistent, bioaccumulative and toxic
vPvB: very persistent and very bioaccumulative
ENG

Book 5 - Page 311

DR
Release Date: 6/7/11

ADD List Number Product Name

6K90-20 SENTINEL Bile Acids Controls

Components:
27002X Bile Acids Controls 1 & 2 Lyo
27002Y

Book 5 - Page 312
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Bile Acids Controls 1 & 2 Lyo
· Article number:
27002X
27002Y
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0
· Note: All information in this safety data sheet refers to the product after reconstitution with water.

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 313

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 07.06.2011

Trade name: Bile Acids Controls 1 & 2 Lyo

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.
ENG
(Contd. on page 3)

Book 5 - Page 314

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 07.06.2011

Trade name: Bile Acids Controls 1 & 2 Lyo

(Contd. of page 2)

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection:
Not required
Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Powder
Solid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value: Not applicable.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
(Contd. on page 4)
ENG

Book 5 - Page 315

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 07.06.2011

Trade name: Bile Acids Controls 1 & 2 Lyo

(Contd. of page 3)
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
(Contd. on page 5)
ENG

Book 5 - Page 316

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 6 Revision: 07.06.2011

Trade name: Bile Acids Controls 1 & 2 Lyo

(Contd. of page 4)
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 317

DR
Release Date: 6/7/11

ADD List Number Product Name

6K90-01 SENTINEL Bile Acids TBA

Components:
27002D Bile Acids Reagent 1a
27002C Bile Acids Reagent 1b
27002G Bile Acids Reagent 2
27002S Bile Acids Standard

Book 5 - Page 318
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Bile Acids Reagent 1a
· Article number: 27002D
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
(Contd. on page 2)
ENG

Book 5 - Page 319

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Reagent 1a

(Contd. of page 1)

· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
(Contd. on page 3)
ENG

Book 5 - Page 320

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Reagent 1a

(Contd. of page 2)

· Conditions for safe storage, including any incompatibilities


· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,09%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7
(Contd. on page 4)
ENG

Book 5 - Page 321

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Reagent 1a

(Contd. of page 3)

· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: 100°C
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 90,1 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
(Contd. on page 5)
ENG

Book 5 - Page 322

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Reagent 1a

(Contd. of page 4)
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 323

DR
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Bile Acids Reagent 1b
· Article number: 27002C
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0
· Note: All information in this safety data sheet refers to the product after reconstitution with "Diluent".

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 324

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Reagent 1b

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.
ENG
(Contd. on page 3)

Book 5 - Page 325

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Reagent 1b

(Contd. of page 2)

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,0882%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection:
Not required
Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.
ENG
(Contd. on page 4)

Book 5 - Page 326

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Reagent 1b

(Contd. of page 3)

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Powder
Solid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value: Not applicable.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water: Soluble
· Viscosity:
kinematic: Not applicable.
Water: 88,3 %
· Other information No further relevant information available.

* 10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
(Contd. on page 5)
ENG

Book 5 - Page 327

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Reagent 1b

(Contd. of page 4)
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
(Contd. on page 6)
ENG

Book 5 - Page 328

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Reagent 1b

(Contd. of page 5)
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 329

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Bile Acids Reagent 2
· Article number: 27002G
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
(Contd. on page 2)
ENG

Book 5 - Page 330

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Reagent 2

(Contd. of page 1)

· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
(Contd. on page 3)
ENG

Book 5 - Page 331

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Reagent 2

(Contd. of page 2)

· Conditions for safe storage, including any incompatibilities


· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,09%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· Change in condition
Melting point/Melting range: Not determined
(Contd. on page 4)
ENG

Book 5 - Page 332

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Reagent 2

(Contd. of page 3)
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 98,0 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Generally not hazardous for water.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
(Contd. on page 5)
ENG

Book 5 - Page 333

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Reagent 2

(Contd. of page 4)
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 334

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Bile Acids Standard
· Article number: 27002S
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
(Contd. on page 2)
ENG

Book 5 - Page 335

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Standard

(Contd. of page 1)

· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
(Contd. on page 3)
ENG

Book 5 - Page 336

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Standard

(Contd. of page 2)

· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Not miscible or difficult to mix.
· Viscosity:
kinematic: Not determined.
Water: 99,0 %
· Other information No further relevant information available.
ENG
(Contd. on page 4)

Book 5 - Page 337

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Standard

(Contd. of page 3)

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Generally not hazardous for water.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
(Contd. on page 5)
ENG

Book 5 - Page 338

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Bile Acids Standard

(Contd. of page 4)
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 339

DR
Release Date: 6/7/11

ADD List Number Product Name

3K28-02 SENTINEL Cholesterol HDL Liquid


17201M

Components:
27201F Cholesterol HDL Liquid Reagent 1
27201G Cholesterol HDL Liquid Reagent 2

Book 5 - Page 340
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Cholesterol HDL Liquid Reagent 1
· Article number: 27201F
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
(Contd. on page 2)
ENG

Book 5 - Page 341

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Cholesterol HDL Liquid Reagent 1

(Contd. of page 1)

· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
(Contd. on page 3)
ENG

Book 5 - Page 342

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Cholesterol HDL Liquid Reagent 1

(Contd. of page 2)

· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
· Other information No further relevant information available.
ENG
(Contd. on page 4)

Book 5 - Page 343

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Cholesterol HDL Liquid Reagent 1

(Contd. of page 3)

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
(Contd. on page 5)
ENG

Book 5 - Page 344

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Cholesterol HDL Liquid Reagent 1

(Contd. of page 4)
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 345

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Cholesterol HDL Liquid Reagent 2
· Article number: 27201G
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
(Contd. on page 2)
ENG

Book 5 - Page 346

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Cholesterol HDL Liquid Reagent 2

(Contd. of page 1)

· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
(Contd. on page 3)
ENG

Book 5 - Page 347

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Cholesterol HDL Liquid Reagent 2

(Contd. of page 2)

· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Yellowish
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
· Other information No further relevant information available.
ENG
(Contd. on page 4)

Book 5 - Page 348

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Cholesterol HDL Liquid Reagent 2

(Contd. of page 3)

* 10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
(Contd. on page 5)
ENG

Book 5 - Page 349

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Cholesterol HDL Liquid Reagent 2

(Contd. of page 4)
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 350

DR
Release Date: 6/7/11

ADD List Number Product Name

6K28-02 SENTINEL Cholesterol LDL Liquid

Components:
LDL R1 LDL Direct Liquid Reagent 1
LDL R2 LDL Direct Liquid Reagent 2

Book 5 - Page 351
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: LDL Direct Liquid Reagent 1
· Article number: LDL R1
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
(Contd. on page 2)
ENG

Book 5 - Page 352

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: LDL Direct Liquid Reagent 1

(Contd. of page 1)

· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
(Contd. on page 3)
ENG

Book 5 - Page 353

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: LDL Direct Liquid Reagent 1

(Contd. of page 2)

· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: 100°C
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
· Other information No further relevant information available.
ENG
(Contd. on page 4)

Book 5 - Page 354

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: LDL Direct Liquid Reagent 1

(Contd. of page 3)

* 10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Generally not hazardous for water.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
(Contd. on page 5)
ENG

Book 5 - Page 355

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: LDL Direct Liquid Reagent 1

(Contd. of page 4)
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 356

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: LDL Direct Liquid Reagent 2
· Article number: LDL R2
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
(Contd. on page 2)
ENG

Book 5 - Page 357

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: LDL Direct Liquid Reagent 2

(Contd. of page 1)

· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
(Contd. on page 3)
ENG

Book 5 - Page 358

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: LDL Direct Liquid Reagent 2

(Contd. of page 2)

· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Light yellow
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: 100°C
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
· Other information No further relevant information available.
ENG
(Contd. on page 4)

Book 5 - Page 359

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: LDL Direct Liquid Reagent 2

(Contd. of page 3)

* 10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
(Contd. on page 5)
ENG

Book 5 - Page 360

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: LDL Direct Liquid Reagent 2

(Contd. of page 4)
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 361

DR
Kit components
Product SENTINEL Cholinesterase Liquid
Product code 6K24-01
Substance number Description Amount Symbols
6K24/R1 Cholinesterase Liquid Reagent 1 6 -
6K24/R2 Cholinesterase Liquid Reagent 2 6 -

Book 5 - Page 362
Page 1/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 23.09.2009 Revision: 23.09.2009

* 1 Identification of substance:
· Trade name: Cholinesterase Liquid Reagent 1
· Article number: 6K24/R1
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency information: MSDS-Support@Abbott.com

2 Hazards identification
· Hazard designation: Void
· Information pertaining to particular dangers for man and environment:
The product does not require labelling based on the calculation procedure of the "General Classification guideline for
preparations of the EU" in the latest valid version.
· Classification system
The classification is in alignment with current EC (European Community) Directives. It is expanded with information from
technical literature and with information provided by supplier companies.

3 Composition/information on ingredients
· Chemical characterization
· Dangerous components according to EC criteria: None
· Additional information For the wording of the listed risk phrases refer to section 16.

4 First aid measures


· General information: No special measures required.
· After inhalation Supply fresh air; consult doctor in case of symptoms.
· After skin contact: Rinse with water.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: In case of persistent symptoms consult doctor.

5 Fire fighting measures


· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Protective equipment: No special measures required.

* 6 Accidental release measures:


· Person related safety precautions: See section 8.
· Measures for environmental protection: Dilute with much water.
· Measures for cleaning/collecting:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
ENG
(Contd. on page 2)

Book 5 - Page 363

DR
Page 2/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 23.09.2009 Revision: 23.09.2009

Trade name: Cholinesterase Liquid Reagent 1

(Contd. of page 1)

7 Handling and storage


· Handling
· Information for safe handling: No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Not required.
· Further information about storage conditions: Protect from heat and direct sunlight.

8 Exposure controls and personal protection


· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
· Personal protective equipment:
· General protective and hygienic measures: The usual precautionary measures for handling chemicals should be followed.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions, if chemical concentrations exceed the exposure limits (if any) listed above.
· Eye protection: Safety glasses recommended during refilling.

* 9 Physical and chemical properties:


· General Information
Form: Fluid
Colour: Yellow
Odour: Odourless
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: 100°C
· Flash point: Not applicable
· Self-inflammability: Product is not selfigniting.
· Danger of explosion: Product is not explosive.
· Density Not determined
· Solubility in / Miscibility with
Water: Fully miscible
· pH-value at 20°C: 7,6

10 Stability and reactivity


· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Dangerous reactions No dangerous reactions known.
· Dangerous products of decomposition: No dangerous decomposition products known.

11 Toxicological information
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitization: No sensitizing effect known.
(Contd. on page 3)
ENG

Book 5 - Page 364

DR
Page 3/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 23.09.2009 Revision: 23.09.2009

Trade name: Cholinesterase Liquid Reagent 1

(Contd. of page 2)
· Additional toxicological information:
The product is not subject to classification according to the calculation method of the General EC Classification Guidelines for
Preparations as issued in the latest version.
When used and handled according to specifications, the product does not have any harmful effects according to our experience
and the information provided to us.

* 12 Ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.

13 Disposal considerations
· Product:
· General notes:
In general laboratory waste is under the special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Please consult the responsible regulatory body for the assignment of disposal codes according to European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.

14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: not restricted
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: not restricted

* 15 Regulatory information
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.

* 16 Other information:
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product features
and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
· * Data compared to the previous version altered.
ENG

Book 5 - Page 365

DR
Page 1/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 23.09.2009 Revision: 23.09.2009

* 1 Identification of substance:
· Trade name: Cholinesterase Liquid Reagent 2
· Article number: 6K24/R2
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency information: MSDS-Support@Abbott.com

* 2 Hazards identification
· Hazard designation: Void
· Information pertaining to particular dangers for man and environment:
The product does not require labelling based on the calculation procedure of the "General Classification guideline for
preparations of the EU" in the latest valid version.
· Classification system
The classification is in alignment with current EC (European Community) Directives. It is expanded with information from
technical literature and with information provided by supplier companies.

* 3 Composition/information on ingredients
· Chemical characterization
· Dangerous components according to EC criteria:
CAS: 1866-16-6 (propylcarbonylthioethyl)trimethylammoniumiodide 2,90%
EINECS: 217-475-7 Xn; R 20/22
· Additional information For the wording of the listed risk phrases refer to section 16.

4 First aid measures


· General information: No special measures required.
· After inhalation Supply fresh air; consult doctor in case of symptoms.
· After skin contact: Rinse with water.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: In case of persistent symptoms consult doctor.

5 Fire fighting measures


· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Protective equipment: No special measures required.

* 6 Accidental release measures:


· Person related safety precautions: See section 8.
· Measures for environmental protection: Dilute with much water.
· Measures for cleaning/collecting:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
ENG
(Contd. on page 2)

Book 5 - Page 366

DR
Page 2/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 23.09.2009 Revision: 23.09.2009

Trade name: Cholinesterase Liquid Reagent 2

(Contd. of page 1)

7 Handling and storage


· Handling
· Information for safe handling: No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Not required.
· Further information about storage conditions: Protect from heat and direct sunlight.

8 Exposure controls and personal protection


· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
· Personal protective equipment:
· General protective and hygienic measures: The usual precautionary measures for handling chemicals should be followed.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions, if chemical concentrations exceed the exposure limits (if any) listed above.
· Eye protection: Safety glasses recommended during refilling.

* 9 Physical and chemical properties:


· General Information
Form: Fluid
Colour: Colourless
Odour: Odourless
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: 100°C
· Flash point: Not applicable
· Self-inflammability: Product is not selfigniting.
· Danger of explosion: Product is not explosive.
· Density Not determined
· Solubility in / Miscibility with
Water: Fully miscible
· pH-value at 20°C: 5

10 Stability and reactivity


· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Dangerous reactions No dangerous reactions known.
· Dangerous products of decomposition: No dangerous decomposition products known.

11 Toxicological information
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitization: No sensitizing effect known.
(Contd. on page 3)
ENG

Book 5 - Page 367

DR
Page 3/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 23.09.2009 Revision: 23.09.2009

Trade name: Cholinesterase Liquid Reagent 2

(Contd. of page 2)
· Additional toxicological information:
The product is not subject to classification according to the calculation method of the General EC Classification Guidelines for
Preparations as issued in the latest version.
When used and handled according to specifications, the product does not have any harmful effects according to our experience
and the information provided to us.

* 12 Ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.

13 Disposal considerations
· Product:
· General notes:
In general laboratory waste is under the special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Please consult the responsible regulatory body for the assignment of disposal codes according to European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.

14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: not restricted
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: not restricted

* 15 Regulatory information
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.

* 16 Other information:
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product features
and shall not establish a legally valid contractual relationship.
· Relevant R-phrases
20/22 Harmful by inhalation and if swallowed.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
· * Data compared to the previous version altered.
ENG

Book 5 - Page 368

DR
25.06.2008 Kit components
Product SENTINEL CK-MB Liquid
Product code 6K25-03
Substance number Description Amount Symbols
6K25-03 R1 CK-MB Liquid Reagent 1 2 -
6K25-03 R2 CK-MB Liquid Reagent 2 2 -

Book 5 - Page 369
Page 1/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

1 Identification of substance:
· Trade name: CK-MB Liquid Reagent 1
· Article number: 6K25-03 R1
· Application of the substance / the preparation Reagent for In Vitro Diagnostic Use
· Supplier:
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency information: MSDS-Support@Abbott.com

* 2 Hazards identification
· Hazard designation: Void
· Information pertaining to particular dangers for man and environment:
The product does not have to be labelled due to the calculation procedure of the "General Classification
guideline for preparations of the EU" in the latest valid version.
· Classification system
The classification is in line with current EC (European Community)-directives. It is expanded, however, by
information from technical literature and by information furnished by supplier companies.

3 Composition/information on ingredients
· Chemical characterization
· Dangerous components according to EC-criteria: Void
· Additional information For the wording of the listed risk phrases refer to section 16.

4 First aid measures


· General information: No special measures required.
· After inhalation Supply fresh air; consult doctor in case of symptoms.
· After skin contact: Rinse with water.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: In case of persistent symptoms consult doctor.

5 Fire fighting measures


· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Protective equipment: No special measures required.

6 Accidental release measures:


· Person-related safety precautions: See point 8.
· Measures for environmental protection: Dilute with much water.
· Measures for cleaning/collecting:
Absorb with liquid-binding material (sand,diatomite,acid binders,
universal binders,sawdust).

7 Handling and storage


· Handling
· Information for safe handling: No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Storage:
· Requirements to be met by storerooms and containers:
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Not required.
(Contd. on page 2)
ENG

Book 5 - Page 370

DR
Page 2/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: CK-MB Liquid Reagent 1

(Contd. of page 1)
· Further information about storage conditions: Protect from heat and direct sunlight.

8 Exposure controls and personal protection


· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be
monitored at the workplace.
· Additional information: The lists that were valid during the compilation were used as basis.
· Personal protective equipment:
· General protective and hygienic measures:
The usual precautionary measures should be adhered to general rules for handling chemicals.
· Breathing equipment:
Not necessary, if room is well-ventilated.
Take precautions, if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
The gloves serve to protect the user against splashes. For safety reasons they should be changed immediately
after wetting.
Since the product is in fact a preparation out of several substances, no specific information can be given on
the permeation breakthrough time. The choice of suitable gloves depends not only on the material, but also
on other quality features and must, therefore, be checked with the respective manufacturer. As far as we
know, disposable gloves, among other things out of nitriles, are suitable. Nevertheless, this recommendation
is not intended to replace a suitability test, which is essential and must be carried out under the respective
conditions of use.
· Eye protection: Safety glasses recommended during refilling.

9 Physical and chemical properties:


· General Information
Form: Fluid
Colour: Colourless
Odour: Sulphurous
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: 100°C
· Flash point: Not applicable
· Self-inflammability: Product is not selfigniting.
· Danger of explosion: Product is not explosive.
· Density Not determined
· Solubility in / Miscibility with
Water: Fully miscible
· pH-value at 20°C: 6,1

10 Stability and reactivity


· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Dangerous reactions Contact with acids releases toxic gases.
· Dangerous products of decomposition: No dangerous decomposition products known.

11 Toxicological information
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitization: No sensitizing effect known.
· Additional toxicological information:
The product is not subject to classification according to the calculation method of the General EC
Classification Guidelines for Preparations as issued in the latest version.
(Contd. on page 3)
ENG

Book 5 - Page 371

DR
Page 3/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: CK-MB Liquid Reagent 1

(Contd. of page 2)
When used and handled according to specifications, the product does not have any harmful effects according
to our experience and the information provided to us.

12 Ecological information:
· General notes:
Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage
system.

13 Disposal considerations
· Product:
· General notes:
In general laboratory waste is under the special supervision of the authorities. Refer to applicable local
regulations.
· European waste catalogue:
Please consult the responsible regulatory body for the assignment of disposal codes according to European
Waste Catalogue.
· Following waste disposal key number are possible:
180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC-regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.

14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: not restricted
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: not restricted

15 Regulatory information
· Designation according to EC guidelines:
Observe the normal safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.

* 16 Other information:
These data are based on our present knowledge. However, they shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
· * Data compared to the previous version altered.
ENG

Book 5 - Page 372

DR
Page 1/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

* 1 Identification of substance:
· Trade name: CK-MB Liquid Reagent 2
· Article number: 6K25-03 R2
· Application of the substance / the preparation Reagent for In Vitro Diagnostic Use
· Supplier:
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency information: MSDS-Support@Abbott.com

* 2 Hazards identification
· Hazard designation: Void
· Information pertaining to particular dangers for man and environment:
The product does not have to be labelled due to the calculation procedure of the "General Classification
guideline for preparations of the EU" in the latest valid version.
· Classification system
The classification is in line with current EC (European Community)-directives. It is expanded, however, by
information from technical literature and by information furnished by supplier companies.

3 Composition/information on ingredients
· Chemical characterization
· Dangerous components according to EC-criteria: Void
· Additional information For the wording of the listed risk phrases refer to section 16.

4 First aid measures


· General information: No special measures required.
· After inhalation Supply fresh air; consult doctor in case of symptoms.
· After skin contact: Rinse with water.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: In case of persistent symptoms consult doctor.

5 Fire fighting measures


· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Protective equipment: No special measures required.

6 Accidental release measures:


· Person-related safety precautions: See point 8.
· Measures for environmental protection: Dilute with much water.
· Measures for cleaning/collecting:
Absorb with liquid-binding material (sand,diatomite,acid binders,
universal binders,sawdust).

7 Handling and storage


· Handling
· Information for safe handling: No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Storage:
· Requirements to be met by storerooms and containers:
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Not required.
(Contd. on page 2)
ENG

Book 5 - Page 373

DR
Page 2/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: CK-MB Liquid Reagent 2

(Contd. of page 1)
· Further information about storage conditions: Protect from heat and direct sunlight.

8 Exposure controls and personal protection


· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be
monitored at the workplace.
· Additional information: The lists that were valid during the compilation were used as basis.
· Personal protective equipment:
· General protective and hygienic measures:
The usual precautionary measures should be adhered to general rules for handling chemicals.
· Breathing equipment:
Not necessary, if room is well-ventilated.
Take precautions, if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
The gloves serve to protect the user against splashes. For safety reasons they should be changed immediately
after wetting.
Since the product is in fact a preparation out of several substances, no specific information can be given on
the permeation breakthrough time. The choice of suitable gloves depends not only on the material, but also
on other quality features and must, therefore, be checked with the respective manufacturer. As far as we
know, disposable gloves, among other things out of nitriles, are suitable. Nevertheless, this recommendation
is not intended to replace a suitability test, which is essential and must be carried out under the respective
conditions of use.
· Eye protection: Safety glasses recommended during refilling.

9 Physical and chemical properties:


· General Information
Form: Fluid
Colour: Colourless
Odour: Odourless
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: 100°C
· Flash point: Not applicable
· Self-inflammability: Product is not selfigniting.
· Danger of explosion: Product is not explosive.
· Density at 20°C 1,006 g/cm³
· Solubility in / Miscibility with
Water: Fully miscible
· pH-value at 20°C: 9

10 Stability and reactivity


· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Dangerous reactions Contact with acids releases toxic gases.
· Dangerous products of decomposition: No dangerous decomposition products known.

11 Toxicological information
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitization: No sensitizing effect known.
· Additional toxicological information:
The product is not subject to classification according to the calculation method of the General EC
Classification Guidelines for Preparations as issued in the latest version.
(Contd. on page 3)
ENG

Book 5 - Page 374

DR
Page 3/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: CK-MB Liquid Reagent 2

(Contd. of page 2)
When used and handled according to specifications, the product does not have any harmful effects according
to our experience and the information provided to us.

12 Ecological information:
· General notes: Generally not hazardous for water.

13 Disposal considerations
· Product:
· General notes:
In general laboratory waste is under the special supervision of the authorities. Refer to applicable local
regulations.
· European waste catalogue:
Please consult the responsible regulatory body for the assignment of disposal codes according to European
Waste Catalogue.
· Following waste disposal key number are possible:
180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC-regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.

14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: not restricted
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: not restricted

15 Regulatory information
· Designation according to EC guidelines:
Observe the normal safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.

* 16 Other information:
These data are based on our present knowledge. However, they shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
· * Data compared to the previous version altered.
ENG

Book 5 - Page 375

DR
25.06.2008 Kit components
Product SENTINEL Clin Chem Control 1
Product code 6K30-20
Substance number Description Amount Symbols
CC1S Clin Chem Control 1 6 -

Book 5 - Page 376
Page 1/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

* 1 Identification of substance:
· Trade name: Clin Chem Control 1
· Article number: CC1S
· Application of the substance / the preparation Reagent for In Vitro Diagnostic Use
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency information: MSDS-Support@Abbott.com
· Note: All information in this safety data sheet refers to the product after reconstitution with water.

2 Hazards identification
· Hazard designation: Void
· Information pertaining to particular dangers for man and environment:
The product does not have to be labelled due to the calculation procedure of the "General Classification
guideline for preparations of the EU" in the latest valid version.
· Classification system
The classification is in line with current EC (European Community)-directives. It is expanded, however, by
information from technical literature and by information furnished by supplier companies.
· Additional information:
This preparation contains human sourced components. No known test method can offer complete assurance
that products derived from human sources will not transmit infection. Therefore, all human sourced materials
should be considered potentially infectious.

3 Composition/information on ingredients
· Chemical characterization
· Dangerous components according to EC-criteria: Void
· Additional information For the wording of the listed risk phrases refer to section 16.

4 First aid measures


· General information: If signs of infection occur, seek medical attention.
· After inhalation Supply fresh air; consult doctor in case of symptoms.
· After skin contact: Rinse with water.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: Seek medical treatment.

5 Fire fighting measures


· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Protective equipment: No special measures required.

6 Accidental release measures:


· Person-related safety precautions: See point 8.
· Measures for environmental protection: Dilute with much water.
· Measures for cleaning/collecting:
Absorb with liquid-binding material (sand,diatomite,acid binders,
universal binders,sawdust).
ENG
(Contd. on page 2)

Book 5 - Page 377

DR
Page 2/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: Clin Chem Control 1


(Contd. of page 1)

7 Handling and storage


· Handling
· Information for safe handling: No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Storage:
· Requirements to be met by storerooms and containers:
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Not required.
· Further information about storage conditions: Protect from heat and direct sunlight.

8 Exposure controls and personal protection


· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be
monitored at the workplace.
· Additional information: The lists that were valid during the compilation were used as basis.
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human sourced materials should be handled according to good laboratory practices
and safe handling procedures.
· Breathing equipment:
Not necessary, if room is well-ventilated.
Take precautions, if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
The gloves serve to protect the user against splashes. For safety reasons they should be changed immediately
after wetting.
Since the product is in fact a preparation out of several substances, no specific information can be given on
the permeation breakthrough time. The choice of suitable gloves depends not only on the material, but also
on other quality features and must, therefore, be checked with the respective manufacturer. As far as we
know, disposable gloves, among other things out of nitriles, are suitable. Nevertheless, this recommendation
is not intended to replace a suitability test, which is essential and must be carried out under the respective
conditions of use.
· Eye protection: Safety glasses recommended during refilling.

* 9 Physical and chemical properties:


· General Information
Form: Fluid
Colour: Colourless
Odour: Odourless
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Self-inflammability: Product is not selfigniting.
· Danger of explosion: Product is not explosive.
· Density Not determined
· Solubility in / Miscibility with
Water: Fully miscible

* 10 Stability and reactivity


· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Dangerous reactions No dangerous reactions known.
· Dangerous products of decomposition: No dangerous decomposition products known.
ENG
(Contd. on page 3)

Book 5 - Page 378

DR
Page 3/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: Clin Chem Control 1


(Contd. of page 2)

11 Toxicological information
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitization: No sensitizing effect known.
· Additional toxicological information:
The product is not subject to classification according to the calculation method of the General EC
Classification Guidelines for Preparations as issued in the latest version.
When used and handled according to specifications, the product does not have any harmful effects according
to our experience and the information provided to us.

12 Ecological information:
· General notes:
Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage
system.

13 Disposal considerations
· Product:
· General notes:
In general laboratory waste is under the special supervision of the authorities. Refer to applicable local
regulations.
· European waste catalogue:
Please consult the responsible regulatory body for the assignment of disposal codes according to European
Waste Catalogue.
· Following waste disposal key number are possible:
180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC-regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.

14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: not restricted
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: not restricted

* 15 Regulatory information
· Designation according to EC guidelines:
Observe the normal safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.

* 16 Other information:
These data are based on our present knowledge. However, they shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
· * Data compared to the previous version altered.
ENG

Book 5 - Page 379

DR
25.06.2008 Kit components
Product SENTINEL Clin Chem Control 2
Product code 6K30-21
Substance number Description Amount Symbols
CC2S Clin Chem Control 2 6 -

Book 5 - Page 380
Page 1/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

* 1 Identification of substance:
· Trade name: Clin Chem Control 2
· Article number: CC2S
· Application of the substance / the preparation Reagent for In Vitro Diagnostic Use
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency information: MSDS-Support@Abbott.com
· Note: All information in this safety data sheet refers to the product after reconstitution with water.

2 Hazards identification
· Hazard designation: Void
· Information pertaining to particular dangers for man and environment:
The product does not have to be labelled due to the calculation procedure of the "General Classification
guideline for preparations of the EU" in the latest valid version.
· Classification system
The classification is in line with current EC (European Community)-directives. It is expanded, however, by
information from technical literature and by information furnished by supplier companies.
· Additional information:
This preparation contains human sourced components. No known test method can offer complete assurance
that products derived from human sources will not transmit infection. Therefore, all human sourced materials
should be considered potentially infectious.

3 Composition/information on ingredients
· Chemical characterization
· Dangerous components according to EC-criteria: Void
· Additional information For the wording of the listed risk phrases refer to section 16.

4 First aid measures


· General information: If signs of infection occur, seek medical attention.
· After inhalation Supply fresh air; consult doctor in case of symptoms.
· After skin contact: Rinse with water.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: Seek medical treatment.

5 Fire fighting measures


· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Protective equipment: No special measures required.

6 Accidental release measures:


· Person-related safety precautions: See point 8.
· Measures for environmental protection: Dilute with much water.
· Measures for cleaning/collecting:
Absorb with liquid-binding material (sand,diatomite,acid binders,
universal binders,sawdust).
ENG
(Contd. on page 2)

Book 5 - Page 381

DR
Page 2/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: Clin Chem Control 2


(Contd. of page 1)

7 Handling and storage


· Handling
· Information for safe handling: No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Storage:
· Requirements to be met by storerooms and containers:
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Not required.
· Further information about storage conditions: Protect from heat and direct sunlight.

8 Exposure controls and personal protection


· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be
monitored at the workplace.
· Additional information: The lists that were valid during the compilation were used as basis.
· Personal protective equipment:
· General protective and hygienic measures:
It is recommended that human sourced materials should be handled according to good laboratory practices
and safe handling procedures.
· Breathing equipment:
Not necessary, if room is well-ventilated.
Take precautions, if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
The gloves serve to protect the user against splashes. For safety reasons they should be changed immediately
after wetting.
Since the product is in fact a preparation out of several substances, no specific information can be given on
the permeation breakthrough time. The choice of suitable gloves depends not only on the material, but also
on other quality features and must, therefore, be checked with the respective manufacturer. As far as we
know, disposable gloves, among other things out of nitriles, are suitable. Nevertheless, this recommendation
is not intended to replace a suitability test, which is essential and must be carried out under the respective
conditions of use.
· Eye protection: Safety glasses recommended during refilling.

* 9 Physical and chemical properties:


· General Information
Form: Fluid
Colour: Colourless
Odour: Odourless
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Self-inflammability: Product is not selfigniting.
· Danger of explosion: Product is not explosive.
· Density Not determined
· Solubility in / Miscibility with
Water: Fully miscible

* 10 Stability and reactivity


· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Dangerous reactions No dangerous reactions known.
· Dangerous products of decomposition: No dangerous decomposition products known.
ENG
(Contd. on page 3)

Book 5 - Page 382

DR
Page 3/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: Clin Chem Control 2


(Contd. of page 2)

11 Toxicological information
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitization: No sensitizing effect known.
· Additional toxicological information:
The product is not subject to classification according to the calculation method of the General EC
Classification Guidelines for Preparations as issued in the latest version.
When used and handled according to specifications, the product does not have any harmful effects according
to our experience and the information provided to us.

12 Ecological information:
· General notes:
Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage
system.

13 Disposal considerations
· Product:
· General notes:
In general laboratory waste is under the special supervision of the authorities. Refer to applicable local
regulations.
· European waste catalogue:
Please consult the responsible regulatory body for the assignment of disposal codes according to European
Waste Catalogue.
· Following waste disposal key number are possible:
180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC-regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.

14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: not restricted
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: not restricted

* 15 Regulatory information
· Designation according to EC guidelines:
Observe the normal safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.

* 16 Other information:
These data are based on our present knowledge. However, they shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
· * Data compared to the previous version altered.
ENG

Book 5 - Page 383

DR
Release Date: 6/7/11

ADD List Number Product Name

6K93-01 SENTINEL Copper

Components:
27638A Copper Reagent 1a
27638C Copper Reagent 1b
27638D Copper Reagent 2
27108S Copper Standard

Book 5 - Page 384
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Copper Reagent 1a
· Article number: 27638A
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
Acetic acid 5,40%
C R35
R10
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 385

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Copper Reagent 1a

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.
ENG
(Contd. on page 3)

Book 5 - Page 386

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Copper Reagent 1a

(Contd. of page 2)

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
Acetic acid (5,40%)
IOELV (European Union) 25 mg/m³, 10 ppm
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 4,7
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
(Contd. on page 4)
ENG

Book 5 - Page 387

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Copper Reagent 1a

(Contd. of page 3)
· Viscosity:
kinematic: Not determined.
Water: 58,1 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
Acetic acid
Oral LD50 3310 mg/kg (rat)
Dermal LD50 1060 mg/kg (rabbit)
Inhalation LC50 1 h 5620 ppm (mouse)
Mutagenicity Negative (Ames Assay)
Target Organ Effects clinical (human)
Workers exposed to 60 ppm 8 hours a day were found to have conjunctivitis, bronchitis,
pharyngitis, and erosion of exposed teeth.
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
(Contd. on page 5)
ENG

Book 5 - Page 388

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Copper Reagent 1a

(Contd. of page 4)
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R10 Flammable.
R35 Causes severe burns.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 389

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Copper Reagent 1b
· Article number: 27638C
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Substances
· CAS No. Designation:
50-81-7 ascorbic acid
· Identification number(s):
· EINECS Number: 200-066-2
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.
ENG
(Contd. on page 2)

Book 5 - Page 390

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Copper Reagent 1b

(Contd. of page 1)

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Most important symptoms and effects, both acute and delayed
Cramps
Gastric or intestinal disorders
Nausea
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent from entering sewage system, storm drains, surface waters, or soil.
· Methods and material for containment and cleaning up:
Damp down dust with water spray.
Collect mechanically.
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: Combustible - finely divided dust may be explosive.
(Contd. on page 3)
ENG

Book 5 - Page 391

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Copper Reagent 1b

(Contd. of page 2)

· Conditions for safe storage, including any incompatibilities


· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
57-50-1 Sucrose, pure (57,50%)
WEL (Great Britain) Short-term value: 20 mg/m³
Long-term value: 10 mg/m³
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection:
Not required
Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Solid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value: Not applicable.
· Melting point/Melting range: 191°C
· Boiling point/Boiling range: Not determined
· Flash point: Not applicable
(Contd. on page 4)
ENG

Book 5 - Page 392

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Copper Reagent 1b

(Contd. of page 3)
· Inflammability (solid, gaseous): Not determined.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Vapour pressure: Not applicable.
· Density Not determined
· Relative density Not determined.
· Vapour density Not applicable.
· Evaporation rate Not applicable.
· Solubility in / Miscibility with
Water at 20°C: 333 g/l
Not miscible or difficult to mix.
Unsoluble
· Viscosity:
kinematic: Not applicable.
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.
ENG
(Contd. on page 5)

Book 5 - Page 393

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Copper Reagent 1b

(Contd. of page 4)

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 394

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Copper Reagent 2
· Article number: 27638D
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
Acetic acid 5,40%
C R35
R10
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 395

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 07.06.2011

Trade name: Copper Reagent 2

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.
ENG
(Contd. on page 3)

Book 5 - Page 396

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 07.06.2011

Trade name: Copper Reagent 2

(Contd. of page 2)

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
Acetic acid (5,40%)
IOELV (European Union) 25 mg/m³, 10 ppm
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Red
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 4,7
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
(Contd. on page 4)
ENG

Book 5 - Page 397

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 07.06.2011

Trade name: Copper Reagent 2

(Contd. of page 3)
· Viscosity:
kinematic: Not determined.
Water: 58,6 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
Acetic acid
Oral LD50 3310 mg/kg (rat)
Dermal LD50 1060 mg/kg (rabbit)
Inhalation LC50 1 h 5620 ppm (mouse)
Mutagenicity Negative (Ames Assay)
Target Organ Effects clinical (human)
Workers exposed to 60 ppm 8 hours a day were found to have conjunctivitis, bronchitis,
pharyngitis, and erosion of exposed teeth.
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
(Contd. on page 5)
ENG

Book 5 - Page 398

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 3 Revision: 07.06.2011

Trade name: Copper Reagent 2

(Contd. of page 4)
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R10 Flammable.
R35 Causes severe burns.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 399

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Copper Standard
· Article number: 27108S
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
(Contd. on page 2)
ENG

Book 5 - Page 400

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Copper Standard

(Contd. of page 1)

· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
(Contd. on page 3)
ENG

Book 5 - Page 401

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Copper Standard

(Contd. of page 2)

· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 99,8 %
· Other information No further relevant information available.
ENG
(Contd. on page 4)

Book 5 - Page 402

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Copper Standard

(Contd. of page 3)

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Generally not hazardous for water.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
(Contd. on page 5)
ENG

Book 5 - Page 403

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Copper Standard

(Contd. of page 4)
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 404

DR
25.06.2008 Kit components
Product SENTINEL CRP Ultra
Product code 6K26-01
Substance number Description Amount Symbols
CRP R1 CRP Ultra Reagent 1 2 -
CRP R2 CRP Ultra Reagent 2 2 -

Book 5 - Page 405
Page 1/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

* 1 Identification of substance:
· Trade name: CRP Ultra Reagent 1
· Article number: CRP R1
· Application of the substance / the preparation Reagent for In Vitro Diagnostic Use
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency information: MSDS-Support@Abbott.com

* 2 Hazards identification
· Hazard designation: Void
· Information pertaining to particular dangers for man and environment:
The product does not have to be labelled due to the calculation procedure of the "General Classification
guideline for preparations of the EU" in the latest valid version.
· Classification system
The classification is in line with current EC (European Community)-directives. It is expanded, however, by
information from technical literature and by information furnished by supplier companies.

3 Composition/information on ingredients
· Chemical characterization
· Dangerous components according to EC-criteria: Void
· Additional information For the wording of the listed risk phrases refer to section 16.

* 4 First aid measures


· General information: If signs of infection occur, seek medical attention.
· After inhalation Supply fresh air; consult doctor in case of symptoms.
· After skin contact: Rinse with water.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: In case of persistent symptoms consult doctor.

5 Fire fighting measures


· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Protective equipment: No special measures required.

6 Accidental release measures:


· Person-related safety precautions: See point 8.
· Measures for environmental protection: Dilute with much water.
· Measures for cleaning/collecting:
Absorb with liquid-binding material (sand,diatomite,acid binders,
universal binders,sawdust).

7 Handling and storage


· Handling
· Information for safe handling: No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
(Contd. on page 2)
ENG

Book 5 - Page 406

DR
Page 2/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: CRP Ultra Reagent 1

(Contd. of page 1)
· Storage:
· Requirements to be met by storerooms and containers:
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Not required.
· Further information about storage conditions: Protect from heat and direct sunlight.

* 8 Exposure controls and personal protection


· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be
monitored at the workplace.
· Additional information: The lists that were valid during the compilation were used as basis.
· Personal protective equipment:
· General protective and hygienic measures:
The usual precautionary measures should be adhered to general rules for handling chemicals.
· Breathing equipment:
Not necessary, if room is well-ventilated.
Take precautions, if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
The gloves serve to protect the user against splashes. For safety reasons they should be changed immediately
after wetting.
Since the product is in fact a preparation out of several substances, no specific information can be given on
the permeation breakthrough time. The choice of suitable gloves depends not only on the material, but also
on other quality features and must, therefore, be checked with the respective manufacturer. As far as we
know, disposable gloves, among other things out of nitriles, are suitable. Nevertheless, this recommendation
is not intended to replace a suitability test, which is essential and must be carried out under the respective
conditions of use.
· Eye protection: Safety glasses recommended during refilling.

* 9 Physical and chemical properties:


· General Information
Form: Fluid
Colour: Colourless
Odour: Odourless
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: 100°C
· Flash point: Not applicable
· Self-inflammability: Product is not selfigniting.
· Danger of explosion: Product is not explosive.
· Density Not determined
· Solubility in / Miscibility with
Water: Fully miscible
· pH-value at 20°C: 7

10 Stability and reactivity


· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Dangerous reactions Contact with acids releases toxic gases.
· Dangerous products of decomposition: No dangerous decomposition products known.

11 Toxicological information
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitization: No sensitizing effect known.
(Contd. on page 3)
ENG

Book 5 - Page 407

DR
Page 3/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: CRP Ultra Reagent 1

(Contd. of page 2)
· Additional toxicological information:
The product is not subject to classification according to the calculation method of the General EC
Classification Guidelines for Preparations as issued in the latest version.
When used and handled according to specifications, the product does not have any harmful effects according
to our experience and the information provided to us.

* 12 Ecological information:
· General notes: Generally not hazardous for water.

13 Disposal considerations
· Product:
· General notes:
In general laboratory waste is under the special supervision of the authorities. Refer to applicable local
regulations.
· European waste catalogue:
Please consult the responsible regulatory body for the assignment of disposal codes according to European
Waste Catalogue.
· Following waste disposal key number are possible:
180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC-regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.

14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: not restricted
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: not restricted

* 15 Regulatory information
· Designation according to EC guidelines:
Observe the normal safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.

* 16 Other information:
These data are based on our present knowledge. However, they shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
· * Data compared to the previous version altered.
ENG

Book 5 - Page 408

DR
Page 1/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

* 1 Identification of substance:
· Trade name: CRP Ultra Reagent 2
· Article number: CRP R2
· Application of the substance / the preparation Reagent for In Vitro Diagnostic Use
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency information: MSDS-Support@Abbott.com

* 2 Hazards identification
· Hazard designation: Void
· Information pertaining to particular dangers for man and environment:
The product does not have to be labelled due to the calculation procedure of the "General Classification
guideline for preparations of the EU" in the latest valid version.
· Classification system
The classification is in line with current EC (European Community)-directives. It is expanded, however, by
information from technical literature and by information furnished by supplier companies.

3 Composition/information on ingredients
· Chemical characterization
· Dangerous components according to EC-criteria: Void
· Additional information For the wording of the listed risk phrases refer to section 16.

* 4 First aid measures


· General information: If signs of infection occur, seek medical attention.
· After inhalation Supply fresh air; consult doctor in case of symptoms.
· After skin contact: Rinse with water.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: In case of persistent symptoms consult doctor.

5 Fire fighting measures


· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Protective equipment: No special measures required.

6 Accidental release measures:


· Person-related safety precautions: See point 8.
· Measures for environmental protection: Dilute with much water.
· Measures for cleaning/collecting:
Absorb with liquid-binding material (sand,diatomite,acid binders,
universal binders,sawdust).

7 Handling and storage


· Handling
· Information for safe handling: No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
(Contd. on page 2)
ENG

Book 5 - Page 409

DR
Page 2/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: CRP Ultra Reagent 2

(Contd. of page 1)
· Storage:
· Requirements to be met by storerooms and containers:
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Not required.
· Further information about storage conditions: Protect from heat and direct sunlight.

* 8 Exposure controls and personal protection


· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be
monitored at the workplace.
· Additional information: The lists that were valid during the compilation were used as basis.
· Personal protective equipment:
· General protective and hygienic measures:
The usual precautionary measures should be adhered to general rules for handling chemicals.
· Breathing equipment:
Not necessary, if room is well-ventilated.
Take precautions, if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
The gloves serve to protect the user against splashes. For safety reasons they should be changed immediately
after wetting.
Since the product is in fact a preparation out of several substances, no specific information can be given on
the permeation breakthrough time. The choice of suitable gloves depends not only on the material, but also
on other quality features and must, therefore, be checked with the respective manufacturer. As far as we
know, disposable gloves, among other things out of nitriles, are suitable. Nevertheless, this recommendation
is not intended to replace a suitability test, which is essential and must be carried out under the respective
conditions of use.
· Eye protection: Safety glasses recommended during refilling.

* 9 Physical and chemical properties:


· General Information
Form: Fluid
Colour: Colourless
Odour: Odourless
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: 100°C
· Flash point: Not applicable
· Self-inflammability: Product is not selfigniting.
· Danger of explosion: Product is not explosive.
· Density Not determined
· Solubility in / Miscibility with
Water: Fully miscible
· pH-value at 20°C: 7

10 Stability and reactivity


· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Dangerous reactions Contact with acids releases toxic gases.
· Dangerous products of decomposition: No dangerous decomposition products known.

11 Toxicological information
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitization: No sensitizing effect known.
(Contd. on page 3)
ENG

Book 5 - Page 410

DR
Page 3/3
Safety Data Sheet
according to 1907/2006/EC, Article 31
Printing date 25.06.2008 Revision: 25.06.2008

Trade name: CRP Ultra Reagent 2

(Contd. of page 2)
· Additional toxicological information:
The product is not subject to classification according to the calculation method of the General EC
Classification Guidelines for Preparations as issued in the latest version.
When used and handled according to specifications, the product does not have any harmful effects according
to our experience and the information provided to us.

* 12 Ecological information:
· General notes: Generally not hazardous for water.

13 Disposal considerations
· Product:
· General notes:
In general laboratory waste is under the special supervision of the authorities. Refer to applicable local
regulations.
· European waste catalogue:
Please consult the responsible regulatory body for the assignment of disposal codes according to European
Waste Catalogue.
· Following waste disposal key number are possible:
180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC-regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.

14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: not restricted
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: not restricted

* 15 Regulatory information
· Designation according to EC guidelines:
Observe the normal safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.

* 16 Other information:
These data are based on our present knowledge. However, they shall not constitute a guarantee for any
specific product features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
· * Data compared to the previous version altered.
ENG

Book 5 - Page 411

DR
Release Date: 6/7/11

ADD List Number Product Name

6K94-01 SENTINEL Fructosamine

Components:
27350A Fructosamine Reagent 1a
27350B Fructosamine Reagent 1b
27351S Calibrator

Book 5 - Page 412
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Fructosamine Reagent 1a
· Article number: 27350A
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
CAS: 497-19-8 Sodium carbonate 2,10%
EINECS: 207-838-8 Xi R36
CAS: 9002-93-1 Triton X-100 1,00%
Xn R22; Xi R41
R52/53
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 413

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Reagent 1a

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.
ENG
(Contd. on page 3)

Book 5 - Page 414

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Reagent 1a

(Contd. of page 2)

* 7 Handling and storage


· Handling
· Precautions for safe handling Avoid contact with eyes.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,09%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· General protective and hygienic measures: Avoid contact with the eyes.
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.
ENG
(Contd. on page 4)

Book 5 - Page 415

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Reagent 1a

(Contd. of page 3)

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 9,9
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: 100°C
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 96,0 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
497-19-8 Sodium carbonate
Oral LD50 4090-6600 mg/kg (mammal)
4000 mg/kg (rat)
(Contd. on page 5)
ENG

Book 5 - Page 416

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Reagent 1a

(Contd. of page 4)
Dermal LD50 2210 mg/kg (mouse)
Inhalation LC50 2 h 0,8-2,3 mg/l (rat)
9002-93-1 Triton X-100
Oral LD50 1800 mg/kg (rat)
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: Irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
(Contd. on page 6)
ENG

Book 5 - Page 417

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Reagent 1a

(Contd. of page 5)
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R22 Harmful if swallowed.
R36 Irritating to eyes.
R41 Risk of serious damage to eyes.
R52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 418

DR
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Fructosamine Reagent 1b
· Article number: 27350B
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0
· Note: All information in this safety data sheet refers to the product after reconstitution with "Diluent".

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
CAS: 298-83-9 Nitro Blue Tetrazolium 6,00%
EINECS: 206-067-4 Xn R22
CAS: 497-19-8 Sodium carbonate 1,953%
EINECS: 207-838-8 Xi R36
· Additional information For wording of the listed risk phrases, refer to Section 16.
ENG
(Contd. on page 2)

Book 5 - Page 419

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Reagent 1b

(Contd. of page 1)

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
(Contd. on page 3)
ENG

Book 5 - Page 420

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Reagent 1b

(Contd. of page 2)
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,0837%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.
ENG
(Contd. on page 4)

Book 5 - Page 421

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Reagent 1b

(Contd. of page 3)

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 89,3 %
· Other information No further relevant information available.

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.
ENG
(Contd. on page 5)

Book 5 - Page 422

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Reagent 1b

(Contd. of page 4)

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
298-83-9 Nitro Blue Tetrazolium
Oral LD50 2000 mg/kg (mouse)
Carcinogenicity Positive (Ames Assay)
Source: CCRIS 9104 - 2 Studies, same reference (Moriya et al., 1982) - both outcomes POSITIVE.
Salmonella Tymphimurium (both)
Strain Indicator: TA100 (both)
Metabolic Activation: None (1 study) S-9 Mix (1 study)
Method: Standard Plate
Dose: 1-10 ug / plate (w/o metabolic activation) 1-100 ug / plate (with metabolic activation)
LD (IV) 5,6 mg/kg (Unknown / Not specified) (By analogy to triphenyl tetrazolium chloride)
Mutagenicity No conclusion (other)
Source: GENETOX 1375
Species/Cell Type: Bacillus subtilis (H17 vs M45T)
Assay Type: Rec-assay, spot test, DNA effects (bacterial DNA repair)
Assay Code: TEXT
497-19-8 Sodium carbonate
Oral LD50 4090-6600 mg/kg (mammal)
4000 mg/kg (rat)
Dermal LD50 2210 mg/kg (mouse)
Inhalation LC50 2 h 0,8-2,3 mg/l (rat)
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
(Contd. on page 6)
ENG
Book 5 - Page 423

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Reagent 1b

(Contd. of page 5)
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R22 Harmful if swallowed.
R36 Irritating to eyes.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 424

DR
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Calibrator
· Article number: 27351S
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
(Contd. on page 2)
ENG

Book 5 - Page 425

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Calibrator

(Contd. of page 1)

· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
(Contd. on page 3)
ENG

Book 5 - Page 426

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Calibrator

(Contd. of page 2)

· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 99,0 %
· Other information No further relevant information available.
ENG
(Contd. on page 4)

Book 5 - Page 427

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Calibrator

(Contd. of page 3)

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

* 12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Generally not hazardous for water.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
(Contd. on page 5)
ENG

Book 5 - Page 428

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Calibrator

(Contd. of page 4)
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 429

DR
Release Date: 6/7/11

ADD List Number Product Name

6K98-10 SENTINEL Fructosamine Control 1

Components:
27352S Fructosamine Control 1

Book 5 - Page 430
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Fructosamine Control 1
· Article number: 27352S
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0
· Note: All information in this safety data sheet refers to the product after reconstitution with water.

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 431

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Control 1

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.
ENG
(Contd. on page 3)

Book 5 - Page 432

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Control 1

(Contd. of page 2)

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
(Contd. on page 4)
ENG

Book 5 - Page 433

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Control 1

(Contd. of page 3)
· Other information No further relevant information available.

* 10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
(Contd. on page 5)
ENG

Book 5 - Page 434

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Control 1

(Contd. of page 4)
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 435

DR
Release Date: 6/7/11

ADD List Number Product Name

6K98-20 SENTINEL Fructosamine Control 2

Components:
27354S Fructosamine Control 2

Book 5 - Page 436
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Fructosamine Control 2
· Article number: 27354S
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0
· Note: All information in this safety data sheet refers to the product after reconstitution with water.

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 437

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Control 2

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.
ENG
(Contd. on page 3)

Book 5 - Page 438

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Control 2

(Contd. of page 2)

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
(Contd. on page 4)
ENG

Book 5 - Page 439

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Control 2

(Contd. of page 3)
· Other information No further relevant information available.

* 10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
(Contd. on page 5)
ENG

Book 5 - Page 440

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Fructosamine Control 2

(Contd. of page 4)
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 441

DR
Release Date: 6/7/11

ADD List Number Product Name

6K23-01 SENTINEL HBDH Liquid

Components:
HBDH R1 HBDH Reagent 1
HBDH R2 HBDH Reagent 2

Book 5 - Page 442
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: HBDH Reagent 1
· Article number: HBDH R1
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
CAS: 77-86-1 Tris Hydroxymethyl Aminomethane 1,1623%
EINECS: 201-064-4 Xi R36/37/38
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 443

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HBDH Reagent 1

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.
ENG
(Contd. on page 3)

Book 5 - Page 444

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HBDH Reagent 1

(Contd. of page 2)

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,09%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
(Contd. on page 4)
ENG

Book 5 - Page 445

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HBDH Reagent 1

(Contd. of page 3)
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 7,5
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: 100°C
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 96,0 %
· Other information No further relevant information available.

* 10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
77-86-1 Tris Hydroxymethyl Aminomethane
Oral LD50 5900 mg/kg (rat)
LDLo 1000 mg/kg (rabbit)
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
(Contd. on page 5)
ENG

Book 5 - Page 446

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HBDH Reagent 1

(Contd. of page 4)
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Generally not hazardous for water.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
(Contd. on page 6)
ENG

Book 5 - Page 447

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HBDH Reagent 1

(Contd. of page 5)
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R36/37/38 Irritating to eyes, respiratory system and skin.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 448

DR
Page 1/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: HBDH Reagent 2
· Article number: HBDH R2
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

* 3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria:
CAS: 77-86-1 Tris Hydroxymethyl Aminomethane 1,1386%
EINECS: 201-064-4 Xi R36/37/38
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
(Contd. on page 2)
ENG

Book 5 - Page 449

DR
Page 2/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HBDH Reagent 2

(Contd. of page 1)

· After skin contact:


Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
This product contains sodium azide, which is toxic and reactive. See Sections 10 and 13 for additional information that could
affect handling and disposal of contaminated spill materials.

NOTE FOR LARGE-VOLUME SPILL: This product contains sodium azide, which reacts with acid to liberate hydrazoic acid,
a very toxic gas. Select a disinfectant with the following properties if disinfection of materials used to absorb a large volume
of spilled product is required:

- Do not use any chemical or product with a pH below 6 to disinfect waste that contains sodium azide. Hydrazoic acid, a toxic
gas, will be released when the pH is lower than 6.
- Do not use any chemical or product that contains mercury or any other metal to disinfect waste that contains sodium azide.
This will create metal azide compounds, which can be highly explosive under pressure or shock (percussion).
- Select a disinfectant that does not bubble, effervesce or otherwise generate aerosols.
- Do not use excess disinfectant.
- Failure to follow manufacturer’s directions may lead to unexpected reactions with the waste.
- Do not use a disinfectant if you do not have the proper facility, equipment and other appropriate protective measures
available to work with it safely.
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.
ENG
(Contd. on page 3)

Book 5 - Page 450

DR
Page 3/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HBDH Reagent 2

(Contd. of page 2)

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

* 8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
26628-22-8 Sodium azide (0,09%)
WEL (Great Britain) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
(as NaN3) Sk
IOELV (European Union) Short-term value: 0,3 mg/m³
Long-term value: 0,1 mg/m³
Skin
· Additional information: The information is based on lists that were valid at the time of compilation.
· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: Liquid
(Contd. on page 4)
ENG

Book 5 - Page 451

DR
Page 4/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HBDH Reagent 2

(Contd. of page 3)
Colour: Colourless
· Odour: Odourless
· Odour threshold: Not determined.
· pH-value at 20°C: 10,4
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: 100°C
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
Water: 94,0 %
· Other information No further relevant information available.

* 10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions
This product contains sodium azide. Sodium azide solutions are reported to:
- react with acids to release hydrazoic acid, a very toxic gas. Higher quantities of hydrazoic acid are released as the solution
becomes more acidic (i.e., as the pH of the solution gets lower). Low quantities of hydrazoic acid can be released from sodium
azide in water.
- react with certain metals (copper, lead, silver, brass) to form explosive metal azide compounds. Violent explosions have
been reported during plumbing work on drain systems containing accumulations of azide on copper, lead, brass, or solder.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· LD/LC50 values that are relevant for classification:
· Components Type Value Species
77-86-1 Tris Hydroxymethyl Aminomethane
Oral LD50 5900 mg/kg (rat)
LDLo 1000 mg/kg (rabbit)
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
(Contd. on page 5)
ENG

Book 5 - Page 452

DR
Page 5/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HBDH Reagent 2

(Contd. of page 4)
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Generally not hazardous for water.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
Contains sodium azide. See Section 10 when considering how to appropriately dispose of unused product. For drain systems
with pipes or solder containing copper, lead, brass and/or silver, flush drains thoroughly with copious amounts of water to
prevent the formation of potentially explosive metal azides in plumbing. Detailed information about azides in drains is
available from the U.S. NIOSH Current Intelligence Bulletin No. 13 (August 16, 1976).
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180106: chemicals consisting of or containing dangerous substances
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
(Contd. on page 6)
ENG

Book 5 - Page 453

DR
Page 6/6
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HBDH Reagent 2

(Contd. of page 5)
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Relevant phrases
R36/37/38 Irritating to eyes, respiratory system and skin.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 454

DR
Release Date: 6/7/11

ADD List Number Product Name

3K28-10 SENTINEL HDL/LDL Calibrator

Components:
16203S HDL/LDL Calibrator

Book 5 - Page 455
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: HDL/LDL Calibrator
· Article number: 16203S
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
(Contd. on page 2)
ENG

Book 5 - Page 456

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HDL/LDL Calibrator

(Contd. of page 1)

· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
(Contd. on page 3)
ENG

Book 5 - Page 457

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HDL/LDL Calibrator

(Contd. of page 2)

· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: lyophilized
Liquid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
· Other information No further relevant information available.
ENG
(Contd. on page 4)

Book 5 - Page 458

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HDL/LDL Calibrator

(Contd. of page 3)

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
(Contd. on page 5)
ENG

Book 5 - Page 459

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: HDL/LDL Calibrator

(Contd. of page 4)
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 460

DR
Release Date: 6/7/11

ADD List Number Product Name

3K28-11 SENTINEL Lipids Controls

Components:
34Q021 Lipids Control 1-3

Book 5 - Page 461
Page 1/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

* 1 Identification of the substance/mixture and of the company/undertaking


· Product identifier
· Trade name: Lipids Control 1-3
· Article number: 34Q021
· Application of the substance / the preparation For In Vitro Diagnostic Use
· Details of the supplier of the safety data sheet
· Supplier:
Abbott GmbH & Co.KG
Max-Planck-Ring 2
65205 Wiesbaden Tel.:(+49)-6122-58-0

MSDS-support@Abbott.com
· Manufacturer:
SENTINEL CH. SpA
Via Robert Koch, 2
20152 MILANO
Italy
Tel: (++)39-23455 141
Fax: (++)39-234551464
· Emergency telephone number: (+49)-6122-58-0

* 2 Hazards identification
· Classification of the substance or mixture
· Classification according to Directive 67/548/EEC or Directive 1999/45/EC None
· Classification system:
The classification is in alignment with current EC (European Community) Directives. It incorporates information from
technical literature and information provided by supplier companies.
· Label elements
· Labelling according to EU guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Additional information: Not applicable.
· Other hazards
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.

3 Composition/information on ingredients
· Chemical characterization: Mixtures
· Dangerous components according to EC criteria: None
· Additional information For wording of the listed risk phrases, refer to Section 16.

* 4 First aid measures


· Description of first aid measures
· After inhalation
Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
In case of unconsciousness, bring patient onto stable side position for transport.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
(Contd. on page 2)
ENG

Book 5 - Page 462

DR
Page 2/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Lipids Control 1-3

(Contd. of page 1)

· After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult doctor.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for doctor:
· Indication of any immediate medical attention and special treatment needed No additional relevant information available.

* 5 Firefighting measures
· Extinguishing media
· Suitable extinguishing agents:
CO2, extinguishing powder or water jet. Fight larger fires with water jet or alcohol-resistant foam.
· Advice for firefighters
· Protective equipment:
Respiratory protection not normally required unless exposure limits for released components are exceeded.

* 6 Accidental release measures


· Personal precautions, protective equipment and emergency procedures See Section 8.
· Environmental precautions: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Clean the spill area carefully. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section 13 for
information that may impact disposal of materials contaminated with this product.
· Reference to other sections
See Section 7 for information on safe handling.
See Section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

* 7 Handling and storage


· Handling
· Precautions for safe handling No special precautions necessary if used correctly.
· Information about protection against explosions and fires: No special measures required.
· Conditions for safe storage, including any incompatibilities
· Storage:
· Requirements to be met by storerooms and containers:
Store only in the original container.
Refer to the package insert or product label for additional information on storage conditions.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions: Protect from heat and direct sunlight.
· Specific end use(s) No additional relevant information available.

8 Exposure controls/personal protection

· Control parameters
· Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the
workplace.
· Additional information: The information is based on lists that were valid at the time of compilation.
(Contd. on page 3)
ENG

Book 5 - Page 463

DR
Page 3/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Lipids Control 1-3

(Contd. of page 2)

· Exposure controls
· Personal protective equipment:
· Breathing equipment:
Not necessary if room is well ventilated.
Take precautions if chemical concentrations exceed the exposure limits (if any) listed above.
· Protection of hands:
Gloves protect the user against splashes. For safety reasons, they should be changed immediately after wetting.

This product is a preparation consisting of several substances. No specific information can be given regarding permeation
breakthrough time. The choice of suitable gloves depends not only on the material, but also on other quality features and must
be confirmed with the respective manufacturer. Per our knowledge, disposable gloves, e.g. made of nitriles, are suitable.

This recommendation is not intended to replace a suitability test, which is essential and must be performed under the
respective conditions of use.
· Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective clothing
required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties


· Information on basic physical and chemical properties
· Appearance:
Form: lyophilized
Liquid
Colour: White
· Odour: Odourless
· Odour threshold: Not determined.
· Change in condition
Melting point/Melting range: Not determined
Boiling point/Boiling range: Not determined
· Flash point: Not applicable
· Inflammability (solid, gaseous): Not applicable.
· Self-inflammability: Product is not self-igniting.
· Danger of explosion: Product is not explosive.
· Critical values for explosion:
Lower: Not determined.
Upper: Not determined.
· Density Not determined
· Relative density Not determined.
· Evaporation rate Not determined.
· Solubility in / Miscibility with
Water: Fully miscible
· Viscosity:
kinematic: Not determined.
· Other information No further relevant information available.
ENG
(Contd. on page 4)

Book 5 - Page 464

DR
Page 4/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Lipids Control 1-3

(Contd. of page 3)

10 Stability and reactivity


· Reactivity
· Chemical stability
· Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications.
· Possibility of hazardous reactions No dangerous reactions known.
· Conditions to avoid No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

* 11 Toxicological information
· Information on toxicological effects
· Acute toxicity:
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritant effect.
· Sensitisation: No sensitizing effect known.

12 Ecological information
· Toxicity
· Aquatic toxicity: No further relevant information available.
· Persistence and degradability No further relevant information available.
· Bioaccumulative potential No further relevant information available.
· Mobility in soil No further relevant information available.
· Additional ecological information:
· General notes: Do not allow undiluted product or large quantities of it to reach ground water, water bodies or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable.
· vPvB: Not applicable.
· Other adverse effects No further relevant information available.

* 13 Disposal considerations
· Waste treatment methods
There are no uniform EC regulations for the disposal of laboratory waste. In general laboratory waste is under the special
supervision of the authorities.
· General notes:
In general, laboratory waste is under special supervision of the authorities. Refer to applicable local regulations.
· European waste catalogue:
Consult the responsible regulatory body for the assignment of disposal codes according to the European Waste Catalogue.
· Following waste disposal key number are possible: 180107: chemicals other than those mentioned in 18 01 06
· Uncleaned packagings: There are no uniform EC regulations for the disposal of packaging as waste.
· Recommendation: Non contaminated packagings can be used for recycling.
· Recommended cleaning agent: Water, if necessary with cleaning agent.

* 14 Transport information
· Land transport ADR/RID (cross-border)
· ADR/RID-GGVS/E Class: -
· Remarks: Not restricted
· Maritime transport IMDG:
· IMDG Class: -
(Contd. on page 5)
ENG

Book 5 - Page 465

DR
Page 5/5
Safety data sheet
according to 1907/2006/EC, Article 31
Printing date 07.06.2011 Version number 2 Revision: 07.06.2011

Trade name: Lipids Control 1-3

(Contd. of page 4)
· Marine pollutant: No
· Air transport ICAO-TI and IATA-DGR:
· ICAO/IATA Class: -
· Remarks: Not restricted
· Special precautions for user Not applicable.
· Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable.

* 15 Regulatory information
· Safety, health and environmental regulations/legislation specific for the substance or mixture
· Designation according to EC guidelines:
Observe general safety regulations when handling chemicals.
The product is not subject to identification regulations under EC Directives.
· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

* 16 Other information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall not establish a legally valid contractual relationship.
· Contact supplier:
Environmental Affairs & Product Safety
Tel.: +49 (0) 6122 58 0
· Contact manufacturer: Telephone number of the company: (++)39-23455 141
ENG

Book 5 - Page 466

DR

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