SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

SECTION 1. IDENTIFICATION

Product name : ALB2

Product code : 03183688122

Manufacturer or supplier's details

Company name of supplier : Roche Diagnostics
-

Address : 9115 Hague Road

46250 Indianapolis IN
USA

Telephone : 1-800-428-5074
Emergency telephone
In case of emergencies: : CHEMTREC 1-800-424-9300 (U.S. or Ca-
nada)
1-703-527-3887 (Internatio-
nal)
Recommended use of the chemical and restrictions on use
Restrictions on use : For professional users only.

SECTION 2. HAZARDS IDENTIFICATION

GHS classification in accordance with 29 CFR 1910.1200

The product is a kit consisting of individual ingredients. The classification of the ingredients can
be obtained from section 3. Section Label elements contains the resulting labelling for the kit
GHS label elements
Not a hazardous substance or mixture.
Other hazards
None known.

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS

R1 (A / B)
GHS Classification
Not a hazardous substance or mixture.
Hazardous ingredients
Chemical name CAS-No. Concentration (% w/w)
Citric acid monohydrate 5949-29-1 >= 1 - < 5

R2 (C)

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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

GHS Classification
Not a hazardous substance or mixture.
Hazardous ingredients
Chemical name CAS-No. Concentration (% w/w)
Citric acid monohydrate 5949-29-1 >= 1 - < 5

SECTION 4. FIRST AID MEASURES

General advice : Do not leave the victim unattended.

If inhaled : Move to fresh air.

If unconscious, place in recovery position and seek medical
advice.
If symptoms persist, call a physician.

In case of skin contact : If on skin, rinse well with water.

In case of eye contact : Immediately flush eye(s) with plenty of water.

Remove contact lenses.
Protect unharmed eye.
If eye irritation persists, consult a specialist.

If swallowed : Keep respiratory tract clear.

Do not give milk or alcoholic beverages.
Never give anything by mouth to an unconscious person.
If symptoms persist, call a physician.
Rinse mouth with water.

Most important symptoms : No information available.

and effects, both acute and
delayed

Notes to physician : The first aid procedure should be established in consultation

with the doctor responsible for industrial medicine.

SECTION 5. FIRE-FIGHTING MEASURES

Suitable extinguishing media : Use extinguishing measures that are appropriate to local cir-
cumstances and the surrounding environment.

Specific hazards during fire : No information available.

fighting

Further information : Standard procedure for chemical fires.

Use extinguishing measures that are appropriate to local cir-
cumstances and the surrounding environment.

Special protective equipment : Wear self-contained breathing apparatus for firefighting if

for fire-fighters necessary.

SECTION 6. ACCIDENTAL RELEASE MEASURES

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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

Personal precautions, protec- : Refer to protective measures listed in sections 7 and 8.

tive equipment and emer-
gency procedures

Environmental precautions : Local authorities should be advised if significant spillages

cannot be contained.

Methods and materials for : Wipe up with absorbent material (e.g. cloth, fleece).
containment and cleaning up Keep in suitable, closed containers for disposal.

SECTION 7. HANDLING AND STORAGE

Advice on protection against : Normal measures for preventive fire protection.

fire and explosion

Advice on safe handling : For personal protection see section 8.

Smoking, eating and drinking should be prohibited in the ap-
plication area.

Conditions for safe storage : Electrical installations / working materials must comply with
the technological safety standards.

Technical : See label, package insert or internal guidelines

measures/Precautions

Materials to avoid : No materials to be especially mentioned.

Further information on stor- : No decomposition if stored and applied as directed.

age stability

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION

R1 (A / B)
Ingredients with workplace control parameters
Contains no substances with occupational exposure limit values.

R2 (C)
Ingredients with workplace control parameters
Contains no substances with occupational exposure limit values.

Engineering measures : No data available

Personal protective equipment

Respiratory protection : No personal respiratory protective equipment normally requi-
red.

Hand protection

Material : Protective gloves

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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

Remarks : Wear appropriate protective gloves to prevent skin contact.

Replace torn or punctured gloves promptly.
Eye protection : Safety glasses

Skin and body protection : Protective suit

Hygiene measures : Handle in accordance with good industrial hygiene and safety
practice.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES

R1 (A / B)
Appearance : liquid

Color : No data available

Odor : No data available

Odor Threshold : No data available

pH : No data available

Melting point/range : No data available

Boiling point/boiling range : No data available

Flash point : does not flash

Evaporation rate : No data available

Flammability (solid, gas) : The product is not flammable.

Flammability (liquids) : Does not sustain combustion.

Self-ignition : No data available

Upper explosion limit / Upper : No data available

flammability limit

Lower explosion limit / Lower : No data available

flammability limit

Vapor pressure : No data available

Relative vapor density : No data available

Relative density : No data available

Solubility(ies)
Water solubility : completely miscible

Solubility in other solvents : No data available

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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

Partition coefficient: n- : No data available

octanol/water

Autoignition temperature : No data available

Decomposition temperature : No data available

Viscosity
Viscosity, dynamic : No data available

Viscosity, kinematic : No data available

Oxidizing properties : The substance or mixture is not classified as oxidizing.

R2 (C)
Appearance : liquid

Color : No data available

Odor : No data available

Odor Threshold : No data available

pH : No data available

Melting point/range : No data available

Boiling point/boiling range : No data available

Flash point : does not flash

Evaporation rate : No data available

Flammability (solid, gas) : The product is not flammable.

Flammability (liquids) : Does not sustain combustion.

Self-ignition : No data available

Upper explosion limit / Upper : No data available

flammability limit

Lower explosion limit / Lower : No data available

flammability limit

Vapor pressure : No data available

Relative vapor density : No data available

Relative density : No data available

Solubility(ies)
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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

Water solubility : completely miscible

Solubility in other solvents : No data available

Partition coefficient: n- : No data available

octanol/water

Autoignition temperature : No data available

Decomposition temperature : No data available

Viscosity
Viscosity, dynamic : No data available

Viscosity, kinematic : No data available

Oxidizing properties : The substance or mixture is not classified as oxidizing.

SECTION 10. STABILITY AND REACTIVITY

Reactivity : No dangerous reaction known under conditions of normal use.

Chemical stability : Stable under normal conditions.

Possibility of hazardous reac- : Stable under recommended storage conditions.

tions No hazards to be specially mentioned.

Conditions to avoid : No data available

Incompatible materials : No data available

Hazardous decomposition : No data available

products

SECTION 11. TOXICOLOGICAL INFORMATION

R1 (A / B)
Acute toxicity
Not classified based on available information.
Ingredients:

Citric acid monohydrate:

Acute oral toxicity : LD50 Oral (Mouse): 5,400 mg/kg

LD50 Oral (Rat): 3,000 mg/kg

LD50 Oral (Rabbit): > 7,000 mg/kg

Skin corrosion/irritation
Not classified based on available information.

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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

Ingredients:

Citric acid monohydrate:

Remarks : Extremely corrosive and destructive to tissue.

Serious eye damage/eye irritation

Not classified based on available information.
Ingredients:

Citric acid monohydrate:

Result : Irritating to eyes.
Remarks : May cause irreversible eye damage.

Respiratory or skin sensitization

Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Ingredients:

Citric acid monohydrate:

Assessment : Did not cause sensitization on laboratory animals.

Germ cell mutagenicity

Not classified based on available information.
Carcinogenicity
Not classified based on available information.
IARC No ingredient of this product present at levels greater than or equal to 0.1% is
identified as probable, possible or confirmed human carcinogen by IARC.

OSHA No component of this product present at levels greater than or equal to 0.1% is
on OSHA’s list of regulated carcinogens.

NTP No ingredient of this product present at levels greater than or equal to 0.1% is
identified as a known or anticipated carcinogen by NTP.

Reproductive toxicity
Not classified based on available information.
STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Not classified based on available information.
Aspiration toxicity
Not classified based on available information.

R2 (C)

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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

Acute toxicity
Not classified based on available information.
Ingredients:

Citric acid monohydrate:

Acute oral toxicity : LD50 Oral (Mouse): 5,400 mg/kg

LD50 Oral (Rat): 3,000 mg/kg

LD50 Oral (Rabbit): > 7,000 mg/kg

Skin corrosion/irritation
Not classified based on available information.
Ingredients:

Citric acid monohydrate:

Remarks : Extremely corrosive and destructive to tissue.

Serious eye damage/eye irritation

Not classified based on available information.
Ingredients:

Citric acid monohydrate:

Result : Irritating to eyes.
Remarks : May cause irreversible eye damage.

Respiratory or skin sensitization

Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Ingredients:

Citric acid monohydrate:

Assessment : Did not cause sensitization on laboratory animals.

Germ cell mutagenicity

Not classified based on available information.
Carcinogenicity
Not classified based on available information.
IARC No ingredient of this product present at levels greater than or equal to 0.1% is
identified as probable, possible or confirmed human carcinogen by IARC.

OSHA No component of this product present at levels greater than or equal to 0.1% is
on OSHA’s list of regulated carcinogens.

NTP No ingredient of this product present at levels greater than or equal to 0.1% is
identified as a known or anticipated carcinogen by NTP.
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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

Reproductive toxicity
Not classified based on available information.
STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Not classified based on available information.
Aspiration toxicity
Not classified based on available information.

SECTION 12. ECOLOGICAL INFORMATION

R1 (A / B)
Ecotoxicity

Ingredients:

Citric acid monohydrate:

Toxicity to fish : LC0 (Carassius auratus (goldfish)): 625 mg/l

Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 120 mg/l
aquatic invertebrates Exposure time: 72 h

Ecotoxicology Assessment
Toxicity Data on Soil : Not expected to adsorb on soil.

Other organisms relevant to : No data available

the environment

Persistence and degradability

Ingredients:

Citric acid monohydrate:

Biodegradability : Remarks: Expected to be ultimately biodegradable

Bioaccumulative potential

Ingredients:

Citric acid monohydrate:

Partition coefficient: n- : log Pow: 1.72
octanol/water

Mobility in soil
No data available
Other adverse effects

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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

R2 (C)
Ecotoxicity

Ingredients:

Citric acid monohydrate:

Toxicity to fish : LC0 (Carassius auratus (goldfish)): 625 mg/l

Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 120 mg/l
aquatic invertebrates Exposure time: 72 h

Ecotoxicology Assessment
Toxicity Data on Soil : Not expected to adsorb on soil.

Other organisms relevant to : No data available

the environment

Persistence and degradability

Ingredients:

Citric acid monohydrate:

Biodegradability : Remarks: Expected to be ultimately biodegradable

Bioaccumulative potential

Ingredients:

Citric acid monohydrate:

Partition coefficient: n- : log Pow: 1.72
octanol/water

Mobility in soil
No data available
Other adverse effects

SECTION 13. DISPOSAL CONSIDERATIONS

Disposal methods
Waste from residues : Can be disposed as waste water, when in compliance with
local regulations.

Contaminated packaging : Empty containers should be taken to an approved waste

handling site for recycling or disposal.
Do not re-use empty containers.

SECTION 14. TRANSPORT INFORMATION

International Regulations
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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

UNRTDG
Not regulated as a dangerous good
IATA-DGR
Not regulated as a dangerous good
IMDG-Code
Not regulated as a dangerous good
Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Not applicable
Domestic regulation

49 CFR
Not regulated as a dangerous good

SECTION 15. REGULATORY INFORMATION

R1 (A / B)
EPCRA - Emergency Planning and Community Right-to-Know

CERCLA Reportable Quantity

This material does not contain any components with a CERCLA RQ.
SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.

SARA 302 Extremely Hazardous Substances Threshold Planning Quantity

This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards : No SARA Hazards

SARA 313 : This material does not contain any chemical components with
known CAS numbers that exceed the threshold (De Minimis)
reporting levels established by SARA Title III, Section 313.

Clean Air Act

This product neither contains, nor was manufactured with a Class I or Class II ODS as defined by
the U.S. Clean Air Act Section 602 (40 CFR 82, Subpt. A, App.A + B).
This product does not contain any hazardous air pollutants (HAP), as defined by the U.S. Clean
Air Act Section 112 (40 CFR 61).
This product does not contain any chemicals listed under the U.S. Clean Air Act Section 112(r) for
Accidental Release Prevention (40 CFR 68.130, Subpart F).
This product does not contain any chemicals listed under the U.S. Clean Air Act Section 111
SOCMI Intermediate or Final VOC's (40 CFR 60.489).
Clean Water Act
This product does not contain any Hazardous Substances listed under the U.S. CleanWater Act,
Section 311, Table 116.4A.
This product does not contain any Hazardous Chemicals listed under the U.S. CleanWater Act,
Section 311, Table 117.3.
This product does not contain any toxic pollutants listed under the U.S. Clean Water Act Section
307

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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

US State Regulations

Massachusetts Right To Know

No components are subject to the Massachusetts Right to Know Act.
Pennsylvania Right To Know
Water 7732-18-5
Maine Chemicals of High Concern
Product does not contain any listed chemicals
Vermont Chemicals of High Concern
Product does not contain any listed chemicals
Washington Chemicals of High Concern
Product does not contain any listed chemicals
California Prop. 65
This product does not contain any chemicals known to the State of California to cause cancer,
birth, or any other reproductive defects.
The ingredients of this product are reported in the following inventories:
DSL : This product contains the following components that are not
on the Canadian DSL nor NDSL.

hydroxyl-2-pyridone

AICS : Not in compliance with the inventory

NZIoC : Not in compliance with the inventory

ENCS : Not in compliance with the inventory

ISHL : Not in compliance with the inventory

KECI : Not in compliance with the inventory

PICCS : Not in compliance with the inventory

IECSC : Not in compliance with the inventory

TCSI : On the inventory, or in compliance with the inventory

TSCA : Not On TSCA Inventory

TSCA list
No substances are subject to a Significant New Use Rule.

No substances are subject to TSCA 12(b) export notification requirements.

R2 (C)

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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

EPCRA - Emergency Planning and Community Right-to-Know

CERCLA Reportable Quantity

This material does not contain any components with a CERCLA RQ.
SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.

SARA 302 Extremely Hazardous Substances Threshold Planning Quantity

This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards : No SARA Hazards

SARA 313 : This material does not contain any chemical components with
known CAS numbers that exceed the threshold (De Minimis)
reporting levels established by SARA Title III, Section 313.

Clean Air Act

This product neither contains, nor was manufactured with a Class I or Class II ODS as defined by
the U.S. Clean Air Act Section 602 (40 CFR 82, Subpt. A, App.A + B).
This product does not contain any hazardous air pollutants (HAP), as defined by the U.S. Clean
Air Act Section 112 (40 CFR 61).
This product does not contain any chemicals listed under the U.S. Clean Air Act Section 112(r) for
Accidental Release Prevention (40 CFR 68.130, Subpart F).
This product does not contain any chemicals listed under the U.S. Clean Air Act Section 111
SOCMI Intermediate or Final VOC's (40 CFR 60.489).
Clean Water Act
This product does not contain any Hazardous Substances listed under the U.S. CleanWater Act,
Section 311, Table 116.4A.
This product does not contain any Hazardous Chemicals listed under the U.S. CleanWater Act,
Section 311, Table 117.3.
This product does not contain any toxic pollutants listed under the U.S. Clean Water Act Section
307
US State Regulations

Massachusetts Right To Know

No components are subject to the Massachusetts Right to Know Act.
Pennsylvania Right To Know
Water 7732-18-5
Maine Chemicals of High Concern
Product does not contain any listed chemicals
Vermont Chemicals of High Concern
Product does not contain any listed chemicals
Washington Chemicals of High Concern
Product does not contain any listed chemicals
California Prop. 65
This product does not contain any chemicals known to the State of California to cause cancer,
birth, or any other reproductive defects.
The ingredients of this product are reported in the following inventories:

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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

DSL : This product contains the following components that are not
on the Canadian DSL nor NDSL.

hydroxyl-2-pyridone

AICS : Not in compliance with the inventory

NZIoC : Not in compliance with the inventory

ENCS : Not in compliance with the inventory

ISHL : Not in compliance with the inventory

KECI : Not in compliance with the inventory

PICCS : Not in compliance with the inventory

IECSC : Not in compliance with the inventory

TCSI : On the inventory, or in compliance with the inventory

TSCA : Not On TSCA Inventory

TSCA list
No substances are subject to a Significant New Use Rule.

No substances are subject to TSCA 12(b) export notification requirements.

R1 (A / B)
GHS label elements
Not a hazardous substance or mixture.
R2 (C)
GHS label elements
Not a hazardous substance or mixture.

SECTION 16. OTHER INFORMATION

Further information

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SAFETY DATA SHEET

ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

R1 (A / B)
NFPA: HMIS® IV:
Flammability
HEALTH / 0
0
FLAMMABILITY

Instability
0
Health

0 0
PHYSICAL HAZARD
0

HMIS® ratings are based on a 0-4 rating

scale, with 0 representing minimal haz-
ards or risks, and 4 representing signifi-
Special hazard.
cant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

R2 (C)
NFPA: HMIS® IV:
Flammability
HEALTH / 0
0
FLAMMABILITY
Instability

0
Health

0 0
PHYSICAL HAZARD
0

HMIS® ratings are based on a 0-4 rating

scale, with 0 representing minimal haz-
ards or risks, and 4 representing signifi-
Special hazard.
cant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

Full text of other abbreviations

AICS - Australian Inventory of Chemical Substances; ASTM - American Society for the Testing of
Materials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,
and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the
German Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Sub-
stances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Haz-
ardous Substance; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized Sys-
tem; GLP - Good Laboratory Practice; HMIS - Hazardous Materials Identification System; IARC -
International Agency for Research on Cancer; IATA - International Air Transport Association; IBC
- International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals
in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organiza-
tion; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime

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ALB2
Version Revision Date: Date of last issue: 06-15-2018
1.4 08-01-2018 Date of first issue: 11-09-2015

Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health
Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemi-
cals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to
50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Pre-
vention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Oth-
erwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory of
Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office
of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic sub-
stance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quanti-
tative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;
REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concern-
ing the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amend-
ments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance
Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG -
United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent
and Very Bioaccumulative

Revision Date : 08-01-2018

The information provided in this Material Safety Data Sheet is correct to the best of our
knowledge, information and belief at the date of its publication. The information given is designed
only as a guidance for safe handling, use, processing, storage, transportation, disposal and re-
lease and is not to be considered a warranty or quality specification. The information relates only
to the specific material designated and may not be valid for such material used in combination
with any other materials or in any process, unless specified in the text.

US / Z8 / 1711

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