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Material Safety Data Sheet

NIPAGIN M Page 1

Substance key: 000000051881 Revision Date: 09.03.2018


Version : 1 - 11 / RI Date of printing : 24.12.2019

1. PRODUCT AND COMPANY IDENTIFICATION

Trade name
NIPAGIN M
Material number: 166901

EC-No.: 202-785-7

Recommended use:
Industry sector : Personal Care
Type of use : Personal Care Preservatives
Supplier name/address/telephone no.:
Clariant Produkte (Deutschland) GmbH

Frankfurt am Main 65926, Germany


Telephone : +49 69 305 18000
Information about the substance/preparation
Product Safety : BU Industrial & Consumer Specialties
Product Stewardship
e-mail: SDS.Europe@clariant.com
Emergency telephone number: 00800-5121 5121

2. HAZARDS IDENTIFICATION

GHS Classification
Chronic aquatic toxicity : Category 3

GHS label elements


Hazard pictograms : None

Signal word : None

Hazard statements : H412 Harmful to aquatic life with long lasting effects.

Precautionary statements :
Prevention:
P273 Avoid release to the environment.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Other hazards which do not result in classification


No additional hazards are known except those derived from the labelling.

3. COMPOSITION/INFORMATION ON INGREDIENTS

Substance / Mixture : Substance

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Material Safety Data Sheet

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Substance key: 000000051881 Revision Date: 09.03.2018


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Chemical nature :

Substance name : methyl-4-hydroxybenzoate

CAS-No. : Not Assigned

Hazardous components
Chemical name CAS-No. Concentration (% w/w)
Methyl-4-hydroxy benzoate 99-76-3 >= 60 -<= 100

4. FIRST AID MEASURES

General advice : Remove/Take off immediately all contaminated clothing.


Get medical advice/ attention if you feel unwell.

If inhaled : Remove to fresh air.

In case of skin contact : In case of contact, immediately flush skin with soap and plenty
of water.

In case of eye contact : Rinse immediately with plenty of water, also under the eyelids,
for at least 15 minutes.
Consult a physician.

If swallowed : Rinse mouth with water.


If conscious, give the victim plenty of water to drink.
Get medical advice/ attention.

Most important symptoms : Treat symptomatically.


and effects, both acute and No additional risks are known.
delayed

Notes to physician : Treat symptomatically.

5. FIREFIGHTING MEASURES

Suitable extinguishing media : Water spray jet


Alcohol-resistant foam

Unsuitable extinguishing : High volume water jet


media Carbon dioxide (CO2)
Dry powder

Specific hazards during : In case of fires, hazardous combustion gases are formed:
firefighting Carbon monoxide (CO)
Carbon dioxide (CO2)

Specific extinguishing : Wear full protective clothing and self-contained breathing


methods apparatus.

Special protective equipment : Self-contained breathing apparatus

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Material Safety Data Sheet

NIPAGIN M Page 3

Substance key: 000000051881 Revision Date: 09.03.2018


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for firefighters Full protective suit

6. ACCIDENTAL RELEASE MEASURES

Personal precautions, : Wear suitable protective clothing.


protective equipment and Ensure adequate ventilation.
emergency procedures Avoid dust formation.
Avoid contact with skin and eyes.

Environmental precautions : If the product contaminates rivers and lakes or drains inform
respective authorities.
Do not empty into drains.

Methods and materials for : Keep in suitable, closed containers for disposal.
containment and cleaning up Take up mechanically

7. HANDLING AND STORAGE

Advice on protection against : Dust can form an explosive mixture in air.


fire and explosion Take measures to prevent the build up of electrostatic charge.
Keep away sources of ignition.
Keep away from heat.

Advice on safe handling : Avoid dust formation.


Avoid dust accumulation in enclosed space.
Provide adequate ventilation.

Conditions for safe storage : Keep only in the original container.


Keep container tightly closed.
Keep container tightly closed in a dry and well-ventilated
place.

Technical : Keep containers tightly closed in a dry, cool and well-


measures/Precautions ventilated place.

Materials to avoid : not required

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Components with workplace control parameters


Contains no substances with occupational exposure limit values.
Personal protective equipment
Respiratory protection : Use respiratory protection in case of insufficient exhaust
ventilation or prolonged exposure

Hand protection
Remarks : Protective gloves complying with EN 374. Minimum thickness

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Material Safety Data Sheet

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Substance key: 000000051881 Revision Date: 09.03.2018


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(glove): not determined With solid dry substances permeation


is not to be expected, therefore the breakthrough-time for this
protective glove has not been measured.

These types of protective gloves are offered by various


manufacturers. Please note the manufacturers´ detailed
statements, especially about the minimum thickness and the
minimum breakthrough time. Consider also the particular
working conditions under which the gloves are being used.

Eye protection : Safety glasses

Skin and body protection : Wear suitable protective clothing.

Protective measures : Avoid contact with skin and eyes.


Do not breathe dust.

Hygiene measures : Use only in well-ventilated areas.


Take off immediately all contaminated clothing.

9. PHYSICAL AND CHEMICAL PROPERTIES

Appearance : Crystalline powder

Colour : white

Odour : odourless

Odour Threshold : not tested.

pH : 7 (20 °C)
Concentration: 1 g/l

Melting point : 125 °C


Method: OECD Test Guideline 102

Boiling point (decomposition) : approx. 270 - 280 °C


(1.013 hPa)
Decomposition: yes

Flash point : Not applicable

Evaporation rate : Not applicable

Self-ignition : Method: EC A.16


The substance or mixture is not classified as self heating.

Burning number : 1
Does not catch fire

Upper explosion limit / upper : Not applicable


flammability limit

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Material Safety Data Sheet

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Substance key: 000000051881 Revision Date: 09.03.2018


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Lower explosion limit / Lower : Not applicable


flammability limit

Vapour pressure : 0,000028 Pa (20 °C)


Method: OECD Test Guideline 104

Relative vapour density : Not applicable

Relative density : not tested.

Density : 1,3775 g/cm3


Method: OECD Test Guideline 109

Bulk density : approx. 880 kg/m3

Solubility(ies)
Water solubility : approx. 1,88 g/l (20 °C)
Method: OECD Test Guideline 105

Partition coefficient: n- : log Pow: 1,98


octanol/water Method: OECD Test Guideline 107

Auto-ignition temperature : not tested.

Decomposition temperature : > 270 - 280 °C


Heating rate: 3 K/min
Decomposition energy (mass): 499 kJ/kg
Method: DSC
No decomposition if used as directed.

Viscosity
Viscosity, dynamic : Not applicable

Explosive properties : Not explosive


Method: Expert judgement

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


Method: Tested according to Directive 92/69/EEC.

Surface tension : Based on chemical structure, no surface activity is expected


or can be predicted.

Sublimation point : not determined

Dust deflagration index (Kst) : 197 m.b_/s

Dust explosion class : ST1 Capable of dust explosion

Minimum ignition energy : 3 - 5 mJ (590 °C)

Particle size : 110 - 150 µm


Median value

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Substance key: 000000051881 Revision Date: 09.03.2018


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10. STABILITY AND REACTIVITY

Reactivity : See section 10.3. "Possibility of hazardous reactions"

Chemical stability : Stable under normal conditions.

Possibility of hazardous : No dangerous reaction known under conditions of normal use.


reactions Stable

Conditions to avoid : not known

Incompatible materials : not known

Hazardous decomposition : When handled and stored appropriately, no dangerous


products decomposition products are known

11. TOXICOLOGICAL INFORMATION

Acute toxicity
Product:
Acute oral toxicity : LD50 (Rat, male): 2.100 mg/kg
Method: OECD Test Guideline 401

Acute inhalation toxicity : Remarks: no data available

Acute dermal toxicity : Remarks: no data available

Components:
Methyl-4-hydroxy benzoate:
Acute oral toxicity : LD50 (Rat, male): 2.100 mg/kg
Method: OECD Test Guideline 401

Acute inhalation toxicity : Remarks: no data available

Acute dermal toxicity : Remarks: no data available

Skin corrosion/irritation
Product:
Species : Rabbit
Method : Other
Result : No skin irritation

Components:
Methyl-4-hydroxy benzoate:
Species : Rabbit
Method : Other

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Substance key: 000000051881 Revision Date: 09.03.2018


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Result : No skin irritation

Serious eye damage/eye irritation


Product:
Species : Rabbit
Result : No eye irritation
Method : Other

Components:
Methyl-4-hydroxy benzoate:
Species : Rabbit
Result : No eye irritation
Method : Other

Respiratory or skin sensitisation


Product:
Test Type : Maurer optimisation test
Species : Guinea pig
Method : OECD Test Guideline 406
Result : Not a skin sensitizer.

Components:
Methyl-4-hydroxy benzoate:
Test Type : Maurer optimisation test
Species : Guinea pig
Method : OECD Test Guideline 406
Result : Not a skin sensitizer.

Germ cell mutagenicity


Product:
Genotoxicity in vitro : Test Type: Ames test
Test system: Salmonella typhimurium
Metabolic activation: with and without metabolic activation
Method: OECD Test Guideline 471
Result: negative

Test Type: Chromosome aberration test in vitro


Test system: Chinese hamster lung cells
Concentration: 125 μg/mL
Metabolic activation: with and without metabolic activation
Method: OECD Test Guideline 473
Result: negative

Genotoxicity in vivo : Test Type: Dominant lethal assay


Species: Rat (male)
Strain: Sprague-Dawley
Application Route: oral (gavage)

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Substance key: 000000051881 Revision Date: 09.03.2018


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Dose: 5, 50, 500 mg/kg/bw


Method: OECD Test Guideline 478
Result: negative

Germ cell mutagenicity - : In vitro tests did not show mutagenic effects
Assessment

Components:
Methyl-4-hydroxy benzoate:
Genotoxicity in vitro : Test Type: Ames test
Test system: Salmonella typhimurium
Metabolic activation: with and without metabolic activation
Method: OECD Test Guideline 471
Result: negative

Test Type: Chromosome aberration test in vitro


Test system: Chinese hamster lung cells
Concentration: 125 μg/mL
Metabolic activation: with and without metabolic activation
Method: OECD Test Guideline 473
Result: negative

Genotoxicity in vivo : Test Type: Dominant lethal assay


Species: Rat (male)
Strain: Sprague-Dawley
Application Route: oral (gavage)
Dose: 5, 50, 500 mg/kg/bw
Method: OECD Test Guideline 478
Result: negative

Germ cell mutagenicity - : In vitro tests did not show mutagenic effects
Assessment

Carcinogenicity
Product:
Species : Rat, male and female
Exposure time : 52 weeks
Frequency of Treatment : twice weekly
: 3,5 mg/kg bw/day
Method : Other
Result : negative

Species : Mouse, male and female


: 2,5 mg/kg body weight
Method : Other
Result : negative

Carcinogenicity - : Not classifiable as a human carcinogen.


Assessment

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Substance key: 000000051881 Revision Date: 09.03.2018


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Components:
Methyl-4-hydroxy benzoate:
Species : Rat, male and female
Exposure time : 52 weeks
Frequency of Treatment : twice weekly
: 3,5 mg/kg bw/day
Method : Other
Result : negative

Species : Mouse, male and female


: 2,5 mg/kg body weight
Method : Other
Result : negative

Carcinogenicity - : Not classifiable as a human carcinogen.


Assessment

Reproductive toxicity
Product:
Effects on fertility : Test Type: Fertility
Species: Rat, male
Application Route: oral (feed)
Dose: 100, 1000, 10000 ppm
General Toxicity - Parent: NOAEL: 1.000 ppm
Method: Other

Effects on foetal : Test Type: reproductive and developmental toxicity study


development Species: Rat
Strain: wistar
Application Route: Oral
Developmental Toxicity: NOAEL: 550 mg/kg body weight
Method: OECD Test Guideline 414

Reproductive toxicity - : No evidence of adverse effects on sexual function and fertility,


Assessment or on development, based on animal experiments.

Components:
Methyl-4-hydroxy benzoate:
Effects on fertility : Test Type: Fertility
Species: Rat, male
Application Route: oral (feed)
Dose: 100, 1000, 10000 ppm
General Toxicity - Parent: NOAEL: 1.000 ppm
Method: Other

Effects on foetal : Test Type: reproductive and developmental toxicity study


development Species: Rat
Strain: wistar
Application Route: Oral
Developmental Toxicity: NOAEL: 550 mg/kg body weight

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Substance key: 000000051881 Revision Date: 09.03.2018


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Method: OECD Test Guideline 414

Reproductive toxicity - : No evidence of adverse effects on sexual function and fertility,


Assessment or on development, based on animal experiments.

STOT - single exposure


Product:
Remarks : not tested.

Components:
Methyl-4-hydroxy benzoate:
Remarks : no data available

STOT - repeated exposure


Product:
Remarks : not tested.

Components:
Methyl-4-hydroxy benzoate:
Remarks : no data available

Repeated dose toxicity


Product:
Species : Rat, male and female
NOAEL : >= 250 mg/kg
Application Route : oral (gavage)
Exposure time : 28 d
Number of exposures : daily
Dose : 50, 250, 1000 mg/kg/day
Method : Other

Components:
Methyl-4-hydroxy benzoate:
Species : Rat, male and female
NOAEL : >= 250 mg/kg
Application Route : oral (gavage)
Exposure time : 28 d
Number of exposures : daily
Dose : 50, 250, 1000 mg/kg/day
Method : Other

Aspiration toxicity
Product:
no data available

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Material Safety Data Sheet

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Substance key: 000000051881 Revision Date: 09.03.2018


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Components:
Methyl-4-hydroxy benzoate:
no data available

Further information
Product:
Remarks : Inhalation of dust causes slight irritation of the respiratory
tract.

12. ECOLOGICAL INFORMATION

Ecotoxicity
Product:
Toxicity to fish : LC50 (Oryzias latipes (Orange-red killifish)): 59,5 mg/l
Exposure time: 96 h
Test Type: semi-static test
Method: OECD Test Guideline 203

Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 11,2 mg/l
aquatic invertebrates Exposure time: 48 h
Test Type: static test
Method: ISO 6341

Toxicity to algae : EC50 (Pseudokirchneriella subcapitata (algae)): 91 mg/l


End point: Growth rate
Exposure time: 72 h
Test Type: static test
Method: ISO 8692

Toxicity to fish (Chronic : Remarks: no data available


toxicity)

Toxicity to daphnia and other : NOEC (Daphnia magna (Water flea)): 0,2 mg/l
aquatic invertebrates End point: Reproduction rate
(Chronic toxicity) Exposure time: 21 d
Test Type: semi-static test
Method: OECD Test Guideline 211

Toxicity to microorganisms : Remarks: not tested.

Toxicity to soil dwelling : Remarks: not tested.


organisms

Plant toxicity : Remarks: not tested.

Toxicity to terrestrial : Remarks: not tested.


organisms

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Ecotoxicology Assessment
Chronic aquatic toxicity : Harmful to aquatic life with long lasting effects.

Components:
Methyl-4-hydroxy benzoate:
Toxicity to fish : LC50 (Oryzias latipes (Orange-red killifish)): 59,5 mg/l
Exposure time: 96 h
Test Type: semi-static test
Method: OECD Test Guideline 203

Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 11,2 mg/l
aquatic invertebrates Exposure time: 48 h
Test Type: static test
Method: ISO 6341

Toxicity to algae : EC50 (Pseudokirchneriella subcapitata (algae)): 91 mg/l


End point: Growth rate
Exposure time: 72 h
Test Type: static test
Method: ISO 8692

Toxicity to fish (Chronic : Remarks: no data available


toxicity)

Toxicity to daphnia and other : NOEC (Daphnia magna (Water flea)): 0,2 mg/l
aquatic invertebrates End point: Reproduction rate
(Chronic toxicity) Exposure time: 21 d
Test Type: semi-static test
Method: OECD Test Guideline 211

Ecotoxicology Assessment
Chronic aquatic toxicity : Harmful to aquatic life with long lasting effects.

Persistence and degradability


Product:
Biodegradability : Biodegradation: 89 % (CO2 formation in % of theoretical
value)
Exposure time: 28 d
Method: OECD Test Guideline 301B
Remarks: Readily biodegradable, according to appropriate
OECD test.

Biochemical Oxygen : Remarks: not available


Demand (BOD)

Chemical Oxygen Demand : Remarks: not available


(COD)

Dissolved organic carbon : Remarks: not available


(DOC)

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Physico-chemical : Remarks: not tested.


removability

Photodegradation : Remarks: not tested.

Components:
Methyl-4-hydroxy benzoate:
Biodegradability : Inoculum: activated sludge, domestic, non-adapted
Carbon dioxide (CO2)
Result: Readily biodegradable.
Biodegradation: 89 %
Exposure time: 28 d
Method: OECD Test Guideline 301B

Bioaccumulative potential
Product:
Bioaccumulation : Remarks: Due to the low logPow bioaccumulation is not
expected

Components:
Methyl-4-hydroxy benzoate:
Bioaccumulation : Remarks: Due to the distribution coefficient n-octanol/water,
accumulation in organisms is not expected.

Partition coefficient: n- : log Pow: 1,98 (20 °C)


octanol/water Method: Other

Mobility in soil
Product:
Distribution among : Remarks: Based upon the calculated log Koc, adsorption to
environmental compartments the soil phase is not expected.

Components:
Methyl-4-hydroxy benzoate:
Distribution among : Koc: 280
environmental compartments
Method: estimated

Other adverse effects


Product:
Environmental fate and : Remarks: Due to the distribution coefficient n-octanol/water,
pathways accumulation in organisms is not expected.

Additional ecological : The product should not be allowed to enter drains, water
information courses or the soil.

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Components:
Methyl-4-hydroxy benzoate:
Results of PBT and vPvB : The substance is not identified as a PBT or as a vPvB
assessment substance.

13. DISPOSAL CONSIDERATIONS

Disposal methods
Waste from residues : In accordance with regulations for hazardous waste, must be
taken to a hazardous waste disposal site

Contaminated packaging : Regulations concerning reuse or disposal of used packaging


materials must be observed.

14. TRANSPORT INFORMATION

IATA not restricted


IMDG not restricted

15. REGULATORY INFORMATION

Safety, health and environmental regulations/legislation specific for the substance or


mixture
Apart from the data/regulations specified in this chapter, no further information is available
concerning safety, health and environmental protection.

Minister of Industry Regulation No. 23/M-IND/PER/4/2013 concerning the Revision of


Minister of Industry Regulation No. 87/M-IND/PER/9/2009 concerning Globally Harmonized
System of Classification and Labelling of Chemicals.
Regulation of the Minister of Health No. 472 of 1996 on the Safeguarding of Substances
Hazardous to Health
Hazardous substances that must be registered : Not applicable

Government Regulation No. 74 of 2001 on the Management of Hazardous and Toxic


Substances
Hazardous substances approved for use : Not applicable

Prohibited substances : Not applicable

Restricted substances : Not applicable

Regulation of the Minister of Trade No. 44 of 2009 on Procurement, Distribution and


Supervision of Hazardous Materials
Types of Hazardous Materials governed by Import : Not applicable
Regulations

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Types of Hazardous Materials of which the Distribution : Not applicable


and Supervision is Regulated

16. OTHER INFORMATION

Further information
Other information : Observe national and local legal requirements

Date format : yyyy/mm/dd

Full text of other abbreviations

AICS - Australian Inventory of Chemical Substances; ANTT - National Agency for Transport by
Land of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR -
Carcinogen, Mutagen or Reproductive Toxicant; CPR - Controlled Products Regulations; DIN -
Standard of the German Institute for Standardisation; DSL - Domestic Substances List (Canada);
ECx - Concentration associated with x% response; 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 System; GLP - Good Laboratory Practice; 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
Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International
Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety
and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea
Existing Chemicals 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 Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified; Nch -
Chilean Norm; NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed
(Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NOM - Official Mexican
Norm; 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 substance; PICCS -
Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure
Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European Parliament and of
the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals;
SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan
Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; 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; WHMIS - Workplace Hazardous Materials Information System

This information corresponds to the present state of our knowledge and is intended as a general
description of our products and their possible applications. Clariant makes no warranties, express
or implied, as to the information's accuracy, adequacy, sufficiency or freedom from defect and
assumes no liability in connection with any use of this information. Any user of this product is
responsible for determining the suitability of Clariant's products for its particular application.
Nothing included in this information waives any of Clariant's General Terms and Conditions of

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Sale, which control unless it agrees otherwise in writing. Any existing intellectual/industrial
property rights must be observed. Due to possible changes in our products and applicable
national and international regulations and laws, the status of our products could change. Material
Safety Data Sheets providing safety precautions, that should be observed when handling or
storing Clariant products, are available upon request and are provided in compliance with
applicable law. You should obtain and review the applicable Material Safety Data Sheet
information before handling any of these products. For additional information, please contact
Clariant.

ID / EN

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