SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
1601090-00014

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Mianserin Formulation

Supplier's company name, address and phone number
Company name of supplier: Organon & Co.
Address:

30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302

Telephone:+1-551-430-6000

E-mail address:

EHSSTEWARD@organon.com

Emergency telephone number :+1-215-631-6999

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable

2. HAZARDS IDENTIFICATIONGHS classification of chemical productReproductive toxicity: Category 2
Specific target organ toxicity single exposure:

Category 1 (Central nervous system)

GHS label elements
Hazard pictograms:

Signal word:

DangerHazard statements:

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child.
H370 Causes damage to organs (Central nervous system).

Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe dust/ fume/ gas/ mist/ vapours/ spray.
P264 Wash skin thoroughly after handling.
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SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
1601090-00014

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response:
P308 + P311 IF exposed or concerned: Call a POISONCENTER/ doctor.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.
Other hazards which do not result in classification
None known.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical nameStarchCAS-No.
9005-25-8

Concentration (% w/w)>= 10 - < 20mianserin hydrochloride

21535-47-7>= 10 - < 20

ENCS No.
8-98

4. FIRST AID MEASURES
General advice:

If inhaled:

In case of skin contact:

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayedProtection of first-aiders::

In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
If inhaled, remove to fresh air.
Get medical attention.
In case of contact, immediately flush skin with soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Never give anything by mouth to an unconscious person.
Suspected of damaging fertility. Suspected of damaging theunborn child.
Causes damage to organs.
First Aid responders should pay attention to self-protection,
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SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

Notes to physician

SDS Number:
1601090-00014:

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

5. FIREFIGHTING MEASURES
Suitable extinguishing media:

Unsuitable extinguishingmedia
Specific hazards during firefighting
Hazardous combustion products:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical
None known.

:

Exposure to combustion products may be a hazard to health.

:

Carbon oxides
Metal oxides
Oxides of phosphorus
Silicon oxides

Specific extinguishing methods:

Special protective equipment
for firefighters:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protec- :tive equipment and emergency procedures

Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).

Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials forcontainment and cleaning up:

Surround spill with absorbents and place a damp coveringover the area to minimise entry of the material into the air.
Add excess liquid to allow the material to enter into solution.
Soak up with inert absorbent material.
Clean up remaining materials from spill with suitable absorbent.
Local or national regulations may apply to releases and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.
3 / 15

SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
1601090-00014

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

7. HANDLING AND STORAGE
Handling
Technical measures:

Local/Total ventilation
Advice on safe handling::

Avoidance of contact
Hygiene measures::

Storage
Conditions for safe storage:

Materials to avoid:

Packaging material:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
Use only with adequate ventilation.
Do not breathe dust, fume, gas, mist, vapours or spray.
Do not swallow.
Avoid contact with eyes.
Avoid prolonged or repeated contact with skin.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
Oxidizing agents
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working
place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
Keep in properly labelled containers.
Store locked up.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Unsuitable material: None known.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Threshold limit value and permissible exposure limits for each component in the work environment
Components

CAS-No.

mianserin hydrochloride

21535-47-7
TWA
Further information: Skin
Wipe limit
9005-25-8
TWA

StarchEngineering measures:

Value type
(Form ofexposure)

Control parameters / Reference
concentration /Permissible concentration
20 µg/m3 (OEB 3)

Basis

200 µg/100 cm²
10 mg/m3

Internal
ACGIH

Internal

Ensure adequate ventilation, especially in confined areas.
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SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
1601090-00014

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

Minimize workplace exposure concentrations.
Personal protective equipment
Respiratory protection: If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Filter type
: Particulates type
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Eye protection:

Skin and body protection:

Choose gloves to protect hands against chemicals dependingon the concentration and quantity of the hazardous substance and specific to place of work. Breakthrough time is notdetermined for the product. Change gloves often! For special
applications, we recommend clarifying the resistance tochemicals of the aforementioned protective gloves with theglove manufacturer. Wash hands before breaks and at theend of workday.
Wear the following personal protective equipment:
Safety glasses
Select appropriate protective clothing based on chemical
resistance data and an assessment of the local exposure
potential.
Skin contact must be avoided by using impervious protective
clothing (gloves, aprons, boots, etc).

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:

Crystalline solid

Colour:white to off-white

Odour

:

No data available

Odour Threshold:

No data available

Melting point/freezing point:

No data available

Boiling point, initial boilingpoint and boiling range:

No data available

Flammability (solid, gas):

Not classified as a flammability hazard

Flammability (liquids):

No data available

Lower explosion limit and upper explosion limit / flammability limit
Upper explosion limit / Up- : No data available
per flammability limit
Lower explosion limit /Lower flammability limit:

No data available

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SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
1601090-00014

Flash point:

Not applicable

Decomposition temperature:

No data available

pH:

No data available

Evaporation rate:

No data available

Auto-ignition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water:

No data available

Vapour pressure:

No data available

Density and / or relative density
Relative density:

No data available

Density

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01:

No data available

Relative vapour density:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:Not applicable

Particle characteristics
Particle size:

No data available:::

Not classified as a reactivity hazard.
Stable under normal conditions.
Can react with strong oxidizing agents.

:::

None known.
Oxidizing agents
No hazardous decomposition products are known.

10. STABILITY AND REACTIVITY
Reactivity
Chemical stability
Possibility of hazardous reactions
Conditions to avoid
Incompatible materials
Hazardous decomposition
products

11. TOXICOLOGICAL INFORMATION
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SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
1601090-00014

Information on likely routes of :exposure

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Product:
Acute oral toxicity:

Acute toxicity estimate: > 2,000 mg/kg
Method: Calculation method

Starch:Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg

mianserin hydrochloride:
Acute oral toxicity:

LD50 (Rat): 780 mg/kg

Components:

LD50 (Mouse): 224 mg/kg
Acute toxicity (other routes of :administration)

LD50 (Mouse): 32 mg/kg
Application Route: Intravenous

Skin corrosion/irritation
Not classified based on available information.
Components:
mianserin hydrochloride:
Remarks:

Not classified due to lack of data.

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Starch:SpeciesResult::RabbitNo eye irritationmianserin hydrochloride:
Remarks:

Not classified due to lack of data.

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SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
1601090-00014

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Components:
Starch:Test Type
Exposure routes
SpeciesResult::::Maximisation Test
Skin contact
Guinea pig
negativemianserin hydrochloride:
Remarks:

Not classified due to lack of data.

Germ cell mutagenicity
Not classified based on available information.
Components:
Starch:Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negativemianserin hydrochloride:
Genotoxicity in vitro:

Test Type: gene mutation test
Result: positive
Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Remarks: Based on data from similar materials
Test Type: sister chromatid exchange assay
Result: negative
Remarks: Based on data from similar materials
Test Type: In vitro mammalian cell gene mutation test
Result: negative
Remarks: Based on data from similar materials
Test Type: unscheduled DNA synthesis assay
Result: negative
Remarks: Based on data from similar materials

Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Rat
Cell type: Bone marrow
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SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
1601090-00014

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

Application Route: Oral
Result: negative
Remarks: Based on data from similar materials
Carcinogenicity
Not classified based on available information.
Components:
mianserin hydrochloride:
Remarks:

Not classified due to lack of data.

Reproductive toxicity
Suspected of damaging fertility. Suspected of damaging the unborn child.
Components:
mianserin hydrochloride:
Effects on fertility:

Test Type: Fertility
Species: Rat, maleFertility: NOAEL: 100 mg/kg body weight
Result: No effects on fertility, No effects on mating performance
Test Type: Fertility
Species: Rat, female
Fertility: LOAEL: 30 mg/kg body weight
Result: Preimplantation loss, ovarian dysfunction, Effect on
estrous cycle

Effects on foetal development:

Test Type: Development
Species: Rat
Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 10 mg/kg body weight
Result: Effects on postnatal development
Test Type: Development
Species: Rat
Developmental Toxicity: LOAEL: 3 mg/kg body weight
Result: Embryolethal effects, No teratogenic effects
Test Type: Development
Species: Rabbit
Result: Reduced foetal weight, No teratogenic effects
Test Type: Development
Species: Mouse
Developmental Toxicity: NOAEL: 30 mg/kg body weight
Result: No effects on foetal development

Reproductive toxicity - Assessment:

Suspected of damaging fertility. Suspected of damaging theunborn child.
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SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
1601090-00014

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

STOT - single exposure
Causes damage to organs (Central nervous system).
Components:
mianserin hydrochloride:
Target Organs
Assessment::

Central nervous system
Causes damage to organs.

STOT - repeated exposure
Not classified based on available information.
Repeated dose toxicity
Components:
Starch:Species
NOAEL
Application RouteExposure time
Method

:
:
:
:
:

Rat
>= 2,000 mg/kg
Skin contact
28 Days
OECD Test Guideline 410

mianserin hydrochloride:
Species
NOAEL
Application RouteExposure time
Remarks

:
:
:
:
:

Rat
30 mg/kg
Oral
6 Months
No significant adverse effects were reported

Species
LOAEL
Application RouteExposure time
Symptoms

:
:
:
:
:

Dog
3 - 30 mg/kg
Oral
6 Months
Reduced body weightAspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
mianserin hydrochloride:
Inhalation:

Remarks: May be harmful if inhaled.
May cause irritation of respiratory tract.

Skin contact:

Remarks: Can be absorbed through skin.
May irritate skin.

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SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
1601090-00014

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

Eye contact:

Remarks: May irritate eyes.

Ingestion:

Symptoms: central nervous system effects, dry mouth, constipation, Headache, Tremors

12. ECOLOGICAL INFORMATION
Ecotoxicity
No data available
Persistence and degradability
No data available
Bioaccumulative potential
Components:
mianserin hydrochloride:
Partition coefficient: noctanol/water:log Pow: 3.36

Mobility in soil
No data available
Hazardous to the ozone layer
Not applicable
Other adverse effects
No data available
13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable
no14. TRANSPORT INFORMATIONInternational Regulations
UNRTDGUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEnvironmentally hazardous

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SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

IATA-DGR
UN/ID No.
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN number
Proper shipping nameClass
Subsidiary risk
Packing group
LabelsEmS Code
Marine pollutant

SDS Number:
1601090-00014

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
National Regulations
Refer to section 15 for specific national regulation.
Special precautions for user
Not applicable
15. REGULATORY INFORMATION
Related Regulations
Fire Service Law
Not applicable to dangerous materials / designated flammables.
Chemical Substance Control Law
Not applicable for Specified Chemical Substance, Monitoring Chemical Substance and Priority
Assessment Chemical Substance.
Industrial Safety and Health Law
Harmful Substances Prohibited from Manufacture
Not applicable
Harmful Substances Required Permission for Manufacture
Not applicable
Substances Prevented From Impairment of Health
Not applicable

12 / 15

SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
1601090-00014

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable
Circular concerning Information on Chemicals having Mutagenicity - Annex 1: Information
on Notified Substances having Mutagenicity
Not applicable
Substances Subject to be Notified Names
Not applicable
Substances Subject to be Indicated Names
Not applicable
Substances Subject to be Indicated Names
Not applicable
Carcinogenic Substances (Article 577-2 of the Occupational Health and Safety Regulations)Not applicable
Ordinance on Prevention of Hazards Due to Specified Chemical Substances
Not applicable
Ordinance on Prevention of Lead Poisoning
Not applicable
Ordinance on Prevention of Tetraalkyl Lead Poisoning
Not applicable
Ordinance on Prevention of Organic Solvent Poisoning
Not applicable
Enforcement Order of the Industrial Safety and Health Law - Attached table 1 (Dangerous
Substances)
Not applicable
Poisonous and Deleterious Substances Control Law
Not applicable
Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof
Not applicable
High Pressure Gas Safety Act
Not applicable
Explosive Control Law
Not applicable
Vessel Safety Law
Not regulated as a dangerous good
Aviation Law
Not regulated as a dangerous good

13 / 15

SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
1601090-00014

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

Marine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Not classified as noxious liquid substance

Pack transportation:

Not classified as marine pollutant

Narcotics and Psychotropics Control Act
Narcotic or Psychotropic Raw Material (Export / Import Permission)
Not applicableSpecific Narcotic or Psychotropic Raw Material (Export / Import permission)
Not applicable
Waste Disposal and Public Cleansing Law
Industrial waste
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined:

Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

16. OTHER INFORMATION
Further information
Sources of key data used tocompile the Safety Data
Sheet

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
Date format:

yyyy/mm/dd

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
ACGIH / TWA:

8-hour, time-weighted average

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; 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 andEquipment 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 Or14 / 15

SAFETY DATA SHEET

Mianserin Formulation
Version
6.0

Revision Date:
2024/04/06

SDS Number:
1601090-00014

Date of last issue: 2023/09/30
Date of first issue: 2017/05/01

ganisation 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) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading 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; TECI - Thailand Existing Chemicals 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; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance forsafe handling, use, processing, storage, transportation, disposal and release and shall not be
considered a warranty or quality specification of any type. The information provided relates only
to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text.
Material users should review the information and recommendations in the specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
JP / EN

15 / 15