SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

SDS Number:
2364255-00013

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11

1. PRODUCT AND COMPANY IDENTIFICATION
Chemical product name:

Felbamate Suspension 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 productNot a hazardous substance or mixture according to the Globally Harmonised System (GHS).
GHS label elements
No hazard pictogram, no signal word, no hazard statement(s), no precautionary statement(s) required
Other hazards which do not result in classification
None known.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name2-phenylpropane-1,3-diyl dicarbamate
Cellulose

CAS-No.
25451-15-4

Concentration (% w/w)>= 10 - < 209004-34-6>= 1 - < 10

4. FIRST AID MEASURES
If inhaled:

If inhaled, remove to fresh air.
1 / 14ENCS No.

SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

SDS Number:
2364255-00013

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11

In case of skin contact:

In case of eye contact:

If swallowed:

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

Get medical attention if symptoms occur.
Wash with water and soap as a precaution.
Get medical attention if symptoms occur.
Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.
If swallowed, DO NOT induce vomiting.
Get medical attention if symptoms occur.
Rinse mouth thoroughly with water.
None known.

::

No special precautions are necessary for first aid responders.
Treat symptomatically and supportively.

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
Nitrogen oxides (NOx)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.
Wear self-contained breathing apparatus for firefighting if necessary.
Use personal protective equipment.

5. FIREFIGHTING MEASURES

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

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.
Prevent spreading over a wide area (e.g. by containment or oilbarriers).
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:

Soak up with inert absorbent material.
For large spills, provide dyking or other appropriate contain2 / 14

SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

SDS Number:
2364255-00013

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11

ment to keep material from spreading. If dyked material canbe pumped, store recovered material in appropriate container.
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.
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.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
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.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.
Keep in properly labelled containers.
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.

Value type
(Form ofexposure)

3 / 14Control parameters / Reference
concentration /Permissible con-Basis

SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

SDS Number:
2364255-00013

2-phenylpropane-1,3-diyl dicarbamate
Cellulose
Engineering measures:

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11

25451-15-4

TWA

9004-34-6

TWA

centration
400 µg/m3 (OEB
2)
10 mg/m3

Internal
ACGIH

Use appropriate engineering controls and manufacturing
technologies to control airborne concentrations (e.g., dripless quick connections).
All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
Laboratory operations do not require special containment.

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
: Combined particulates and organic vapour type
Hand protection
Material: Chemical-resistant gloves
Eye protection:

Skin and body protection:

Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state:suspension

Colour:Pinkish beige

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 applicable

Flammability (liquids):

No data available

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

4 / 14

SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

Lower explosion limit /Lower flammability limit

SDS Number:
2364255-00013:

No data available

Flash point:

No data available

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:

Not applicable

Vapour pressure:

No data available

Density and / or relative density
Relative density:

No data available

Density

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11:

No data available

Relative vapour density:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle characteristics
Particle size:

Not applicable:::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
5 / 14

SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

SDS Number:
2364255-00013

Information on likely routes of :exposure

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
2-phenylpropane-1,3-diyl dicarbamate:
Acute oral toxicity: LD50 (Rat): > 5,000 mg/kg
LD50 (Mouse): > 5,000 mg/kg
Cellulose:
Acute oral toxicity:

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

Acute inhalation toxicity:

LC50 (Rat): > 5.8 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

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

Skin corrosion/irritation
Not classified based on available information.
Serious eye damage/eye irritation
Not classified based on available information.
Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Germ cell mutagenicity
Not classified based on available information.
Components:
2-phenylpropane-1,3-diyl dicarbamate:
Genotoxicity in vitro: Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosomal aberration
Result: negative
Cellulose:
6 / 14

SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

Genotoxicity in vitro

SDS Number:
2364255-00013:

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: In vitro mammalian cell gene mutation test
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Ingestion
Result: negative

Carcinogenicity
Not classified based on available information.
Components:
2-phenylpropane-1,3-diyl dicarbamate:Species: MouseApplication Route: OralExposure time
: 92 weeks
LOAEL: 300 mg/kg body weight
Target Organs: Liver
Species
Application RouteExposure time
NOAEL
Target Organs
Remarks

:
:
:
:
:
:

Rat
Oral
104 weeks
30 mg/kg body weight
Liver, Testes
Benign tumor(s)Cellulose:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
72 weeks
negative

Reproductive toxicity
Not classified based on available information.
Components:
2-phenylpropane-1,3-diyl dicarbamate:
Effects on fertility: Test Type: Fertility
Species: Rat
Application Route: Oral
Fertility: NOAEL: 1,000 mg/kg body weight
Remarks: No significant adverse effects were reported
Effects on foetal development:

Test Type: Development
Species: Rat
7 / 14

SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

SDS Number:
2364255-00013

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11

Application Route: Oral
Developmental Toxicity: NOAEL: 500 mg/kg body weight
Result: Reduced foetal weight, Embryotoxic effects and adverse effects on the offspring were detected only at high maternally toxic doses
Test Type: Development
Species: Rabbit
Application Route: Oral
Developmental Toxicity: NOAEL: 300 mg/kg body weight
Result: Embryotoxic effects and adverse effects on the offspring were detected only at high maternally toxic doses
Cellulose:
Effects on fertility

Effects on foetal development:

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Result: negative:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Ingestion
Result: negative

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Not classified based on available information.
Repeated dose toxicity
Components:
2-phenylpropane-1,3-diyl dicarbamate:Species: Rat
NOAEL: 100 mg/kg
Application Route: OralExposure time
: 3 Months
Target Organs: Liver
Remarks: May cause damage to organs.
Species
NOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Dog
280 mg/kg
Oral
3 Months
Liver, Central nervous system

Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
30 mg/kg
Oral
1 yr
8 / 14

SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

SDS Number:
2364255-00013

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11

Target Organs
Remarks::

Liver
May cause damage to organs.

Species
NOAEL
Application RouteExposure timeTarget Organs
Remarks

:
:
:
:
:
:

Dog
30 mg/kg
Oral
1 yr
Liver, Central nervous system
May cause damage to organs.

Cellulose:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
>= 9,000 mg/kg
Ingestion
90 Days

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
2-phenylpropane-1,3-diyl dicarbamate:Ingestion: Target Organs: Liver
Symptoms: anorexia, Nausea, Vomiting, Headache, Dizziness, insomnia, Drowsiness
12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
2-phenylpropane-1,3-diyl dicarbamate:
Toxicity to fish
: LC50 (Oncorhynchus mykiss (rainbow trout)): > 100 mg/l
Exposure time: 96 h
Method: OECD Test Guideline 203
Toxicity to daphnia and otheraquatic invertebrates

Cellulose:
Toxicity to fish:

EC50 (Daphnia magna (Water flea)): > 100 mg/l
Exposure time: 48 h
Method: OECD Test Guideline 202:

LC50 (Oryzias latipes (Japanese medaka)): > 100 mg/l
Exposure time: 48 h
Remarks: Based on data from similar materials

9 / 14

SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

SDS Number:
2364255-00013

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11

Persistence and degradability
Components:
2-phenylpropane-1,3-diyl dicarbamate:
Stability in water: Hydrolysis: < 10 %(5 d)Cellulose:
Biodegradability:

Result: Readily biodegradable.

Bioaccumulative potential
Components:
2-phenylpropane-1,3-diyl dicarbamate:
Partition coefficient: n: log Pow: 0.381
octanol/water
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.

UNRTDGUN number
Proper shipping nameClass
Subsidiary risk
Packing group
Labels

:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable

IATA-DGR
UN/ID No.
Proper shipping name
Class

:
:
:

Not applicableNot applicableNot applicable

14. TRANSPORT INFORMATIONInternational Regulations

10 / 14

SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

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:
2364255-00013

:
:
:
:

Not applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11

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
Circular concerning Information on Chemicals having Mutagenicity - Annex 2: Information
on Existing Chemicals having Mutagenicity
Not applicable

11 / 14

SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

SDS Number:
2364255-00013

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11

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
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 goodMarine Pollution and Sea Disaster Prevention etc Law
Bulk transportation:

Noxious liquid substance(Category Z)

Pack transportation:

Not classified as marine pollutant

Narcotics and Psychotropics Control Act
Narcotic or Psychotropic Raw Material (Export / Import Permission)
Not applicable
12 / 14

SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

SDS Number:
2364255-00013

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11

Specific 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 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) 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, Bioaccumu13 / 14

SAFETY DATA SHEET

Felbamate Suspension Formulation
Version
4.0

Revision Date:
2023/09/30

SDS Number:
2364255-00013

Date of last issue: 2023/04/04
Date of first issue: 2018/01/11

lative 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

14 / 14