SAFETY DATA SHEET
Felbamate Suspension Formulation
Version
1.11

Revision Date:
30.09.2023

SDS Number:
2364253-00012

Date of last issue: 04.04.2023
Date of first issue: 11.01.2018

SECTION 1. PRODUCT AND COMPANY IDENTIFICATION
Product name:

Felbamate Suspension Formulation

Manufacturer or supplier's details
Company name of supplier: Organon & Co.
Address: Avenida 16 de Septiembre No. 301
Xaltocan - Xochimilco Mexico 16090
Telephone: +52 55 57284444
Emergency telephone: 1-215-631-6999
E-mail address: EHSSTEWARD@organon.com
Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
SECTION 2. HAZARDS IDENTIFICATIONGHS Classification
Not a hazardous substance or mixture.
GHS label elements
No hazard pictogram, no signal word, no hazard statement(s), no precautionary statement(s) required
Other hazards
None known.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Glycerine
2-phenylpropane-1,3-diyl dicarbamate
Cellulose

CAS-No.
56-81-5
25451-15-4
9004-34-6

Concentration (% w/w)>= 10 -< 20>= 10 -< 20>= 1 -< 5

SECTION 4. FIRST AID MEASURES
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:

If inhaled, remove to fresh air.
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.
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SAFETY DATA SHEET
Felbamate Suspension Formulation
Version
1.11

Revision Date:
30.09.2023

Notes to physician

SDS Number:
2364253-00012:

Date of last issue: 04.04.2023
Date of first issue: 11.01.2018

Treat symptomatically and supportively.

SECTION 5. FIRE-FIGHTING 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
Nitrogen oxides (NOx)Specific extinguishing methods:

Special protective equipment
for fire-fighters:

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.

SECTION 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
oil barriers).
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 diking or other appropriate
containment to keep material from spreading. If diked material
can be pumped, store recovered material in appropriate
container.
Clean up remaining materials from spill with suitable
absorbent.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need todetermine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

SECTION 7. HANDLING AND STORAGE
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SAFETY DATA SHEET
Felbamate Suspension Formulation
Version
1.11

Revision Date:
30.09.2023

SDS Number:
2364253-00012

Technical measures:

Local/Total ventilation
Advice on safe handling::

Hygiene measures:

Conditions for safe storage:

Materials to avoid:

Date of last issue: 04.04.2023
Date of first issue: 11.01.2018

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.
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 labeled containers.
Store in accordance with the particular national regulations.
Do not store with the following product types:
Strong oxidizing agents
Gases

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
Components

CAS-No.

Glycerine

56-81-52-phenylpropane-1,3-diyl dicarbamate
Cellulose

25451-15-4

Value type
(Form ofexposure)
VLE-PPT(Mist)
TWA

9004-34-6

VLE-PPT

400 µg/m3 (OEB
2)
10 mg/m³

TWA

10 mg/m³

Engineering measures:

Control parameters / Permissible
concentration
10 mg/m³

Basis

NOM-010STPS-2014
Internal
NOM-010STPS-2014
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 therecommended guidelines, use respiratory protection.
Filter type
: Combined particulates and organic vapor type
Hand protection
Material: Chemical-resistant gloves
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SAFETY DATA SHEET
Felbamate Suspension Formulation
Version
1.11

Revision Date:
30.09.2023

SDS Number:
2364253-00012

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.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:

suspension

Color

:

Pinkish beige

Odor

:

No data available

Odor Threshold:

No data available

pH:

No data available

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

No data available

Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

No data available

Relative vapor density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available:

Not applicable:

No data available

Partition coefficient: noctanol/water
Autoignition temperature

Date of last issue: 04.04.2023
Date of first issue: 11.01.2018

4 / 13

SAFETY DATA SHEET
Felbamate Suspension Formulation
Version
1.11

Revision Date:
30.09.2023

SDS Number:
2364253-00012

Date of last issue: 04.04.2023
Date of first issue: 11.01.2018

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Particle size:

Not applicable

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

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.

SECTION 11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Inhalation
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Components:
Glycerine:
Acute oral toxicity:

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

Acute dermal toxicity:

LD50 (Guinea pig): > 5,000 mg/kg

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
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SAFETY DATA SHEET
Felbamate Suspension Formulation
Version
1.11

Revision Date:
30.09.2023

Acute dermal toxicity

SDS Number:
2364253-00012:

Date of last issue: 04.04.2023
Date of first issue: 11.01.2018

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

Skin corrosion/irritation
Not classified based on available information.
Components:
Glycerine:
SpeciesResult::RabbitNo skin irritation

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Glycerine:
SpeciesResult::RabbitNo eye irritation

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Germ cell mutagenicity
Not classified based on available information.
Components:
Glycerine:
Genotoxicity in vitro:

Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosome aberration test in vitro
Result: negative
Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Result: negative

2-phenylpropane-1,3-diyl dicarbamate:
Genotoxicity in vitro: Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosomal aberration
Result: negative
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SAFETY DATA SHEET
Felbamate Suspension Formulation
Version
1.11

Revision Date:
30.09.2023

Cellulose:
Genotoxicity in vitro

SDS Number:
2364253-00012:

Date of last issue: 04.04.2023
Date of first issue: 11.01.2018

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:
Glycerine:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
negative2-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:
Glycerine:
Effects on fertility:

Test Type: Two-generation reproduction toxicity study
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SAFETY DATA SHEET
Felbamate Suspension Formulation
Version
1.11

Revision Date:
30.09.2023

SDS Number:
2364253-00012

Date of last issue: 04.04.2023
Date of first issue: 11.01.2018

Species: Rat
Application Route: Ingestion
Result: negative
Effects on fetal development:

Test Type: Embryo-fetal development
Species: Rat
Application Route: Ingestion
Result: negative

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 fetal development:

Test Type: Development
Species: Rat
Application Route: Oral
Developmental Toxicity: NOAEL: 500 mg/kg body weight
Result: Reduced fetal weight., Embryotoxic effects andadverse effects on the offspring were detected only at highmaternally 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 theoffspring were detected only at high maternally toxic doses

Cellulose:
Effects on fertility:

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

Effects on fetal development:

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:
Glycerine:
Species:Rat
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SAFETY DATA SHEET
Felbamate Suspension Formulation
Version
1.11

Revision Date:
30.09.2023

SDS Number:
2364253-00012

Date of last issue: 04.04.2023
Date of first issue: 11.01.2018

NOAEL
LOAEL
Application RouteExposure time

:
:
:
:

0.167 mg/l
0.622 mg/l
inhalation (dust/mist/fume)
13 Weeks

Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat
8,000 - 10,000 mg/kg
Ingestion
2ySpecies
NOAEL
Application RouteExposure time

:
:
:
:

Rabbit
5,040 mg/kg
Skin contact
45 Weeks2-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 timeTarget Organs
Remarks

:
:
:
:
:
:

Rat
30 mg/kg
Oral
1y
Liver
May cause damage to organs.

Species
NOAEL
Application RouteExposure timeTarget Organs
Remarks

:
:
:
:
:
:

Dog
30 mg/kg
Oral
1y
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.

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SAFETY DATA SHEET
Felbamate Suspension Formulation
Version
1.11

Revision Date:
30.09.2023

SDS Number:
2364253-00012

Date of last issue: 04.04.2023
Date of first issue: 11.01.2018

Experience with human exposure
Components:
2-phenylpropane-1,3-diyl dicarbamate:Ingestion: Target Organs: Liver
Symptoms: anorexia, Nausea, Vomiting, Headache, Dizziness, insomnia, Drowsiness
SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Glycerine:
Toxicity to fish:

LC50 (Oncorhynchus mykiss (rainbow trout)): 54,000 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 1,955 mg/l
Exposure time: 48 h

Toxicity to microorganisms:

NOEC (Pseudomonas putida): > 10,000 mg/l
Exposure time: 16 h
Method: DIN 38 412 Part 82-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

Persistence and degradability
Components:
Glycerine:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 92 %Exposure time: 30 d
Method: OECD Test Guideline 301D

2-phenylpropane-1,3-diyl dicarbamate:
Stability in water: Hydrolysis: < 10 %(5 d)
10 / 13SAFETY DATA SHEET
Felbamate Suspension Formulation
Version
1.11

Revision Date:
30.09.2023

Cellulose:
Biodegradability

SDS Number:
2364253-00012

Date of last issue: 04.04.2023
Date of first issue: 11.01.2018:

Result: Readily biodegradable.

:

log Pow: -1.75

Bioaccumulative potential
Components:
Glycerine:
Partition coefficient: noctanol/water

2-phenylpropane-1,3-diyl dicarbamate:
Partition coefficient: n: log Pow: 0.381
octanol/water
Mobility in soil
No data available
Other adverse effects
No data available
SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

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

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDG
Not regulated as a dangerous good
IATA-DGR
Not regulated as a dangerous good
IMDG-CodeNot regulated as a dangerous goodTransport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Domestic regulation
NOM-002-SCT
Not regulated as a dangerous goodSpecial precautions for user
Not applicable

11 / 13SAFETY DATA SHEET
Felbamate Suspension Formulation
Version
1.11

Revision Date:
30.09.2023

SDS Number:
2364253-00012

Date of last issue: 04.04.2023
Date of first issue: 11.01.2018

SECTION 15. REGULATORY INFORMATION
Safety, health and environmental regulations/legislation specific for the substance or
mixtureFederal Law for the control of chemical precursors,: Not applicableessential chemical products and machinery for
producing capsules, tablets and pills.
The ingredients of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Revision Date
Date format::

30.09.2023
dd.mm.yyyy

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
NOM-010-STPS-2014: Mexico. Norm NOM-010-STPS-2014 on Chemicals Polluting
the Work Environment - Identification, Assessment and Control - Appendix 1 Occupational Exposure Limits
ACGIH / TWA: 8-hour, time-weighted average
NOM-010-STPS-2014 / VLE- : Time weighted average limit value
PPT
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, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substanc12 / 13

SAFETY DATA SHEET
Felbamate Suspension Formulation
Version
1.11

Revision Date:
30.09.2023

SDS Number:
2364253-00012

Date of last issue: 04.04.2023
Date of first issue: 11.01.2018es; (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

Sources of key data used tocompile the Material Safety
Data Sheet:Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

The information is considered as correct, but not exhaustive, and will be used only as a guide,
which is based in the current knowledge of the substance or mixture, and is applicable to proper
safety precautions for the product.
MX / Z8

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