1. PRODUCT AND COMPANY IDENTIFICATION
Product name Felbamate Suspension Formulation .. Manufacturer or supplier's details Company Organon & Co. :
30 Hudson Street, 33nd floor : Jersey City, New Jersey, U.S.A  07302 E-mail address EHSSTEWARD@organon.com .. Recommended use of the chemical and restrictions on use Recommended use Pharmaceutical : Restrictions on use Not applicable ..
2. HAZARDS IDENTIFICATION
GHS Classification Not a hazardous substance or mixture. GHS label elements No hazard pictogram, no signal word, no hazard statement(s), no precautionary statement(s) re- quired Other hazards which do not result in classification None known. 3. COMPOSITION/INFORMATION ON INGREDIENTS Substance / Mixture : Mixture
4. FIRST AID MEASURES If inhaled : If inhaled, remove to fresh air.
ment to keep material from spreading. If dyked material can be pumped, store recovered material in appropriate container. Clean up remaining materials from spill with suitable absor- bent. Local or national regulations may apply to releases and dis- posal of this material, as well as those materials and items employed in the cleanup of releases. You will need to deter- mine which regulations are applicable. Sections 13 and 15 of this SDS provide information regarding certain local or national requirements.
7. HANDLING AND STORAGE

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Engineering measures Use appropriate engineering controls and manufacturing : technologies to control airborne concentrations (e.g., drip- less quick connections). All engineering controls should be implemented by facility design and operated in accordance with GMP principles to protect products, workers, and the environment. Laboratory operations do not require special containment.
flammability limit
The substance or mixture is not classified as oxidizing.
10. STABILITY AND REACTIVITY

11. TOXICOLOGICAL INFORMATION

Skin contact 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
:    LD50 (Rat): > 5,000 mg/kg LC50 (Rat): > 5.8 mg/l .. Exposure time: 4 h Test atmosphere: dust/mist :    LD50 (Rabbit): > 2,000 mg/kg Skin corrosion/irritation Not classified based on available information. Components: Glycerine:
Rabbit .. No skin irritation : Serious eye damage/eye irritation Not classified based on available information. Components:
: Rabbit No eye irritation : 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:
Carcinogenicity Not classified based on available information. Components:
Reproductive toxicity Not classified based on available information. Components:
2-phenylpropane-1,3-diyl dicarbamate: Effects on fertility .
STOT - single exposure Not classified based on available information. STOT - repeated exposure Not classified based on available information. Repeated dose toxicity Components: Glycerine: : : : : : : : : : : : .. : 2-phenylpropane-1,3-diyl dicarbamate: : :
: :
Target Organs Remarks : :
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, Dizzi- ness, insomnia, Drowsiness 12. ECOLOGICAL INFORMATION Ecotoxicity Components: Glycerine: Toxicity to fish LC50 (Oncorhynchus mykiss (rainbow trout)): 54,000 mg/l .. Exposure time: 96 h
ORGANON
Toxicity to daphnia and other aquatic 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 8 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
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:
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) Cellulose: Biodegradability Result: Readily biodegradable. . Bioaccumulative potential Components: Glycerine: Partition coefficient: n- octanol/water log Pow: -1.75 .. 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
13. DISPOSAL CONSIDERATIONS
Disposal methods

14. TRANSPORT INFORMATION
International Regulations
Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable for product as supplied.
Special precautions for user Not applicable 15. REGULATORY INFORMATION Safety, health and environmental regulations/legislation specific for the substance or mix- ture Workplace Safety and Health Act and Workplace Safety and Health (General Provisions) Regulations: This product is subjected to the SDS, labelling, PEL and other requirements in the Act/Regulations. Environmental Protection and Management Act and Not applicable : Environmental Protection and Management (Hazard- ous Substances) Regulations Fire Safety (Petroleum and Flammable Materials) Regulations Not applicable : The components of this product are reported in the following inventories: AICS not determined .. ..
.. not determined
16. OTHER INFORMATION

AIIC - Australian Inventory of Industrial Chemicals; 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; 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 Sys- tem; 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 con- centration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemi- cal Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Or- ganisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Con- centration 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 Develop- ment; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumu- lative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substanc- es; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evalua- tion, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Tem- perature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Trans- portation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Sub- stances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recom- mendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumu- lative; WHMIS - Workplace Hazardous Materials Information System The information provided in this Safety Data Sheet is correct to the best of our knowledge, infor- mation and belief at the date of its publication. The information is designed only as a guidance for safe 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 mate- rial 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 their intended manner of handling, use, processing and storage, including an assessment of the ap- propriateness of the SDS material in the user's end product, if applicable. SG / EN