1. PRODUCT AND COMPANY IDENTIFICATION
Product name .. Enalapril Formulation Manufacturer or supplier's details Company : Organon & Co.
.. 30 Hudson Street, 33nd floor Jersey City, New Jersey, U.S.A  07302
： +1-551-430-6000 Emergency telephone number   :    +1-215-631-6999 E-mail address .. EHSSTEWARD@organon.com Recommended use of the chemical and restrictions on use Pharmaceutical Recommended use : Not applicable Restrictions on use ..
2. HAZARDS IDENTIFICATION
Emergency Overview
May damage the unborn child. May cause damage to organs through prolonged or repeated ex- posure. GHS Classification Reproductive toxicity .. Category 1A Specific target organ toxicity -    :    Category 2 repeated exposure GHS label elements Hazard pictograms Signal word
Hazard statements
H360D May damage the unborn child. H373 May cause damage to organs through prolonged or re-
peated exposure. Precautionary statements :
Response: P308 + P313 IF exposed or concerned: Get medical advice/ attention. Storage: P405 Store locked up. Disposal: P501 Dispose of contents/ container to an approved waste disposal plant. Physical and chemical hazards Not classified based on available information. Health hazards May damage the unborn child. May cause damage to organs through prolonged or repeated ex- posure. Environmental hazards Not classified based on available information. Other hazards which do not result in classification Dust contact with the eyes can lead to mechanical irritation. Contact with dust can cause mechanical irritation or drying of the skin. May form explosive dust-air mixture during processing, handling or other means.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture : Mixture

4. FIRST AID MEASURES
General advice In the case of accident or if you feel unwell, seek medical ad- : vice immediately.
according to GB/T 16483 and GB/T 17519
SAFETY DATA SHEET according to GB/T 16483 and GB/T 17519
according to GB/T 16483 and GB/T 17519
Hand protection

11. TOXICOLOGICAL INFORMATION
Exposure routes Inhalation .. Skin contact Ingestion Eye contact Acute toxicity Not classified based on available information. Product: Acute oral toxicity :    Acute toxicity estimate: > 5,000 mg/kg
Method: Calculation method Components:
(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate: Acute oral toxicity :    LD50 (Rat): 2,000 - 3,500 mg/kg LDLo (Rat): 1,775 mg/kg
LDLo (Dog): 200 mg/kg Skin corrosion/irritation Not classified based on available information. Components: (S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate: Species : Rabbit Result No skin irritation .. Serious eye damage/eye irritation Not classified based on available information. Components:
Rabbit .. No eye irritation : (S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate: Species Rabbit .. Result
Respiratory or skin sensitisation Skin sensitisation Not classified based on available information. Respiratory sensitisation Not classified based on available information. Components: Starch:
(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
Germ cell mutagenicity Not classified based on available information. Components: Starch: Genotoxicity in vitro .. Test Type: Bacterial reverse mutation assay (AMES) Result: negative (S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate: Genotoxicity in vitro Test Type: Bacterial reverse mutation assay (AMES) : Result: negative
Test Type: Mutagenicity (in vivo mammalian bone-marrow Genotoxicity in vivo
cytogenetic test, chromosomal analysis) Species: Mouse Application Route: Ingestion Result: negative Carcinogenicity Not classified based on available information. Components: (S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
Reproductive toxicity May damage the unborn child. Components: (S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate: Effects on fertility :    Test Type: Fertility Species: Rat, male and female Application Route: Ingestion Fertility: NOAEL: 90 mg/kg body weight Result: No effects on fertility Effects on foetal develop- ment
Species: Rat Application Route: Ingestion Developmental Toxicity: LOAEL: 1,200 mg/kg body weight Result: Fetotoxicity
Reproductive toxicity - As- sessment Positive evidence of adverse effects on development from .. human epidemiological studies. STOT - single exposure Not classified based on available information. STOT - repeated exposure May cause damage to organs through prolonged or repeated exposure. Components: (S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate: Target Organs Assessment Kidney, Cardio-vascular system : Causes damage to organs through prolonged or repeated .. exposure. Repeated dose toxicity Components: Starch:
(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate:
: : : : : Species NOAEL :
:
NON
Remarks
Aspiration toxicity Not classified based on available information. Experience with human exposure Components: (S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate: Ingestion :    Target Organs: Cardio-vascular system Symptoms: hypotension, Cough, Dizziness, Headache, Blurred vision, Fatigue, Oedema, Nausea, hyperkalemia, faint- ing, Weakness, skin rash Remarks: May cause harm to the unborn child. 12. ECOLOGICAL INFORMATION Ecotoxicity Components: (S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate: :    LC50 (Pimephales promelas (fathead minnow)): > 1,000 mg/l Toxicity to fish
Persistence and degradability No data available Bioaccumulative potential No data available Mobility in soil No data available Other adverse effects No data available
according to GB/T 16483 and GB/T 17519

13. DISPOSAL CONSIDERATIONS

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. National Regulations GB 6944/12268 UN number Proper shipping name Not applicable : Not applicable :
Special precautions for user Not applicable
15. REGULATORY INFORMATION
National regulatory information Law on the Prevention and Control of Occupational Diseases Regulation on the Administration of Precursor Chemicals Catalogue and Classification of Precursor Chemicals      :    Not listed Yangtze River Protection Law This product does not contain any dangerous chemicals prohibited for inland river transport. The components of this product are reported in the following inventories: AICS :    not determined DSL : not determined
not determined :
16. OTHER INFORMATION

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 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 Leve!; 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
Disclaimer
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. CN / EN