SECTION 1. PRODUCT AND COMPANY IDENTIFICATION Product name :    Enalapril Formulation Manufacturer or supplier's details Company : Organon & Co.
Rua Treze de Maio, 1161 Campinas, São Paulo, Brazil  13106-054 +55 (19) 3758-2000 +55 (11) 3173-4931 EHSSTEWARD@organon.com Recommended use of the chemical and restrictions on use Recommended use : Restrictions on use : Pharmaceutical Not applicable
SECTION 2. HAZARDS IDENTIFICATION
GHS Classification in accordance with ABNT NBR 14725 Standard Reproductive toxicity Category 1A .. Specific target organ toxicity -    :    Category 2 (Kidney, Cardio-vascular system) repeated exposure GHS label elements in accordance with ABNT NBR 14725 Standard Hazard pictograms : Signal Word : Danger
.. H360D May damage the unborn child. H373 May cause damage to organs (Kidney, Cardio-vascular system) through prolonged or repeated exposure. Precautionary Statements :
Response: P308 + P313 IF exposed or concerned: Get medical advice/
attention. Storage: P405 Store locked up. 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. SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS Substance / Mixture : Mixture
SECTION 4. FIRST AID MEASURES
SAFETY DATA SHEET
Sections 13 and 15 of this SDS provide information regarding certain local or national requirements.
SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
SAFETY DATA SHEET

SECTION 10. STABILITY AND REACTIVITY

RGANON
SECTION 11. TOXICOLOGICAL INFORMATION Information on likely routes of   : exposure Inhalation Skin contact Ingestion
Acute toxicity Not classified based on available information. Product: Acute oral toxicity :    Acute toxicity estimate: > 5.000 mg/kg Method: Calculation method Components:
:    LD50 (Rat): > 5.000 mg/kg
(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
LD50 (Mouse): 2.000 - 3.500 mg/kg LDLo (Mouse): 1.000 mg/kg LD50 (Rat): 850 mg/kg Application Route: Intravenous LD50 (Mouse): 750 mg/kg Application Route: Intravenous LD50 (Dog): > 100 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: Starch:
: Rabbit No eye irritation .. (S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate: Species : Rabbit Result Severe irritation .. Respiratory or skin sensitization Skin sensitization Not classified based on available information. Respiratory sensitization Not classified based on available information. Components: Starch:
(S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate: Maximization Test Test Type .. Routes of exposure Species Result
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: In vitro sister chromatid exchange assay in mam- malian cells Result: negative Test Type: Alkaline elution assay
Result: negative Genotoxicity in vivo
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 fetal development
STOT-single exposure Not classified based on available information. STOT-repeated exposure May cause damage to organs (Kidney, Cardio-vascular system) through prolonged or repeated exposure. Components: (S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate: Target Organs Kidney, Cardio-vascular system .. Assessment 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:
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, Edema, Nausea, hyperkalemia, faint- ing, Weakness, skin rash Remarks: May cause harm to the unborn child. SECTION 12. ECOLOGICAL INFORMATION Ecotoxicity Components: (S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline maleate: Toxicity to fish LC50 (Pimephales promelas (fathead minnow)): > 1.000 mg/l :
EC50 (Daphnia magna (Water flea)): 346 mg/l EC50 (Natural microorganism): > 1.000 mg/l Exposure time: 3 h Test Type: Respiration inhibition Method: OECD Test Guideline 209 Persistence and degradability No data available Bioaccumulative potential No data available Mobility in soil No data available Other adverse effects No data available
SECTION 13. DISPOSAL CONSIDERATIONS
SECTION 14. TRANSPORT INFORMATION International Regulations UNRTDG Not regulated as a dangerous good IATA-DGR Not regulated as a dangerous good IMDG-Code Not regulated as a dangerous good Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable for product as supplied. Domestic regulation ANTT Not regulated as a dangerous good Special precautions for user Not applicable SECTION 15. REGULATORY INFORMATION Safety, health and environmental regulations/legislation specific for the substance or mixture National List of Carcinogenic Agents for Humans - :    Not applicable (LINACH) Brazil. List of chemicals controlled by the Federal Police Sodium hydrogencarbonate : The ingredients of this product are reported in the following inventories: AICS not determined ..
..
.. not determined SECTION 16. OTHER INFORMATION Revision Date 30.09.2023 ..
Full text of other abbreviations ACGIH ..
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, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Tempera- ture; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transporta- tion 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, information 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 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 their intended 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. BR / Z8