Material Safety Data Sheet NFPA HMIS Personal Protective Equipment 0 Health Hazard Fire Hazard 0 See Section 5. Section. Chemical Product and Company Identification Common Name/ Trade Name Manufacturer Commercial Name(s) Synonym Enalapril Maleate SPECTRUM LABORATORY PRODUCTS INC. 4422 S. SAN PEDRO STREET GARDENA, CA 90248 (S)--(N-(-(Ethoxycarbonyl)-3-phenylpropyl)-L-alanyl)- L-proline maleate (:); N-((S)--Ethoxycarbonyl-3-phenylpropyl)- L-alanyl-L-proline maleate (:); -[N-[-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-, (S)- (Z)-2-butenedioate (:) Catalog Number(s). CAS# RTECS TSCA CI# E205, E350 76095-6-4 TW3666000 TSCA 8(b) i nventory: No products were found. Not listed on TSCA 8(b) inventory. IN CASE OF EMERGENCY CHEMTREC (24hr) 800-424-9300 Page Number: Chemical Name Chemical Family Chemical Formula Supplier L-Proline, -(N-(-(ethoxycarbonyl)-3-phenylpropyl)-L-alanyl)-, (S)-, (Z)-2-butenedioate (:) C20-H28-N2-O5.C4-H4-O4 SPECTRUM LABORATORY PRODUCTS INC. 4422 S. SAN PEDRO STREET GARDENA, CA 90248 CALL (30) 56-8000 Section 2.Composition and Information on Ingredients Name CAS # Exposure Limits TWA (mg/m 3 ) STEL (mg/m 3 ) CEIL (mg/m 3 ) % by Weight ) Enalapril Maleate 76095-6-4 00 Toxicological Data on Ingredients Enalapril Maleate: ORAL (LD50): Acute: 2973 mg/kg [Rat]. 3507 mg/kg [Mouse].
Enalapril Maleate Page Number: 2 Section 3. Hazards Identification Potential Acute Health Effects Potential Chronic Health Effects Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. CARCINOGENIC EFFECTS: MUTAGENIC EFFECTS: TERATOGENIC EFFECTS: DEVELOPMENTAL TOXICITY: The substance may be toxic to kidneys. Repeated or prolonged exposure to the substance can produce target organs damage. Section 4. First Aid Measures Eye Contact Skin Contact Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 5 minutes. Cold water may be used. WARM water MUST be used. Get medical attention if irritation occurs. Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops. Serious Skin Contact Inhalation Serious Inhalation If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention. Ingestion Serious Ingestion Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if symptoms appear. Section 5. Fire and Explosion Data Flammability of the Product Auto-Ignition Temperature Flash Points Flammable Limits Products of Combustion May be combustible at high temperature. These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...). Fire Hazards in Presence of Various Substances Explosion Hazards in Presence of Various Substances Fire Fighting Media and Instructions Fire Hazards Explosion Hazards Slightly flammable to flammable in presence of heat. Risks of explosion of the product in presence of mechanical impact: Risks of explosion of the product in presence of static discharge: SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray, fog or foam. Do not use water jet. Material in powder form, capable of creating a dust explosion. As with most organic solids, fire is possible at elevated temperatures Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source is a potential dust explosion hazard.
Enalapril Maleate Page Number: 3 Section 6. Accidental Release Measures Small Spill Large Spill Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements. Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate through the sanitary system. Section 7. Handling and Storage Precautions Storage Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe dust. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatibles such as oxidizing agents. Keep container tightly closed. Keep container in a cool, well-ventilated area. Section 8. Exposure Controls/Personal Protection Engineering Controls Personal Protection Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit. Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves. Personal Protection in Case of a Large Spill Exposure Limits Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product. Section 9. Physical and Chemical Properties Physical state and appearance Molecular Weight ph (% soln/water) Solid. (Crystalline powder.) 492.52 g/mole Odor Taste Color White. Off-white. Boiling Point Melting Point 43 C (289.4 F) - 44.5 C. Critical Temperature Specific Gravity Vapor Pressure Vapor Density Volatility Odor Threshold Water/Oil Dist. Coeff. Ionicity (in Water) Dispersion Properties Solubility Very slightly soluble in cold water, methanol. Solubility in Water: 0.02-0.025 g/ml at room temperature. Solubility in Methanol: 0.2 g/ml at room temperature. Solubility in alcohol: 0.08 g/ml at room temperature.
Enalapril Maleate Page Number: 4 Section 0. Stability and Data Stability Instability Temperature Conditions of Instability Incompatibility with various substances Corrosivity The product is stable. Excess heat, incompatible materials, dust generation Reactive with oxidizing agents. Corrosivity Polymerization Will not occur. Section. Toxicological Information Routes of Entry Toxicity to Animals Chronic Effects on Humans Other Toxic Effects on Humans Toxicity to Animals Chronic Effects on Humans other Toxic Effects on Humans Ingestion. Acute oral toxicity (LD50): 2973 mg/kg [Rat]. May cause damage to the following organs: kidneys. Slightly hazardous in case of skin contact (irritant), of ingestion, of inhalation. Acute Potential Health Effects: Skin: May cause skin irritation. Eyes: May cause eye irritation. Inhalation: May cause respiratory tract irritation. Ingestion: May cause abdominal pain, vomiting, nausea, anorexia, dyspepsia, inflammation of the mucous lining of the mouth, flushing, sweating. It may affect behavior/central nervous system/nervous system (headache, central nervous system depression, convulsions, ataxia, somnolence, nightmares, confusion, insomnia, nervousness, vertigo, paresthesia, weakness/loss of strength, tingling, pricking or numbness of skin (feeling of "pins and needles"), cardiovascular system (hypotension, palpitation, chest pain, tachycardia, bradycadia), respiration (dyspnea, respiratory depression, cyanosis, pulmonary edema), skin (dermatitis, rash, redness, itchiness), liver (hepatitis, liver function tests impaired), kidneys (renal function tests depressed, changes in urine composition), blood (normocytic anemia, leukopenia, changes in serum composition), metabolism (potassium balance). Chronic Potential Health Effects: Ingestion: Prolonged or repeated ingestion may cause weight loss and symptoms similar to that of acute ingestion. Section 2. Ecological Information Ecotoxicity BOD5 and COD Products of Biodegradation Toxicity of the Products of Biodegradation the Products of Biodegradation Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise. The product itself and its products of degradation are not toxic.
Enalapril Maleate Page Number: 5 Section 3. Disposal Considerations Waste Disposal Waste must be disposed of in accordance with federal, state and local environmental control regulations. Section 4. Transport Information DOT Classification Not a DOT controlled material (United States). Identification Special Provisions for Transport DOT Section 5. Other Regulatory Information and Pictograms Federal and State Regulations California Proposition 65 Warnings Other Regulations No products were found. California prop. 65: This product contains the following ingredients for which the State of California has found to cause cancer which would require a warning under the statute: No products were found. California prop. 65: This product contains the following ingredients for which the State of California has found to cause birth defects which would require a warning under the statute: No products were found. EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances (EINECS No. 278-460-9). Canada: Listed on Canadian Domestic Substance List (DSL). China: Not listed on National Inventory. Japan: Not listed on National Inventory (ENCS). Korea: Not listed on National Inventory (KECI). Philippines: Not listed on National Inventory (PICCS). Australia: Not listed on AICS. Other Classifications WHMIS (Canada) Not controlled under WHMIS (Canada). DSCL (EEC) This product is not classified according to the EU regulations. HMIS (U.S.A.) Health Hazard Fire Hazard 0 National Fire Protection Association (U.S.A.) Health 0 Flammability Personal Protection E Specific hazard WHMIS (Canada) DSCL (Europe)
Enalapril Maleate Page Number: 6 TDG (Canada) ADR (Europe) Protective Equipment Gloves. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Safety glasses. Section 6. Other Information MSDS Code References Other Special Considerations E302 Mjaor Use: Medication - an angiotensin converting enzyme (ACE) inhibitor used in treatment of hypertension and congestive heart failure. Validated by Sonia Owen on 3/6/2009. Verified by Sonia Owen. Printed 3/6/2009. CALL (30) 56-8000 Notice to Reader All chemicals may pose unknown hazards and should be used with caution. This Material Safety Data Sheet (MSDS) applies only to the material as packaged. If this product is combined with other materials, deteriorates, or becomes contaminated, it may pose hazards not mentioned in this MSDS. It shall be the user's responsibility to develop proper methods of handling and personal protection based on the actual conditions of use. While this MSDS is based on technical data judged to be reliable, Spectrum Quality Products, Inc. assumes no responsibility for the completeness or accuracy of the information contained herein.