Material Safety Data Sheet

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1 Material Safety Data Sheet NFPA HMIS Personal Protective Equipment 2 0 Health Hazard Fire Hazard 2 0 See Section 5. Section. Chemical Product and Company Identification Common Name/ Trade Name Manufacturer Commercial Name(s) Synonym Chemical Name Diltiazem Hydrochloride SPECTRUM CHEMICAL MFG. CORP S. SAN PEDRO STREET GARDENA, CA Diltiazem Hydrochloride Catalog Number(s). CAS# RTECS TSCA CI# D DL IN CASE OF EMERGENCY CHEMTREC (24hr) Page Number: TSCA 8(b) inventory: No products were found. Chemical Family Chemical Formula Supplier Bulk Pharmaceutical C22-H26-N2-O4-S.HCL SPECTRUM CHEMICAL MFG. CORP S. SAN PEDRO STREET GARDENA, CA CALL (30) 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 ) Diltiazem Hydrochloride Toxicological Data on Ingredients Diltiazem Hydrochloride: ORAL (LD50): Acute: 560 mg/kg [Rat]. 508 mg/kg [Mouse]. Section 3. Hazards Identification Potential Acute Health Effects Hazardous in case of eye contact (irritant), of ingestion, of inhalation. Potential Chronic Health Effects CARCINOGENIC EFFECTS: MUTAGENIC EFFECTS: TERATOGENIC EFFECTS: DEVELOPMENTAL TOXICITY: Classified Development toxin [POSSIBLE]. The substance is toxic to liver, gastrointestinal tract, cardiovascular system, skin, central nervous system (CNS). Repeated or prolonged exposure to the substance can produce target organs damage.

2 Diltiazem Hydrochloride Page Number: 2 Section 4. First Aid Measures Eye Contact Check for and remove any contact lenses. Do not use an eye ointment. Seek medical attention. Skin Contact Serious Skin Contact No known effect on skin contact, rinse with water for a few minutes. Inhalation Allow the victim to rest in a well ventilated area. Seek immediate medical attention. Serious Inhalation Ingestion Serious Ingestion Do not induce vomiting. Examine the lips and mouth to ascertain whether the tissues are damaged, a possible indication that the toxic material was ingested; the absence of such signs, however, is not conclusive. Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek immediate medical attention. Section 5. Fire and Explosion Data Flammability of the Product Auto-Ignition Temperature Flash Points Flammable Limits Products of Combustion Fire Hazards in Presence of Various Substances May be combustible at high temperature. These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...), sulfur oxides (SO2, SO3...). Explosion Hazards in Presence of Various Substances Risks of explosion of the product in presence of mechanical impact: Risks of explosion of the product in presence of static discharge: Fire Fighting Media and Instructions Fire Hazards Explosion Hazards SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray, fog or foam. Do not use water jet. 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.

3 Diltiazem Hydrochloride Page Number: 3 Section 7. Handling and Storage Precautions Storage Keep locked up Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not breathe dust. Avoid contact with eyes Wear suitable protective clothing In case of insufficient ventilation, wear suitable respiratory equipment If ingested, seek medical advice immediately and show the container or the label. Keep container dry. Keep in a cool place. Ground all equipment containing material. Carcinogenic, teratogenic or mutagenic materials should be stored in a separate locked safety storage cabinet or room. 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. Splash goggles. Lab coat. Personal Protection in Case of a Large Spill Exposure Limits Splash goggles. Full suit. Boots. Gloves. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product. Section 9. Physical and Chemical Properties Physical state and appearance Solid. Odor Molecular Weight ph (% soln/water) g/mole Taste Color Boiling Point Melting Point 22 C (43.6 F) Critical Temperature Specific Gravity Vapor Pressure Vapor Density Volatility Odor Threshold Water/Oil Dist. Coeff. Ionicity (in Water) Dispersion Properties Solubility Section 0. Stability and Data Stability Instability Temperature Conditions of Instability Incompatibility with various substances Corrosivity The product is stable.

4 Diltiazem Hydrochloride Page Number: 4 Corrosivity Polymerization No. 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 Absorbed through skin. Eye contact. Inhalation. Ingestion. Acute oral toxicity (LD50): 508 mg/kg [Mouse]. DEVELOPMENTAL TOXICITY: Classified Development toxin [POSSIBLE]. The substance is toxic to liver, gastrointestinal tract, cardiovascular system, skin, central nervous system (CNS). Hazardous in case of ingestion, of inhalation. 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 products of degradation are less toxic than the product itself. Section 3. Disposal Considerations Waste Disposal Section 4. Transport Information DOT Classification Identification Not a DOT controlled material (United States). Special Provisions for Transport DOT

5 Diltiazem Hydrochloride Page Number: 5 Section 5. Other Regulatory Information and Pictograms Federal and State Regulations California Proposition 65 Warnings Other Regulations cause cancer, birth defects or other reproductive harm, which would require a warning under the statute: Diltiazem Hydrochloride cause reproductive harm (female) which would require a warning under the statute: Diltiazem Hydrochloride cause reproductive harm (male) which would require a warning under the statute: Diltiazem Hydrochloride cause cancer which would require a warning under the statute: Diltiazem Hydrochloride TSCA 8(b) inventory: 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: Diltiazem Hydrochloride EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances. Other Classifications WHMIS (Canada) DSCL (EEC) Not controlled under WHMIS (Canada). R22- Harmful if swallowed. R40- Possible risks of irreversible effects. HMIS (U.S.A.) Health Hazard Fire Hazard Personal Protection 2 0 j National Fire Protection Association (U.S.A.) Health 2 0 Flammability Specific hazard WHMIS (Canada) DSCL (Europe) TDG (Canada) ADR (Europe) Protective Equipment Lab coat.

6 Diltiazem Hydrochloride Page Number: 6 Splash goggles. Section 6. Other Information MSDS Code References Other Special Considerations D334 Validated by Sonia Owen on 8//2006. Verified by Sonia Owen. Printed 9/2/2006. CALL (30) 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.