Tetracycline Hydrochloride Capsules Finished Product Material Safety Data Sheet

Transcription

1 SECTION 1 - IDENTIFICATION PRODUCT NAME Tetracycline Hydrochloride Capsules Finished Product SYNONYMS Achromycin V CHEMICAL FAMILY Tetracycline THERAPEUTIC CATEGORY Anti-Bacterial; Anti- Amebic; Anti- Rickettsial SECTION 2 HEALTH HAZARD INFORMATION EMERGENCY OVERVIEW EYE SKIN INGESTION INHALATION ADVERSE SYSTEMIC EFFECTS CHRONIC (CANCER) INFORMATION REPRODUCTION INFO WARNING The information in this MSDS is based on the hazards of the active ingredient. While diluted, this material may present the following hazards POTENTIAL SENSITIZER AND REPRODUCTIVE HAZARD. Contact may cause irritation. Contact may cause irritation. Ingestion may cause irritation. Inhalation may cause irritation of the respiratory tract. Photosensitivity (excessive sunburn reaction). Benign intracranial hypertension with headache and blurred vision. Nausea, vomiting, diarrhea, genital area yeast infection, hypersensitivity skin reactions, reduced blood cell counts, elevated liver enzymes, jaundice. NTP - Not listed. IARC - Not listed. OSHA - Not listed. Tooth discoloration and retarded bone development has been found after exposure in the last half of pregnancy. Page 1 of 6

2 MEDICAL CONDITIONS/MEDS AGGRAVATED BY EXPOSURE TARGET ORGANS Hypersensitivity to material, impaired kidney or liver function, and myasthenia gravis. Liver. APPEARANCE Capsules. ODOR SECTION 3 INGREDIENT INFORMATION COMPONENT CAS NUMBER % BY WEIGHT Tetracycline Hydrochloride NA Lactose NA Magnesium Sterate NA Sodium Lauryl Sulfate NA NA SECTION 4 FIRST AID MEASURES EYES SKIN INGESTION INHALATION NOTE TO PHYSICIANS Flush with large quantities of water for 15 minutes. Brush off material; remove contaminated clothing, flush with large quantities of water for 15 minutes. Flush mouth with water obtain medical attention. Remove to fresh air. N/A SECTION 5 FIRE FIGHTING MEASURES FLAMMABLE PROPERTIES Material is assumed to be combustible. Page 2 of 6

3 HAZARDOUS COMBUSTION PRODUCTS EXTINGUISHING MEDIA FIRE FIGHTING INSTRUCTION Emits toxic fumes under fire conditions. Water spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and materials. As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing. SECTION 6 ACCIDENTAL RELEASE MEASURES SPILL Wear appropriate PPE. Scoop up slowly without breaking capsules and generating dust. (NO DRY SWEEPING). Wet wipe surfaces. SECTION 7 HANDLING AND STORAGE HANDLING STORAGE Keep container closed, minimize dust generation during transfer. Store in tight container. SECTION 8 EXPOSURE CONTROL AND PPE ENGINEERING CONTROLS RESPIRATORY PROTECTION SKIN PROTECTION EYE PROTECTION Operations involving handling/transferring of dry power should be performed using containment measures (i.e. enclosures, etc.) and local exhaust ventilation. Wear appropriate PPE according to dust level. Wear appropriate PPE according to dust level. Wear appropriate PPE according to dust level. COMPONENT EXPOSURE LIMIT Tetracycline Hydrochloride PIEL 1000 µg/m 3. Lactose Page 3 of 6

4 Magnesium Sterate Sodium Lauryl Sulfate SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES BOILING POINT No information found. MELTING POINT 214 ºC (API) ph No information found. VAPOR PRESSURE VAPOR DENSITY SOLUBILITY IN WATER Practically Insoluble (API). ODOR APPEARANCE Tablets. SPECIFIC GRAVITY 0.37 (API). AUTOIGNITION TEMPERATURE FLAMMABLE LIMITS MOLECULAR WEIGHT (API) FLASHPOINT OCTANOL/WATER COEFFICIENT (API) EVAPORATION RATE SECTION 10 STABILITY AND REACTIVITY CHEMICAL STABILITY (CONDITIONS TO AVOID) INCOMPATIBILITY HAZARDOUS DECOMPOSITION PRODUCTS This material is considered stable from a safety point of view. When heated to decomposition, material emits toxic fumes. Page 4 of 6

5 HAZARDOUS POLYMERIZATION SECTION 11 TOXICOLOGICAL INFORMATION EYE SKIN INGESTION INHALATION ACUTE/SUBCHRONIC MUTAGENICITY/ CARCINOGENICITY REPRODUCTION LD 50 (6443 mg/kg oral-rat). (API) Animal studies have not shown evidence of mutagenicity or carcinogenicity. Animal studies have shown evidence of teratogenicity and no evidence of impaired fertility. SECTION 12 ECOLOGICAL INFORMATION ECOTOXICOLOGICAL INFORMATION CHEMICAL FATE INFORMATION SECTION 13 DISPOSAL CONSIDERATIONS Dispose of in accordance with all applicable federal, state, and local regulations. SECTION 14 TRANSPORTATION INFORMATION Finished products in final packaging ready for consumer use are NOT regulated by DOT. Page 5 of 6

6 SECTION 15 REGULATORY INFORMATION OSHA CERCLA SECTION 313 (SARA TITLE III) OTHER REGULATIONS API is subject to California Proposition 65 (known to the state as a reproductive toxicant) warning and release requirements April 1, 1990 and the California Safe Drinking Water and Toxic Enforcement Act of 1986 to keep out of water supplies and sewers. SECTION 16 OTHER INFORMATION PREPARED BY REVISIONS Rob Mc Cafferty. New MSDS. DISCLAIMER: Teva Pharmaceuticals USA, Inc. provides the information contained in this MSDS sheet in good faith but makes no claim as to its accuracy or Comprehensiveness. This MSDS sheet is intended as a guide for a properly trained person to utilize appropriate precautionary methods while handling this product. Individuals must exercise their own judgment in determining the appropriateness of this information for a particular purpose. All MSDS sheets are subject to revision from time-to-time as new information becomes available. Anyone proposing to rely on information regarding the substance that is the subject of this MSDS sheet is responsible for ensuring that he or she has obtained and reviewed the most recent version of the sheet available at the time. Teva Pharmaceuticals USA, Inc. will not be responsible for damages resulting from the use or misuse of the information contained in this MSDS sheet. Page 6 of 6