SIGMA-ALDRICH MATERIAL SAFETY DATA SHEET Date Printed: 08/14/2007 Date Updated: 01/26/2006 Version 1.7 Section 1 - Product and Company Information Product Name Tetracycline hydrochloride, meets USP testing specifications Product Number T4062 Brand SIAL Company Sigma-Aldrich Canada, Ltd Address 2149 Winston Park Drive Oakville ON L6H 6J8 CA Technical Phone: 9058299500 Fax: 9058299292 Emergency Phone: 800-424-9300 Section 2 - Composition/Information on Ingredient Substance Name CAS # SARA 313 TETRACYCLIN HYDROCHLORIDE, MEETS 64-75-5 Yes USP TESTING SPECS. Formula C22H24N2O8 ˇ HCl Synonyms Achromycin hydrochloride * ALA TET * Amycin, hydrochloride * Artomycin * Bristacycline * Cancycline-250 * Cefracycline tablets * Chlorhydrate de tetracycline (French) * Chlorowodorku tetracykliny (Polish) * Cyclopar * Diacycine * Dumocyclin * Hostacycline * Medamycin * Mephacyclin * NCI-C55561 * Neocycline B * Paltet * Panmycin hydrochloride * Partrex * Piracaps * Polycycline hydrochloride * Polyotic ointment * Qidtet * Quadracycline * Quatrex * Remicyclin * Ricycline * Ro-Cycline * Sanclomycine * Steclin * Stilciclina * Subamycin * Sumycin * Supramycin * Tefilin * Teline * Telotrex * Tet-Cy * Tetrabakat * Tetrabid * Tetrablet * Tetracaps * Tetrachel * Tetraciclina cloridrato (Italian) * Tetracompren * Tetracycline chlorohydrate * Tetracycline hydrochloride * Tetra-D * Tetrakap * Tetralution * Tetramavan * Tetra-wedel * Tetrosol * Topicycline * Triphacyclin * U-5965 * Unicin * Unimycin * Vetquamycin-324 RTECS Number: QI9100000 Section 3 - Hazards Identification EMERGENCY OVERVIEW Harmful. Possible risk of harm to the unborn child. Irritating to eyes, respiratory system and skin. Calif. Prop. 65 developmental hazard. Possible sensitizer. Target organ(s): Liver. Teeth.
HMIS RATING HEALTH: 2* FLAMMABILITY: 0 REACTIVITY: 1 NFPA RATING HEALTH: 2 FLAMMABILITY: 0 REACTIVITY: 1 *additional chronic hazards present. For additional information on toxicity, please refer to Section 11. Section 4 - First Aid Measures ORAL EXPOSURE If swallowed, wash out mouth with water provided person is conscious. Call a physician. INHALATION EXPOSURE If inhaled, remove to fresh air. If not breathing give artificial respiration. If breathing is difficult, give oxygen. DERMAL EXPOSURE In case of contact, immediately wash skin with soap and copious amounts of water. EYE EXPOSURE In case of contact, immediately flush eyes with copious amounts of water for at least 15 minutes. Section 5 - Fire Fighting Measures FLASH POINT N/A AUTOIGNITION TEMP N/A FLAMMABILITY N/A EXTINGUISHING MEDIA Suitable: Noncombustible. Use extinguishing media appropriate to surrounding fire conditions. FIREFIGHTING Protective Equipment: Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. Specific Hazard(s): Emits toxic fumes under fire conditions. Section 6 - Accidental Release Measures PROCEDURE(S) OF PERSONAL PRECAUTION(S) Wear respirator, chemical safety goggles, rubber boots, and heavy rubber gloves. METHODS FOR CLEANING UP Sweep up, place in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and wash spill site after material pickup is complete. SIAL - T4062 www.sigma-aldrich.com Page 2
Section 7 - Handling and Storage HANDLING User Exposure: Do not breathe dust. Avoid contact with eyes, skin, and clothing. Avoid prolonged or repeated exposure. STORAGE Suitable: Keep tightly closed. Store at -20˚C SPECIAL REQUIREMENTS Light sensitive. Section 8 - Exposure Controls / PPE ENGINEERING CONTROLS Safety shower and eye bath. Use only in a chemical fume hood. PERSONAL PROTECTIVE EQUIPMENT Respiratory: Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Where risk assessment shows air-purifying respirators are appropriate use a dust mask type N95 (US) or type P1 (EN 143) respirator. Hand: Compatible chemical-resistant gloves. Eye: Chemical safety goggles. GENERAL HYGIENE MEASURES Wash thoroughly after handling. Section 9 - Physical/Chemical Properties Appearance Physical State: Solid Property Value At Temperature or Pressure Molecular Weight 480.91 AMU pH N/A BP/BP Range N/A MP/MP Range 220.0 - 223.0 ˚C Freezing Point N/A Vapor Pressure N/A Vapor Density N/A Saturated Vapor Conc. N/A SG/Density N/A Bulk Density N/A Odor Threshold N/A Volatile% N/A VOC Content N/A Water Content N/A Solvent Content N/A Evaporation Rate N/A Viscosity N/A Surface Tension N/A Partition Coefficient N/A Decomposition Temp. N/A Flash Point N/A Explosion Limits N/A Flammability N/A Autoignition Temp N/A Refractive Index N/A SIAL - T4062 www.sigma-aldrich.com Page 3
Optical Rotation N/A Miscellaneous Data N/A Solubility N/A N/A = not available Section 10 - Stability and Reactivity STABILITY Stable: Stable. Conditions of Instability: May discolor on exposure to light. Materials to Avoid: Strong oxidizing agents. HAZARDOUS DECOMPOSITION PRODUCTS Hazardous Decomposition Products: Carbon monoxide, Carbon dioxide, Nitrogen oxides, Hydrogen chloride gas. HAZARDOUS POLYMERIZATION Hazardous Polymerization: Will not occur Section 11 - Toxicological Information ROUTE OF EXPOSURE Skin Contact: Causes skin irritation. Skin Absorption: May be harmful if absorbed through the skin. Eye Contact: Causes eye irritation. Inhalation: Material is irritating to mucous membranes and upper respiratory tract. May be harmful if inhaled. Ingestion: May be harmful if swallowed. SENSITIZATION Sensitization: Prolonged or repeated exposure may cause allergic reactions in certain sensitive individuals. TARGET ORGAN(S) OR SYSTEM(S) Teeth. Bones. Liver. SIGNS AND SYMPTOMS OF EXPOSURE Exposure can cause: Nausea, vomiting, diarrhea. To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated. TOXICITY DATA Oral Rat 6443 mg/kg LD50 Intraperitoneal Rat 318 MG/KG LD50 Subcutaneous Rat 700 MG/KG LD50 Remarks: Gastrointestinal:Hypermotility, diarrhea. Intravenous Rat SIAL - T4062 www.sigma-aldrich.com Page 4
128 MG/KG LD50 Oral Mouse 2759 mg/kg LD50 Intraperitoneal Mouse 368 MG/KG LD50 Intravenous Mouse 157 MG/KG LD50 NTP CARCINOGEN LIST Rating: No evidence. Species: Mouse/rat Route: Feed CHRONIC EXPOSURE - TERATOGEN Result: Possible risk of congenital malformation in the fetus. Species: Rat Dose: 14 GM/KG Route of Application: Oral Exposure Time: (3D MALE/3D PRE-22D PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Specific Developmental Abnormalities: Urogenital system. Species: Rat Dose: 240 MG/KG Route of Application: Subcutaneous Exposure Time: (16-20D PREG) Result: Effects on Embryo or Fetus: Other effects to embryo. Species: Rat Dose: 240 MG/KG Route of Application: Intramuscular Exposure Time: (10-15D PREG) Result: Effects on Embryo or Fetus: Fetotoxicity (except death, e.g., stunted fetus). Species: Mouse Dose: 600 MG/KG Route of Application: Intraperitoneal Exposure Time: (8-13D PREG) Result: Effects on Embryo or Fetus: Fetotoxicity (except death, e.g., stunted fetus). Species: Mouse Dose: 150 MG/KG Route of Application: Intraperitoneal Exposure Time: (10D PREG) Result: Specific Developmental Abnormalities: Musculoskeletal system. Species: Mouse SIAL - T4062 www.sigma-aldrich.com Page 5
Dose: 2250 MG/KG Route of Application: Subcutaneous Exposure Time: (10-18D PREG) Result: Specific Developmental Abnormalities: Urogenital system. Effects on Newborn: Viability index (e.g., # alive at day 4 per # born alive). Effects on Newborn: Growth statistics (e.g., reduced weight gain). CHRONIC EXPOSURE - MUTAGEN Species: Human Dose: 500 UMOL/L Cell Type: fibroblast Mutation test: DNA damage Species: Human Dose: 750 UMOL/L Cell Type: fibroblast Mutation test: Unscheduled DNA synthesis Species: Human Dose: 1250 UMOL/L Cell Type: fibroblast Mutation test: DNA inhibition Species: Rat Dose: 200 UMOL/L Cell Type: liver Mutation test: DNA damage Species: Mouse Dose: 31600 UG/L Cell Type: mammary gland Mutation test: DNA inhibition Species: Mouse Dose: 31600 UG/L Cell Type: mammary gland Mutation test: Other mutation test systems Species: Mouse Dose: 31600 UG/L Exposure Time: 24H Cell Type: mammary gland Mutation test: Cytogenetic analysis Species: Mouse Dose: 120 MG/L Cell Type: lymphocyte Mutation test: Mutation in mammalian somatic cells. Species: Mouse Dose: 100 MG/L Cell Type: mammary gland Mutation test: Mutation in mammalian somatic cells. Species: Hamster Dose: 3 MG/L Cell Type: Embryo Mutation test: Sister chromatid exchange CHRONIC EXPOSURE - REPRODUCTIVE HAZARD SIAL - T4062 www.sigma-aldrich.com Page 6
Species: Rat Dose: 6 GM/KG Route of Application: Oral Exposure Time: (9-14D PREG) Result: Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). Species: Rat Dose: 425 MG/KG Route of Application: Intraperitoneal Exposure Time: (14-18D PREG) Result: Effects on Fertility: Abortion. Effects on Embryo or Fetus: Extra embryonic structures (e.g., placenta, umbilical cord). Species: Rat Dose: 450 MG/KG Route of Application: Unreported Exposure Time: (7-15D PREG) Result: Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). Effects on Embryo or Fetus: Fetotoxicity (except death, e.g., stunted fetus). Species: Rat Dose: 765 MG/KG Route of Application: Unreported Exposure Time: (7-15D PREG) Result: Effects on Fertility: Abortion. Species: Rat Dose: 100 MG/KG Route of Application: Intrauterine Exposure Time: (1D PRE) Result: Maternal Effects: Uterus, cervix, vagina. Species: Mouse Dose: 900 MG/KG Route of Application: Intraperitoneal Exposure Time: (8-13D PREG) Result: Effects on Embryo or Fetus: Fetal death. Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). Specific Developmental Abnormalities: Musculoskeletal system. Species: Mouse Dose: 750 MG/KG Route of Application: Subcutaneous Exposure Time: (1-6D PREG) Result: Effects on Fertility: Abortion. Species: Mouse Dose: 2250 MG/KG Route of Application: Parenteral Exposure Time: (10-18D PREG) Result: Effects on Newborn: Growth statistics (e.g., reduced weight gain). Species: Rabbit Dose: 9 GM/KG Route of Application: Oral SIAL - T4062 www.sigma-aldrich.com Page 7
Exposure Time: (8-16D PREG) Result: Effects on Fertility: Post-implantation mortality (e.g., dead and/or resorbed implants per total number of implants). Section 12 - Ecological Information No data available. Section 13 - Disposal Considerations APPROPRIATE METHOD OF DISPOSAL OF SUBSTANCE OR PREPARATION Contact a licensed professional waste disposal service to dispose of this material. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all federal, state, and local environmental regulations. Section 14 - Transport Information DOT Proper Shipping Name: None Non-Hazardous for Transport: This substance is considered to be non-hazardous for transport. IATA Non-Hazardous for Air Transport: Non-hazardous for air transport. Section 15 - Regulatory Information EU ADDITIONAL CLASSIFICATION Symbol of Danger: Xn Indication of Danger: Harmful. R: 36/37/38-63 Risk Statements: Irritating to eyes, respiratory system and skin. Possible risk of harm to the unborn child. S: 26-36/37 Safety Statements: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Wear suitable protective clothing and gloves. US CLASSIFICATION AND LABEL TEXT Indication of Danger: Harmful. Risk Statements: Possible risk of harm to the unborn child. Irritating to eyes, respiratory system and skin. Safety Statements: In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). Wear suitable protective clothing. Do not breathe dust. US Statements: Calif. Prop. 65 developmental hazard. Possible sensitizer. Target organ(s): Liver. Teeth. UNITED STATES REGULATORY INFORMATION SARA LISTED: Yes DEMINIMIS: 1 % NOTES: This product is subject to SARA section 313 reporting requirements. TSCA INVENTORY ITEM: Yes UNITED STATES - STATE REGULATORY INFORMATION CALIFORNIA PROP - 65 California Prop - 65: This product is or contains chemical(s) SIAL - T4062 www.sigma-aldrich.com Page 8
known to the state of California to cause developmental toxicity. This product is or contains chemical(s) known to the state of California to cause developmental toxicity. CANADA REGULATORY INFORMATION WHMIS Classification: This product has been classified in accordance with the hazard criteria of the CPR, and the MSDS contains all the information required by the CPR. DSL: Yes NDSL: No Section 16 - Other Information DISCLAIMER For R&D or manufacturing use. Not for prescription compound or other uses. WARRANTY The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. Sigma-Aldrich Inc., shall not be held liable for any damage resulting from handling or from contact with the above product. See reverse side of invoice or packing slip for additional terms and conditions of sale. Copyright 2007 Sigma-Aldrich Co. License granted to make unlimited paper copies for internal use only. SIAL - T4062 www.sigma-aldrich.com Page 9
PREPAROS E ORIENTAÇÕES PARA REALIZAÇÃO DE ABDÔMEN TOTAL, PÉLVICA, TRANSVAGINAL COM JUV, PRÓSTATA- VIA ABDOMINAL, E TRANS RETAL, APARELHO URINÁRIO, OBSTÉTRICA ATÉ 3 (TRÊS ) MESES. ABDÔMEN SUPERIOR, ABDÔMEN TOTAL, ABDÔMEN PARA PESQUISA DE REFLUXO, HIPOCÔNDRIO, VIAS BILIARES, RETROPERITÔNIO. PREPARO PARA ABDÔMEN TOTAL OU SUPERIOR NA VÉSPERA DO EXAME: ÀS 20:00hs JANTAR LEVE
APPENDIX A Appendix A tabulates the monthly cost (US $) of available anti-hypertensive and lipid lowering drugs individually in each SAARC country. For each drug within a class the minimum effective and the ceiling recommended dosage has been listed. For both, the minimum and the maximum monthly cost packages have been calculated. These cost packages are based on the available minimum and max