Material Safety Data Sheet

Transcription

1 SECTION 1 - PRODUCT Material Safety Data Sheet ANASTROZOLE TABLETS 1 mg Anastrozole Tablets SECTION 2 COMPOSITION, INFORMATION ON INGREDIENTS Active: Anastrozole Inactive: Lactose monohydrate, Sodium starch glycolate (Type A), Magnesium Stearate, Hypromellose, Macrogol, Povidone, Titanium dioxide. SECTION 3 - HAZARDS IDENTIFICATION Emergency Overview Form Hazard Overview Adverse Effects Acute Chronic Tablets Cancer Suspect Agent. Reproductive Hazard. Toxic. Adverse effects may include chest pain, difficulty breathing, swelling of feet or lower legs, numbness or tingling in hands or feet, unusual tiredness or weakness, severe dizziness, continuing headache, fever or chills, cough, hoarseness, body aches or pain, sore throat, dry mouth or throat, bluishdiscoloration of leg or foot, change in appetite or weight, bone pain, constipation, diarrhea, nausea or vomiting, runny nose, tender glands in neck, trouble swallowing or voice changes, mood or mental changes, flushing, sweating, skin rash or itchy skin, breast pain, trouble sleeping, vaginal dryness, heavy vaginal bleeding, painful or difficult urination, and hair loss. Possible allergic reaction to material if inhaled, ingested or in contact with skin. Possible eye, skin, gastrointestinal and/or respiratory tract irritation. Possible hypersensitization.

2 Medical Conditions Target Organs Aggravated by Exposure: Hypersensitivity to material, pregnancy, and osteoporosis. Endocrine system SECTION 4 - EMERGENCY & FIRST AID MEASURES Inhalation: May cause irritation. Remove to fresh air. Eye: May cause irritation. Flush with copious quantities of water. Skin: May cause irritation. Flush with copious quantities of water. Ingestion: May cause irritation. Flush out mouth with water. This material is rapidly and almost completely absorbed from the gastrointestinal tract. Effects may occur within 24 hours and last up to 6 days. General First Aid Procedures: Remove from exposure. Remove contaminated clothing. Persons developing serious hypersensitivity (anaphylactic) reactions must receive immediate medical attention. If person is not breathing give artificial respiration. If breathing is difficult give oxygen. Obtain medical attention. Note to Physicians Overdose Treatment: Treatment of overdose should be symptomatic and supportive and may include the following: 1. Administer activated charcoal as slurry. 2. Hemodialysis may be beneficial. SECTION 5 - FIRE FIGHTING MEASURES Extinguishing Media: Water spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and materials. Fire and Explosion Hazards: This material is assumed to be combustible. As with all dry powders it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity. Firefighting Procedures: As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing.

3 SECTION 6 - ACCIDENTAL RELEASE MEASURES Spill Response: Wear approved respiratory protection, chemically compatible gloves and protective clothing. Wipe up spillage or collect spillage using a high efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately labeled container for disposal. Wash spill site. SECTION 7 - HANDLING AND STORAGE Handling Avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Wash thoroughly after handling. Storage - keep containers tightly closed - room temperature SECTION 8 - EXPOSURE CONTROLS/PERSONAL PROTECTION Respiratory protection: Required when dusts are generated. Eye protection: Safety glasses or goggles Protective Clothing: Protect exposed skin. Gloves: Chemically compatible Exposure Limits: Industry: mg/m 3

4 SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES Physical state and appearance: Solid Odor: Odorless Solubility (Water): Moderately soluble Solubility (Other): Freely soluble in methanol, in acetone, in ethanol, and in tetrahydrofuran; very soluble in acetonitrile. SECTION 10 - STABILITY AND REACTIVITY Stability: The product is stable Conditions to avoid: Avoid exposure to light. Decomposition Products: When heated to decomposition, material emits toxic fumes. Emits toxic fumes under fire conditions. Polymerization: Will not occur. SECTION 11 - TOXICOLOGY INFORMATION Oral Rat: LD 50 : mg/kg Other Toxicity Data: Oral Dog: LD 50 : >45 mg/kg Irritancy Data: Rabbit/eye: non-irritant Other Carcinogenicity Data: A study of rats administered anastrozole at doses of 1.0 to 25 mg/kg/day by oral gavage for up to 2 years revealed an increase in the incidence of hepatocellular adenoma and carcinoma and uterine stromal polyps in females and thyroid adenoma in males at the high dose. A dose related increase was observed in the incidence of ovarian and uterine hyperplasia in females. A study in mice at oral doses of 5 to 50 mg/kg/day for up to 2 years produced an increase in the incidence of benign ovarian stromal, epithelial and granulosa cell tumors at all dose levels. A dose related increase in the incidence of ovarian hyperplasia was also observed in female mice. These ovarian changes are considered to be rodent-specific effects of aromatase inhibition and are of questionable significance to humans. The incidence of lymphosarcoma was increased in male and female mice at the high dose. Mutagenicity Data: Anastrozole has not been shown to be mutagenic in vitro tests (Ames and E. coli bacterial tests, CHO-K1 gene mutation assay) or clastogenic either in vitro (chromosome aberrations in human lymphocytes) or in vivo (micronucleus test in rats). Reproductive and Developmental Effects: There was no evidence of increased birth defects in rats or rabbits administered anastrozole doses up to 1.0 and 0.2 mg/kg/day, respectively.

5 Oral administration of anastrozole to female rats produced significant incidence of infertility and reduced numbers of viable pregnancies at 1 mg/kg/day. Increased pregnancy loss occurred in rats and rabbits administered doses equal to or greater than 0.1 and 0.02 mg/kg/day, respectively. Evidence of fetotoxicity, including delayed fetal development (i.e., incomplete ossification and depressed fetal body weights), was observed in rats administered doses of 1 mg/kg/day. In rabbits, anastrozole caused pregnancy failure at doses equal to or greater than 1.0 mg/kg/day. Multiple-dose studies in rats administered anastrozole for 6 months at doses equal to or greater than 1 mg/kg/day resulted in hypertrophy of the ovaries and the presence of follicular cysts. In addition, hyperplastic uteri were observed in 6-month studies in female dogs administered doses equal to or greater than 1 mg/kg/day. SECTION 12 - ENVIRONMENTAL IMPACT INFORMATION This material has a low potential for bioaccumulation and is unlikely to be biodegradable in water. SECTION 13 - TRANSPORTATION INFORMATION Not applicable. SECTION 14 - DISPOSAL INFORMATION Waste must be disposed of in accordance with state, local and other environmental control regulations. SECTION 15 - OTHER DATA The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no event shall INTAS be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if INTAS has been advised of the possibility of such damages.