Material Safety Data Sheet

Transcription

1 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 Fluconazole SPECTRUM LABORATORY PRODUCTS INC S. SAN PEDRO STREET GARDENA, CA Diflucan Catalog Number(s). CAS# RTECS TSCA CI# F278, F XZ IN CASE OF EMERGENCY CHEMTREC (24hr) Page Number: TSCA 8(b) inventory: No products were found. Chemical Name Chemical Family Chemical Formula Supplier 2,4-Dfluoro-alpha, alpha--bis(h-,2,4-triazol--ylmethyl)benzyl Alcohol; 2-(2,4-Difluorophenyl)-,3-bis(iH-,2,4-triazol--yl)-2-propanol; alpha-(2,4-difluorophenyl)-alpha-(ih-,2,4-triazol--ylmethyl)-h-,2,4- H-,2,4-Triazole--ethanol,alpha-(2,4-difluorophenyl)-alpha-(H-,2,4- C3-H2-F2-N6-O SPECTRUM LABORATORY PRODUCTS INC 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 ) Fluconazole Toxicological Data on Ingredients Fluconazole: ORAL (LD50): Acute: 27 mg/kg [Rat]. 408 mg/kg [Mouse]. Section 3. Hazards Identification Potential Acute Health Effects Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Potential Chronic Health Effects CARCINOGENIC EFFECTS: MUTAGENIC EFFECTS: TERATOGENIC EFFECTS: Classified POSSIBLE for human. DEVELOPMENTAL TOXICITY: Repeated or prolonged exposure is not known to aggravate medical condition.

2 Fluconazole Page Number: 2 Section 4. First Aid Measures Eye Contact Skin Contact Serious 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. Get medical attention if irritation occurs. Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops. 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. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing such as a collar, tie, belt or waistband. 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. 450 C (842 F) These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...), halogenated compounds. Slightly flammable to flammable in presence of heat. Non-flammable in presence of shocks. 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. 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. 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 Fluconazole Page Number: 3 Section 7. Handling and Storage Precautions Storage Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe dust. Avoid contact with skin. Wear suitable protective clothing. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatibles such as oxidizing agents, acids. 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 Solid. (Crystalline solid.) Odor Molecular Weight ph (% soln/water) g/mole Taste Color White. Boiling Point Melting Point 36 C (276.8 F) - 4 C. Critical Temperature Specific Gravity Vapor Pressure Not applicable. Vapor Density Volatility Odor Threshold Water/Oil Dist. Coeff. Ionicity (in Water) Dispersion Properties Solubility Easily soluble in methanol. Soluble in acetone. Slightly soluble in cold water. Soluble in alcohol. Sparingly soluble in chloroform, isopropyl alcohol. Slightly soluble in toluene.

4 Fluconazole 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 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 Inhalation. Ingestion. Acute oral toxicity (LD50): 27 mg/kg [Rat]. TERATOGENIC EFFECTS: Classified POSSIBLE for human. Slightly hazardous in case of skin contact (irritant), of ingestion, of inhalation. May cause birth defects (teratogenic). There are no adequate and well controlled studies of pregnant women. There have been reports of multiple congenital abnormalities in infants whose mothers wre being treated for 3 or more months with high doses ( mg/day). Excreted in maternal milk in human. Acute Potential Health Effects: Skin: Causes skin irritation Eyes: May cause eye irritation. Inhalation: May cause respiratory tract irritation. Ingestion: May be harmful if swallowed. May cause gastrointestinal tract irritation with nausea, vomiting, abdominal pain, acid or sour stomach, flatulence, diarrhea, dyspepsia, and taste perversion. May also affect behavior/central nervous system (headache, fatigue, dizziness, seizures), metabolism (hyperkalemia), blood (leukopenia, neutropenia, agranulocytosis, thrombocytopenia), and cardiovascular system. Other symptoms may include skin rashes, exfoliative skin disorders such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Skin reactions are rare and have occured more commonly in people with AIDS. Anaphylaxis and angioedema (swelling of face, bloating) have been reported rarely. Chronic Potential Health Effects: Ingestion: Prolonged or repeated ingestion may affect the cardiovascular system (increase in pulse rate, EKG changes), metabolism (electrolyte balance - Hypokalemia), liver(hyperlipidemias (hyperchlolesterolemia, hypertriglyceridemia)elevated liver enzymes, jaundice). It may cause alopecia (hair loss). It may also cause hypersensitization (anaphylaxis). Note: Possible allergic reaction to material if it is inhaled, ingested or in contact with skin. Medical Conditions Aggravated by Exposure: Hypersensitivity to material; alcoholism; congestive heart failure; ventricular dysfunction; hypochlorhydria or achlorhydria; impaired liver or or kidney function; AIDS or malignancy; Persons sensitive to imidazoles, azoles, or amphotericin B may also be sensitive to this material. Clincally or potentially significant drug interactions between Fluconazole and the following agents/classes have been observed: Oral hypoglycemics, Coumarin-type anticoagulants, Phenytoin, Cyclosporine, Rifampin, Teheophylline, Terfenadine, Cisapride, Astemizole, Rifabutin, Tacrolimus.

5 Fluconazole Page Number: 5 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 as toxic as the product itself. 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 Identification Not a DOT controlled material (United States). Not applicable. Special Provisions for Transport Not applicable. DOT Section 5. Other Regulatory Information and Pictograms Federal and State Regulations California Proposition 65 Warnings Other Regulations 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: 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 not listed on the European Inventory of Existing Commercial Chemical Substances. Canada: Not 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) R22- Harmful if swallowed. R63- Possible risk of harm to the unborn child. S46- If swallowed, seek medical advice immediately and show this container or label. HMIS (U.S.A.) Health Hazard Fire Hazard 0 National Fire Protection Association (U.S.A.) Health 0 Flammability

6 Fluconazole Page Number: 6 WHMIS (Canada) Personal Protection E Specific hazard DSCL (Europe) 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 F5672 Major Use: Antifungal medication. Validated by Sonia Owen on /26/2007. Verified by Sonia Owen. Printed /29/2007. CALL (30)

7 Fluconazole Page Number: 7 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.