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 Itraconazole SPECTRUM LABORATORY PRODUCTS INC. 4422 S. SAN PEDRO STREET GARDENA, CA 90248 Catalog Number(s). CAS# RTECS TSCA YY542, I2304, I2202 84625-6-6 XZ548000 Page Number: TSCA 8(b) i nventory: No products were found. Commercial Name(s) Synonym Chemical Name Oriconazole 3H-,2,4-Triazol-3-one,4-(4-(4-(4-((2-(2,4-dichlorophenyl)-2-(H-,2,4-triaz CI# IN CASE OF EMERGENCY CHEMTREC (24hr) 800-424-9300 Chemical Family Chemical Formula Supplier C35-H38-Cl2-N8-O4 SPECTRUM LABORATORY PRODUCTS INC. 4422 S. SAN PEDRO STREET GARDENA, CA 90248 CALL (30) 56-8000 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 ) Itraconazole 84625-6-6 00 Toxicological Data on Ingredients Itraconazole: ORAL (LD50): Acute: >320 mg/kg [Rat]. >320 mg/kg [Mouse]. >60 mg/kg [Guinea pig]. Section 3. Hazards Identification Potential Acute Health Effects Potential Chronic Health Effects Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. CARCINOGENIC EFFECTS: MUTAGENIC EFFECTS: TERATOGENIC EFFECTS: DEVELOPMENTAL TOXICITY: Repeated or prolonged exposure is not known to aggravate medical condition.
Itraconazole 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 Explosion Hazards in Presence of Various Substances Fire Fighting Media and Instructions Fire Hazards Explosion Hazards May be combustible at high temperature. 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. Risks of explosion of the product in presence of static discharge: Non-explosive in presence of shocks. 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 presences 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.
Itraconazole Page Number: 3 Section 7. Handling and Storage Precautions Storage Keep away from heat. Keep away from sources of ignition. Do not ingest. Do not breathe dust. Wear suitable protective clothing. If ingested, seek medical advice immediately and show the container or the label. Keep container tightly closed. Keep container in a cool, well-ventilated area. Sensitive to light. Store in light-resistant containers. 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 Molecular Weight ph (% soln/water) Solid. (Powdered solid.) 705.6 g/mole Odor Taste Color White. Off-white. Boiling Point Melting Point 63 C (325.4 F) - 70 C. Critical Temperature Specific Gravity Vapor Pressure Not applicable. Vapor Density Volatility Odor Threshold Water/Oil Dist. Coeff. Ionicity (in Water) Dispersion Properties Solubility Insoluble in cold water. Sparingly soluble in Tetrahydrofuran Freely soluble in Methylene Chloride. Very slightly soluble in alcohol. Section 0. Stability and Data Stability Instability Temperature Conditions of Instability Incompatibility with various substances The product is stable. Excess heat, dust generation, incompatible materials. Reactive with oxidizing agents, acids, alkalis.
Itraconazole Page Number: 4 Corrosivity Corrosivity Polymerization Sensitive to light. Will not occur. Section. Toxicological Information Routes of Entry Toxicity to Animals Chronic Effects on Humans Inhalation. Ingestion. Acute oral toxicity (LD50): >60 mg/kg [Guinea pig]. Other Toxic Effects on Humans Toxicity to Animals Chronic Effects on Humans other Toxic Effects on Humans Slightly hazardous in case of skin contact (irritant), of ingestion, of inhalation. May cause adverse reproductive effects and birth defects (teratogenic) based on animal test data Potential Health Effects: Skin: May cause skin irritation. Eyes: May cause eye irritation. Inhalation: May cause respiratory tract irritation. Ingestion: May be harmful if swallowed. May cause nausea or upset stomach, abdominal cramps, vomiting, diarrhea or loose stools. May affect the liver (jaundice/hepatitis, liver function tests impaired). Symptoms may include dermatitis (skin rash/itching), yellow eyes, dark urine, loss of appetite, vertigo, headache, dizziness, depression, paraesthesias, loss of libido, edema (swelling) of the legs or feet, confusion, weakness, excessive tiredness, shortness of breath, cough. It may also cause hypertension, heart failure. It may affect the blood (changes in serum composition), liver, metabolism (weight loss or anorexia, hypokalemia or loss of potassium), and adrenal gland. 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.
Itraconazole Page Number: 5 Section 4. Transport Information DOT Classification Not a DOT controlled material (United States). Identification 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 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. OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 90.200). 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: Listed on AICS. Other Classifications WHMIS (Canada) Not controlled under WHMIS (Canada). DSCL (EEC) R22- Harmful if swallowed. 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 Personal Protection E Specific hazard WHMIS (Canada) DSCL (Europe) TDG (Canada)
Itraconazole Page Number: 6 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 I3306 Validated by Sonia Owen on 9/24/2008. Verified by Sonia Owen. Printed 9/24/2008. CALL (30) 56-8000 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.