ITRACONAZOLE, USP 5GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name Itraconazole USP Supplier Information Letco Medical, LLC 1316 Commerce Drive NW Decatur, AL 35601 1 (800) 239-5288 +1 (734) 843-4693 IN CASE OF EMERGENCY: Chemtrec 1 (800) 424-9300 (24 hours) Product Synonym(s) N/A Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Skin Irritation (Category 2), Eye Irritation (Category 2A), Specif ic target organ toxicity (Category 3), Acute Oral toxicity (Category 4) Signal Word Warning Hazard Statement(s) H302 Harmf ul if swallowed H315 Causes skin irritation H319 Causes serious eye irritation H335 May cause respiratory irritation Pictogram(s) Precautionary Statement(s) P261 Avoid breathing dust/f ume/gas/mist/vapours/spray. P270 Do not eat, drink or smoke when using this product. P271 Use only outdoors or in a well-ventilated area. P280 Wear protective gloves/protective clothing/eye protection/f ace protection. P301+P312 IF SWALLOWED Call a POISON CENTER or doctor/physician if you f eel unwell. P302+P352 IF ON SKIN Wash with soap and water. P304+P340 IF INHALED Remove victim to fresh air and keep at rest in a position comf ortable f or breathing. P305+P351+P338 IF IN EYES Rinse cautiously with water f or several minutes. Remove contact lenses if present and easy to do. continue rinsing. P330 Rinse mouth. P337+P313 If eye irritation persists Get medical advice/attention. P362 Take of f contaminated clothing and wash bef ore reuse. Hazards Not Otherwise Classified Not available Ingredient(s) with Unknown Toxicity Not available Section 3: Composition/Information on Ingredients Chemical Name 4-[4-[4-[4-[[cIS-2-(2,4-dichlorophenyl)-2-(1H-1,2, 4-triazol-l-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1- yl]phenyl]-2-[(1RS)-1-methylpropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one. Common Name Itraconazole CAS Number 84625-61-6 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice Not available If Inhaled Remove to fresh air. If not breathing, give artif icial respiration. Call a physician. In Case of Skin Contact Immediately wash skin f or at least 20min. Flush area with large amounts of water. Use soap. Remove contaminated clothes. Call a physician/Doctor. In Case of Eye Contact Hold eyelids apart and f lush eyes with plenty of water f or at least 20 minutes. Have eyes examined and tested by medical personnel. If Swallowed Wash out mouth with water provided person is consciousness. Call a physician. Do NOT induce vomiting unless directed to do so by medical personnel. Most Important Symptoms and Effects No data available Page 1 of 4 Section 5: Fire Fighting Measures Suitable Extinguishing Media Use alcohol-resistant f oam, dry chemical spray, or carbon dioxide. Special Hazards Arising From the Substance/Mixture Emits oxidizing agents i.e. nitrates, oxidizing acids, chlorine beaches, pool chlorine. Special PPE and/or Precautions for Firefighters Wear approved positive pressure, self-contained breathing apparatus pressure-demand (NIOSH) approved and f ull protective turn out gear. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Personnel involved in clean-up should wear appropriate personal protective equipment like rubber boots, saf ety goggles, and heavy rubber gloves. Methods and Materials Used for Containment Contain spill and collect, as appropriate. Transf er to a chemical f or disposal in accordance with local regulations. Cleanup Procedures Care should be taken to avoid environmental release. Section 7: Handling and Storage Precautions for Safe Handling Avoid breathing dust/f ume/gas/mist/spray. Avoid prolonged or repeated exposure. Conditions for Safe Storage Preserve in tight, light-resistant containers, and store at room temperature. Avoid contact with skin and eyes, don't reuse this container. Wash thoroughly af ter handling. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Lower exposure limits: 30g/m3. Upper exposure limits: Not available Appropriate Engineering Controls General protective and hygienic measures: Immediately remove all soiled and contaminated clothing. Wash hands bef ore breaks and at the end of work. Avoid contact with the eyes. PPE - Eye/Face Protection Saf ety goggles. PPE - Skin Protection Wash thoroughly af ter handling. PPE - Body Protection The selection of the suitable gloves does not only depend on the material, but also on f urther marks of quality and varies from manuf acturer to manuf acturer. Penetration time of glove material: The exact break through time has to be f ound out by the manuf acturer of the protective gloves and has to be observed. PPE - Respiratory Protection NIOSH approved respirator, as conditions warrant. Section 9: Physical and Chemical Properties Appearance A crystalline solid. Upper/Lower Flammability or Explosive Limits No data available Odor No data available Vapor Pressure No data available Odor Threshold No data available Vapor Density No data available pH No data available Relative Density No data available Melting Point/Freezing Point 163C Solubility Soluble in DMSO and DMF. Initial Boiling Point and Boiling Range No data available Flash Point No data available Evaporation Rate No data available Flammability (Solid, Gas) No data available Partition Coefficient No data available Auto-Ignition Temperature No data available Decomposition Temperature No data available Viscosity No data available Page 2 of 4 Section 10: Stability and Reactivity Reactivity Unstable in the presence of incompatible materials. Product is considered stable. Chemical Stability Product is considered stable. Possibility of Hazardous Reactions No data available Conditions to Avoid No data available Incompatible Materials No data available Hazardous Decomposition Products Carbon dioxide (CO2), Carbon monoxide, Hydrogen chloride gas, nitrogen oxides. Section 11: Toxicological Information Acute Toxicity - LD50 Oral Oral LD50 > 320 mg/Kg 2 Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye No data available Skin Corrosion/Irritation No data available Serious Eye Damage/Irritation No data available Respiratory or Skin Sensitazation No data available Germ Cell Mutagenicity No data available Carcinogenicity IARC No data available Carcinogenicity ACGIH No data available Carcinogenicity NTP No data available Carcinogenicity OSHA No data available Reproductive Toxicity No data available Specific Target Organ Toxicity - Single Exposure No data available Specific Target Organ Toxicity - Repeated Exposure No data available Aspiration Hazard No data available Section 12: Ecological Information Toxicity Avoid release into the environment. Runof f from f ire control or dilution water may cause pollution. Persistence and Degradability No data available Bio-accumulative Potential No data available Mobility in Soil No data available Other Adverse Effects No data available Section 13: Disposal Considerations Waste Treatment Methods Product Dissolve or mix the material with a combustible solvent and waste chemicals of reduction, reuse, recycling, disposal. Waste Treatment Methods Packaging No data available Special Precautions Landfill or Incinerations No data available Other Information No data available Section 14: Transport Information UN Number Not dangerous goods. UN Proper Shipping Name N/A Transport Hazard Class(es) N/A Packaging Group N/A Environmental Hazards N/A Page 3 of 4 Section 15: Regulatory Information DSCL (EEC): Unlisted HMIS (USA) Unlisted Section 16: Other Information Additional Information N/A Prepared By Scarlotte Smith Revision Date 12/31/2018 16:44 Disclaimer Letco Medical, LLC believes that the above information is 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. If the product is used as a component in another product, this information may not be applicable. NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, IS MADE CONCERNING THE INFORMATION PROVIDED ABOVE. Letco Medical shall not be held liable for any loss or damage resulting from handling, storage, use or from contact with the above product. Page 4 of 4
