TRIAMCINOLONE ACETONIDE, USP (MICRONIZED) 1KG by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name TRIAMCINOLONE ACETONIDE MICRO 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) Aristocort; Flutone; Nasacort; Rineton; Tramacin; Vetalog Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Eye Irrit. 2; H319, STOT SE 3; H335, Skin Irrit. 2; H315,Repr. 2; H361d Signal Word Warning Hazard Statement(s) H315 Causes skin irritation H319 Causes serious eye irritation H335 May cause respiratory irritation H361d Suspected of damaging the unborn child Pictogram(s) Precautionary Statement(s) P260 Do not breathe dust/f ume/gas/mist/vapours/spray. P262 Do not get in eyes, on skin, or on clothing. P312 Call a POISON CENTER or doctor/physician if you f eel unwell. Hazards Not Otherwise Classified Not available Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name Pregna- 1,4-diene-3,20-dione, 9-f luoro-11,21-dihydroxy-, 16,17-[(1-methylethylidene)b is(oxy)]- (11�, 16a) Common Name Triamcinolone acetonide CAS Number 76-25-5 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice Notes to Physician Treat symptomatically. If Inhaled If breathing is dif f icult, give oxygen. If not breathing, give artif icial respiration. Remove from exposure, lie down. In Case of Skin Contact Wash of f immediately with soap and plenty of water removing all contaminated clothes and shoes In Case of Eye Contact Rinse thoroughly with plenty of water f or at least 15 minutes and consult a physician. If Swallowed Clean mouth with water, only if the person is in conscious. Get medical attention. Most Important Symptoms and Effects Irritation: Irritating to eyes, respiratory system and skin. Corrosivity: No inf ormation available Sensitization No inf ormation available Eyes: May cause irritation, Elevation in intraocular pressure, Glaucoma, Cataracts Skin: May cause irritation, Skin rash, Urticaria, Pruritus, Erythema, Edema, Hirsutism, Dryness, Folliculitis, Acne Inhalation: May cause irritation. Rhinitis. Pharyngitis. Epistaxis. Dry throat. Dry nose. Nasal congestion. Sinusitis. Itching. Ingestion: May cause irritation Section 5: Fire Fighting Measures Suitable Extinguishing Media Water spray. Carbon dioxide (CO 2). Foam.Dry powder. Special Hazards Arising From the Substance/Mixture Thermal decomposition can lead to release of irritating gases and vapors. Combustible material. Special PPE and/or Precautions for Firefighters As in any f ire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and f ull protective gear. Page 1 of 4 Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Use personal protective equipment. Avoid contact with dusts/f umes/mists/vapors. Methods and Materials Used for Containment Prevent entry into waterways, sewers, basements or conf ined areas. Prevent f urther leakage or spillage if saf e to do so. Cleanup Procedures PContain spillage, and then collect with non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite) and place in container f or disposal according to local / national regulations (see section 13). If emergency, enf orce internal emergency plan. Section 7: Handling and Storage Precautions for Safe Handling Avoid contact with skin, eyes and clothing. Handle in accordance with good industrial hygiene and saf ety practice. Do not breathe vapors/dust. Provide appropriate exhaust ventilation at places where dust is f ormed. Handle in accordance with good industrial hygiene and saf ety practice. Conditions for Safe Storage Keep at temperatures 25�?°C. Excursions permitted to 15-30 �?°C. Protect from light. keep in well closed containers. Keep away from heat. Store in accordance with local regulations. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters No occupational exposure limit values have been def ined by Authorities in production Country Appropriate Engineering Controls Provide engineering control. Handle in accordance with good industrial hygiene and saf ety practice. Environmental exposure controls: Ensure local dust collection system. PPE - Eye/Face Protection Approved saf ety goggles/glasses. PPE - Skin Protection Rubber/latex/neoprene or other suitable chemical resistant gloves. PPE - Body Protection Long sleeved clothing. PPE - Respiratory Protection Approved f ull f ace respirator P3 or airline respirator. Section 9: Physical and Chemical Properties Appearance White Almost white crystalline powder. Upper/Lower Flammability or Explosive Limits No inf ormation available. Odor Odourless Vapor Pressure No inf ormation available. Odor Threshold No inf ormation available. Vapor Density No inf ormation available. pH No inf ormation available. Relative Density 1.33 g/cm3 (pred) Melting Point/Freezing Point 292 - 294 �C Solubility Water Solubility: Practically insoluble Initial Boiling Point and Boiling Range 576.9 �C (Predicted) Flash Point 302.7 �C (Predicted) Evaporation Rate No data available Flammability (Solid, Gas) No inf ormation available. Partition Coefficient Octanol/water Partition Coef f icient ( Log Kow ) 2.428 (pred) Auto-Ignition Temperature No inf ormation available Decomposition Temperature No inf ormation available Viscosity No inf ormation available Page 2 of 4 Section 10: Stability and Reactivity Reactivity No data available Chemical Stability Stable under normal conditions. Possibility of Hazardous Reactions Hazardous polymerization does not occur. Conditions to Avoid Heat, f lames and sparks. Incompatible Materials Strong oxidizing agents Hazardous Decomposition Products Toxic f umes of . Carbon monoxide (CO). Carbon dioxide (CO 2). Hydrogen f luoride. Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 Oral rat 6300 mg/kg LD50 Subcutaneous rat 13.1 mg/kg LD50 Oral mouse 5000 mg/kg LD50 Subcutaneous mouse 132 mg/kg LD50 Intraperitoneal mouse 105 mg/kg Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye No data available Skin Corrosion/Irritation No inf ormation available Serious Eye Damage/Irritation May cause irritation, Elevation in intraocular pressure, Glaucoma, Cataracts Respiratory or Skin Sensitazation May cause irritation. Rhinitis. Pharyngitis. Epistaxis. Dry throat. Dry nose. Nasal congestion. Sinusitis. Itching. Germ Cell Mutagenicity No evidence of mutagenicity was detected from in vitro tests (a reverse mutation test in Salmonella bacteria and a f orward mutation test in Chinese hamster ovary cells) Carcinogenicity IARC Not listed by IARC, NTP and OSHA. In a two-year study in rats, the product caused no treatment-related carcinogenicity at oral doses up to 1.0 mg/kg. In a two- year study in mice, the product caused no treatment-related carcinogenicity at oral doses up to 3.0 mg/kg. Carcinogenicity ACGIH No data available Carcinogenicity NTP Not listed by IARC, NTP and OSHA. In a two-year study in rats, the product caused no treatment-related carcinogenicity at oral doses up to 1.0 mg/kg. In a two- year study in mice, the product caused no treatment-related carcinogenicity at oral doses up to 3.0 mg/kg. Carcinogenicity OSHA Not listed by IARC, NTP and OSHA. In a two-year study in rats, the product caused no treatment-related carcinogenicity at oral doses up to 1.0 mg/kg. In a two- year study in mice, the product caused no treatment-related carcinogenicity at oral doses up to 3.0 mg/kg. Reproductive Toxicity The product was teratogenic in rats, rabbits and monkeys. In rats and rabbits Triamcinolone was teratogenic at inhalation doses of 20 mg/kg and above. In monkeys the product was teratogenic at an inhalatio n dose of 500 mg/kg. Doserelated teratogenic ef f ects in rats and rabbits included clef t palate and/or internal hydrocephaly and axial skeletal def ects, whereas the ef f ects observed in the monkey were cranial malf ormations. Ef f ects in humans are not conclusive and asthmatic patients use corticosteroids during pregnancy without adverse outcome. However, in some studies use during pregnancy has been associated with an increased risk of clef t palate and impaired f etal growth Specific Target Organ Toxicity - Single Exposure No inf ormation available Specific Target Organ Toxicity - Repeated Exposure No inf ormation available Aspiration Hazard No data available Section 12: Ecological Information Toxicity No inf ormation available Persistence and Degradability Hazard of persistence may be possible Bio-accumulative Potential Not expected to bioaccumulate : Log Po/w
