LEVOFLOXACIN (HEMIHYDRATE) 500GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name LEVOFLOXACIN HEMIHYDRATE 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) (-)-Of loxacin; 7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-f luoro-2,3- dihydro-3-methyl-10-(4-methyl-1- piperazinyl)-7-oxo-hydrate (2:1), (S)-,Hemihydrate C18H20FN3O4��H2O Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Acute toxicity, Oral (Category 4), Respiratory sensitization (Category 1), Skin sensitization (Category 1), Reproductive toxicity (Category 2), Ef f ects on or via lactation Signal Word Danger Hazard Statement(s) H302 Harmf ul if swallowed H317 May cause an allergic skin reaction H334 May cause allergy or asthma symptoms or breathing dif f iculties if inhaled H361d Suspected of damaging the unborn child H362 May cause harm to breast-f ed children Pictogram(s) Precautionary Statement(s) P261 Avoid breathing dust/f ume/gas/mist/vapours/spray. P263 Avoid contact during pregnancy/while nursing. P280 Wear protective gloves/protective clothing/eye protection/f ace protection. P342+P311 If experiencing respiratory symptoms Call a POISON CENTER or doctor/physician. Hazards Not Otherwise Classified No data available Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name (-)-Of loxacin; 7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-f luoro-2,3- dihydro-3-methyl-10-(4-methyl-1- piperazinyl)-7-oxo-hydrate (2:1), (S)-,Hemihydrate C18H20FN3O4��H2O Common Name Levof loxacin Hemihydrate CAS Number 138199-71-0 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice Consult physician. Show this data sheet to the doctor in attendance. Move out of dangerous area. If Inhaled If breathed in, move person into fresh air. If not breathing, give artif icial respiration. Consult a physician. In Case of Skin Contact Wash of f with soap and plenty of water. Consult a physician. In Case of Eye Contact Flush eyes with water as a precaution. If Swallowed Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician. Most Important Symptoms and Effects Not f lammable or combustible Section 5: Fire Fighting Measures Suitable Extinguishing Media Use water spray, alcohol-resistant f oam, dry chemical or carbon dioxide. Special Hazards Arising From the Substance/Mixture Hazardous decomposition products f ormed under f ire conditions- Carbon oxides, nitrogen oxides (NOx), Hydrogen f luoride. Special PPE and/or Precautions for Firefighters Wear self contained breathing apparatus f or f ire f ighting if necessary. Page 1 of 4 Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Use personal protective equipment. Avoid dust f ormation. Avoid breathing vapours, mist, or gas. Ensure adequate ventilation. Evacuate personnel to saf e areas. Avoid breathing dust. Methods and Materials Used for Containment Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers f or disposal. Cleanup Procedures Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers f or disposal. Prevent f urther leakage or spillage if saf e to do so. Do not let product enter drains. Section 7: Handling and Storage Precautions for Safe Handling Avoid contact with skin and eyes. Avoid f ormation of dust and aerosols. Provide appropriate exhaust ventilation at places where dust is f ormed. Conditions for Safe Storage Keep in tight, light-resistant container and store in a dry and well-ventilated place. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Contains no substances with occupational exposure limit values. Appropriate Engineering Controls Handle in accordance with good industrial hygiene and saf ety practice. Wash hands bef ore breaks and at the end of workday. Use mechanical exhaust or laboratory f ume hood to avoid exposure. PPE - Eye/Face Protection Faceshield and saf ety glasses. Use equipment f or eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166 (EU). PPE - Skin Protection Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surf ace) to avoid skin contact with this product. Dispose of contaminated gloves af ter use in accordance with applicable laws and good laboratory practices. Wash and dry hands. PPE - Body Protection Complete suit protecting against chemicals. The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specif ic workplace. Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching gloves outer surf ace) to avoid skin contact with this product. Dispose of contaminated gloves af ter each use in accordance with applicable laws and good laboratory practices. Wash and dry hands. PPE - Respiratory Protection Where risk assessment shows air-purif ying respirators are appropriate use a f ull-f ace particle respirator type N99 (US) or type P2 (EN 143) respirator cartridges as a backup to engineering controls. If the respirator is the sole means of protection, use a f ull-f ace supplied air respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Section 9: Physical and Chemical Properties Appearance Form: Powder Colour: Light yellow 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 No data available Solubility No data available 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 No data available Chemical Stability Stable under recommended storage conditions. Possibility of Hazardous Reactions No data available Conditions to Avoid No data available Incompatible Materials Strong oxidizing agents Hazardous Decomposition Products Hazardous decomposition products f ormed under f ire conditions-Carbon oxides, nitrogen oxides, nitrogen oxides (NOx) Other decomposition products - No data available Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 Oral - rat - 1,478 mg/kg Remarks: Sense Organs and Special Senses (Nose, Eye, Ear, and Taste):Eye:Ptosis. Behavioral: Somnolence (general depressed activity). Respiratory disorder 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 May cause allergic reaction. May cause allergic skin reaction. Causes photosensitivity. Exposure to light can result in allergic reactions resulting in dermatologic lesions, which can vary from sunburn like responses to edmatous, vesiculated lesions, or bullae. Germ Cell Mutagenicity No data available Carcinogenicity IARC No component of this product present at levels greater than or equal to 0.1% is identif ied as probable, possible or conf irmed human carcinogen by IARC. Carcinogenicity ACGIH No component of this product at levels greater than or equal to 0.1% is identif ied as a carcinogen or potential carcinogen by ACGIH. Carcinogenicity NTP No component of this product present at levels greater than or equal to 0.1% is identif ied as a known or anticipated carcinogen by NTP. Carcinogenicity OSHA No component of this product present at levels greater than or equal to 0.1% is identif ied as carcinogen or potential carcinogen by OSHA. Reproductive Toxicity Reproductive toxicity -rat -Oral Ef f ects on Newborn: Growth statistics (e.g. reduce weight gain). Teratogenicity Developmental Toxicity - rat - Oral Ef f ects on Embryo or Fetus: Fetotoxicity (except death, e.g., stunted f etus). Ef f ects on Embryo or Fetus: Fetal death. Specif ic Developmental Abnormalities: Musculoskeletal system. Suspected of damaging the unborn child. Suspected human reproductive toxicant Ef f ects on a via lactation. 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 No data available 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 Of f er surplus and non-recyclable solutions to a licensed disposal company. Contact a licensed prof essional waste disposal service to dispose of this material. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an af terburner and scrubber. Waste Treatment Methods Packaging Dispose of as unused product. Special Precautions Landfill or Incinerations No data available Other Information No data available Page 3 of 4 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 Section 15: Regulatory Information WHMIS Classif ication D2A Very Toxic Material Causing Other Toxic Ef f ects Teratogen D2B Toxic Material Causing Other Toxic Ef f ects Respiratory sensitizer Skin sensitizer This product has been classif ied in accordance with the hazard criteria of the Controlled Products Regulations and the MSDS contains all the inf ormation required by the Controlled Products Regulations. Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/11/2019 10:00 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
