ENROFLOXACIN 1KG by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name Enrof loxacin 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 Serious eye damage/eye irritation Category 2A Signal Word Warning Hazard Statement(s) H319 Causes serious eye irritation Pictogram(s) Precautionary Statement(s) P264 Wash hands thoroughly af ter handling. P280 Wear protective gloves/protective clothing/eye protection/f ace protection. 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. P337+P313 If eye irritation persists Get medical advice/attention. Hazards Not Otherwise Classified Not classif ied Ingredient(s) with Unknown Toxicity Not available Section 3: Composition/Information on Ingredients Chemical Name Enrof loxacin Common Name Enrof loxacin CAS Number 93106-60-6 Impurities and/or Stabilizing Additives N/A Section 4: First Aid Measures General Advice Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance from an occupational health physician or other licensed health-care provider f amiliar with workplace chemical exposures. In the United States, the national poison control center phone number is 1-800-222-1222. If person is not breathing, give artif icial respiration. If breathing is dif f icult, give oxygen if available. Persons developing serious hypersensitivity (anaphylactic) reactions must receive immediate medical attention. If Inhaled Move to fresh air. Call a physician if symptoms develop or persist. In Case of Skin Contact Rinse skin with water/shower. Get medical attention if irritation develops and persists. In Case of Eye Contact Rinse cautiously with water f or several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Get medical attention if irritation develops and persists. If Swallowed Rinse mouth. If ingestion of a large amount does occur, call a poison control center immediately. Most Important Symptoms and Effects Irritation of eyes and mucous membranes. Central nervous system ef f ects. Indication of immediate medical attention and special treatment needed: Treatment f or f luoroquinolone overdose should be symptomatic and supportive and may include the f ollowing: 1. For acute ingestions, administer activated charcoal as a slurry. 2. Treat seizures with intravenous administration of a benzodiazepine. If seizures recur, consider phenobartital or propof ol. 3. Monitor f or hypotension, dysrhythmias, respiratory depression, need f or endotracheal intubation, hypoglycemia, electrolyte disturbances, and hypoxia. [Meditext 2008] Page 1 of 5 Section 5: Fire Fighting Measures Suitable Extinguishing Media Use f ire-extinguishing media appropriate f or surrounding materials. Water. Foam. Dry chemical or CO2. Special Hazards Arising From the Substance/Mixture No unusual f ire or explosion hazards noted. Special PPE and/or Precautions for Firefighters Wear suitable protective equipment. Use water spray to cool unopened containers. As with all f ires, evacuate personnel to a saf e area. Firef ighters should use self-contained breathing equipment and protective clothing. Use standard f iref ighting procedures and consider the hazards of other involved materials. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. Ensure adequate ventilation. Avoid inhalation of dust from the spilled material. Wear appropriate personal protective equipment. Methods and Materials Used for Containment Sweep up or vacuum up spillage and collect in suitable container f or disposal. Avoid the generation of dusts during clean-up. For waste disposal, see section 13 of the SDS. Clean surf ace thoroughly to remove residual contamination. Cleanup Procedures Sweep up or vacuum up spillage and collect in suitable container f or disposal. Avoid the generation of dusts during clean-up. For waste disposal, see section 13 of the SDS. Clean surf ace thoroughly to remove residual contamination. Section 7: Handling and Storage Precautions for Safe Handling As a general rule, avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Clean equipment and work surf aces with suitable detergent or solvent af ter use. Af ter removing gloves, wash hands and other exposed skin thoroughly. Conditions for Safe Storage Preserve in well-closed, tight, light-resistant-containers. This material should be handled and stored per label instructions to ensure product integrity. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters No biological exposure limits noted f or the ingredient(s). No exposure standards allocated. Appropriate Engineering Controls Airborne exposure should be controlled primarily by engineering controls such as general dilution ventilation, local exhaust ventilation, or process enclosure. Local exhaust ventilation is generally pref erred to general exhaust because it can control the contaminant at its source, preventing dispersion into the work area. An industrial hygiene survey involving air monitoring may be used to determine the ef f ectiveness of engineering controls. Ef f ectiveness of engineering controls intended f or use with highly potent materials should be assessed by use of nontoxic surrogate materials. Handle in accordance with good industrial hygiene and saf ety practice. PPE - Eye/Face Protection Saf ety glasses with sideshields are recommended. Face shields or goggles may be required if splash potential exists or if corrosive materials are present. Approved eye protection (e.g., bearing the ANSI Z87 or CSA stamp) is pref erred. Maintain eyewash f acilities in the work area. PPE - Skin Protection Chemically compatible gloves. For handling solutions, ensure that the glove material is protective against the solvent being used. Use handling practices that minimize direct hand contact. Employees who are sensitive to natural rubber (latex) should use nitrile or other synthetic nonlatex gloves. Use of powdered latex gloves should be avoided due to the risk of latex allergy. PPE - Body Protection For handling of laboratory scale quantities, a cloth lab coat is recommended. Where signif icant quantities are handled, work clothing may be necessary to prevent take-home contamination.. PPE - Respiratory Protection Where respirators are deemed necessary to reduce or control occupational exposures, use NIOSH-approved respiratory protection and have an ef f ective respirator program in place (applicable U.S. regulation OSHA 29 CFR 1910.134). Page 2 of 5 Section 9: Physical and Chemical Properties Appearance Creamy white to yellow crystalline or amorphous powder. Upper/Lower Flammability or Explosive Limits Not available Odor Not available Vapor Pressure < 0.0000001 kPa at 25 �C Odor Threshold Not available Vapor Density Not available pH Not available Relative Density Not available Melting Point/Freezing Point 426.2-437F (219 - 225 C) / 426.2 - 429.8 F (219 - 221 C) Solubility Slightly soluble in water. Initial Boiling Point and Boiling Range Not available Flash Point Not available Evaporation Rate Not available Flammability (Solid, Gas) Not applicable Partition Coefficient 3.1 (25C; pH 7) Auto-Ignition Temperature Not available Decomposition Temperature Not available Viscosity Not available Section 10: Stability and Reactivity Reactivity No reactivity hazards known. Chemical Stability Stable at normal conditions Possibility of Hazardous Reactions No dangerous reaction known under conditions of normal use. Conditions to Avoid None known. Incompatible Materials Strong oxidizing agents. Alkalis Hazardous Decomposition Products NOx, F - Irritating and/or toxic f umes or gases. Emits toxic f umes under f ire conditions. Page 3 of 5 Section 11: Toxicological Information Acute Toxicity - LD50 Oral Mouse 4336 mg/kg. Rat 5 g/kg Acute Toxicity - Inhalation Due to the lack of data the classif ication is not possible. Acute Toxicity - Dermal LD50 Rabbit >2000 mg/kg Acute Toxicity - Eye Causes serious eye irritation Skin Corrosion/Irritation Based on available data, the classif ication criteria are not met. Serious Eye Damage/Irritation Causes serious eye irritation. Respiratory or Skin Sensitazation Due to lack of data the classif ication is not possible. Germ Cell Mutagenicity Due to lack of data the classif ication is not possible. Chromosomal aberration test in Chinese hamster cells Result: Positive. Forward mutation assay in Chinese hamster cells Result: Equivocal. In vivo Chinese hamster bone marrow sister chromatid exchange assay Result: Negative. In vivo mouse bone marrow micronucleus assay Result: Negative. In vivo rat bone marrow chromosomal aberration assay Result: Negative. Unscheduled DNA synthesis in rat hepatocytes Result: Negative. Carcinogenicity IARC Based on available data, the classif ication criteria are not met. This material is not considered to be a carcinogen by IARC, NTP, or OSHA. Carcinogenicity ACGIH Based on available data, the classif ication criteria are not met. Carcinogenicity NTP Based on available data, the classif ication criteria are not met. This material is not considered to be a carcinogen by IARC, NTP, or OSHA. Carcinogenicity OSHA Based on available data, the classif ication criteria are not met. This material is not considered to be a carcinogen by IARC, NTP, or OSHA. Reproductive Toxicity Based on available data, the classif ication criteria are not met. In a multi-center, prospective controlled trial in 400 women, therapeutic use of f luoroquinolones during embryogenesis was not associated with an increased risk of major malf ormations. In animal studies, f luoroquinolones have been shown to have a destructive ef f ect on juvenile cartilage and weight-bearing joints. Specific Target Organ Toxicity - Single Exposure Based on available data, the classif ication criteria are not met. Specific Target Organ Toxicity - Repeated Exposure Based on available data, the classif ication criteria are not met. Aspiration Hazard Based on available data, the classif ication criteria are not met. Section 12: Ecological Information Toxicity Aquatic: Crustacea EC50 Whiteleg shrimp (Penaeus vannamei) 0.0143 mg/l, 48 hours. Acute: Fish: LC50 Bluegil (Lepomis macrochirus) 216 ppm, 96 hours. Rainbow Trout: > 196 ppm, 96 hours. Persistence and Degradability No data is available on the degradability of this product. Bio-accumulative Potential Not available Mobility in Soil Not available Other Adverse Effects Not available Section 13: Disposal Considerations Waste Treatment Methods Product Dispose in accordance with all applicable regulations. Under RCRA, it is the responsibility of the user of the product to determine, at the time of disposal, whether the product meets RCRA criteria f or hazardous waste. Waste Treatment Methods Packaging Empty containers should be taken to an approved waste handling site f or recycling or disposal. Since emptied containers may retain product residue, f ollow label warnings even af ter container is emptied. Special Precautions Landfill or Incinerations Dispose of in accordance with local regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a saf e manner (see: Disposal instructions). Other Information Not available. Section 14: Transport Information UN Number UN3077 UN Proper Shipping Name Environmentally hazardous substance, solid, n.o.s. (Enrof loxacin) Transport Hazard Class(es) 9 Packaging Group III Environmental Hazards Environmentally hazardous substance, solid, n.o.s. (Enrof loxacin) Page 4 of 5 Section 15: Regulatory Information CERCLA/SARA Hazardous Substances - Not applicable One or more components are not listed on TSCA. Superf und Amendments and Reauthorization Act of 1986 (SARA): Hazard categories Immediate Hazard-Yes, Delayed Hazard-No, Fire Hazard-No, Pressure Hazard-No, Reactivity Hazard-No, SARA 302 Extremely hazardous substance-No, SARA 311/312 Hazardous chemical No. Other f ederal regulations: Saf e Drinking Water Act (SDWA): Not regulated. US State regulations: Calif ornia Saf e Drinking water and Toxic Enf orcement Act of 1986 (Proposition 65): This material is not known to contain any chemicals currently listed as carcinogens or reproductive toxins. International Inventories: Country: Australia: AICS-No, Canada: DSL-No, Canada: NDSL-No, China: IECSC-Yes, Europe: EINECS-No, Europe: ELINCS-No, Japan: ENCS-No, Korea: ECL-Yes, New Zealand: New Zealand Inventory-Yes, Philippines: PICCS-No, United States & Puerto Rico-TSCA-No. Section 16: Other Information Additional Information N/A Prepared By Scarlotte Smith Revision Date 12/31/2018 16:46 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 5 of 5
