MAFENIDE ACETATE, USP 5KG by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name MAFENIDE ACETATE 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) Benzenesulf onamide, 4-(aminomethyl)-, monoacetate 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 2B), Sensitization, respiratory (Category 1B), Sensitization, skin (Category 1B) Signal Word Danger Hazard Statement(s) H317 May cause an allergic skin reaction H320 Causes eye irritation H334 May cause allergy or asthma symptoms or breathing dif f iculties if inhaled Pictogram(s) Precautionary Statement(s) P264 Wash hands thoroughly af ter handling. P272 Contaminated work clothing should not be allowed out of the workplace. P280 Wear protective gloves/protective clothing/eye protection/f ace protection. P285 In case of inadequate ventilation wear respiratory protection. P302+P352 IF ON SKIN Wash with soap and water. P304+P341 IF INHALED If breathing is dif f icult, 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. P333+P313 If skin irritation or a rash occurs Get medical advice/attention. P337+P313 If eye irritation persists Get medical advice/attention. P363 Wash contaminated clothing bef ore reuse. P501 Dispose of contents/container to an approved waste disposal plant. Hazards Not Otherwise Classified No data available Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name Benzenesulf onamide, 4-(aminomethyl)-, monoacetate Common Name Maf enide Acetate CAS Number 13009-99-9 Impurities and/or Stabilizing Additives No data available Page 1 of 4 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. Oxygen or artif icial respiration if needed. Do not use mouth-to-mouth method if victim inhaled the substance. Induce artif icial respiration with the aid of pocket mask equipped with a one-way valve or other proper respiratory medical advice. 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. Get medical attention if irritation develops and persists. If Swallowed Rinse mouth. Get medical attention if symptoms occur. Most Important Symptoms and Effects 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. Section 5: Fire Fighting Measures Suitable Extinguishing Media Water spray, dry chemical, carbon dioxide, or f oam as appropriate f or surrounding f ire and materials. 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. As with all f ires, evacuate personnel to saf e areas. Firef ighters should use selfcontained breathing equipment and protective clothing. 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. Cool containers exposed to f lames with water until well af ter f ire is out. Methods and Materials Used for Containment Sweep up and 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 SDS. Wash spill site. Cleanup Procedures Sweep up and 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 SDS. Wash spill site. Section 7: Handling and Storage Precautions for Safe Handling As a general rule, when handling chemicals, 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 Store in tight container as def ined in the USP-NF. 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 Material Maf enide Acetate (CAS 13009-99-9) Type TWA Value: 0.5 mg/m3 No biological exposure limits noted f or the ingredient(s). 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. Local exhaust ventilation such as a laboratory f ume hood or other vented enclosure is recommended, particularly f or grinding, crushing, weighing, or other dust-generating procedures. 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 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. 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. Page 2 of 4 Section 9: Physical and Chemical Properties Appearance Form: Solid Powder Colour: White crystalline powder Upper/Lower Flammability or Explosive Limits No data available Odor Slight acidic odor Vapor Pressure 0.0000032 kPa at 25 �C Odor Threshold No data available Vapor Density No data available pH No data available Relative Density No data available Melting Point/Freezing Point 323.6 - 341.6 �F (162 - 172 �C) ; also reported 151 - 152 �C Solubility Solubility in water Freely soluble. 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 Section 10: Stability and Reactivity Reactivity No reactivity hazards known. Chemical Stability Stable at normal conditions. Possibility of Hazardous Reactions No dangerous reaction under condition of normal use. Conditions to Avoid None under normal conditions Incompatible Materials Strong bases. Oxidizers. Hazardous Decomposition Products SOx. NOx. Irritating and/or toxic f umes or gases. Emits toxic f umes under f ire conditions. Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 Oral Guinea pig 5425 mg/kg Mouse 10183 mg/kg Rat 9212 mg/kg Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye Causes eye irritation. Skin Corrosion/Irritation Due to lack of data the classif ication is not possible. Serious Eye Damage/Irritation Causes eye irritation. Respiratory or Skin Sensitazation May cause allergy or asthma symptoms or breathing dif f iculties if inhaled. Germ Cell Mutagenicity Due to lack of data the classif ication is not possible. Carcinogenicity IARC This product is not considered to be a carcinogen by IARC. Carcinogenicity ACGIH This product is not considered to be a carcinogen by ACGIH. Carcinogenicity NTP This product is not considered to be a carcinogen by NTP. Carcinogenicity OSHA This product is not considered to be a carcinogen by OSHA. Reproductive Toxicity Bases on available data, the classif ication criteria are not met. 1 - 1000 mg/kg/day Reproductively test Result: Frequency of malf ormations was no greater than expected. Species: Rat 1 g/kg Reproductively test Result: Some decrease in implantation but no congenital def ects were noted. Species: Mouse 600 mg/kg/day Reproductively test Result: No f etal toxicity. Species: Rat Specific Target Organ Toxicity - Single Exposure Due to lack of data the classif ication is not possible. Specific Target Organ Toxicity - Repeated Exposure Due to lack of data the classif ication is not possible. Aspiration Hazard Based on available data, the classif ication criteria are not met. Page 3 of 4 Section 12: Ecological Information Toxicity No ecotoxicity data noted f or the ingredient(s). 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 This product, in its present state, when discarded or disposed of , is not hazardous waste according to Federal regulations (40 CFR 261.4 (b) (4)). 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. Dispose in accordance with all applicable regulations. Waste Treatment Methods Packaging 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). Empty containers should be taken to an approved waste 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 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 Section 15: Regulatory Information Us f ederal regulations: CERCLA/SARA Hazardous Substances - Not applicable. One or more components are not listed on TSCA. Superf und Amendments and Reauthorization Act of 1986 (SARA) Hazardous Categories: Immediate Hazard - No 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. Food and Drug Administration (FDA). 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 a carcinogens or reproductive toxins. Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/11/2019 09:53 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
