DOXYCYCLINE HYCLATE, USP 25GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name DOXYCYCLINE HYCLATE 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) Doxycycline hydrochloride hemiethanolate hemihydrate 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), Reproductive toxicity (Category 2) Signal Word Warning Hazard Statement(s) H302 Harmf ul if swallowed H361 Suspected of damaging f ertility or the unborn child Pictogram(s) Precautionary Statement(s) P201 Obtain special instructions bef ore use. P202 Do not handle until all saf ety precautions have been read and understood. P264 Wash hands thoroughly af ter handling. 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. P308+P313 IF exposed or concerned Get medical advice/attention. P330 Rinse mouth. P405 Store locked up. 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 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12apentahydroxy-6-methyl1,11-dioxo-, monohydrochloride, compound with ethanol (2:1),monohydrate, [4S-(4alpha, 4a alpha, 5alpha, 5a alpha, 6alpha, 12a alpha)]- Common Name Doxycycline hydrochloride hemiethanolate hemihydrate CAS Number 24390-14-5 Impurities and/or Stabilizing Additives No data available 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. Person 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 with water. Get medical attention if irritation develops and persists. If Swallowed Rinse mouth. If SWALLOWED: Call a POISON CENTER or doctor/physician if you f eel unwell. Most Important Symptoms and Effects No data available Page 1 of 4 Section 5: Fire Fighting Measures Suitable Extinguishing Media Water spray, dry chemical, carbon dioxide, or f oam a 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 area. 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. 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. 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 the 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, mist, 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. Use of designated area is recommended f or handling of potent materials. 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: Doxycycline Hyclate CAS-No. 24390-14-5 Type: TWA Value: 250 micrograms/m3 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 be control the contaminant at its source, preventing dispersion into the work area. An industrial hygiene survey involving air monitoring may be used to determined 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 on 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. Handle in accordance with good industrial hygiene and saf ety practice. PPE - Eye/Face Protection Saf ety glasses with side shields are recommended. Face shields or goggle may be required if splash potential exits or if corrosive materials are present. Approved eye protection 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. (applicable U.S. regulation OSHA 29 CFR 1910.34) Page 2 of 4 Section 9: Physical and Chemical Properties Appearance Form: Powder Physical state: Solid Colour: Light yellow crystalline powder Upper/Lower Flammability or Explosive Limits No data available Odor Essentially odorless Vapor Pressure < 1mm Hg Odor Threshold No data available Vapor Density No data available pH 2 - 3 (1% aqueous solution) Relative Density No data available Melting Point/Freezing Point 393.8 �F (201 �C) (chars without melting) Solubility Solubility in water 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 Auto ignition temperature 1652 �F (900 �C) 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 known under conditions of normal use. Conditions to Avoid None known. Incompatible Materials Strong oxidizing agents. Hazardous Decomposition Products NOx. CI-, 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 Dog >500 mg/kg Mouse 1890 mg/kg Rat 1700 mg/kg Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye No data available Skin Corrosion/Irritation Due to lack of data the classif ication is not possible. Serious Eye Damage/Irritation Due to lack of data the classif ication is not possible. 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. Data from germ cell mutagenicity tests were not f ound. Carcinogenicity IARC Due to lack of data the classif ication is not possible. This material is not considered to be a carcinogen by IARC. Carcinogenicity ACGIH Due to lack of data the classif ication is not possible. This material is not considered to be carcinogen by ACGIH. Carcinogenicity NTP Due to lack of data the classif ication is not possible. This material is not considered to be carcinogen by NTP. Carcinogenicity OSHA Due to lack of data the classif ication is not possible. This material is not considered to be a carcinogen by OSHA. Reproductive Toxicity Suspected of damaging f ertility or the unborn child. Use of tetracycline during the last half of pregnancy may cause permanent discoloration of the teeth, incomplete development of lack of enamel, an inhibition of skeletal grown in the f etus. In addition, f atty inf iltration of the liver, leading to damage or f ailure, may occur in pregnant women. Tetracyclines administered early in pregnancy have been f ound to cause harm to the embryo. 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. Page 3 of 4 Section 12: Ecological Information Toxicity No ecotoxicity data noted f or the ingredients. 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 in not hazardous waste according to Federal regulations (40 CFR 26.14 (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 of waste in accordance with all applicable Federal, State, and local laws. 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). Special Precautions Landfill or Incinerations 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. Other Information No data available Section 14: Transport Information UN Number Not regulated as hazardous material by DOT. UN Proper Shipping Name N/A Transport Hazard Class(es) N/A Packaging Group N/A Environmental Hazards N/A 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) Superf und Amendments and Reauthorization Act of 1986 (SARA) Immediate Hazard - Yes Delayed Hazard - Yes 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) Not regulated. US state regulations WARNING: This product contains chemical know to the State of Calif ornia to cause birth def ects or other reproductive harm. Issue Date 07/01/2008 Revision Date 10/18/2013 Section 16: Other Information Additional Information Prepared By Lisa Russell Revision Date 01/11/2019 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 4 of 4
