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MATERIAL SAFETY DATA SHEET - Boehringer Ingelheim Vetmedica

MATERIAL SAFETY DATA SHEET - Boehringer Ingelheim Vetmedica

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Metacam® (meloxicam) 2 mg/mLSolution for Injection2013-February-04Keep away from ignition sources such as heat/sparks/open flames-No smoking.Wear protective gloves and eye/face protection.Accidental human injection can cause serious local reactions or anaphylactic reaction andsystemic effects.Keep only in original container.Store at a controlled room temperature, 20°- 25° C (68°-77° F).Fire-fighting: Use carbon dioxide, dry chemicals, water spray or foam.Avoid contact with eyes, skin and clothing.Wash thoroughly with soap and water after handling.Spills: Cover with nonflammable absorbent or contain. Collect and dispose.In case of accident or if you feel unwell, seek medical advice immediately (show the label wherepossible).Have the product container or label with you when calling a poison control center or doctor, orgoing for treatment.If swallowed, seek medical advice immediately and show this container or label.This material and its container must be disposed of in a safe way.Keep out of reach of children.Keep away from food, drink, and animal feedstuffs.Potential Health EffectsInhalation: Not expected to be an inhalation hazard.Eye Contact: Not expected to be a hazard to the eye with prescribed use. Exposure to liquid ineye may cause eye irritation.Skin Contact: Not expected to be a hazard to the skin with prescribed use. Exposure to liquid toskin may cause transient irritation.Ingestion: Not expected to be an ingestion hazard with prescribed use. Ingestion may causevomiting, nausea or other systemic effects.Injection: Swelling at injection site may occur.Chronic Health Effects: Possible hypersensitization (development of abnormal sensitivity).Target Organ(s): Skin, muscles, gastrointestinal tract, kidneys, liverOSHA Regulatory Status: Nonhazardous, exemptEnvironment: No data available3 COMPOSITION / INFORMATION ON INGREDIENTSChemical Name EC No. CAS- No. Concentration Classification NotesMeloxicam ---- 71125-38-7 2 mg/mL ---- ----Ethanol 2005786 64-17-5 15 % R11, S(2), 7, 16 ----The full texts for all R-Phrases are displayed in Section 16.4 FIRST AID MEASURES2/9


Metacam® (meloxicam) 2 mg/mLSolution for Injection2013-February-04General: Animals or persons developing anaphylactic (life-threatening) reactions, such asdifficulty in breathing or unconsciousness, must receive immediate medical attention.Inhalation: Move to fresh air. Treat symptomatically. Get medical attention if symptoms persist.Eye Contact: Any material that contacts the eye should be washed out immediately with water.If easy to do, remove contact lenses. Get medical attention if symptoms persist.Skin Contact: In case of contact, immediately flush skin with plenty of water for at least 15minutes while removing contaminated clothing and shoes. Get medical attention if symptomsoccur.Ingestion: Call a physician or poison control center immediately. Only induce vomiting at theinstruction of medical personnel. Never give anything by mouth to an unconscious person.Injection: In case of accidental injection, wash the site thoroughly. Contact a physicianimmediately.Note to Physician: For animal injection only. Not for human use.Antidote: Epinephrine is indicated for anaphylactoid reactions.5 FIRE-FIGHTING MEASURESExtinguishing Media: Use carbon dioxide, dry chemicals, water spray or foam.Unsuitable Extinguishing Media: Water Jet. USE WATER WITH CAUTION. Material willfloat and may ignite on the surface of the water. Use water spray to keep fire-exposed containerscool. Water may be ineffective in fighting the fire.Special Fire Fighting Procedures: Wear self-contained breathing apparatus and protectiveclothing.Unusual Fire & Explosion Hazards: Vapors may cause a flash fire or ignite explosively.Vapors may travel considerable distance to a source of ignition and flash back. Prevent build-upof vapors to explosive concentrations.Hazardous Combustion Products: Carbon monoxide, carbon dioxideFlammability Class: IC6 ACCIDENTAL RELEASE MEASURESPersonal Precautions: Wear appropriate personal protective equipment. See Section 8.Spill Cleanup Methods: Small liquid spill: Eliminate all ignition sources. Use water to dispersevapors and dilute spill to a nonflammable mixture. Use a non-combustible material likevermiculite, earth or sand to soak up the product and place into container for later disposal. Forlarge liquid spill: Absorb or cover with dry earth, sand or other non-combustible material andtransfer to containers.3/9


Metacam® (meloxicam) 2 mg/mLSolution for Injection2013-February-04Environmental Precautions: Prevent runoff from entering drains, sewers or streams. Dike forlater disposal.7 HANDLING AND STORAGEHandling: Avoid contact with eyes, skin and clothing. Avoid accidental injection. Do not taste orswallow. Wash thoroughly with soap and water after handling. Use only with adequateventilation.Fire and Explosion Protection: Keep away from heat, sparks and flame. Keep from contact withoxidizing materials. Comply with all national, state and local codes pertaining to the storage,handling, dispensing and disposal of flammable liquids.Storage: Keep only in the original container. Store at a controlled room temperature, 20°- 25° C(68°-77° F). Do not refrigerate. Avoid freezing. Keep out of reach of children. Keep away fromfood, drink, and animal feedstuffs.8 EXPOSURE CONTROLS / PERSONAL PROTECTIONExposure Limits:Chemical Name Source Type ExposureNotesLimitsMeloxicam BIEL* TWA 150 µg/m 3 --Meloxicam BIEL* STEL 600 µg/m 3 --(15 minutes)Meloxicam BIEL* STEL 300 µg/m 3 --( 1 hour)Ethanol ACGIH TWA 1000 ppm IrritationEthyl alcohol NIOSH IDLH 3300 ppm --Ethyl alcohol OSHA TWA 1000 ppm --Ethyl alcohol Cal OSHA TWA 1000 ppm --*BIEL is the BI (<strong>Boehringer</strong> <strong>Ingelheim</strong>) Exposure Control Level. Where lower governmentallyimposed occupational exposure limits exist, such limits should take precedence.Engineering Controls: Not generally required when handling vials or containers. Goodventilation (typically 10 air changes per hour) should be used. Ventilation rates should bematched to conditions. If applicable, use process enclosures, local exhaust ventilation, or otherengineering controls to maintain airborne levels below recommended exposure limits. If exposurelimits have not been established, maintain airborne levels to an acceptable level.Respiratory Protection: Not generally required when handling vials or containers. Ifengineering controls do not maintain airborne concentrations below recommended exposurelimits (where applicable) or to an acceptable level (in countries where exposure limits have notbeen established), an approved respirator must be worn. In the United States of America, if4/9


Metacam® (meloxicam) 2 mg/mLSolution for Injection2013-February-04respirators are used, a program should be instituted to assure compliance with OSHA standard 63FR 1152, January 8, 1998. Respirator type: NIOSH approved organic vapor respirator.PERSONAL PROTECTIVE EQUIPMENT: Not generally required when handling containers.If containers are compromised or exposure to the active ingredient or mixture is likely wear:Eye Protection: Wear safety glasses with side shields (or goggles).Hand Protection: Wear suitable gloves.Skin Protection: Wear protective clothing appropriate for the risk of exposure.Hygiene Measures: Eye bath, washing facilities, shower9 PHYSICAL AND CHEMICAL PROPERTIESColor: Clear yellowOdor: Like ethanolOdor Threshold: No data availablePhysical State: Aqueous liquid 2 mg/mL vialpH: 8.0 – 8.9Melting Point: No data availableFreezing Point: No data availableBoiling Point: No data availableFlash Point: 35.6° C (96.0 F)Flammability Limit – Upper (%): No data availableFlammability Limit – Lower (%): No data availableEvaporation rate: No data availableVapor Pressure: No data availableVapor Density (Air=1): No data availableSpecific Gravity: 1.0Solubility: InsolublePartition Coefficient (n-Octanol/water): No data availableAutoignition Temperature: No data availableDecomposition Temperature: No data available10 STABILITY AND REACTIVITYStability: StableConditions to Avoid: Heat; ignition sourcesIncompatible Materials: Strong oxidizing agentsHazardous Decomposition Products: None knownPossibility of Hazardous Reactions: Hazardous polymerization will not occur.11 TOXICOLOGICAL INFORMATION5/9


Metacam® (meloxicam) 2 mg/mLSolution for Injection2013-February-04Specified SubstancesAcute ToxicityChemical Name – Meloxicam drug substance2H-1,2-Benzothiazine-3-carboxamide, 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-1,1-dioxideTest ResultsOral LD 50 (rat): 84 mg/kgOral LD 50 (mouse): 470 mg/kgOral LD 50 (rabbit): 320 mg/kgConsult the MSDS for Metacam 5 mg/mL Solution for Injection produced by BIVI, 2621 NorthBelt Highway, St. Joseph, MO.Listed CarcinogensChemical Name IARC NTP OSHA ACGIHAlcoholic beverages 1- Carcinogenic(alcohol)to human-- -- --Alcoholic beverageKnown--consumption (alcohol)carcinogen-- --12 ECOLOGICAL INFORMATIONEcotoxicity: No data availablePersistence and degradability: No data availableMobility in soil: No data availableOther adverse effects: No data availableGermany WGK: Meloxicam (:2H-1,2-benzothiazine-3-carboxamide, 4-hydroxy-2-methyl-n-(5-methyl-2-thiazolyl)-,1,1-dioxide: ID No: 7588; Class: 2: water-endangering; Ethanol: ID No. 96;Class 1: slightly water-endangering.13 DISPOSAL CONSIDERATIONSGeneral Information: Dispose of in accordance with local, state and federal regulations.Disposal Methods: No specific disposal method required. Do not empty into drains; dispose ofthis material and its container in a safe way. Do not contaminate water, food, or feed by storagedisposal.RCRA Information: Not applicableContainer: Since emptied containers retain product residue, follow label warnings even aftercontainer is emptied.14 TRANSPORT INFORMATIONDOT:Proper Shipping Name: UN1170, Ethanol Solution, 3, IIITDG:Proper Shipping Name: UN1170, Ethanol Solution, 3, III6/9


Metacam® (meloxicam) 2 mg/mLSolution for Injection2013-February-04ADR:Proper Shipping Name: UN1170, Ethanol Solution, 3, IIIHazard ID No.: 33RID:Proper Shipping Name: UN1170, Ethanol Solution, 3, IIIHazard ID No.: 30IATA:Proper Shipping Name: UN1170, Ethanol Solution, 3, IIIIMDG:Proper Shipping Name: UN1170, Ethanol Solution, 3, III15 REGULATORY INFORMATIONCanadian Controlled Products Regulations: This product has been classified according to thehazard criteria of the Canadian Controlled Products Regulations, Section 33, and the MSDScontains all required information.WHMIS Classification: Noncontrolled, exemptInventory StatusThis material is not listed on the US TSCA Inventory. Therefore, it can only be used for TSCA exemptpurposes such as R&D or veterinary use.This material is not listed on the DSL Inventory.Canada CEPA Schedule 1 - NoneUS RegulationsCERCLA Hazardous Substance List (40 CFR 302.4): NoneSARA Title IIISection 302Extremely Hazardous Substance (40 CFR 355, Appendix A): NoneClean Water Act Section 311 Hazardous Substances (40 CFR 117.3): NoneFEDERAL LAW restricts this drug to use by or on the order of a licensed veterinarian.State RegulationsCalifornia Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65):WARNING: This product contains a chemical known to the state of California to cause cancerand birth defects or other reproductive harm.California Prop 65 chemicals: Alcoholic beverages, when associated with alcohol abuseCalifornia Hazardous Substance List: Ethyl alcoholMassachusetts Right-To-Know List: EthanolMinnesota Hazardous Substances List: Ethyl alcohol7/9


Metacam® (meloxicam) 2 mg/mLSolution for Injection2013-February-04New Jersey Right-To-Know List: EthanolPennsylvania Right-To-Know List: EthanolRhode Island Right-To-Know List: EthanolEuropean RegulationsAustria MAK List (Annex I): Ethylalkohol, S. ethanolDenmark (Annex 3.6, April 2005): NoneGermany (Dangerous Substances Ordinance 2004, Annex III): NoneNorway (List of Dangerous Substance): EtanolSweden (Sensitizers- Annex 3): NoneSwitzerland (Toxins List 1): None16 OTHER INFORMATIONHazard RatingsHealth Hazard Fire Hazard Reactivity HazardHMIS 1* 3 0Health Hazard Fire Hazard Reactivity Hazard Special HazardNFPA 1 3 0 N/A*- Chronic health effect; 0 – Minimal; 1 – Slight; 2 – Moderate; 3 – Serious; 4 – SevereR11 – Highly flammableR43 - May cause sensitization by skin contact.S7- Keep container closedS16 – Keep away from sources of ignition – No smoking.S24 - Avoid contact with skin.S37 – Wear suitable gloves.ABBREVIATIONS:BIEL - <strong>Boehringer</strong> <strong>Ingelheim</strong> Exposure Control Level.BIV - <strong>Boehringer</strong> <strong>Ingelheim</strong> <strong>Vetmedica</strong>, Inc.AIHA- American Industrial Hygiene AssociationN/A - Not applicable.N/E - Not established.References:1. Ariel WebInsight Regulatory Database. Regulatory Summary for North America,Western Europe, and Global Inventories Database2. Metacam® Product Information, Package Insert, <strong>Boehringer</strong> <strong>Ingelheim</strong> <strong>Vetmedica</strong>,Inc.3. RTECS4. Food & Drug Administration. www.fda.gov5. Food & Drug Administration, NADA 141-2196. GHS Manual8/9


Metacam® (meloxicam) 2 mg/mLSolution for Injection2013-February-04Prepared by: <strong>Boehringer</strong> <strong>Ingelheim</strong> <strong>Vetmedica</strong>, Inc.Issue Date: 06/05/07Revision Date: 2/4/2013Disclaimer: The information provided herein is offered by <strong>Boehringer</strong> <strong>Ingelheim</strong> <strong>Vetmedica</strong>,Inc. (“BIV”) in good faith as accurate as of the date hereof, but without guarantee. Thisinformation includes information which has been generated by other parties and provided to BIV,and which BIV has not independently verified. The information provided herein relates only tothe specific product designated, and may not be valid where such product is used in combinationwith any other materials or in any process. The information provided herein is offered solely foryour consideration, investigation and verification, and <strong>Boehringer</strong> <strong>Ingelheim</strong> <strong>Vetmedica</strong>, Inc.(“BIV”) expressly disclaims all liability for reliance thereon. BIV EXPRESSLY DISCLAIMSALL WARRANTIES OF EVERY KIND AND NATURE (INCLUDING WARRANTIES OFMERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE) WITH RESPECTTO THE USE OR SUITABILITY OF THE PRODUCT. In addition, since the conditions of useand suitability of the product for particular uses are beyond BIV’s control, ALL RISKS OF USEOF THE PRODUCT ARE THEREFORE ASSUMED BY THE USER, AND BIV EXPRESSLYDISCLAIMS ANY AND ALL LIABILITY AS TO ANY RESULTS OBTAINED ORARISING FROM ANY USE OF THE PRODUCT. Use or transmission of the informationcontained herein in any other format than the format as presented is strictly prohibited. Nothingherein shall be construed as permission or recommendation for the use of the product in a mannerthat might infringe an existing patent. BIV neither represents nor warrants that the format, contentor product formulas contained in this document comply with the laws of any other country exceptthe United States of America.© Copyright 2013 <strong>Boehringer</strong> <strong>Ingelheim</strong> <strong>Vetmedica</strong>, Inc. All rights reserved.9/9

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