Metacam® 2% (20 mg/mL) Solution for Injection - Boehringer ...

Metacam® 2% (20 mg/mL) Solution forInjectionNovember 26, 2012MATERIAL SAFETY DATA SHEET1 PRODUCT AND COMPANY IDENTIFICATIONProduct Name: Metacam® (Meloxicam) 2% Solution for Injection (20 mg/mL)Product No.: Not applicableGHS Product Identifier: Not applicableSynonyms: MeloxicamMolecular Formula: Mixture, not applicableMolecular Weight: Mixture, not applicableCAS Number: Mixture, not applicableChemical Family: Oxicam class of non-steroidal anti-inflammatory drugs (NSAID)Manufacturer:Boehringer Ingelheim Vetmedica, Inc.2621 North Belt HwySt. Joseph, MO 64506-2002Transportation Emergency: For ChemicalEmergency Spill, Leak, Fire, Exposure, orAccident Call CHEMTREC Day or NightWithin USA and Canada: 1-800-424-9300Outside USA and Canada: +1 703-527-3887(collect calls accepted)Medical Emergency (24HR): (866) 638-2226Non-Emergency Telephone: (800) 821-7467Intended Use: Non-steroidal antiinflammatoryfor use in animals2 HAZARDS IDENTIFICATIONUS GHS ClassificationPhysical HazardsHazard Classification Hazard CategoryFlammable Liquids Category 3Health HazardsHazard ClassificationSerious Eye Damage/IrritationHazard CategoryCategory 2A1/10

Metacam® 2% (20 mg/mL) Solution forInjectionNovember 26, 2012US GHS Label ElementsSignal Word: WARNING!Symbol(s):Hazard Statements: Flammable liquid and vapor. Causes serious eye irritation.Precautionary Statement(s):General:If medical advice is needed, have product container or label at hand.Keep out of reach of children.Read label before use.Prevention:Keep away from heat/sparks/open flames/hot surfaces – No smoking.Keep container tightly closed.Ground/bond container and receiving equipment.Use explosion-proof electrical/ventilating/lighting equipment.Use only non-sparking tools.Take precautionary measures against static discharge.Wash thoroughly after handling.Wear protective gloves/eye protection/face protection.Response:In case of fire: Use water spray, carbon dioxide, dry chemical or alcohol foam to extinguish.IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin withwater/shower.IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if presentand easy to do. Continue rinsing.If eye irritation persists: get medical advice/attention.Storage:Store in a well-ventilated place. Keep cool.Disposal:Dispose of contents/container to in accordance with applicable local authority requirements.OSHA Regulatory Status: Hazardous (exempt)Environment: No data available2/10

Metacam® 2% (20 mg/mL) Solution forInjectionNovember 26, 20123 COMPOSITION / INFORMATION ON INGREDIENTSChemical Name EC No. CAS- No. Concentration Classification NotesMeloxicam 615-253-8 71125-38-7 20 mg/mL ---- ----Ethanol 200-578-6 64-17-5 15% F; R11 ----Components not listed are not hazardous or are below reportable limits.The full texts for all R-Phrases are displayed in Section 16.4 FIRST AID MEASURESGeneral: 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. Ifeasy to do, remove contact lenses. Get medical attention.Skin Contact: In case of contact, immediately flush skin with plenty of water for at least 15minutes while removing contaminated clothing and shoes. If skin irritation or rash occurs, seekmedical advice. Wash contaminated clothing before reuse.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.5 FIRE-FIGHTING MEASURESExtinguishing Media: Extinguish with water spray, dry chemical, carbon dioxide, foamUnsuitable Extinguishing Media: None knownSpecial Fire Fighting Procedures: Wear self-contained breathing apparatus and protectiveclothing. Fight fire from a protected location. Use water spray to keep fire-exposed containerscool.Unusual Fire & Explosion Hazards: Vapors may cause a flash fire or ignite explosively.Vapors may travel to a source of ignition and flashback. Prevent build-up of vapors or gases toexplosive concentrations.Hazardous Combustion Products: Carbon monoxide, carbon dioxide, nitrogen oxides, sulfuroxides3/10

Metacam® 2% (20 mg/mL) Solution forInjectionNovember 26, 20126 ACCIDENTAL RELEASE MEASURESPersonal Precautions: Wear appropriate personal protective equipment (See Section 8).Spill Cleanup Methods: STEPS TO BE TAKEN IF SIGNIFICANT QUANTITIES OFPRODUCT IS SPILLED: Eliminate all ignition sources. Absorb or cover with dry earth, sand orother non-combustible material. Place spillage in appropriate container for waste disposal. Washcontaminated clothing before use.Environmental Precautions: Prevent runoff from entering drains, sewers or streams. Dike forlater disposal.7 HANDLING AND STORAGEHandling: HANDLING SIGNIFICANT QUANTITIES OF LIQUID: Avoid breathing vapors.Avoid contact with eyes, skin or clothing. Avoid accidental injection. Use adequate ventilation.Wash hand thoroughly after handling.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 Exposure Limits NotesEthyl alcohol ACGIH STEL 1000 ppm IrritationEthyl alcohol OSHA Z-1 PEL 1000 ppm ----Meloxicam BIEL* TWA 150 µg/m 3 ----Meloxicam BIEL* STEL 600 µg/m 3 ----(15 minutes)Meloxicam BIEL* STEL 300 µg/m 3 ----( 1 hour)*BIEL is the BI (Boehringer Ingelheim) Exposure Control Level.Where lower governmentally imposed 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, ifrespirators 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.4/10

Metacam® 2% (20 mg/mL) Solution forInjectionNovember 26, 2012Europe: Wear appropriate personal protective equipment according to the CouncilDirective 89/686/EEC (4) and the appropriate CEN standards.PERSONAL PROTECTIVE EQUIPMENT: Not generally required when handling containers.If containers are compromised or exposure to the mixture is likely wear:Eye Protection: Wear safety glasses with side shields (or goggles).Hand Protection: Wear suitable gloves.Skin Protection: Wear lab coat, apron or appropriate clothing to prevent skin contact.Hygiene Measures: Eye bath, washing facilities9 PHYSICAL AND CHEMICAL PROPERTIESColor: Clear yellowOdor: Like ethanolOdor Threshold: No data availablePhysical State: Aqueous liquid 20 mg/mL vialpH: 8.0 – 9.7Melting Point: No data availableFreezing Point: No data availableBoiling Point: No data availableFlash Point: 35.6°C (96°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: 1.56Solubility: InsolublePartition Coefficient (n-octanol/water): No data availableAutoignition Temperature: No data availableDecomposition Temperature: No data available10 STABILITY AND REACTIVITYStability: Stable.Conditions to Avoid: Elevated temperatures, sparks, flame and ignition sourcesIncompatible Materials: Strong oxidizing agentsHazardous Decomposition Products: Nitrogen oxides, sulfur oxidesPossibility of Hazardous Reactions: Hazardous polymerization will not occur.5/10

Metacam® 2% (20 mg/mL) Solution forInjectionNovember 26, 201211 TOXICOLOGICAL INFORMATIONSpecified SubstancesAcute ToxicityChemical NameEthanolMeloxicamTest ResultsEye Irritation (rabbit): 500 mg/24 H – Moderate irritationOral LD50 (rat) : 7060 mg/kgOral LD50 (mouse) : 3450 mg/kgInhalation LC50 (rat): 5900 mg/m 3 /4HOral LD50 (rat): 84 mg/kgOral LD50 (mouse): 470 mg/kgOral LD50 (rabbit): 320 mg/kgChronic Health Effects: Possible hypersensitization (development of abnormal sensitivity).Listed Carcinogens:Chemical Name IARC NTP OSHA ACGIHEthanol in alcoholic Group 1 – NTP Known ---- ----beveragesCarcinogenic tohumanscarcinogenEthanol ---- ---- ---- A3 – Confirmedanimal carcinogenwith unknownrelevance tohumans12 ECOLOGICAL INFORMATIONEcotoxicity: No data availablePersistence and degradability: No data availableMobility in soil: No data availableOther adverse effects: No data availableGermany WGK: Ethanol: ID 96: WGK 1 (slightly water-endangering); Meloxicam: ID 7588:WGK 2 (water-endangering)13 DISPOSAL CONSIDERATIONSGeneral Information: Dispose of in accordance with local, state, federal, national orinternational regulations.6/10

Metacam® 2% (20 mg/mL) Solution forInjectionNovember 26, 2012Disposal Methods: Incinerate the material under controlled conditions in an approvedincinerator. Do not empty into drains. Dispose of this material and its container in a safe way. Donot contaminate water, food, or feed by disposal. If discarded, this product is considered a RCRAignitable waste.RCRA Information: D001: Waste flammable material with a flashpoint

Metacam® 2% (20 mg/mL) Solution forInjectionNovember 26, 2012be packaged in suitable outer packaging (i.e. UN certified box). The gross mass of the packagemust not exceed 30 kilograms (66 pounds).For All Transportation Agencies:For packages that do not meet a specific agency’s limited quantity packaging requirements, thefollowing transportation classification must be utilized for that agency:UN-Number: UN1170Proper Shipping Name: Ethanol solutionClass: 3Packaging Group: IIIEMS No.: F-E, S-D15 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: B/2, D/2/BInventory StatusThis material is not listed on the following inventories: TSCA, DSL, AICS, EINECS, IECSC, ENCS,PICCS, KECI, and NZIoC. Therefore, it can only be used for TSCA exempt purposes such as R&D orveterinary use.Canada CEPA Schedule 1 – None listed.US RegulationsFEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON ORDER OF LICENSEDVETERINARIANS.CERCLA Hazardous Substance List (40 CFR 302.4): None listed.Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130): Nonelisted.Clean Water Act Section 311 Hazardous Substances (40 CFR 117.3): None listed.SARA Title IIISection 302 Extremely Hazardous Substance (40 CFR 355, Appendix A): None listed.Section 311/312 (40 CFR 370):X Acute (Immediate) Chronic(Delayed)X Fire Reactive PressureGeneratingSection 313 Toxic Release Inventory (40 CFR 372): None listed.8/10

Metacam® 2% (20 mg/mL) Solution forInjectionNovember 26, 2012State RegulationsCalifornia Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): Ethylalcohol in alcoholic beverages – California Prop 65 Carcinogen and Developmental ToxinMassachusetts Right-To-Know List: EthanolMinnesota Hazardous Substances List: EthanolNew Jersey Right-To-Know List: EthanolPennsylvania Right-To-Know List: EthanolRhode Island Right-To-Know List: EthanolEuropean RegulationsAustria MAK List (Annex I): EthanolDenmark (Annex 3.6): None listed.Germany (Dangerous Substances Ordinance 2004, Annex III): EthanolNorway (List of Dangerous Substance): EthanolSweden (Annex 3): None listed.Switzerland (Toxins List 1): Ethanol16 OTHER INFORMATIONHazard RatingsHealth Hazard Fire Hazard Reactivity HazardHMIS 2 3 0Health Hazard Fire Hazard Reactivity Hazard Special HazardNFPA 2 3 0 N/A* – Chronic health effect; 0 – Minimal; 1 – Slight; 2 – Moderate; 3 – Serious; 4 – SevereEU Symbol and R Phrase DefinitionsF – Highly flammableR11 – Highly flammable.ABBREVIATIONS:BIV – Boehringer Ingelheim Vetmedica, Inc.AIHA – American Industrial Hygiene Associationmppcf – million particles/cubic footN/A – Not applicable.N/E – Not established.References:1. Metacam® Product Information, Package Insert, Boehringer Ingelheim Vetmedica,Inc.2. Ariel WebInsight Regulatory Database. Regulatory Summary for North America,Western Europe, and Global Inventories Database.3. GHS ManualRevision Information: Updated Sections 1, 2, 4, 5, 7, 8, 10, 11, 14, 15, 16Issue Date: 11/26/2012Supersedes Date: 06/27/20079/10

Metacam® 2% (20 mg/mL) Solution forInjectionNovember 26, 2012Prepared by: Boehringer Ingelheim Vetmedica, Inc.Disclaimer: The information provided herein is offered by Boehringer Ingelheim Vetmedica, Inc.(“BIV”) in good faith as accurate as of the date hereof, but without guarantee. This informationincludes information which has been generated by other parties and provided to BIV, and whichBIV has not independently verified. The information provided herein relates only to the specificproduct designated, and may not be valid where such product is used in combination with anyother materials or in any process. The information provided herein is offered solely for yourconsideration, investigation and verification, and Boehringer Ingelheim Vetmedica, Inc. (“BIV”)expressly disclaims all liability for reliance thereon. BIV EXPRESSLY DISCLAIMS ALLWARRANTIES 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 2012 Boehringer Ingelheim Vetmedica, Inc. All rights reserved.10/10