Material Safety Data Sheet

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Material Safety Data Sheet

Material Safety Data Sheet1. PRODUCT AND COMPANY IDENTIFICATIONProduct InformationProduct nameVersion 2.0, 07/18/2007JurisdictionActive substanceSynonymsKenalog Injection (10 or 40 mg/ml)This Material Safety Data Sheet was prepared for the jurisdiction USA.Triamcinolone AcetonideSterile Triamcinolone Acetonide Suspension USP; Kenalog-10 Injection; Kenalog-40 InjectionProduct UsesThis material is a finished drug product for patient use. This material is used toprovide relief of inflammatory and pruritic skin conditions.Company/Undertaking IdentificationAddressBristol-Myers Squibb CompanyP.O. Box 191New Brunswick, New Jersey 08903United States of America1-732-227-7380Emergency PhoneNumberCHEMTREC 1-800-424-9300. For all international transportation emergencies callCHEMTREC at 1-703-527-3887. Collect calls accepted.2. COMPOSITION/INFORMATION ON INGREDIENTSComponents Concentration CAS-No.Hazardous componentsTriamcinolone Acetonide 1 - 4 % 76-25-5Other ingredientsWater 90 - 100 % 7732-18-5Sodium Carboxymethylcellulose


Kenalog Injection (10 or 40 mg/ml) Bristol-Myers Squibb Company Page 2 of 100000000007823. HAZARDS IDENTIFICATIONPrecautionary MeasuresPotential Health EffectsEyesSkinIngestionInhalationTarget OrgansSigns and SymptomsMedical conditions aggravatedinclude:Avoid ingestion, inhalation, skin and eye contact. Wash hands afterhandling to minimize exposure. Wear suitable protective clothing andgloves. Pregnant or nursing women should avoid exposure. Preventrelease to the environment.Possible mild eye irritantEnvironmental Effects Refer to Section 124. FIRST AID MEASURESEye contactSkin contactInhalationIngestionRapidly absorbed through skin., Repeated exposure may cause skindryness or cracking., May be harmful if absorbed through skin.May cause damage to organs through prolonged or repeated exposure ifswallowed.May cause damage to organs through prolonged or repeated exposure ifinhaled.adrenal glands, bone, muscle, gastrointestinal tract, immune system, eyes,nervous system, skin, female reproductive organs, (embryo/fetus)Chronic: muscle weakness, muscle pain, bone fractures, infection,oedema, headache, difficulty sleeping, vertigo, restlessness, euphoria,mental disturbance, depression, anxiety, mood changes, seizure disorders,nosebleeds, cough, fever, nausea, vomiting, anorexia, gastrointestinaldisturbance, sore throat, dry mouth, taste disturbance, speech difficulty,congestion, redness and swelling of eyes, vision changes, facial swelling,skin thinning, acne, redness and swelling of skin, hives, bruising,superficial burning sensation, tingling.diabetes, Liver disorders, infection, immunodeficiency, hypertension,myasthenia gravis, osteoporosis, peptic ulcer, psychotic disorders, colitis,kidney disordersRinse immediately with plenty of water for at least 15 minutes. Keep eye wide openwhile rinsing. Obtain medical attention.Take off contaminated clothing and shoes immediately. Wash off immediately withplenty of water for at least 15 minutes. Obtain medical attention. Wash contaminatedclothing before re-use.Move to fresh air. Oxygen or artificial respiration if needed. Obtain medical attention.Do NOT induce vomiting. Consult a physician if necessary. Never give anything bymouth to an unconscious person.Continued


Kenalog Injection (10 or 40 mg/ml) Bristol-Myers Squibb Company Page 3 of 100000000007824. FIRST AID MEASURESNotes to physicianMedical SurveillanceThis material is a finished drug product for patient use. This material is used to providerelief of inflammatory and pruritic skin conditions. This product may cause: muscleweakness, muscle pain, bone fractures, infection, oedema, headache, difficulty sleeping,vertigo, restlessness, euphoria, mental disturbance, depression, anxiety, mood changes,seizure disorders, nosebleeds, cough, fever, nausea, vomiting, anorexia, gastrointestinaldisturbance, sore throat, dry mouth, taste disturbance, speech difficulty, congestion,redness and swelling of eyes, vision changes, facial swelling, skin thinning, acne,redness and swelling of skin, hives, bruising, superficial burning sensation, tingling,increase in blood pressure, Cushing's syndrome, electrolyte disturbance, hyperglycemia,adrenocortical insufficiency, withdrawal symptoms, osteoporosis, bone effects,menstrual irregularities, sperm abnormalities, cataracts, glaucoma, nose changes, otitis,peptic ulcer, psychotic disorders, pancreatitis, changes in white blood cell parameters.Organs effected may include: adrenal glands, bone, muscle, gastrointestinal tract,immune system, eyes, nervous system, skin, female reproductive organs,(embryo/fetus). Medical conditions aggravated include: diabetes, Liver disorders,infection, immunodeficiency, hypertension, myasthenia gravis, osteoporosis, pepticulcer, psychotic disorders, colitis, kidney disorders. This product has been reported tointeract with the following medications: diuretic, cyclosporine, immunosuppressants,NSAID (non-steroidal antiinflammatory drugs), drug metabolized by cytochrome P-450, drugs that cause hyperglycemia, oral hypoglycemic drugs, neuromuscular blockingagents, fluoroquinoline antibiotics, certain vaccines, drugs that inhibit cytochrome P-450. Refer to Section 11. Pregnant or nursing women should avoid exposure.A pre-placement physical examination and history for employees with potentialexposure to this compound is recommended. Baseline testing would include: Preplacement:,blood glucose test, a complete blood count with differential. Based onopportunity for exposure and duration of exposure a periodic follow-up examinationmay be considered.Employees, who are pregnant, are breast-feeding, or who are concerned with otherreproductive issues should be encouraged to consult with the occupational healthphysician monitoring worker's health.5. FIRE-FIGHTING MEASURESFlammable Properties Not availableExtinguishing Media Suitable extinguishing media: Dry chemical, Water spray, FoamProtection of FirefightersOther information:Unsuitable extinguishing media: Do NOT use water jet.Specific hazards: Teratogen skin absorption hazardProtective equipment: Use personal protective equipment. In the event of fire, wearself-contained breathing apparatus.Hazardous Combustion Products: carbon oxides, hydrogen halidesDecontaminate protective clothing and equipment before reuse. Heating can releasehazardous gases. HCl gas can form flammable or explosive mixtures with alcoholsor metals.6. ACCIDENTAL RELEASE MEASURESPersonal precautions Refer to protective measures listed in sections 7 and 8. Use personal protectiveequipment. Examples include tightly fitting safety goggles, disposable lab coat of lowpermeability with cuffs, double gloves and shoe covers. Wear respiratory protection.Depending on the nature of the spill (quantity and extent of spill) additional protectiveclothing and equipment such as a self-contained breathing apparatus may be needed.Continued


Kenalog Injection (10 or 40 mg/ml) Bristol-Myers Squibb Company Page 4 of 100000000007826. ACCIDENTAL RELEASE MEASURESEnvironmentalprecautionsContainment MethodsCleanup MethodsPrevent release to drains and waterways. Prevent release to the environment.Contain spillage, and then collect with non-combustible absorbent material, (e.g. sand,earth, diatomaceous earth, vermiculite) and place in container for disposal according tolocal / national regulations (see section 13).Contain and collect spillage and place in container for disposal according to localregulations (see Section 13). Clean spill area with a deactivating solution (if available)followed by detergent and water after spill pick-up. Handle waste materials, includinggloves, protective clothing, contaminated spill cleanup material, etc., as appropriate forchemically and pharmacologically similar materials.7. HANDLING AND STORAGEHandling Precautions Highly potent material. Avoid exposure - obtain special instructions before use. Avoidinhalation of vapour or mist. Keep away from heat and sources of ignition. Preventrelease to drains and waterways.Storage ConditionsContainerRequirementsStore at room temperature. ( 20 - 25°C ) Protect against light. Avoid freezing.Store in sturdy containers appropriate to maintain the integrity of this material for itsintended use.8. EXPOSURE CONTROLS / PERSONAL PROTECTIONExposure limit(s)CompanyGuidelineACGIH OSHA NIOSHTriamcinoloneAcetonide1 µg/m3(Skin),DevelopmentalToxicity-- -- --Benzyl alcohol -- -- -- --Sodium Hydroxide -- 2 mg/m3 Ceiling 2 mg/m3 TWA 2 mg/m3 Ceiling10 mg/m3 IDLHHydrochloric acid -- 2 ppm Ceiling 5 ppm Ceiling7 mg/m3 Ceiling5 ppm Ceiling7 mg/m3 Ceiling50 ppm IDLHExposure Control BandBristol-Myers Squibb ExposureGuidelines SummaryRecommended Industrial HygieneMonitoring MethodsTriamcinolone Acetonide4 -- The established company exposure guideline falls within ExposureControl Band 4 (range 1 -20 µg/m3).Triamcinolone AcetonideMaterials require particular care and handling. Adherence to thisguideline should protect employees from experiencing the therapeuticand/or adverse effects of this drug.Contact the Bristol-Myers Squibb AIHA accredited Industrial HygieneLaboratory at 732-227-7368. See Section 4 "Notes to Physician" forinformation on medical surveillance.Continued


Kenalog Injection (10 or 40 mg/ml) Bristol-Myers Squibb Company Page 5 of 100000000007828. EXPOSURE CONTROLS / PERSONAL PROTECTIONEngineering Controls andVentilationRespiratory protectionEye protectionHand protectionSkin and body protectionHygieneWhen handling small quantities in a clinical setting, good roomventilation is desirable. Specific engineering controls should not beneeded. When handling larger quantities, such as in a manufacturingsetting, ensure worker exposure is below the recommended exposurelimit. If significant aerosol (mist) is generated, use process enclosures,containment technology, or other engineering controls to keep airbornelevels below recommended exposure limit.Respiratory protection is not required for normal use of this material. Ifthe occupational exposure limit (OEL) is exceeded, wear an appropriaterespirator with a protection factor sufficient to control exposures to belowthe OEL. Note: May cause damage to organs through prolonged orrepeated exposure if inhaled.Chemical splash resistant goggles should be worn when potential forsplash exists.Impervious nitrile, rubber and latex gloves are recommended. Please notethat employees who are allergic to natural rubber latex should use nitrilegloves.It is recommended that a laboratory coat be worn when handling product.Wash hands before breaks and immediately after handling the product.9. PHYSICAL AND CHEMICAL PROPERTIESAppearancePhysical StateliquidColorwhite to off-whiteFormsuspensionDescriptive propertiesMolecular WeightNot availableMolecular formulaNot applicableBulk densityNot availableEvaporation rateNot availableHydrolysis/PhotolysisNot availableHygroscopicityNot availableLog Octanol/Water Partition Not availableCoeff [log Kow]Surface TensionNot availableOdorNot remarkable.Odor ThresholdNot availablepH 5 - 7pKaNot availableParticle SizeNot availableSolubility, WatersolubleSpecific Gravity/ Relative 1.015densityViscositysimilar to waterThermal/Stability propertiesAutoignition temperature Not availableBoiling Point 100 °CThermal decomposition Not availableExplosive Limits, LEL Not availableExplosive limits, LELNot availableContinued


Kenalog Injection (10 or 40 mg/ml) Bristol-Myers Squibb Company Page 6 of 100000000007829. PHYSICAL AND CHEMICAL PROPERTIESExplosivenessNot availableFlammabilityNot availableFlash pointNot availableMelting Point 0 °COxidizing PotentialNot availableVapor PropertiesVapor Density(Air =1): If adequate temperatures caused material to volatize, its vapordensity would be much greater than 1. (Heavier than air)Vapor PressureNot availableSaturated Vapor Concentration Not available10. STABILITY AND REACTIVITYStabilityChemical StabilityConditions to avoidIncompatible productsHazardous decompositionproductsHazardous reactionsSensitivity to static discharge/Dust exp.Summary StatementsStable under normal conditions.Not availableNot availableHazardous decomposition products formed under fire conditions.: carbonoxides, hydrogen halidesNot availablenot applicable11. TOXICOLOGICAL INFORMATIONRoutes of EntryEye irritationIngestion, Inhalation, Eye contact, Skin contactTriamcinolone AcetonidePossible mild eye irritantSkin irritationRespiratory IrritationSensitisationAcute Toxicity StudyTriamcinolone AcetonideRepeated exposure may cause skin dryness or cracking. skin thinningTriamcinolone AcetonideMay cause irritation of respiratory tract.Triamcinolone AcetonideNot a dermal sensitizer Allergic contact dermatitis is quite rare but has been reported.Acute OralTriamcinolone AcetonideOral LD50(mouse): 5,000 mg/kgAcute toxicity (other routes of administration)Triamcinolone AcetonideLD50 (rat, subcutaneous): 13.1 mg/kgLD50 (mouse, subcutaneous): 132 mg/kgLD50 (mouse, Intraperitoneal): 105 mg/kgContinued


Kenalog Injection (10 or 40 mg/ml) Bristol-Myers Squibb Company Page 7 of 1000000000078211. TOXICOLOGICAL INFORMATIONRepeated dose toxicityTriamcinolone AcetonideAssessment Repeat Dose ToxicitySeveral studies were conducted. Results from these studies in multiple species weregenerally similar with respect to target organs and effects. See Section 11 TargetOrgans and Symptoms for a description of effects.Genetic ToxicityCarcinogenicityTriamcinolone Acetonidein vitroAmes reverse-mutation assay -- negativeForward gene mutation assay -- negativeMutagenicity AssessmentSeveral studies were conducted. The weight of evidence demonstrates that thismaterial is not genotoxic.Triamcinolone Acetonide104 Weeks Oral rat study :[tumor organs: liver] positive104 Weeks Oral rat study : NOAEL = 0.001 mg/kg No treatment-related tumorswere observed.104 Weeks Oral mouse study : NOAEL = 0.003 mg/kg No treatment-relatedtumors were observed.Carcinogenicity AssessmentSeveral studies were conducted. The results were negative and positive. Notclassifiable as to its carcinogenicity to humans.Carcinogenicity ACGIH OSHA NTP IARCTriamcinolone-- -- -- --AcetonideReproductive ToxicityTriamcinolone AcetonideAssessment Reproductive ToxicitySeveral studies were conducted. May impair fertility. Maternal effects include:menstrual irregularities . Paternal effects include: sperm abnormalities See "HumanExperience". See also "Developmental Toxicity" for information on reproductiveeffects.Developmental ToxicityTriamcinolone AcetonideDevelopmental Toxicity AssessmentSeveral developmental studies were conducted. Birth defects were observed in animalstudies. Compound may be toxic during early embryonic development. TeratogenThis compound and/or its metabolites may be excreted into the milk. May cause harmto breastfed babies.Human experienceExperiences with Human ExposureTriamcinolone AcetonideGeneral effects therapeutic use - Symptoms: muscle weakness, muscle pain, bonefractures, infection, oedema, headache, difficulty sleeping, vertigo, restlessness,euphoria, mental disturbance, depression, anxiety, mood changes, seizuredisorders, nosebleeds, cough, fever, nausea, vomiting, anorexia, gastrointestinaldisturbance, sore throat, dry mouth, taste disturbance, speech difficulty,Continued


Kenalog Injection (10 or 40 mg/ml) Bristol-Myers Squibb Company Page 8 of 1000000000078211. TOXICOLOGICAL INFORMATIONcongestion, redness and swelling of eyes, vision changes, facial swelling, skinthinning, acne, redness and swelling of skin, hives, bruising, superficial burningsensation, tingling.Other effects include: increase in blood pressure, Cushing's syndrome, electrolytedisturbance, hyperglycemia, adrenocortical insufficiency, withdrawalsymptoms, osteoporosis, bone effects, menstrual irregularities, cataracts,glaucoma, nose changes, otitis, peptic ulcer, psychotic disorders, pancreatitis,changes in white blood cell parameters.EpidemiologyTriamcinolone AcetonideEpidemiological study - Several studies have associated the development of oralclefts with exposure during pregnancy. Fetal effects include: decreased bodyweight .Target OrgansTriamcinolone Acetonideadrenal glands, bone, muscle, gastrointestinal tract, immune system, eyes, nervoussystem, skin, female reproductive organsSymptomsTriamcinolone AcetonideSee "Human Experience".Other ToxicityInformationOther Information:Not availableThis MSDS may contain toxicological and/or pharmacological information derivedfrom either the specified product or from compounds in the same pharmacological class.12. ECOLOGICAL INFORMATIONEcotoxicological Information (Aquatic)Acute Toxicity to Aquatic InvertebratesTriamcinolone AcetonideEC50 (Daphnia magna, 48 H) : > 100 mg/lEcotoxicological Information (Terrestrial) Not availableChemical fate informationBiodegradationTriamcinolone AcetonideUltimate aerobic biodegradation (28 D) : 3 % ; Not Readily Biodegradable - unlikely to undergorapid biodegradation in the environmentSummary StatementsAquatic toxicityExperimental data indicate low potential for acute harm to aquatic invertebratesChemical FateNot readily biodegradable.Continued


Kenalog Injection (10 or 40 mg/ml) Bristol-Myers Squibb Company Page 9 of 1000000000078213. DISPOSAL CONSIDERATIONSAdvice On Disposal And PackagingOther information14. TRANSPORT INFORMATIONThis material is not a dangerous good for the purpose of transportation.Disposal should be in accordance with applicable regional, national, andlocal laws and regulations. Local regulations may be more stringent thanregional or national requirements. This information presented onlyapplies to the material as supplied.Disposal by incineration is recommended.15. REGULATORY INFORMATIONUnited States of AmericaOSHA Hazard Classification313 Toxic Release Inventory.Listed Chemicals/CompoundsTSCA InventoryInternationalCanadaWHMISTeratogen, Target Organs.No components listed on the SARA 313 inventory.Not listed. Food, drug and cosmetic products are exempt from TSCA.This product is not regulated under the Hazardous Products Act andControlled Products Regulations.This product, however, may have significant health hazard and couldmeet the criteria for:D2A Very Toxic Material Causing Other Toxic EffectsDSL/NDSLMexicoMexico ClassificationyesHealth classification - Serious Hazard - 3 - Substances that can causeserious or permanent harm under emergency conditionsEuropeEINECS/ELINCS Number Triamcinolone Acetonide: 200-948-7Water: 231-791-2Benzyl alcohol: 202-859-9Sodium Chloride: 231-598-3Sodium Hydroxide: 215-185-5Hydrochloric acid: 231-595-7R-phrase(s)Medicinal products are exempt from classification and labelingrequirements under EU Preparations Directive 1999/45/EC.16. OTHER INFORMATIONMSDS preparation informationPrepared by Corporate Quality, Environmental Health & Safety 1-732-227-7380Prepared on 07/18/2007This Safety Data Sheet has been revised. This MSDS has beenreformatted in a new electronic system. This data sheet contains changesfrom the previous version in section(s): All.Continued


Kenalog Injection (10 or 40 mg/ml) Bristol-Myers Squibb Company Page 10 of 10000000000782Other informationHMIS Health 2*FlammabilityNot Determined (ND)ReactivityNot Determined (ND)Personal protective equipment See Section 8.NFPAHealth 2FireNDReactivity NDSpecial ND2NDNDNDThe information contained in this MSDS is believed to be accurate and represents the best informationreasonably available at the time of preparation. However, we make no warranty, express or implied, with respectto such information. and we assume no liability from its use.End of Safety Data Sheet

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