Roche-Tiberal

OrnidazoleSafetyDataSheet1.ProductandCompanyIdentificationProductnameOrnidazoleProductcode0441384Manufacturer:F.Hoffmann-LaRocheAGPostfachCH-4070BaselSwitzerlandPhone*41-61/6885480Fax*41-61/6817276Localrepresentation:Companyinformation2.Composition/InformationoningredientsCharacterizationpharmaceuticalactivesubstanceintheclassofnitroimidazolesChemicalname-α-Chloromethyl-2-methyl-5-nitro-1H-imidazole-1-ethanol-1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazoleSynonyms-TIBERALsubstanceCASnumber16773-42-5EINECSnumber2408260RochenumberRo07-0207/000EmpiricalformulaC7H10ClN3O3Molecularmass219.63g/molNN+NOO-OHCl3.HazardsidentificationMostimportanthazards-Harmfulifswallowed.-Possiblerisksofirreversibleeffects.-Harmfultoaquaticorganisms,maycauselong-termadverseeffectsintheaquaticenvironment.Page:1/5Replacingeditionof:10.5.01Date:6.8.02/CSE(SEISMO)Ornidazole4.First-aidmeasuresEyecontact-rinseimmediatelywithtapwaterfor10minutes-openeyelidsforcibly-consultphysicianSkincontact-removeimmediatelycontaminatedclothes,washaffectedskinwithwaterandsoap-donotuseanysolventsInhalation-removethecasualtytofreshairandkeephim/hercalm-consultphysicianNotetophysician-treatsymptomatically5.Fire-fightingmeasuresSuitableextinguishingmedia-watersprayjet,drypowder,foam,carbondioxideSpecifichazards-riskofbursting:coolexposedcontainerswithwater-formationoftoxicandcorrosivecombustiongases(nitrousoxide,hydrogenchloride)possible-considerdustexplosionhazardProtectionoffire-fighters-precipitategases/vapours/mistswithwaterspray6.AccidentalreleasemeasuresEnvironmentalprotection-donotallowtoenterdrainsorwaterwaysMethodsforcleaningup-collectsolids(avoiddustformation)andhandovertowasteremoval-cleancontaminatedareaswithlittleethanol7.HandlingandstorageHandlingTechnicalmeasures-processinginclosedsystems,ifpossiblesuperposedbyinertgas(e.g.nitrogen)-localexhaustventilationnecessary-takeprecautionarymeasuresagainstelectrostaticcharging-avoiddustformation;veryhighdustexplosionhazardSuitablematerials-stainlesssteel,glass,polyethylene-testplasticsbeforeuseStorageStorageconditions-protectedfromlightValidity-48months,atroomtemperaturePackagingmaterials-tightlyclosing;material:metal(linedwithpolyethylenebag)Page:2/5Replacingeditionof:10.5.01Date:6.8.02/CSE(SEISMO)Ornidazole8.Exposurecontrols/PersonalprotectionEngineeringMeasures-see7.MonitoringAnalytics-samplingonglassfibrefilterandgravimetricorchemicaldeterminationPersonalprotectiveequipmentRespiratoryprotection-incaseofopenhandlingoraccidentalrelease:particlemaskorrespiratorwithindependentairsupplyHandprotection-protectiveglovesEyeprotection-safetyglasses9.PhysicalandchemicalpropertiesColourwhitetoyellowishFormcrystallinepowderOdournonetofaintBulkdensity0.37g/cm3Solubility13’900mg/l,water(20°C)166’000mg/l,ethanol(20°C)450’000mg/l,acetone(20°C)5’600mg/l,toluene(20°C)100mg/l,hexane(20°C)pHvalue5.0to7.0(1%aqueoussolution)DissociationconstantpK1=2.4Meltingtemperature88to92°C10.StabilityandreactivityConditionstoavoid-light:gradualdecompositionofsolutions-warming:exothermicdecompositionwithhighdecompositioncapacityathightemperatures(100°C)11.ToxicologicalinformationAcutetoxicityLD501’139mg/kg(oral,mouse)-LD501’780mg/kg(oral,rat)-LD50375mg/kg(i.v.,mouse)-Subchronictoxicity-reversiblelossofweight,reversibleneurologicdisturbances(monkey,rat)Page:3/5Replacingeditionof:10.5.01Date:6.8.02/CSE(SEISMO)OrnidazoleChronictoxicity-NOAEL40mg/kg/d(dog)Mutagenicitymutagenic(variousinvivoandinvitrotestsystems)-Carcinogenicitycarcinogenic-induces,likeallnitroimidazoles,afterlongerduringapplicationandinhigherdosis,tumorsinmouseandrat,noinductionoftumorsinhamster-preliminarystudiesinhuman(10-19yearsofobservation)andtheincominginformationsdidnotshowanyindicationforcarcinogeniceffectsinhuman-Reproductiontoxicity-notteratogenic-notembryotoxic-reversibleretardationofthesperm-mobility,thatmayleadtoreversibledisturbancesoffertility(malerat,400mg/kg*day)Note-side-effects:dizziness,headache,gastrointestinaldisturbances,rarelyepilepticseizuresandfunctionaldisturbancesoftheperipheralnerves-antiinfectivumfortheoral,intravenousandlocalapplicationagainstprotozoon-andanaerobicbacterialinfections-therapeuticaldailydose:750-2000mg/kgoralori.v.-half-lifeofelimination:13hours12.EcologicalinformationReadybiodegradability-notreadilybiodegradable1%,28days(CO2EvolutionTest(ModifiedSturmTest),OECDNo.301B)Ecotoxicitybarelytoxicforfish(rainbowtrout)LC50(96h)100mg/lNOEC(96h)100mg/l-moderatelytoxicforalgae(Scenedesmussubspicatus)EbC50(72h)30mg/lNOEbC(72h)0.4mg/l-barelyinhibitoryonaerobicbacterialrespiration(activatedsludge)EC50(3h)100mg/l(ActivatedSludgeRespir.Inhib.Test,OECDNo.209)-barelytoxicforplanktoniccrustaceans(Daphniamagna)EC50(48h)100mg/lNOEC(48h)100mg/l-Airpollution-observelocal/nationalregulations13.DisposalconsiderationsWastefromresidues-incinerateinqualifiedinstallationwithfluegasscrubbing-observelocal/nationalregulationsregardingwastedisposal14.TransportinformationNote-notclassifiedbytransportregulationsPage:4/5Replacingeditionof:10.5.01