PHARMACHEM HALOTHANE BP

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
HALOTHANE
Available from:
BOCKO P/L & FLEXSKY P/L IN PARTNERSHIP
INN (International Name):
halothane(1mL/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
HALOTHANE ANAESTHETIC Active 1.0 ml/ml
Units in package:
250mL
Class:
VM - Veterinary Medicine
Therapeutic group:
CAT | DOG | HORSE | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH
Therapeutic area:
ANAESTHETICS/ANALGESICS
Therapeutic indications:
ANAESTHETIC - LOCAL/GENERAL | GENERAL ANAESTHETIC | IMMOBILISER | LOCAL ANAESTHETIC | PREMEDICATION | SEDATIVE | TRANQUILLISER | TRAVEL SICKNESS
Product summary:
Poison schedule: 4; Withholding period: WITHOLDING PERIOD (HORSES) MEAT: Not t o be used in horses intended for human consumption.; Host/pest details: CAT: [ANAESTHETIC - LOCAL/GENERAL]; DOG: [ANAESTHETIC - LOCAL/GENERAL]; HORSE: [ANAESTHETIC - LOCAL/GENERAL]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANAESTHETIC - LOCAL/GENERAL]; DOG: [ANAESTHETIC - LOCAL/GENERAL]; HORSE: [ANAESTHETIC - LOCAL/GENERAL]; Inhalation anaesthetic for dogs, cats and horses.
Authorization status:
Registered
Authorization number:
49894
Authorization date:
2020-07-01

Info

pest

Verified

PHARMACHEM DateofIssue: March2011

MATERIALSAFETYDATASHEET

SECTION 1 IDENTIFICATION OF THE MATERIAL AND SUPPLIER

Product (material)name: HalothaneBP

Othernames: Not Applicable

Recommended use: Veterinaryanaesthetic

Supplier Details: Pharmachem

Unit6,70 Fison AveWest

Eagle Farm QLD 4009

Telephone: (07) 38680333

Facsimile:(07)38680344

ContactPerson: Mr GrayBoston

EmergencyTelephone: (07)3630 1654

SECTION 2 HAZARDS IDENTIFICATION

Thisproductisclassifiedasdangerousgoodsonlywhentransportedbyairandsoisnotsubjecttothe

AustralianDangerousGoods(ADG)Code.However,itisclassifiedashazardousaccordingtotheclassification

criteriaofNOHSC:1008(2004),ApprovedCriteriaForClassifyingHazardousSubstancesandtheNationalCode

ofPractice for thePreparationofMaterialSafetyDataSheets2 nd

Edition[NOHSC:2011(2003)].

HealthHazard Information

Severeeyeirritant.Mayactasacarcinogenormutagen.Maycausereproductivedamage.Experimental

teratogen.Harmfulifinhaled.Maybeharmfulincontactwiththeskinorifswallowed.Narcotic.ceilinglimit2

ppm.

RiskPhrases:

R37 Irritatingto respiratorysystem

R38 Irritatingto skin

R41 Riskofseriouseyedamage

R61 Maycause harmtothe unborn child

SafetyPhrases:

S23 Do not breathefumes

S26 Incase ofcontactwith eyes, rinse immediatelywith plentyofwaterand seek

medicaladvice

S36 Wear suitable protective clothing

S37 Wear suitable gloves

S45 Incase ofaccidentorifyoufeelunwellseekmedicaladviceimmediately(show

thelabelwherepossible)

S53 Avoidexposure –Obtain specialinstructionsbefore use

AcuteEffects:

Swallowed: Not available

Eyes: Irritatingto eyes

Skin: Irritatingto skin

Inhaled: Anesthesia,dizziness, depressedbreathing

ChronicEffects: Chroniceffectsofoverexposure-mostlyunknown. Liver damage hasbeen

reportedafter repeatedanestheticexposure.

OtherHealthHazardInformation:

HalothaneisanAPVMAapprovedgeneralinhalationanaesthetic.Healthprofessionalsusingthisanaesthetic

asprescribedbythedruginsertwillcontrolhandling proceduresfor medicaluse.

Theanaestheticrangebeginsatabout0.7%but initialinductionmaybe ashighas3% or higher.

PHARMACHEM DateofIssue: March2011

MATERIALSAFETYDATASHEET

Acuteaccidentalexposuretolargedosesmaycausedizzinessanddepressbreathing.Continuedexposureto

higherlevelswillcausecessationofbreathing.Ifthisoccurs,giveartificialrespirationandadministeroxygen

andobtainimmediatemedicalhelp fromananaesthetist ifavailable.

Halothaneisessentiallynontoxicbysingledoseingestion(ratoralLD

:6.7g/kg).Itisslightlyirritatingtorabbit

eyesbutnottheskin.Becauseofconcernsofthehealthofthoseoperatingroompersonnelexposedtowaste

anestheticgasestherehavebeenmanyanimalstudiesontheeffectsoflowlevelsofanestheticgasesand

manyepidemiologicalstudiesonoperatingroompersonnel.Thesewerefullyreviewedin1978(1)andin1982

(2) andinpartin 1985(3) and1990 (4).

Theepidemiologicalstudieswereseriouslychallenged(1,2)andaftercarefulreviewofthosestudiesaneminent

groupofstatisticiansandepidemiologists(3)foundthestudiesinconclusiveandstatedthat,‘prospectivecohort

studiesareneededtodeterminewhetherthereisarelationshipbetweencurrentlevelsofoccupationalexposure

toanaestheticgasesandadversegasesandadverseoutcomes,particularlyspontaneousabortion,andliver

disease.

In1987anepidemiologicalstudyonveterinarypersonnel(5)showedthatthereproductiveoutcomeforthose

personnelexposedtoanestheticgasesisnodifferent fromthe generalpublic.

InacomprehensivemortalitystudyamongUSphysicians(6)anaesthetistshadadeathrateofonly98%ofthat

ofallphysiciansandlessthan66%ofUSwhitemalesasawhole.Thus,anesthesiologistswereshowntohave

aboveaveragehealth.

The1990reviewlistsmanyanimalstudiesshowingmicroscopicchangesafterprolongedexposuresduring

gestationtosmallconcentrationsofhalothane.Themostsignificantoftheanimalstudies(7),wasonavery

largenumberofanimals.Itshowedthatexposuresat500ppmofhalothanefortwohoursdailytobothmales

andfemalesfornineweekspriortomatingandthentofemalesthroughoutpregnancyshowednodifferences

fromthe controlsfor fertility, reproduction and postnatalsurvival.

SECTION 3 COMPOSITION/INFORMATION ON INGREDIENTS

Ingredients CasNo. Proportion

HalothaneBP 151-67-7 100%

SECTION 4 FIRST AID MEASURES

ThefollowingFirstAiddirectionshavebeensetbytheOfficeofChemicalSafetyandEnvironmentalHealth

(OCSEH)ofthe Commonwealth Department ofHealthandAging:

Ifpoisoningoccurs,contactadoctororPoisonsInformationCentre.Telephone131126.(FAISDHandbook,

HandbookofFirstAidInstructions,SafetyDirections,WarningStatements,andGeneralSafetyPrecautionsfor,

AgriculturalandVeterinaryChemicals)

However, thefollowingadditionalinformationisprovided toassist inemergentcircumstances:

Swallowed: Do not inducevomiting

Eye: Wash withcopiousamountsofwater.

Skin: Wash withsoapandwater.

Inhaled: Remove to fresh air,giveartificialrespirationifneeded.

First Aid Facilities: Eyewash facilities.

Advice To Doctor: Not available.

SECTION 5FIRE FIGHTING MEASURES

Fire/ExplosionHazard: Non-flammable.

SuitableExtinguishingMedia: Use extinguishing media suitable for surroundingfire

SpecialFire Fighting Procedures: Wear self-containedbreathingapparatusifthereisdangerof

leakage.

Hazardsfromcombustionproducts: Thermaldecompositionproductsare toxicand corrosive

PHARMACHEM DateofIssue: March2011

MATERIALSAFETYDATASHEET

SECTION 6 ACCIDENTAL RELEASE MEASURES

Emergencyprocedures: Containspillsusinginertabsorbentmaterials.Wearself-contained

breathing apparatusfor cleaningup spills

Methodsand materialsfor

containment andclean up: Absorb spilledmaterialswith inert absorbentmaterialssuch as

powderedclay,vermiculite,sandetc.Collectwastematerialand

disposeofin accordancewithlocalauthorityinstructions.

SECTION 7 HANDLING AND STORAGE

Precautionsfor safe handling: Donoteat,drink,smoke,applycosmetics,ortakemedicationsinareas

where halothaneor a solutioncontaining halothaneishandled,

processed, orstored.

Conditionsfor safe storage,

includinganyincompatibilities: ApprovedstoragedirectionsforHalothaneBPfromtheAustralian

Pesticides&VeterinaryMedicinesAuthority(APVMA)indicatethat

Halothaneshouldbestoredinairconditioningandprotectedfromlight.

Opaque,chemicallyresistantcontainersshouldbeusedforstorage.

Containersofhalothaneshouldbeprotectedfromphysicaldamageand

shouldbestoredseparatelyfromacids,directsunlight,heat,sparks,

andopenflame.Becausecontainersthatformerlycontainedhalothane

maystillhold product residues, theyshould be handled appropriately.

SECTION 8 EXPOSURE CONTROLS/PERSONAL PROTECTION

Nationalexposure standards: TWA(ppm) –0.5

TWA(mg/m 3

) –4.1

Biologicallimit values: NoneSet

Engineering controls: Provide adequateventilation to meet theTWA

Personalprotectiveequipment:

Respiratory: Nonenormallyneeded.

Eyeand Face: Safetyglassesor goggles.

Gloves: Imperviousgloves.

OtherEquipment: Nonenormallyneeded.

SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES

Appearance: Colorlessliquidwithetherealodour

BoilingPoint: 50C

Melting Point: N/A

VapourPressure: 243 mmHg (20C)

SpecificGravity: 1.87(H

0=1)

FlashPoint: None

FlammabilityLimits: N/A

Autoignition Temp: Not determined

Rel.Vapourdensity: 6.9(Air=1)

OtherProperties: Solubilityinwater –Negligible

PHARMACHEM DateofIssue: March2011

MATERIALSAFETYDATASHEET

SECTION 10 STABILITY AND REACTIVITY

Chemicalstability: Stable,butmaybelightsensitive

Conditionstoavoid: No informationavailable

Incompatible materials: Incompatiblewithrubber,plastics, strong oxidizingagents. Reactive

withmetalssuchassodium, potassiumand finelydividedzinc,

aluminiumand magnesium,especiallyathightemperatures

Hazardousdecomposition

products: Thermal, oxidative decompositiongiveshalogenacidsand

carbonylhalides

Hazardousreactions: Hazardouspolymerisationwillnotoccur

SECTION 11 TOXICOLOGICAL INFORMATION

Healtheffectsfromthe likelyroutesofexposure:

Halothaneisessentiallynon toxicbysingle dose ingestion. Itisslightlyirritatingto rabbit eyesbutnot to skin.

LDLO a

Oral(Human) 140 mg kg -1

LCLO b

Inhalation(Human) 7000ppm/3h

LDLO Intravenous(Man) 129 mg kg -1

Oral(Rat) 5680mgkg -1

Inhalational(Rat) 29000 ppm

Inhalational(Mouse) 98g/m3/2h

Oral(GuineaPig) 6000mgkg -1

(a) Lowestpublishedlethaldose

(b) Lowestpublishedlethalconcentration

SECTION 12 ECOLOGICAL INFORMATION

No ecologicalinformationavailable

SECTION 13 DISPOSAL CONSIDERATIONS

Disposalmethodsand containers: APVMAapprovedcontainerdisposaldirectionsindicate that containers

maybewrappedinpaper andplacedinhouseholdgarbage. Unused

product should be disposedofin accordancewithlocalauthority

instructions

Specialprecautionsfor landfill

or incineration: Noneknown

SECTION 14 TRANSPORT INFORMATION

Thismaterialisdangerousgoodsonlywhentransportedbyair.

UN Number: 3334

UN ProperShippingName: AVIATION REGULATED LIQUID N.O.S. (HALOTHANE)

Classand subsidiaryrisk: 9.0

PackingGroup: Noneallocated

Specialprecautionsfor user: Noneknown

HazchemCode: Noneallocated

PHARMACHEM DateofIssue: March2011

MATERIALSAFETYDATASHEET

SECTION 15 REGULATORY INFORMATION

ThisproducthasbeenregisteredbytheAustralianPesticidesandVeterinaryMedicinesAuthority(APVMA).In

grantingregistrationtoanyproduct,theAPVMAhasexerciseditslegislativeresponsibilitytoensurethatthe

productissuitablyformulated andproperlylabelled and,whenused accordingtoinstructionsis:

safe to thehost, theuser, consumersand theenvironment;

efficacious(that is, theproduct doesthejobit claimsitshalldo);and

not undulyprejudicialto trade.

TheAPVMAusestheservicesofanumberofAustralianandStategovernmentagenciesasadviserstohelp

withsomeoftheseevaluationsofapplicationsforregistrationofagriculturalandveterinarychemicalproducts.

These include:

theOffice ofChemicalSafety(OCS)ofthe Commonwealth Department ofHealthandAgeingwhich:

evaluatesandreportsontoxicologyandmetabolismstudies;proposesfirstaidandsafetydirections;

determinespoisonscheduleclassifications;andestablishesacceptabledailyintakes(ADIs)andacute

reference doses(ARfD); and

evaluatestheoccupationalhealthandsafetyaspectsofanapplicationandrecommendssafety

directionsandoccupationalcontrolson useand advisesonaMaterialSafetyDataSheet(MSDS);

theCommonwealthDepartment ofthe Environment andHeritage(DEH)whichevaluatesenvironmentaldata

andrecommendsappropriateusecontrolsandinstructionsfortheproductthatwillprotecttheenvironment;

and

StateandTerritorydepartmentsresponsibleforagriculturalandprimaryindustrieswhichevaluateand

reportsonefficacyandtargetcroporanimalsafetydatafornewagriculturalchemicalsandnewusesof

registeredproducts.InsomecasestheAPVMAcontractsthisworkouttootheragenciessuchas

universities, theCSIROor to other experts.

Althoughallingredientsappear in theAustralian InventoryofChemicalSubstances(AICS), theyhave not been

assessedbyNICNAS(NationalIndustrialChemicalsNotificationandAssessment Scheme)

HalothaneaspresentedinthiscontextappearsinSchedule4ofStandardfortheUniformSchedulingof

MedicinesandPoisons(SUSMP).

SECTION 16 OTHER INFORMATION

MSDSversion: 2

DateofRevision: March2011

Update ofsections:2,4,10,15,16

CONTACTPOINT Mr GrayBoston,GeneralManager

B/HrsPhone(07)38680333 A/Hrs(07)36301654

References:

1.FAISDHandbook,HandbookofFirstAidInstructions,SafetyDirections,WarningStatements,andGeneral

SafetyPrecautionsfor, AgriculturalandVeterinaryChemicals, (asupdated)

2. Approved CriteriaFor ClassifyingHazardousSubstances, NOHSC:1008 (2004)

3.NationalCodeofPracticeforthePreparationofMaterialSafetyDataSheets2 nd

Edition[NOHSC:2011

(2003)]

4.AICS(Australian InventoryofChemicalSubstances), SafeworkAustralia

5.APVMAManualofRequirementsand Guidelinesfor AgriculturalChemicals, Version4.1,(asupdated)

6.ADI [AcceptableDailyIntake]List, CommonwealthDepartment ofHealth&AgedCare, TGA, (asupdated)

7.TheAustralianCode for theTransport ofDangerousGoodsbyRoadandRail(ADGCode)7 th Edition

8.ThePoisonsStandard(asupdated),NationalDrugsandPoisonsScheduleCommittee

9.HazardousSubstancesInformationSystem, SafeworkAustralia (asupdated)

PHARMACHEM DateofIssue: March2011

MATERIALSAFETYDATASHEET

AllinformationcontainedinthisMaterialSafetyDataSheetisasaccurateanduptodateaspossible.SincePharmachemcannotanticipate

orcontroltheconditionsunderwhichthisinformationmaybeused,eachusershouldreviewtheinformationinthespecificcontextofthe

intendedapplication.Pharmachemwillnotberesponsiblefordamagesofanynatureresultingfromuseoforrelianceupontheinformation.

NoexpressedorimpliedwarrantiesaregivenotherthanthoseimpliedasmandatorybyCommonwealthStateorTerritorylegislation.

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