窗體頂端

窗體底端

EnablingStatute:

HazardousProductsAct

HazardousProducts(Toys)Regulations(C.R.C.,c.931)

Disclaimer:Thesedocumentsarenottheofficialversions(

more

).

RegulationcurrenttoApril22nd,2009

Attention:Seecomingintoforceprovisionandnotes,whereapplicable.

TableOfContents

Backtosearchresults

HazardousProducts(Toys)Regulations

C.R.C.,c.931

HAZARDOUSPRODUCTSACT

HazardousProducts(Toys)Regulations

RegulationsRespectingtheAdvertising,SaleandImportationofHazardousProducts(Toys)

SHORTTITLE

1.TheseRegulationsmaybecitedastheHazardousProducts(Toys)Regulations.

INTERPRETATION

2.IntheseRegulations,

"Act"meanstheHazardousProductsAct;(Loi)

"softtoy"includesastuffedtoy,apliablerubbertoyandapliableplastictoy.(jouetmou)

GENERAL

3.(1)Apersonmayadvertise,sellorimportintoCanadaaproductincludedinanyofitems13to20ofPartIIofScheduleItotheActonlyifthatproductmeetstherequirementsoftheseRegulations.

(2)AnywrittenstatementorwarningorotherwritteninformationrequiredbytheseRegulationsshallappearinboththeEnglishandFrenchlanguages.

SOR/91-267,s.1.

PACKAGING

4.(1)Aflexiblefilmbagusedtopackageanyproductdescribedinparagraph13(a)ofPartIIofScheduleItotheActshallmeetthefollowingrequirements:

(a)theopeningofthebagshallbelessthan14inchesincircumference;or

(b)thebagshall

(i)bemadefromfilmthatisatleast0.75mlthick,and

(ii)haveprintedlegiblyonitthefollowingwarning:

“PLASTICBAGSCANBEDANGEROUS.TOAVOIDDANGEROFSUFFOCATIONKEEPTHISBAGAWAYFROMBABIESANDCHILDREN.”

(2)Thewarningsetoutinparagraph(1)(b)maybeexpressedindifferentwordsifthosewordsconveyclearlythesamewarning.

SOR/91-267,s.2.

ELECTRICALHAZARDS

5.Everyproductdescribedinparagraph13(b)ofPartIIofScheduleItotheActshallmeettherequirementsapplicabletoitthataresetoutinCanadianStandardsAssociationStandardC22.2No.149-1972,entitledElectricallyOperatedToys.

SOR/78-393,s.1;SOR/91-267,s.3.

6.Everywood-burningelectrictoolincludedinparagraph13(b)ofPartIIofScheduleItotheActshallmeettherequirementsapplicabletoitthataresetoutinCanadianStandardsAssociationStandardC22.2No.122-M1989,entitledHand-HeldElectricallyHeatedTools.

SOR/91-267,s.3.

MECHANICALHAZARDS

7.Noproductincludedinparagraph13(c)ofPartIIofScheduleItotheActshallhaveacomponentorpart,otherthanacomponentorpartconstructedentirelyofsofttextilefibrematerial,that

(a)isseparable;

(b)maybecomedetachedwithreasonablyforeseeableuse;and

(c)canbetotallyenclosedinthesmallpartscylinderdescribedinScheduleVIII.

SOR/91-267,s.4;SOR/2004-65,s.3.

8.Everyproductdescribedin

(a)paragraph13(d)ofPartIIofScheduleItotheActshallhaveallexposedmetaledgesfoldedbackorsprayedwithordippedinpaintorotherwisetreatedsothatallsharpnessandburrsareeliminated;

(b)paragraph13(e)ofPartIIofthatScheduleshallhaveallendsofwirecovered,turnedinorturnedbacksothatnosharpendsbecomeexposedwithreasonablyforeseeableuse;

(c)paragraph13(f)ofPartIIofthatScheduleshallhaveallofitsplasticpartsthatwould,onbreaking,exposesharpedges,

(i)madesufficientlythicktoresistbreakagethroughreasonablyforeseeableuse,or

(ii)wheresuchpartsarenecessarilythinbecauseofthefunctionoftheproduct,madeofinherentlytoughmaterials;

(d)paragraph13(g)ofPartIIofthatScheduleshallhaveallofitsexposedwoodensurfaces,edgesandcornerssmoothlyfinished;

(e)paragraph13(h)ofPartIIofthatScheduleshallhavealledgesandcornersoftheglasssmoothlyfinished;

(f)paragraph13(i)ofPartIIofthatScheduleshallhaveonlysuchfastenersas,byreasonoftheirtype,sizeandmannerofuse,willnot,withreasonablyforeseeableuse,causepersonalinjuryand,withoutlimitingthegeneralityoftheforegoing,shallhave

(i)anynailsandstaplesproperlysecured,

(ii)anyflatheadorovalheadwoodscrewsofthecountersunkheadtypeproperlycountersunk,

(iii)anywoodscrewsfreeofallexposedburrs,

(iv)anyfastenersinupholsteringorupholstering-likeapplicationproperlysecuredandofatypethat,ifexposedwouldnotbeahazard,and

(v)anythreadedboltsprotectedbyacornorsimilarnutsorprotectivecaps,unlesstheboltsaresoplacedthattheyprotrudeintoaprotectedareawherecontactwiththethreadedendsisnotlikelytooccur;

(g)paragraph13(j)ofPartIIofthatScheduleshallhaveasafetystoporalockingdevicetopreventtheunintentionalcollapseoftheproduct;

(h)paragraph13(k)ofPartIIofthatScheduleshallhave

(i)itsspring-wounddrivingmechanismenclosedsothatthemovingpartsthereofcannotbetouchedunderreasonablyforeseeableuse,

(ii)anoutercasethatwillwithstandreasonableabuseiftheproductissoconstructedthatdamagetotheoutercasewouldcausethemechanismtobeexposed,

(iii)whereanon-detachablewindingkeyhasbeeninstalled,suchwindingkeyofashapeandsizethatachild’sfingercannotbecomeensnaredinit,and

(iv)whereadetachablekeyorstartinghandleistobeused,aclearancespacebetweenthekeyorhandle,wheninplace,andthebodyoftheproduct,thatislessthan1/16inch(2mm)orgreaterthan3/8inch(10mm);

(i)paragraph13(l)ofPartIIofthatScheduleshallhavearubbertiporotherdurablefittingplacedontheleadingendoftheprojectilecomponentwithsufficientsecuritytowithstandapullingforceoftenpounds(44.5N);

(j)paragraph13(m)ofPartIIofthatScheduleshallhaveholesofsufficientsizeandnumberineachoftwoormoreadjacentsidestopreventthesuffocationofachildenclosedtherein;and

(k)paragraph13(n)ofPartIIofthatScheduleshallstandlevelandfirmwhenused.

SOR/78-393,s.2;SOR/91-267,s.5.

THERMALHAZARDS

9.Everyproductdescribedinparagraph13(o)ofPartIIofScheduleItotheActshallmeetthethermalandlabellingrequirementsapplicabletoitthataresetoutinCanadianStandardsAssociationStandardC22.2No.149-1972,entitledElectricallyOperatedToys.

SOR/78-393,s.3;SOR/91-267,s.6.

TOXICOLOGICALHAZARDS

10.Everyproductdescribedinparagraph13(p)ofPartIIofScheduleItotheActshallmeetatleastoneofthefollowingrequirements:

(a)theproduct,byreasonofitsnature,physicalform,sizeoranyothercharacteristic,shallbesuchthatthetoxicsubstanceorthesubstanceorpartcontainingthetoxicsubstancecannotbeingested,inhaledorabsorbedthroughtheskin;

(b)thetotalquantityoftheavailabletoxicsubstanceshallnotexceedone-hundredthoftheacuteoralordermalmedianlethaldose,whicheveristhelesser,calculatedforachildhavingabodyweightof10kg;or

(c)thetoxicityofthetoxicsubstancedoesnotexceedthelimitsprescribedbyScheduleI.

SOR/78-393,s.4(E);SOR/91-267,s.7.

11.Everyproductdescribedinparagraph13(q)ofPartIIofScheduleItotheActshallmeetatleastoneofthefollowingrequirements:

(a)theproduct,byreasonofitsnatureoranycharacteristic,shallbesuchthatthecorrosivesubstance,irritantorsensitizercannotcomeincontactwiththeskin;or

(b)thecorrosivesubstance,irritantorsensitizershallnotbeexcessivelycorrosiveorirritantoranexcessivelystrongsensitizerasdeterminedinaccordancewiththetestsprescribedbyScheduleII.

SOR/91-267,s.8.

12.(1)Subjecttosubsection(2),resins,plasticizers,antioxidants,dyes,pigmentsandothersubstancesandthegrade,quality,quantityandproportionsthereofusedinmanufacturinganyplasticmaterialusedinanyproductincludedinparagraph13(r)ofPartIIofScheduleItotheActshallbethoseconsideredacceptableforuseinthemanufactureoffoodpackagingmaterialsandfoodcontainers.

(2)Asubstance,otherthanaheavymetal,acompoundofaheavymetalorasubstancesetoutinitem8or9ofPartIofScheduleItotheAct,may,subjecttosections10and11,bepresentinaplasticmaterialreferredtoinsubsection(1)intheamountofonepercentorless.

SOR/91-267,s.9.

SPECIFICPRODUCTS

DollsandSoftToys

13.Allparts,clothingorornamentationattachedtoanyproductdescribedinparagraph14(a)ofPartIIofScheduleItotheActshallbeattachedtotheproductinsuchamannerthatnosharpedgeorpointwillbecomeexposedasaresultofreasonablyforeseeableuseoftheproduct.

SOR/91-267,s.10.

14.Allmaterialusedforstuffinganyproductdescribedinparagraph14(b)ofPartIIofScheduleItotheActshall

(a)becleanandfreefromvermin;

(b)befreefromhardandsharpforeignmatter;and

(c)benon-toxicandnon-irritantasrequiredbySchedulesIandII.

SOR/91-267,s.11.

15.Everyeyeornosereferredtoinparagraph14(c)ofPartIIofScheduleItotheAct,exceptapartthatismadeentirelyoffeltorothersofttextilematerial,shallbeattachedtotheproductinsuchamannerthat

(a)theeyeornosecannotbegrippedbyathree-prongedclawhookreferredtoinScheduleIII;or

(b)whentestedinaccordancewiththemethoddescribedinScheduleIII,theeyeornosedoesnotbecomedetached.

SOR/91-267,s.12.

16.(1)Subjecttosubsections(2)and(3),everyproductdescribedinparagraph14(d)ofPartIIofScheduleItotheActshall,whentestedinaccordancewiththetestproceduressetoutinScheduleV,haveatimeofflamespreadinexcessof7seconds.

(2)Where,duetothesmallsizeofaproductreferredtoinsubsection(1),sufficientmaterial,includinganyseam,cannotberemovedfromtheproducttoprovideatleastoneofthetestspecimensrequiredinthetestreferredtoinScheduleVandtheexposedpilelengthistwoinchesormore,theproduct,afterbeing

(a)subjectedtothelaunderingprocedureprescribedinitem5ofScheduleVII,ifthetextilematerialornaturalfurisknowntohaveaflame-retardingfinish,orifpreliminarytestingindicatesthatsuchafinishmaybepresent,

(b)driedinanovenfor30minutesat221°F(105°C)orfor120minutesat167°F(75°C),

(c)removedfromtheoven,and

(d)placedoveradesiccantsuchasanhydrouscalciumchlorideinadesiccatoruntilcool,butfornotlessthan15minutesormorethantwohours,

shall

(e)notflameuponaone-secondimpingementofthecalibratedflameappliedbytheflammabilitytesterspecifiedinitem1ofScheduleVI;or

(f)self-extinguishwithintwosecondsoftheremovaloftheflamereferredtoinparagraph(d).

(3)Where,duetothesmallsizeofaproductreferredtoinsubsection(1),sufficientmaterial,includinganyseam,cannotberemovedfromtheproducttoprovideatleastoneofthetestspecimensrequiredinthetestreferredtoinScheduleVandtheexposedpilelengthislessthantwoinches,subsection(1)isnotapplicabletotheproduct.

(4)[Revoked,SOR/80-312,s.1]

SOR/80-312,s.1;SOR/91-267,s.13.

17.(1)Subjecttosubsection(2),everyproductdescribedinparagraph14(e)ofPartIIofScheduleItotheActshallhaveatimeofflamespreadinexcessof7seconds,

(a)whentestedinaccordancewiththetestproceduressetoutinScheduleVII;or

(b)where,duetotheshortlengthoftheyarn,sufficientmaterialcannotberemovedfromtheproducttoprovideatleastoneofthetestspecimensrequiredinthetestproceduressetoutinScheduleVII,whentestedinaccordancewiththetestproceduressetoutinScheduleV.

(2)Where,duetotheshortlengthoftheyarnandthesmallsizeofaproductreferredtoinsubsection(1),sufficientmaterial,includinganyseam,cannotberemovedfromtheproducttoprovideatleastoneofthetestspecimensrequiredinthetestproceduressetoutinScheduleV,subsection(1)isnotapplicabletotheproduct.

SOR/91-267,s.14.

18.Thehairormane,orsimulatedhairorsimulatedmane,ofeveryproductdescribedinparagraph14(f)ofPartIIofScheduleItotheAct,afterbeing

(a)subjectedtothelaunderingprocedureprescribedinitem5ofScheduleVIIifthehairormane,orsimulatedhairorsimulatedmaneisknowntohaveaflame-retardingfinish,orifpreliminarytestingindicatesthatsuchafinishmaybepresent,

(b)driedinanovenfor30minutesat221°F(105°C)orfor120minutesat167°F(75°C),

(c)removedfromtheoven,and

(d)placedoveradesiccantsuchasanhydrouscalciumchlorideinadesiccatoruntilcool,butfornotlessthan15minutesormorethantwohours,

shall

(e)notflameuponaone-secondimpingementofthecalibratedflameappliedbytheflammabilitytesterspecifiedinitem1ofScheduleVI,or

(f)self-extinguishwithintwosecondsoftheremovaloftheflamereferredtoinparagraph(d).

SOR/91-267,s.15.

19.Everysqueaker,reed,valveorothersimilardevicereferredtoinparagraph14(g)ofPartIIofScheduleItotheActthatcanbetotallyenclosedinthesmallpartscylindershowninScheduleVIIIshallbesecuredtotheproductinsuchamannerthatitcannotcomelooseasaresultofreasonablyforeseeableuse.

SOR/91-267,s.16;SOR/2004-65,s.4.

20.Everyproductdescribedinitem14ofPartIIofScheduleItotheActshallmeetallsuchrequirementsprescribedbytheseRegulationsinrespectofproductsincludedinitem13ofPartIIofthatScheduleasareapplicabletoit.

SOR/91-267,s.16.

PullandPushToys

21.Everyproductdescribedinitem15ofPartIIofScheduleItotheActshall

(a)meetallsuchrequirementsprescribedbytheseRegulationsinrespectofproductsdescribedinitems13and14ofPartIIofthatScheduleasareapplicabletoit;and

(b)haveaprotectivetipplacedontheendoftheshaft-likehandlethereof

(i)forthepurposeofpreventingpuncturewounds,and

(ii)withsufficientsecuritytowithstandapullingforceof10pounds(44.5N).

SOR/78-393,s.5;SOR/91-267,s.17.

ToySteamEngines

22.Everyproductincludedinitem16ofPartIIofScheduleItotheActshallmeetsuchrequirementsprescribedbytheseRegulationsinrespectofproductsdescribedinitem13ofPartIIofthatScheduleasareapplicabletoit.

SOR/91-267,s.18.

23.(1)Toysteamengineboilersshallmeetthefollowingrequirements:

(a)eachboilershallbefittedwithafirmlyinstalledspringvalveoranyothersafetyvalveexceptaweightvalve;

(b)theoperatingpressureofasafetyvalveshallnotbemorethanoneandone-halftimestheoperatingpressureofthesteamboilertowhichitisfitted;and

(c)eachboilershallbeconstructedtowithstand,withoutrupture,apressurethatisatleastthreetimestheoperatingpressureoftheboiler.

(2)Forthepurposeofsubsection(1),theoperatingpressureofaboileristhesteampressureintheboilerthatadjustsitselfafterthesteamenginehasbeenrunningwithoutaload.

FingerPaints

24.Everyproductincludedinitem17ofPartIIofScheduleItotheActshall

(a)bewater-based;and

(b)meetsuchrequirementsprescribedbytheseRegulationsinrespectofproductsincludedinitem13ofPartIIofthatScheduleasareapplicabletoit.

SOR/91-267,s.19.

Rattles

25.Everyproductincludedinitem18ofPartIIofScheduleItotheActshallbesoconstructed

(a)thatnosharpwirewill,withreasonablyforeseeableuse,becomeexposed;and

(b)thatnopartoftheproductandnoneofitscomponentsthatcanberemovedbytheapplicationofaforceof50Newtons(11.23lbs.)orlessoratorqueoflessthanoneNewtonmetre(8.85in.lbs.)willimpingeonthebaseofthetemplatedepictedinScheduleIX,whentestedinaccordancewiththeinstructionssetoutinthatSchedule.

SOR/91-267,s.20.

Elastic

26.Everyproductdescribedinitem19ofPartIIofScheduleItotheActshallmeetatleastoneofthefollowingrequirements:

(a)itsextensibilityshallnotbemorethan75percentofitsunstretchedlength;or

(b)itsfully-stretchedlengthshallnotbemorethan30inches(0.75m).

SOR/91-267,s.21.

Batteries

27.Everyproductincludedinitem20ofPartIIofScheduleItotheActshallbeconstructedtowithstandthetestprescribedinScheduleIVwithoutleakage.

SOR/91-267,s.22.

SCHEDULEI

(ss.10and14)

PERMISSIBLELIMITSOFTOXICITY

1.

(1)Forthepurposesofparagraphs10(c)and14(c)oftheRegulations,asubstanceshallbeconsideredexcessivelytoxicforhumansif

(a)theacuteoralLD50valuethereofforratis5gramsorlessperkilogrambodyweight;

(b)theacutedermalLD50valueforrabbitis2gramsorlessperkilogrambodyweight;and

(c)wheregas,vapour,mistordustislikelytobeencounteredwhenthesubstanceisusedinanyreasonablyforeseeablemanner,theLC50valuethereofforaone-hourexposuredeterminedusingrats,is20,000partspermillionbyvolumeofgasorvapororless,or200milligramsperlitrebyvolumeofmistordustorless.

(2)LD50valuesaretobedeterminedinconformitywithgoodtoxicologicalpractice.

(3)Thenumberofdeathsduringa14-dayperiodfollowingdosageshallbeusedasthebasisforcalculationoftheLD50value.

(4)Sufficientanimalsshallbeusedtogiveastatisticallysignificantresult,whichresultshallbecalculatedusingmethodsbasedupongoodstatisticalpractice.

(5)ThemethodsusedbyC.I.Bliss(1938)andJ.T.LitchfieldandW.F.Wilcoxon(1949)areacceptablebutothermethodsgivingsimilarresultsmayalsobeaccepted.

2.ThedermalLD50valueshallbedeterminedinthefollowingmanner:

Intheacuteexposurestheagentisheldincontactwiththeskinbymeansofasleeveforperiodsvaryingupto24hours.Thesleeve,madeofrubberdamorotherimperviousmaterial,issoconstructedthattheendsarereinforcedwithadditionalstripsandshouldfitsnuglyaroundthetrunkoftheanimal.Theendsofthesleevearetucked,permittingthecentralportionto“balloon”andfurnishareservoirforthedose.Thereservoirmusthavesufficientcapacitytocontainthedosewithoutpressure.Thedimensionsofsleevesandtheapproximatebodysurfaceexposedtothetestsubstancearegiveninthefollowingtable:

DIMENSIONSOFSLEEVESFORACUTEDERMALTOXICITYTEST

(TestAnimalRabbits)

Measurementsincentimetres

Average

Rangeof

Average

percentage

weightof

areaof

oftotal

Diameter

Overall

animals

exposure

body

atends

length

(grams)

(cm.2)

surface

7.0

12.5

2,500—3,500

240

10.7

Thesleevesmayvaryinsizetoaccommodatesmallerorlargersubjects.Inthetestingofunctuousmaterialsthatadherereadilytotheskin,meshwirescreenmaybeemployedinsteadofthesleeve.Thescreenispaddedandraisedapproximately2centimetresfromtheexposedskin.Inthecaseofdrypowderpreparations,theskinandsubstancearemoistenedwithphysiologicalsalinepriortoexposure.Thesleeveorscreenisthenslippedoverthegauzewhichholdsthedoseappliedtotheskin.Inthecaseoffinelydividedpowdersthemeasureddoseisevenlydistributedoncottongauze,whichisthensecuredtotheareaofexposure.

Theanimalsarepreparedbyclippingtheskinofthetrunkfreeofhair.Approximatelyonehalfoftheanimalsarefurtherpreparedbymakingepidermalabrasionsevery2centimetresor3centimetreslongitudinallyovertheareaofexposure.Theabrasionsaresufficientlydeeptopenetratethestratumcorneum(hornylayeroftheepidermis),butnottodisturbthederma—thatis,nottoobtainbleeding.

Thesleeveisslippedontotheanimal,thatisthenplacedinacomfortablebutimmobilizedpositioninamultipleanimalholder.Selecteddosesofliquidsandsolutionsareintroducedunderthesleeve.Ifthereisslightleakagefromthesleeve,whichmayoccurduringthefirstfewhoursofexposure,itiscollectedandreapplied.Dosagelevelsareadjustedinsubsequentexposures(ifnecessary)toenableacalculationofadosethatwouldbefatalto50percentoftheanimals.Thiscanbedeterminedfrommortalityratiosobtainedatvariousdosesemployed.Attheendof24hoursthesleevesorscreensareremoved,thevolumeofunabsorbedmaterial,ifany,ismeasured,andtheskinreactionsarenoted.Thesubjectsarecleanedbythoroughwiping,observedforgrosssymptomsofpoisoning,andthenobservedfortwoweeks.

3.Forthepurposesofthisschedule,“LD50"meansthedosethatwillkill50percentoftestanimalsunderthespecifiedconditionsoftest;and“LC50"meanstheconcentrationofgasandvapourthatwillkill50percentoftestanimalsunderthespecifiedconditionsoftest.

4.Themethodsreferredtoinsubsection1(5)aredescribedinpublicationsasfollows:

(a)C.I.Bliss,Thedeterminationofthedosage-mortalitycurvefromsmallnumbers,QuarterlyJournalofPharmacyandPharmacology,1939,Volume11,page192;and

(b)J.T.LitchfieldandW.F.Wilcoxon,Asimplifiedmethodofevaluatingdose-effectexperiments,JournalofPharmacologyandExperimentalTherapeutics,1949,Volume96,page99.

SCHEDULEII

(ss.11and14)

CRITERIAFORDECIDINGIFASUBSTANCEISEXCESSIVELYCORROSIVEORIRRITANTORANEXCESSIVELYSTRONGSENSITIZER

1.Asubstanceormixtureofsubstancesshallbeconsiderednotexcessivelyirritantforthepurposesofsection11andparagraph14(c)oftheRegulationsifitisnotexcessivelyirritantto

(a)theeyejudgedonhumanexperienceorbaseduponthetestmethoddescribedhereunder;and

(b)theskinjudgedonhumanexperienceorbaseduponthetestmethoddescribedhereunder.

MethodforTestingEyeIrritantProperties

2.

(1)Sixalbinorabbitsareusedforeachtestsubstance.Animalfacilitiesforsuchproceduresshallbesodesignedandmaintainedastoexcludesawdust,woodships,orotherextraneousmaterialsthatmightproduceeyeirritation.Botheyesofeachanimalinthetestgroupshallbeexaminedbeforetesting,andonlythoseanimalswithouteyedefectsorirritationshallbeused.Theanimalisheldfirmlybutgentlyuntilquiet.Thetestmaterialisplacedinoneeyeofeachanimalbygentlypullingthelowerlidawayfromtheeyeballtoformacupintowhichthetestsubstanceisdropped.Thelidsarethengentlyheldtogetherforonesecondandtheanimalisreleased.Theothereye,remaininguntreated,servesasacontrol.Fortestingliquids,0.1millilitreisused.Forsolidsorpastes,100milligramsofthetestsubstanceisused,exceptthatforsubstancesinflake,granule,powderorotherparticulateformtheamountthathasavolumeof0.1millilitre(aftercompactingasmuchaspossiblewithoutcrushingoralteringtheindividualparticles,suchasbytappingthemeasuringcontainer)shallbeusedwheneverthisvolumeweighslessthan100milligrams.Insuchacase,theweightofthe0.1millilitretestdoseshouldberecorded.Theeyesarenotwashedfollowinginstillationoftestmaterialexceptasnotedbelow.

(2)Theeyesareexaminedandthegradeofocularreactionisrecordedat24,48,and72hours.Readingofreactionsisfacilitatedbyuseofabinocularloupe,handslit-lamp,orotherexpertmeans.Aftertherecordingofobservationsat24hours,anyoralleyesmaybefurtherexaminedafterapplyingfluorescein.Forthisoptionaltest,onedropoffluoresceinsodiumophthalmicsolutionU.S.P.orequivalentisdroppeddirectlyonthecornea.AfterflushingouttheexcessfluoresceinwithsodiumchloridesolutionU.S.P.orequivalent,injuredareasofthecorneaappearyellow;thisisbestvisualizedinadarkenedroomunderultravioletillumination.AnyoralleyesmaybewashedwithsodiumchloridesolutionU.S.P.orequivalentafterthe24-hourreading.

(3)Ananimalshallbeconsideredasexhibitinganexcessivereactionifthetestsubstanceproducesatanyofthereadingsulcerationofthecornea(otherthanafinestippling),oropacityofthecornea(otherthanaslightdullingofthenormalluster),orinflammationoftheiris(otherthanaslightdeepeningofthefolds(orrugae)oraslightcircumcornealinjectionofthebloodvessels),orifsuchsubstanceproducesintheconjunctivae(excludingthecorneaandiris)anobviousswellingwithpartialeversionofthelidsoradiffusecrimson-redwithindividualvesselsnoteasilydiscernible.

(4)Thetestshallbeconsideredpositiveiffourormoreoftheanimalsinthetestgroupexhibitapositivereaction.Ifonlyoneanimalexhibitsapositivereaction,thetestshallberegardedasnegative.Iftwoorthreeanimalsexhibitapositivereaction,thetestisrepeatedusingadifferentgroupofsixanimals.Thesecondtestshallbeconsideredpositiveifthreeormoreoftheanimalsexhibitapositivereaction.Ifonlyoneortwoanimalsinthesecondtestexhibitapositivereaction,thetestshallberepeatedwithadifferentgroupofsixanimals.Shouldathirdtestbeneeded,thesubstancewillberegardedasexcessivelyirritantifanyanimalexhibitsapositiveresponse.

(5)Toassisttestinglaboratoriesandotherinterestedpersonsininterpretingtheresultsobtainedwhenasubstanceistestedinaccordancewiththemethoddescribedinsubsection(1)ofthissection,an“IllustratedGuideforGradingEyeIrritationbyHazardousSubstances”issoldbytheSuperintendentofDocuments,GovernmentPrintingOffice,Washington,D.C.,U.S.A.Theguidecontainscolourplatesdepictingresponsesofvaryingintensitytospecifictestsolutions.Thegradeofresponseandthesubstanceusedtoproducetheresponsewillbeindicated.

MethodforTestingSkinIrritantProperties

3.

(1)Primaryirritationtotheskinismeasuredbyapatch-testtechniqueontheabradedandintactskinofanalbinorabbit,clippedfreeofhair.Aminimumofsixsubjectsareusedinabradedandintactskintests.Introduceunderasquarepatchsuchastwosinglelayersofsurgicalgauze,measuring1inchby1inch,0.5millilitre(inthecaseofliquids)or0.5gram(inthecaseofsolidsandsemisolids)ofthetestsubstance.Dissolvesolidsinanappropriatesolventandapplythesolutionasforliquids.Theanimalsareimmobilizedwithpatchessecuredinplacebyadhesivetape.Theentiretrunkoftheanimalisthenwrappedwithanimperviousmaterialsuchasrubberizedclothforthe24-hourperiodofexposure.Thismaterialaidsinmaintainingthetestpatchesinpositionandretardstheevaporationofvolatilesubstances.Afte