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85020000003
H-24921: Dermal Seasitizaton Test - Buehler Method
Dupout7977
TRADE SECRET
STUDY TITLE
H-24921: Dermal Sensitization Test - Buehler Method
LABORATORY PROJECT IDENTIFICATION
DuPont7977 PSL Study Number 11321 Work Request Number 13890 Service Code Number641
DATA REQUIREMENT
U.S. EPA Health Effects Test Guidelines, OPPTS 870.2600, August, 1998
AUTHOR
George E. Moore, B.S.
STUDY COMPLETED ON
December 17, 2001
PERFORMING LABORATORY
Product Safety Labs 2394 Route 130 Dayton, New Jersey, 08810
SUBMITTER
"DuPont Haskell Laboratory for Health and Environmental Sciences
Elkton Road, P.0. Box 50 Newark, Delaware 19714-0050
Page 1of25
24521 DealSnsiTezBauiiMoethnod
Duran 7977
`GOOD LABORATORY PRACTICE STATEMENT
"CTohnitsrsotludAycmke4e0tsCtFhRe r7e9q3uiwrietmhetnhtsfolfowU.iSn.gEePxAceGptoioondsLaboratoryPractice Standard:ToxicSubstances 1. sTurbesattamnecnest.soTlhuetipornoscweedrureensoutsaendalbyyzredifnrecopnecresnotnraetlio0n,purniefporamrihteeyoremsaebnitltyoonfitohnsteust eansd control
lm9e)asTtehtewoaacdweeicutisrhmeaaylguropafadcucreoasntceedentdreavdtiieo.n Tbehceauesethseubtseasncseuwbsatsawnceeigdihleudent00.(veBhiAcSleE)Swacs eaccuratteelsy
s)ysUntiefoarnmdiy, because al souions wee thoroughly mixed prior to administration 0 the test
Stability, because treatment solutions werprepared ust prior se n2.ot deterTmhienesd.ail, uniformityofmisuse and verifoifcoantecitioonn of ICAi scares were
ApplcantSponsor:
Study Director:
NEeLwdarukP,oDnetldsewNareemoandCuomrpasny Usa, L=egere Sh----
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F-24921: Dermal Seasitizaton Test - Buehler Method
DuPont7977
QUALITY ASSURANCE STATEMENT Re`TchoerdQusaolfittyheAsfisnudrianngcsoe fUtnhietseriannsdpoemctliyonssealercetks epinttoernvaflislef.oTrhQesAumimnsaprecytbieonlsowpprrioorvitdoessvteudryifiinictiaattiiooonf.n statements made inthefinal eportsectionthataddressesQualityAssuranceaudits,
Inspections weremadeof:
DATE 1026/01 112001 112001 1x2fay
PROCEDUREINSPECTED 48hourscoring (Induction #3) Raw data Draft report Final report
Findingsreportedto:
StudyDirector 1120/01 Management 11/20/01
Annamarie LaPorte QualityAssurance Auditor
Page 3 of2s
H24921:Derm ScsiznionTs uleMethod
p----
CERTIFICATION
rocataes soo anv ancolletoddheamtyng. Wethe undersigned declarethatthemethods,resultsanddatacontainedinthisreportfaithfullyreflectthe
V/V SGueodrsgeDEi.rMeoiorre, B.S.
Gar= y Wore,L BA. e LaboratoryDieor
nl, CarolFinlay,B.A.
`Study Monitor
Date Dee pool
Bie Xe 11,10
2: han -as6e
Date
Fagederzs
H:24921: Dermal Sensitization Test - Buehler Method
DuPout7977
`TABLE OF CONTENTS GOOD LABORATORYPRACTICESTATEMENT...
TABLE OF CONTENTS...
H-24921; DERMAL SENSITIZATION TEST - BUEHLER METHOD...
1. PURPOSE...ror.
A
ommsm--
2. SUMMARY...
"
soso]
3. MATERIALS..........
er
--
"
wa
one 8
4 METHODS............
pr
wi
won
N--
5. PROCEDURE...
A.
-- omni
6. EVALUATION...........
"
cram
7. HISTORICAL POSITIVE CONTROL VALIDATION STUDY...
pn 1"
8. STUDY CONDUCT...
sn nmm--
9. REFERENCES...
nsm--
"
mn
10. QUALITYASSURANCE ..
i
won
12
11. DEVIATION FROM THE FINAL PROTOCOL .... sn
nmol
12. FINAL REPORT AND RECORDS RETENTION...
A
"1
13. RESULTS...
sw
sms mnt
14. CONCLUSION...
-- smn
TABLE1: PRELIMINARYIRRITATION TESTINGSCORESFORDETERMINATIONOF HNIC (TEST
`TABLE 1 (cont; PRELIMINARY IRRITATION TESTING SCORES FOR DETERMINATION OF HNIC
`TABLE 2: INDIVIDUAL BODY WEIGHTSIWEIGHT GAIN (6)...
18
`TABLE 2 (cont.): INDIVIDUAL BODY WEIGHTSIWEIGHT GAIN (6) cece
AT
`TABLE 3; INDIVIDUAL BODYWEIGHTSIWEIGHTGAIN (@)....cveverssnsnssnns 18
`TABLE 4: INDUGTION PHASE SKIN REACTION SCORES........ceccecsmsssssssssmsmnrmnne 19
`TABLE 4 (cont: INDUCTION PHASE SKIN REACTIONSCORES....cssessersereermernces 20
TABLE 5: INDUCTION PHASE SKIN REACTION SCORES...
21
`TABLE 6: CHALLENGE PHASE SKIN REACTION SCORES...
22
`TABLE 6 (cOnt.): CHALLENGE PHASE SKIN REACTION SCORES...
23
`TABLE 7: GHALLENGE PHASE SKIN REACTION SCORES...
24
APPENDIX A: FEED AND WATER ANALYSES......ocrcsnersenssssssmsmmsonsmsnnens 25
Page sof2s
H:24921; Deal Sesidzatin Tes-Bucher Method
Duron 7977
thCollective Nomenclature: `Synonyms/Cades:
HaskellNumber: CASRegistryNumber: Sommesifon
Rusty:
`PhysicalCharacteristics:
Subility: `Sponsor; Study InitiatedCompleted: In-LifeInitiated Complete:
STUDY INFORMATION Octanoic acid, pentadecafluoro-, ammonium salt ++ AFCm-m1o4n3iFuLmUpOerRfAluDorBoroacntadnoFaltueorochemical Surfactant . c(3sM Chemicals) .+ PPerOflAuorooctanoste, ammonium salt +LHot 3a32 (3M Specialty Materials) (Lot No.) 24921
325261
96.5-100% 0-15% 01% 01%
952%
A(mCAmSon#i38u2m5.p2e6r-fl1u)drooctanoate A[mCmAoSn#i2u1m6p1er5f4l7uo)rohexanoate (ACmAmSon#i6u1m30p4er3l4u]oroheptanoste SHaelptta[dCeAcSaf#lu4o1r4o9n-o6n0a4no)ie acid, Ammonium
White solid
"tThheestetsutdys;unbsotaenvciedeanpcpeeoafrinesdta0bbielisttyawblaesuonbdseerrvtehde.conditionsof
E.WiLlmdiungPtoonnt,dDeelNaewmaoruer1s9a8n9d8 Company USA.
September 27, 2001 (se reptcoverpage) October 10,2001 Novembe2r00,1
Page 025
H-24921: Dermal Sensitization Tes: - Buehler Method
DuPout7977
'H-24921: DERMALSENSITTESIT -ZBUEAHLTERIMEOTHNOD
PROTOCOL NO: AGENCY: PSL STUDY NUMBER: SPONSOR:
SUBMITTER:
`TEST SUBSTANCE IDENTIFICATION: `TEST SUBSTANCE DESCRIPTION: DATE RECEIVED: PSLREFERENCE NO: DATE OF PROTOCOL APPROVAL: EXPERIMENTAL INITIATION DATE: EXPERIMENTAL COMPLETION DATE: STUDY COMPLETION DATE: NOTEBOOK NO.:
P328 DUP EPA (TSCA) m1 `EWLildmuinPgotnotn,deDeNleawmaoruers1a9n89d8Company USA. `aDnudPEonntviHraosnkmeelnltLaalbSocriaetnocreysfor Health NElekwtaornk,RoDadE, 1P9.O7.14B-o00x5500 H24921 White solid `September 19, 2001 010919-19R. September 27, 2001 October 10,2001 November 9, 2001 December 17,2001 01-55: pages 133-146
1. PURPOSE `To assess the sensitization potentialofH-24921 ater repeated topical applications.
2 SUMMARY HA-d2e4r9m2a1ltsoepnsriotdiuzcateiosnenstietsiztawtiaonsacfoenrdruecpteeadtewdittohpigcuailnseppalpiciagtsiotnso.determinethepotential for
Page of25
H:24521; Dermal Sesitzation Test -BucherMechod
DuPon7977
`&vhT5eeh0haeuiltcptelhseyttets(enudsaibtnsstgitiumalianlnecledesa()pw9awit0gaes%sr,,moawnic1/ne0wte0ma%aii)cnxhetdfuwourerneedtikehnerfdtoiishrntedisultclahetrmdieweoeanwctaoepvchria)krswoienan.mdseutcnoTttpwiiaecolnanctloyplne-ydrsaiieptovpdie.loninseaddfnatoeydsrsttsevaisetxhteihercodluwertihscettohnoftti2rohs0let swiauntbdesurtc)tainaocnnedidvroeistheai,tcilaoencdchioasntltilrleolnlegdegwudiaontseeea,po1if0g.0t%hAe)pwtpeersrotexasipumbpaslttieaelndyce204(aaHnnNadIvC4,e8 Ssht0oeu%orsnwc aifwtersa ooelafuctthhic eointnedsiuntchtediinosdntial(leneaddt chaldlosee,tnhegteestand tet iitationcontrolanimalswerescoredforerythema.
iAstafobulnesdubmemlaorw.izingtheincidenceandseverityofthe sensitizationresponsenotedaferchallenge
50% wDiiwsitnldeidstwialtleedrwater ||
Test AniTmoaclisdence wih TSeksitnIRmeiatcattiioonn Cornrol Amizals
Hours
2
48
00/2200 002200
24 [a|
oo no i on] o|
Test Apnirmals
Swi
idled water|
2 0.13
is 005
Distilled water | 0007" 000
"itTyest Ietation Control Animals
Hours
34 010
0805
000 [000
TBhhaeesxyepldocosiinntntiavhmeearrledesesuhplytodsneos,feottebhcsshensirtcvdaelyd,igtrnhaedte,htees8Ht5iss%utbosvraailcniacdeatpeoisssciotthniesvietdceeotrnestdyrnsootletvma0lubisdeeadaticioonnnstthtaiuscdtsystweuuidsyitth(zSaeer.o Section 7).
3. MATERIALS
A Test Substance
"tiTdehemenptteierfsaitteudsruewb.isttThahnePcSesLaidmRepneltfeiewfriaeesdncaaeswNHh-ui2mt4eb9es2orl1i,d0.1w0a9s19r-e1c9eiRv.ed TohneSetepsttemsbuebrsta1n9,ce20w0a1s asntodrewda.satfurtohoemr
d*Tsihleletdewstatsepuriobrpapsslriectcaetiaivoendn.,wcaseasl,id. Tocabanc skincontact the estsubtance was
#Animals withscoresgreater than 0.5 *Sumoftheerythemascoresdivided bythenumberofanimals evaluated.
Pages ofa
isiened with
F-24921: Dermal SusiTtesti-BzueahletrMeothnod
DuPont.7977
Characterization ofthe tes substanceprovidedtoProduct SaftyLabsbytheSponsor was: `Composition: 96.5+100%Ammoniumperfluorooctanoate PH: (0.5%aqueous)
Solubility: Not applicable
Stability: Thetestsubsitseaxpneccteedtobestableforthedurationoftesting ExpiDartea:Detceimbeor 1n5, 2001
B. Animals
3B.1 NumofAbnimeals:r34 3B2 NumberofGroups: 3 3B3 Nuofm Animb alspe erGrr oup:
TPreesltiGmrionuapry:I2i0tation Testing: 4 Test Vehicle Control Group: 10 3B4 SexMale 3B SpociGeui'neaSpitgsrHaraleiyalnbi:no. 3B Age/Bodyweight:`PTreesltiamnindaTreysItiVteahtiicolnGerCoounpt;roYloGurnoguapdsu:lYtoungadult349-443
ramsatexperimentstaarlt 3B.7 S2o0u0r1ce:Receivedfrom ElmHill BreedingLab,Chelmsford, MAonOctober3, 4 METHODS A Husbandry 4A. fHloouosrisnog:rThpleaasntiimcaplesrwfeorraetgerdobuoptthooumsecdaignisnugswpehnidcehdsctoainnfloesrsmsteteol wtihtehmseiszhe
rAerciommamlesnDdHatEioWn(sNiInF)t.hLeimtoerstparepceerwntaGsupildaecfedobretnheeatChatrheecaangdeUansdewoafsLcahbaonrgaetdoraty leastthre timesperweek. 4A2 AnimalRoom TemperatureandRelative Humidity Ranges: 13-C2an3d 30-68% 4A3 Photoperiod:12hourlightdark cycle: 4A4 AcclimationPeriod: 7days 4AS Food:PelctedPurinaGuineaPigChow#5025 4A6 Wsyastteerm:.Filleredtap waterwassuppliedadlibitumbyautomaticwaterdispensing 4A7 iCnotnhtaemfionoandiosr:wTahteerreawtelreevenloskwnhoiwcnhwcoonutladmihnaavntesinrteearsfoenraebdlwyietxhptehcetreedstuoltbseoffotuhnids study. Analysesofthefoodandwaterareconductedatleastonce ayearandthe.
Page9of2s
H-24921: DermalSeosiTetsti-BuzehalertMeothnod
Dupont7977
raerceoprdrsareekseipnetAopnnpfeitlndaeitPxArdo.ductSafety Labs.Thedatesofthemostrecentanalyses B. Identification
4B.1 Caangdei:Edacehcnagtewiaanfsdisdieenxctoifafitehtdewiiitomhmnaac.agecardindicatinga leastthestudy number 4B2 aAnniimmaall:nuEmabcehrgausisnieganpeditgoswtausdyma#1r1k3e2d1,wwihtihchccoonlsotritcuotdedeuannidqugeiivdeenntiafsiecaqtuieonnt.ial 5. PROCEDURE A PrepanadSreleactiotnoifAnoimanls
``vWeihtihcilne2co4nhtrooulrsgprroiuoprstwoacsarcehmaopvpelidcbayticolni,ptphinfgutrhoedfoerascahlgaurienaeaanpdifglaasnskisg.neCdtowa teasstr taankdete netsot
cavhoeicdkaedbforr aantdyhiesbsnnkoimgna.lPirtieosr. selecfotrteesdt,
toOsntluydyhienailttihaytiaonni,tmahlesawniitmhaolustwperre-eexwisetiignhgesdakinndrtihteatsikoinnwwearse
B. InductionPhase
``wOantceerewaacsh wapepelkicfdotrotthhreeleewteeskidse,o0f.e4amclhotfesat a9n0i%m'alwf/owrsmiixxhtouurresoufstihnegatensotscucblsutsainvcee2i5nmduismtiHlilleld DuTroappoChraemTMbaedrhe.sivTehteapecthaomabveorisddwieslroecasteicounorefdthien cphlaacmeberasnadndwrtaopmpiendimwiiztehlonsosno-afltlheregteensitc `sguebnsttlaynwciep.eAdfwtiththweastiexrahonudr eaxcploesanutroepweerliotod,rehmeocvheaamnbyerressiwdeuraelrteesmtosvubesdtaanndcet.hetAepptroixtiemsawteerley. (2e4ryatnhdema4)8 ahcocuorrsdinafgtetro ctahechscionrdiuncgtisoynstaepmplidceastciroinb,edreiandiSnegcstiowner5e.0.madTeheofvehloiccalle r(deiascttiilolnesd water, 100%) was usedforthe inductionof the est vehicle control anaindsmcoreadaslabosve. C. ChallengePhase
s`ubTstwanecen(tHNyIdCa-)yissnaefdtivsetietllhneed wfairtsteriwndauscatpiopnlideods1e,0 0a.n4aimvleosfieao5n0t%hewriigwhtsroelautriofnlaonfk tohfectaecsht
atnhiemrailghutsfirnogntthfelpankrofoecachedetsdecsrtuaibneirdmaaeblofvsoer.tThhecehvaelhliecnlege(dpihsatsilel.edTwhaetetre,st1s0u0b%s)twaansceapimpiltiaetditoon
sciotnetrswolergreeovuaplwuaastaeldfsoortraesaetnesdiwtiiztahttihonetreesstpsounbsseta(necreytahnedmvae)haipcplreofxoirmtahteelcyha2l4laenngde4p8hahsoeu.rsTahfetseer
the challenge applicationaccordingto thesystemdescribedinSection 5.0.
D. Scoring System
0 0.5
- no erythema - veryfinterythema,usuallynon-confluent
1 2
--mofadientraertyetehreymat,huesumaally confluent
3 +severeerythemawith orwithoutedema
d!iTshtiellteedswatsuebrsptrainocre,toaaspprleicceatiivoend.,was asolid. Toenhanceskincontact,thetetsubstancewasmoistenedwith Page10025
H-24921: Dermal Sensitization Test - Buehler Method
DuPont1977
E. BodyWeights Iwangedaiiigvnhiotdsnuaatlnhbdeobddoaydywyaefwitgeehrtcihsaolggflaethinhgntees..aTnTihhmeealmosveweaernaralelnrmdeecsaotnradnbedoaddpryrdidoewrveiitagothtitohgnaewifneisrsfetociranldtcueucslttaaitonendd,twfeeosreatklvllebyhioacdnlyde b`cyonGtrroalpahnPiamdalSsofwtewraree,evSaalunatDeidegsoa,tiasntdiaClAl.y).byan unpaired ttest (INSTAT Biostatistics, created.
F. Clinical Observations `rTehceoradendi.mals were observed daily. If any unusual clinical signs were observed, they were
6. EVALUATION uIisnnecodin;ddoeennrceteofeoovrfailenurcayittdehetenmhcaeesa(ensnedsniostinitzeiazftaoitoironsrneevreserpsioptnyos.neseT)nhoeatpepdidnrucorixidinemgnacteteihlenycdhe2a4xlwlaaennsdgcea4lp8chuahlsoaeut,rtesdwaotfoitenevrdailccuheaastlwleeetnhrgeee. according to the following:
`oSacnnoeirm(ea1ls)sootfhragt1roeerxagctreeereaadtrteehrsieemnetonhseottsneetsvtheegrcreoocnuotpnratorrloealrrneeiqamucaitlirsoe,nttshaoenbeetcihonenrdseiiacdcaettriievoden1os0fobsfeentpshoiestititzeiasvttseisouncb.osIrteafsns.cceogrersooufp Ionfciandiemnaclesistreespteodrtinedtahasttghreonupu.mberofpostiveanimalsineachgroupdividedbythetotal mumber Staehgveievrnieetanrygersistoruetpepnotdrhettoeedfraamsiutnnihetdefsourmbootfthh2e4atensdtgr4a8dheosudrisv.idAeldlbayvetrhaegetgortaaldenusambreertoofbaenirmoaulnsdteedsotfefditno
7. HISTORICAL POSITIVE CONTROL VALIDATION STUDY
p8`eTr5hfe%op(rrpmouercdiebtdyuy)rPaessraoudspueocdstiitSniavfteeictsoynsLttrauobdlyssawunebsdrtecanovcmaepl.ildeaTttheeedd umosonisnMtgaroye-che1ne0tx,yv2la0cl0ii1dn.antTaimhoanel,dPreSahLywddSea,ttuatdeaycnh#dn1ir0ce5ap4lo5gr,rtawdfaeos,r
`tThhiisstsetsutdwyaasrceoanrdcuhcitveeddaitntPhreodDuacyttoSnafFeatcyilLiatbywsitHihstHorCicAaulsDiantgaHNarottleebyosotkraNiona.lb01i,nopgaugiensea2p0-i2g8s.
dfersocmriEbeldminHiSlelctBiroene5d.inTgheLadbastafforlolmowtihnisgpionsdiutcitvieocnonatnrdolcshtauldlyenisgesupmrmoacreidzureedsbesliomiwl.ar to those
IncidenceofPositSicvaesReiszpaotnosne'Response
Indies Sever
ww Hows uw]
[PositiveVehicleControlAnimals|
sno 05
|
210 0s
070 |oso| 04s 1030
*Animals with scoresgreaterthan 0.5, Sum oftheerythema scoresdividedbythe numberofanimalsevaluated
Page 11 of25
H-24921: Dermal Sensitization Test - Buchler Method
Dupont977
8. STUDY CONDUCT ``TchoimsspltiuadnycewawsicthotnhdefuoclltoeawdinPgrroedguuclattSiaofn:ey Labs, 2394 Route 130, Dayton, NewJersey, 08810 in U.S. EPA Good Laboratory Practice Standards: Toxic Substances Control Act (TSCA): 40 CFR 792 `Theproceduresasdescribed intheprotocolarebasedonth following testing guideline: U.S. EPA Health Effects Test Guidelines, OPPTS 870.2600, August, 1998 `The primary technician for tis study was Rolland Colis, BS.
9. REFERENCES RoTSbeonxisinicstoiolzonag,tyi,Mo.n6,1T,eNs9ut1s-aA1i0rn,7d,TI,1t9sF9l0Ue.stceheirn, aE.R,iaskodARsistezs,sHm,entARPreovciesesw ofofrtHhuemBaunehSlkeirnGuSiennseiatiPziagtiSokn iinn
NtReestiws, tYiHon.rz,Caku,n,rd2r5e,Bnut1eC9h8ol0ne.rc,epEt.s,PilnaCnunitnagn,ecoounsduTocxti,ciatny,diVn.tAe.rprDertilaltiaonndoPf. gLuaiznaera(pEidgss)e,nAsictiazadtioenmpPraieisccsh,
10. QUALITY ASSURANCE `p`aTruhodetiotfcsiponelalrafrneodpromPrertdwoddauusrcaitunSdgaitftheeedtsfytoLuradabyg,sraeSnetdmanetdhneatdwraditOtephsetrhofaertreiapnwogrdPtaritnoagcreeodfcutorhreedsis.nasnDpdaefctoteirsocnooamfnpildniaasundpcieetcfwitintidhoiatnnhgseds totheStudyDirectorandFacility ManagementarepresentedintheQuality AssuranceStatement.
11. DEVIATION FROM THE FINAL PROTOCOL None
12. FINAL REPORTAND RECORDS RETENTION tAhceoopriygoifnatlhseisgingendepdrroetpoocrotl,,cwoiplilebseomfaailnltaaiwndedaitnagtehneePrraotdeudcattPSrafoedtuycLtaSbasfeatrycLhiavbess.and a copyof bLearboertaationreyd-bsypetchieffiacciolritsiytwe-hsepreectifhiecwroarwkdwataa,sdsounchea,s personnel files and equipment records will `HTahsekoerlilgiLnaablorraatwodray,taN,etwhaerko,riDgeilnaawlafrien,aolrreaptorItroanndMouanctoapiynoRfectohredpsroMtaoncaoglewmilelnb,eWrieltmaiinngetdoant, Delaware.
13. RESULTS aPrreelpirmeisneanrtyedimiintaTtaiobnltees1t. inIgndsicvoirdeusaflobrotdhye wteeisgshutbsstaanndcebaondydwheiistgohrticgaalipnosfiotrivteestcoantnrdolhiasntoirmiaclasl Ph4poatsshitreiosvukegichno.rnetraocltiaonnismcaolrsesafreorptreessteantneddhiisntoTraibclaelspo2siatnidve3,cornetsrpoelctaivneilzya.alIsnadruecptrieosneannteddiCnhalTlaebnlgees. Page 120125
H-24921: Dermal Sensitization Test - BuehlerMethod
DuPont.7977
sAtaltlistteicsatlalnydsciognntirfoilcaanntidmiaflfsesruernvceisvbedetawnedaepntpehaeroevdenroarlmlablotdhyrwouegihgohuttgtahiensotufdyh.eThteersetawnedretensot vehiclecontrol animals.
InductionPhase
f`aTienstteArnyitmhaelmsa((0te.s5t1s)uwbastsannocteeadpfpolriaeldaesst2si9t0es%duwriiwngmtihxetinudruecitniodnipsthlalseed. water): Veryfaintto
tTeessttveVheihcilcelceonCtornotlrsotleAdnuirminaglsth(ediisntdiulclteidownapthears,e.100%): No dermal irritation was noted for any
Historical was noted
fPoorsailtlitveetCiotnetsrdoulriAngnitmhaelsin(duHcCtAio,n
apsharseec.eived):
Very
faint
to
faint
erythema
(0.5-1)
ChallengePhase
e`rTyesttheAmnaim(a0l.5s)w(taesstnostubesdtfaonrcfeivaepopfli2e0dtaesstsai5te0s2%4whoiurssoalfutteirocnhIanlldeinsgtiel.lIedrrwitaatteiro)n:peVrseirsytefdaaintt twoofthese sites through 48 hours.
d`iTsetsitlSleudbswtaatnerc)e:IrVreirtaytifoaninCtoenrtyrtohleAmani(m0a.l5)sw(taesstnsoutbesdtafonrcetwapopolfiteednastaest50si%tesw/24w hsooluurtsioanftienr challenge. Imitation persisted at one ofthes sites through 48 hours. t`TheescthAanlilemnaglesph(adisset.illed water, 100%): No dermal irritation was noted for any tet site following
n`ToetsetdfSoubrsatnayncteestIrsruibtsattainocneCiornttartioolnAcnointmraol!ssi(tdefiostlillolwedinwgatthere,c1ha0l0l%e)n:geNpohasdee.rmal iitation was
HimsitnoerriaclaolfP)o:siFtiivveeofCotnetnraonliAmnailsmaelxhsi(baiptpeldiseidganssof& 7a5s%enswi/tiwzsaotilountrieosnpoofnsHeC(Af.ai(taserreyctehievmead)[i1]n)
24 hours erythems
(a0f.t5e)rnocthaeldlefnogrem.osStiomtihlearr siitnedstichartoioungsh4pe8rshiosutresd. at
twoofthese
sites
with
very
faint
rHisetorcicaeil nPimosivinteiervaeldVoeilh))i:cVleerCyofnatirnotlerAyntihmeamlaswa(aspnpoltieeddfaosrfaou7r5o%ffwiivewtessotluntaiiovnecoofntHrColAsi(tseass 24 hours after challenge. Imitation persisted at threeofthese sites through 48 hours.
14. CONCLUSION cBoansteadctosnastihteiszeerf.indings and on the evaluation system used, H-24921 is considered not to be a
hTehxeylpcoisnintaimvealdreehsypdones,eteocbhsneicravledgriande,th8e5h%ist(oarsicraelceipvoesdit)ivvealicdoanttersolthveatleisdtatsiyosntesmtuudsyedwiitnhthai-s study (See Section 7).
d!iTshtiellteedswtastuebrsptrainocre,toaaprpelciceaitvieodn.,was asolid. Tocabanceskincontact,thetetsubstance wasmoistenedwith Page 130125
21 ordSeno otBe od
oe
TABLE1: PRELIMINARYIRRITATIONTESTINGSCORES FORDETERMINATIONOF HNIC!(TEST'!SUBSTANCE)
as Ani"mal No.| Sex
CEO 9% Hours5afer P[ aich Res movalo25] -| 0s Tos Tos os [us [0[0] 24 [4872448[2448] 24] a8
= aE
"HNIC - Highest Non-Irritating Concentration
oo iio st cs i ld i ire seinon dei `waterusinganocclu25smimvHiellTop Chamber. i He ?The testsubstance,asreceived,was asolid. Toenhanceskin contact, the testsubstancewasmoistenedwith
24521:DelSeszation Tet Buel ithod
Duron 7577
`TABLE 1 (cont): PRELOIMFINHANRIYC'I(RPROISTIATTIIVOENCTOESNTTIRNOGLSHCCOAR)ESFORDETERMINATION
HistoricalPositiveControlValidation Study
ro] sa | =Concentrations -
paimel
Je [os | so [as|
020
ou
|M
05
|M[os |
05
0
0
0
0
0
0s | 0 | 0 | o
os | 0 |
"HNIC ighesNooraingConeciron 2? F5omurn-tenlthlsToofpCamailmliblieterrof HCA wasappliedasreceived andas wiwsolutions inmineraloilusing anocclusive
Page 150125
rsemtsone. es
ram
TABLE 2: resin INDIVIDUALBODYWEIGHTSMWEGIAIGNH(gT)
[een ro BE re| een | oe
ele
w Iswwls |wwso |Tsn |w ws|
B[nta5ln[0or wsTam|a30T20Ts Tala To oe]
rosea
[sssm[s]n] oo
ae [en |
eis] o |a|
es
[ar]
| ast
wo las [or
wo [ws | | as
[[ssrsso 2Ta[s|| >asao ose[| 5 ||osrw|| 0|[arw|| [[5ss5sum3m[9ans| 0J4ou5] [0] 5[ sm a|0 w w]|
[5100[aoa[an | 1 [sn] 56 [2] os | o|m36 | mms
[[1s6ia[[39l6[[aawaa| sr3r8 [[a|m| o3 w[sm] ao[|aswee|e a0|
[ies ms [am | 1 [wi] @ [sn] 0 | ss | 5 | me
pe
w |e |
[EMeain [962o(u9m4| v51e2 [m50m94 sao m[sss]meaa|wwnz|| a$ao|m]0|
----
teen oe
opr
TABLE 2(cont):INDIVIDUAL BODYWEIGHTS/WEIGHTGAIN(g)
`Test Vehicle Control Group
eslan ale5e]3oa2r, ToV5a] Gotm Towen]vunm [Taoormamee||coumee 8-[0
[sv
S169
aT52[1|
[98||a9|
2
a1
sor]
| a7
wo
| [ wo | |5 ew|| r 55 [o[nam]
[ov asss ro se [a [08 [m0 | so [ms
from onJo] nnow fun sa [fs
ss [ss
[09| msm] w0 m9|ss|e] sw
[s#w | s] e | | im (se @| a | a | am |
asiris[ums[ma1 || asw0w][oe
5
Tan
[sa]
do [am |ne|
wes
sve
am
[w[u 9v8o[[4s6o51[s]no]m
0
0 [sm
wa To| ]
i Mean s|3[75z.6z[4i2s9.]6] a56m0 [4o8u94s] 9s9o68 s|seasss2]| s5a5r8|| rsend || s4e1s2 | 2108
--
et moe
J
TABLE3:INDIVIDUAL BODYWEIGHTSWEIGHT GAIN (g) Historical Positive Control Validation Study'
fAiNmoa.llg|g(Week loGaainn [We5ek| wGiainn|We4ek! DCaiyltAefntgeer||riGatien)
Coorn [[aowo[[raon]] [o0s| 5| ws0fo]ol 5[oaww [||+|ur|] [os os [ss [so Tia| ss[30552 om | 35[or|
Th[womr ][a| ao> sTmn]| ass [ Tw a|s oTwe |sTtm a || [[oows[TeuTa[[|oo as] > [0| w To =|
2v6en[[|o0ns a[al0]]oass
|eiedenosu1636 om5
4m
Jfmass]
a [ss] 4
ssmss JJos]aavsaoir]s||
[C|2o|
nanrT| ooro| Tiooms
Jas] sw [se] vais|wm| no| |
ais
5 Cr[wowo [Tsn]al0s [omne[a[aa||
[[5ouws[50 [5o5n0 |[ a[ow6 | 5[[sosw] 00 |aas |mau]
(Man om] en sn] et|e] 5s | es |
[52m sf] Mean ro
Standard
"
sas
[s0o2n4]]
iwzse
J[ssos]owsas|| oenasn |
" PSL Study #10548,performedby J PSLandcompleted onMay 10,2001.
petse e p
wo
TABLE 4:INDUCTIONPHASESKIN REACTIONSCORES
`Test Substance Group'
eTe Te-- ] ete]
3149
05
05
0s | 05
05
0s
vos os [os| 0
ere ete Ss Ss
os os
[os | os|
5 [0[os 0] os| 0[os[0]
e os||oeo ros TorTTeertau]r]
ere
3164 [7 [Tos 1 05 tos|
seo os es [tas Ts 3167 [Tos[0Tos| 0s | os | os
Frmof miller af het bc a pd 50% i isin dled
Hoursafter inductdioosen.
is
er,wig
emtSemon eS
oan
TABLE 4 (cont): INDUCTIONPHASESKIN REACTION SCORES
`Test VehicleControlGroup"
[Er Boi --
a EE
FMaE man Rn
soo oooo[or]
smo
wm
ooo oo]
0 [0| ov
wn 0 | 0 | 0 [oo
Co omme To o o To TofTooooto]]
! Four-teathsof amilleofthevehicle(distilledwater, 100%),wasappliedusing an occlusive 25mum Hil Top.
? Hoursafterinductdioosen.
--
1emt nn ets
oom
"TABLE5:INDUCTIONPHASE SKINREACTIONSCORES
Historical Positive Control Validation Study'
pe
PositiveControl Group'
1]
mos]
0 oso [eso]-
78 Tos [os | 1 os |1 |os|
mes ow[0s1 ws
2w 83 os0 | 00 [0o5s |00] 0.5 0.5
reit----St----
*Fourtenthsofa milliliterof HCAwasappliedasreceivedusinganocclusive 25mmHillTopChamber,
*Ho afteu r indur ctions dose.
--
1 DeSoto
I
"TABLE 6: CHALLENGEPHASE SKINREACTIONSCORES
Test SubstanceGroup!
-- on " wo we Tn oT ooao m] T Te os m o o Tee|
TToomm [0es o oo oo o Tooswe To oT eoe eo o| omeee Tw ee [eo
TTooewe ee o e eo o T Tow e Teoe e o o|
an Four-tenthsof amilliliterofthetestsubstancewasappliedss 8 50%w/wsolutionindistilled water,usingan
`occlusive 25mmHill TopChamber to therightrearflankandthevehicle (distilledwater, 100%)wasapplied to Page220f25
----
oor
"TABLE 6(cont): CHALLENGEPHASESKINREACTIONSCORES
`Test SubIrs ritat tiona Contn rolc Groe up'
m To T e wa] `HoursafterDosing
3173
0
0
|
0
|
0
om Te TC
Chm -- o*cFcoluur-stievaeth2s5mofnaHmiillllilTioteprCohfatmhebteerstsoutbhsetarnicgehwtraesaspfpllainkeadnasdt8h5v0e%hiwclwes(odliusttiiolnlednwadtiestri,l1le0d0w%a)twerasusspipnlgiaond 0
H.24521:DermalSensitizationTes - BuhlerMethod
Dupont7977
`TABLE 7:CHALLENGE PHASE SKINREACTIONSCORES'
`Historical Positive Control Validation Study
h [Fosm |o|e3w0ce |oe0m]a
Ie Es Ee T
ED
0s
0s
x
rt
a T2)es 5 | 0
Naeem [|
258
0
0
x |os os
m0 | os |os|
ow
os |0|
|Sortsof asillierof 75% wh bio of HC (os resid) mie i winanose 25on PSLStudy#10548, performedbyPSLandcompletedonMay 10, 2001 Hoursater challednogse
Page240125
H-2Derm4alS9esi2tza1ton Test - BuehlerMethod
DuPont.7977
APPENDIX A: FEED AND WATER ANALYSES
On June 21,2001 animal feed was analyzed forthe presenceofthe following contaminants:
Aldrin
'BHC-A (Alpha-Hexachlorocyclohexanc) BHC:B (Beta-Hexachlorocyclohexane) BHC.D (Delta-Hexachlorocyclohexane) BHC (Lindane) Captan Chlordane
Chlorpyrifos-Methyl Chlorpyrifos (Dursba) 44DDD
44DDE 44DDT Dieldrin
"Dylox (Trichlorfon) Endosulfan1& TI Endsolfan Sulfate
Endrin Endrin Aldehyde Esfenvalerate Fenvalerate: Heptachlor Heptachior Epoxide Mavrik (Tau-Fluvalinate) Methoxychlor Mirex Quintozene:
Noneoftheabovecompoundswerepresentabovethelimitofdetection (0.005ppm)
LABORATORY: F12O0O03DNP.ER.OADiUnCswToSrtLhACiBrOclReATORY, INC. PSourittlean1d0,5OR 97220
On June 21,2001, waterwasanalyzedforNIDEPESafeDrinkingWaterActparameters.
LABORATORIES: NNIEDEWPJEELRASEBYLLDA.B#O1R50A0T1ORIES OSFINLLEIWKERJELRASBEOYR,AITNCO.RIES
2A.2A2.BLasatbosnDAivviesniuoen
4Ga0r0wSoooudt,h NAJve0n7u0e27
New Brunswick, NJ 08901
Resultsofwater analysis for possible contaminants were acceptable within regulatory standards.
Page25of25
