Document km2280b0a5NGdzjZx4R44QmQq

R226 _ 3RUO 5130Dr SteBed AR236- = 3240 TRADE SECRET 1425136 DslSSTeUDmYiTnITTeLE Bul Metied LABORAITORPYt.PsuRotOywJNuEnmCbseTr I1D71E6NT)IFICATION GeorAgUe.TMHowOeR. 5 STUDY aptsCOMPLETED ON PERFORoModIteNRGfoLeeAy3BL0OasRATORY Doi,ower, 08810 [E-- rS--UBM--I-- TTE--R -- NeEvan,kDaeorPeO9B7o1x405008 - CompanySanitized. DoesnotcontaTSiCnA Cay - Page 1of25 125134: Domual Seasitzaton Tet- Buhler Mebod Dupont 9303 QUALITY ASSURANCESTATEMENT RTehceorQduasloifttyhAesfsinudrianngcseoUftnhietsreainndsopmecltyiosneslacrtskienptteornvalislfeoTrhQeAs.uinmsmpaercytbioenlsopwrpiroorv1i0desstvuedryiifniictaitoionof.n statementsmadeinthe inal reportsectionthataddressesQualityAssuranceaudits. Inspewcerte imaodenosf: DATE PROCEDUREINSPECTED 12202 Testsubstancedispensingrecords 12202 Testsubstancepreparation 02 48 hourscoring(Induction #3) = MP2 Rawdata 31802 Draper 4/5/02 Final report Findingsreported to: StudyDirector 1802 Management" 31802 A`sQunaalmitayrAiscsuLraaPonrcteeAuditor Pagozetzs COMPANY Baio. Loes not conta TSCA Car 25134 DelSesitizationTestBuehlerMethod Dupoues303 `CERTIFICATION `pWreoctehdeuurnedseursseidgnaendddreacwldareathcaotltlheectmeedtdhuordis,nrteseultsdayn.ddatacontained inthisreportfaithfully reflectthe --- GeorgEe.MoorsBS. StudyDirector --= LGaabroryaWtaoorryoDwiarkecit,orBA. GrolFi{laa,pBe.Al Hnlusy `StudyMonitor Due 4)sfoa +s [o= Bee 4lefon Bate -- Pagedof2s Company Sanhized. DossnotcontainTSCACBI 125154DoS Tt Bud STUDY INFORMATION I stan: `HaskellNumber: Bui: 25134 (EEN) (--) `Physical Characteristics: `Stability: Sponsor: `StudyInitisted/Completed: In-LifeInitiated/Completed: IR \ Dark brown solid ee oe Thetestsubstanceappearedtobestableundertheconditionsof VinELduPontdeNemaonduComrpasny `Wilmington, Delaware 19898 January21, 2002/(seereportcoverpage) January 23, 2002/ February 23, 2002 Pagedof25 CompanySanitized.Doesnotcontain TSCACBI 25134: DermalSensitization Test - Buehler Method `TABLE OF CONTENTS DuPont9303 TABLE OF CONTENTcSrc STUDY INFORMATION ccm H-26134: DERMAL SENSITIZATION TEST -BUEHLER METHOD... cocvrnrmsinnnnen 1. PURPOSE... w-- wsdl 3. MATERIALS......... ws " " oT 4. METHODS... N nee iB 5 PROCEOURE mmm -- 6. EVALUATION sm-------- a 7. HISTORICAL POSITIVE CONTROL VALIDATION STUDY ccc 10 8. STUDY CONDUCT.......... C---------- with 9. REFERENCES. " A------------ wlth - 10. QUALITYASSURANCE mm----------_t 11. DEVIATION FROM THE FINAL PROTOCOL . ssmmmm----_--r 12. FINAL REPORT AND RECORDS RETENTION sms 13. RESULTS. - amm----1 14. CONCLUSION ....... ------ wld `TABLE 1: PRELIMINARY IRRITATION TESTING SCORES FOR DETERMINATION OF HNIC (Test TPAOBRL1EC(coIntD); PREcLmIMmIeNAsRmYrIRmRmITsATmIrONmTsEsSTsIsNGmSmCeORrEmSmFeOmRmDEmTmEiRMmImNAmTmIOmNmOmFmHmNIoCnn 15 TABLE 2: INDIVIDUALBODYWEIGHTSWEIGGAHITN (g)(TOtSUBSANCE) corres 16 TABLE 2 (cont): INDIVIDUALBODYWEIGHTSIEIGGAHITN (g) (Test SUbSHance)......eveeveee 17 `TABLE 3: INDIVIDUAL BODY WEIGHTSWEIGGAHITN (g) (POSS CORTON vice 18 `TABLE 4: INDUCTION PHASE SKIN REACTION SCORES (Test SUbSIANGe)....ccvovvvnv 19 `TABLE 4 (cont): INDUCTION PHASE SKIN REACTION SCORES (Tost SUStaNCR) vse 20 `TABLE 5: INDUCTION PHASE SKIN REACTION SCORES (POSHIV COTO... 21 `TABLE 6: CHALLENGE PHASE SKIN REACTION SCORES(To8tSUBBIANGE) ccc 22 TABLE 6 (cont): CHALLENGE PHASE SKIN REACTION SCORES(Te6tSUbSLANGR).....vvcn 23 `TABLE 7: CHALLENGE PHASE SKIN REACTION SCORES (POSIVCOMO) vcr: 2 APPENDIX A: FEED AND WATER ANALYSES. .cecressssssnscsssnes 25 Pages of25 `Company Sanitized. Doesnotcontain TSCA CBI 128134; DermalSentTietzBuaehlterMoethnod Dupont530 H-25134: DERMAL SENSITIZATION TEST - BUEHLER METHOD PROTOCOLNO: PSL STUDY NUMBER: SPONSOR: SUBMITTER: TEST SUBSTANCEIDENTIFICATION: TEST SUBSTANCE DESCRIPTION: - DATE RECEIVED: PSLREFERENCE NO: DATE OF PROTOCOLAPPROVAL: EXPERIMENTALINITIATION DATE: EXPERIMENTAL COMPLETION DATE: STUDY COMPLETION DATE: P28 DUP uns EWLildmiunPgolnotn,deDeNlawearem1a9on8d98uComrpasny USA. DuaPndoEnntviHraosnkmeelnltLalaScbieoncrefsaortHoearltyh ENlekwtaornk,RoDadE,1P9O7.14B0o0x5050 [ _" Dark brownslid January 15,2002 011520 January 21,2002 Jamary 23,2002 February 23,2002 1. "PTUo aRsPseOssSEthe sensitization potential ofH-25134 after repeated opial applications. 2 SUMMARY A dermal sensitization tet was conducted with guinea pigs to determine the potential for 1.25134 to produce sensitization fer repeated topical applications. --_ PPR ey| Pugs sar2s 128134:DermaSenza TetBucher Method Durn3303 `An 80%' w/w mixture of thetestsubstanceinmineraloilwas topicallyapplied forsixhoursto 20 eth est eine pigs, one cachweek foratresweekinductionperiod, testvehiclecontol group(tenanimals)wasmaintainedunderthesameenvironmentalconditionsandtreated with `mineraloil, 100%,fortheinductionphase.Thirtydays (SeeSection 11) afterthefirstinduction dose, a challenge doofts hete estsubstance(HNICorHighest Non-ritatingConcentration, determinedinthe preliminaryirritation screentobe an 80%' w/wmixturein mineraloil)and ticle angelof 100%)weeapple 0.8 ivesieon each of(he tsand tet subsance imitationcontrolguineapig.Approximately24and48hoursaftereachinductionandchallenge `dose, the test and testirritationcontrol animalswere scoredfor erythema. rAetaobulensdubmemlaorwi.zing he incidenceandseverityofthesensitization sponsenotedsercllege "Test ImitationCorel Ais a 80% Mwiiwnemnmlinoienalol__|__ 0022001 on0 [o_[oono| ~ |S TetAime als |Tesy tIitatonCont] rolAis I Ta e Ta [--80%Mwiwniennmlinoelrslol |000 000||000000| 000000 | |000000|] bBTaohseyedpoonsaitihvreerlerseuypltosn,osfetihoibssvitruvdeyd,tiahn.de,thees$t5sH9ui4sbtsotraicnaclteeipssocseotnisvieedecreodnneo]tstvoaablieddataiicnoonnitsasctysenlwsyiittih(zeSrGe.- ection 7). 3 MATERIALS A Test Substance T{{hdeenetiesetdmsuwbistTpthhanePcsSeeaLmidpRerlentfeiewfraiaeesndcaeaudNaFu-kmr2bb5re1or3ew40n2sw0.ao1s1i5r..cP3srDi,ivedTioohunsi,JaonheuSaurtbeysstt1as5nu,bcse2t0aw0na2sawsnidrswheaastaettdohioen mr 60-68C waterbath,producing athick liquid, which wassti ane dthd enseparatedinto rasodpsn The testsubstance, enasreceiesdimin ved,was asolid. of pra spain. Toenhanceskincontact,thepreparedtest substancewascrushedwith ?Animalswithscoresgreaterthan 0.5 ~. Sum oftheerythema scores dividedby the umber ofsimalsevaluated. pany Saco. ows wn unis 1SCACEL Page 70f25 Ga st Dern Te Bt od Deronsts tir. Om xhdo fdesing oe. cetnsoavsebesatsedtfhn i0o65,Cya Abithrle foroionshou etissprovddo roe StyLasbhprva: "Compositior sont aii T[hs ts baice\ttobe sl rhdarionof sg -- 5 Anima-- s 238012 NNeuomhbeerrofrOriupse 4 383 Na p umbroe r fAnio lperGg rou 4 To,oe ro 10 - 31B845 186 ApSeuxB:Mialse i:guPlsinyiranoGro: Young 387 Sou:Rcdfn m Fl o illringLab,ior,MA o uy 1, Test and Test Vehicle Control Groups: Youngadult/342-399 so 4 METHOA-- DAS T owing:Th ioswe grouEpaRosseele aeiisgpiehenCdheadrsaalmsToio1odf0Lwaeibhomrnah rEer sheco da sdood 41hAAt2 PAmrmo12eppdrmektre AnimalRoomTemperature andRelativeHumidityRanges: 17-22Cand 32-65% ~ 4x065 oWpntit::oPFeilttPoniOewsFisgpCeond5a0d25inby ors wisdining os Company Bes vos cnt SGACBI H.25134:DermalSeasiization Test- Buehler Method DuPoni.9303 4A7 Contaminants:Therewerenoknown in thefoodorwateratlevelswhich cwoonutlamdihnaavntisrnetaescofneaebldwyietxhpethctreedstuoltbseoffotuinds srteucdoyr.dsAnraelkyespetsoonfftihleefaoPordoaduncdtSwaafteetyaLraebcso.nTdhucetdeadtaetsolfeatshteomnocsteraecyeenatraananldytshees arepresienApnpetndeix dA. B. identification 4B.1 Caangdei:dEaechncatgeiwaanfsdsiidxecntoifaftiehtdewaiintiohmanalc.agecandindicatingatlastth studynumber 4B2 Aanniimamla:lnuEmabcehrgausisnieganepditgo wsatdsym#a1r17k1e6d,wwihtihchaccoonlsotirtcuotdedeuaninqdugeivdeenntiisceaqtuieonnt.ial 5. PROCEDURE A PrepanadSerlecatiotnoifAnoimanls vWeihtihcilne2co4nhtroowlsgrporiuoprstwoaesarcehmaopvpleidcbatyicoln,itphpienfgutrhoefdeoarscahlarienaeasnpdifglaanskssi.gneCd tota weassttr aankdeete0st cavhoeicdkesdbrfaodriangnythaebnsokrimna.litPireiso.r toOnsltyudhyeailntiihaytiaonni,mtahles awniitmhaolust wpreer-eexwiestiignhgedskainndrathteisokninwwearse selectedfortes. B. Induction Phase - `oOilnwceaesaacphpwlieeedktoftorhtehlreefeweideekso,fe0a4cghotfstaann8i0m%al'fowrwsimixxhotuurrseousfitnhgeatensotccslubusstiavnec2ei5nmmninHeiralll DuTorpapCohraemTMbeardh.esiTvheteapcehaomabveorisddiwselroecasteicounreodftihnepclhaacmebearnsdanwdrtaoppmeindiwmiizteh n1o05ns-oalfltehregetneisct sguebnsttlaynwcie.peAdfweirtthheetshiaxnohlotuhreenxwpaotseurr,eupseirinogd,aclheeacnhatmowbeelrs10werreemroevemoavneydranedtsheteiessttdssuibutsetsaawnecler.e Apreparcotxioinmsa(teerlytyh2e4maa)nadcco4r8dhionugrs0afthtersccoarcihnignsdyusctteimodnaepspclriicbaetdiionn,Srectieon a5w.De.dreFmoiuard-neenotfghlsoocsafla amilnlilaionifdttsmehcreorvaeedhaicsllaeb(osmvien.eral oi,100%)was usedforthe inductionofthe fst vehicle control C. ChallengePhase . tTehsitrstuybdsatyasnc(eS(eHeNSIeCct)iionnm1i1n)earfatlerotihlwafisrsatipnpdluicetdiotno daosneai,ve0s.i4tgeoofnatnhe8r0i%gh'twr/eawrmfilxatnukroefoefatchhe anoii,m1a00u%si)nwgatshaepprpolcieddturoetshdersicgrhitbfreodnatbfolvaen.koFfocuarcthetnethsstaonfimamaillfliolrittehrecohftahlleevenhgiepchlaes(em.ineTrhael : ctehsatllseunbgsetanpcheasirei.tatioTnhecsonetroslitgesrouwperweas eavlasloutaetsetdedfwoirththesetnessittsiuzabtsitoannceresapnondsev.ehi(cclreyftohremtsh)e ianpSpercotxiiomnat5e.l0y.24 and 48 hours afer the challenge application according to the system described --- amTohrettaerstasnudbpsetsatnlce,ethsernemcoeiisvteed,nweadwsitahsmliinde.rTaloeinlhparniocres0kipnpcloincaitaico,nt.hepreparedfstsubstancewascrushedwith Page of25 Sanz. woes not conta sor vil H25134:DermalSensitizationTest Buehler Method Duponi5303 D. ScoringSystem 005 --vpeoreyntfahinetmeraythema,usuallynon-confluent 21 --mfoadienreatreeryytthuesmhuaalelycmonfalue,nt 3 severeerythemawith orwithoutedema E. BodyWeights aIngdaiivniodunatlhbeoddayywaefiegrhcthsalolfentghee.anTihmaelmsewaenreanrdecsoarnddeadprrdidoervitsotitohnewfeirrsetcianldcuucltaitoend,fwoereaklllbyaodnyd wcoenitgrhotls aannidmbalosdywewreeiegvhatlguaatiends.sTthateisotviecraablllylymaenanunbpoadiryewdetitgehsttg(aIiNnSsTfAoTrtBeisotstaantidstteiscst,vcerheiactleed byGraphPadSoftware,SanDiego, andCA). F. Clinical Observations "rTehceoardedn. wieremobsaervleddasily. If any unusual clinicalsignswereobserved, they were 6 EVALUATION uIsnedor;doenreofeovrianlucaitdeetnhceesaennsdiotinzeatfioornsreevseprointsye.Tnohteeidndcuirdienngcetihnecdheaxlwlaesngceaplhcualsaet,etdwo0ienvdailcueastewtehree - inacicdencceootfortehredyfohilelmonawi(nsgegn:sitizationresponse)approximately24and48hoursafte challenge oSnceor(e1s) oorf1goreragtreeraatreersienenthontetshtgercoonutpraorlearneiqmuailrse,tdhoebntehiendriecaacttiivoenosoffsentshiettiezsattsiounb.st1afnscceogrersouofp animalsthat exceedthemastseverecontrol reactionsareconsideredfobepositivesores. Inocfaidennceiistresetpmeodritnaedthaaslttghreosunpu.mber ofpositiveanimals ineachgroup dividedbythe total umber Sageivevreintgy rios rueppdoertteerdmasintehdefsourmbootfht2h4 taesntdgr4a8dheosudriv.iAdledlbayvetrhagteogtraal duesmabreerotofbaenriomualnsdetedsotfedfitno theneaterntheofsa untit. 7. HISTORICALPOSITIVECONTROLVALIDATION STUDY g"rTahdeep,ro8c5ed%u(rpeusriutsye)daisn thaipsossittuidyvewceornetrvoallisduabtsetdanucsien.gThhexeymionsntarmeacelndtevbayldideat(iHonC,AP)StLechSntiucdaly Co11737,wasperformedbyProductSafely Labs andcompletedon February22, 002. Therav,) `Company Sanilized.Doesnotcontain TSCACBl Page100125 1525134;Der Sesion TetBuhleMethod Dupons303 "doTehmssrtieFesitdmwHianisSlcelocnBtdriueocentd.eidTnghaLatbhetsDafafoyrltooomwniinFgaciplnotdsyuicwitiviteohsnoHnnCrdoAlcushsaaidllnlygeinHsgaerspulrmeomycaersdiruzirenedsbasleiblmioinwlog.aurin0ea(p5ig0s% EE ES NT Fate Vehicle Conrol Animal | 05 |05 030Toa] a STUDY CONDUCT "pirs sotucdyewsaddsescucroribneeddiuttchPrtpordeoutcodetaSlaaritbLaaabsd,o2n3t9h4eRfoolultoewin13g0t,esDtyitngon,idNeleiwneJ:ersey, 08810.The US. EPA Heath Effects Test Guideline, OPTS 870.2600, August, 1998 "The primary technician fori tudy was Rolland Cols B.S. 9. RRSeoEnbsFiitEsioRznaE,tiNoMCn.,ETSeNsusAsn,dTl.isFUlsetechienr,aE.R,isakndAsRistezs,mHe,ntAPRroecveiseswfoorftHhuemBaunchSklienGSueinnseitaizPaitgioSnkiinn Tosiologs61, 91-107, 199. ~ eRiz,siHn.taanrdeeBnutsChoenso,e.p,s PinlaCnuntiann,eocuosndTuoctx,iacn,dVi-nAe.prDeritlaltaiodn oP.fgLuaiznaea(Bpidg),sencsaitdizeatnisonPpraecsh, New York, 25, 1980 10. p"rQTohUtAofcLioInlaTalYrnepAaoSrPtrSowUdaRuscAtaNSudaCifEteetdyfoLruabgesScteamnedatwridtOhptehraetaingdPartoacreedcuorredssa.nDdaftoerscoofmpmlisapnceewtiitohsnthsde S{0u1dhsSpteurdfyorDmierdedsuorrianndthPecsitltyy,MaanndagheemdeanttssorfprreepsoernttiendgonfthheeQiunaslpietcytAiosnsuarnadnacuediSttantedmienngt.s 11. "DThEeVpIrAoTtoIcOoNlsFtaRteOsMthTatHaEppFrIoNxiAmLatPeRlyOfToOuCrwOeLcks(27-28das)afterthe itdoaperim,ary challengeof the HNICofthetestsubstancewillbeappliedto anaivesiteontherightflankof *epacheguirneoafnpDiagoyus3ir0ngofmatHhieelsludTdyo.pCThhaimsbdeirt.iDounebatdooa itmecphancictioann hoevevrasilght,tohfe tchehasluledn.gewas 12. oFArIcgNoinApaLyloRfsEitgPhneeOdsRpiTrgotnAoeNcdoDlr,eRwpiErC,bOceoRpmDiaieSnstRaoEifnTaelEdNriTnaItwhOedNPirtoadguecnterSaatfedtyatLaPbrsodaurccthiSvaef.eyLabsandthe ale vit ont CompanySaniizad.Does not contTSaCAiCBnI _ Sumoftheerythemasores divided by thenumberof animalscvaluated. Page 1 orzs 25134: Dermal Seasiization Test -BuehlerMeihod DuPont5303 bLeabroertaaitnoerdyb-syptehcieffcacoirlistiytweh-sepreectifhiec wraowrdkatwaa,sdsounceh.s personnel files and equipment records will `HTahsekoerlilgiLnaabolrraatwordya,teN,etwahreko,riDgeilnaawlafrien,alorrepatorotannMdouacnoapiynoRfetcohredpsroMtaoncaoglewmielnltb,eWrieltmaiinngetdoant, Delaware 13. RESULTS aPrreelpimrinearsyeimiinntatTtaiebolndetIe.sItnindgisvciodrueaslbfoodrythweetiegshttssuabnsdtabnocedyawnedihgihsttoariicnaflpoortseistivseucbosnttarncoelaannidmtaelsst sruebssptecatnicveevley.hiIcnldeuccotnitoonla,nanddChhiasltloerincgaelpPohsaitsievsekcoinntrroelacationnscioarremespfraoersletenststesdiunbsTtaabnlceesa2nadntdes3,t stuhbrsotuagnhc7e. vehicle control, and historical positive control animals are presented in Tables 4 A`wlerteensotansdutvieshticcalleycsoingtnriofilcaannitmdailffsesruernvciesvbeedtawnedenatppheearoevedrnaollrmbaoldtyhwroeuigghhougtatihnoefsttuhdeyt.eTshtaenrde vehicle control animals. InductionPhase TiemisttaAtinoinmwaalsnsot(teedsftsourbasntyantcesetsaitpepdluireidngatshaeni8n0d%u'cwtipihwaosmnei.xture in mineral oi): No dermal - "vTeehsitclVeehcionctlreolCointterdoulriAnngltmhaelisn(dmucitnieornalpohfas}e,.100%): Noderma imitation was notedforanytest wHiasstonroitceadlfPoosailrtipvoesiCtoinvtercoolntArnolismiatelssd(uHrCAit,nhegasirnedcuecitvieodn)p:haVseer.y faint to faint erythema (0.5-1) ChallengePhase irTieasttiAonniwmaalssno(tteesdtfsoubasntyatnecsetsaiptpelifoeldloawsinagnth80c%ha"llweingwempihxatsue.reinmineraloi): No eral TinesmtinSeurbastlaonicle):INrroitdaetiromnaCloinmtirtoatliAonnwiamsalno(tteesdtfsourbastnayntceesatpspulbisetdanacseainmi8t0a%ti'onwciowntmrioxltusritee folltohewchaillnengge phase. cTheasltleAnngiempahlassee.nineral of, 100%): Nodermal ritawtasinootend for any test sitefollowingthe - TnestofSoutrbasnetyatndecsetIsrurbisttaatnicoen CotnattiroonlcoAnntiromlalsste(mfionlleorwailngoitl,hc1h0a0l%l)e:ngeNpohasdee.rmal iriation was. _ a"mTohrettaersatnsdbspaenacle,,tahernemcoeiivseed,newdavsitshlmiidn.eraTloaeinlbparnicoers1kianpcloicnattaico,nt.he preparedtest substancewas crushedwit Puge120f25 Company Sanilzed. Doss not contain TSCACBI 25134DermalSensTesat. BtuciheroMitnhod Dupouts303 H`imsitnoerrailcaollP):oiFitvveeoCfotnentrpoosliAtniviemcaolnstr(oapapnliimeadl1sse8xb$ib0i%edws/iwgmsixotfurseeoaftzHaCiAon(r1esrsepconesieve(df)iaItn rythema(1) 24boursafterchallenge. Similar indicationspersisted attreeofthesesiteswith `veryfainterythema (0.5)notedforallothersitesthrough48hours. BristeorlceailinPomsviitnieevreadlVoelb)i)c:lVeeCroynftarnotleAryntihmeamlas((0.a5p)pwlieesd1noste15fo0r%trweiewmofisitv uproesoitfivHevCeAhi(calse controlsits24hoursafterhalenge. Ittionpersistedattwoof heseietrough 4 hours. #4. CONCLUSION cBoantsacotsnetnhsietsiezfeirndingsandonth evaluationsystemused, H-25134 isconsideredno fobe a Thehxeylpcoismitmiavmealrdeeshpyodnes,etoohbrsiecravledgriande,th8e 5h%ist(o4ricraelcepivoesdi)ivvealicdoanttersolthevatleisdtatsiyosntesmtusdey dwiitnhhioss(uSeeSdectioyn'). --_ CompanySanitized. VO IiL GuS i: + 9A UBL Page130t25 H25134 Dermal Sensitization Test- Buhl Method Dupont5303 "TABLE 1: PRELIMINARYIRHRNIITCA"T(ITOENSTTESSUTBISNTGASNCCOER)ES FORDETERMINATION OF [Concenmtioncy [Cs 1 5 [ s [ 25 | | Animal No.| Sex [ows [m[2o 4[4o8 [o24l[o48l[o24l[o48l[o24l[ao8]| [aoeef[uw loeo lloeltoolloolloollooflool]of] [ews [mo 0 0 ololololol] "HNIC -HighestNon-lrritating Concentration ?Four-tenthsof agramormilliliterofthecrushedtestsubstancewas appliedaswiwmixturesinmineoirl sainlg `an occlusive 25 mm Hill Top Chamber. _ a*mTohrettaestasnudbpsetsatnlcee,, ahsernemcoeiisvteed,newdawsiatshomliinde.rTaoleailpnihrsakiannpcpolincctaatceito,nt.hepreparedtestsubswatscrausnhedcwieth Page 140125 Company Sanilized. Does not contain TSCA Cai H:25134:DermalScasiizaton Test - BucherMethod Dupone9303 TABLE 1 (cont): PRELIMINARY IRRITATION TESTING SCORES FOR DETERMINATION OF HNIC' (POSITIVE CONTROL-HCA) Historical Positive Control Validation Study by ma] |Anima No. Sex 10 |`Hou7r5after PaichsReomova| l 328 mT Teen [CamTor osoJo | [oo[0 0] [ofos]o]oo] *HNIC - Highest No riatingConcentration PSL Study #11737, performed by PSL and completed an 22202. . "HCAwasapplied (0.4ml)asreceivedaada5wiw mixture inminers il. Page 150125 [Company Sanized. Lowa wscura (9A CBI H25134:Dermal Sensitization Test BchlerMethod DuPonts303 TABLE 2: INDIVIDUALBODYWEIGHTSMWEGIAIGNH(gT) TestSubstanceGroup Ep | BE No. ok2 03) 4 [nk to.) Challcewng10e) (Fras[uwl [[0w5o J[ono] 5o[[snml[ wwn[m oo|w@|]| [Faemsr[[ | [[ 200|5 o J[oon v mJJam 7m|o | om | aw| Foam s3s9T[awreJJsoawa Jo[onnl wso |s || |mn e ve|| f awful om[a| aTo an asolnlwn|o Loomnf|am ee| _ [0[full san|| eos JJaonm]!5[mwol]n@e|msw ||m mam e|| [[eeiso [[2o0m0|| aJJoos]na Js]|wwrw|ewo ||oss|mai]] F[sir3[3s5u [aosr|| Jaasra!] 5 fJoan ura |osra || mrn || [esI 3s[semna[ow]s | en | ws |ar] [[ eo [s ov[0wose |osJa ou|| 3or sJsanw 5 | o[awn || w0n ||saom ]| [oEmNoTsEN]1 C[Naos|2 [aor] aCT [sCms]T |BsEt[w|EiT] [htase[roess]osaas ond svosmnial ena[|wesa|asssT|mor|| - Page lgorzs CompanySantas DOFnotcontain TSCACBL st Semiso- d J. arleeemneeBE "TABLE -- 2(cont):INDIVIDUALBODYWEIGHTS/WEGIAIGNH(gT) -- T= [rs | [we]5[ow[on | 0 owA| [[aisse o[s0c[Toos| 0os FTovm]| sma0 [fooon 53s||osm0 [| os| amms|| FFiart[eom a059 aor[[5so0|aaJfoor]| wo | o|o |[o s||oo|n| {owlfs nLar|niTenn [fo|nwe omwf[eoee]n _ [Vomemoe aTTwo]usrmTo]a w 5 w no [m w] e [i ifvmer[rmss0loina6s|[] 5dmsess[Joaneoa]]r5a1TJ[ooonmsr]| mo60z||| mowzao |||s5o1s|||awonmoa||| -- rr CompanySamase. vues wscomin ICACa 1.25134: Dermal Sensitization Test - Buehler Mod Dupont5303 TABLE3: INDVIDUALBODYWEIGHTSWEGIAGINH(9T) EEN ENE HistoricalPositiveControlValidation Study" Gain Gain |DayAfter| Gain | WTeoiguhrt alm ep maLee[em [[2s3mse[l[eame[[aans|[ssos[[sess| sws[[asins|] @ms|[ om|[s |[a mass|| [[sanfl as[[s0o1| 3@5[[s5o0]| n@na]n] oor||o0n2||5a||]| [i ilFesoo | 00r [[ssosa || @5[[n oonn]] 02||oonn || ws || mwse|| [r eae[lassToa| r sr Tow| or [sol t or | oam ~ [eolu[wleo wl 0 Jo] ww |ww] [oo[ss Jou[os| 1| ws |ws| Contra|l [ulam Tn[ ]a Teas ]nT [oo s |oa[] | [sas[u[en[os] @[sn]7Jo]a [en [ 35[ae| [ase[wlamsos| 78[sss] 76 [os]oo|or[ 22 [| 20| [207[ufassJan]a4[se] or [on] &2 [mo [an[24| [os mla jas 3 [ss] 5 [sm] [ a2 [0[on| [ Menlasoalassa]sno [sna ws [ons]era |ern| sma|asa| . BSL Study #11737, performedby PSL and completed on2/22/02. Fie 180125 pany Sanized.DosnotcontainTSCACEL 515 ee To. od rer `TABLE 4: INDUCTIONPHASESKIN REACTION Test Substance Group! C[ how m [7 we w][w3m w 3 we w]] [ews [oToToooTlo] | wos [0[0[0[0|oof EC 4208 o [0[To[To[oo| |e To 70 70[To[0[0| | a0 ToToo[To[00| [oo[oT] [To] [ooo| - [es [0[70[0[o[o o| [ee To[0 70 [To[0[0| | es [0[oo[ooo] [ee Too[00] [oT] o [To [oo] [oT] | ew [0 To "0 "0 [|0 o| [es [oo [ool 0 [| [eo Too"oT 000| [ea To Too oo| abr fe] . Les [oToo]0] [0] : gas ore a pag snAsa aT a it wr iston nate of sig _ Hoafueinrductsion dose. Page 190025 `Dnootcoentasin 15CACEL . somo TAB 4(cL ontE): INDUCTIONPHASE SKINREACTIONSCORES "TestVehicleControl Group' [meTwTwwww] [induction NuE mber] E = ee mT e STe T e] T ECNOe E RO eTTe - E eN T NC *Fourtenhs ofa milolftehe vehicle (mineral il, 100%), wasapplied singaosclusi2v5e mm Hill Top Chamber. _ Hours afeinduction dose. mcs Company Sanilized. Doss not contain TSCA CBI 25134:Dermal SensiTetstizBuablteiMeothnod Dupont9303 `TABLE 5: INDUCTION PHASE SKIN REACTION SCORES Historical Positive Control Validation Study Positive Control Group [osuct1+on|t2 um|be3r]| [owe | 20 |a |26|| 0a| dome|] [es TiTiTo esTs 1 [T ol] eee ee os 1 os s[os|0] meee ue | oo TosTos [1| [o|s [ea | [To os[s 0| [ea TvTos[1[1] aE ' PSL Study #11737, performed byPSLand completoend 2/22/02. ? Four-tenths ofa milliliter ofHCA was applied as received usinganocclusi2v5e mm Hill Top Chamber. . ? Hoursafterinduction dose. Page 21 of25 JPompany Sanitized. Uoeswucunvtait L3GA CBY H.25154 DermalSesiizaion TetBuehlerMethod Dupont9303 `TABLE 6: CHALLENGE PHASE SKIN REACTION SCORES Test SubstanceGroup! mare. |ua| [we [ (100%) e| e [10| 0% LmLenebeLe [e |o m| [o1 m0e| [eo To 0[0 0] [am TT 0[o 0[T o| [aw oTo o[o| [aoTo oT oo [o| [an oToTo [o| - | en To[0To[o| . o [oo] o ' [oe] [esTo oTo [o| [| me To To To |o| | ar [ o o [| o [ o| [esT[ o o oT [0| [eeTo ooTo[o| em [o0T|] en [7o ] 0o| ' | am [ o 1 o | [esTo 1 oTo |o| oc*cFluosuirvtee2n5smofmHigrlalmToopftChheacmrbsebredttoetshesruibgshttarnecaewalsanakppolidefdoauarnth8s0%ofw8wmmiliteur iofniheeverhicoliel,(umsiinnegraalnoi, 100%) apptotlhrigiht Feon ddak. --- Tmohrtaesrtasnudbpsteasntcee,,tahsernemcoiivsetde,nweadwitshomliinde.rTalo ilbparnicoestokiapnlciocnattaicon,.he prepare etsubstancewas crushedwith Page 220025 Company Sane OLS ron 125134: Del Secsitzaon Test BuhlerMethod Dupont9303 `TABLE 6 (cont): CHALLENGEPHASESKINREACTIONSCORES `TestSubIrsitattionaConniolcGroeup" Animal No. 2 wr: u[e |[ wem[a MMia noernal||] nL woeo [em 0 0 0[0 | es | oo 1 o[17 o | a1s0*lF0uo%su)irvtwees2s5pmpuolfmieFdgitrloalmThoeopfrCitghhheatcmrSbsoebnredltatenskhtsruibgshttaencaewaaskapapnlidefdosura-nts8t0s9o4wfi3vlmiistsa oifnmGoeverhiocl,e(musiiancgralnof, _ mTohrettaerstasdbpsetsatnlee,,hasernmcociivsetde,nwedawitshlmiidr.eT)oalbaronresoksipncploepsiao,nthepreparedetsbsancewascrushedwih Page230125 CompanySenilized. Donotsconsan +o CBI $2134:DermalSensitesit-zBuachteriMeothnod Dupens9303 TABLE7: CHAPHAL SESL KINRE EACTNIONG SCORE ES" Historica Positive Control Validation Study' Bou? nl % [aT os | as Tos| | ase Tr] os | [erTvTes | aax 111| [a T os Te os| [ea Tos Tos| [| we [ +Tv] - [a|tsceceam1| 0[| 1| [aa Tos Tos| mee as [oo [o| [| eo 1oT o| [e 1 os |s os] o*sFchouusriiveea2t8smaofmaHimlillTolperChaofhe8r5,0%whwmixtureofHCA(sreceived)inmiseral oflwassppledusing 3a PSLSty #11737, performedbyPSLandcomplone2t22e0d2 -- Hoursaterchalleage dose Page240625 `Company Sanhized. DoesnotcontainTSCACB He25134:DermalSensitizationTest -BuehlerMethod DuPont9303 APPENDIX A: FEED AND WATERANALYSES On January 3, 2002 animal feed was analyzed forthe presenceofthe following contaminants: Aldrin Dylox (Trichlorfon) 'BHC-A (Alpha-Hexachlorocyclohexane) Endosulfan 1& 11 BHCB (Beta-Hexachlorocyclohexane) Eodsolfan Sulfate: 'BHC-D (Delta-Hexachlorocyciohexane) Endrin BHC.G (Lindane) Endrin Aldehyde Captan Esfenvalerate Chlordane Fenvalerate Chiorpyrifos-Methyl Heptachlor Chlorpyrifos(Dursban) Heptachlor Eporide 44DDD Mavrik (Tau-Fluvalinate) 44DDE Methoxychior _ 44DDT Dieldrin Mirex. Quintozene Noneofthe above compounds were present above the limitofdetection (0.005 ppm) LABORATORY: FOOD PRODUCTS LABORATORY, INC. S1u2i0t0e31N05E.AinsworthCircle Portland, OR 97220 OnDecember 14, 2001,waterwas analyzedforNIDEPE SafeDrinking WaterActparameters. LABORATORIES: NNIEDWEPJEELRSAEBYLLDA.B#O15R0A0T1ORIES ~~`SOIFNLLEIWKERJELRASBEOYR,AITNCO.RIES A.A. Labs Division 400 South Avene 2N2e2wEaBsrtuonnswAivceka,nNeJ 08901 Garwood, NJ 07027 Resultsofwateranalysis for possible contaminants were acceptable within regulatory standards. Page 25 of25 Company Sani. Does notcontainTSCACB!