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PCoAsSsNuummePreat7uosrss3o0c3anesutos AR 226-0560 abort RSuMsEsndNouFrmmeeerenLatALNaTCosooonnosg --- ANALYTICAL LABORATORY REPORT oNTHE Determination of the Presence andConcentration of Potassium Perfluorooctanesulfonate (CAS Number: 2759-39-3) in the Serum and Liver of Sprague-Dawley Rats Exposed to PFOS via Gavage Laboratory Report No. <U2006> Requester Project No. <3M TOX 6295.9> _-- Study Dates Study Initiation: 26 May 1998 Study Completion: At Signature 000038 P`oCtAaSsNsuimumbPeerr2tu7o5r9oo3c8a3nesutorats TABLE OF CONTENTS Taofb COlREeS... rm Sty PSAdO COME BOS `StaofCtOmPeRANmCE.e...n...t......... QUAIRY ASSUANGE SIZE... Laboratory ReIcMueEsntvNiuroRmnebmpeeanrrtt(aNLloR.NL-aTbUoo2rxa0ot0orr52y ------------ ssn 3 PY SEPIE RECEP sss] MalEr alSBA Mo OMOUc S...o sms 8 PrOOCO!DVIaONS..........oo "1 Data`SSummU aryoMfAQNuBI aIlSteyT SC,o3n1tr r0oRl AEY nSaUlSy, ses SUT Of SAMRPESUILSE co RESUES.....r ..........s coorrnn e rms 12. 13 13 SUSHI MENOS cc. rssrmssssns ommamerssns T Data Quality ObjeacndtDiB vINEeGHsY ccm 45 SBOfO CONE CILSION...c.comssmsnsssmssssmnssssmmmemmnn 48 References EE ssi 6 AttachmenAt:ReportSignature Page Attachmen8t`:STparbalgeuoe-fDRaewsluelytRsoafsAAdmniniasotfeLrliedveyPrSFaOsmSplDeiasyfrsboym GFaOvMaagleeand Female. Attachment C`:STparbalgeuoe-fDaRewsluelytRsaotfsAAnadlmyisniissotferSeedraPSFaOmSplDaeislfyrboymGFaOvMaagleeand Female AttachmenDt`:STpraaguoeb-fDRaelwslueleytsRoaftsAnAadlmyisniissotfeLrievdePrFSOaSDmaipllyfberyosmGaF1vaMgaeleand Female Attachment E In-ife Protocol andAnalyticalStudyProtocol Attachment F: Preparatory andAnalytical Methods. AttachmenGt:DoseAnalyses 60039 Pagar PoCtAaSsNsuimubmePreu2o7r5s8o3c6a3nesutonsts STUDY PERSONNEL AND CONTRIBUTORS A3nMaElnyvtiircoanmlenCthaelmTiecshtnroylogLyaboratories 3M`anEdnvSiarfoentmyeSnetravlicLeas.boratory Fl2u3o8ri0n9eAnalyticalChemisty Team (FACT) 9St35PaBuuls,hMANve5n5u1e06 LKiiissa HCalnesmeenn,, APnha.lDy,tiAcnaallCyhtiecmailsSttsu)y Director AIrn-gluisfeReTseesatricnhgLaLboarbatoorraietso,rInyc. 9H0o5rsShhaeme,hPyA.Dri1v9e0,4B4uiding A RaymonGd. York, Ph.D, StudyDirector S3MpoTonxsicoorlogy Services 3BuMilCdienngte2r20-26.02 St Paul, MN 55144 Marvin Case,SponsorReprasentatie LsbrstayRoMcuEemsoNoRmreeanr(a10a)Tb0oo2rc0s01a5ys 00010 Pigosats CPAoSsNsuummbePre2tu7o5m6o3c5a3nssutonss STATEMENT OF COMPLIANCE abort ReWuMsEsnvriRoeensrmeetn(tALNaTt0oc3rta0or0ys8 Study Tie: GoAncaatvlayantegisecuailfLoanbaotreaitnoSryerReupmoratndoLnivPerroesfeSnpcreaagnude-CoDnacwelnteryaRtiaotnsoEfxPpootsaesdsi(6umPRPOerGfor. Study Identicaton Number: FACTTox012 t(ThGheiLsPe)xsctReuepdgtyiuwolanasstincotonhnedfourbcNtloeendceiidnricscotamlpblLeilaaobnwoc.reaItnwoiartych tSFuiodnoi,deshane[dDparDterasueRgneAtqdtumirdneimserhanat(sisob:neeG2no1oaGdtFLaReb(oPrraaettroor2syp8Prrcaiwcvitatihlcye pEbnyevraintroninnemdenentpthetainlosdLesantbtuodqryuaiatlnoirtayyarasnscduarhtaainptacrtvethiueecniiIpstMatAilunadgbioctroapnttrororacyceatdnluardbewosrialatnobdreirfeeistnaadriinengehsdofofuosureactdltweisatshptdeor1cf0uoymreemanertsda.ottTiohtnee aut `EannvaliyrtoincamlepnotratlioTnecchonmoplloegtyedanatdtShaef3etMyESnevrivricoensmeSnttaanldLaarbd OwpaesrapteirnfgorPmroecdeidnuarcasc.ordance with SM Exceptions o GLP complance: + bSatlocrhagneumcobnetra,ineexrpsifroratthnedarteef,eorrenscteosruabgsetcaonncdei,iPonFsOS, were not labeled with name, CAS number, + sDuebtsatlasncoef,thPeFpOrSep,araarteiounn,kmnoawxni.mum storage me, and stably propertiesofthe reference + atThthitsehaeentanlitymlteiyoc,aflsttshrteeundsgytt.uhd,y:puhorw,evaenrd,caonmaplyosseisitoonddeetfainlitnhgechehtaesrt oar cconttoelwaerrrieteoznwgaaositnngiottohdeneterpmineeodf + + FTrwoomse1p5aSreatpetesmtbeur i1v9e9c8toursnwe1rOecatsosbiegrn1e9d9t8o,tthehiprvoitvoocoalnwdatshenoantaslyptoincsaolroarpiporonveofd hainsdswtaudsy. during that time period nat in compliance. + Dat DeviactoirornesctwieornsewneortceonnsoitsatewnatlyysarpepcroorvdeeddabsyrtehqeusitrueddybdiyrGecLtPorraesgurieaqtuoinrse.d by GLP regulations. + Data werenotaways atibute to the individual responsible for recording the data. + Recordisn elecfortmdronootnmeeittchecriteriastforth under21 CFR(11). + Adfoicnuamleznetdsdsiadmepxliestloag-nidnwterracekiunsgedsytstoegmiwnaasndnortaicn klsaacmeplatesthe timeofthe suc; however, draft 00011 Pasedctis StrinmPuss etMmenp aritni Nott tawarenbyhssstr, + Noin-phase audits were conducted during the present study. + TAoDoienctehe rosary pone Se dd ot avers centrationofen and method training; however, personnel files have been updated, and this noncompliance has Sorctssuetyveenr _ fin 27099 SanatofSua SporM3ari. Tbs 20684, 0cooaz Pasar Ci NTs -- GLP STupY `QUALITY ASSURANCE STATEMENT LabrstoyRocussEtniNoRnmerepntolrt0eL0aTbooros?s Study Tit: APPneFarlOoySrtiocvaaiclaiLGaaanbveosarugaiteforoynaRteepoirntSeornuPmreasnednLcievearondfSCponrcaegnuter-aDtiaownieofyPoRtaatsesEixupmosed to Study ID Number: FACT Tox012 iTnhdiiscsatteuddyihtahsebfeoelnowiinnsgpteacbtlee.d bTyhethnedSiMngEsnvwierroenmreenptoarlteLdabtortahteosrtyuQduyadliirteyctAassaunrdanmcaenUangiet (wQeAnUt) as INSPECTION DaTeS Zr DATE RepoRTED TO 2 70 srsastion |2rcopenets |oarusot [RY |scumerton | ove mo | | || loom \U Representative 10-15- Date 00043 Pasosatts CPoAtSaNsiuummbePre2u7o5r5o3c5a3nesuorate INTRODUCTION LaboratoryRecuesitcNeumh emnbtesrl(LRHd L.abo3ra0to0rys Potassium Perfluorooctanesulfonate CAS Number: 2795-39-3 Chemical Forma: CF SOK MolecularWeight 538 TyIenwhheiceelnepr8c0eo.sneTrnhtlesFtsOuedryd,aosgsrweoesurcpeosraordfemFsipOiosrntadetrtoewdecroonenclaeydnTmtrieantieisnotnesr80eo.fd M0.a10l.,0e2,0F40.O,0a81,n6i,0m.ao3lr2,s3.wa2nedrmeg0.tP6re4RaOmteiSdm4ke2i.dd)aaGyyrsionru0po.sr5o%f Wptroeirmoreatteioxnmpgaotasinendgd,tohtrhtorhioeguhcghhtehgmeeismctaaattliioinnng,upeaernrodioaudnpdf0ed.mu2ar0liencgaFlyOascatfnaoitlmiooawnlisnFgwoieltroeewriadndegmfiwvneeirasyrt.ienrge1damPtaF2l1OedSaancydsaofyfaam2gied,aayss saenldecbtioeldog1icaalipmaarlasmewteerres weearteedmodnuirtionrgeddeivneFlOo,pFm1e,natannddF2praondiumacliso.n of F2 animals. Various prysical dPInoFsOtheSed,aan(naAilnymataillcysasl(egsswetnueedrryeatriepopenorrfFtoOer)dmaheendrdet,othdveeeitreoarfmfnsidpnresientgrhae(gspearnmeepsraletneicsoencooFfl1iE)eIcwFteOerSefEr,aonmPalFtyhOezSenAdi,faolPOiphoApAupSiraPetoRsnOeSomfEcoAaf, wPeFrOeSAnoAt,reaponrdtetd.h)e monosster however, these data were colectedforinformational purposes only. anc ceLhxitrvroearmcasttiaoomgnprplarepohscyew/deeurlreeec.htorTmohsoepgreeanxytirztaeacdtn,sdewamenrdmevaqesursanastipntedacttsireverolamyestaarnmyapl(lyHezLsewdPeCurIseEienSxgMtShriMagSch)t-e,pdraebsnyedcarPneFfoOqpuSailefvienlsgwere aevvaallubalteedinagtahienssttuedxytrbaicntdeedrsmtaainndtaaridnse.d bAnyatlyhteic3aMlFdleutoarlsAnaarleyitnccalludCehdeimnitshtisyrTepoorta,f(uFrtAhGeTr)ceteitsme AwmneeartlehyocsdoesnsdaaunscdstesestdsaiinnndcgaortmdhpeolptieoarxnaicctoeilnowggiitpchraolGcoeefodfduecrtLesasbowofrePartFeoOrfSyolPlirnoawtcethdicdveuerRriensgguatlnhadetisporenerspaa(ro2fa1tSiGporFnaFgaun5ed8.).aDnavaavlylesiyiastreoadfttshe samples associated with tis sudy. SAMPLE RECEIPT T{thiresos3uugMehEsJnaavmnipurlaoernsym,ewne1t9ra9el5.rLeacSbeaoirmvapetldoferrsyomarenAcdreigtvuresadnRwseefsreeearprrtacoechadkLafagbeordraietoflroeiryeszsitoeser.paoSgrreap.ceiccSiaamlmye,pnflsreworemercAeeiuprgteu.gsid,einet1ri9ei9dc6a,wtiifon, sistolroacgaet,eadnidn cthhea3inMofarccuhsitveosd,yprotocolsanddataare located ithestudyfolderfo 1staport th fatter `SapnedwciilmebenssatnoraeldyaztedthaetltahbooIraMtoErnyvatin-m2e0nCtal1L0aboCratory wil be maintained foar period of 10 years 00044 Page7t 16 Stnrem rn rr eeni ETmE e contr MATERIALS ANDMETHODS TTlle mpeerms maanperresieactionoftet con, nd rcs oo 4 Saomnori SeoTr ia isi, enn [oonTr -- | Fry Oesptonsryrn aE i Re ---- TY [T rHoowmeorsto or w I n] SomeGara ters SaErEa Pr tr Trane Cont etc, ar Perfluorooctanesulfonate in Serum and Liver.of Sprague-Dawley Rats Exposed to rons 60045 Snrrete PR erpety a EateCnhraemeeer rroa Ee [mmSosta gSerasmn Attachment F) PACTS ot r[eFomaare PCrrmy Cer ryres fr w rr] Cf B i pde Team tt Con, Perfluorooctanesulfonate in Serum and Liver of tree,ar Sprague-Dawiey Rats Exposed to Faimn ros,oeiibtospietretmardcncmtwrrn eth Summaries rS Fooslaireo yaMtetdm :esm pote ic daugresmicslayyven P IHteoodmFAr atCT 41E1pe0onrFansr inenftTreooEemskEp aesPotpevt esttveee ctredmtsocooenofrnensswa TT SE,Bo eteiyLorn rms Ceo4 CPAoSsNsuummbePre2t75u0o3s5o.c3anesnats LabermayRecauesS t Ne r(09-- 02005 + aS`MeCgeroteamhnpostodaumwFnpAadlCsseTs-afMrdw-ode3mer.deS0e:teorxutEtxhamtecrotsarecadttmihpuoelsnroeifnFaPginoaudtndatfoshoesrriAnnuaaimltyPgeesrifsoelxnuUtposrraiaocniotgricwotHanaPnLperCso-uclEefldouenrcaett.eoosIrnpOsrtuahmyemfraarsFysi,u`Soaprneoccothnreommpiecitarnlyg. areytt.thaecrEha(ecMdIh1Se0E2) 0F.xo2uwuramtmsinryloeafocnhafetcneMtrIeiBtndEoiegnxlta1rs.a0scmtawuLtaoosfvimrlee.mtovheadnaaonndldspfuptarroetndttootnaeodnuiigonhgoeamn3eetvpyaapksetiareeusyrtronge Analytical Methods + SMpetehcotdomFeACtTy.M-2.0: AnaoflFucyrocshemiicasls nLiverExtractUsing HPLCElckosprayass sTuhcehaansaltyhseispewrafslupcreorocotmaenedsublyfomnraitto(ring a singe ion characteristic of particularfuorochemica, daentaelcytziendg dusainuggahatnoednrsemofmtahsesseslpeecctetedroPpmFaerOteSenr)ttaioonfni.ront,emrivze=r4y99t.eAKddeintitoynoalfly3, csoammpploeusnwdeorye * `MSeetrhuomdorFAotChTerMF-l4u.i0d:UAsnianlgyHsiPsLoCEflPeocttarssoisupmraPyeMrafsusoSrpcecotcrotmaentreysufoorntahteerFluorochemical in The analysis was performed by monitoring a single on characteristic of apartcuar `suchas theperfiuorooctanesulfonat (PF uorochertica, daentaelcytziendg duasuingghtaertaonndsemofmtahesspasrpeenctetorno.meOtSer) taonifornt,hmrivze=r4y69.theAdddietinotnalolyf, scaommpploeusnwderbey enfdiosemanalaysetsweroecornducyted flotwheeindnoftghestucy,andth resultsofthese analyses are presented in Attachment G. 000047 Pago t0ct16 frpmietrannid norteRss hnbse Lbl Analytical Equipment asFreoetliornwegicsnovrgadarerydesainocdmaeplwnraanodautsnagteeahqcnmauneaelndyatsdtiass ctsoielneccgoisonon,frhBtreeacsprtsoecyteidbnurgdessruunsegcFgainlctphrespereseseecnrt micy,eThaese HPLC Systom: Hewat PackardSeries 1100Liquid Chromatograph Column: Fow ate: Soventi: 2KXey1s0t0onmem,BeStasmil pC1a8rCcolsusmn 300 min 20mMammonium acetate `Solvent B: SoventGradient IiectonVoume: Run Time: Methanol RH4o0l%ed 10t5500u40%0%m%Bi05n.r1831.050mmmiiinnesesss Ho a40% 8 or 10 mine Tou ToS mines ElecTatndremoMasssSppecrtroametyer: MicromassQuatro Mass Lynx 3.1 Software Cone Votage: CoGaosEnenrgy. Mode: Source Bock Temperate: soy 406v Eectospray Negatve 115% Desolvation Temperature: ~~ 250C Elctode: Zopray Primary lonDaugher ons; 49980, 59, 130, 120,230 amu APMass Spectrometer . 660018 [en CPAoStaNsusimubmePre7ru5o8r.s3o5ca3nesutonsts abortoryReSuMsEsnvMoRmnembpeeorsrtts(NLLAoaboTUra2atc0o0or8sy Protocol Deviations Tuhmerbsewra2s17;anheowdeevvieart,ioonttnoutmhebeprrot1o9c3olw:aTshusperdotdoucroilncgaltlheedfaonratyhiecaulspeoorftiroenfoefrehnecessttyan.dard ot DATA SUMMARY, ANALYSES, AND RESULTS Summary of Quality Control Analyses Results + `lCaeanaldsbtarlaeltvcieaorlnyibCr1ah0teisocankmcpSrlitteaensridataorwdmesra:eimAoermtiid(n-wsiettvrheuilnm,e+netx3t0dr%ia)tc..teCdalmibarlatsiocnachretckonstcahnedcarkdwsawseraenacloymzpeidnatt, mbBallaatrnkkssw:weeFrroeutrypbpraiecnpaaklrsyepwdrweeirptehaerwxeatdtrewarictth2esrdaacbsbouinrrcvouegrarotreresmnweaitritrayhx.aenaTdcwwheobraaedtdcuthsoieofdsnfaarmlspeelxmetprsal.ceTtsewodofcaielxntbrrkaacttioonn curves. All blanks were nondetect or the compound(s) of interest. Dupo1ln3e0i%cc.aontierlmaanitmals.piWkietahnaalfyeswesexicnepcthiionngs,arletcaogveertiaensawleytreeswwietrien phreepaacrceedptaanbdleanraalnygzeeodff3or0`ATnhaeoslsfyemseiarsteortcfioxvtewsrpoiieiksveeasrraemmbapeltleioswswpteihrkeeelswoiwatemripnlbeotsuhenrdeasacurclyetpeotdfatibhnle5ea1rca%cnegaepn.idaNb6lo1ea%rcatrineogcneowvhearosiweeasvkeoorfn,PFt(0OaSf,suetcuornd characterize these matrix spikes. ilAnnitahlmoeyfsisteehtsreaoafocfbotleesnpttsaaenbtilsmarolfasns,geeor.nalAmyiaaotsuimgalshlpi1akmmeosluroneftssuoetfrseaedrwinuaPsmRu(O5s0eS0drfutoelc)hovweearisaensaavglayrisaeibsaltoefafPborRo(vOneSetalhaeuyhesirgh pseaxprtitrkiaeccutpliraorenlpyairssaustscicaoenl;peidtb-hldseoiwtmnoitoteosdsaoqcufcaonstmoimvtyeondotaftmdaeutetrhioex maevvaaaypioharbaalvteieomnba.eteT,nhaetssheeoreevsuauploorirfnagoctoieevxret.rfao4cs5stestso,g which s`GWeooruualddmraneorstuxetfsfnpeacitgertsehaeatrPeerFp-OetrShfaconorenmxcepednetwcritatethidaoPnfu(OlPS1 OmcSLonohcfaensstearrlaaot,iwhovingahipn oPtrhFpeOreSexsraseuccrtoev)eWriihneeshnearaeexnstartaaecatsn,of MalWtoirchaitaxedmSipnintkihesme:uamroMcafhtitrvioexdspspetirukdebysabacinnhddedrmu.rainrgsapniaykteicdaulplaincaaltyessesw,erTeheanraelsyzuesdoevterhys4e0ansaalmypsleess,are 00049 Page 20116 Poptarsh iPersucreocanesuteats Laboratory ReMcuEemstioumrRbmeerereni(anAeLNa)TbUoo2us0o0r5s Summary of Sample Results + FaPnOFimOmaaSllswe.saPsanFddeOtSiencwsteaersdaidsneattmhepecltveeedsricsnoltolfheeacltsleecdroanftrsroaomlmpaallnleddsoescxoepldolesFceOtdefdgefmrarolouempss.aollfTohfFeOthPaeFciOonrStrsloelvaeanlndsdFfd1aonsgedin `htghereoulspoa,wmg-pedloneseserfgarrloomuipnc.oanPtdroFosOle-Sarnecilomanatcleesdntwmreaarntenieoqrn.uinielxopwo--sgeednaenriamlayls1i0n0c-ree5assetdhawnitlhevienlcsredaestiencgtdedos1.e tPhFaOn Slelveelvseldseitnecbttehd sinersaamapnldeisvceorlsleacmtpeldefsrcoomlltehcetceodmfersopmofnedmianlgegFrOouapriofmlFsO mwaetreesmuch fess tFPh1FeOacnSoimmceaoslnpscoesnnhtdoriranttgyioganrfsoeumrpebsaiorstfuh rFweOedrfeeinmrapoloueogshl.leydNevoqeusraalsmafpmolpeolrselscoowlcelorelcttchetadenfdcoofmnocemFnOttrhfeaatmeiaxolnpesossmteehdactgarrueoceuepnisv1eodf `3q.u2anmtigtaPtiFveOaSnpaelryksgesldpaeyrfwoerrmeedsuobnmitthteeFdfOoIravnearlaynsdiss.erTaasbalmep1lseusmemxaarmiinzeeds.resultsof he Grove [-- 0.0 mghgiday Oimgkgday | o04 o4mgkgiay | 04 1.6 mggiday 32mghgldey + Sompleswer ot eceves. L Dose: S pr po PFOpSeHSGuM Sifeo PF[OSM3LNER Female: 0.0307 | Female: 0.171 Male: 0.0244 Male: 0665 Female:528 | Female: 148 Male: 105 Male: 84.9 008 Female: 189 | Female: 58.0 Male: 45.4 Male: 176 032 Female: 820 | Female: 184 Male: 152 Male: 323 Female: NR* Female: NR* Male: 273 Male: 1350 Table 2. DPaFwOlSeyCoRnactesntrations in Serum andLiver Samples from FO Male and Female Sprague- 060050 Page 13at16 Ca AS Numberz2756383---- Laboratory ReWqMueEsnteeoRnemmpeorn(btsLhLAaaebT0oor3xt0roo0rr8ys mgPreFoaOuspSusrcoeofdnFci1enntaihnreiamctaoolmnssessmhpeoarantsdlyuirnaegftdGerrinobuiptpohsoiwoefedrFieOvreforeumsgaahllmeysp.ltehesNoecqoslulaaelmcpt(leodeosrflrcooowmlectrhtteeadconrntoGrmooln1acnmdaalneextspeoosefdemales `thhXaeptoFr1seecsdeeirgvareodsua3p.m2splomfegsF1le/xaadnmiaimyanleswd.e.rTeabsluebm2istuemdmfaorriaznaelsysries.sulPsFoOfSthweaqsuadenttetcattedeiantahleyfseerpoaf arfton on Grown Dose (aicion) LLr--a [= pr) Jo JJ aw ] + Someswerent ecevec. Table 3. PFOS Concentrations nLiverSamples from F1 Malo and Female Sprague-Dawley Rats PPKerapoptceferodruaarntedlse.saiPseacttpareornpiaecrnicdoodpeoilfeecsmtorefonriaacswceodpseitaeabsoiasnfhdreesdptoubrdtyysr,reegppurolorattotsciooglnesan,enardnadbtyemdetdhteuhro3idMnsgStgtheaennepcrraaertsdeednOtpbesyrtatutdeiinegs wil be lEenavsitronpmeernitoadolfTeticmhenoalsoegsytaanbdisShaefdetbyy Sreergvuilacteisolnaabonrdatboyrythweil3bMeSrteatnadianerdd wOpiertahteinsghuPcrfoocldeecrafoer at STATISTICAL METHODS cFaolrcdulaattaedgeunseirnagtMeidcbroystohfte E3xMceErn,viarnodnmreenlattailveLsatbaornadtaorrdy,demveiaatniosnasnwdersetacnadlacrudladteevdiamtainounasllwye.re `Satnaanlydsaersd. dReevliaattiivoensitsaandmaeradsduerveiamteinotn opfreasneanlyttsicaalmepraescuisrieoon;ftthhuesmiatgisniutsueddeotoftghauegsetatnhdeaprrdecdiesviioantioofn.the Ex - (2? x)? iMnedaivnisduaalroecnatlciu.laSttedanbdyaraddddienvgiaItnidoinvsidwuealreenActa(ilaec=suDlaa)tneddduisviidnignghetheeqrueastuiiotna:nt sum by the numberof sRuelbasteiqvueesnttanmdualridpidecvaitaotnioonfstwheerqeuoctailecnutlabtyed10b0y.division ofthe standard deviation by the mean with 00051 Page tacts PoCtAaSssNiuummbPeerr7o5r8s.c3c5n3esutonse Laberstay RWecMuEesvtecMnaRmmeebnoatr(ttLL0sa3s0T.o0os2cao0rr0ys8 DATA QUALITY OBJECTIVES AND DATA INTEGRITY tNhoe idactuam.sTthaenfcoelsoweixnigsdtaedtaduqruianlgtythoebpjreectsievnetss(tDuQdyOtsh)atwweoreudflroawveedadfuercitnegdtthheesqtuuadyl:ty or integrity of Nthoe cdaitrac.umTshteanfcolelsoweixnigstdeadtaduqruianlgttyhoejpercetsievnetss(tDudQyOtsh)atwweorueiodlhoawveedafdufreicntgetthheesqtuuadty:ty or integrity of + uLsiinnega1rixtwyeiTghheticnogrrelation coefficient (R9) of the standard curve was equal o orgreaterthan 0.9. Limitsofdetection--PFOS in serum=1.75 ppb + Limitsofquanttaton--Equal othe lowest acceptable standard nthe cafbation curve: + Duplicate frequencylacceptatle precision--<30% + Spikefraquency/acoeptablerecoveries--70% to 130% Use of confirmatory methods--no confimatory methods were used + Dmeamsosnsstpreacttiroandoafusghpteecriffcony--cshpareaccitfercitzyatwiaons demonstrated by chromatographic retention time and STATEMENT OF CONCLUSION Statement of Conclusion: fUivnedresranthdesecronadoifioalnlsogfrotuhpesopfrersaetnsetxsptuodsieesd, tpootthaescshieummipcearlfudourroinogctthaniensuviifvoonpaottwioansoofbhsee.rsvueddiiensthe. _ REFERENCES OO None COCO52 Page 150116 pPotassium Peruorsocnesutonat werimeLabora Laboratory Recoest Mrmr(38003003 ATTACHMENTS * Atiachment A Report signature page + DtaawclhemyernattsBa:dmTianbilsteeorfedrePsFuOsSofdaanlaylybsyisgaofvavgee.rsamples fom FO male and female Sprague. + tDaawcehymreatnsCat:dmTinaibslteeorfedesPuFtOsSofdaanailybsyisgoavfasgeer.a samples rom FO male and famale Sprague. + DtaawcihemyernatsDa:dmiTnaibslteeorfedrePsFuOsSofdaanlaylbysyigsaovfagvee.r samples from Ff male and female Sprague Attachment E: In-ife protocol and study protocol Attachment: Preparatory and analytical methods Attachment G: Dose Analyses C0053 Pasot6otts SEIT ee ATTACHMENT A REPORT SIGNATURE PAGE Kibt1en Jf.HoansHen,ePh.D, StudyDirector MarMvinnT..Casew,w.DVM,7 Ph(.aD,, Study Sporser / Back, Direcor SE LabrstyRocuestNumber (A)02008 fo/z7 144 Date 200 Date Ae, loop (o/23/5 Date 6005% Pago t7otts PCoAtSasNsuimumbePre2r7u5o6rs.o3c5anssutonate Laboratory Re3qMueEsntNveRooenmpmoeerrtt(aNLoAL.aNb)ToUor3xa0t0o10r38y ATTACHMENT B ETE Number MMeettooadBBaannkk ||HwoOmBaanncc2 MMaotirxgBlaarrkk || @Raabnok)Ler Rasneke Lier GC 100s | ssorFus I Pe omgigesy | semis seo asoonrar sear as stom sstotom stom soem O10r2mmgghmodya)y || sssaiorr sear ass sor0r at13oamm sam sasm ssw EVeeo) I] | NA | na NA Na | roves, rs pre | 1082s 10169 11005m84 1008 1008 T0225 110050878 r10o10t4 1T0058784 1089 r10o00s8 T100580197 ose 1008 oars CaPPcOas o Cowmanon (mac) ol wor AmPoFunSt.ol std wot or wou wou ou ou wo " 10 0% om @ a on 874 1165s8 oroe1ss.s or 168 0197 0168 0 0 os10 0800 sm sss osm 0503 os 083 7251 an 7a " 15557 12007 156 ns 2784 28 am Teszs 3 76 sa ar 21 ws sist as E (io) E Standard Deviation wor wo 1 TM To oor 2s ozs ne wn 739 ss Table 4. ASapnnradalCgyousneec-seDnoaftwrLlaietvyie"ornSRaaotfmspPlEoetxsapsofssrieoudmmtFPoOePrSfFplrOuaSogruvoieoa-cDtGaaanwvelaseguyeifRoantasteininthSeeSrtuumdyanodf tLhievePrroefsence PropritayandConant 0C0055 PCoAtSaNstuumnbePro2r7tu5r0o3o5c3anesufnsts ATTACHMENT B (CONTINUED) bray RoMguEesnvNorRomeerprott(shoL9abTUoor2raootor0rssy LT [a re -- LL v=e concenmamon orProS [EC EE ey 04min | 8090 0346 5653[ 519[= [oy momt) | easae anosr 10207 as 10154 ws as 0s asaer aos 100 eon ros soz 1 ss 1s on EC sir To Ea 10087 1002 IE] I airs sire tom 10335 183050 1rsze8 " 63 stem Tomas | wee 10197 150173 Tore 20 158 3 24 2mom) | sszir sas 10544 212504 10219 282001 2 = assar 102 arr I) Toss 0058 04 "0 Ed aim EQ ran amy sesonr am azn 1021 11s rss sug moron sz | WR 10318 sores = Ww ostmony) [NR w "" "> wR "" wR " w " = w= " nw Nw wa aan Toss tor arise 11e2sn arr me aon sou 1007 10522 rasa risaras 7 16s 0 ease asses srasess 50 wr + SampleBROT vai was exch fom hocolitis. Table 4. A`S2npnadrlaCyosgneucseeonf-tLDriaavtweirloRneSaoaytfms"pPlEoetxaspsofssrieoudmmtFPoOePrSfFplOruaSogruvoieoa-ctGDaaanwvelaseguyelfR(oacntoasntteiininntuheSede)Srtuumdyanodf tLhievePrroofsence Propetary andContant 060056 EmLtTe-- c AmachmENTC abort ScMueEsnomrRmeeerpnotLAOLaTs0oo2ro0in0nsy8 DoscGrowr LSaEume CocoEmmSanon TPRoOmS MeWwAPrNos Raame fies MethodBark | HOBank1 | DLLe) G5) iy MsaerpiocsBsiinnkk |[|ewRotascaynokrz | wot aol ao uot Maro | raanseter pry Tis s|sorreuusso [[7a2 somas | 100 aSnon so oan wo omar s[soemm o |[3 [o2n] on TM wwooren | s[satzs cooossts sem [sr ooszr asceoraest 2 Trop a[ssssenm J s|oez osoor ora Oozrom) [wsooremm || 7su0o 7sis swooermm || aerriess sonn moro | som | so wr o2em Cosmo) [aossmeemn | [oarremsa aorr wsoorsn || asooasr a0s Tomorgiey | essen [7a Im annr Oszrom | wsasmn [orsessne s2a0s wcoernm || esesesr eosso 2ass + Sample801F voor cdnscali Table 5. AannadlCyosnecsenoftrLaitvieornSoafmpPloetsasfsrioummFP1erSfplruaogruoeo-ctDaanwelseuylfRoantasteinitnhSeeSrutm auonfddtLhiyveePrroefsence Sprague-Dawley" Rats Exposed to PFOS via Gavage Propray sodConsort 000057 PoCtAaSssNiuummbPeort2u7o5r6o3oc0a3nesuonste LaboratoryReauMeEsntvNkuomRnebmpeeorrrLttRaNoHL.a}bTUoor2xa00to10r28y ATTACHMENT D Dose Group. Nthod Bank Motrod Blanc MMaattiex BBaornkk ac-- 100558. Q0mgigiay 01 mangiiay (002mg) Camanciiay (008 mom) J-- (mg/m) #0Blnk | HoBank2 ot "wou RRaboae ivbeerr@(onBakn)tk_| | iMoOrL [CR as0tFas0 sRsoTmmuSs sore ase 027 ooze ances sere oot oous. a ooxs Baotoomm 006 oan satoomm oom 003 sos aner 00214 su asmsaiorr 9 sa sssanss 52 0 arom ns som sam ose 985 sas som "wo 104 assor aner 29 1s aaosrs tae 174 esosr vam 91 or stam se rs asm as pA som 3 ME[RrPaFyOS or 00st oos0 52 188 ReLfamve e San)oneo 090 00850 7s oou 208 000605 an oss 002 oss ss 130 21 se Table 6. A`aSnnpadrlaCygosuneecs-eoDnfatwSrleaetryia?oSnRaaomtfspPlEoetxsapsfosrsioeumdmFtPOoeSPrpfFlrOuaSogruvoeioa-cDtGaaawnvelaseguylefRoantastienitnhSeeSrtuumdyoanfdtLhievePrroefsence ProprietaryandContent 0C00S8 CPAotSasNsuimumbePre2rt7u5c6ro3o0ca3nssutonsts Laborato Re3qMueEsntvNeRuoenmpmeoarrrtt(NaLoRL.NabToor2xa0too01r28y DoseGroup TNe-- n ren) IE fC) 16mokgay anor 753 32mgm) asa suze m"2 aor as 744 84 24 75 = tea 21am 151 aio ws saasm 15s 153 s2 01 S2sm4gmhpgmilin)y WR NR NR wR aR NR NR a wR saan 20 20am 22 som 257 a2sou 1 sass 255 + SampleS801F vale ot nckdedn 4s caclaion Table 6. APnraelsyesnecse oafndSeCroanSceanmtprlaetsiofnroofmPFoOtSapsrsaiguumeP-eDrafwllueoyroRoacttsanIenstuhlefoSntautdeyionfStehreum andLiverof Sprague-Dawley Rats Exposed to PFOS via Gavage (continued) Proprtay andCont 0C00s9 PonstsePotsroas canenonste Emii rs aToorrok i Labor Recuest omer(LNC008 --_-- ATTACHMENT E IN-LIFE PROTOCOL AND ANALYTICAL STUDY PROTOCOL Proprietary and Confidential 00060