Document 6wdErKEBXK40YZnDmm0bQ2ov3

Lo. ." se am Lam KABA tt ert StaffaVicere, SEHR President __ 0399_ - 373 ee nARE-S0842 s A POBoxiN 3320n n.m Lo 9pose cb2 pay 19 27gedTR ay%q \, 0 Mr. Terry R. O'Bryan" United States Environmental Protection Agency 401 M Street SW `Washington, DC 20460 Dear Mr. O'Bryan: aAtmteacmhbeedroisfaosuurmTmoaxriycopluotgtyosgteatffh.erHbey Dsru.mmMaarrivzeCsasoeu,r aap3pMrocaocrhpotorautnedescrisetnatinsdtinagnd of the studies that you cited during our visit in December. Its my understanding that we will probably have more face to face meetings in the dfuattuarea,saunbdjiefctthoaftooncecoufrtshowseecamenetcienrgtasi.nly make the reproductive and developmental Please contact meif you'd like any further information. Foy AE Regards, AGEH-BO Larry R. Zobel, MD MPH StaffVice President & Medical Director LRZ:jme Attachment epa-ors R000R 8117S 648 DIY 5=8 3 5= I==3 a5 3333 s 32 | FC Rat Teratology Study Results Larry Status ZRoebpeolrtreoqnueBsEtHedQ-t1hi1s8s0u-m0m3a7r3yS/,reBvEieHwQi-n r1e1s8p0o-n0s3e74t5o, comments made in a BEHQ-0281-0373S EPA JSouspepplhemJ.enMetraennddaB.EFTQh-i0s2E8P1A-0d3o7c4uSmeSnutppcloenmceenrtnswrhaitcthersaetnotlofgryomstFurdaynrkesDu.ltKsoovner3Mto FflCu-o9r5ocdheimdincoatlsp.rodInuctheeatnhiirndcpraerasaegrianpshokefletthael arbenpoorrmtatlhietifeosl,lotwhienmgiisstsutraetedo:f *.. while - p(esrigfnliufoircoaentthianntohledheirgivhadtoisveesgprrooupd)u,cebdlocloedftinpatlhaetfeestailn ktihdenheiygphadroesnecahnydmamiindadlolstehrgereoups gskreolueptasl(asbiegrnirfaitciaonntsionfvthaeryhiignhgdsoisgen)ifaincadnmcaelaftodrimfafteireonntsdionsfeetlaevleslst.ernTehberfaienaalndreoptohretralso msatatteersntahlaltyFtCox-i9c5ina rethdeuchiingghwdeoisgehtangdaitnhedpuerrifnlgudooroseitnhgabnuotlddeirdinvoattiavfefemcitxtthuereovwaerriees or reproductive tract contentsof the damsand were not embyrotoxic. " WrehsiulltestrheefearbroedvetoquwoetreedttheoxsteffrooumndthoenEtPwAo d3oMcufmleunortocshaeymsicFaCl-s9.5,Oint eapcpheeamrisctahlatisthe ppeerrfflluuoorroooccttaanneessuullffoonnaamtiedo()F-Ca-l9c5o)hoalnd the other chemical is 2-(N-ethyl Perfluorooctanesulfonate (FC-95, Tfiwrsot srtautdtyerwaatsolaogRyikseturdiSetsudhyav(estbuedeynnduomnbeerwi0t6h8p0eTrRf0l0uo0r8o)o;ctaanndestuhlefofninaatler(eFpCo-r9t5)i.s daTtheed 18 December 154-160); and 1980. The other study was the final report is dated 22 done at Hazleton November 1983. Laboratories (study number The oral dose levels in both rat teratology studies were the same, study, there was maternal toxicity at namely 0, the higher 1, 5, two and dose 10 mg/kg/day. levels (5 & 10 In the Hazleton mg/kg/day). Two high dose females died and there was reduced consumption at the higher two dose levels. A body slight weight gain increase in along with number of reduced in-utero food rReiskoerrptsitoundysiotnelsyinthtehehihgihghdodsosee(d10ammgs/kwga/sdaayn)otfheemrailnedsichaatdiorneodufcmeadtebrondayl twoexiigcihttys. In the 3VaMriautsieosntshewhwiicdhelayreacncoenp-tpeedrcmlaansesinfticaantdiocnoofmamlotenrnfaitnidoinnsgsfoinuncdonitnroaltse(rnaotno-ltoegryasttougdeyn.ic edveevnetsl)o.pmReenvtearlsidbelleaydselaaryes firneqdueevnetllyopsmeeenntatwhmiatcehranrael utsouxailclydodseelsayasndinaorsesiafirceaftlieocnt.ioTnhoefse tohcecumrataetrlnoawl tionxciicdietnycienitnhceofnettruosless.(tMearlaftoogremnaitcieovnesntws)h.ichMaalrfeorirmraetvierosnisblceacnhbaengfeusrtthheart subdivided toxic dose. iInntoretgwaordcattoepgootreinetsia--l those related human risk, to dam toxicity the latter are of moorrtehocsoentcheartnoacscutrheayt non- representa fetal effect at non-toxic maternal dose. 2 OiInnncetihdmeeinHdcaezdolofescteloenffeptteuprsafhllaautdoerao(oaccltteefartnaeptsaoulglaeftnoeincbaetuveet(nhFtiC)s -dw9oa5es)s rfnaootuttneidrnadatitcotalhtoeegyhaistgtehurdadyto,osgieennc(ir1ce0afmsigen/ddkign/gdaays)3. rmlaaot/whkeirgncpwiradosefnocculeneodafrrlcyeldetufoctxtiipcoalntaoittnehbceoadndaymbsew.esiegTehnhteirgneaciwonnaotfsrtothlweorathhiifggethhusddeooss.see dTdahamems.hdiegahthdsosase woefll10as a Increased incidenceofcleft palate in rodent teratology studies has been related to dam mtoaxtiecritnya.l sTthriesssraelnadtisounbssheiqpuweantslyresphorotwend atonoucmcbuerraotftyoexiacrsdoasgeos iinn mmiocuese* itnerraetgoalrodgtyo * rsteuvdeiaelsedonthcatheamisciamlisl.ar*reAlnatieoxntsehnispiveexis1t9e8d5 irnervaitse.wofThaantiim,alintcerreaatsoeldogiyncsitduednyceroesfulctlseft palate in rat fetuses was associated with maternal toxicity. sNtoudcyleefvtepnaltahtoesugwhertheefhoiugnhd dionstehewaRsiktehre psearmfelu(o1r0oomcgt/ankegs/udlafyo)naatsei(nFtCh-e9H5a)zrlaetttoenratology dHoosweevdearm, dtehaetdhesgarnedeotfhedbaomdytowxieciigthytweafsfeclte,ssalinthtohuegRhipkreersesnttu,dyw. asThoefrelewsserseevneroithyigh aNsotaeteirnatthoegeRniikcereffsetcut.dy Baultenssubasbenqouremnatlietxyawmiansatfioounnodfitnhaellldeonssesegcrtoiuopnss abyndE.waMsarrsehpaolrlted aJrothifnascot.n, AcocnsouplytaonftMeaxrpsehratllteJraothonlsogoins'ts, lreetvteearlreedpotrhtatisthaetalcenhsedchtaontgheewEaPsAassteacttusiorneipnogrt The that MEaPrsAharlelviJeowhenrsdoind'snoetxpmleanntaitoinonthweasleancsccephtaanbglee. in his summary and it would appear tIhnebroetwhapsersfolmueorionoccrteaanseesdulifnocniadteenc(eFoCf-9d5e)laraytetdeorsastiofliocgaytisotnudaineds astkehliegtahlervadroisaetiloenvsel(s,which 2t(lteseroraatctoaolgnoegbnyiesctieunvdceirenestasso)endinpaeterimftalhtueerorrsnotaoulcdtyt.aonxeiTschuuldsfo,soensta)ht.ee f(eBFtuaCtl-9atl5hte)errceaatnnioobnseskefrleoelutanatldedminatlobfmooatrthmearratntiaolns toxicity. 2:(N-ethyl perfluoroctanesulfonamido)-aleohol rROeirpkaoelrrtras2tt-ut(edNry-aenttouhlmyolbgeypreorn0f6l2u8-o0(rNTo-Rce0tt0ahn1ye!0s;puelfrfifonalnluaomrrieodpcoort)ta-naielsscduoalhtfoeoldniaJsmarinedufoae)rr-ryaeld2c2otho1o9al8s1w.FaMs-(3tN4ho2et2es.ui)bnjetchte of ltehveehlisgfhordotshee satsumdayrwkeerdely0,r2e5d,uc3e7d.5b,oadnydw7e5imggh/kgsa.insM,actlienircaaltsoixgincsiotyfwtaosxicmiatnyif(leesttDheaodrsgeiatc, Lbtvuhetiingtnhhitenegdsiasfi,fnebsrloeocnoccdeurifrnresodtmoaotclo)tnhtaernodmlistdhwrdaeoessed.neoattThssht.eatilAsotiwdceadfloilsnyiestieggrnaoinfudipcasaniltgs.noifhTiahcdaunstr,ermdeaudtcueecrdendwalebiotgodhxyticgiatiyn wtwhoaeusjldudedfhgiaenvimteeenbatetettnhhaemtohtirhgeehdeaorpsptreowploreivdaeotless.eulseevdelisn atnhed sptruodbyabwleeraetttohoehliogwh daonsde.loOwnere dcoosueldlemvaelkse 3 An increased incidenceofcleft above increased cleft palate isa palate was found reflectionof dam in the high dose fetuses toxicity. Skeletal ab but as indicated fsetteursnees.braAelatnhdouvgehrtseobrmaeeoafstwheelsleasskeilnectraelascehainngneosn-woesrseifiineddisciatteedwe1rseteorebarstreoargtveienoidncsineivntehnets in tttoehxreiacrtieotpygo.erntiB,clwoeeovednntio.nwfetktianslokawirdtehnfaeltyectpthiaeosrneoenffecthhalyowmsaketilhseetaaflfeetmtuaaslnwivfaaerssitahatatinoidnolnaesndaddruenroaitsnsigoncdriieacmtaoetvidavweliotfhrfaodmatmhe" uterus at Cesarean sectionof the dam. In summary, the fetal aberrations found in the oral rat teratology studies with 3M fluorochemicals [(perfluorooctanesulfonate - FC-95) and 2-(N-ethyl perdreoffslleeucolterivooeclnst.oafnemsautlefronnaalmitodxoi)ci-tayl. coNhool]t,ruoectceurrarteodgeanticmaetfefrencatsl otcocxuicrrdeodseats naonnd-twoexriec amaternal 4Wess. 76. CMoarrpvoirnatT.e SCcaiseentiDsVt M, PhD 3M Corporate Toxicology 105d 195, Date 9 References *deBparrivlaotwioSnM..plMacsEmlahacotrttoincoPsRte,roSnuel,liavnadn RinMd:ucTtihoenorfelcalteifonsphailpatbeeitnwetheenomfafstpermianlgorfemsirciaen.taTnedratfooloodgy 12:97104,1975 19* 8K4h.era KS: Maternal toxicity -- A possible factori fetal malformations in mice. Teratology 29:411-16, >maKlhfeorramaKtSi:onMsoatfermoadlenTto-xircaibtby:i sApepcoises.ibTleeraettioollooggyic3a1l:f1a2c9t-o5r3i,n e19m8b5r.yo-ftal deaths and fetal