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R205 ATtotxaiccohlmoegnytsSttuodLieetstaenrdtoOCt.heArueIrnfdoartmeadtiMoanyon25P,F2O00A0 [[ amonrotors| Update to Submission ofMay 18" 1) tLeetrtaetrolforgoymstEu.diMeasr,sdhaatleldJDoehcnesomnbetro W7,il1l9i8a3m. C. McCormick, II, re Hazleton 2) sLteutdtieersfornomPEF.OMSarasnhdalelthJylohFnOsSoEn,todaWtieldliNaomveC.mbMecrCo1r2,mi1c9k8,2.IIT re Riker teratology 8. N-EtFOSE alcohol|N-ethyl perfluorooctane sulfonamidoethanol 1) sLteutdtieersfornomPEF.OMSarasnhdalelthJylohFnOsSoEn,todaWtieldliNaomveC.mbMecrCo1r2m,i1c9k82,. Ill re Riker teratology 2) EFitnhaalnoRlep(oNrett,-FBoisoel;ogTi-ca6l31P6h)asIen,CMyentoamboollgiusmsoMfoNn-kEetyhsylFoPlelrofwliunogroAodcmtiannisSturlaftainoonmoidfao NSiontgel:eACnaaplystuilcealDowsoer,kCaosvsaonccieat,eSdtwuidtyhNtoh.is6s3t2u9d-y2i2s6o,ngJouinneg.9, 1999 10 04135 JE-FFERSON ME.DICAL COLLEGE T THOMAS JEFFEoRfSON UNIVERSITY ! DDaenpiaelriniBeaenughooffIrteasmes Director ond oniman uk | = December 7, 1983 Phiadoettsp)hii,s3a1c0n7 TMro.xicWoillolgiyanSeC.rviMceeCso,rmiMcekd,ica1l11 Department S2t2.0-2P5aul, MNCentSe1r01 Dear Mr. NeCommick: TIevhaiveew rfeicnedivietdtothebodraafctleraerployrtexpolfaiT3n3e5d1stfurdoym.Dr.ItWeitszealsatnadte-aofft.erthec-aarretful Safety evaluation for developmental toxicity. TG"hrteoourpdattwaarseadtethmmeeonnmtsotrraeattbesoetvsheevreerleyanmdaaftf1ee0rctnaeagdl.T3t3o5xTi1ic/eiikrtgy/dfaoisodaenvdiindttehaanktte btohtehhidguhreirngdoasnded was reduced and, flootsseosnlbyecduirdretdheindambsotnhott.hepsaeintwreeiagthntenntorgmraolulpys,. aNcutmuealroumsatcelmianlicawleigshitgns of mTaetleartneadlreddiusctrteisosnsanidn ofevteanlhabiordylowsesigwhetrseforbosnertvheeds.e 11T1herdeansw.ereHodwierveecrt,ly dFoerlayssuchtha1n11omnoethmeirgshtanedxpescntallinfestuucshess,evetrheelSy nsgtregrsosuepd msohtohweerds.fowNeor sskieglnestaolf eeIxnietrshthesorrton,naltayotmaadlorseeloratlideveveveleslfoepwsmeevoneftraetllhyetamodaxvtieecrirstneyalelofcyfceutcrotrxseidconainndthteehevecnolnocwleeptdthouaslse, ognrTeo3u3p5.1 oCTuoasutledotohfeexspfeectstai.lgnsdeAtvoeflaomapdotmseeernntalleavnedtl,oxaibtceiltotywh,e tahtlahlterepirmwopedoruretcainontgnlmmyaattmeeirrnnnoaarlllefydefaentcohtn,stoxobinuct tdnheousmeer- Tevel, enbryonic and fetal development were absolutely normal. acThnoidnsceopnstetuuswd.oyulcdlTheeacromlnoycltuhidelerlusattphrpaaettaaersss lmotohnrege assvaufleentxeyproaosubfrleetshetoarteeTs3t3k5e1pstubtshbatenalnowcteheadfuoclrotnctehtpeotxuisc Tevels, enbryonic development would also not be affected. SThaifsetys.tudyYouofhaTv33e51gomnaeketsheaexctlreaarmislteateamnedntareoftoa bneo cefofnegcrtatulleavetledanfdorfoytoaulr - 04136 Page 2 WDielcleimabnerC.7, Mc1C9o83rmick hbiegihngmoctoinvfautsieodn.by, Iorcahnnaovtingenvriessieornvataiocnusstormeegarrdoirnga, rethgiusladtaotray agency base clearly establishing T3351 to not represent a developmental hazard to the conceptus. Sincerely, E. Marshall Jojffeon, Ph.D. Professor and Chairman Director, Daniel Baugh Institute EMI ranf cc Dr. Lawrence T. Wetzel, Ph.D. Department of Toxicology Hazleton Laboratories America, Inc. 9Vi2e0n0naL,eesVbAurg22T1u8r0npike ' 04137