Document 9LZK3qb88bZRvmkZwQV7Dx8D

SummaryN-ETFOSERabbitTeratology StudyNumbers:3M T-6316.8A,rgus418-010 Compound & Lot: N-ETFOSE (N-Ethyl-PerfluoroocyanesulfonaEmtihdaonol-) LotFM3923 (30035, 30037,30039)98.2% pure(SNM AnalyticaRlequest52489) AnalyticaDlocumentationfiledalongwith finalreport.Note - same lotasused intwo-yearratcarcinogenicisttyudy(T-6316,Covance 6329-212). StudyTitle:Oral(StomachTube)DevelopmentalToxicityStudyofN-ETFOSE inRabbits ReportDate: II January1999 StudyMonitorSummary: (writtebny Marvin T. Case) Pregnantrabbitfemales2,2 pergroup,weregiven dailyoral(intubatioonf)N-ETFOSE atdoselevelsof 0,0.1,1.0,2.5,and 3.75mgtkgtdayon days 7 through20 ofgestationT.he rabbitfetusewshich had been exposedinuteroduringorganogensiswere collecteadtday 29 of gestationA.llof thefetusewsere examined forsofttissue(visceralc)hangesusinga dissectiomnicroscopeand thenallfetuswere examined forskeletaclhanges. A doserelatedbody weighteffectoccurredinthe1.0,2.5,and 3.75mgtkg dose groups.The differencien mean body weightswas statisticaslilgynificaantthe2.5and 3.75mg/kg doses.A significarnetductionin food consumptionwas alsopresentatthe2.5 and 3.75mgtkg doses.No compound relatedeathsoccurred atany dose level. Abortionsoccurredinone controldoe,intwo 2.5mgtkg does,and infive3.75mg/kg does. The abortions atthehighesttwo doseswere consideredtobe compound related.The mean number oflateresorptions was alsoincreasedinthe2.5 and 3.75mgtkg females.The reducedfoodconsumption and adversebody weighteffecthatoccurredatthesetwo highestdose levelwere indicativoefdam toxicityT.he increased number of abortionasnd lateresorptionwsere probablysecondarytothedam toxicity. No compound-relatedsofttissuoer skeletamlalformationswere found atanydose level.Thus,the compound was notfoundtobe teratosteniinctherabbit. The maternaltoxicNOEL was 0.1 mgtkg. The fetatloxicNOEL was 1.0mgfkg. TeratogenicNOEL intherabbitwas > 3.75mg/kg. NOTE: Dose preparatiosnampleswere collectetdwiceduringthestudyand thesesampleswere sentto 3M EvirornmentaAlnalyticalaboratoriynBldg 2. Likewise,sampleswere collectefdrom extrafemales assignedastoxicokinetsiactelliatneimals(3/groupexceptlow and highdose5/group).These animals were killedon gestatiodnay 21 (dayafterlastdose)and thefollowingsampleswere collecteds:erum and liverfrom pregnantdams, fetuseasnd placenta(spooledby littefrr)om uterus.These sampleswere frozen and sentto3M EvirommentalAnalyticallaboratoriynBldg 2. At timeof thissummary, March 1999, analysisofthesesampleshad notbeen done;thereforet,heseanalyticarlesultwsere riotincludedinthe finalreportnor inthissummary.