Document MG2MD1RLry5oaR23M0YDxGYxV

-- --.r I I I 1-co i(,-Pi COVAA'Cio,rEm.o"@ THE DEVELOPMENT SERVICES COMPANY Summary Report 104-Week DietaryCarcinogenicitSytudy with Narrow Range (98.1%) N-Ethyl Perfluorooctanesulfonamido Ethanol in Rats PREPARED FOR: 3M COVANCE STUDY NUMBERS: 6329-212 and -228 SUMMARY REPORT -WEEK 53 104-Week DietaryCarcinogenicitSytudywithNarrow Range (98.1%) N-Ethyl PerfluorooctanesulfonamiEdtohanolinRats Ilmelines Covance 6329-212: In-hfestartdate:January26, 1998 Week 53 completed:January31, 1999 Covance 6329-228: In-lifsetartdate:April6, 1998 Week 53 completed:April11,1999 Introduction The purposeof thesestudieswas to assessthecarcinogeniciotfythetestmaterialT,-6316 (Narrow Range N-EthylPerfluooctanesulfonamiEdtohanoLNETFOSE), when administereidnthediettoratsforatleast104 weeks. Thissummary reportincludes informationthroughWeek 53 and containscurrentfindingsi;tisnot,however,thefxW reportforthestudy.Covance LaboratoriesInc.,reservetsherightof reviewof thesedata beforeissuingthefinalreport. Methods Male and femaleCrl:CDO(SD)IGS BR ratswere assignedto groupsaccordingto the followingdesign. Group No. ofAnimals Male Female DietaryLevels (I)pmNETFOSE) Covance 6329-212 I (Control) b 70 70 0 2 (Low) 60 60 3 3 (Mid) 60 60 30 4 (Nfid-ifigh) 70 70 100 5 (Bgh) 70 70 300 6 (Mid-lEgbRecovery) 40 40 100 7 (leghRecovery) 40 40 300 Covance 6329-228 8 (Controlb) 70 70 0 9 (Treated) 70 70 1 a T-6316is98.1% n-ethyplerfluoroodtanesulfonaemtihdaonol(NEtFOSE);doselevelasre ewessed asppm ofNETFOSE. b 7'becontroalnimalsreceivetdhebasaldietonly. Covance 6329-212/228 3M T-6316.1 Food was provided ad libitum,except when qnimil were fasted. Water was provided ad libitum. "ne animals were observed twice daily(a.m. and p.m.) for mortality and moribundity;findingswere recorded as they were observed. At leastonce priorto treatmentand weekly thereaftere,ach animal was removed from itscage and examined; abnormal findingsor an indicationof normal was recorded. Body weight data were recorded weekly for each animal for Weeks 1 through 17 and once every 4 weeks thereafter.Food consumption data were collectedforeach animalforWeeks 1 through 16 and once every 4 weeks thereafter.Body weights were alsorecorded forallanimalsin Groups 5 and 7 before sacrificdeuring Week 8. CHnical Pathology. Blood and urinesamples were collectedfor hematology, clinical chemistry,urinalysisa,nd urinechen3istryfrom fiveanimals/sex/groupin Groups I and 5 during Week 8. Blood and urinesamples were collectedforhematology, clinical chen3istryu,rinalysisu,rinechemistry,and serum sampling from 10 animql.-s;ex/group in Groups I through 4 during Weeks 14,27, and 53. Blood and urinesamples were collectedforhematology, clinicaclhemistry,urinalysisa,nd urinechemistryfrom 10 animals/sex/groupfrom animals in Groups 8 and 9 during Weeks 14, 27, and 53. Animals were fastedovernight,and urinewas collectedchilledovernight(approximately 16 hours) beforeblood sampling. Blood was collectedfrom a jugulirvein. The anticoagulantwas potassium EDTA forhematology tests.The samples forclinical chemistry and serum samples were collectedwithout anticoagulant.The serum samples (thatserum not used forclinicaclhemistry)were storedin a freezersetto maintain-60 to -80*C, untilshipped to the Sponsor forpossiblefutureanalysis.When possible,a blood fihnwas made forpossiblefutureexamination from animals sacrificedatunscheduled intervals.A blood fihnwas alsomade and held forpossiblefutureexamination for aninaals at the scheduled sacrificdeuring Week 53. Serum Analyses. Blood samples were collectedfor senun analysesfrom fiveanimaL%/sex/groupinGroups I through 5, 8, and 9 during Week 4; fiveanimals/sex/groupinGroups I and 5 during Week 8;fiveanimnl ex/group in Groups I through 4, 8, and 9 during Week 14;and fiveanimaLs/sex/groupfrom Groups 1, 4, 8, and 9 duringWeek 53. Animals were fastedovernight.Blood (approximately2 mL duringWeeks 4, 8, and 14,and approximately3 mL during Week 53) was collectedfrom a jugulirveiTL Samples were collectedwithout anticoagulant.Serum was harvested, storedin a keezer,setto maintain -60 to -80*C, untilsentto the Sponsor forpossible future analyses. 2 Covance 6329-2121228 3M T-6316.1 TenWnation. DuringWeek 4,fiveanimals/sex/groiunpGroups 1through5,8,and 9 were fastedovernightb,ledforserum samples,anesthetizewdith sodium pentobarbital (Groups 1 through5) or carbondioxide(Groups 8 and 9),weighed,and exsanguinated. The abdominalcavityofeach animalwas opened,theliverwas removed and weighed,and liversampleswere collectedA.nimalswere discardedafterlivercollection. During Week 8,fiveanfinals/sex/groiunpGroups I and 5 were fastedovernightb,ledfor clinicaplathologyand serum analyses,anesthetizewdithsodium pentobarbitawle,ighed, exsanguinateda,nd necropsied.At necropsy,macroscopicobservationswere recorded, selectedorganswere weighed,and selectedtissueswere collectedand preserved. Additionaliversampleswere alsocollected.Adrenals,brain,eyes,kidneys,hver, mesentericlymph node,pancreas,spleen,testesa,nd ovarieswere processedand examined microscopicallyT.he remaininganimalsinGroups 5 and 7 were euthanatizedwith carbon dioxideand discardedwithoutnecropsy. During Week 14,fiveanimalYsex/groupinGroups I through4 were fastedovernight, bledforclinicaplathologyand serum analysesa,nesthetizewdith carbondioxide,weighed, exsanguinated,and necropsied.At necropsy,macroscopicobservationwsere recorded, selectedorganswere weighed,and selectedtissueswere collectedand preserved. Additionalhversampleswere alsocollectedA.drenals,brain,eyes,kidneys,hver, mesentericlymph node,pancreas,spleen,testesa,nd ovarieswere processedand examined microscopicallyA.lsoduringWeek 14,fiveanimals/sex/grouipnGroups 8 and 9 were fastedovernightb,ledforclinicaplathologyand serum samples,anesthetizewdithcarbon dioxide,weighed,and exsanguinated.The abdominalcavityof each anirnawlas opened, theliverwas removed and weighed,and liversampleswere collected.Animalswere discardedafterlivercollection. During Week 53,fiveanimals/sefxrom Group I and 10 animalvscxfrom Groups 4, 8,and 9 werefastedovernighbtl,edforclinicpaalthologayndserumanalyse(sasappropriate), anesthetizewdithcarbondioxide,weighed,exsanguinateda,nd necropsied.At necropsy, macroscopicobservationwsere recorded,selectedorganswere weighed,and selected tissueswere collecteadnd preserved.Additionaliversampleswere alsocollected. Tissuesfrom each animalinGroups 1 and 4 were processedand examined microscopically. Animals thatdiedon testor were sacrificeadtan unscheduledintervawlere also necropsied,but organ weightswere not recordedand hversampleswere notcollected. 3 Covance 6329-212/228 3M T-6316.1 Proliferation Cell Nuclear Antigen (PCNA) Evaluation. At the Week 4 sacrificefor animalsin Groups I through 5 (fiveanimals/sex/group)r,epresentativseamples of the left lateralr,ightmedian, and rightlateralobes of the liverand any macroscopic lesionsof the liverwere collectedand preservedin zincformabn. At theWeek 8 sacrificfeoranimalsin Groups I and 5 (fiveanimals/sex/group)r,epresentativseamples of the leftlateralobe of the liverand any macroscopic lesionsof the liverwere collectedand preservedin zinc formahn. At the Week 14 sacrificfeoranimalsin Groups 1 through 4, 8, and 9 (fiveanimals/sex/group)r,epresentativseamples of the leftlateralobe of the liverand any macroscopic lesionsof theliverwere collectedand preserved in zincformahn. Liver samples were embedded, and blocks were sentto Pathology Associates International (PAI);PAI willevaluatethe s=ples aeftlaterallobe only)forPCNA- In addition,liver sectionswillbe stainedwith hematoxylin and eosin and examined microscopically. Mitochondrial Analyses. At the Week 4 sacrificfeor animal in Groups 1 through 5 (fiveanimals/sex/group)a,sample (approximately1.5 g) of the liverwas collectedfrom selectedanfinals.Samples were placed on wet iceand transferredto the Sponsor for mitochonddal analysis. Palnidtoyi-CoA (PCOA) Oiddase Analyses. At the Week 4 sacrificfeor animals in Groups I through 5, 8, and 9 (fiveanfinaldsex/group)a,sample (approximately500 mg) of the rightlateralobe of the liverwas collectedand flash-frozeninliquidnitrogen.At the Week 8 sacrificfeoranimalsin Groups I and 5 (fiveanimals/sex/group)a, sample (approximately500 mg) of the rightlateralobe of the liverwas collectedand flash-frozen in liquidnitrogerlAt the Week 14 sacrificfeoranimalsinGroups I through 4, 8, and 9 (fiveanimals/sex/group)a,sample (approximately500 mg) of the rightlateralobe of the liverwas collectedand flash-frozenin liquidnitrogen.The samples were storedin a freezer,setto maintain-60 to -80*C, untilanalyzedby Covance forPCOA oxidase activity. Additional Liver Sample Coflecdon. At theWeek 4 sacrificfeoranimalsin Groups 1 through 5, 8, and 9 (fiveanirnals/sex/groupa),portionof theliverwas storedin a freezer,setto maintain-60 to -80*C, untilsentto the Sponsor forpossiblefuture analysis.At theWeek 8 sacrificfeoranimalsin Groups 1 and 5 (fiveanimals/sex/group)a, portionof theliverwas storedin a freezer,setto maintain -60 to -80*C, untilsentto the Sponsor forpossiblefutureanalysis.At theWeek 14 sacrificfeoranimalsinGroups I through 4, 8,and 9 (fiveanimaWsex/group), a portionof the liverwas storedina freezer, setto maintain-60 to -800C, untilsentto theSponsor forpossiblefutureanalysis. 4 Covance 6329-212/228 3M T-6316.1 Results Survival.AdjustedsurvivadlataaresummarizedinTablesI and 2. Because oftoxiceffectseenforthebody weightsand food consumptionat300 ppm, the animalsinGroups 5 and 7 were sacrificedarly(duringWeek 8). For theremaining groups,survivalafter53 weeks oftreatmentwas 98.0%, 96.0%, 98.0%, 96.0%, 90.0%, 96.0%, and 96.0% formalesinGroups 1,2,3,4, 6,8,and 9,respectivelayn,d 98.0%, 100%, 98.0%, 96.0%, 100%, 92.0%, and 96.0% forfemalesinGroups 1,2,3,4, 6,8, and 9,respectively. ClinicalObservations. Clinicaolbservationdata aresummarized inTables3 and 4. There were no apparenttestmaterial-relatoebdservationnsoted throughWeek 53. Body Weights. Body weightand body weightchange dataaresummarized inTables5 through8. Animals given100 or 300 ppm had significantlloywer body weightscompared to thoseof . alsgiventhecontrolmateriasltartinagfterthefirswteek of treatment.Animal given 30 ppm had lower body weightscompared to thoseof anim@ giventhecontrolmaterial startinagfterthefirswteek of treatmenth;owever,theywere not generallsyignificanutntil approximatelWyeek 8. There were no toxicologicalmleyaningfulsignificabnotdy weight differencefsoranimalsgiven 1 or 3 ppm. Animals given300 ppm had significantlloywer body weightchangescompared to thoseof animalsgiventhecontrolmaterialstartinwgiththefirswteek of treatment.Animalsgiven 100 ppm had numerous significantlloywer body weightchangescompared to thoseof animalsgiventhecontrolmaterialand theoverallbody weightchange(Week 1-53)was significantlloywer thanthoseof animalsgiventhecontrolmaterial.Animals given30 ppm had sporadicsignificantlloywer body weightchangescompared withthoseof animals giventhecontrolmaterialand theoverallbody weightchange(Week 1-53)was significantlloywerthanthoseof animalsgiventhecontrolmaterialThere were no toxicologicalmleyaningfulsignificabnotdy weightchangedifferencefsoranimalsgiven 1or 3 ppm, and theoverallbody weightchange (Week 1-53)was notsignificantly differentthanthoseof animalsgiventhecontrolmaterial 5 Covance 6329-212/228 3M T-6316.1 Food Consumption. Food consumptiondataaresummarizedinTables9 and 10. Animals given100 or 300 ppm had significantlloywer food consumptioncompared to thoseof animalsgiventhecontrolmaterials@artinwgith thefirswteek of treatment. Males given30 ppm had numerous significantlloywer food consumptionintervals compared to thoseofanimalsgiventhecontrolmaterialstartinwgithWeek 3. There were no toxicologicalmleyaningfulsignificadnitfferencefsorfemalesgiven30 ppm or for animalsgiven 1 or 3 ppm. Test Matexial Consumption. Testmaterialconsumption dataaresummarized in Tables 11 and 12. Animals were feddietscontaining0, 1,3,30, 100,and 300 ppm- The amount of test materialconsumed by animalson a mg/kg ofbody weight/daybasiswas asfollows. TargetDose Levels (ppm) 1 3 30 100 300 100 300 Achieved Dose Levels- Range (mg/kgbody weight/day) Males Females 0.036-0.103 0.049-0.108 0.108-0.259 0.147-0.307 1.126-2.618 1.454-3.070 3.847-8-724 16.058-25.408 5.686-10.166 19.568-28.712 3.841-8.873 5.355-10.135 15.803-25.193 20.004-29.270 Clinicaland Anatomic Pathology. Hematology,clinicaclhemistryu,rinalysiasn,d urine chemistrydataaresummarized inTables 13 through42. Terminalbody weights,absolute organ weights,organ-to-bodyweightpercentagesa,nd organ-to-braiwneightratiosare summarized inTables43 through49. Incidencesof macroscopicand microscopic observationasresummarized inTables50 through59. Incidenceof severitoyf selected microscopicobservationisssummarized inTables60 through62. The PathologyReport containsa discussionofthedata. 6 Covance 6329-212/228 3M T-6316.1 Dose Analyses. Results of the homogeneity, stabilitayn,d dose preparationanalysesare in Tables 63 through 68. Prestudy, severalhomogeneity analyseswere conducted on each of severaln-dxesin an attempt to resolveissuesrelatedto the inherentvariabilitaynd lackof sufficienstensitivity at low levelsinthe analyticamlethod formeasuring NETFOSE. Mean values of the homogeneity analysesfor the mix done on January 15, 1998, ranged from 89.7-104%, 92.0-98.7%, 86.8-98.4%, and 94.0-96.7% of the theoreticacloncentrationsfor the diets containing3, 30, 100, and 300 ppm NETFOSE, respectivelyM.ean valuesof the homogeneity analysesforthe mix done on March 30, 1998, ranged 91.3-106% of the theoreticacloncentrationsforthe dietcontainingI ppm NETPOSE. These resultsindicate thatthemixing procedure produced a homogeneous distributioonf the testmaterialin the dose preparations;althoughvariabilitgyenerallyappeared slightlgyreaterat thelower dietaryconcentrations. Prestudy,severalstabilitaynalyseswere conducted on each of severalmixes in an attempt to resolveissuesrelatedto the inherentvariabilitaynd lackof sufficienstensitivitayt low levelsinthe analyticamlethod for measuring NETFOSE. Resultsof stabilitaynalysesfor the mix conducted on October 15,1997, of samples storedfor 19 days at room temperature conditionsindicatedthatthe mean concentrationswere 89.8 % and 87.5% of the initiacloncentrationsof 3 ppm and 300 ppm respectivelyR.esultsof stabilitaynalyses forthe mix conducted on October 15, 1997, of samples storedfor34 days at room temperature conditionsindicatedthatthe mean concentrationswere 90.4 % and 89.6% of the initiacloncentrationsof 3 ppm and 300 ppm respectivelyR.esultsof stabilitaynalyses forthe mix conducted on October 15, 1997, of samples storedfor8 weeks under frozen conditionsindicatedthatthe mean concentrationswere 89.2% and 95.3% of the initial concentrationsof 3 ppm and 300 ppm respectively.Resultsof stabilitaynalysesforthe mix conducted on June 5, 1998, of samples stored32 days at room temperature conditions indicatedthatthe mean concentrationwas 77.9% of the initiacloncentrationof 1 ppm. Results of stabilitaynalysesfor the mix conducted on June 5, 1998, of samples stored at room temperaturefor 46 days conditionsfor indicatedthatthe mean concentrationwas 93.4% of the initiacloncentrationof 1 ppm. 7 -.iosuodsolqiXq poplaoid 2-m goql uzlqtasuo!lrulwal-ap loaol -ioaq pu*epoolqatpuioijsllnsorioolialuouq*iuqilm uopc)unluoouTpoi-unltAo2o.qiULi&sllnso2isoU -o,g6I:Fjo sauuqpieptmis-aijlol 2p!Slno sosto Sutui uT oi-aailttp tliepsosgreimoupnoi put,Xiqiqtis All-juogomoquqpoilnsol lasoaiam Surinsi,=.ipoojtp2uTioonAIvuovqixis!TgAzl mol it,Si!A!i!siuuo;s)IoUjns joqo"qpuu Ai.rFqvprAlu-ajgqu*i(sTsXlmmp-oaji!nbiiuqieilp2mp. nloxoinqIsossimm olducmuso!luoiopiueALssewaqlgxr!pnlosuu!o)ilbiluoouoo luop-aioalp2ql jo oloteI-olo8,19 IUO.lj POSULI.I SIOAZI Ugiojsosalmmuopiandoidzsop2iqjio suoiltijugouUoL:'Dzuoiql l,9lE9-1WE 8ZZ/ZIZ-6ZE9 23tmAOD PATHOLOGY REPORT Covance 6329-212/228 3M T-6316.1 SUNMARY The purposeof thesestudieswas to assessthecarcinogeniciotfythetestmaterialN,-Ethyl PerfluorooctanesulfonamiEdtohanol(NETFOSE) when administereidnthedietto ratsfor atleast104 weeks. The testmaterialwas administereadtdose levelsof 1,3,30, 100,and 300 ppm. Animalsgiven300 ppm were sacrificedduringWeek 8. Thisinterimreport discusses:findingtshroughthefirs5t3 weeks ofthestudy. DietaryadministrationfNETFOSE was associatewdithrmuy decreasedredblood cell count,hemoglobin,and hematocritforfemalesgiven100 ppm; mildlylower glucoseand mildlyhigherureanitrogenformalesand femalesgiven100 ppm (predominantlayt Weeks 14 and 27);moderatelyhigheralbuminand moderatelylower globulifnormales given100 ppm (predominantlaytWeeks 27 and 53);and moderatelytomarkedlylower cholesteroflormales given30 or 100 ppm and femalesgiven100 ppm. Administratioonf NETFOSE at 1 or 3 ppm forapproximatel5y2 weeks had no effectosn clinicaplathology testresults. At a doselevelof300 ppm forapproximately8 weeks,administratioonfNETFOSE was associatewdithmany effectosn clinicaplathologyresultisncludinglower redblood cell count,hemoglobin,hematocrit,glucose,globulina,nd cholesteroalnd higherurea nitrogena,lbumin,totalbihrubin(malesonly),aspartataentinotransfera(smealesonly), alanineaminotransferasaen,d hepaticpah-nitoyl-CooAxidase(alsoobservedatWeek 4). Most oftheeffectwsere moderate tomarked inmagnitude. One male given3 ppm, threemales given100 ppm, and fourmales given300 ppm diedon testor were sacrificemdoribund. The male given3 ppm was sacrificeddue to a fracture ofthehard palate.The cause ofdeathwas undeterminedforone male given100 ppm and one male given300 ppm. Allof theotheranimalsthatdiedor were sacrificeadt unscheduledintervalhsad hepatocellulahrypertrophyor hepatocellulunecrosisdue to treatmentwiththetestmaterialor both. Hepatocellulunecrosiswas thecauseofdeath fortwo males given100 ppm and threemales given300 ppnl 9 Covance 6329-212/228 3M T-6316.1 At theWeek 4 sacrifictee,rminalbody weightswere lower formales given300 ppm, and absoluteand relativleiverweightswere higherformales and femalesgiven100 or 300 ppm. There were no grossfindingasttheWeek 4 sacrificaen,d tissueswere not examined histologically. At theWeek 8 sacrificfei,veanimals/segxiven0 or 300 ppm were necropsied.Terminal body weightswere lower and absoluteand relativheverweightswere significanthliygher formales and femalesgiven300 ppm. The onlytestmaterial-relatfeidndingsatnecropsy were largeliverfsorfivemalesand two femalesgiven300 ppm and mottlingof theliverof one femalegiven300 ppm. Mcroscopically,testmaterial-relatfeidndingswere limitedto theliverand consistedofhepatocellulahrypertrophy,hepatocellulanrecrosisa,nd hemorrhage. At the Week 14 sacrifictee,rminalbody weightswere lower and absoluteand relativeliver weightswere significanthliygherformales and femalesgiven 100 ppm. There were no testmaterial-relatgerdossfindingsnoted atnecropsy.The onlytestmaterial-related microscopicfindingwas hepatocellulh-yiprertrophyformales given30 or 100 ppm and femalesgiven100 ppm. At theWeek 53 sacrifictee,rminalbody weightswere lower and absoluteand relativleiver weightswere significanthliygherformalesand femalesgiven100 ppm. There were no testmaterial-relatgerdossfindingsnoted atnecropsy.Testmaterial-relatfeidndingswere limitedtothelivearnd consistedofhepatocellulhayrpertrophyv,acuolationn,ecrosisa,nd bilestasifsoranimalsgiven100 ppm. 10 METHODS Covance 6329-212/228 3M T-6316.1 Nine groupsofCrl:CD@(SD)IGS BR ratswere studiedusingthefollowingstudydesign. Group No. ofAnimals Male Female Covance 6329-212 DietaryLevels (ppm NETFOSE) 1 (Control)b 70 70 0 2 (Low) 60 60 3 3 (Mid) 60 60 30 4 (Mid-I-ligh) 70 70 100 5 (High) 70 70 300 6 (Mid-I-liRgehcovery) 40 40 100 7 (IRghRecovery) 40 40 300 Covance 6329-228 8 (Controlb) 70 70 0 9 (Treated) 70 70 1 a T-6316 is98.1% n-ethylperfluorooctanesulfonameitdhoanol(NEtFOSE); doselevelsare expressedasppm of NETFOSE. b Tlkecontrolanimals receivedthebasaldietonly. During Week 8,blood and urinewere collectefdorhematology,clinicaclhemistry, urinalysiasn@d urinechemistrytestsfrom fiveanknals/sex/grouipnGroups 1 and 5. During Weeks 14,27,and 53,blood and urinewere collectefdorthesetestsfrom 10 animals/sex/grouipnGroups I through4,8,and 9. Blood smearswere made forall anir@ sacrificeadtunscheduledintervalosr duringWeek 53 (interismacrifice). Necropsieswere performedon fiveanimals/sexinGroups 1 and 5 sacrificedduring Week 8;fiveanimals/seixnGroups 1 through4 sacrificedduringWeek 14;and five animals/seixnGroup 1 and 10 animals/sexinGroups 4, 8,and 9 sacrificedduring Week 53. At necropsy,macroscopicobservationwsere recorded,organ weightswere obtained(forsacrificdeusringWeeks 8,14,and 53),and tissueswere placedinfixativaes specifiebdy theprotocol.At unschedulednecropsiesforanimalsthatdiedor were sacrificebdecauseofpoor healthm,acroscopicobservationwsere recorded,and tissues were placedinfixativeb,ut organweightswere notobtained.Nficroscopiecxaminations were done on selectedtissuefsrom animalsinGroups 1 through5 necropsiedduring Weeks 8 and 14. The tissuewsere adrenalsb,rain,eyes,kidneys,liverm,esentericlymph node,pancreas,spleen,testesa,nd ovaries.l@ficroscopeixcaminationswere done on all collectetdissuefsrom animalsinGroups land4 necropsiedattheWeek 53 interim sacrifice. Covance 6329-2121228 3M T-6316.1 In additionm,icroscopicexaminationswere done on tissuefsrom animalsthatdiedor were sacrificeddue to poor health. Five animals/seixnGroups 1 through5 were sacrificedduringWeek 4,and five animawsex inGroups I through4 were sacrificedduringWeek 14 forhepatocellular proliferatiroantemeasurementsand hepaticpalmitoyl-CoAoxidaseactivityA.t the Week 4 collectiofnoranimalsinGroups 1 through5,samplesofliverwere collectefdor mitochondriaalnalysisF.iveanimals/seixnGroups 8 and 9 were sacrificedduringWeek 4 forhepaticpalmitoyl-CoAoxidaseactivitaynd duringWeek 14 forhepatocellular proliferatiroantemeasurementsand hepaticpalmitoyl-CoAoxidaseactivity. StatisticalsliygnificadnitfferencecsitedintheResultsand Discussionsectionarebased on comparisonsbetween thecontroland treatedgroups. RESULTS AND DISCUSSION Chnical Pathology Week 4. Males and femalesgiven300 ppm had mildlyb,utstatisticalhliyg,herhepatic pahnitoyl-CoAoxidaseactivitcyonsistenwtithperoxisomalproliferation. Week 8. There were many statisticaslilgynificaonrtotherwisenotabledifferencefsor clinicaplathologyresultbsetween animalsgiventhecontrolmaterialand animalsgiven 300 ppm. Those differencecsonsideredto be effectosfthetestmaterialwere lower red bloodcellcount,hemoglobin,hematocritg,lucose,globulina,nd cholesteroalnd higher ureanitrogena,lbumin,totalbihrubin(malesonly),aspartataeminotransferas(emales only),alanineaminotransferasaen,d hepaticpamitoyl-CoA oxidase.With theexception of higheralanineaminotransferasfeorthefemales,thesedifferencewsere statistically significanTth.e effectosn theerythrocytpearametersg,lucose,and globulinwere consistenwtithpoor healthand failurteo gainweightappropriatelyH.igherureanitrogen and albun-dwnere most consistenwtithmild dehydrationand indicatedtheeffectson other parameters(e.g.t,heerythrocytpearameters)would likelhyave been greateriftheanimals were normovolemic. The effectson alanineaminotransferasea,spartateaminotransferase, and totalbffimbinwere indicativoefthehepatocehuludegenerationand necrosisobserved microscopically. 12 Covance 6329-212/228 3M T-6316.1 Other statisticalsliygnificandtifferenceswere consideredto be of uncertainrelationshitpo administrationof the testmateria]LMildlylower plateletcount was observed formales but not females. Absolute eosinophilcount was statisticallloywer for both males and females, but the differenceswere extremely small as normal eosinophilcount isvery low. Weeks 14,27, and 53. There were severalstatisticalsliygnificanotr otherwisenotable differencesforclinicaplathology resultsbetween controland treatedanimals. Those differencesconsidered to be effectsof the testmaterialwere not always statistically significanbtut were generallyconsistentover time and exhibiteda relationshitpo dose. Several statisticalsliygnificandtifferencesthatwere inconsistentover time or did not affectthe high-dose group were consideredincidental. Administrationof thetestmaterialwas associatedwith decreasedred blood cellcount, hemoglobin, and hematocritforfemales given 100 ppm; lower glucose and higher urea nitrogenformales and femalesgiven 100 ppm (predominantlyatWeeks 14 and 27); higheralbumin and lower globulinformales given 100 ppm (predominantlyat Weeks 27 and 53);and lower cholesterolformales given 30 or 100 ppm and females given 100 ppm. These effectswere consistentwith those observed atWeek 8 foranirnalgiven 300 ppm but were lessprominent. The effectof greatestmagnitude was thatforcholesterolAt the highestdose level cholesterolwas markedly decreased for the males. The erythrocyteeffectsand the effects on glucose and urea nitrogenwere very mild,and the serum proteineffectswere considered of moderate severity. Administrationof thetestmaterialat 1 or 3 ppm forapproximately52 weeks had no effect on clinicaplathology testresults. Anatonjic Pathology Unscheduled Deaths. One Group I controlmale (Animal No. C90721) and one Group I controlfemale (Animal No. C91179), two Group 2 males given3 ppm (Animals Nos. C90806 and C90813), one Group 3 male given 30 ppm (Animal No. C90878), one Group 3 female given30 ppm (Animal No. C91282), two Group 4 males given 100 ppm (Animals Nos. C90945 and C90949), one Group 4 female given 100 ppm (Animal No. C91322), threeGroup 5 males given 300 ppm (Animal Nos. C90993, C91003, and C91029), four Group 6 males given 100 ppm (Animal Nos. C91045, C91046, C91049, 13 Covance 6329-212/228 3M T-6316.1 and C91068), one Group 7 male given300 ppm (AnimalNo. C91099),two Group 8 controlmales (AnimalNos. C92198 and C92213),fourGroup 8 controlfemales(Animal Nos. C92235, C92342, C92345, and C92347),two Group 9 malesgivenIppm (Animal Nos. C92273 and C92293) and two Group 9 femalesgiven1 ppm (AnimalNos. C92403 and C92437) diedon testor were sacrificemdoribund. Animal No. C90721, a Group 1 controlmale,dieddue to a widespreadmalignant lymphoma. Animal No. C90806, a Group 2 male given3 ppm, was sacrificebdecauseof a largesubcutaneousundifferentiatseadrcoma,and Animal No. C90813, a Group 2 male given3 ppm, was sacrificebdecauseithad a fracturoef thehardpalate.Animal No. C91003, a Group 5 male given300 ppm and Animal No. C91282, a femalegiven 30 ppm, were sacrificemdoribund withpituitaraydenomyt.-A.n.imalsNos. C91045, C91046, and C91068, Group 6 males given100 ppm, and Animal No. C91099, a Group 7 male given300 ppm, were sacrificeodr dieddue to hepaticnecrosis.Animal No. C91049, a Group 6 male given100 ppm, diedwithnecrosisofthemusculatureoftheanus. Animal No. C91179, a Group 1 controlfemale,was sacrificebdecauseof a largemammary fibroadenoma.The cause of deathwas undeterminedfortheotherGroup I to 7 animals. Histopathologywas notdone on theGroup 8 and 9 animals.The macroscopicfindings were typicaolf thoseobservedinratsinlong term studies. Week 4 Sacrifice Organ Weights. Terminalbody weightswere lowerformalesgiven300 ppm. Absolute and relativleiverweightswere higherfornialesand femalesgiven 100 or 300 ppm. There were no othertestmaterial-relatcehdangesforabsoluteorgan weights,organ-to-body weightpercentagesor organ-to-braiwneightratios. Maaoseopic Findings.There were no grossfindingnsoted atnecropsy. Week 8 Sacrifa"ce Organ Weights. Terminalbody weightswere lower and absoluteand relativleiver weightswere significanthliygherformalesand femalesgiven300 ppm. There were no othertestmaterial-relatcehdangesforabsoluteorgan weights,organ-to-bodyweight percentageso,r organ-to-braiwneightratios. 14 Covance 6329-212/228 3M T-6316.1 Macroscopic Findings. The only testmaterial-relatefdindingsat necropsy were large liversforfivemales and two femalesgiven 300 ppm and mottlingof theliverof one female given 300 ppm. There were no othertestmaterial-relategdross findingsnoted at necropsy. Microscopic Findings. Test material-relatfeidndingswere limitedto theliver.The test material-relatehdepaticfindingswere hepatocellulahrypertrophy,hepatocellulu necrosis,and hemorrhage. The incidenceand severityof the hepaticlesionsare listedin Text Table 1. Text Table I Incidenceand Severityof Test Material-RelatedMicroscopic Findings Males Females N-Ethyl Perfluorooctanesulfonamido(ppm) Dose Level Number examined lffl 5- Q 2m 5 5- Liver Hypertrophy Moderate 0 5 Moderately-severe 0 0 0 4 0 1 Necrosis Minimal 0 1 Moderate 0 2 0 0 0 1 Hemorrhage Minimal 0 3 Moderate 0 0 0 0 0 1 Week 14 Sacrifice Organ Weights. Terminalbody weightswere lowerand absoluteand relativleiver weightswere significanthliygherformales and femalesgiven100 ppm. There were no othertestmaterial-relatcehdangesforabsoluteorganweights,organ-to-bodyweight percentageso,r organ-to-braiwneightratios. Macroscopic Findings. There were no testmatedal-relategdrossfindingnsoted at necropsy. 15 Covance 6329-212/228 3M T-6316.1 MicroscopicFindings. The onlytestmaterial-relatfeidndingwas hepatocellular hypertrophyformales given30 or 100 ppm and femalesgiven 100 ppm. The incidence and severitoyfthehepatocellulhayrpertrophyarelisteidnText Table 2. Text Table2 Incidenceand SeverityofHepatocellulaHrypertrophy Dose Level Number examined Males Females N-EthylPerfluorooctanesulfonami(dpopm) 3. 3-0 100 Q 3- 30 100 55 5 5 555 5 Liver Hypertrophy Minimal Slight Moderate 00 1 0 000 0 00 1 4 000 2 00 1 1 000 0 Week 53 Sacrifice Organ Weights. Terminalbody weightswere lowerand absoluteand relativEever weightswere significanthliygherformales and femalesgiven 100 ppm. There were no othertestmaterial-relatcehdangesforabsoluteorgan weights,organ-to-bodyweight percentageso,r organ-to-braiwneightratios. Macroscopic Findings.There were no testmaterial-relatgerdossfindingsnotedat necropsy. MicroscopicFindings.Hepatocelluluhypertrophyandvacuomon oftheliverwere observedonlyforanimalsgiven100 ppm. Ile incidenceand severitoyf hepatocellular hypertrophyand vacuolationarelisteidnText Table3. Othertestmaterial-relatheedpatic findingswere hepatocellulanrecrosisforone male and two femalesgiven100 ppm and bilestasifsorone male and two femalesgiven100 ppm. One femalegiven100 ppm had a hepatocelluluadenoma. Hepatocellulaardenomas areoccasionalloybservedas an incidentaflindingin 1 yearoldrats. 16 Covance 6329-2121228 3M T-6316.1 Text Table 3 Incidenceand Severityof HepatocelluLuHypertrophy Dose Level Number examined Males Females N-EthylPerfluorooctanesulfonami(dpopm) 3 10 100 -Q 2 30 100 5 0 0 10 5 0 0 10 Liver Vacuolation Minimal Slight Moderate 00 0 3 000 2 00 0 3 000 0 00 0 3 000 0 Hypertrophy Slight Moderate ModeratelySevere 0 000 0 00 0 3 0 00 3 00 0 2 000 4 00 0 5 000 0 17 Table 1 summary of Adjusted survival Data 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULFONAMIDO ETHANOL IN RATS *DRAFT* -------------------------------------------------------------------------------------------------------------- GROUP AND DOSE LEVEL (PPM) ---------- WEEK: START 1 2 3 4 5 6 7 8 9 ------------------------------------------------------------------------------------------------ MALE 1 0 70/70 70/70 70/70 70/70 65/65 65/65 65/65 65/65 60/60 60/60 2 3 60/60 60/60 60/60 60/60 55/55 55/55 55/S5 55/55 54/55 54/55 3 30 60/60 60/60 60/60 60/60 ss/s5 5S/55 55/55 55/55 55/SS 55/55 4 100 70/70 70/70 70/70 70/70 6S/6s 6S/65 6SI65 6S/6s 65/65 65/65 5 300 70/70 70/70 70/70 70/70 65/65 65/65 65/6S 63/65 0 0 6 100 40/40 40/40 40/40 40/40 40/40 40/40 40/40 39/40 39/40 39140 7 300 40/40 40/40 40/40 40/40 40/40 40/40 39/40 39/40 0 0 Table 1 summary of Adjusted Survival Data 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFOXAMIDO ETHANOL IN RATS *DP-ZPT* --------------------------------------------------------------------------------------------------------------- GROUP AND DOSE L4=L (PPM) ---------- Wl=: 12 13 14 15 16 17 18 19 20 21 ------------------------------------------------------------------------------------------------- MALE I 0 60/60 60160 SS/55 55/SS SS/SS SS/SS SS/SS SS/S5 55/SS SS/SS 2 3 54/SS 54/SS 49/50 49/50 49/50 49/50 49/50 49/50 49/SO 49/50 3 30 55/55 55/5S SO/50 50/SO SO/SO SO/SO 50/50 SO/50 50/50 SO/50 4 100 65165 64/65 59/60 59/60 59/60 S9160 59/60 59/60 59/60 59/60 s 300 0 0 0 0 0 0 0 0 0 0 6 100 39/40 39/40 38/40 39/40 38/40 38/40 38/40 38/40 38/40 38/40 7 300 0 0 0 a 0 0 0 0 0 0 Table 1 Summary of Adjusted Survival Data 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUORGOCTANESULPONAMIDO ETHANOL IN RATS *DRAFT* ---------------------------------------------------------------------------------------------------------------- GROUP AND DOSE LEVEL (PPM) ---------- 1 0 2 3 3 30 4 100 5 300 6 100 7 300 WE=- 24 25 26 27 28 29 30 31 32 33 -------------------------------------------------------------------------------------------------- 55/55 55/55 SS/55 55/SS MALE 55/55 55/55 55/SS 55/55 55/55 55/55 49/50 49/50 49/50 49/50 49/50 49/50 49/50 49/50 49/50 49/50 50/50 50/50 50/50 50/50 50/50 50/50 50/SO 50/SO 50/50 50/50 59/60 59160 59/60 59/60 59/60 59/60 59/60 59160 59160 59/60 0 0 0 0 0 0 0 0 0 0 38/40 38/40 38/40 38/40 38/40 38/40 38/40 38/40 38/40 38/40 0 0 0 0 0 0 0 0 0 0 Table 1 Suminaryof Adjusted Survival Data 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DP-bJ"* -------------------------------------------------------------------------------------------------------- GROUP AND DOSE LEVEL (PPM) ---------- WEEK: 36 37 38 39 40 41 42 43 44 45 ------------------------------------------------------------------------------------------------ MALE 0 55/SS 55/55 55/55 SS/S5 55/SS SS/SS SS/55 55/SS 54/55 54/55 2 3 48/50 48/50 48/50 48/50 48/50 48/50 48/50 48/50 48/50 48/50 3 30 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 4 100 59/60 59/60 59/60 59/60 59/60 S9/60 59/60 59/60 S9/60 58/60 s 300 0 0 0 0 0 0 0 0 0 0 6 100 38/40 38/40 38/40 38/40 38/40 38/40 38/40 37/40 37/40 37/40 7 300 0 0 0 0 0 0 0 0 0 0 Table 1 Sutwnary of Adjusted survival Data 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* --------------------------------------------------------------------------------------------------------------- GROUP AND DOSE ISVEL IPPM) ---------- 0 2 3 3 30 4 100 5 300 6 100 7 300 WE3M: 48 49 50 51 52 53 ------------------------------------------------------------------------------------------------- MALE 54/55 54/55 54/55 54/55 54/55 49/50 48/50 48/50 48/SO 48/SO 48/50 48/50 50/SO 50/50 50/50 50/50 50/50 49/50 58/60 58/60 58/60 58/60 58/60 48/SO 0 0 0 0 0 0 37/40 37/40 37/40 36/40 36/40 36/40 0 0 0 0 0 0 Table 1 Summary of Adjusted Survival Data 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DRAFT* --------------------------------------------------------------------------------------------------------------- GROUP AND DOSE LEVEL (PPM) ---------- Wis : START 1 2 3 4 5 6 7 8 9 ------------------------------------------:---------------------------------------------------- FEMALE 1 0 70/70 70/70 70/70 70/70 65/65 6S/65 65/65 65/65 60160 60/60 3 60/60 60160 60/60 60160 55/55 55/55 55/55 55/55 55/55 55/55 3 30 60/60 60/60 60/60 60/60 55/55 55/55 55/55 55/5S SS/SS 55/55 4 100 70/70 70/70 70/70 70/70 65/65 65/6S 65/65 65/65 65/65 65/65 5 300 70/70 70/70 70/70 70/70 65/6S 65/65 GS165 6S/65 0 0 6 100 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 7 300 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 0 0 Table 1 summary of Adjusted Survival Data 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHHUOL IN RATS *DRAFT* ----------------------------------------------------------------------------------------------------------------- GROUP AND DOSE LEVEL (PPM) ---------- WEEK: 12 13 14 15 16 17 18 19 20 21 2 --------------------------------------------------------------------------------------------------- PEKALE 1 0 60/60 60160 55/55 55/55 55/SS SS/55 55/55 55/SS 55/SS 55/SS s 2 3 55/55 55/55 50/50 50/50 50/50 50/50 50/50 50/50 50/50 50/50 5 3 30 55/55 55/55 50/50 50/50 50/50 50/SO 50/50 50/50 50/50 50/SO 5 4 100 65/6s 65/6s 60/60 S9/s9 59/59 59/s9 59/59 59/59 59/59 59/59 5 5 300 0 0 0 0 0 0 0 0 0 0 6 100 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 4 7 300 0 0 0 0 0 0 0 0 0 0 Table 1 summary of Adjusted survival Data 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULFONAMIDO ETHANOL IN RATS *DRAFT* ---------------------------------------------------------------------------------------------------------------- GROUP AND DOSE LIML (PPM) ---------- 1 0 2 3 3 30 4 100 5 300 6 100 7 300 WEEK: 24 25 26 27 28 29 30 31 32 33 -------------------------------------------------------------------------------------------------- 55/55 55/55 SS/SS SS/5s FEMALE ss/s5 55/5s SS/55 55/55 55/55 55/55 50/50 50/50 50/50 50/50 50/SO 50/50 50/50 50/SO 50/50 50/50 50/50 SO/50 50/50 50/SO 50/SO 50/SO 50/50 50/SO 50/50 50/50 59/59 58/59 58/59 58/59 s8/s9 59/59 58/59 58/59 S8/59 58/59 0 0 0 0 0 0 0 0 0 0 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 0 0 0 0 0 0 0 0 0 0 Table 1 sumary of Adjusted Survival Data 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98-1t) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DPJU;'r* ------------------------------------------------------------------------------------------------------------------ GROUP AND DOSE LKVEL IPPM) ---------- WEEK: 36 37 38 39 40 41 42 43 44 45 46 ---------------------------------------------------------------------------------------------------- FEMALE 1 0 55/55 55/55 55/55 55/55 55/55 55/55 55/55 55/SS 55/55 55/55 ss 2 3 50/50 50/SO 50/50 50/50 50/50 50/50 50/SO 50/SO 50/SO 50/50 so 3 30 SO/SO 50/SO 50/SO 50/50 50/50 50/SO 50/SO 50/50 50/50 solso 50 4 100 58/59 58/59 s8/s9 58/59 58/59 58/59 58/59 S8/59 59/59 s8/s9 58 5 300 0 0 0 0 0 0 0 0 0 0 6 loo 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40/40 40 7 300 0 0 0 0 0 0 0 0 0 0 Table 1 Sumnary of Adjusted Survival Data 104-WEEK DIETARY CARCINOGEWICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DRAFT* -------------------------------------------------------------------------------------------------------------- GROUP AND DOSE LEVEL (PPM) ---------- WEEK: 48 49 so 51 52 53 ------------------------------------------------------------------------------------------------ FEKALE 0 54/55 54/55 S4/SS SA/SS S4/55 49/50 2 3 50/50 50/50 50/SD solso 50/50 50/50 3 30 50/50 50/50 50/50 50/50 SO/50 49/50 4 100 s8/s9 59/59 SS/59 58/59 58/59 48/49 5 300 0 0 0 0 0 0 6 100 40/40 40/40 40/40 40/40 40/40 40/40 7 300 0 0 0 0 0 0 Table 2 Summal7i of AdJusted survival Data *DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ---------------------------------------------------------------------------------------------------------------- GROUP AND DOSE LENL (PPM) ---------- WEEK: START 1 2 3 4 s 6 7 a 9 -------------------------------------------------------------------------------------------------- 0 70/70 70/70 70/70 70/70 6S/65 GS/6s 6S/65 6516S 65165 6516S 9 1 70/70 70/70 70/70 70/70 65165 6S/6s 6sl6s 65/65 65/65 65/65 FML%LE 8 0 70/70 70/70 70/70 70/70 65/65 65/65 65/65 65165 64/65 64165 9 1 70/70 70/70 70/70 70/70 65/65 6516S 65/65 65/6s 65/6s 65/65 Table 2 Summary of Adjusted survival Data *DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (99.1%) N-RTHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------- GROUP AND DOSE LEVEL (PPM) ---------- WEEK: 12 13 14 is 16 17 is 19 20 21 ------------------------------------------------------------------------------------------------- MALE 8 0 64/65 64/65 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 9 1 65165 65/65 60/60 60/60 60160 60/60 60160 60160 60160 60/60 PEKHLE 8 0 64/65 64/65 59/60 59/60 59/60 59/60 59/60 59/60 59/60 59/60 9 1 65/6S 65165 60160 60/60 60/60 60160 60160 60160 60/60 60/60 Table 2 summary of Adjusted survival Data *DRAFT* 104-WEEK DIETARY CARCINOCENICM STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ---------------------------------------------------------------------------------------------------------------- GROUP AND DOSE LEVEL (PPM) ---------- WEEK: 24 25 26 27 28 29 30 31 32 33 -------------------------------------------------------------------------------------------- KALB 8 0 59/60 S9/60 S9/60 59/60 59/60 S9/60 S9/60 59/60 59/60 S9/60 9 1 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 PEKALE 8 0 59160 59160 59/60 S9/60 59/60 59/60 SO/60 58/60 58/60 58/60 9 1 60/60 60160 60160 60/60 60/60 60/60 60160 60/60 60160 60160 Table 2 summary of Adjusted Survival Data ---------- *DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1!k) H-VMYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ----------------------------------------------------------------------------------------------------- GROUP AND DOSE LRVEL IPPM) ---------- WBEK: 36 37 38 39 40 41 42 43 44 45 -------------------------------------------------------------------------------------------------- MALE 8 0 59/60 59/60 59/60 59/60 59160 S9/60 59/60 59/60 sq/60 S9/60 9 1 60/60 60/60 60/60 60/60 60/60 60/60 58/60 58/60 58/60 58/60 PEKALE 0 58/60 58/60 58/60 58/60 58/60 58/60 58/60 59/60 58/60 58/60 9 1 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 60/60 Table 2 Summary of Adjusted Survival Data -*DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) H-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------- GROUP AND DOSE LEVEL (PPM) ---------- WEEK: 48 49 so 51 52 53 ------------------------------------------------------------------------------------------------- MALE 8 0 59/60 S9/60 59/60 58/60 58/60 48/50 9 1 58/60 58/60 58/60 So/60 S8/60 48/SO FEMALE 8 0 57/60 57/60 56/60 56/60 56160 46/50 9 1 60/60 60/60 59/60 58/60 58/60 48/50 Table 3 Summary of Clinical observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-VMYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* ------------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: -------------K-H-LE -------------- GROUP: 1 2 3 4 5 67 CATEGORY DOSE: 0 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 ------------------------------------------------------------------------------------------------------------------- *** TOP OF LIST APPEARANCE BENT TAIL CONVULSIONS DEHYDRATED 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 1 HUNCHED MALOCCLUSION 0 0 0 0 0 1 0 3 3 5 19 2 62 MISSING TAIL-PROXIKAL TEETH 0 0 0 0 0 0 0 1 0 1 3 0 0 0 PARALYSIS LIMB-PRONT-LJEFT 0 0 0 1 0 1 0 SWOLLEN LIMB-HIM-LEFT LIMB-HIND-RIGHT MOUTH NOSE PAW-HIND-LEFT VENTRHL-ABDOMINIAL THIN 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 3 0 1 1 1 1 BEHAVIOR HYPOACTIVE RECUMBENT LATERAL STERNAL 0 0 0 0 1 1 1 0 0 0 0 0 1 0 1 0 0 0 0 0 0 Table 3 Summary of Clinical Observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DRAFT* ---------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: ---------------MALE -------------- GROUP: 1 2 3 4 s 6 7 CATEGORY DOSE: 0 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 ----------------------------------------------------------------------------------------------------------------- BEHAVIOR SENSITIVE TO TOUCH VOCALIZATION DISCHARGE GENITAL RED IN ORAL RED IN CLEAR NASAL RED IN UNKNOWN RED IN COLOR COLOR COLOR COLOR EXCRETION DISCOLORED URINE RED IN COLOR ORANGE IN COLOR FEW FECES LIQUID FECES NO FECES NOWFORKED FECES 1 0 0 0 0 0 0 0 0 0 0 1 0 0 1 1 1 0 0 2 0 0 1 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 2 1 4 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 1 0 0 0 0 0 0 1 3 0 0 0 2 1 0 0 0 0 0 1 0 1 0 0 0 0 1 0 5 5 5 3 0 2 0 Table 3 Summary of clinical observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DRAPT* --------------------------------------------------------------------------------------------------------------- DAYS 1-371 NUMBER OF ANIMALS AFFECTED CATEGORY KEYWORD SEX: GROUP: DOSE: --------------MA-LE -------------- 1 2 3 4 5 67 0 3 30 100 300 100 300 QUALIFIER NUMBER- 70 60 60 70 70 40 40 ---------------------------------------------------------------------------------------------------------------- EYES CLEAR DISCHARGE EYE-RIGHT EYES CLOUDY DISCHARGE . EYE-RIGHT OPAQUE EYE-RIGHT RED DISCHARGE EYE-LEFT EYE-RIGHT EYES SQUINTED PERI-ORDITAL HOUSING,FOOD,WATER TEETH CUT RESPIRATION AUDIBLE IRREGULAR LABORED SKIN & PELAGE ALOPECIA MAINT. 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 2 0 0 3 0 0 1 0 1 0 0 0 2 1 0 1 0 3 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 1 0 0 0 0 1 0 0 0 2 0 0 1 0 0 1 1 0 0 0 0 0 0 0 0 Table 3 Summary of Clinical observations 104-WEEK D M ARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* ---------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: --------------M-ALE -------------- CROUP: 1 2 3 4 5 6 7 CATEGORY DOSE: 0 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 ---------------------------------------------------------------------------------------------------------------- SKIN & PELAGE BROWN HAIR COAT PERINEAL AREA SCROTUM VENTRAL-ABDOMINAL BLUE SKIN VENTRAL-ABDOMINAL-RIGHT COLD TO TOUCH ENTIRE BODY PALE F.ARS ENTIRE BODY RED HAIR COAT HEAD-ENTIRE HEAD-CRANIAL LIMBS-ALL VENTRAL-ABDOMINAL ROUGH HAIR COAT SCALY SKIN TAIL-DISTAL SORE/SCAB AXILLARY REGION-RIGHT DORSAL DORSAL-CERVICAL DORSAL-CERVICAL-LEFT DORSAL-CERVICAL-RIGHT 1 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 1 0 0 1 0 0 0 2 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0 0 0 1 0 1 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 a 0 0 0 0 0 0 0 1 0 a 0 0 Table 3 summary of clinical observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* --------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: --------------M-ALE -------------- CATEGORY GROUP: 1 r)osg- 0 2 3 4 5 6 7 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 --------------------------------------------------------------------------------------------------------------- SKIN & PELAGE SORE/SCAB EAR-RICHT HEAD-ENTIRE HFAD-CRANIAL HEAD-MAXILLARY-RIGHT LATERAL-ABDOMINAL-RIGHT LATERAL-CERVICAL-LEFT LATERAL-CERVICAL-RIGHT LIMB-HIND-LEFT LIHB-HIND-RIGHT LIMBS-HIND MOUTH PAW-HIND-LEFT PAW-HIND-RIGHT PAWS-FRONT PAWS-HIND SHOULDBR-LEPT SHOULDER-RIGHT TAIL VENTRAL-ABDOMINAL VENTRAL-ABDOMINAL-LEFT VENTRHL-ABDOMINAL-RIGHT VENTRAL-CERVICAL VENTRAL-CERVICAL-LEFT VENTRAL-CERVICAL-RIGHT 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 1 1 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 0 1 0 0 2 1 1 0 1 0 0 0 0 0 0 0 0 1 1 0 1 0 1 0 0 2 1 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 1 1 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 1 1 0 0 0 1 0 0 0 0 0 0 1 0 0 0 0 Table 3 Summary of Clinical Observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (99.1%) N-ETHYL PE"LUOROOCTAXESULPONAMIDO ETHANOL IN RATS *DRAFT* ----------------------------------------------------------------------------------------------------- 7 NUMBER OP ANIMALS AFFECTED DAYS 1-371 SEX: ---------------HALE -------------- GROUP: 1 2 3 4 5 6 7 CATEGORY DOSE: 0 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 --------------------------------------------------------------------------------------------------------------- SKIN L PELAGE YELLOW HAIR COAT KHSS(ES) AXILLARY REGION-LEFT WEEK 26 WEEK 33 WEEK 43 WEEK 47 AXILLARY REGION-RIGHT WEEK 31 WEEK 35 WEEK 38 WEEK 45 WEEK 47 WEEK 48 WEEK 52 DORSAL WEEK 49 HRAD-MAXILLARY-RIGHT WEEK 17 WEEK 48 wmm si 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 Table 3 Summary of Clinical observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DP-k"* ----------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: --------------MA-LE -------------- GROUP: 1 2 3 4 5 6 7 CATEGORY DOSE: 0 3 30 100 300 100 300 KEYWORD QUALIPIER NUMBER: 70 60 ' 60 70 70 40 40 ---------------------------------------------------------------------------------------------------------------- HASS(ES) LIMB-HIND-LEFT WEEK 25 MOUTH WEEK 20 SHOULDER-LEFT WEEK 40 VENTRAL-ABDOMINAL WEEK 33 WEEK 35 WEEK 40 WEEK 44 WEEK 49 WEEK 51 VENTRAL-ABDOMINAL-LEFT WEEK 21 WEEK 22 WEEK 37 WEEK 4S WEEK 46 WEEK 49 WEEK 51 WEEK 53 VENTRAL-ABDOMINAL-RIGHT WEEK 29 WEEK 32 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 a 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Table 3 Summary of Clinical Observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULPONAMIDO ETHANOL IN RATS *DRAFT* ---------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX - --------------MA-LE -------------- GROUP: 1 2 3 4 5 6 7 CATEGORY DOSE: 0 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 ---------------------------------------------------------------------------------------------------------------- KASS(ES) VENTRAL-ABDOMINAL-RIGHT WEEK 36 WE" 38 WEEK 40 WEEK 49 WEEK 51 WEEK S3 VENTRAL-CERVICAL-LEFT WEEK 43 WEEK 46 WEEK 48 VMCML-CERVICAL-RIG'HT WEEK 43 VENTRAL-THORACIC WEZK 42 WART LIKE LESION(S) DORSAL WEEK 47 WEEK 51 EAR-LEFT WEEK 47 MOUTH WEEK 21 WEEK 23 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Table 3 Summary of Clinical observations 104-WEEK DIETARY CARCINGOM41CITY STUDY WITH NARROW RANGE (98.1%) N-ETNYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DRAYT* ---------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: --------------M-ALE -------------- GROUP: 1 2 3 4 5 6 7 CATEGORY DOSE: 0 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 ---------------------------------------------------------------------------------------------------------------- WART LIKE LESION(S) MOUTH WEEK 31 WEEK S2 PAW-HIND-RIGHT WEEK 34 SHOULDER-LEFT WEEK 37 TAIL WEEK 19 WEEK 22 VENTRAL-THORACIC WEEK 46 END OF LIST 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 1 2 0 0 0 0 0 0 0 0 0 0 0 Table 3 Summary of Clinical Observations 104-WEEK DIETARY CARCINOGENICITY STUDI WITH NARROW RANGE (9a.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DRAFT* --------------------------------------------------------------------------------------------------------------- DAYS 1-371 NUMBER OF ANI14ALS AFFECTED CATEGORY SEX: GROUP: DOSE: -------------F-EMALE -1 2 3 4 0 3 30 100 ------------- 5 6 7 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 --------------------------------------------------------------------------------------------------------------- *** TOP OF LIST APPEARANCE BENT TAIL CONVULSIONS DEHYDRATED HUNCHED MALOCCLUSION MISSING TAIL-PROXIMAL TEETH PARALYSIS 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 5 9 6 13 0 6 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 LIMB-PRONT-LEFT 0 0 0 0 0 0 0 SWOLLEN LIMB-HIND-LEFT LIHE-HIND-RIGHT MOUTH NOSE PAW-HIND-LEFT VENTRAL-AJBDOMINAL THIN 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 1 0 BEHAVIOR HYPOACTIVE RECUMBENT LATERAL STERNAL 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Table 3 Summary of Clinical observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (99.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DRAFT* ---------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: -------------F-EMALE ------------- CATEGORY GROUP: DOSE: 1 2 3 4 5 6 7 0 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 ---------------------------------------------------------------------------------------------------------------- BEHAVIOR SENSITIVE TO TOUCH VOCALIZATION DISCHARGE GENITAL RED IN ORAL RED IN CLEAR NASAL RED IN UNKNOWN RED IN COLOR COLOR COLOR COLOR EXCRETION DISCOLORED URINE RED IN COLOR ORANGE IN COLOR FEW FECES LIQUID FECES NO FECES NONFORKED FECES 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 2 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 1 1 3 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 2 0 0 0 0 0 0 Sumary Table 3 of clinical observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DP-%"* ----------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 CATEGORY SEX: GROUP: DOSE: -------------FE-MALE ------------- 1 2 3 4 5 67 0 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 ---------------------------------------------------------------------------------------------- EYES CLEAR DISCHARGE EYE-RIGHT EYES CLOUDY DISCHARGE EYE-RIGHT OPAQUE EYE-RIGHT RED DISCHARGE EYE-LEFT EYE-RIGHT EYES SQUINTED PERI-ORBITAL HOUSING,FOOD,WATER TEETH CUT RESPIRATION AUDIBLE IRREGULAR LABORED SKIN & PELAGE ALOPECIA f. MAINT. 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 1 2 1 0 0 1 0 0 1 0 0 0 2 0 0 1 1 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 1 2 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 2 0 1 0 Table 3 Summary of clinical observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* ---------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 CATEGORY SEX: GROUP: DOSE: --------------FEMALE 1 2 3 4 0 3 30 100 ------------- 5 6 7 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 ----------------------------------------------------------------------------------------------------------------- SKIN & PELAGE BROWN HAIR COAT PERINEAL AREA SCROTUM VENTRAL-ABDOMINAL BLUE SKIN VENTRAL-ABDOMINAL-RRGHT COLD TO TOUCH ENTIRE BODY PALE EARS ENTIRE BODY RED HAIR COAT HEAD-ENTIRE HEAD-CRANIAL LIMBS-ALL VENTRAL-ABDOMINAL ROUGH HAIR COAT SCALY SKIN TAIL-DISTAL SORE/SCAB AXILLARY REGION-RIGHT DORSAL DORSAL-CERV3:CAL DORSAL-CERVICAL-LLPFT DORSAL-CERVICAL-RIGHT 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 1 1 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 4 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 Table 3 summary of Clinical observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAviNESULPONAMIDO ETHANOL IN RATS *DRAFT* ---------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: --------------FEMALE ------------- GROUP: 1 2 3 4 5 6 7 CATEGORY DOSE: 0 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 --------------------------------------------------------------------------------------------------------------- SKIN & PELAGE SORE/SCAB EAR-RIGHT HEAD-ENTIRE HEAD-CRANIAL HEAD-KAXILLHRY-RIGHT LATERAL-ABDOMINAL-RIGHT LATERAL-CERVICAL-LEFT LATERAL-CERVICAL-RIGHT LIMB-HIND-LEFT LIHB-HIND-RIGHT LIMBS-HIND MOUTH PAW-HIND-LEFT PAW-HIND-RIGHT PAWS-FRONT PAWS-HIND SHOULDER-LEFT SHOULDER-RIGHT TAIL VENTRAL-ABDOMINAL VENTRAL-ABDOMINAL-LEFT VENTRAL-ABDOMINAL-RIGHT VENTRAL-CERVICAL VENTRAL-CERVICAL-LEFT VENTRAL-CERVICAL-RIGHT 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 1 0 1 0 0 0 0 1 2 0 0 0 0 0 0 1 0 0 0 0 Table 3 Sumnary of Clinical Observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO *Dpb ,FT* ETHANOL IN RATS -----------------------------------------------------;------------------------------------------------------ NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: --------------FEMALE ------------- GROUP: 1 2 3 4 5 6 7 CATEGORY DOSE: 0 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 --------------------------------------------------------------------------------------------------------------- SKIN & PELAGE YELLOW HAIR COAT HASS(ES) AXILLARY REGION-LEFT WEEK 26 WEEK 33 WEEK 43 WEEK 47 AXILLARY REGION-RIGHT WEEK 31 WEEK 35 WEEK 38 WEEK 45 WEEK 47 WEEK 48 WEEK 52 DORSAL WEEK 49 HEAD-MAXILLARY-RIGHT WEEK 17 WEEK 48 WEEK 51 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 2 2 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 2 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Table 3 Summary of Clinical observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DP-b"* -------------------------------------------------------------------------------------------------------------- NU14BEROF ANIMALS AFFECTED DAYS 1-371 SEX: --------------FEMALE ------------- GROUP: 1 2 3 4 5 6 7 CATEGORY DOSE: 0 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 ------------------------------------------------------------------------------------------------------------- HASS(ES) LIHB-HIND-LEFT WEEK 25 MOUTH WEEK 20 SHOULDER-LEFT WEEK 40 VENTRAL-ABDOMINAL WEEK 33 WEEK 35 WEEK 40 WEEK 44 WEEK 49 WEEK 51 VENTRAL-ABDOMINAL-LEFT WEEK 21 WEEK 22 si 37 WEEK 45 WEEK 46 WEEK 49 WEEK 51 WEEK 53 VENTPAL-ABDOMINAL-RIGHT WEEK 29 WEEK 32 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 2 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 Table 3 Summary of Clinical Observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULFONAMIDO ETHANOL IN RATS *DRAFT* ---------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: --------------FEMALE ------------- GROUP: 1 2 3 4 5 6 7 CATEGORY DOSE: 0 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 ---------------------------------------------------------------------------------------------------------------- MASS(ES) VENTRAL-ABDOMINAL-RIGWR WEEK 36 WEEK 38 WEEK 40 WEEK 49 WEEK 51 WEEK 53 VENTRAL-CERVICAL-LEFT WEEK 43 WEEK 46 WEEK 48 VENTRHL-CERVICAL-RIGHT WEEK 43 VENTRAL-THORACIC WEEK 42 WART LIKE DORSAL WEEK WEEK EAR-LEFT WEEK MOUTH WEEK WEEK LESIONIS) 47 51 47 21 23 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 1 0 1 1 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 a 0 a Table 3 summary of Clinical observations 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* --------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: --------------FEMALE ------------- GROUP: 1 2 3 4 5 6 7 CATEGORY DOSE:. 0 3 30 100 300 100 300 KEYWORD QUALIFIER NUMBER: 70 60 60 70 70 40 40 --------------------- ------------------------------------------------------------------------------------- WART LIKE LESION(S) MOUTH WEEK 31 W--t% 52 PAW-HIND-RIGHT WEEK 34 SHOULDER-LEFT WEEK 37 TAIL WEEK 19 WEEK 22 VENTRAL-THORACIC WEEK 46 END OF LIST 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 @o 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 Table 4 sumulary of clinical observations *DP-%"* 104-WMM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ----------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: --HALE-- -FEKALB- GROUP: a 9 a 9 CATEGORY DOSE- 0 1 0 1 KRMRD QUALIPIER NUMBER: 70 70 70 70 ----------------------------------------------------------------------------------------------------------------- *** TOP OP LIST APPEARANCE HUNCHED MALOCCLUSION MISSING PARALYSIS LIMB-FRONT-LEFT SMLLEN MOUTH THIN 0 1 0 0 10 4 13 a 0 1 0 a 0 1 0 0 0 0 1 0 0 1 2 1 BEHAVIOR AGGRESSIVE .CUNSPECIFIEDI> MODERATE ATAXIC <UNSPECIFIED> HYPOACTIVE <UNSPECIFIED> SENSITIVE TO TOUCH COLD TO TOUCH ENTIRE BODY 0 1 0 0 0 1 0 0 0 0 0 1 1 0 0 0 0 1 0 1 1 0 0 0 DISCHARGE GENITAL RED IN COLOR 0 2 0 1 Table 4 summary of clinical observations *DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULFONAMIDO ETHANOL IN RATS ---------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: --MALE-- -FEMALE- CROUP: 8 9 a 9 CATEGORY DOSE: 0 1 0 1 KEYWORD QUALIFIER NUMBER: 70 70 70 70 ---------------------------------------------------------------------------------------------------------------- DISCHARGE CLEAR ORAL MODERATE NASAL RED IN COLOR MUCOID FROM RECTUM E=RETION FEW FECES NO FECES NoNFoRKM FECES EYES DISPLACED PUPIL MM-RIGHT RED DISCHARGE EYE-LEFT EYE-RIGHT EYES SQUINTED PERI-ORBITAL RESPIRATION AUDIBLE LABORED 0 1 0 0 0 0 3 1 0 0 1 0 0 0 1 0 1 1 0 0 6 7 0 0 0 0 1 0 0 2 1 3 0 1 1 1 1 1 1 1 0 0 0 1 1 0 1 0 0 0 1 0 Table 4 Sunnary of Clinical observations *DRAFT* 104-WEEK DIETARY CARCINOGENICITY =MY WITH NARROW RANGE (98.1%) N ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ----------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 SEX: --MALE-- -FEMALE- GROUP: a 9 8 9 CATEGORY DOSE: 0 1 a 1 KEYWORD QUALIFIER NUMBER: 70 70 70 70 ----------------------------------------------------------------------------------------------------------------- SKIN & PELAGE ALOPECIA BLUE SKIN VENTRAL-ABDOMINAL-LRPT PALE ENTIRE BODY RED HAIR COAT DORSAL HEAD-ENTIRE RED SKIN TAIL SORE/SCAB DORSAL DORSAL-CWTVICAL HEAD-EMIRE HM-CRANM HFM-KAXILLARY-LMVT LATERAL-CERVICAL-LEFT LUMBAR-RIGHT MOUTH SCROTUM SHOULDER-RICHT VENTRAL-ABDOMINAL VENTRAL-ABDOMINAL-t.EFT VENTRAL-ABWMUIAL-RIGHT VENTRAL-CERVICAL 0 0 1 0 0 0 0 1 0 0 1 0 0 0 0 @l 2 0 1 0 1 0 0 0 0 0 0 1 1 1 0 0 0 0 1 0 0 0 0 1 0 0 1 0 0 0 0 1 1 0 0 0 0 1 0 a 1 0 0 0 0 0 1 0 2 1 0 0 2 1 0 0 1 1 0 0 0 0 1 0 Table 4 summary of clinical observations *DP-%FT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-VMYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ NUMBER OF ANIMALS AFFECTED DAYS 1-371 CATEGORY SEX: GROUP: DOSE: --MALE-- a 9 0 1 -FEMALE- a 9 0 1 KEYWORD QUALIFIER NUMBER: 70 70 70 70 ------------------------------------------------------------------------------------------------------------------ SKIN & PELAGE YELLOW HAIR COAT HASS(ES) AXILT.ARY REGION-LEFT WEEK 42 W13EK 45 WEEK 48 WEEK 51 AXILLARY REGION-RIGHT WEEK 28 WEEK 39 WEEK 40 WEEK 42 =GUIXAL REGION-L]IFT WEEK 48 INGUINAL REGION-RI(;HT WEEK 35 WE= 40 WEEK 42 LIMB-PRONT-RIGHT WEEK 35 0 1 2 0 0 0 0 1 0 0 1 0 0 0 0 1 0 0 0 2 0 0 0 1 0 0 0 1 0 0 1 0 0 0 1 1 0 0 0 1 0 0 0 I. 0 0 0 1 0 0 0 1 0 0 0 1 Table 4 Sumary of Clinical Observations *DRAYT* 104-WMM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULPONAMIDO ETHANOL IN RATS ---------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-311 SEX: --)UkLE-- -FEKALE- GROUP: a 9 8 9 CATEGORY DOSE: 0 1 0 1 KEYWORD QUALIFIER NUMBER: 70 70 70 70 ---------------------------------------------------------------------------------------------------------------- XASS(RS) PAW-HIM-RIGHT WEEK 42 SHOULI)ER-LE" WEEK 38 SHOUE.D]3R-RIGHT WEEK 19 VENTRAL-ABDOMIKKL WEEK 32 WEEK 35 WEEK 40 WEEK 44 WEEK 45 WEEK so VERTRAL-ABDOMINAL-LEFT WEEK 28 WEEK 34 WWEEEEKK 40 44 WEEK 46 WEEK 49 WEEK so WEEK 51 VENTRHL-ABDDMXNAL-RIGHT WEEK 28 WEEK 33 0 0 0 1 0 0 1 0 0 0 1 0 2 0 0 0 0 0 0 1 0 1 0 0 0 0 0 2 0 1 0 0 0 0 1 1 1 0 0 0 0 0 0 1 1 0 0 0 0 0 2 1 0 1 0 0 0 0 2 0 0 0 2 1 0 0 2 0 1 0 0 0 1 0 0 0 Table 4 summary of clinical Observations *DPh"* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE f98.l%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ---------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-371 CATEGORY SEX: GROUP: DOSE: --KALE-- 8 9 0 1 -FEMALE- a 9 0 1 KEYWORD QUALIFIER NUMBER: 70 70 70 70 --------------------------------------------------------------------------------------------------------------- KASS(ES) VENTRAL-ABDONNIAL-RIGHT WEEK 40 WEEK 44 WEEK 4S WEEK 48 WEEK 51 WEEK 53 VENTRAL-CERVICAL WEEK 36 WEEK 46 VENTRAL-CEWICAL-Lts WEEK 31 WEEK 38 WART LIKE LESION(S) DORSAL WEEK 41 NOSE WEEK 46 VENTRAL-ABDOMINAL WEEK 20 END OF LIST *** 0 0 0 1 0 0 0 1 0 0 0 1 0 1 0 0 0 0 1 0 0 0 2 0 0 0 1 0 0 0 2 0 0 0. 1 0 0 0 0 1 1 0 0 0 0 0 1 0 1 0 0 0 Table 5 Sunmeary of Body Weight Data fg) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* ----------------------------------------------------------------------------------------------------------------- SEX: ----------------------------------M-AL-E---------------------------------------- GROUP: 1 2 3 4 s 6 7 DOSE: 0 3 30 100 300 100 300 WE= UNITS: PPM PPM PPM PPM PPM PPM PPM ----------------------------------------------------------------------------------------------------------------- I N 70 MEAN 261 S.D. 20.4 2 N 70 mehm 308 S.D. 23.1 3 N 70 MEAN 3SO S.D. 25.7 4 NMEAN 70 387 S.D. 29.0 5 N 65 NEW 417 S.D. 31.S 6 N 6s MEAN 444 S.D. 33.6 7 N 65 Am 467 S.D. 37.0 60 260 19.9 60 307 22.S 60 3si 26.6 60 389 29.9 55 416 31.5 ss 444 33.9 55 467 37.1 60 260 20.S 60 302 24.S 60 344 29.9 60 379 34.8 55 404 38.2 55 431 40.5 55 450 42.6 70 2S8 19.2 70 298* 21.7 70 337* 2S.3 70 367* 28.3 65 393* 30.5 65 418* 33.6 GS 436* 35.5 69 257 19.0 70 288,k 23.0 70 318* 25.9 70 338* 28.8 64 3SS* 31.8 6s 370* 35.3 65 380* 37.6 40 2S4 17.8 40 296* 20.0 40 334* 24.2 40 364* 27.8 40 391* 32.5 40 416* 36.2 40 427* 42.8 40 256 19.2 40 286* 21.2 40 313* 24.0 40 334* 27.3 40 351* 30.3 40 366* 33.1 39 374* 33.9 Table 5 Summary of Body Weight Data (g) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO BTHANOL IN RATS *DRAFT* ----------------------------------------------------------------------------------------------------------------- SEX: -------------------------------------M-AL-E --------------------------------------- GROUP: 2 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEK UNITS: ppm PPM PPH PPM PPM PPN PPM ----------------------------------------------------------------------------------------------------------------- 8 N MEAN S.D. 9 N MEAN S.D. 10 N Him S.D. 11 N MEAN S.D. 12 N MEAN S.D. 13 N MEAN S.D. 14 N MEAN S.D. 65 483 39.5 60 504 43.4 60 521 4S.1 60 532 4S.4 60 543 46.8 60 553 47.7 60 563 SO.1 55 480 40.0 54 S07 40.2 54 524 41.1 54 S37 43.3 54 550 44.6 S4 559 48.3 54 567 48.0 55 464* 43.4 55 483* 45.9 55 497* 49.3 ss sio* 49.8 55 522 51.5 55 531 52.7 ss S38* 54.5 65 449* 39.4 65 46S* 40.9 6s 477* 41.8 fis 486* 43.7 6s 496* 46.9 6s 504* 51.2 64 513* 45.3 63 386* 42.4 0 0 0 0 0 0 39 448* 44.8 39 464* 51.0 39 473* 57.6 39 484* 62.4 39 496* 64.9 38 S15* 44.9 38 522* 45.5 39 384* 38.5 0 0 0 0 0 0 Table 5 Summary of Body Weight Data ig) 104-Wis DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PE"LUOROOCTAKESULFONAMIDD ETHANOL IN RATS *DRAFT* ------------------------------------------------------------------------------------------------------------------- SEX: ----------------------------------K-AL-E---------------------------------------- OROUP: 1 DOSE: 0 2 3 4 s 6 7 3 30 100 300 100 300 WMM UNITS: PPM ppm PPM ppm ppm ppm ppm ------------------------------------------------------------------------------------------------------------------- is NMEAN 55 49 50 59 0 38 0 569 574 540* 519* S28* S.D. 51.8 50.9 51.9 45.8 47.5 16 n 55 49 so 59 0 38 0 HEM 578 S85 547* 528* 536* S.D. 52.9 52.3 53.1 45.6 48.4 27 N 55 49 so 59 0 38 0 MEAN 590 595 557* 536* S46* S.D. 55.0 54.0 53.4 46.4 SO.2 21 NMEAN 55 49 50 59 0 38 0 619 625 582* 5SS* S67* s.D. 58.8 59.3 57.0 51.4 55.5 25 NMEAN 55 49 so 59 0 644 651 603* 572* S.D. 62.8 64.2 62.1 SI.3 38 0 582* 60.7 29 x ss 49 so 59 0 38 0 HEM S.D. 663 67.1 668 69.6 618* 66.S 590* 54.7 602* 64.8 33 N 55 49 so 59 0 38 0 MEAN 678 682 634* S99* 612* S.D. 71.S 72.0 70.2 57.5 64.5 Table 5 Summary of Body Weight Data ig) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PFMLUOROOCTANESULFONAMIDO ETHAML IN RATS *DRAFT* ------------------------------------------------------------------------------------------------------------------ SRX: -------------------------------------K-AL-E --------------------------------------- GROUP: 1 DOSE.- 0 2 3 4 5 6 7 3 30 100 300 100 300 WEEK UNITS: ppm PPM PPM ppm ppm ppm PPM ------------------------------------------------------------------------------------------------------------------ 37 N ss 48 50 59 0 38 0 MRAN 694 701 646* 610* 623* S.D. 77.1 75.1 74.0 S7.6 67.4 41 N 55 49 so 59 0 38 0 MEAN 700 714 653* 619* 632* S.D. 71.4 75.2 77.1 60.1 68.2 45 N 54 48 50 58 0 37 0 MRAN 723 740 678* 639* 650* S.D. 76.2 82.8 $2.6 64.9 76.4 49 N 54 48 so se 0 37 0 mam 741 758 698* 6S4* 666* S.D. 78.3 91.5 $7.5 68.7 $0.4 53 N 54 48 so 58 0 36 0 MEAN 762 777 716* 672* 688* S.D. 81.9 9S.0 92.5 68.4 86.3 Table 5 Summary of Body Weight Data (g) 104-WEEK DIETARY CARCIVOGENICITY STUDY WITH NARROW RANGE (99.1%) N-ETNYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DP-kn* ------------------------------------------------------------------------------------------------------------------ SEX: ------------------------------------F-EK-ALS -------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WE= UNITS: ppm ppm ppm PPM ppm PPM PPM ------------------------------------------------------------------------------------------------------------------ I N 70 HEM iss S.D. 13.2 2 N 70 MEAN is$ S.D. 16.9 3 N 70 MEAN 211 S.D. 20.8 4 N 70 xm 229 S.D. 22.3 s N 65 MEAN 244 S.D. 25.4 6 N 65 MEAN 258 S.D. 28.3 7 N 65 MEAN 267 S.D. 30.0 60 163 13.3 60 iss 14.7 60 205 18.5 60 224 20.2 55 236 21.2 55 246 22.7 ss 256 23.8 60 165 12.9 60 iss 14.4 60 205 26.5 60 222 18.3 55 233* 19.9 ss 245 21.2 55 2S3 22.7 70 164 12.1 70 isi* 13.S 70 200* 15.5 70 215* 17.1 65 22S* 18.6 65 235* 19.4 65 239* 19.6 70 164 12.6 70 172* 13.3 70 182* is.1 70 191* IS.2 6s 196* 16.4 65 202* 16.6 65 205* 16.5 39 164 12.5 40 lal 14.1 40 202 15.8 40 214* 15.9 40 223* 16.7 40 234* 17.3 40 240* 17.4 40 163 12.0 40 17S* 11.7 40 166* 12.2 40 196* 12.7 40 200* 13.3 40 206* 14.4 40 210* 13.2 Table 5 Summary of Body Weight Data lg) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DP-&JFT* ---------------------------------------------------------------------------------------------------------------- SEX: ------------------------------------F-EM-ALE -------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEK UNITS: ppm ppm PPM ppm ppm ppm PPM ---------------------------------------------------------------------------------------------------------------- 8 N 65 MEAN 274 S.D. 30.4 9 N 60 MEAN 283 S.D. 32.1 10 N 60 MEAN 290 S.D. 33.6 11 N MEAN S.D. 60 29S 35.1 12 N MRAN S.D. 60 302 36.6 13 N MEAN S.D. 60 306 36.3 14 N MEAN S.D. 60 308 36.3 55 261 24.9 55 271 25.6 55 277 27.3 55 281 28.7 55 284 28.6 55 289 27.S 55 292* 27.9 55 258* 23.6 ss 268* 24.1 ss 273* 25.1 55 27S* 26.3 ss 280* 26.7 ss 284* 26.6 55 286* 27.7 65 246* 20.7 65 250* 20.7 65 254* 20.3 65 256* 21.8 65 2,58* 21.4 65 260* 21.7 65 262* 22.3 65 212* 17.1 0 0 0 0 0 0 40 243* 19.4 to 2SO* 18.9 40 253* 21.5 40 255* 19.9 40 259* 20.8 40 261* 20.2 40 264* 20.8 40 213* 14.9 0 0 0 0 0 0 Table 5 Summary of Body Weight Data (g) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198-1%) N-BniYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* ---------------------------------------------------------------------------------------------------------------- SEX: ---------------------------------F-E-MA-L-E --------------------------------------- GROUP* 1 2 3 4 5 6 7 I)OSE: 0 3 30 100 300 100 300 WEEK UNITS: PPM ppm PPM PPM PPM PPM PPM ---------------------------------------------------------------------------------------------------------------- is N 55 so so 60 0 40 0 HEM S.D. 310 36.0 295* 29.0 288* 27.9 263* 23.3 266* 21.9 16 NMEAN 31565 30s0o* 29s3o* 26S69* 0 24609* 0 S.D. 36.8 31.0 28.2 23.0 21.7 17 N ss so so S9 0 40 0 MEAN 320 306 297* 270* 272* S.D. 37.9 30.2 29.3 23.2 22.2 21 N 55 50 so 59 0 40 0 MEAN 334 318 311* 277* 279* S.D. 41.9 33.7 32.8 24.8 23.3 2S N ss so so sa 0 40 0 MEAN 349 334 324* 286* 291* S.D. 47.6 38.7 37.2 26.4 24.S 29 NMEAN S.D. 55 361 51.9 so 346 42.7 so 336* 40.2 58 294* 28.2 0 40 0 299* 26.6 33 n MRAN S.D. 55 375 SS.1 so 359 48.3 so 349 44.1 so 301* 31.8 0 40 307* 30.0 Table 5 summary of Body Weight Data (g) 104-WEEK DIETARY CARCINOC;ENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDD ETHANOL IN RATS *DRAPPT* ----------------------------------------------------------------------------------------------------------------- SEX: ------------------------------------F-E-KALE -------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEK UNITS: ppm PPM PPM PPM PPM PPM PPM ----------------------------------------------------------------------------------------------------------------- 37 N 55 50 so 58 0 40 0 MEAN 384 366 3S5* 304* 313* S.D. 58.2 48.9 46.4 34.0 32.2 41 N 5s 50 so 59 0 40 0 MEAN 400 380 370 313* 323* S.D. 64.7 52.3 48.2 36.5 34.9 4S N 55 50 so 58 0 40 a MEAN 423 397 388 320* 332* S.D. 72.3 59.3 54.0 40.S 38.0 49 N 54 so 50 58 0 40 0 MEAN 439 412 396* 329* 339* S.D. 76.0 63.2 55.3 43.1 40.6 53 N S4 so 50 so 0 40 0 MEAN 454 42S 404* 338* 350* S.D. 82.1 67.9 62.5 48.7 44.3 Table 6 Surnnary of Body Weight Data (g) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98-1%) H-ETRYL PERFLUOROOCTAUSSULPONAMIDO ETHANOL IN RATS *DPJU"* ------------------------------------------------------------------------------------------------------------------ SU: ---------KALE --------- --------FMQLE -------- GROUP- a 9 8 9 DOSE: 0 1 0 1 WMM UNITS: ppm PPM PPM PPM ------------------------------------------------------------------------------------------------------------------ I N 70 MEAN 204 S.D. 18.8 2 N 70 MPAN 260 S.D. 21.9 3 N 70 MEAN 309 S.D. 2S.3 4 N 70 MRAN 3Sl S.D. 28.4 s N 6s HEM 381 S.D. 33.1 6 N 6s MEAN 409 S.D. 36.9 7 N GS MEAN 433 S.D. 40.2 70 202 19.4 70 260 22.1 70 309 25.4 70 3SO 28.4 65 383 33.4 65 413 36.4 65 438 40.4 70 152 10.8 70 179 13.9 70 202 16.1 70 224 19.6 6s 240 19.9 6s 253 22.3 6s 263 24.S 70 IS2 11.7 70 179 13.3 70 203 IS.3 70 223 17.6 65 236 17.8 6S 251 20.1 65 260 21.4 Table 6 Summary of Body Weight Data (g) 104-WMM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DRAFT* --------------------------------------------------------------------------------------------------------------- SEX: ---------MALE --------- --------PEKHLE -------- GROUP: a 9 8 9 DOSE: 0 1 0 1 WEEK UNITS: PPM PPM PPM PPM --------------------------------------------------------------------------------------------------------------- a N 65 HE" 451 S.D. 43.0 9 N 65 MEAN 468 S.D. 4S.9 10 N MRAN S.D. 6s 484 49.7 11 N 65 MEAN 496 S.D. 54.3 12 N MEAN S.D. 64 510 59.2 13 N MEAN S.D. 64 523 Se.0 14 NMEAN S.D. 64 S31 58.7 65 454 42.9 6s 472 45.3 6s 490 47.4 65 503 48.9 65 S17 51.2 65 529 53.4 65 537 54.4 64 272 25.2 64 282 27.6 64 287 28.4 64 287 29.0 64 296 30.2 64 301 30.7 64 306 31.4 64 267 23.3 6s 274 23.9 65 281 25.7 65 284 26.3 65 288 27.1 65 294 27.3 65 298 29.8 Table 6 Summary of Body Weight Data (g) *DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLTIOROOCTANESULFOXMIDO ETHANOL IN RATS ---------------------------------------------------------------------------------------------------------------- SEX: ---------MALE --------- --------FM4MZ -------- GROUP: 8 9 a 9 DOSE: 0 2 0 1 WEEK UNITS: PPM PPM PPM PPM ---------------------------------------------------------------------------------------------------------------- 15 N MEAN S.D. 16 N MEAN S.D. 17 N mm S.D. 21 N mm S.D. 25 N MEAN S.D. 29 N MEAN S.D. 33 N MEAN S.D. 59 541 60.2 59 553 60.8 59 562 61.8 59 591 68.4 S9 617 73.3 S9 631 76.8 59 6S2 $1.0 60 545 56.4 60 555 59.9 60 564 62.7 60 593 70.0 60 616 74.S 60 630 77.5 60 655 84.4 59 307 34.1 59 314 35.0 59 319 35.9 59 332 41.3 S9 345 46.7 59 354 49.3 se 371 53.9 60 302 30.8 60 307 32.3 60 309 33.9 60 325 39.3 60 340 46.4 60 348 Sl.5 60 366 60.0 Table 6 sumary of Body Weight Data lo) *DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ----------------------------------------------------------------------------------------------------------------- SEX: ---------MALE --------- --------FEMALE -------- CROUP: 8 9 8 9 DOSE: 0 1 0 1 WEEK UNITS: PPM PPM PPM ppm ----------------------------------------------------------------------------------------------------------------- 37 N MEAN S.D. 41 N HEAR S.D. 45 N MEM S.D. 49 N MEAN S.D. 53 N MEAN S.D. S9 681 85.7 59 697 90.0 59 719 94.9 59 732 98.6 58 7Sl 102.7 60 674 89.2 60 693 93.2 58 709 99.8 58 726 105.2 58 738 110.7 sa 389 60.1 58 402 63.8 58 416 68.8 57 431 74.4 56 445 78.1 60 380 60.3 60 392 64.5 60 407 68.9 60 423 72.3 58 436 74.2 Sumary Table 7 of Body Weight Change Data (g) 104-WMM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-VMYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* ----------------------------------------------------------------------------------------------------------------- SEX: ----------------------------------M-AL-E---------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEK UNITS: PPM PPM ppm ppm ppm PPM ppm ----------------------------------------------------------------------------------------------------------------- 1-2 n MEAN S.D. 2-3 N MEAN S.D. 3-4 N ME" S.D. 4-5 N mm S.D. 5-6 N HEM S.D. 6-7 N MEAN S.D. 7-8 N mm S.D. 70 47 S.5 70 42 S.1 70 37 S.9 6S 29 5.9 6s 27 4.6 65 23 5.4 65 16 5.1 60 47 5.0 60 43 6.1 60 38 5.8 55 28 7.5 ss 29 S.5 55 22 5.3 ss 13 7.4 60 43* 7.2 60 41 7.7 60 35 7.0 55 25* 5.7 ss 27 S.2 55 19* 4.6 55 13 4.4 70 40* 6.3 70 38* 5.7 70 31* 5.6 65 26* 5.6 65 24* 6.2 65 19* 4.2 65 13 9.9 69 31* 6.4 70 30* 5.8 70 206 5.4 64 16* 5.7 64 16* 5.9 65 io* 5.1 63 S* 14.1 40 42* 5.9 40 38* 6.6 40 30* 5.7 40 27 6.S 40 2S 6.1 40 ll* 26.5 39 20 6.0 40 30* 5.2 40 27* 5.8 40 21* 6.2 40 17* 6.3 40 is* 6.0 39 7* 11.3 39 io* 13.0 Table 7 summary of Body Weight Charige Data lg) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANCE (98.1%) N-ETHYL PERFLUOROOCTAKESULFONAMIDO RTHANOL IN RATS *Dltik"* ------------------------------------------------------------------------------------------------------------------ SMC: ----------------------------------M-AL-E---------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEK UNITS: PPM PPM PPM PPM PPK PPM ppm ------------------------------------------------------------------------------------------------------------------ 8-9 N 60 54 55 65 0 MEAN 20 2S* 19 16* S.D. 5.9 5.0 8.0 6.3 9-10 N 60 54 55 65 0 HEM 17 17 14 ll* S.D. 5.1 4.7 9.2 6.2 10-12 N 60 54 55 65 0 MEAN 11 13 13 9 s.D. 5.1 S.9 5.2 7.0 11-12 N 60 54 55 65 0 MEAN 11 13 12 12 s.D. 6.1 5.2 4.7 7.3 12-13 N 60 S4 55 65 0 MEAN 10 9 9 7 S.D. 9.4 12.1 4.1 7.S 13-14 N 60 54 ss 64 0 MEAN 10 8 8 6 S.D. 7.6 716 5.7 8.4 14-15 N 55 49 50 59 0 in" 7 a 6 5 S.D. 5.7 5.5 7.8 5.5 39 0 16 14.2 39 9* 13.0 39 0 10 7.1 39 0 12 4.9 38 0 12 5.8 39 0 7 3.9 38 0 6 4.0 Table 7 summary of Body Weight Change Data (g) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-RMYL PERFLUOPMOCTANESULFOXAMIDO E7%ANOL IN RATS *DRAFT* ------------------------------------------------------------------------------------------------------------------ SEX: ----------------------------------K-AL-E---------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 w UNITS: ppm PPM PPM PPM ppm PPM ppm ------------------------------------------------------------------------------------------------------------------ 15-16 N 55 49 so 59 0 MRM 10 11 7* 9 S.D. 4.1 5.3 4.5 4.1 16-17 NMEAN 5115 4109 s10o 589* a S.D. 5.9 7.1 5.5 5.3 17-21 N 55 49 so 59 0 MEAN 29 30 25 19* S.D. 8.6 8.2 8.6 11.8 21-25 N ss 49 so 59 0 MEAN 26 26 21* 17* S.D. 7.6 10.0 8.9 9.8 25-29 N ss 49 so S9 0 MRAN 19 17 is is S.D. 9.1 13.3 10.4 8.2 29-33 N 55 49 so 59 0 MEAN 16 14 16 9 S.D. 10.1 30.0 12.1 11.4 33-37 N 55 48 so 59 0 In" is is 12 io* S.D. 13.8 10.1 7.5 9.6 38 0 a 5.1 39 0 10 5.6 38 0 21* 10.8 38 a 16* 11.0 38 0 20 8.7 38 0 10 9.9 38 0 11 8.6 Table 7 Summary of Body Weight Change Data lg) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYEP PERFLUOROOCTANESULFONAMIDD B7WANDL IN RATS *DRAFT* ----------------------------------------------------------------------------------------------------------------- SEX: ----------------------------------M-AL-E---------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 W-E-R-X ---UN-I-T-S.-------p-p-m --------P-P-M---------p-pm---------p-pm----------PP-M---------p-pm---------P-PM----------------------------------- 37-41 N ss 48 so S9 0 HEL]KN 6 12 7 9 S.D. 20.8 IS.7 8.2 9.3 38 0 9 25.6 41-4S N 54 48 so sa 0 M13AN 2S 27 24 19* s.D. 10.5 12.3 9.S 10.7 37 0 28* 13.5 45-49 N S4 48 so se 0 MRAN 19 is 20 15 S.D. 10.7 21.1 10.S 9.3 37 0 is 20.7 49-S3 N S4 48 so so 0 mpm 20 19 is is S.D. 8.1 18.3 9.1 11.3 36 0 23 13.0 1-S3 N S4 48 so so 0 36 0 MEM Soo S16 458* 414* 432* S.D. 73.2 $4.8 82.1 59.2 $0.6 Table 7 Su=Rary of Body Weight change Data fg) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRA"* ------------------------------------------------------------------------------------------------------------------ SEX: ------------------------------------F-E-KALE -------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEX UNITS: ppm PPM PPM ppm ppm ppm PPM ------------------------------------------------------------------------------------------------------------------ 1-2 N MEAN S.D. 2-3 N MEAN S.D. 3-4 N MEAN S.D. 4-5 N MEAN S.D. 5-6 NMEAN S.D. 6-7 N MEAN S.D. 7-8 N MEAN S.D. 70 23 6.8 70 22 7.7 70 is 6.1 65 14 6.6 6s 14 6.2 65 10 6.5 6S 7 5.4 60 22 5.2 60 20 7.3 60 19 5.8 ss 12 6.2 ss io* 5.8 55 11 5.4 ss 4 6.1 60 20 5.7 60 20 6.4 60 17 6.9 55 12 6.0 55 12 5.4 55 a 5.5 55 5 5.6 70 17* 5.4 70 19* 5.5 70 is* 4.9 65 io* 4.3 65 9* 4.1 65 4* 5.4 65 7 4.7 70 9* 6.3 70 io* 4.6 70 9* 3.9 65 5* 4.8 6s 7* 5.0 6s 2* 3.9 65 8 4.6 39 17* 4.7 40 20 4.3 40 13* 4.7 40 9* 4.2 40 io* 3.8 40 6* 4.2 40 3* 5.7 40 12* 4.9 40 21* 4.8 40 9* 3.4 40 4* 4.3 40 6* 3.5 40 4* 4.5 40 3* 3.8 swmary Table 7 of Body Weight change Data (g) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO =HANOL IN RATS *DPAIPT* ------------------------------------------------------------------------------------------------------------------ SEX: ------------------------------------F-EN-AL]3 -------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEK UNITS: ppm PPM ppm PPK ppm PPM ppm ------------------------------------------------------------------------------------------------------------------ 8-9 N 60 55 55 65 0 MEAN 9 10 9 4* S.D. 5.8 5.0 6.0 4.2 9-10 N 60 55 55 65 0 MEAN a 5 5* 4* S.D. 5.6 5.9 4.9 5.0 10-11 N 60 55 55 65 0 ME" 5 s 2 2 S.D. 6.4 6.5 S.9 4.9 11-12 N 60 55 55 65 0 MEAN 7 3 5 2* S.D. 6.7 5.0 6.4 3.8 12-13 N 60 ss 55 65 0 MEAN 4 5 4 2* S.D. 6.2 4.8 5.1 4.6 13-14 N 60 55 55 65 0 MEAN 2 3 2 3 S.D. 5.8 5.2 4.8 4.3 14-IS N 55 50 50 60 0 MEAN 3 3 2 1 S.D. 5.0 6.0 4.6 4.2 40 0 7 5.2 40 0 4* 5.3 40 0 2 4.5 40 0 3 4.9 40 0 2 4.0 40 0 3 3.9 40 0 2 3.8 Table 7 SUMary of Body weight change Data (g) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE C98.141 N-VMYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* ----------------------------------------------------------------------------------------------------------------- SEX: ---------------------------------r-p-x-n-z--------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 200 300 WEEK UNITS: ppm PPM ppm PPM PPM PPM ppm ----------------------------------------------------------------------------------------------------------------- 15-16 N 55 so so 59 0 mm 6 5 5 3* S.D. 5.1 5.4 5.1 4.1 16-17 N 55 so so 59 0 MEAN s 6 5 4 S.D. 5.4 6.0 4.9 4.S 17-21 N ss so 50 S9 0 HEM 13 12 14 -1* S.D. 7.9 8.1 8.8 4.8 21-25 N 55 so so 58 0 MEAN 14 16 13 9* S.D. 10.9 10.3 9.0 6.0 25-29 N 5S so so sa 0 MEAN 13 12 12 8* S.D. 10.9 8.8 7.7 6.3 29-33 NMEAN 55 so so se 0 13 13 13 7* S.D. 10.1 11.9 8.7 7.8 33-37 N ss so 50 58 0 MRAN 10 7 6 3* S.D. 12.4 9.9 9.7 9.4 40 0 3* 3.6 40 0 4 4.3 40 0 7* S.4 40 0 12 5.7 40 0 8* 6.2 40 0 8* 6.2 40 0 6 4.6 Table 7 Summary of Body Weiaht Change Data fg) 104-WEM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DPA@* ------------------------------------------------------------------------------------------------------------------ SEX: ------------------------------------F-EM-ALE -------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: a 3 30 100 300 100 300 WEEK UNITS: PPM PPM PPM ppm PPM PPM PPM ------------------------------------------------------------------------------------------------------------------ 37-41 N ss 50 so se 0 MEAN 16 14 14 9* S.D. 12.9 10.4 8.6 9.8 40 0 io* 5.4 41-45 N ss so so se 0 MEAN 23 17* is 7* S.D. 12.3 12.4 10.9 8.3 40 0 io* 6.0 4S-49 N 54 so 50 ss 0 MEAN 17 is 9* 8* S.D. 9.2 10.2 16.0 8.3 40 0 7* 7.3 49-53 N 54 so 50 58 0 MEAN 15 13 7 9 S.D. 11.3 10.2 27.5 8.7 40 0 11 8.0 1-53 N 54 50 50 58 0 39 0 MEAN 289 260 240* 172* 186* S.D. 77.3 62.4 59.2 47.0 42.4 Table 8 Summary of Body Weight Change Data (Ul 104-WEEK DIETARY CARci[NoGENIcITy sTuDy WITH NARROW RANGE (.98.1%) N-ETHYL PERFLUOROOCTAKESULFONAMIDO ETHANOL IN RATS *DRAFT* ------------------------------------------------------------------------------------------------------------------ SEX: ---------MALE --------- --------FEMMA -------- GROUP: a 9 9 9 DOSE: 0 1 0 1 WEEK UNITS: PPM PPM PPM PPM ------------------------------------------------------------------------------------------------------------------ 1-2 N MEAN S.D. 2-3 N mRhN S.D. 3-4 N MRAN S.D. 4-5 N MEAN S.D. 5-6 N MEAN S.D. 6-7 N mm S.D. 7-8 N MEAN S.D. 70 56 6.2 70 49 7.2 70 42 6.2 65 30 6.3 65 28 5.9 65 24 5.7 65 17 5.3 70 se S.8 70 49 7.3 70 41 7.2 65 33 7.8 65 30 6.0 65 25 6.3 65 16 6.2 70 27 6.7 70 22 7.7 70 22 7.9 65 is 6.9 65 14 6.8 65 10 7.1 64 10 6.5 70 27 6.1 70 24 8.0 70 20 7.5 65 is 7.0 GS 15 6.2 65 9 S.9 64 7 7.2 Table 8 summary of Body Weight Change Data to) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* ----------------------------------------------------------------------------------------------------------------- SEX: --------K-ALE --------- -------F-OIALE -------- GROUP: 8 9 8 9 DOSE: 0 1 0 1 WEEK UNITS: PPM ppm ppm PPM ----------------------------------------------------------------------------------------------------------------- 8-9 N MRAN S.D. 65 is 5.5 6s is 4.4 63 9 5.6 64 7 5.2 9-10 10-11 11-12 N MEAN S.D. N MEM S.D. N MEAN S.D. 6s 16 10.7 65 12 10.7 64 13 7.3 65 11) S.2 6s 13 5.0 65 14 5.4 64 s 6.0 64 0 7.0 64 9 6.1 65 7 6.0 65 3* 6.5 65 4* 6.2 12-13 N MEM S.D. 64 12 7.2 6S 12 S.7 64 6 6.6 6s 6 6.1 13-14 N MEAN S.D. 64 9 7.7 65 8 4.5 64 s 6.0 65 s 6.5 14-lS N MEAN S.D. S9 10 8.1 60 10 S.2 59 0 6.5 60 2 6.7 Table 8 Sumary of Body Weight Change Data (g) *DRAYT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (99.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ----------------------------------------------------------------------------------------------------------------- .SIM: --------M-ALE --------- -------F-EMALE -------- GROUP: 8 9 a 9 DOSE: 0 1 0 1 WE= UNITS: PPM PPM ppm PPM ----------------------------------------------------------------------------------------------------------------- 15-16 N MEAN S.D. 16-17 N mm S.D. 17-21 N MEAN S.D. 21-25 N MEAN S.D. 25-29 N )MM S.D. 29-33 NMEAN S.D. 59 22 5.8 59 9 5.2 59 29 9.6 59 26 8.7 59 14 9.4 59 21 11.3 60 11 6.2 60 8 S.S 60 29 11.0 60 23 8.7 60 14 8.6 60 2S 10.6 59 7 5.7 59 4 7.4 59 13 12.0 59 13 10.5 59 9 14.9 58 is 10.5 60 5* 5.9 60 2 6.2 60 16 11.2 60 15 12.5 60 8 10.1 60 is 27.9 33-37 N MEAN S.D. 59 29 12.4 60 19* 10.2 58 18 10.1 60 14 27.0 Table 8 Summary of Body Weight Change Data tg) *DRAFT* 104-WMEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198-1t) N-ETHYL PMPLUOROOCTANESULFONAMIDO ETHML IN RATS ---------------------------------------------------------------------------------------------------------------- SEX: ---------KALE --------- --------PENALE -------- CROUP: a 9 8 9 DOSE: 0 1 0 1 WEEK UNITS: PPM PPM PPM ppm ---------------------------------------------------------------------------------------------------------- 37-41 41-45 4S-49 49-53 1-53 N MEAN s.D. N MEAN S.D. N MEAN S.D. N )UIAN S.D. N MEAN S.D. 59 16 9.9 59 23 12.5 S9 13 10.9 se 17 20.5 sa 548 93.5 60 19* 9.2 58 is* 20.3 se 17* 10.4 so 12* 11.1 58 536 102.5 so 13 8.5 58 13 11.0 5'1 14 11.6 56 12 15.7 56 292 72.1 60 12 10.9 60 15 10.2 60 16 15.9 58 13 9.1 se 284 70.0 Table 9 Summary of Food Consumption Data (g) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* ------------------------------------------------------------------------------------------------------------------ SEX: -------------------------------------MA-L-E --------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WE= UNITS: PPM PPM PPM ppm PPM PPM ppm ------------------------------------------------------------------------------------------------------------------ 1 N 68 HEM 175 S.D. 15.2 2 N 69 MEAN iso S.D. 13.3 3 N 6s HEAN 186 S.D. 13.5 4 N 65 MEAN 191 S.D. IS.2 s N 64 HEAN 190 S.D. 15.6 6 N 62 KEAN 191 S.D. 16.9 7 N se MEAN 192 S.D. 17.6 59 171 15.2 59 177 IS.2 58 181 16.2 S4 185 15.7 52 188 15.5 54 188 15.4 53 190 17.0 58 172 16.6 57 174 11.5 58 176* 17.6 50 177* 14.2 54 180* 16.8 52 179* 15.9 si 180* 14.4 69 170 14.9 68 168* 14.8 67 169* 14.0 63 170* 13.9 65 172* 14.3 64 170* 13.2 64 168* 18.9 68 162* 15.9 68 IS4* 14.3 67 iso* 14.4 63 147* 14.6 60 147* 16.2 62 146* 15.8 59 145* 15.9 39 170 11.3 39 170* 14.9 40 171* 14.1 40 173* 16.6 39 173* 16.0 40 170* 21.1 39 170* 19.5 38 160* 13.3 39 isi* 13.2 38 147* 13.0 40 146* 17.5 39 14S* 13.9 39 146* 15.9 38 140* 24.0 Table 9 summary of Food Consumption Data (g) 104-WF-EK DIETARY CARCINOGENICITY STUDY WITH NARROW RANCE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* -------------------------------------------------------------------------------------------------------------- SEX: -------------------------------------MA-L-E --------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEK UNITS: ppm PPM PPM PPM PPM PPM ppm -------------------------------------------------------------------------------------------------------------- 8 N 55 52 53 65 0 38 0 MEAN 191 189 179* 170* 171* S.D. 18.4 15.2 15.1 14.6 25.4 9 N 56 52 52 64 0 39 0 MEAN 187 188 178* 166* 167* S.D. 16.5 16.4 17.7 13.S 27.8 10 N 60 54 55 65 0 39 0 MEAN 186 ise 178 164* 166* S.D. 15.4 18.2 16.8 16.9 26.1 11 N 58 54 52 64 0 39 0 MEAN 184 187 177 164* 169* S.D. 16.8 16.3 15.5 17.9 25.2 12 N 56 53 55 64 0 38 0 HEM 181 183 174 162* 171* S.D. 17.2 is.o 16.2 19.9 15.2 13 N so 52 54 63 0 37 0 MEAN 188 186 178* 165* 174* S.D. 20.7 15.6 16.0 18.4 14.3 14 N 52 48 48 59 0 38 0 MEAN iss 184 169* 168* 173* S.D. 17.9 17.6 21.5 1S.7 14.6 Table 9 Summary of Food Consumption Data (g) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PB?.FLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* --------------------------------------------------------------------------------------------------------------- SEX: -------------------------------------MA-L-E --------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEK UNITS: PPM PPM PPM PPM ppm PPM ppm --------------------------------------------------------------------------------------------------------------- 15 N 54 49 46 57 0 38 .0 MEAN 191 189 176* 170* 17S* S.D. 19.1 17.9 16.9 11.5 15.5 16 N 51 49 49 59 0 38 0 MEAN is? 188 178* 171* 176* S.D. 13.1 18.4 17.4 13.1 1S.3 20 N S4 49 48 S7 0 38 0 MEAN 192 194 184 177* lei* S.D. 16.7 17.8 15.9 19.2 17.0 24 N 55 49 so 58 0 38 0 MEAN 190 189 183 177* 180* S.D. 18.2 17.3 16.5 14.2 17.7 28 N 54 49 49 59 0 37 0 MEAN 189 176* 176* 176* 178* S.D. 17.5 24.2 18.1 14.7 16.2 32 x ss 48 50 57 0 35 0 MEAN 193 190 187 181* 181* S.D. 17.5 28.1 is.8 14.7 18.1 36 N 55 47 49 59 0 38 0 MEAN 195 197 188 185* 187 S.D. 20.7 19.0 16.5 17.0 18.6 Table 9 6'umary of Food Consumption Data (g) 104-WEEr, DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONMIDO B7%MOL IN RATS *DRAFT* --------------------------------------------------------------------------------------------------------------- SEX: ----------------------------------K-AL-E---------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEK UNITS: ppm PPM PPM PPM PPM ppm PPM --------------------------------------------------------------------------------------------------------------- 40 N 54 MEAN 204 S.D. 26.9 44 N 54 MEAN 195 S.D. 20.1 46 209 16.4 48 196 17.3 so 203 19.7 so iss 18.1 59 195 17.8 S7 183* 18.3 0 37 .0 192* 30.6 0 37 0 184* 18.9 48 N 54 48 so 58 0 37 0 MEAN 194 196 186 182* 185 S.D. 17.6 18.9 18.0 16.5 18.0 52 N 54 48 49 58 0 36 0 MEAN 192 194 186 iso* 183 S.D. 17.4 24.0 17.4 17.0 18.4 Table 9 Summary of Food Consumption Data (g) 104-WEEK DIETARY CARCINOGENICITY STUDY WITN NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DRAFT* --------------------------------------------------------------------------------------------------------------- SEX: ------------------------------------F-EM-ALE -------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEK UNITS: PPM PPM PPM PPM PPM PPH PPM --------------------------------------------------------------------------------------------------------------- 1 N 63 MEAN 130 S.D. 23.8 2 N 61 MEAN 132 S.D. 20.7 3 N 57 MEAN 136 S.D. 15.5 4 N ss MEAN 141 S.D. 15.8 5 N 55 MEAN 142 S.D. 18.7 6 N 55 MEAN 138 S.D. is.8 7 N 53 MEAN 140 S.D. 17.6 56 124 15.2 55 130 15.9 53 135 22.4 42 138 23.0 46 134 15.5 42 139 18.7 44 133 14.9 54 125 16.0 50 127 16.6 49 129 16.7 46 134 15.2 50 136 20.3 4S 13S 19.6 50 130* 16.9 59 122* 13.2 60 125 16.9 57 124* 14.9 S7 127* 15.0 56 122* 12.0 59 121* 11.5 61 117* 10.8 57 112* 14.9 63 ios* 15.9 62 99* 14.3 ss 96* 12.5 59 97* 16.0 sa 96* 12.6 60 95* 11.2 36 121* 16.0 39 122* 17.8 40 122* 14.8 35 121* 13.2 40 122* 13.8 39 117* 13.4 40 116* 16.2 33 iis* 14.3 35 ill* 16.5 36 ioi* 12.3 36 ioo* 13.1 35 98* 10.3 36 98* 14.6 38 98* 16.0 Table 9 Summary of Food Consumption Data (g) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDD ETHANOL IN RATS *DRAFT* -------------------------------------------------------------------------------------------------------------- SEX: ------------------------------------F-EM-ALE -------------------------------------- CROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEK UNITS: ppm ppm PPM PPM PPM PPM PPM -------------------------------------------------------------------------------------------------------------- 8 N 52 45 44 57 0 33 .0 MEAN 135 140 136 119* 120* S.D. 16.3 23.7 25.0 12.0 16.0 9 N 54 47 48 60 0 39 0 MEAN 131 128 127 Ila* 114* S.D. 14.4 19.2 17.3 23.4 13.7 10 N 51 44 47 60 0 37 0 MEAN 135 130 127 115* 114* S.D. 21.5 19.6 18.4 15.6 10.4 11 N 52 44 49 62 0 37 0 MEAN 131 128 131 115* 116* S.D. 18.9 22.2 25.6 20.1 13.6 12 N 54 43 51 62 0 38 0 MEAN 127 121 128 113* 114* S.D. 13.6 13.7 16.5 14.4 16.9 13 N 56 47 54 64 0 39 0 MEAN 124 125 125 113* ill* S.D. 15.9 21.8 20.3 20.9 14.0 14 N 52 4S 45 57 0 38 0 MEAN 127 126 124 113* 112* S.D. 17.8 22.9 15.6 19.5 11.7 Table 9 Summary of Food Consumption Data (g) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N- M YL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS *DRAFT* ------------------------------------------------------------------------------------------------------------------ SMC: ------------------------------------F-EM-ALE -------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEK UNITS: PPM ppm PPM PPM PPM PPM PPM ------------------------------------------------------------------------------------------------------------------ is N MEAN S.D. 48 127 13.4 38 125 21.6 42 128 16.1 ss 114* 10.8 0 39 .0 114* 12.0 16 N 49 42 44 56 0 38 0 MEAN 127 127 127 113* 114* S.D. 13.6 16.1 19.4 10.5 13.4 20 N 48 41 47 53 0 38 0 MEAN 134 132 134 120* 121* S.D. 15.4 19.6 21.0 12.0 13.1 24 N 53 47 47 54 0 38 0 HEM 134 140 135 123* 122* S.D. 17.1 24.0 20.1 18.1 12.4 28 N 51 46 45 55 0 39 0 MEAN 137 136 133 122* 125* S.D. 19.3 19.0 14.6 15.1 13.5 32 N 54 48 48 55 0 36 0 MEAN 140 143 141 130* 129* S.D. 20.7 20.6 21.4 18.0 12.0 36 N 54 47 49 S4 0 37 0 MEAN 146 149 142 135* 134* s.D. 23.1 25.0 19.S 27.0 12.8 Table 9 Summary of Food Consumption Data (g) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* ------------------------------------------------------------------------------------------------------------------- SEX: ------------------------------------F-E-MALE -------------------------------------- GROUP: 1 2 3 4 5 6 7 DOSE: 0 3 30 100 300 100 300 WEEK UNITS: ppm ppm PPM PPM ppm ppm PPM ------------------------------------------------------------------------------------------------------------------- 40 N 51 48 49 56 0 38 .0 MEAN 158 162 158 148 149 S.D. 21.8 21.1 22.4 24.9 1S.2 44 N 54 48 so 56 0 40 0 MEAN 154 149 iso 133* 137* S.D. 24.0 20.3 19.6 20.4 20.3 48 N 53 49 so 56 0 39 0 MEAN 147 145 142 137* 135* S.D. 22.6 19.3 19.9 26.5 14.8 52 N 54 46 48 55 0 39 0 MEAN 148 144 137* 133* 130* S.D. 24.8 15.7 25.2 20.8 15.6 Table 10 Summary of Food Consumption Data (g) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* -------------------------------------------------------------------------------------------------------------------- SEX: --------M-ALE --------- -------F-EMALE -------- GROUP: a 9 8 9 DOSE: 0 1 0 1 WEEK UNITS: PPM PPM ppm PPM -------------------------------------------------------------------------------------------------------------------- 1 N 70 MEAN 167 S.D. 12.9 69 166 13.9 46 128 13.5 57 126 12.6 2 N 69 MEM 174 S.D. 15.6 3 N 69 MEAN 180 S.D. 15.6 4 N 63 mam 182 S.D. 16.2 5 N 63 MEAN 185 S.D. 17.7 6 N 62 MEAN 186 S.D. 19.2 7 N 65 MEAN 189 S.D. 19.1 69 175 17.4 67 180 21.6 64 183 17.7 60 186 19.2 62 187 19.5 64 189 20.1 51 129 13.9 63 137 19.3 50 138 13.6 55 136 14.5 55 141 18.8 61 141 17.8 55 129 13.5 66 138 20.1 58 138 18.6 53 137 12.3 52 139 13.4 57 137 15.2 Table 10 Summary of Food Consumption Data (g) 104-WEEK DILrrARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PMTFLUOROOCTANESULFONAMIDO RTHANOL IN RATS *DRAFT* -------------------------------------------------------------------------------------------------------------------- SEX: ---------KALE --------- --------FEMALE -------- CROUP* a 9 a 9 DOSE: 0 1 0 1 WEEK UNITS: PPM ppm PPM PPM -------------------------------------------------------------------------------------------------------------------- 8 N MEAN S.D. 9 N MEAN S.D. 10 N MEAN S.D. 11 N MEAN S.D. 12 N MEAN S.D. 13 N MEAN S.D. 14 N MEAN S.D. 63 188 19.6 63 iss 18.9 63 186 28.8 62 187 19.9 63 192 19.4 64 194 19.7 47 196 19.0 61 lag 20.8 64 191 21.0 63 190 17.6 61 187 16.9 64 194 17.6 64 195 18.4 50 189 16.2 54 139 17.4 57 137 18.4 51 138 15.1 52 132 14.9 53 131 16.7 60 136 17.6 42 131 13.7 49 137 17.0 58 135 16.0 51 136 20.1 51 127 13.7 55 134 13.9 61 140 19.4 38 138 20.2 Table 10 Summary of Food ConsurWtion Data (g) *DRAFT* 104-WEEK DIETARY CARCINOCENICITY STUDY WITH NAItRow RANGE (98.1%) N-B"MYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ SEX: ---------KHLE --------- --------FEMALE -------- GROUP: a 9 a 9 DOSE: 0 1 0 1 WEEK UNITS: PPM PPM PPM PPM ------------------------------------------------------------------------------------------------------------------ 15 N MEAN S.D. S9 190 19.5 16 N 55 MEAN 192 .S.D. 20.3 20 N sa MEAN 187 S.D. 19.9 24 N 58 MEAN 191 S.D. 21.3 28 N 55 MEAN 194 S.D. 20.0 32 N MEAN S.D. 59 192 21.3 36 N MEAN S.D. 58 190 18.5 58 193 18.4 60 193 20.6 57 187 19.6 60 190 17.9 56 194 19.0 60 197 20.7 56 192 19.4 56 132 14.8 47 131 18.2 56 136 19.3 57 144 28.2 53 150 21.4 S7 149 21.9 57 144 19.1 S4 138 22.9 48 134 14.7 52 141 24.4 55 141 20.S 57 isi 23.3 S9 151 23.2 54 148 15.9 Table 10 Summary of Food Consumption Data fg) *DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHA140L IN RATS -------------------------------------------------------------------------------------------------------------------- SF.X:---------KALE --------- --------FEMALE -------- GROUP., 8 9 8 9 DOSE: 0 1 0 1 WEEK UNITS: PPM PPM PPM PPM ------------------------------------------------------------------------------------------------------------------- 40 N 59 MEAN 189 S.D. 19.9 60 189 19.6 57 143 17.7 S7 144 20.1 44 N sa HEM iss S.D. 21.8 se 186 21.4 58 143 17.3 58 145 18.6 48 N 59 me" 182 S.D. 21.8 58 187 21.4 56 144 19.9 59 146 27.0 52 N ME" S.D. sa 189 21.7 57 183 20.7 55 146 27.1 51 148 27.4 Table 11 Summary of Test Material Consumption Data (mg/kg/day) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULFONAXMIDO ETHANOL IN RATS *DRAFT* ------------------------------------------------------------------------------------------------------------------ SEX: -------------------------------N-IA-LE --------------------------------- GROUP: 2 3 4 s 6 7 DOSE: 3 30 100 300 100 300 WEEK UNITS: PPM PPM PPM PPM PPM PPM ------------------------------------------------------------------------------------------------------------------ 1 N MEAN S.D. 2 N MEAN S.D. 3 N MEAN S.D. 4 N MEAN S.D. 5 N MEAN S.D. 6 N MEAN S.D. 7 N MEAN S.D. 59 0.259 0.016 59 0.231 0.012 58 0.210 0.011 54 0.197 0.011 52 0.187 0.009 54 0.177 0.008 53 0.172 0.011 58 2.618 0.170 57 2.323 0.166 sa 2.088 0.123 so 1.9S3 0.108 54 1.852 o.iis 52 1.737 0.102 51 1.694 0.091 69 8.724 0.561 68 7.544 0.467 67 6.864 0.306 63 6.393 0.280 6s 6.067 0.300 64 5.698 0.236 64 5.418 0.409 68 25.408 1.919 68 21.735 1.585 67 19.S33 1.195 62 18.112 0.938 S9 17.253 0.987 62 16.576 0.999 59 16.OS8 0.918 39 8.873 0.572 39 7.707 0.503 40 6.988 0.339 40 6.533 0.338 39 6.135 0.341 40 5.764 0.435 39 5.536 0.320 38 2S.193 1.230 39 21.759 1.462 38 19.SS9 0.920 40 18.294 1.663 39 17.415 0.733 39 16.815 1.021 38 15.803 2.209 Table 11 Summary of Test Material Consumption Data (mg/kg/day) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULFONAHIDO ETHANOL IN RATS *DRAFT* ------------------------------------------------------------------------------------------------------------------ SEX: -------------------------------K-A-LE --------------------------------- GROUP: 2 3 4 5 .6 7 DOSE: 3 30 100 300 100 300 WEEK UNITS: PPM PPM PPM PPM ppm PPM ------------------------------------------------------------------------------------------------------------------ 8 N 52 53 65 0 MEAN 0.164 1.629 5.329 S.D. 0.008 0.099 0.2Sl 9 N 52 52 64 0 MEAN 0.156 1.564 5.031 S.D. 0.010 0.104 0.280 10 N 54 ss 65 0 MEAN 0.152 1.517 4.871 S.D. 0.011 0.105 0.355 11 N 54 52 64 0 MEAN 0.147 1.472 4.772 S.D. 0.009 0.086 0.324 12 N 53 55 64 0 MEAN 0.141 1.421 4.616 S.D. 0.009 0.101 0.364 13 N 52 54 63 0 MEAN 0.143 1.426 4.616 S.D. 0.010 0.097 0.346 14 N 48 48 59 0 MEAN 0.139 1.357 4.655 S.D. 0.010 0.153 0.348 38 0 5.325 0.496 39 0 5.043 o.s92 39 0 4.940 0.477 39 0 4.926 0.349 38 0 4.800 0.279 37 0 4.808 0.263 38 0 4.709 0.241 Table 11 Summary of Test Material Consumption Data (mg/kg/day) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* ------------------------------------------------------------------------------------------------------------------- SEX: -------------------------------M-A-LE --------------------------------- GROUP: 2 3 4 5 6 7 DOSE: 3 30 100 300 100 300 WEEK UNITS: PPM PPM PPM PPM PPM PPM ------------------------------------------------------------------------------------------------------------------- 15 N 49 46 57 0 MEAN 0.140 1.397 4.641 S.D. 0.009 0.115 0.222 16 N 49 49 59 0 MEAN 0.137 1.384 4.608 S.D. 0.009 0.105 0.248 20 N 49 48 57 0 MEAN 0.134 1.367 4.545 S.D. 0.008 0.087 0.340 24 N 49 50 58 0 MEAN 0.126 1.309 4.447 S.D. 0.008 0.090 0.291 28 N 49 49 59 0 MEAN 0.114 1.231 4.300 S.D. 0.018 0.116 0,275 32 N 48 so 57 0 MEAN 0.120 1.276 4.298 S.D. 0.016 0.093 0.303 36 N 47 49 59 0 MEAN 0.120 1.261 4.355 S.D. 0.008 0.102 0.428 38 0 4.694 0.241 38 0 4.661 0.227 38 0 4.586 0.264 38 0 4.438 0.245 37 0 4.249 0.246 35 0 4.246 0.250 38 0 4.305 0.255 Table 11 Summary of Test Material Consumption Data (mg/kg/day) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *DRAFT* -------------------------------------------------------------------------------------------------------------------- SEX: -------------------------------M-A-LE --------------------------------- GROUP: 2 3 4 5 6 7 DOSE: 3 30 100 300 100 300 WEEK UNITS: PPM PPM PPM PPM PPM PPM -------------------------------------------------------------------------------------------------------------------- 40 N 46 so S9 0 MEAN 0.126 1.340 4.532 S.D. 0.009 0.110 0.407 44 N 48 so 57 0 MEAN 0.115 1.203 4.103 S.D. 0.007 0.094 0.346 48 N 48 so 58 0 MEAN 0.111 1.155 3.994 S.D. 0.010 0.09S 0.321 52 N 48 49 58 0 KEAN 0.108 1.126 3.847 S.D. 0.012 0.084 0.332 37 0 4.3S8 0.631 37 0 4.069 0.229 37 0 3.996 0.268 36 0 3.941 0.222 Table 11 Summary of Test Material Consumption Data (mg/kg/day) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO MMANOL IN RATS *DRAPT* ----------------------------------------------------------------------------------------------------------------- SEX: ----------------------------F-EM-A-LE- -------------------------------- GROUP: 2 3 4 s 6 7 DOSE: 3 30 100 300 100 300 WEEK UNITS: PPM PPM PPM PPM PPM PPM ----------------------------------------------------------------------------------------------------------------- 1 N MEAN 56 0.307 54 3.070 59 10.166 57 28.712 36 10.135 33 29.270 S.D. 0.037 0.386 1.080 3.562 1.157 3.365 2 N MEAN S.D. ss 0.286 0.033 so 2.791 0.319 60 9.372 1.179 63 25.6S3 4.087 39 9.093 1.058 3S 26.381 4.036 3 N MEAN 53 0.271 49 2.S95 57 8.509 62 22.650 40 8.376 36 22.SOS S.D. 0.051 0.317 0.873 3.249 0.800 2.640 4 N 42 46 57 55 35 36 MEAN 0.256 2.540 8.314 21.385 7.946 21.S93 S.D. 0.038 0.238 0.912 2.132 0.574 2.667 5 N MEAN 46 0.239 so 2.442 56 7.Sel 59 20.872 40 7.644 35 20.702 S.D. 0.023 0.271 0.610 2.782 0.593 1.771 6 N MEAN S.D. 42 0.234 0.027 45 2.312 0.271 S9 7.316 0.624 S8 20.229 2.277 39 7.115 0.638 36 20.300 3.150 7 N 44 so 61 60 40 38 MEAN S.D. 0.219 0.018 2.183 0.225 6.942 0.555 19.568 1.815 6.839 0.727 20.004 3.757 Table 11 Summary of Test Material Consumption Data (mg/kg/day) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANCE (99.1t) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RARS *DRAFT* ------------------------------------------------------------------------------------------------------------------- SEX: ------------------------------F-E-MALE -------------------------------- CROUP: 2 3 4 5 6 7 DOSE: 3 30 100 300 100 300 WEEK UNITS: PPM ppm PPM PPM PPM PPM ------------------------------------------------------------------------------------------------------------------- 8 N 45 44 57 0 MEAN 0.22S 2.237 6.907 S.D. 0.040 0.390 0.67S 9 N 47 48 60 0 MEAN 0.201 2.007 6.656 S.D. 0.029 0.203 1.398 10 N 44 47 60 0 MEAN 0.199 1.993 6.413 S.D. 0.027 0.228 0.760 11 N 44 49 62 0 MEAN 0.193 2.016 6.456 S.D. 0.035 0.342 1.352 12 N 43 51 62 0 MEAN 0.181 1.952 6.213 S.D. 0.023 0.246 0.720 13 N 47 54 64 0 MEAN 0.184 1.879 6.200 S.D. 0.031 0.275 1.400 14 N 45 45 57 0 MEAN 0.182 1.846 6.174 S.D. 0.031 0.155 1.263 33 0 7.017 0.722 39 0 6.4sa 0.446 37 0 6.488 0.543 37 0 6.508 0.898 38 0 6.312 0.861 39 0 6.045 0.705 38 0 6.058 0.429 Table 11 Summary of Test Material Consumption Data (mg/kg/day) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS *Dft;,"* ------------------------------------------------------------------------------------------------------------------ SEX: -------------------------------FE-MALE -------------------------------- GROUP: 2 3 4 5 6 7 DOSE: 3 30 100 300 100 300 WEEK UNITS: PPM PPM PPM PPM PPM PPM ------------------------------------------------------------------------------------------------------------------ is N 38 42 55 0 MEAN 0.179 1.873 6.130 S.D. 0.028 0.178 0.515 16 N 42 44 56 0 MEAN 0.177 1.841 6.010 S.D. 0.018 0.217 0.423 20 N 41 47 53 0 MEAN 0.178 1.844 6.163 S.D. 0.027 0.184 0.484 24 N 47 47 54 0 MEAN 0.183 1.782 6.214 S.D. 0.036 0.192 1.082 28 N 46 4S 55 0 MEAN 0.170 1.696 5.916 S.D. 0.025 0.120 0.575 32 N 48 48 55 0 MEAN 0.172 1.739 6.162 S.D. 0.028 0.207 0.808 36 N 47 49 54 0 MEAN 0.175 1.732 6.349 S.D. 0.031 0.205 1.458 39 0 6.128 0.383 38 0 6.018 0.47S 38 0 6.206 0.436 38 0 6.030 0.348 39 0 S.977 0.413 36 0 6.080 0.475 37 0 6.125 0.448 Table 11 summary of Test material Consumption Data (mg/kg/day) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ SEX: ------------------------------F-E-MALE -------------------------------- GROUP: 2 3 4 5 6 7 DOSE: 3 30 100 300 100 300 WEEK UNITS: PPM PPM PPM PPM PPM PPM ------------------------------------------------------------------------------------------------------------------ 40 N 48 49 56 0 MEAN 0.184 1.853 6.788 S.D. 0.027 0.258 1.158 44 N 48 so 56 0 MEAN 0.163 1.677 5.946 S.D. 0.020 0.19S 0.888 48 N 49 50 S6 0 KEAN 0.153 i.sso 5.976 S.D. 0.018 0.215 1.169 52 N 46 48 55 0 MEAN 0.147 1.454 5.686 S.D. 0.018 0.250 0.899 38 0 6.631 0.448 40 0 5.912 0.783 39 0 5.715 0.425 39 0 5.3SS O.SS2 Table 12 summary of Test Material Consumption Data (mg/kg/day) *DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.ltl N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- SEX: ---MALE ---- ---FEMALE-- GROUP: 9 9 DOSE: 1 1 WEEK UNITS: PPM PPM ------------------------------------------------------------------------------------------------------------------ 1 N MEAN S.D. 2 N MEAN S.D. 3 N MEAN S.D. 4 N MEAN S.D. 5 N MEAN S.D. 6 N MEAN S.D. 7 N MEAN S.D. 69 O.ID3 0.007 69 0.088 0.007 67 0.078 0.008 64 0.071 0.004 60 0.066 0.004 62 0.063 0.003 64 0.061 0.005 S7 0.108 0.010 55 0.096 0.009 66 0.092 0.013 58 0.086 0.011 53 0.080 0.005 52 0.077 0.007 56 0.075 0.008 Table 12 summary of Test Material Consumption Data lmg/kg/day) *DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- SEX: ---MALE ---- ---FEMALE-- CROUP- 9 9 DOSE: 1 1 WEEK UNITS: PPM PPM ------------------------------------------------------------------------------------------------------------------- 8 N MEAN S.D. 9 N MEAN S.D. 10 N MEAN S.D. 11 N MEAN S.D. 12 N MEAN S.D. 13 N MEAN S.D. 14 N MEAN S.D. 61 0.058 o.oos 64 0.057 0.004 63 o.oss 0.004 61 0.053 0.003 64 O.OS3 0.004 64 0.052 0.003 50 0.051 0.003 47 0.072 0.010 58 0.070 0.009 51 0.069 0.010 51 0.063 0.007 55 0.066 0.006 61 0.067 0.009 38 0.065 0.009 Table 12 Summary of Test Material Consumption Data (mg/kg/day) *DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANBSULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- SEX: ---MALE ---- ---FEKALE-- GROUP: 9 9 DOSE: 1 1 WEEK UNITS: PPM PPM ------------------------------------------------------------------------------------------------------------------- is N MEAN S.D. se 0.050 0.003 54 0.064 0.012 16 N MEAN S.D. 20 N MEAN S.D. 24 N MEAN S.D. 28 N MEAN S.D. 32 N MEAN S.D. 36 N MEAN S.D. 60 0.049 0.003 57 0.045 0.003 60 0.045 0.004 56 0.044 0.004 60 0.043 0.003 56 0.041 0.003 48 0.062 0.006 52 0.062 0.012 55 0.060 0.009 57 0.062 0.008 59 0.060 0.010 54 0.056 0.007 Table 12 Sumnary of Test Material Consumption Data (mg/kg/day) *DRAFT* 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- SEX: ---MALE ---- ---FEMALE-- GROUP: 9 9 I)OSE: 1 1 WEEK UNITS: PPH PPM ------------------------------------------------------------------------------------------------------------- 40 N MEAN S.D. 44 N MEAN S.D. 49 N MEAN S.D. 52 N MEAN S.D. 60 0.039 0.003 S8 0.038 0.003 sa 0.037 0.003 57 0.036 0.003 57 0.053 0.007 so 0.052 0.006 59 0.050 0.009 51 0.049 0.008 104-WEEK Table 13 Summary of Clinical Hematology Data Males Week 8 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ RBC XIO'/.UL -------- HGB HCT G/DL % -------- -------- mcv PL -------- MCH HCHC PLT PG % X101/,uL -------- -------- -------- 0 MEAN S.D. N 8.27 .267 5 15.3 .44 5 44.7 1.43 5 54.1 1.10 5 18.5 .40 5 34.1 .61 s 1269 111.0 s 300 MEAN S.D. N 6.61 .609 5 12.7 .68 5 37.1 2.14 5 56.3 2.65 5 19.2 .82 s 34.1 .72 5 1092 112.7 5 104-WEEK Table 13 Summary of clinical Hematology Data males Week 8 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGZ 198.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ WBC X101/,uL -------- N-SEG X101/lAL -------- LYMPH X101/,uL -------- MONO X10'/,uL -------- EOSIN X103/.uL -------- BASO X101/,uL -------- N-SEG% -------- LYMPH% -------- MONO% -------- EOSIN ------ 0 MFM S.D. N 300 MRAN S.D. N 8.5 3.27 5 6.5 1.98 5 1.2 .41 5 I.o .29 5 6.9 3.52 5 5.2 2.10 5 .4 .1 .0 15 78 6 .29 .04 .00 6.1 8.8 4.0 5 5 5 5 5 5 .3 .0 .0 17 78 4 .19 .05 .00 11.7 12.1 2.9 5 5 5 5 5 104-WEEK Table 13 Summary of Clinical Hematology Data Females Week 8 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ RBC HGB HCT mcv HCH MCHC PLT X10'1,uL C/DL % FL P(; % XIO'/,uL -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 300 HPAN S.D. N 7.83 .321 5 6.83 .388 5 14.7 .40 5 13.0 .81 5 43.6 1.62 5 37.9 2.43 5 55.6 1.13 5 55.5 1.31 5 18.8 .56 19.0 .46 s 33.8 .48 5 34.2 .29 5 1114 88.8 5 1110 113.7 5 Table 13 summary of Clinical Hematology Data Females Week 9 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ WBC X103/,uL N-SEC LYMPH X10"/,uL X10'/,uL MONO EOSIN BMO X101/.uL XIOI/liL XIO"/,uL N-SEG% LYMPH% MONO% EOSIN% -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 7.7 .7 6.6 .3 .1 .0 10 84 4 2 S.D. 2.85 .31 2.95 .11 .09 .00 6.5 9.1 2.2 1 N 5 5 5 5 5 s 5 s 5 5 300 MEAN 5.8 .6 5.0 .2 .0 .0 10 86 3 1 S.D. N .78 .30 .93 5 5 5 .10 .00 .00 5 5 5 6.4 5.7 1.1 5 5 5 5 104-WREK Table 14 Summary of Clinical Hematology Data Males Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESVLFONAMIDO ETHANOL IN RATS DOSE P-P-M---- RBC HGB HCT XIOI/,uL G/DL % mcv MCH MCHC PLT FL PG t X103/,uL -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N S.S4 .403 10 15.3 .48 10 45.7 1.34 10 53.6 1.46 10 17.9 SS 10 33.5 .53 10 1240 156.0 10 3 MEM S.D. N 8.72 .268 10 15.6 .45 10 46.6 1.17 10 53.5 1.21 10 17.9 .54 10 33.5 .47 10 1140 67.8 10 30 MEAN S.D. N 100 HEM S.D. N 8.33 .455 10 8.18 .347 10 15.0 .71 10 is.0 .43 10 44.6 1.87 10 44.4 1.57 10 53.6 1.45 10 54.4 1.23 10 18.0 .38 10 18.4 .51 10 33.7 .37 10 33.8 .42 10 1143 158.3 10 1141 80.6 10 104-WEEK Table 14 Summary of Clinical Hematology Data Males Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ WBC X103/,uL -------- N-SEC X101/ijL -------- LYMPH X101/.uL -------- MONO X101/,uL -------- EOSIN X101/,uL -------- llkso XIO'/IAL -------- N-SEG% -------- LYMPH% -------- MONO% -------- EOSIN% ------- 0 MEAN 7.4 1.2 5.3 .7 .1 .0 17 71 10 S.D. 1.31 .38 1.27 .19 .04 .00 5.2 7.1 2.8 N 10 10 10 10 10 10 10 10 10 1 3 MEAN 10.4 1.5 7.9 .9 .2 .0 15 75 7 S.D. 3.31 .54 2.79 .29 .11 .00 4.6 6.6 2.3 N 10 10 10 10 10 10 10 10 10 1 30 MEAN 9.2 1.3 7.0 .7 .2 .0 is 7S 8 S.D. 1.85 .41 1.59 .28 .07 .00 4.6 4.7 2.4 N 10 10 10 10 20 10 10 10 10 -1 100 MEAN 8.8 1.3 6.7 S.D. 2.64 .39 2.23 N 10 10 10 .7 .1 .24 .05 10 10 .0 15 76 8 .00 2.6 3.3 2.5 10 10 10 10 1 Table 14 Sumnary of Clinical Hematology Data Females Week 14 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE P-P-M ---- RBC HGB HCT X101/.uL C/DL % mcv MCH MCHC PLT FL PC % X103/,uL -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 8.15 .469 10 8.12 .411 10 8.01 .419 10 7.79 .258 9 15.5 .65 10 15.3 .64 10 15.2 .55 10 14.9 .23 9 45.9 2.09 10 45.3 2.16 10 45.5 1.63 10 43.7 .82 9 56.4 1.17 10 55.8 1.97 10 56.8 1.72 10 56.2 1.46 9 19.0 .61 10 18.8 .67 10 19.1 .80 10 19.2 .61 9 33.7 .46 10 33.7 .38 10 33.6 .45 10 34.1 .54 9 1040 113.7 10 1000 222.8 10 1054 124.0 10 1023 56.2 9 104-WEEK Table 14 summary of clinical Hematology Data Females Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERPLUOROOCTANESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ WBC X102/,uL -------- N-SEG XIOI/,uL -------- LYMPH X101/,uL -------- MONO X101/,uL -------- EOSIN X101/,uL -------- BASO X10'/,uL -------- N-SEG% -------- LYMPH% -------- MONO% -------- BOSIN% ------- 0 MEAN 6.4 .8 5.1 .4 .1 .0 13 79 6 S.D. 1.63 .22 1.44 .13 o4 .00 3.6 4.2 1.4 N 10 10 10 10 10 10 10 10 10 1 3 MEAN S.D. 6.9 1.77 10 .8 5.5 .43 1.48 10 10 .4 .1 .12 .03 10 10 .0 11 81 6 .00 4.S 4.8 2.0 10 10 10 10 1 30 MEAN 7.5 .8 6.3 .4 .1 .0 12 80 5 S.D. 5.43 .22 5.06 .19 .09 .00 5.5 5.9 1.8 N 10 10 10 10 10 10 10 10 10 1 100 MEAN S.D. N 6.2 1.80 9 .6 5.1 .26 1.68 9 9 .4 .1 .0 11 80 6 .12 .06 .00 4.8 6.6 3.0 9 9 9 9 9 9 Table 15 Sunwnary of Clinical Hematology Data males Week 14 104-WEEK DIETARY CARCINOGENICITY SWDY PERFLUOROOCTANESULFONAMIDO WITH NARROW RANGE (98.1%) N-ETHYL ETHANOL IN RATS DOSE PPM ------ RBC X101/,uL -------- HGB O/DL -------- HCT % -------- mcv FL -------- MCH PG -------- MCHC PLT % X10'/,uL -------- -------- 0 KEAN S.D. N 8.32 .838 10 15.2 1.18 10 44.3 3.23 10 53.4 2.55 10 18.3 .80 10 34.2 .45 10 1094 94.6 10 1 MEAN S.D. N 8.38 .411 10 IS.0 .64 10 44.1 1.62 10 52.6 1.35 10 17.9 .53 10 34.0 .31 10 1094 90.4 10 Table 15 Summary of clinical Hematology Data Males Week 14 104-WEEK DIETARY CARCINOGENICITY STUDY WITH IIARROW RANGE t98.l%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ WBC X10'/.uL -------- N-SEG X103/,uL -------- LYMPH X101/oL -------- MONO X101/,uL -------- EOSIN X101/lAL -------- BASO X101/.uL -------- N-SEG% LYMPH% -------- -------- MONO% -------- EOSIN% -------- 0 MEAN 10.4 1.3 7.9 .9 .3 .0 13 76 9 3 S.D. 2.18 .28 2.04 .23 .12 .00 2.6 5.2 2.9 1. N 10 10 10 10 10 10 20 10 10 10 1 MEM 10.2 2.3 7.5 1.1 .3 .0 13 74 11 2 S.D. 2.12 .39 1.72 .50 .18 .03 4.1 4.4 3.9 1. N 10 10 10 10 10 10 10 10 10 10 Table 15 Summary of clinical Hematology Data Females Week 14 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.194) N-ETHYI, PR"LUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ RBC X10'/ML -------- HGB G/DL -------- HCT % -------- mcv FL -------- MCH PG -------- MCHC PLT % XIO'/juL -------- -------- 0 MEAN S.D. N 7.82 .358 10 14.7 .73 10 43.1 2.10 10 S5.1 1.05 10 18.8 .53 10 34.2 .4S 10 1064 88.2 10 MEAN S.D. N 8.01 .350 10 15.2 .39 10 44.2 1.44 10 SS.3 1.32 10 19.0 .53 10 34.4 .52 10 1112 83.6 10 104-WEEK Table 15 Summary of clinical Hematology Data Females Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONANIDO ETHANOL IN RATS DOSE PPM ------ WBC X101/,uL -------- N-SEG X103/,uL -------- LYMPH X10'/,UL -------- MONO X101/jwL -------- EOSIN X101/,uL -------- RASO X101/,uL -------- N-SEG% -------- LYMPH% -------- MONO% -------- EOSIN% ------- 0 MEAN S.D. N 1 MEAN S.D. N 7.3 2.61 10 6.5 1.23 10 .8 5.8 .38 2.24 10 10 .9 S.o .20 1.37 10 10 .5 .2 .0 12 78 7 .16 .09 .00 4.3 4.7 1.7 10 10 10 10 10 10 1 .4 .2 .0 15 75 7 3 .17 .06 .00 5.0 8.7 3.7 10 10 10 10 10 10 1 104-WEEK Table 16 Summary of Clinical Hematology Data Males Week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE ppm ------ RBC HGB HCT X101/ijL C/DL % mcv MCH MCHC PLT FL PG % XlO'ImL -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 8.33 .445 10 8.19 .879 10 8.27 .374 10 8.22 .398 10 14.8 .47 10 14.6 1.46 10 14.9 .51 10 14.5 .59 10 44.2 1.41 10 44.0 4.15 10 44.0 1.12 10 42.9 2.12 10 53.1 1.63 10 53.8 1.83 10 53.2 1.98 10 52.2 2.24 10 17.8 .66 10 17.9 .66 10 18.0 .78 10 17.6 .77 10 33.4 .40 10 33.3 .45 10 33.8 .44 10 33.7 .44 10 1270 107.3 10 1096 100.5 10 1190 131.4 10 1206 55.6 10 104-WEEK Table 16 suimary of Clinical Hematology Data Males Week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ WBC X101/juL -------- N-SEC X10IIAiL -------- LYMPH X10'/,uL -------- MONO X10'/,uL -------- EOSIN XIO'IML -------- BASO X101/,uL -------- N-SEG% -------- LYMPH% -------- MONO% -------- EOSIN% -------- 0 MEAN S.D. 7.9 1.77 1.4 .34 5.5 1.52 .8 .2 .19 .06 .0 19 69 10 2 .00 4.2 4.7 1.8 N 10 10 10 10 10 10 10 10 10 10 3 MEAN S.D. N 7.9 1.62 10 1.4 .65 10 5.6 1.14 10 .7 .2 .0 17 71 9 2 .23 .08 .00 4.5 5.3 4.1 10 10 10 10 10 10 10 30 MEAN 8.8 2.0 S.8 .8 .2 .0 22 68 9 2 S.D. 1.91 .98 1.22 .27 .07 .00 8.3 8.7 2.2 N 10 10 10 10 10 10 10 10 10 10 100 MEAN 8.9 2.4 5.6 .9 .0 24 65 9 2 S.D. 3.06 2.34 1.27 .28 .04 .00 11.6 11.7 2.4 N 10 10 10 10 10 10 10 10 10 10 104-WEEK Table 16 Summary of Clinical Hematology Data Females Week 27 DIETARY CARCINOGENICITY STUDY WM NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ RBC X101/,uL -------- HGB C/DL -------- HCT % -------- mcv PL -------- MCH PC -------- MCHC PLT t X10'/,uL -------- -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 7.93 .316 10 7.54 .243 10 7.78 .396 10 7.25 .268 10 15.3 .29 10 14.7 so 10 14.9 .46 10 14.1 .61 10 45.1 1.04 10 43.2 1.23 10 43.9 1.38 10 41.0 1.82 10 56.9 1.76 10 57.4 1.88 10 56.4 1.99 10 S6.5 1.74 10 19.3 .76 10 19.5 .82 10 19.1 .80 10 19.4 .51 10 33.9 .38 10 34.0 .49 10 33.9 .49 10 34.4 .56 10 1076 96.6 10 987 176.1 10 968 94.2 10 996 103.9 10 104-WEEK Table 16 Summary of Clinical Females Hematology Week 27 Data DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N WBC X101/mL -------- 5.1 1.29 10 5.2 1.85 10 4.8 1.20 10 4.9 .69 10 N-SEG X10'/,uL -------- LYMPH X1011PL -------- MONO X10'/,uL -------- EOSIN X10'/pL -------- BASO X10'/14L -------- N-SEG% -------- LYMPH% -------- MONO% -------- EOSIN% ------- .7 3.7 .17 1.39 10 10 .6 .1 .0 14 71 12 .21 .00 .03 5.2 10.3 5.5 10 10 10 10 10 10 1 .7 3.9 .5 .1 .0 14 74 10 .24 1.55 .17 .03 .00 2.8 4.0 3.2 10 10 10 10 10 10 10 10 1 .8 3.3 s .1 .0 is 69 11 .22 .98 .21 .03 .00 4.6 7.5 4.1 10 10 10 10 10 10 10 10 1 .8 3.5 .4 .1 .0 17 72 a .28 .73 .07 .03 .00 5.7 6.7 2.2 10 10 10 10 10 10 10 10 1 104-WEEK Table 17 Summary of Clinical Hematology Data Males Week 21 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ RBC XIOI/,uL -------- HGB G/DL -------- HCT t -------- mcv FL -------- MCH PG -------- MCHC PLT t X101/;AL -------- -------- 0 MEAN S.D. N 8.22 .430 10 15.2 .67 10 44.6 1.98 10 54.3 1.63 10 18.5 .62 10 34.0 .36 10 1083 109.2 10 I MEAN S.D. N 8.28 .487 10 14.8 .78 10 43.9 2.19 10 53.1 1.28 10 17.9 .54 10 33.8 .39 10 1112 83.2 10 Table 11 Summary of Clinical Hematology Data Males Week 27 104-WP,EK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1t) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ WBC XIOI/,uL -------- H-SEG Xlol/,wL -------- LYMPH X10'/,uL -------- MONO X101/oL -------- EOSIN BASO X101/,uL X10'/AL -------- -------- N-SEGI -------- LYMPH% -------- MONO% -------- EOSINT -------- 0 MEAN 8.6 1.7 5.7 1.0 .2 .0 19 66 11 3 S.D. 1.85 .81 1.12 .34 .13 .04 5.4 0.0 4.0 1 N 10 10 10 10 10 10 10 10 10 10 MEAN 8.9 1.5 5.9 1.2 .2 .1 17 66 14 2 S.D. N 1.34 10 .28 1.17 10 10 .67 .08 .13 4.0 7.6 6.2 1 10 10 10 10 10 10 10 104-WEEK Table 17 Summary of Clinical Hematology Data Females Week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ RBC X10'/juL -------- HGB G/DL -------- HCT % -------- mcv FL -------- MCH PG -------- MCHC PLT % X10'/,uL -------- -------- 0 MEAN S.DN 7.31 .267 10 13.9 .75 10 40.6 1.79 10 55.6 1.46 10 19.1 .66 10 34.3 .50 10 1038 101.1 10 MEAN S.D. N 7.63 .451 10 14.7 .54 10 42.5 1.93 10 55.8 1.45 10 19.3 .58 10 34.6 .41 10 1098 161.0 10 Table 11 Summary of Clinical Hematology Data Females Week 27 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1t) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ WBC X101/,uL N-SEG LYMPH X101/.uL X10'/,uL MONO EOSIN BASO XIO'/,uL X101/,uL X101/,uL N-SEGS LYMPH% MONO% EOSIN% -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 6.4 1.0 4.6 .6 .2 .0 15 73 9 2 S.D. 2.32 .72 1.46 .28 .15 .00 5.7 7.'l 2.3 1 N 10 10 10 10 10 10 10 10 10 10 I MEAN 5.8 .9 4.2 .5 .1 .0 16 12 9 2 S.D. 1.90 .30 1.63 .21 .04 .00 5.6 9.9 3.6 N 10 10 10 10 10 10 10 10 10 10 104-WEEK Table 18 Summary of Clinical Hematology Data Males Week 53 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.194) N-ETHYL PERFLUOROOCTAKESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ RBC XIO'/,wL -------- HOB G/DL -------- HCT % -------- mcv FL -------- MCH PC -------- MCHC PLT % XIOI/,uL -------- -------- 0 MEAN S.D. N 3 KEAN S.D. N 8.01 1.004 10 8.42 .499 10 14.5 1.52 10 15.2 .76 10 43.3 4.50 10 45.3 2.79 10 54.2 2.32 10 53.8 1.89 10 18.2 .78 10 18.1 .52 10 33.4 .30 10 33.6 .61 10 1238 229.3 10 1210 176.3 10 30 MEAN S.D. N 100 MEAN S.D. N 8.39 .585 10 8.45 .454 10 14.8 1.12 10 14.7 .68 10 43.8 3.17 10 43.3 1.73 10 52.2 1.82 10 51.3 1.06 10 17.6 .90 10 17.4 .45 10 33.8 S6 10 33.9 .55 10 1199 97.5 10 1129 184.1 10 104-WEEK Table le Summary of Clinical Hematology Data Males Week 53 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ WBC X101/,uL -------- N-SEG X101/,uL -------- LYMPH X101/,uL -------- MONO X10'/14L -------- EOSIN X10'/,uL -------- BASO X10'/,uL -------- N-SEG% -------- LYMPH% -------- MONO% -------- EOSIN% -------- 0 MEAN 8.5 2.4 4.9 1.0 .2 .0 29 58 12 2 S.D. 2.14 .88 1.26 .35 .08 .00 5.1 5.4 3.4 N 10 10 10 10 10 10 10 10 10 10 3 MEAN 7.9 1.9 4.9 .9 .1 .0 24 62 11 2 S.D. 1.11 .73 .70 .28 .05 .03 6.9 6.6 3.2 N 10 10 10 10 10 10 10 10 10 10 30 MEAN 8.8 2.5 5.5 .7 .2 .0 28 62 8 2 S.D. .90 .79 1.01 .43 .07 .00 8.3 8.8 4.6 N 10 10 10 10 10 10 10 10 10 10 100 MEAN 7.5 1.8 4.7 .8 .2 .0 25 62 11 2 S.D. 2.02 .53 1.74 .19 .05 .00 7.1 9.5 3.6 N 10 10 10 10 10 10 10 10 10 10 104-WEEK Table 18 Summary of Clinical Hematology Data Females Week 53 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ RBC XIO'/,uL -------- HOB G/DL -------- HCT % -------- mcv FL -------- MCH PG -------- MCHC PLT % X10'/juL -------- -------- 0 MEAN S.D. N 3 MEAN s.D. N 30 MEAN S.D. N 100 MEAN S.D. N 7.23 1.388 10 7.42 .589 10 7.44 .979 10 6.92 1.008 10 14.2 1.95 10 14.3 1.03 10 14.6 1.86 10 13.6 1.62 10 41.5 6.15 10 42.4 2.99 10 42.8 S.57 10 39.4 4.74 10 58.2 4.19 10 57.2 1.78 10 57.6 2.13 10 57.1 2.24 10 20.0 1.81 10 19.3 .85 10 19.6 .83 10 19.7 .79 10 34.4 .64 10 33.7 .56 10 34.0 .51 10 34.6 .43 10 998 125.1 10 935 125.9 10 918 133.9 10 907 80.9 10 Table 18 summary of Clinical Hematology Data Females Week 53 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.llk) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ WBC X10'/,uL -------- N-SEG X101/,uL -------- LYMPH X10'/,uL -------- MONO X101/mL -------- EOSIN X101/mL BASO X101/,uL -------- -------- N-SEG% -------- LYMPH% -------- MONO% -------- EOSIN% -------- 0 MEAN 4.S 1.1 2.7 .6 .1 .0 25 60 13 2 S.D. s9 .39 .40 .08 .03 .00 6.8 6.8 1.2 N 10 10 10 10 10 10 10 10 10 10 3 MEAN 4.8 1.5 2.6 .6 .1 .0 26 59 12 2 S.D. 1.95 1.60 .74 .34 .03 .03 13.8 14.8 1.9 N 10 10 10 10 10 10 10 10 10 10 30 MEAN S.D. N 5.7 1.60 10 1.2 .49 10 3.8 1.43 10 .5 .1 .0 22 66 9 3 .20 .07 .00 7.4 8.4 3.8 1 10 10 10 10 10 10 10 100 MEAN 5.8 1.6 3.4 .7 .2 .0 28 58 11 3 S.D. .74 .33 .63 .19 .08 .00 4.6 5.7 4.0 1 N 10 10 10 10 10 10 10 10 10 10 104-WEEK Table 19 Summary of Clinical Hematology Data Males Week 53 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (9B.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE ppm ------ RBC HGB HCT mcv MCH MCHC PLT XIO'/,uL G/DL I FL PG I Xl 0'/,uL -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N I MEAN S.D. N 8.20 .530 10 8.42 .439 10 15.2 .78 10 15.2 .71 10 42.6 2.22 10 43.4 1.97 10 52.0 1.89 10 51.6 2.54 10 18.5 .69 10 18.1 1.04 10 35.6 .24 10 35.2 .38 10 1171 158.9 10 1131 185.5 10 Table 19 Summary of Clinical Hematology Data Males Week 53 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.11) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ WBC Xl 01/,uL -------- N-SEG XIOI/,uL -------- LYMPH X101/,uL -------- MONO XIOI/,uL -------- EOSIN X101/,uL BASO XIOI/,uL -------- -------- N-SEG% -------- LYMPH% -------- MONO% -------- EOSIN% -------- 0 MEAN 6.8 2.0 3.9 .8 .1 .0 29 57 11 2 S.D. 1.64 .73 1.29 .34 .05 .03 8.6 10.4 4.7 N 10 10 10 10 10 10 10 10 10 10 MEAN 6.7 2.0 3.8 .8 .1 .0 28 57 12 2 S.D. 2.12 1.17 .93 .29 .05 .00 7.3 6.7 2.7 N 10 10 10 10 10 10 10 10 10 10 104-WEEK Table 19 Summary of Clinical Females Hematology Week 53 Data DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ RBC X101/tiL -------- HGB G/DL -------- HCT I -------- mcv FL -------- MCH PG -------- MCHC PLT I XIO'/iAL -------- -------- 0 MEAN S.D. N I MEAN S.D. N 7.71 .362 10 7.78 .435 10 14.9 .58 10 14.9 .46 10 41.4 1.77 10 41.6 1.16 10 53.8 1.63 10 53.5 1.75 10 19.4 .67 10 19.2 .61 10 36.0 .46 10 35.7 .41 10 941 117.1 10 1053 102.5 10 104-WEEK Table 19 Summary of Clinical Hematology Data Females Week 53 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ 0 MEAN S.D. N 1 MEAN S.D. N WBC XIOI/ijL -------- N-SEG X101/,uL -------- LYMPH X101/mL -------- MONO X101/,uL -------- EOSIN X101/pL -------- BASO X101/.uL -------- N-SEGS -------- LYMPH% -------- MONO% -------- EOSIN% -------- 5.2 1.4 3.2 1.64 .48 1.16 10 10 10 .6 .1 .0 27 60 11 2 .13 .03 .00 4.7 5.0 2.3 10 10 10 10 10 10 10 5.1 1.3 3.2 .6 .1 .0 26 60 12 2 2.18 .73 1.66 .24 .04 .03 8.6 9.5 4.6 10 10 10 10 10 10 10 10 10 10 Table 20 Summary of Clinical Chemistry Data males Week 4 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ PCOAO IU/G -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 300 MEAN S.D. N 7 3.8 5 8 2.5 5 9 1.7 5 6 1.9 5 14 3.6 s 104-WEEK Table 20 Summary of Clinical Chemistry Data Females Week 4 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ PCOAO IU/C -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 300 MEAN S.D. N 3 2.7 5 5 1.6 4 2.7 5 5 1.6 5 15 7.9 5 104-WEEK Table 21 Summary of Clinical Chemistry Data Males Week 4 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ PCOAO IU/G -------- 0 MEAN 7 S.D. 2.6 N 5 1 MEAN 7 S.D. 3.8 N 5 104-WEEK Table 21 Sumnary of Clinical chemistry Data Females Week 4 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1'4) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ PCOAO IU/G -------- 0 MEAN 3 S.D. N 1 MEAN 4 S.D. 2.3 N 5 104-WEEK Table 22 summary of clinical Chemistry Data Males Week 8 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ CLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO CIDL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- CHOL MG/DL -------- 0 MEAN S.D. N 300 MP" S.D. N 106 6.3 5 94 6.2 5 13 1.9 5 is 2.2 5 .8 6.7 .13 .48 5 5 .7 7.1 .08 .61 5 5 4.6 .19 5 5.5 .38 5 2.2 .31 51 1.6 .30 5 .1 53 .08 13.3 5 5 .5 7- .09 5.2 5 5 104-WEEK Table 22 summary of clinical Chemistry Data Males Week 8 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ AST/SCOT ZU/L ALT/SGPT IU/L -------- -------- GGT IU/L -------- CA MG/DL I PHOS MG/DL -------- -------- NA MMOL/L K MMOL/L -------- -------- CL MMOL/L -------- 0 MEAN S.D. N 300 MEAN S.D. N 113 24.8 5 179 55.6 5 42 7.0 5 271 213.8 5 2 10.5 1.6 .21 5 5 1 10.4 1.2 .26 5 5 7.8 .79 5 7.7 .34 5 148 1.5 147 1.6 5 5.7 .26 5 5.6 .32 5 103 1.9 5 103 2.2 5 Table 22 Summary of clinical Chemistry Data Males Week 8 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ PCOAO IU/G -------- 0 MEAN 9 S.D. 3.5 N 5 300 MEAN S.D. N 26 5.3 5 104-WEEK Table 22 summary of clinical Chemistry Data Females Week 8 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOC,RANESULFONAHIDO ETHANOL IN RATS DOSE PPM ------ GLU MG/DL UN MG/DL CREAT MG/DL -------- -------- -------- T PRO C/DL ALB C/DL -------- -------- GLOB C/DL T BILI MG/DL CHOL MG/DL -------- -------- -------- 0 MEAN S.D. N 300 MEAN S.D. N 109 8.8 5 86 20.0 5 13 2.3 5 22 3.7 5 .8 7.3 5.4 1.9 .11 .31 .29 .19 5 5 5 S' .8 7.7 .10 1.00 5 5 6.2 .63 5 1.5 .40 5 .3 69 .09 16.2 5 5 .4 11 .08 4.0 5 5 104-WEEK Table 22 Summary of Clinical chemistry Data Females Week 8 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHMOL IN RATS DOSE PPM ------ AST/SCOT IU/L -------- ALT/SGPT IU/L -------- GGT IU/L -------- CA NO/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- 0 MEAN S.D. N 300 MEJKN S.D. N 129 21.6 5 145 78.4 5 42 19.8 5 94 67.7 5 1 11.1 1.1 .38 5 5 1 11.2 1.7 .40 5 5 8.4 1.99 5 8.6 1.22 5 148 2.3 5' 149 2.8 5 5.9 .61 5 5.6 .34 5 103 2.6 5 105 1.5 5 104-WEEK Table 22 Summary of Clinical Chemistry Data Females Week 8 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ PCOAO IU/G -------- 0 MEAN S.D. N 300 MEAN S.D. N 3 2.7 5 26 6.6 5 Table 23 Summary of Clinical Chemistry Data Males Week 14 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.19,) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ CLU MG/DL -------- um MG/DL -------- CREAT MO/DL -------- T PRO G/DL -------- ALB C/DL -------- GLOB G/DL -------- T BILI MG/DL -------- CHOL MG/DL -------- 0 MEAN S.D. ill 18.0 13 1.4 .7 7.4 5.0 2.4 .13 .32 .16 .23 .2 82 .12 14.4 N 10 10 10 10 10 to. 10 10 3 MEAN 101 14 .7 7.1 4.7 2.4 .2 61 S.D. 5.7 2.2 .06 .28 .14 .21 .08 6.8 N 10 10 10 10 10 10 10 10 30 MEAN 102 14 .7 7.1 4.8 2.4 .1 53 S.D. N 8.6 2.0 .14 .36 .18 .31 .10 7.9 10 10 10 10 10 10 10 10 100 MEAN S.D. N 94 15 .6 7.2 5.1 2.2 .2 29 7.0 1.6 .05 .31 .25 .25 .08 9.8 10 to 10 10 10 10 10 10 104-WEEK Table 23 Summary of Clinical Chemistry Data males Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ AST/SGOT IU/L -------- ALT/SGPT IU/L -------- GGT IU/L -------- CA MO/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 128 32.7 10 130 27.0 10 116 31.0 10 ill 32.3 10 41 6.9 10 42 6.1 10 46 14.2 10 47 11.1 10 0 .4 10 0 .7 10 0 .3 10 0 1.3 10 10.8 .37 10 10.6 .28 10 10.8 .28 10 10.6 .35 10 7.7 .62 10 7.8 .69 10 7.8 .55 10 7.7 .42 10 149 1.7 10' 148 1.7 10 148 i.s 10 148 1.7 10 6.S .41 10 6.2 .28 10 6.1 * .34 10 6.1 * .3S 10 ios 1.3 10 104 2.4 10 106 2.1 10 106 2.4 10 104-WEEK Table 23 Summary of Clinical Chemistry Data Females Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ CLU MG/DL -------- UN MGIDL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- CHOL MG/DL -------- 0 MEAN 106 13 .8 8.3 6.1 2.2 .2 95 S.D. N 10.4 i.s .12 .47 .43 .21 .10 29.6 10 10 10 10 10 10. 10 10 3 MEAN 108 14 .7 8.0 6.0 2.0 .2 so S.D. 7.9 2.3 .10 .39 .43 .12 .18 12.9 N 10 10 10 10 10 10 10 10 30 MEAN S.D. N 97 11.9 10 16 3.8 10 .8 7.8 .16 .53 10 10 5.8 .37 10 2.0 .24 10 .1 69 .13 18.3 10 10 100 MEAN S.D. N 94 9.9 19 4.3 .7 8.1 .12 .31 6.1 .19 2.0 .32 .2 se .12 22.9 10 10 10 10 10 10 10 10 104-WEEK Table 23 Summary of Clinical Chemistry Data Females Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ AST/SGOT IU/L -------- ALT/SGPT IU/L -------- GG"r IU/L -------- CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- 0 MEAN S.D. N 3 MEAN S.t). N 30 MEAN S.D. N 110 30.2 10 96 14.8 10 118 16.0 10 39 18.5 10 32 6.5 10 34 6.0 10 0 1.0 10 0 .5 10 0 .5 10 11.3 .37 10 11.4 .38 10 10.8 .46 10 7.0 1.22 10 7.3 .95 10 6.8 1.00 10 149 2.4 10' 148 1.8 10 149 2.2 10 6.0 .80 10 6.1 .59 10 5.8 .35 10 106 2.0 10 105 1.2 10 106 1.4 10 100 MEAN S.D. N 87 17.1 10 33 4.7 10 1 1.5 10 11.1 .27 10 6.8 .74 10 149 2.0 10 5.9 .37 10 106 2.2 10 104-WEEK Table 23 Summary of Clinical Chemistry Data Males Week 14 DIETARY CARCINO(;ENICITY STUDY WITH NARROW RMAE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ PCOAO IU/G -------- 0 MEAN 7 S.D. .9 N 5 3 MEAN 7 S.D. 1.4 N s 30 MEAN 5 S.D. 1.6 N s 100 MEAN 6 S.D. 2.7 N 104-WEEK Table 23 Sunanary of Clinical Chemistry Data Females Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ PCOAO IU/0 -------- 0 MEAN 4 S.D. 1.9 N 5 3 MEAN 5 S.D. 1.6 N 5 30 MEAN 4 S.D. 2.9 N 5 100 MEAN a S.D. 3.3 N 5 104-WEEK Table 24 summary of Clinical chemistry Data malos Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE ppm ------ GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- CHOL MG/DL -------- 0 MEAN 113 14 .7 6.9 4.8 2.1 .0 59 S.D. 9.6 2.1 .10 .40 .22 .28 .05 7.0 N 10 10 10 10 10 io* 10 10 I MEAN 114 13 .6 7.0 4.7 2.3 .0 63 S.D. 7.4 2.1 .11 .32 .19 .26 .05 12.8 N 10 10 10 10 10 10 10 10 104-WEEK Table 24 S- ary of Clinical Chemistry Data Males Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMXDO ETHANOL IN RATS DOSE ppm ------ 0 KEAN S.D. N 1 MEAN S.D. N AST/SGOT IU/L -------- ALT/SGPT IU/L -------- GGT IU/L -------- CA MG/DL -------- 110 21.4 10 ill 14.9 10 39 8.1 10 48 21.2 10 2 2.1 10 3 2.2 10 10.6 .19 10 10.6 .24 10 I PHOS MO/DL -------- 7.3 .63 10 7.0 .31 10 NA MMOL/L K MMOL/L -------- -------- 147 .8 10' 147 .8 10 5.9 .39 10 6.3 .31 10 CL MMOL/L -------- 106 1.9 10 107 .6 10 104-WEEK Table 24 Summary of Clinical Chemistry Data Females Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAHIDO ETHANOL IN RATS DOSE PPM ------ GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB C/DL -------- CLOB G/DL -------- T BILI MG/DL -------- CHOL MG/DL -------- 0 MEAN 114 14 .8 8.2 6.1 2.1 .2 94 S.D. 8.7 2.3 .14 .60 .52 .22 .16 22.1 N 10 10 10 10 10 10. 10 10 1 KEAN 110 is .7 7.9 5.8 2.1 .1 88 S.D. 3.8 2.4 .12 .68 .66 .27 .13 20.3 N 10 10 10 10 10 10 10 10 104-WEEK Table 24 Summary of Clinical chemistry Data Females Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ 0 MEAN S.D. N 1 KEAN S.D. N AST/SGOT IU/L -------- ALT/SGPT IU/L -------- GGT IU/L -------- CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- 110 58.6 10 108 24.1 10 44 24.9 10 44 19.1 10 2 1.3 10 2 2.0 10 11.4 .54 10 11.2 .29 10 6.0 .44 10 6.4 .43 10 145 1.6 10' 147 .8 10 5.8 .38 10 6.0 .36 10 106 1.8 10 107 2.2 10 Table 24 Summary of Clinical chemistry Data Males Week 14 104-WEEK DIETARY CARCINOGENICITY SWDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAKIDO ETHANOL IN RATS DOSE PPM ------ PCOAO IU/C -------- 0 MEAN 6 S.D. 1.3 N 5 1 MEAN 5 S.D. 1.1 N 5 104-WEEK Table 24 summary of Clinical Chemistry Data Females Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ PCOAO IU/G -------- 0 MEAN 3 S.D. .9 N MEAN S.D. 1.6 N 5 104-WEEK Table 25 Summary of Clinical chemistry Data Males Week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAHIDO ETHANOL IN RATS DOSE PPM ------ CLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO C/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- CHOL MG/DL -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 106 11 .6 7.4 4.6 2.7 .1 11.8 1.2 .13 .31 .25 .13 .13 10 10 10 10 10 10. 10 108 13 .7 7.4 4.8 2.6 .2 12.1 1.8 .12 .43 .39 .19 .11 10 10 10 10 10 10 10 98 13 .7 7.2 4.7 2.5 * .1 6.2 1.7 .10 .51 .39 .20 .10 10 10 10 10 10 10 10 9s 7.3 10 15 1.6 10 .6 7.7 5.3 2.4 * .1 .11 .32 .25 .28 .11 10 10 10 10 10 96 30.3 10 86 19.8 10 68 18.8 10 42 16.2 10 104-WEEK Table 25 summary of Clinical Chemistry Data Males Week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) PERFLUORGOCTANESULFONAMIDO ETHANOL IN RATS N-ETHYL DOSE PPM ------ AST/SCOT IU/L -------- ALT/SGPT IU/L -------- CGT IU/L -------- CA MG/DL -------- I PHOS MG/DL -------- NA MHOL/L K MMOL/L -------- -------- CL MMOL/L -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 114 28.0 10 119 38.3 10 114 38.7 10 165 192.1 10 40 13.8 10 42 21.2 10 57 31.0 10 94 113.7 10 1 1.3 10 0 .7 10 1 1.0 10 1 .8 10 10.8 .38 10 10.6 .39 10 10.6 .34 10 10.7 .32 10 7.4 .82 10 6.9 .66 10 7.2 .40 10 7.2 .40 10 149 1.9 10. 147 2.3 10 147 1.4 10 147 1.4 10 6.7 .48 10 6.2 .48 10 6.3 .37 10 6.3 .35 10 106 1.1 10 105 2.4 10 106 1.2 in 106 1.1 10 104-WEEK Table 25 Summary of Clinical Chemistry Data Females Week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO C/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- CHOL MG/DL -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 HEM S.D. N 101 13.4 10 is 3.7 10 .9 8.0 .24 .65 10 10 5.9 .53 10 2.2 .23 10' 103 14 .7 8.2 7.3 2.2 .11 S4 10 10 10 10 S.8 S7 10 2.4 .28 10 107 16 .6 8.0 5.8 2.2 8.9 3.7 .08 .61 .41 .28 10 10 10 10 10 10 92 7.1 10 21 7.0 10 .8 8.5 6.2 2.4 .21 .50 .30 .25 10 10 10 10 .2 87 .10 14.3 10 10 .2 104 .14 21.4 10 10 .2 86 .12 19.6 10 10 .2 71 .14 20.6 10 10 Table 25 summary of Clinical Chemistry Data Females Week 27 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.106) N-ETHYL PERFLUOROOCTANESULPONAMIDO ERHANOL IN PATS DOSE PPM ------ AST/SGOT IU/L -------- ALT/SGPT IU/L -------- GGT IU/L -------- CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- x MMOL/L -------- CL MMOL/L -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 122 30.0 10 102 23.6 10 104 22.1 10 105 42.4 10 44 19.3 10 41 17.7 10 37 10.8 10 47 17.3 10 1 1.1 10 2 4.7 10 2 1.4 10 1 1.3 10 11.0 .41 10 11.0 .41 10 11.0 .53 10 11.2 .24 10 6.0 .44 10 5.8 .76 10 6.1 .92 10 6.2 .63 10 147 2..9 10 147 .9 10 147 1.7 10 146 1.6 10 6.1 .57 10 5.7 .54 10 6.1 .69 10 S.a .71 10 105 2.0 10 105 1.4 10 107 1.3 10 104 2.1 10 104-WEEK Table 26 Summary of Clinical Chemistry Data Males Week 21 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) H-ETHYL PERFLUOROOCTANESULFONAMLDO ETHANOL IN RATS DOSE PPM ------ GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALD G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- CHOL MG/DL -------- 0 MEAN S.D. N I MEAN S.D. N 103 12 .6 6.9 4.6 2.2 10.1 1.2 .06 .32 .17 .28 10 10 10 10 10 10, ill 13 .6 7.1 4.6 2.5 7.3 .9 .04 .29 .18 .25 10 10 10 10 10 10 .1 75 .05 12.5 10 10 .2 84 .05 17.1 10 10 104-WEEK Table 26 Summary of Clinical Chemistry Data Males Week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ AST/SGOT IU/L -------- ALT/SGPT IU/L -------- GGT IU/L -------- CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- 0 MEAN S.D. N 120 21.8 10 43 23.3 10 2 .8 10 10.6 .16 10 7.0 .41 10 146 1.2 10 - 5.9 .34 10 105 2.0 10 1 MEAN S.D. N 110 20.4 10 45 18.1 10 1 .8 10 10.8 .20 10 7.0 .47 10 147 1.1 10 6.3 .29 10 105 2.6 10 104-WEEK Table 26 Summary of Clinical Chemistry Data Females Week 21 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- CHOL MG/DL -------- 0 MEAN S.D. N 1 MEAN S.D. N 106 14 .7 0.0 1.7 .03 10 10 10 104 13 .7 7.2 2.2 .05 10 10 10 8.3 .41 10 8.2 .45 10 6.1 .32 10 5.9 .64 10 2.2 .23 10 2.3 .50 10 .2 117 .00 27.5 10 10 .2 ill .06 33.8 10 10 104-WEEK Table 26 Summary of Clinical Chemistry Data Females Week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE ppm ------ AST/SGOT IU/L ALT/SGPT IU/L GGT IU/L CA MG/DL I PHOS MG/DL NA MMOL/L K MMOL/L CL MMOL/L -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 115 50.2 10 58 38.8 10 2 1.9 10 11.3 .38 10 5.6 .59 10 144 1.3 10. 5.2 .50 10 103 2.7 10 1 MEAN S.D. N 178 168.9 10 96 113.8 10 4 6.3 10 11.2 .43 10 6.1 .59 10 146 1.3 10 5.5 .54 10 104 2.3 10 104-WEEK Table 27 summary of Clinical Chemistry Data males Week S3 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAHIDO ETHANOL IN RATS DOSE PPM ------ GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO C/DL -------- ALB C/DL -------- GLOB C/DL -------- T BILI MG/DL -------- CHOL MG/DL -------- 0 MEAN S.D. N 3 MEAN S.D. N 115 13 .6 7.3 4.4 2.9 11.7 1.5 .10 .38 .25 .45 10 10 10 10 10 10. ill 12 .6 7.6 4.7 2.9 10.8 1.6 .11 .67 .49 .49 10 10 10 10 10 10 .1 146 .10 70.8 10 10 .2 119 13 36.1 10 10 30 MEAN 116 14 .7 7.3 4.7 2.6 .2 92 S.D. 9.4 2.2 .18 .32 .18 .35 .13 38.3 N 10 10 10 10 10 10 10 10 100 MEAN 113 14 .6 7.7 5.3 2.4 .1 49 S.D. 13.7 1.0 .11 .3S .30 .27 .09 21.4 N 10 10 10 10 10 10 10 10 Table 27 Sumnary of Clinical Chemistry Data Males Week 53 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANCE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ AST/SGOT IU/L ALT/SGPT IU/L GOT IU/L CA MG/DL I PHOS MC/DL NA MMOL/L x MMOL/L CL MMOL/L -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 117 23.7 10 108 22.9 10 ios 25.4 10 83 16.2 10 40 9.4 10 48 14.4 10 51 19.2 10 68 26.5 10 4 3.S 10 3 2.7 10 4 4.5 10 6 4.2 10 11.1 .41 10 11.0 .35 10 10.9 .30 10 10.9 .20 10 6.5 .87 10 6.7 S3 10 6.9 .62 10 6.5 .37 10 iso 1.7 10, iso 1.6 10 150 1.9 10 148 1.6 10 6.4 .36 10 6.5 .52 10 6.5 .42 10 6.3 .45 10 109 2.3 10 108 1.3 10 109 1.6 10 109 2.0 10 104-WEEK Table 27 summary of clinical chemistry Data Females Week 53 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO EMMOL IN RATS DOSE P13M ------ CLU MG/DL UN MG/DL CREAT MG/DL T PRO C/DL ALB G/DL GLOB G/DL T BILI MG/DL CHOL MG/DL -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN 108 13 .7 8.0 5.9 2.1 S.D. 14.0 3.0 .12 .70 .58 .25 N 10 10 10 10 10 10, 3 MEAN S.D. N 105 13.0 10 13 .7 8.2 5.8 2.5 1.6 .17 .55 .57 .40 10 10 10 10 10 .3 116 .16 22.1 10 10 .2 119 .19 39.1 10 10 30 MEAN S.D. N 93 14 .8 8.4 5.9 2.4 7.8 2.1 .09 .37 .22 .33 10 10 10 10 10 10 .3 94 .25 23.9 10 10 100 MEAN 103 16 .6 8.5 5.9 2.6 .1 88 S.D. 11.3 4.2 .08 .42 .22 .37 .12 23.2 N 10 10 10 10 10 10 10 10 104-WEEK Table 27 Summary of clinical chemistry Data Females Week 53 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ - AST/SGOT IU/L ALT/SGPT IU/L GGT IU/L CA MG/DL I PHOS MG/DL NA MMOL/L x MMOL/L CL MMOL/L -------- -------- -------- -------- -------- -------- -------- -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 107 33.7 10 104 27.4 10 125 56.9 10 89 19.9 10 43 16.5 10 48 22.0 10 66 72.0 10 63 26.1 10 2 1.8 10 2 2.8 10 5 6.8 10 4 4.0 10 11.1 .44 10 11.2 .43 10 11.1 .42 10 11.3 .29 10 5.9 .73 10 5.8 .44 10 6.2 .85 10 5.8 .48 10 148 2.2 10 149 1.7 10 150 3.9 10 147 1.9 10 5.6 .51 10 6.1 .45 10 5.9 .56 10 5.7 .40 10 106 3.S 10 108 2.8 10 107 2.4 10 107 2.9 10 Table 28 Summary of Clinical Chemistry Data Males Week 53 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- CHOL MG/DL -------- 0 MEAN S.D. N 119 19.5 10 12 .7 7.1 4.6 2.5 2.0 .09 .35 .37 .29 10 10 10 10 10 .2 105 .05 33.8 10 10 1 MEAN S.D. N 127 13.2 10 12 .7 7.1 4.6 2.5 2.3 .03 .31 .31 .30 10 10 10 10 10 .2 102 .05 42.1 10 10 Table 28 Summary of Clinical Chemistry Data Males Week 53 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (90.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ AST/SGOT IU/L -------- ALT/SGPT IU/L -------- GGT IU/L -------- CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- 0 MEAN S.D. N 108 55.4 10 77 118.8 10 2 1.1 10 10.3 .55 10 6.2 .89 10 149 3.5 10 6.1 .58 10 106 3.o 10 MEAN S.D. N 110 40.0 10 42 12.3 10 1 1.3 10 10.5 .34 10 6.4 .53 10 ISO 4.3 10 6.4 .50 10 107 3.0 10 Table 28 Summary of Clinical chemistry Data Females Week 53 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.11) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ GLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BILI MG/DL -------- CHOL MG/DL -------- 0 MEAN S.D. N 1 MEAN s.D. N 113 17.5 10 108 8.9 10 11 .8 1.1 .07 10 10 14 .8 2.5 .07 10 10 8.4 .44 10 8.5 .47 10 5.9 .36 10 5.8 .40 10 2.4 .34 10 2.7 .41 10 .3 142 .22 34.0 10 10 .2 126 .06 20.8 10 10 Table 28 Summary of Clinical Chemistry Data Females Week 53 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ AST/SGOT IU/L -------- ALT/SGPT IU/L -------- GGT IU/L -------- CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- 0 MEAN S.D. N 100 29.1 10 54 24.7 10 2 1.0 10 11.1 .44 10 5.4 1.05 10 147 4.1 10 5.4 .37 10 102 2.6 10 MEAN S.D. N 156 160.1 10 72 62.1 10 2 2.6 10 11.0 .50 10 5.7 1.14 10 147 2.3 10 5.3 .68 10 104 3.0 10 104-WEEK Table 29 summary of Clinical Urinalysis Data Males Week 8 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ U VOL ML -------- SP GR -------- U PH -------- 0 MEAN S.D. N 300 MEAN S.D. N 17.5 10.64 5 28.5 10.88 5 1.020 .0086 5 1.010 .0047 5 7.0 .35 5 6.9 .22 5 Table 29 Summary of Clinical Urinalysis Data Females Week 8 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ U VOL ML -------- SP CR -------- U PH -------- 0 MEAN S.D. N 300 MEAN S.D. N 19.9 17.75 5 21.6 12.63 5 1.012 .0102 5 1.010 .0051 5 6.8 .27 5 6.7 .45 5 104-WEEK Table 30 Summary of Clinical Urinalysis Data Males Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS DOSE PPM ------ U VOL ML SP GR U PH -------- -------- -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 18.7 14.79 10 25.1 15.47 10 15.8 9.53 10 19.9 15.56 10 1.024 .0151 10 1.015 .0079 10 1.022 .0109 10 1.022 .0160 10 6.9 .39 10 6.9 .21 10 6.8 .26 10 6.8 .35 10 104-WEEK Table 30 Summary of Clinical Urinalysis Data Females Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ U VOL ML -------- SP GR -------- u PH -------- 0 MF.AN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 19.0 13.21 10 22.2 16.26 10 19.2 16.50 10 23.2 16.13 10 1.012 .0082 10 1.012 .0102 10 1.014 .0109 10 1.012 .0086 10 6.7 .26 10 6.8 26 10 6.6 .39 10 6.6 .16 10 104-WEEK Table 31 Summary of clinical Urinalysis Data Males Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE ppm ------ U VOL ML SP GR U PH -------- -------- -------- 0 MEAN S.D. N 22.7 15.31 10 1.015 .0116 10 7.1 .32 10 1 MEAN S.D. N 21.9 13.22 10 1.017 .0085 10 7.2 .24 10 104-WEEK Table 31 summary of clinical Urinalysis Data Females Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ U VOL ML -------- SP GR -------- U PH -------- 0 MEAN 12.5 1.017 S.D. 13.89 .0078 N 10 10 1 MEAN 22.0 1.012 D. 18.74 .0112 NS. 10 10 6.8 .26 10 6.7 .26 10 104-WEEK Table 32 Summary of Clinical Urinalysis Data Males Week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE ppm ------ U VOL ML SP OR U PH -------- -------- -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N is.s 8.17 10 13.7 5.65 10 13.7 13.33 10 15.4 13.36 10 1.024 .0087 10 1.025 .0090 10 1.030 .0137 10 1.025 .0100 10 7.0 .33 10 7.2 .35 10 7.0 .33 10 7.0 .33 10 104-WEEK Table 32 Summary of Clinical Urinalysis Data Females week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ U VOL ML SP CR U PH -------- -------- -------- 0 MEA.N S.D. N 3 MEAN S.D. N 18.1 16.96 10 15.9 15.38 10 1.019 .0140 10 1.016 .0100 10 6.9 .32 10 6.8 .41 10 30 MEAN S.D. N 100 MEAN S.D. N 13.0 13.35 10 13.2 8.01 10 1.020 .0190 10 1.019 .0081 10 6.7 .35 10 6.8 .49 10 104-WEEK Table 33 Summary of Clinical Urinalysis Data Males Week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ U VOL ML SP GR U PH -------- -------- -------- 0 MEAN S.D. N 1 MEAN S.D. N 13.8 12.00 10 15.4 13.27 10 1.022 .0081 10 1.026 .0125 10 6.9 .39 10 7.0 .28 10 104-WEEK Table 33 Summary of Clinical Urinalysis Data Females Week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFOt4AMIDO ETHANOL IN RATS DOSE PPM ------ U VOL ML -------- SP GR -------- U PH -------- 0 MEAN S.D. N 17.1 17.79 10 1.019 .0134 10 6.6 .21 10 1 MEAN S.D. N 20.0 17.04 10 1.018 .0126 10 6.6 .16 10 104-WEEK Table 34 summary of clinical Urinalysis Data Males Week 53 DIETARY CARCINOGENICITY STUDY WITH NARROW RHNGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE ppm ------ U VOL ML SP CR U PH -------- -------- -------- 0 MEAN S.D. N 3 MEAN S.D. N 19.3 15.90 10 13.7 6.72 10 1.024 .0092 10 1.029 .0106 10 6.8 .26 10 7.0 .33 10 30 MEAN S.D. N 14.7 7.46 10 1.026 .0078 10 6.8 .3S 10 100 MEAN S.D. N 17.3 12.78 10 .1.023 .0110 10 6.8 .34 10 104-WEEK Table 34 Summary of Clinical Urinalysis Data Females Week 53 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ U VOL ML -------- SP GR -------- U PH -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 13.1 7.81 10 19.3 17.82 10 13.7 12.84 10 17.0 14.38 10 1.018 .0074 10 1.018 .0122 10 1.021 .0101 10 1.021 .0131 10 6.4 .28 10 6.4 .16 10 6.4 .24 10 6.4 .16 10 104-WEEK Table 35 Summary of Clinical Urinalysis Data Males Week 53 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE ppm ------ U VOL ML SP GR U PH -------- -------- -------- 0 MEAN S.D. N 14.7 12.83 10 1.026 .0110 10 7.0 .33 10 MEAN S.D. N 10.5 6.47 10 1.030 .0123 10 6.9 .21 10 104-WEEK Table 35 Summary of Clinical Urinalysis Data Females Week 53 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETRYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ U VOL ML SP GR U PH -------- -------- -------- 0 MEAN S.D. N 27.2 19.88 10 1.014 .0106 10 6.5 .24 10 MEAN S.D. N 13.0 10.19 10 1.019 .0093 10 6.5 .33 10 104-WEU Table 3 6 summary of Urine Chemistry Data Males Week 8 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (99.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ERRMOL IN RATS DOSE PPM ------ U NA KNOL/L ux MMOL/L UK MCC MMOL x EXC MMOL -------- -------- -------- -------- 0 MEAN S.D. N 300 MEAN S.D. N 27 13.5 5 20 14.2 5 120 36.4 5 41 18.8 5 .37 .135 5 .53 .213 4 1.99 1.394 5 1.10 .403 4 104-WEEK Table 36 Summary of Urine Chemistry Data Females Week 8 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIT)O ETHANOL IN RATS DOSE PPM ------ U NA KNOL/L -------- uK KNOL/L -------- NA EXC MMOL -------- K EXC MMOL I -------- 0 MEA14 S.D. N 16 11.4 5 53 47.3 5 .15 .074 4 .46 .164 4 300 MEAN S.D. N 20 9.9 5 42 18.0 5 .38 .178 4 .76 .113 4 Table 37 Summary of Urine Chemistry Data Males Week 14 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE ppm ------ U NA MMOL/L ux MMOL/L NA EXC KKOL K EXC KNOL -------- -------- -------- -------- 0 MEAN S.D. N 28 15.9 10 iss 111.3 10 .35 .159 10 1.70 .469 10 3 MEAN S.D. N 22 14.5 10 82 51.3 10 .40 .197 10 1.40 .521 10 30 MEAN S.D. N 30 24.4 10 127 88.4 10 .32 .108 10 1.44 .405 10 100 MEAN S.D. N 29 28.2 10 128 115.5 10 .31 .071 10 1.35 .335 10 104-WEEK Table 37 Summary of Urine Chemistry Data Females Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ U MA MWL/L -------- uK MMOL/L -------- NA EXC KNOL -------- K EXC MMOL -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 19 12.0 10 21 16.5 10 is 11.0 10 20 15.4 10 61 47.7 10 70 73.0 10 73 76.5 10 57 51.3 10 .25 .062 la .26 .139 10 .22 .132 10 .31 .098 10 .74 .256 10 .66 .214 10 .65 .244 10 .72 .271 10 104-WEEK Table 38 Sumary of Urine Chemistry Data Males Week 14 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ U NA MMOL/L -------- UK KNOL/L -------- NA EXC MMOL -------- x EXC MMOL -------- 0 MEAN S.D. N 1 MEAN S.D. N 24 16.7 10 30 14.3 10 80 72.9 10 89 43.9 10 .3S .079 9 .51 .151 9 1.06 .227 9 1.53 .425 9 Table 38 Suimnary of Urine Chemistry Data Females Week 14 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAHIDO ETHANOL IN RATS DOSE PPM ------ U NA MMOL/L uK HMOL/L NA EXC MMOL K EXC MMOL -------- -------- -------- -------- 0 MEAN S.D. N 26 12.0 10 76 34.6 10 .22 .119 9 .64 .273 9 1 MEAN S.D. N 18 12.0 10 51 41.3 10 .22 .126 8 .56 .333 8 104-WEEK Table 39 summary of Urine Chemistry Data Males Week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO E"niANOL IN RATS DOSE PPM ------ U NA MMOL/L -------- uK MMOL/L -------- NA EXC UNOL -------- K EXC MMOL -------- 0 KEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 28 15.9 10 34 11.2 10 46 20.5 10 43 25.3 10 102 47.8 10 102 34.0 10 135 76.2 10 114 56.2 10 .37 .227 10 .46 .227 10 .43 .197 10 .46 .186 9 1.30 .281 10 1.26 .274 10 1.12 .266 10 1.26 .413 9 Table 39 Summary of Urine Chemistry Data Females Week 27 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE ppm ------ U NA MMOL/L -------- uK KHOL/L -------- NA EXC KNOL -------- X EXC MMOL -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 23 16.1 10 29 22.9 10 21 10.7 9 27 20.8 10 85 58.0 10 66 43.7 10 52 20.2 9 78 38.4 10 .24 .164 8 .26 .148 9 .24 .133 a .27 .098 10 .81 .318 8 .61 .173 9 .57 .229 a .81 .191 10 Table 40 Summary of Urine Chemistry Data Males Week 27 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE ppm ------ U NA MMOL/L UK MMOL/L NA EXC MMOL K EXC MMOL -------- -------- -------- -------- 0 MEAN S.D. N 18 9.3 10 112 52.8 10 .18 .062 10 1.11 .383 10 MEAN S.D. N 26 18.7 10 151 123.3 10 .24 .135 9 1.34 .363 9 104-WEEK Table 40 Summary of Urine Chemistry Data Females Week 27 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (90.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ U 14A MMOL/L UK MMOL/L NA EXC MOL K EXC MMOL -------- -------- -------- -------- 0 MEAN S.D. N 1 MEAN S.D. N 16 16.3 10 10 7.1 9 101 83.6 10 70 47.4 9 .08 .025 8 .14 .057 9 .61 .212 .96 .383 9 Table 41 Summary of Urine Chemistry Data Males Week 53 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE PPM ------ U NA MMOL/L -------- UK MMOL/L -------- NA EXC MMOL -------- K EXC MMOL -------- 0 MEAN S.D. N 23 9.5 10 110 S2.S 10 .28 .077 1.50 .296 3 MEAN S.D. 11 30 MEAN S.D. N 100 MEAN S.D. N 27 7.2 10 28 11.2 10 28 12.5 10 141 60.8 10 136 61.5 10 116 58.9 10 .33 .102 10 .39 .221 10 .38 .142 9 1.62 .273 10 1.63 .462 10 1.45 .335 9 Table 41 summary of urine chemistry Data Females Week 53 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.ltl N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE ppm ------ U NA MMOL/L UK HMOL/L NA EXC MMOL K EXC MMOL -------- -------- -------- -------- MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 29 16.8 10 29 23.4 10 24 12.6 10 31 27.4 10 88 40.9 10 92 68.9 10 101 60.4 10 113 82.0 10 .33 .206 10 .26 .086 8 .24 .107 9 .28 .107 10 .91 .240 10 .87 .283 a .98 .395 9 1.01 .329 10 104-WEEK Table 42 Summary of Urine Chemistry Data Males Week 53 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN PATS DOSE PPM ------ U NA MMOL/L UK MMOL/L NA EXC MMOL K EXC MMOL -------- -------- -------- -------- 0 MEAN S.D. N 20 13.0 10 143 68.2 10 .23 .135 9 1.61 .579 9 1 MEAN S.D. N 26 17.9 10 165 88.6 10 .20 .100 10 1.29 .256 10 104-WEEK Table 42 Summary of Urine Chemistry Data Females Week 53 DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS DOSE ppm ------ U NA MMOL/L uK MOL/L NA EXC MMOL K EXC MMOL -------- -------- -------- -------- 0 MEAN S.D. N 13 9.6 10 64 48.6 10 .25 .191 6 .93 .569 6 MEAN S.D. N 20 14.9 10 118 101.1 10 .18 .065 10 .93 .290 10 TABLE 43 sumnary of organ weight Data Week 4 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4,5;WEEKS=ALL DRATH=1:SUBSET=T LIVER -- -- --- ---- ---- ----- -- --- -- ---- - -- --- -- -- ------ -- ----- --- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY Wr WEIGHT BODY WT BRAIN WT SEX DOSE BODY WT WEIGHT BODY GROUP tg) lg) (%) RATIO GROUP (g) (g) (%) ---------------------------------------------------------------------------------------------------------------- m 1 - -- ---- -- - --- ----- --- --- -- ---- - p 1 ---- - ---- -- ----- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 350.7 33.3 5 10.8223 1.57S3 5 3.0744 0.1520 NUMBER IN GROUP: MEAN: STANDARD DEV: s 196.1 20.3 5 6.4594 0.41SS 5 3.317 0.367 ---------------------------------------------------------------------------------------------------------------- m 2 - -- ---- --- ----- ---- -- ---- -- --- - F 2 - --- -- --- ---- --- ----- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 362.8 32.S 5 10.7856 1.1739 5 2.9699 0.1104 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 209.0 29.8 s 6.7264 0.7320 5 3.232 0.14S ---------------------------------------------------------------------------------------------------------------- m 3 -- --- --- -- - ------ -- ---- -- --- -- - F 3 - --- -- --- ---- ---- --- ---- NUMBER IN GROUP: s s 5 NUMBER IN GROUP: s 5 s MEAN: 344.4 10.9453 3.1683 MEAN: 198.8 6.8324 3.437 STANDARD DEV: 28.5 1.5396 0.2257 STANDARD DEV: 17.2 0.6354 0.136 ---------------------------------------------------------------------------------------------------------------- TABLE 43 summary of Organ Weight Data week 4 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;CROUP=1,2,3,4,5;WEEKS=ALL DP-ATH=1;SUBSET=T LIVER - --- --- --- --- ---- -- ---- --- --- --- -- --- ---- -- ---- ---- --- --- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL BODY wr ORGAN WEIGHT ORGANBODY SEX DOSE BODY Wr WEIGHT BODY WT (%) BRAIN Wr RATIO SEX DOSE GROUP (g) (g) (%) ----G-RO-U-P---------------(-g--)-------(-g-)------------------------------------------------------------------------------ m 4 F 4 - ---- --- -- --- --- --- -- ---- --- -- - NUMBER IN GROUP: ME": STANDARD DEV: 5 343.8 36.4 5 12.2371 0.9341 5 3.5708 0.2090 NU-MBE-R - I-N -GR-OUP-: - - - - -5- - - -5 - - - - - -5 - - MEAN: 191.3 7.1709 3.757 STANDARD DEV: 13.1 0.5706 0.34 --------------------------------------------------------------------------------------------------------------- m 5 F 5 NU-MBE-R - -IN -GR-OUP-: - - - - -5 - - - -5 - - - - - -5 - - - - - - - - - MEAN: 310.0 15.7639 S.0860 STANDARD DEV: 28.3 1.4058 0.1240 NU-MB-ER - -IN -GR-OU-P: HEM: STANDARD DEV: 5 181.6 15.1 5 9.2338 1.4896 5 5.10 0.81 --------------------m--------------------------------------- --- ------------------------------------ TABLE 44 summary of organ Weight Data Week 4 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-MYL PE"LUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP--8,9;WEEKS=ALL DEATH=1;SUBSET=T LIVER - -- -- ----- -- --- --- --- --- -- ---- -- -- ---- -- ----- --- ---- ----- SEX DOSE TERMINAL BODY WT ORGAN WEIGHT ORGAN-TOBODY WT ORGAN-TOBRAIN WT SEX DOSE TERMINAL BODY Wr ORGAN WEIGHT ORGAN-T( BODY w GROUP (a) (g) (It) RATIO GROUP (,g) (g) (%) ---------------------------------------------------------------------------------------------------------------- N 8 -- --- -- --- --- --- -- ----- -- --- --- F a --- --- -- ----- --- ----- --- NUMBER IN GROUP: ME": STANDARD DEV: 5 314.0 18.3 5 11.5023 1.4141 5 3.6573 0.3062 NUMBER IN GROUP: MEAN: STANDARD DKV: 5 199.2 14.9 5 7.7008 0.9577 5 3.860 0.278 ---------------------------------------------------------------------------------------------------------------- m 9 -- --- -- --- --- --- -- --- ---- -- --- - p 9 --- --- -- ---- --- ----- --- - NUMBER IN GROUP: MEANSTANDARD DEV: s 308.7 14.1 5 11.1683 0.9088 5 3.6223 0.3092 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 218.0 20.1 5 8.1095 1.1330 5 3.721 0.379 ---------------------------------------------------------------------------------------------------------------- TABLE 45 Summary of Organ Weight Data Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDESSMC=ALL;GROUP=1,5;WBM=ALL DEATH=2;SUBSET--ALL LEFT ADRENAL - --- --- -- --- --- --- --- --- --- --- -- --- -- --- --- ---- --- --- --- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY WT WEIGHT BODY Wr BRAIN Wr SEX DOSE BODY WT WEIGHT BODY GROUP 10) (a) (t) RATIO GROUP (g) (0) (%) --------------------------------------------------------------------------------------------------------------- m 1 -- ---- - --- --- --- --- --- -- --- ---- F 1 --- -- --- ---- --- --- --- --- NUMBER IN GROUP: MHM-. STANDARD DEV: 5 442.3 31.8 5 0.0319 0.0042 5 0.0072 0.0013 5 0.0146 0.0020 NUMBER IN GROUP: MEAN: STANDARD DEV- 5 257.4 31.4 5 0.0400 0.0077 5 0.01 0.00 --------------------------------------------------------------------------------------------------------------- u 5 --- --- -- --- --- -- ---- -- --- --- --- F 5 --- -- --- ---- ---- -- ---- -- NUMBER IN GROUP: MEAN: STANDARD DEV: s 317.3* 50.6 s 0.0278 O.OOS6 s 0.0088 0.0018 s 0.0136 0.0029 NUMBER IN GROUP: HEM- STANDARD DEV: 5 170.3* 14.1 5 0.0304* 0.0043 5 0.01 0.00 --------------------------------------------------------------------------------------------------------------- TABLE 45 Co, summary of Organ Weight Data Week 8 Sacrifice 104-WMM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL pERpLvoRoocTANESULPONAMIDO ETHANOL IN RATS ---------------------------------------------------------------------------------------------------------------------- TABLE INCLTIDESSEX=ALL;CROVP=1,5:WEMXS=ALL DEATH=2;SVBSET--ALL RIGHT ADRENAL -- -- ----- -- -- --- -- --- --- -- ---- -- -- --- -- ---- ---- -- ----- --- - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO- SME DOSE BODY Wr WEIGHT BODY Wr BRAIN WT SEX DOSE BODY.WT WEIGHT BODY Wr GROUP (g) (v) (%) RATIO GROUP (a) (g) (%) ------------------------------------------------------------------------------------------------------------------- m 1 -- ---- --- -- --- ---- -- -- --- --- -- - p 1 --- --- -- ---- --- ---- ---- --- NUMBER IN GROUP- MEAN: STANDARD DEV: 5 442.3 31.8 5 0.0295 0.0029 5 0.0067 0.0011 5 0.0136 0.0014 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 257.4 31.4 5 0.0373 0.0060 5 0.0145 0.0014 ------------------------------------------------------------------------------------------------------------------- u 5 - --- ---- -- - ---- --- -- --- -- --- -- - p s --- --- -- ---- --- --- --- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 317.3* 50.6 s 0.0261 0.0064 5 0.0082 0.0013 5 0.0126 0.0024 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 170.3* 14.1 5 0.0283 0.0078 5 0.0166 0.0043 ------------------------------------------------------------------------------------------------------------------- TABLE 45 Sumary of organ Weight Data Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198-141 N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SRX=ALL,GROUP=1,5;WERXS=ALL DRATH=2;SUBSETzALL BRAIN --- -- ---- --- -- --- ---- -- --- --- -- - ---- --- --- --- ---- --- ----- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-7 SME DOSE BODY Wr WRIGHT BODY Wr BRAIN WT S13X DOSE BODY WT WRIGHT BODY W, GROUP (u) (g) (t) RATIO GROUP (.g) fg) (%) ---------------------------------------------------------------------------------------------------------------- m 1 -- ---- ---- - ---- -- --- ---- --- -- -- p 1 - -- ---- --- --- ---- --- ---- NUMBER IN GROUP: MEAN- STANDARD DEV: 5 442.3 31.9 5 2.1728 0.0240 5 0.4934 0.0382 5 1.0000 0.0000 NUMBER IN GROUP: MEAN: STANDARD DEV: s 257.4 31.4 5 2.0222 0.0981 5 0.791 0.068 ---------------------------------------------------------------------------------------------------------------- m 5 - -- ---- --- - ---- -- --- --- --- --- -- p 5 --- --- ---- -- ---- --- ----- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 317.3* 50.6 s 2.0419 0.1770 5 0.6519* 0.0594 5 1.0000 0.0000 NUMBER IN GROUP: NM- STANDARD DEV: s 170.3* 14.1 5 1.8176* 0.1064 5 1.070 0.066 ---------------------------------------------------------------------------------------------------------------- TABLE 45 summary of organ Weight Data Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,5;WEEKS=ALL DEATH=2;SUBSET=ALL KIDNEY -- -- --- ---- --- ---- -- ----- --- -- - --- --- -- ---- -- ---- ----- -- 72=INAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-T( SEX DOSE BODY WT WEIGHT BODY WT BRAIN Wr SEX DOSE BODY WT WEIGHT BODY W. ----G-RO-U-P----------------(-g-)-------1-0)----------1-%)--------R-AT-I-O------------G-RO-U-P---------------1-g--)--------1-0)----------(-%-)--- m 1 -- -- --- ---- ---- --- --- --- --- --- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 442.3 31.8 s 1.4309 0.13SO s 0.3240 0.0269 s 0.6586 0.0623 F I --- --- -- ---- -- ---- ----- - NUMBER IN GROUP: MEAN: STANDARD DEV-. 5 257.4 31.4 5 0.9220 0.1189 5 0.358 0.026 ---------------------------------------------------------------------------------------------------------------- u s -- -- --- --- - --- --- --- ---- --- -- -- F 5 - ---- -- --- --- ---- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 317.3* 50.6 5 1.4077 0.2404 s 0.4435* 0.0220 5 0.6856 0.0805 NUMBER IN GROUP: MRANI STANDARD DEV: 5 170.3* 14.1 s 0.7974* 0.0384 5 0.464 0.030 ---------------------------------------------------------------------------------------------------------------- TABLE 45 c summary of organ Weight Data week 8 sacrifice 104-WE33K DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98-1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,5;WBM=ALL DRATHr.2;SUBSET--ALL RIGHT KIDNEY -- -- --- --- - --- ---- --- -- ----- -- -- -- --- --- --- -- ---- ----- -- -- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT SEX DOSE BODY Wr WEIGHT BODY WT GROUP (g) (g) (%) RATIO GROUP (g) (g) (%) ------------------------------------------------------------------------------------------------------------------ u 1 --- -- ---- - --- --- --- ---- -- --- --- p I --- --- -- --- --- --- ---- ---- NUMBER IN GROUP: uM : STANDARD DEV: 5 442.3 31.8 s 1.4168 0.1080 5 0.3207 0.0177 s 0.6520 0.0489 NUMBER IN GROUP: MEANSTANDARD DEV: 5 2S7.4 31.4 s 0.9348 0.1123 s 0.3637 0.0252 ----------------------------------------------------------------------------------------------------------------- x 5 - --- --- -- - ---- -- --- ---- -- --- -- - F 5 --- --- -- --- --- --- ---- --- - NUMBER IN GROUP: MEAN: STANDARD DEV: s 317.3* 50.6 5 1.4785 0.29SO 5 0.4640* 0.0242 5 0.7191 0.1033 NUMBER IN GROUPT MEAN: STANDARD DEV: s 170.3* 14.1 5 0.7994* 0.0471 s 0.4710 0.0323 ----------------------------------------------------------------------------------------------------------------- TABLE 45 Suounary of Organ Weight Data Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE iga.lpi) N-VMYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: S=--ALL,GROUP=1,5;WEKKS=ALL DRATH=2;SUBSRT--ALL LIVER --- --- --- -- --- --- --- -- ---- --- -- - -- -- --- -- --- --- ---- ----- - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO SM DOSE BODY WT WRIGHT BODY WT BRAIN WT SME DOSE BODY Wr WEIGHT BODY WT GROUP (g) (g) (%) RATIO GROUP (g) (g) (%) ----------------------------------------------------------------------------------------------------------------- x 1 -- -- ---- -- -- --- -- ---- --- --- --- - F 1 - --- --- -- ---- -- ----- ---- - NUMBER IN GROUP: MM: STANDARD DEV: 5 442.3 31.8 5 11.4244 1.6279 5 2.SI34 0.2217 5 5.2S7$ 0.7478 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 257.4 31.4 5 7.2921 0.7864 5 2.8388 0.1299 ---------------------------------------------------------------------------------------------------------------- m 5 -- --- --- -- -- --- -- --- ---- -- --- -- p 5 - --- -- --- --- --- --- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 317.3* 50.6 5 21.6104* 3.4376 s 6.8321* O.S778 5 10.5688* 1.4711 NUMBER IN GROUP: MM: STANDARD DEV: 5 170.3* 14.2 5 11.1394* 0.7420 5 6.9106 0.3939 ---------------------------------------------------------------------------------------------------------------- TABLE 45 Summary of Organ Weight Data Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=I,S;WM3KS=ALL DEATH=2;SUBSET--ALL LUNG - --- --- -- -- ---- -- --- --- --- --- --- - --- ----- -- --- -- ---- ----- TERMINAL ORGAN ORGM-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN WT SEX DOSE BODY WT WEIGHT BODY Wr GROUP (g) (g) (%) RATIO GROUP (g) (g) (%) ----------------------------------------------------------------------------------------------------------------- m 1 - --- -- ---- -- -- --- --- --- ---- -- -- F 1 - --- ---- --- --- --- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 442.3 31.8 s 1.4802 0.1217 5 0.3350 0.0213 5 0.6809 0.0501 NUMBER IN GROUP: NEW: STANDARD DEV: 5 2S7.4 31.4 5 1.2S46 0.1756 s 0.4874 0.0348 ----------------------------------------------------------------------------------------------------------------- m 5 - --- -- --- -- --- --- -- --- ---- -- -- - p 5 --- --- ---- --- -- --- ----- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 317.3* 50.6 5 1.2530 0.2690 5 0.3928* 0.0306 5 0.6091 0.0971 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 270.3* 14.1 5 0.8541* 0.0609 5 0.5028 0.0340 ----------------------------------------------------------------------------------------------------------------- TABLE 45 Sumnary of Organ Weight Data Week 8 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98-1t) X-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TA13LE INCLUDES: SEX=ALL;GROUP=1,5;WlgMnALL DRATH=2;SUBSET-ALL LE" OVARY - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - TERMINAL ORGAN ORGAN-70- ORr.AN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT SEX DOSE BODY WT WEIGHT BODY GROUP (a) lg) (%) RATIO GROUP (a) (a) (t) --------------------------------------------------------------------------------------------------------------- m 1 --- -- ---- -- --- --- -- -- --- ---- -- - F 1 -- --- ---- --- --- -- ------ - NUMBER IN GROUP: NM- STANDARD DEV: s 442.3 31.8 NUMBER IN GROUP: KEAN: STANDARD DEV: 5 25'7.4 31.4 5 0.0663 0.0160 5 0.02 0.00 --------------------------------------------------------------------------------------------------------------- N 5 - --- --- -- --- -- --- -- -- ---- -- --- - p 5 -- -- ----- -- --- --- ----- -- NUMB13R IN GROUP: MEAN: STANDARD DEV: 5 317.3* 50.6 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 170.3* 14.1 5 0.0468* 0.0078 5 0.02 0.00 --------------------------------------------------------------------------------------------------------------- TABLE 45 Summary of Organ Weight Data Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PB"LUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,5;WEEKS=ALL DEATH=2;SUBSBT=ALL RIGHT OVARY - --- -- -- --- ---- --- -- --- ---- -- --- - --- --- ---- --- -- ----- ---- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TK SEX DOSE BODY Wr W13IGHT BODY WT BRAIN Wr SEX DOSE BODY WT WRIGHT BODY M GROUP (g) (g) (t) RATIO GROUP (g) (g) (%) ---------------------------------------------------------------------------------------------------------------- N 1 - --- --- - ----- -- --- ---- -- --- --- - F 1 -- -- --- ---- --- --- --- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 442.3 31.8 NUMBER IN GROUP: IMM: STANDARD DEV: 5 257.4 31.4 5 0.0733 0.0184 5 0.028 0.004 ---------------------------------------------------------------------------------------------------------------- m 5 -- --- -- -- ---- -- --- --- --- -- --- -- p 5 - --- -- ----- --- -- --- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 317.3* 50.6 NUMBER IN GROUP: MEAN: STANDARD DKV.* s 170.3* 14.1 5 0.0527 0.0085 5 0.031 0.005 --------------------------------------------------------------------------------------------------------------- TABLE 45 Summary of Organ Weight Data Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (.9a.,*) N-ETHYL PERFLUOROOCTANESULFONAmiDo ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=I,S;WMM=ALL DRATH=2;SUBSET--ALL SPLEEN -- --- -- --- -- --- --- --- -- --- ---- -- -- --- -- ---- --- -- ---- ----- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-To SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN Wr SM DOSE BODY Wr WEIGHT BODY Wr GROUP (g) (a) (t) RATIO --------------------------------------------------------------- GROUP (u) (g) (t) -------------------------------------------------- n I -- -- --- --- -- --- --- -- -- --- ---- -- p I - --- -- --- --- ---- -- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV. s 442.3 31.8 5 0.7326 0.1440 5 0.1646 0.0248 5 0.3372 0.0666 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 257.4 31.4 5 0.4972 0.0520 5 0.1942 0.0188 ----------------------------------------------------------------------------------------------------------------- m 5 - --- -- -- --- --- --- -- -- --- --- ---- p 5 --- -- --- --- -- --- ---- ---- - NUMBER IN GROUP: MEAN.STANDARD DEV: 5 317.3* 50.6 5 o.s9ol 0.1298 5 0.1852 0.0199 s 0.2869 0.0482 NUMBER IN GROUP: MRAN: STANDARD DEV: 5 170.3* 14.1 5 0.3599* 0.0407 5 0.2127 0.0312 ----------------------------------------------------------------------------------------------------------------- TABLE 45 Summary of Organ Weight Data Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-BTHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,5;WEMM=ALL DRATH=2;SUBSET--ALL LEFT TESTIS --- -- --- --- - ----- -- --- -- ---- --- - -- --- -- ----- -- ---- ---- --- SME DOSE TERMINAL BODY Wr ORGAN WEIGHT ORGAN-TOBODY Wr ORGAN-TOBRAIN WT SEX DOSE TERMINAL BODY WT ORGAN WEIGHT ORGAN-TO BODY Wr GROUP (a) (g) (%) RATIO GROUP (g) 10) (%) ----------------------------------------------------------------------------------------------------------------- m 1 - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - F 1 - -- -- --- ---- --- --- ----- -- NUMBER IN CROUP: MF.AN: STANDARD DEV: 5 442.3 31.8 5 1.4941 0.1390 5 0.3318 0.0185 5 0.6875 0.0615 NUUM IN GROUP: MEAN: STANDARD DEV: 5 257.4 31.4 ----------------------------------------------------------------------------------------------------------------- N 5 - -- -- ---- -- - ----- --- -- ---- --- -- F 5 - -- -- --- ---- --- --- ----- -- NUMBER IN GROUP: ME": STANDARD DEV: 5 317.3* SO.6 5 1.7s29* 0.1520 5 0.5580* 0.0501 5 0.8581* 0.0633 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 170.3* 14.1 ---------------------------------------------------------------------------------------------------------------- TABLE 45 c Summary of Organ Weight Data Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SRX=ALL;GROUP=1,5;WEEKS=ALL DRATH=2:SUBSET--ALL RIGHT TESTIS ---- -- -- --- - --- ---- -- --- --- --- - ---- --- -- --- ---- -- ---- ---- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO- SEX DOSE BODY WT WRICHT BODY WT BRAIN WT SLEX DOSE BODY Wr WEIGHT BODY WT GROUP (a) (a) (%) RATIO GROUP (g) (a) (%) ------------------------------------------------------------------------------------------------------------------ x 1 - --- -- --- -- -- ---- --- -- ---- --- -- F 1 - --- --- --- --- --- -- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 442.3 31.8 5 1.5159 0.1642 5 0.3424 0.0221 5 0.6976 0.0746 NUMBER IN GROUP: MEAN: STANDARD DEV: s 257.4 31.4 ------------------------------------------------------------------------------------------------------------------ m 5 -- --- -- -- -- --- --- -- ---- --- --- -- p s - -- ---- -- ---- --- -- ---- --- NUMBER IN GROUP: HEM: STANDARD DEV.- 5 327.3* 50.6 5 1.7399 0.1642 5 O.SS3S* 0.0492 5 0.8511* 0.0601 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 170.3* 14.1 ----------------------------------------------------------------------------------------------------------------- TABLE 45 Summary of Organ Weight Data Week 8 Sacrifice 104-Wi= DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDESSEX=ALL;GROUP-I,S;WREK.S-ALL DEATH=2;SUBSBT=ALL LEFT THYROID/PAR --- --- --- -- -- ---- --- --- --- --- -- - - --- --- -- -- -- -- ---- ---- - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO SEX DOSE BODY Wr WRIGHT BODY WT BRAIN WT SEX DOSE BODY WT WEIGHT BODY Wr GROUP (g) (a) (%) RATIO GROUP (g) (a) (%) ----------------------------------------------------------------------------------------------------------------- m 1 - --- --- -- -- --- --- --- ---- -- -- --- p 1 -- -- --- --- ---- -- ---- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 442.3 31.8 4 0.0128 0.0026 4 0.0028 0.0006 4 0.0059 0.0012 NUMBER IN GROUP: uM : STANDARD DEV: 5 257.4 31.4 5 0.0083 0.0021 5 0.0032 0.0007 ----------------------------------------------------------------------------------------------------------------- m 5 - ---- -- -- -- -- ---- --- ---- -- -- --- p s - --- -- --- ---- --- --- ---- -- NUMBER IN GROUP- MEAN: STANDARD DEV: 5 317.3* 50.6 4 0.0093 0.0015 4 0.0031 0.0009 4 0.0047 0.0012 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 170.3* 14.1 4 0.0076 0.0022 4 0.0043 0.0013 ----------------------------------------------------------------------------------------------------------------- TABLE 45 Summary of organ Weight Data Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: STX=ALL: CROUP=L, S; WEEKS=)LLL DEATH=2;SUBSET--ALL RIGHT THYROID/PR - --- ---- -- -- -- ----- -- --- -- ---- -- --- -- --- --- ---- --- -- ----- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY Wr WEIGHT BODY WT BRAIN WT SEX DOSE BODY Wr WRIGHT BODY GROUP (g) (g) (t) RATIO GROUP (0) (g) (t) ---------------------------------------------------------------------------------------------------------------- x I --- --- -- -- -- ----- -- --- -- --- --- - F 1 --- -- --- --- ---- --- -- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 442.3 31.8 s 0.0113 0.0049 5 0.0025 0.0010 5 0.0052 0.0022 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 257.4 31.4 s 0.0074 0.0022 5 0.002 0.000 ---------------------------------------------------------------------------------------------------------------- m s - --- --- -- -- -- ---- -- --- --- -- --- - F s - - - - - - - - - - - -- - - - - - - - - - - - NUMBER IN GROUP: HE": STANDARD DEV: 5 317.3* 50.6 5 0.0102 0.0033 s 0.0032 0.0009 5 O.OOSO 0.0015 NUMBER IN GROUP: MEAN: STANDARD DEV: s 170.3* 14.1 s 0.0078 0.0024 s 0.004 0.001 ---------------------------------------------------------------------------------------------------------------- TABLE 45 summary of organ Weight Data Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98-1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SM=ALL;GROUP=I,S;WRM=ALL DRATH=2;SUBSET--ALL UTERUS -- --- -- --- - --- ---- --- --- -- --- --- -- --- -- --- ---- --- ---- -- -- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-D SBX DOSE BODY Wr WEIGHT BODY WT BRAIN WT SEX DOSE BODY WT WEIGHT BODY W GROUP (a) (a) 1%) RATIO GROUP (g) (g) (%) ---------------------------------------------------------------------------------------------------------------- m I -- --- -- ---- - --- --- --- -- --- --- -- NUMBER IN GROUP: MEAN: 5 442.3 STANDARD DEV: 31.8 p 1 NU-MB-ER - -IN -GR-OU-P: - - - - -5 - - - -5 - - - - - -5 - - MEAN: 257.4 0.5992 0.233 STANDARD DEV: 31.4 0.1269 0.046 ---------------------------------------------------------------------------------------------------------------- m 5 -- -- --- -- -- -- ----- -- -- --- --- --- p 5 - -- -- ---- ---- --- --- -- --- NUMBER IN GROUP: MFJW: STANDARD DEV: 5 317.3* SO.6 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 170.3* 14.1 5 0.4823 0.1903 5 0.282 0.107 ---------------------------------------------------------------------------------------------------------------- TABLE 46 Sunnary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PMTFLUOROOCTAKESULPONAKIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WZM=ALL DRATH=3,SUBSET--ALL LEFT ADRENAL --- --- -- --- - ---- -- --- --- ---- --- - --- -- --- --- --- -- ----- --- SME DOSE TERMINAL BODY WT ORGAN WEIGHT ORGAN-TOBODY Wr ORGAN-TOBRAIN WT SRX DOSE TERMINAL BODY Wr ORGAN WEIGHT ORGANBODY GROUP (g) (u) (t) RATIO GROUP (0) (g) (%) --------------------------------------------------------------------------------------------------------------- x 1 - --- -- --- -- -- ---- --- -- --- ---- -- p 1 - -- -- --- ---- -- ----- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: s 53S.9 S4.5 s 0.0373 0.0090 s 0.0069 0.0008 s 0.0168 0.0035 NUMBER IN GROUP: MEAN: STANDARD DEV: s 291.3 46.9 s 0.0336 O.OOS2 s 0.01 0.00 --------------------------------------------------------------------------------------------------------------- m 2 -- -- --- -- -- -- ----- -- -- --- ---- -- NUKBER IN GROUP: MEAN: STANDARD DEV: 5 531.5 24.6 5 0.0277 0.0061 5 0.0052 0.0013 5 0.0127 0.0031 p 2 - -- --- --- --- -- ----- ---- - NUMBER IN GROUP: 5 5 5 HEM: 2SS.2 0.0360 0.01 STANDARD DEV: 30.7 0.0055 0.00 -------------------------------------------------------------------------------------------------------------- x 3 -- --- -- -- -- -- ---- --- -- --- ---- -- F 3 - -- --- -- --- --- --- ------ - NUMBER IN GROUP: HEM: STANDARD DEV: 5 539.3 70.5 5 0.0295 0.0022 5 0.0055 0.0007 5 0.0129 0.0010 NUMBER IN GROUP: MEAN: STANDARD DEV- 5 264.2 31.1 5 0.0369 0.0077 5 0.01 0.00 -------------------------------------------------------------------------------------------------------------- TABLE 46 Summary of organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98-1%) N-ETHYL pmwLuoROOCTANEsut.PONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL LEFT ADRENAL -- --- -- --- --- --- --- --- -- ---- --- - --- -- -- ----- -- --- ---- ---- TERMINAL ORGAN ORGAN-TO- ORGAN-IM- TERMINAL ORGAN ORGAN-A SME DOSE BODY Wr WEIGHT BODY Wr BRAIN Wr SEX DOSE BODY Wr WEIGHT BODY Wl GROUP (g) (g) RATIO (%) GROUP (0) (a) (%) ---------------------------------------------------------------------------------------------------------------- x 4 p 4 --- -- -- --- --- --- -- ---- -- --- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 473.3 39.1 5 0.0303 0.0034 5 0.0065 0.0011 5 0.0139 0.0019 -- -- --- ---- --- -- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 236.9 21.2 5 0.0322 0.0049 5 0.013 0.002 ---------------------------------------------------------------------------------------------------------------- TABLE 46 Sumnary of Organ weight Data Week 14 Sacrifice 104-WMM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (9g.1%) N-ETHYL PMWLUOROOCTANESULPoNAMiDo ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WEMZS=ALL DEATH=3;SUBSBT--ALL RIGHT ADRENAL ---- -- --- -- --- ---- -- -- --- ---- -- - - --- --- ---- --- --- ---- -- -- SEX DOSE TERMINAL BODY Wr ORGAN WRIGHT ORGAN-TOBODY Wr ORGAN-TOBRAIN Wr SEX DOSE TERMINAL BODY WT ORGAN WEIGHT ORGAN-To BODY Wr GROUP (a) (a) (%) RATIO GROUP (g) (0) (t) ----------------------------------------------------------------------------------------------------------------- x I --- --- -- -- --- --- -- --- --- --- ---- F 1 -- --- ---- --- --- -- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: s S3S.9 54.5 5 0.0353 0.0076 5 0.006S 0.0009 5 o.ols9 0.0033 NUMBER IN GROUP: HE": STANDARD DEV: 5 291.3 46.9 5 0.0337 0.0071 5 0.0119 0.0034 ----------------------------------------------------------------------------------------------------------------- x 2 - -- ---- -- -- --- --- -- --- -- ---- --- F 2 -- --- ---- ---- --- -- --- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 531.S 24.6 5 0.0256* 0.0043 5 0.0048* 0.0009 5 0.0118 0.0023 NUMBER IN GROUP: lam: STANDARD DEV: 5 255.2 30.7 5 0.0336 0.0052 5 0.0132 0.0016 ----------------------------------------------------------------------------------------------------------------- x 3 -- -- --- --- -- --- -- -- --- --- ---- -- NUMBER IN GROUP: 5 5 5 5 MEAN: 539.3 0.0273 0.0051* 0.0119 STANDARD DEV: 70.5 0.0034 0.0004 0.0012 F 3 - -- --- ----- -- --- -- --- ---- NUMBER IN GROUP: MEAN.- 5 264.2 5 0.0345 5 0.0131 STANDARD DEV: 31.1 0.0059 0.0019 ---------------------------------------------------------------------------------------------------------------- TABLE 46 sumnary of organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98-1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: MM=ALL;CROUP=1,2,3,4;WEM=ALL DEATH=3;SUBSBT=ALL RIGHT ADRENAL - --- --- -- -- ---- --- -- ---- --- -- --- - --- ---- --- --- --- ---- --- TERMINAL ORGAN ORGAN-TO- ORGAN-70- TERMINAL ORGAN ORGAN- SME DOSE BODY Wr WEIGHT BODY WT BRAIN Wr SEX DOSE BODY WT WEIGHT BODY GROUP (g) (g) (%) RATIO CROUP (4) (a) (t) --------------------------------------------------------------------------------------------------------------- m 4 p 4 - --- -- --- -- --- ---- -- ---- -- --- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 473.3 39.1 s 0.0286 0.0030 5 0.0061 0.0009 s 0.0131 0.0018 - -- --- ---- ---- -- --- ----- NUMBER IN GROUP: MEAN: STANDARD DEV: s 236.9 21.2 s 0.0307 0.0036 5 0.01 0.00 --------------------------------------------------------------------------------------------------------------- TABLE 46 sunnary of organ weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTMESULRONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDESSEX=ALL;GROUP=1,2,3,4:WEEKS=ALL DRATH=3;SUEMET--ALL BRAIN ---- -- --- -- -- ---- --- --- -- --- --- - --- -- --- ----- --- --- ---- - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT SEX DOSE BODY WT WEIGHT BODY GROUP (a) (a) (f*) RATIO citovp (u) (a) (%) --------------------------------------------------------------------------------------------------------------- N 1 - --- ---- -- - ---- --- --- --- -- -- --- F I -- -- -- --- ---- --- --- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 535.9 S4.S 5 2.2215 0.0445 5 0.4182 0.0452 5 1.0000 0.0000 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 291.3 46.9 5 1.9905 0.0791 5 0.69 0.10 --------------------------------------------------------------------------------------------------------------- m 2 -- --- -- --- - ---- --- --- --- -- -- --- p 2 - --- -- --- ---- --- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 531.5 24.6 5 2.1920 0.0960 5 0.4126 0.0123 5 1.0000 0.0000 NUMBER IN GROUP: HE": STANDARD DEV: 5 255.2 30.7 5 1.9423 0.1026 5 0.76 0.05 -------------------------------------------------------------------------------------------------------------- x 3 -- --- --- -- - ---- ---- -- --- -- -- --- p 3 - --- -- --- ---- --- --- ---- - NUMBER IN GROUP: MEAN: STANDARD DRV: s 539.3 70.5 5 2.2818 0.1054 5 0.4273 0.0430 5 1.0000 0.0000 NUMBER IN GROUP: xM : STANDARD DEV: 5 264.2 31.1 5 1.9846 0.1121 5 0.75 0.06 -------------------------------------------------------------------------------------------------------------- TABLE 46 Sumary of Organ Weight Data week 14 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SM--ALL;GROUP=1,2,3,4;WEM=ALL DRATH=3;SURSLYT--ALL BRAIN TERMINAL - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- ORGAN ORGAN-TO SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN Wr SEX DOSE BODY vrr WEIGHT BODY WT GROUP (g) (g) (%) RATIO GROUP lg) (o) 1%) ---------------------------------------------------------------------------------------------------------------- x 4 F 4 -- --- -- - --- -- ----- --- --- -- -- --- NUMBER IN GROUP: MEAN: STANDARD DEV - 5 473.3 39.1 5 2.1861 0.0723 5 0.4642 0.0397 5 1.0000 0.0000 - --- -- --- ---- ---- --- ----- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 236.9 21.2 5 1.8793 0.1322 5 0.7961 0.-0609 ----------------------------------------------------------------------------------------------------------------- TABLE 46 c Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SME=ALL;GROUP=1,2,3,4;WBM=ALL DRATH=3;SUBSET--ALL LEFT KIDNEY --- --- -- --- - ---- --- ---- -- --- --- - - --- -- -- --- ---- -- ----- ---- TERMINAL ORGAN OPr.M-7V- ORGAN-70- TERMINAL ORGAN ORGAN-TO- SEX DOSE BODY Wr WEIGHT BODY WT BRAIN WT smc DOSE BODY WT WEIGHT BODY WT GROUP lg) (a) (%) RATIO GROUP (g) (g) (%) ------------------------------------------------------------------------------------------------------------------ m 1 -- --- -- --- - --- ---- --- --- -- --- -- F I -- -- -- -- ----- -- ---- ---- -- NUMBER IN GROUP: MEAN: STANDRRD DEV: 5 53S.9 54.5 5 1.9711 0.1974 s 0.3686 0.0233 5 0.8814 0.0880 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 291.3 46.9 5 1.1328 0.1492 5 0.3911 0.0263 ------------------------------------------------------------------------------------------------------------------ m 2 - --- -- --- -- - ---- -- ---- --- -- --- - p 2 --- -- -- --- --- --- --- ---- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 S31.5 24.6 5 1.9955 0.1575 5 0.3570 0.0307 5 0.8661 0.0818 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 255.2 30.7 5 0.9311 0.1262 5 0.36S8 0.0386 ------------------------------------------------------------------------------------------------------------------ x 3 ---- -- --- -- - ---- -- ---- --- -- -- -- p 3 - - - - - - - - - - - - - - - - - - - - - -- - - NUMBER IN GROUP: MRANT STANDARD DEV: 5 539.3 70.5 5 2.0805 0.2924 5 0.3863 0.0302 5 0.9111 0.1154 NUMBER IN GROUP: HE".- STANDARD DZV: 5 264.2 31.1 5 1.134S 0.1316 5 0.4307 0.0362 ------------------------------------------------------------------------------------------------------------------ TABLE 46 Summary of organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUPul,2,3,4;WRM=ALL DEATH=3;SUBSRT--ALL LEFT KIDNEY -- ---- --- -- -- --- --- --- --- --- --- - - -- --- --- --- ---- --- --- --- TERMINAL ORGAN OROM-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-T SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT SEX DOSE BODY Wr WEIGHT BODY W GROUP (g) (g) (t) RATIO GROUP (g) (g) (%) ---------------------------------------------------------------------------------------------------------------- m 4 F 4 ---- --- -- -- -- --- --- --- --- --- --- NUN= IN GROUP: MEAN: STANDARD DEV: 5 473.3 39.1 5 2.1488 0.2660 5 0.4535* 0.0313 5 0.9817 0.1017 - -- -- --- ---- --- --- --- --- NUMBER IN GROUP. MEAN: STANDARD DEVI 5 236.9 21.2 5 0.9648 0.1536 5 0.40S 0.030 ---------------------------------------------------------------------------------------------------------------- TABLE 46 summary of Organ Weight Data Week 14 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PMTPLUOROOCTANESULPONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES-. SME=ALL;GROUP-1,2,3,4;WBEKS=ALL DRATH=3;SUBSET--ALL RIGHT KIDN13Y - --- ---- -- --- -- --- ---- -- -- ---- -- -- --- --- --- ---- -- ---- ---- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO SME DOSE BODY WT WEIGHT BODY WT BRAIN WT SEX DOSE BODY Wr WEIGHT BODY Wr GROUP (a) (g) (%) RATIO GROUP (g) (g) ----------------------------------------------------------------------------------------------------------------- m 1 -- --- --- -- --- --- --- -- --- -- ---- - p I -- --- --- --- ---- -- --- ---- - NUMB13R IN GROUP: MEAN: STANDARD DEV: s 535.9 54.5 5 2.0585 0.2090 5 0.3846 0.0203 5 0.9265 0.0904 NUMBER IN GROUP: MEAN: STANDARD DEV: s 291.3 46.9 5 1.1236 0.1700 s 0.3874 0.0341 ----------------------------------------------------------------------------------------------------------------- m 2 --- --- -- -- ---- -- --- -- --- --- --- - NUMBER IN GROUP: MEAN: STANDARD DEV: s 531.S 24.6 5 1.9405 0.1411 5 0.36S6 0.0297 s 0.8873 0.0831 p 2 --- -- --- --- ---- --- -- ---- - NUMBER IN GROUP: MEAN: 5 255.2 5 0.9328 5 0.3652 STANDARD DEV: 30.7 0.1505 0.0354 ----------------------------------------------------------------------------------------------------------------- m 3 - --- --- - --- --- --- -- ---- -- -- --- - F 3 --- -- --- --- ---- --- -- ---- - NUMM ]INGROUPMEAN: STANDARD DEV: 5 539.3 70.5 5 2.0643 0.2531 s 0.383S 0.0209 5 0.9041 0.0972 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 264.2 31.1 5 1.1634 0.1471 s 0.4418 0.0451 ----------------------------------------------------------------------------------------------------------------- TABLE 46 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SRX=ALL;GROUP=1,2,3,4;WRBKS=ALL DEATH=3;SUBSET--ALL RIGHT KIDNEY ---- -- --- -- -- --- ---- --- -- --- --- - - --- -- --- ---- --- ---- --- -- TERMINAL ORGAN ORGAN-7V- ORGAN-TO- TERMINAL ORGAN ORGAN-TX SWE DOSE BODY WT WEIGHT BODY Wr BRAIN WT SEX DOSE BODY.WR WEIGHT BODY w GROUP (a) (a) (%) RATIO GROUP (9) (g) (%) ---------------------------------------------------------------------------------------------------------------- m 4 F 4 - --- -- -- --- ---- -- ---- --- -- --- -- NUMBER IN GROUP-. 5 5 5 5 MEAN: 473.3 2.1724 0.4581* 0.9929 STANDARD DEV.- 39.1 0.2812 0.0303 0.1136 - --- --- -- ---- ---- --- --- - NUMBER IN GROUP: MEAN: 5 236.9 5 0.9912 5 0.416 STANDARD DNV: 21.2 0.1534 0.030 ---------------------------------------------------------------------------------------------------------------- TABLE 46 Summary of Organ Weight Data Week 14 Sacrifice 104-WMM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE C98.1%) N-VMYL PE"LUOROOCTANESULPONAMIDO E7%MOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WEEKS=ALL DEATH=3;SUBSBT=ALL LIVER -- --- ---- -- -- --- --- --- --- -- --- -- --- -- --- --- ---- ---- --- -- SMC DOSE TERMINAL BODY Wr ORGAN WEIGHT ORGAN-TOBODY Wr ORGAN-TOBRAIN Wr SEX DOSE TERMINAL BODY WT ORGAN WEIGHT ORGANBODY GROUP 10) (u) (t) RATIO GROUP (a) (a) (t) --------------------------------------------------------------------------------------------------------------- x I ---- -- --- -- -- ---- --- -- --- --- --- NUMBER IN GROUPMEAN: STANDARD DEV: 5 53S.9 S4.5 5 is.9996 2.ISOS s 2.9783 0.1425 5 7.2008 0.9432 p 1 - - - - - - - -- - - - - - - - - - - - - - - - NUMBER IN GROUP: MEAN: STANDARD DEVT 5 291.3 46.9 5 8.7487 1.2794 5 3.00 0.12 --------------------------------------------------------------------------------------------------------------- m 2 - --- -- --- -- -- ---- --- -- -- ---- --- F 2 --- -- -- ---- --- ---- ---- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 531.5 24.6 s 15.6102 1.7249 5 2.9345 0.2531 5 7.124S 0.7384 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 255.2 30.7 s 7.4501 1.084S s 2.92 0.27 --------------------------------------------------------------------------------------------------------------- N 3 ---- -- -- --- -- --- --- --- -- --- --- - p 3 -- --- -- ---- --- ---- --- --- NUMB= IN GROUP: MEAN: STANDARD DEV: 5 539.3 70.5 s 18.0657 1.7387 5 3.3764 0.3717 5 7.9217 0.7535 NUMBER IN GROUP: HE". STANDARD DEV: 5 264.2 31.1 5 8.8944 1.3628 s 3.36 0.31 --------------------------------------------------------------------------------------------------------------- TABLE 46 sunnary of organ Weight Data Week 14 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,2,S,4;WBE"=ALL DRATH=3;SUBSET--ALL LIVER - --- -- ---- --- --- -- --- ---- --- --- - -- --- -- ---- --- --- ----- --- TERM31NAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY Wr WEIGHT BODY WT BRAIN WT SEX DOSE BODY WT WEIGHT BODY GROUP (g) (g) 1%) RATIO GROUP (a) (g) (%) ------------------------------------------------ --------------------------------------------------------------- x4 F4 - --- -- --- ---- -- --- --- --- ---- -- - MNOM IN GROUP: MEAN: STANDARD DEV: 5 473.3 39.1 5 24.2906* 3.5145 5 5.1173* 0.3964 5 11.1093* 1.5191 - --- --- -- ---- --- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 236.9 21.2 5 9.7445 1.1880 5 4.11 0.35 --------------------------------------------------------------------------------------------------------------- TABLE 46 summary of organ Weight Data Week 14 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WE M =ALL DEATH=3,SUBSET--ALL LUNG - -- --- --- -- --- --- --- -- ---- --- -- - - ---- -- --- --- --- --- ------ TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-7 SEX DOSE BODY Wr WRIGHT BODY WT BRAIN Wr SEX DOSE BODY.WT WRIGHT BODY M GROUP (g) (g) (%) RATIO GROUP (g) la) (%) ---------------------------------------------------------------------------------------------------------------- m 1 -- -- --- -- --- --- -- --- ---- -- --- -- p 1 -- --- --- -- --- -- ---- ----- NUMBER IN GROUP: MEAN: STANDARD DEV- 5 535.9 54.5 5 1.8736 0.1592 5 0.3510 0.0280 5 0.8428 0.0609 NUMBER IN GROUP: MM: STANDARD DEV: 5 291.3 46.9 5 1.2020 0.1063 5 0.418 0.055 ---------------------------------------------------------------------------------------------------------------- m 2 -- -- -- --- --- --- -- --- ---- -- --- -- p 2 - ---- -- --- --- -- --- ------ NUMBER IN GROUP: MEAN: STANDARD DEV: 5 531.5 24.6 5 1.7104 0.0972 5 0.3226 0.0267 5 0.7811 0.0493 NUMBER IN GROUP: HEM: STANDARD DEV: 5 25S.2 30.7 5 1.1997 0.1562 5 0.469 0.010 --------------------------------------------------------------------------------------------------------------- x 3 - --- -- --- --- -- --- --- --- --- --- -- P 3 ---- --- -- --- -- --- ------ - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 539.3 70.5 5 1.9907 0.2684 5 0.3701 0.0333 5 0.8707 0.0899 NUMBER IN GROUP: ]WAN: STANDARD DEV: 5 264.2 31.1 5 1.1830 0.0601 5 0.451 0.039 --------------------------------------------------------------------------------------------------------------- TABLE 46 summary of organ Weight Data Week 14 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL, -GROUP=1,2,3,4;WEEKS=ALL DRATH=3;SUBSET--A%LL LUNG - --- --- --- -- --- --- --- --- ---- -- -- -- ---- --- -- --- --- ---- ---- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SMC DOSE BODY Wr WEIGHT BODY Wr BRAIN WT SEX DOSE BODY Wr WEIGHT BODY GROUP (a) (a) (%) RATIO GROUP (0) (a) (%) ---------------------------------------------------------------------------------------------------------------- x 4 p 4 - --- --- --- -- -- --- --- --- ---- --- - NUMBER IN GROUP: HEAN3 STANDARD DEV: 5 473.3 39.1 s 1.6290 0.1108 5 0.3467 0.0448 5 0.7450 0.0411 NU-MB-ER - -IN -GR-OU-P- - - - - -5 - - - -5 - - - - - -5 - - MEAN: 236.9 1.0859 0.460 STANDARD DEV: 21.2 0.0776 0.03 ---------------------------------------------------------------------------------------------------------------- TABLE 46 Sunnary of Organ Weight Data Week 14 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.lP4) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WEEKS=ALL DEATH=3;SUBSBT--ALL LEFT OVARY - --- --- --- -- -- ---- --- --- --- ---- - -- --- -- ---- --- --- ---- ---- TERmnLYAL ORGAN ORGAN-TO- ORGAN-TD- TERMINAL ORGAN ORGAN-TO SEX DOSE BODY Wr WRIGHT BODY WT BRAIN WT smc DOSE BODY WT WRIGHT BODY WT GROUP (g) (g) 9%) RATIO GROUP (g) (g) (%) ----------------------------------------------------------------------------------------------------------------- m 1 -- --- --- -- -- --- --- ---- -- ---- --- p 1 -- --- ---- -- ---- --- --- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 535.9 S4.5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 291.3 46.9 5 0.0742 0.0125 5 0.0263 0.0072 ----------------------------------------------------------------------------------------------------------------- x 2 --- --- -- -- --- --- --- --- -- --- ---- F 2 -- --- --- --- ---- --- --- ---- NUMBER ]IN GROUP: MEAN: STANDARD DEV: 5 S31.5 24.6 NUMBER IN GROUP: NSMI STANDARD DZV: 5 255.2 30.7 5 0.0523 0.0097 5 0.0206 0.0034 ----------------------------------------------------------------------------------------------------------------- n 3 --- --- -- -- -- --- --- --- --- -- ---- - p 3 -- --- --- --- --- --- --- ----- NUMM IN GROUP: MEAN- STANDARD DEV: 5 S39.3 70.5 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 264.2 31.1 5 0.0608 0.0201 5 0.0230 0.0070 ----------------------------------------------------------------------------------------------------------------- TABLE 46 summary of organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98-1%) N-ETHYL PB"LUOROOCTAKESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP=1,2,3,4;WEEKS=ALL DEKTH=3;SUBSBT--ALL LEPT OVARY - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- TERMINAL OROM ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-T SME DOSE BODY WT WRIGHT BODY WT BRAIN Wr SEX DOSE BODY WT WEIGHT BODY W GROUP (a) (g) (%) RATIO GROUP (g) (g) (%) ------------------------------------------------- --------------------------------------------------------------- m 4 F 4 - --- -- --- -- -- --- --- --- --- --- -- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 473.3 39.1 --- -- ---- --- ---- --- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 236.9 21.2 5 0.0514 0.0017 5 0.021 0.001 ---------------------------------------------------------------------------------------------------------------- TABLE 46 c SumarY of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1t) N-ETHYL PMTFLUOROOCTANESULPONAMIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX--ALL;CROUP=1,2,3,4;WEM=ALL DRATH=3;SUBSBT--ALL RIGHT OVARY -- --- -- --- ---- -- --- -- --- -- ---- -- - --- --- ---- --- --- --- ------ TERMINAL ORGAN oRcAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO- SEX DOSE BODY Wr WEIGHT BODY wr BRAIN Wr SEX DOSE BODY wr WEIGHT BODY WT GROUP (g) fg) (t) RATIO GROUP (a) (g) (t) ------------------------------------------------------------------------------------------------------------------ x 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - p I - - --- --- ---- --- --- ----- -- NUMB= IN GROUP: MEAN: STANDARD DEV: 5 535.9 54.5 NUMBER IN GROUP: HE": STANDARD DEV: 5 291.3 46.9 5 0.0596 0.0166 5 0.0208 0.0061 ------------------------------------------------------------------------------------------------------------------ m 2 -- -- -- ---- --- -- --- -- --- -- ---- -- F 2 - -- -- ----- --- -- ---- ---- -- NUMBER IN GROUP: MEAN: 5 531.5 NUMBER IN GROUP: MEAN: 5 255.2 5 0.0sia 5 0.0201 STANDARD DEV: 24.6 STANDARD DEV: 30.7 0.0140 0.0047 ----------------------------------------------------------------------------------------------------------------- m 3 ---- -- -- --- -- ---- -- -- -- ---- -- -- p 3 - -- ---- --- --- -- --- ----- -- NUMBER IN GROUP: MEAN: 5 S39.3 NUMBER rU GROUP: MEAN: 5 264.2 5 0.0623 5 0.0236 STANDARD DEV: 70.S STANDARD DEV: 31.1 0.0128 0.0040 ----------------------------------------------------------------------------------------------------------------- TABLE 46 Summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL.GROUP=1,2,3,4;WE3MS=ALL DEATH=3;SUBSET=ALL RIGHT --- -- -- --- -- ---- --- -- ---- -- ---- - OVARY -- --- --- ---- -- --- ---- --- TERMINAL ORGAN ORGAN-TO- ORGAN-70- TERMINAL ORGAN ORGAN- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT SME DOSE BODY WT WRIGHT BODY GROUP (g) (g) it) RATIO GROUP (gr) (g) (%) ------------------------------------------------ --------------------------------------------------------------- x 4 F 4 -- -- --- --- - ---- --- -- ---- --- --- - NUMBER TN GROUP: HEM: STANDARD DEV: 5 473.3 39.1 -- -- --- ---- --- -- --- ----- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 236.9 21.2 5 0.0541 0.0054 s 0.02 0.00 --------------------------------------------------------------------------------------------------------------- TABLE 46 sunnary of organ Weight Data Week 14 Sacrifice 104-WMM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 199.141 N-WMYL PERFLUOROOCTANESULPOKAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE RNCLUDES- SEX=ALL;GROUP=1,2,3,4;WBM-ALL DRATH=3;SUBSBTzALL SPLEEN -- --- -- --- -- ---- --- --- --- --- ---- - --- -- ---- --- -- -- ------ -- TEMIM ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-T( SEX DOSE BODY WT WEIGHT BODY Wr BRAIN WT SEX DOSE BODY WT WEIGHT BODY W. GROUP (g) (g) (4) RATIO GROUP (g) (g) (%) ---------------------------------------------------------------------------------------------------------------- m 1 ---- -- --- -- -- ----- -- --- --- --- -- NUMBER IN GROUP: 5 s 5 s MEAN: 535.9 0.7252 0.1345 0.3266 STANDARD DEV: 54.5 0.1659 0.0257 0.075S p 1 - --- --- --- --- --- --- ---- - NUMB= IN GROUP: MEAN: STANDARD DEV: s 291.3 46.9 5 0.4690 0.0560 s 0.162 0.015 ---------------------------------------------------------------------------------------------------------------- x 2 --- -- -- -- -- --- ---- -- --- --- --- -- F 2 - --- ---- -- --- --- --- ----- NUMBER IN GROUP: HEM: STANDARD DEV: 5 531.5 24.6 s 0.8193 0.0229 5 0.1544 0.0079 5 0.3743 0.0186 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 255.2 30.7 5 0.4603 0.0829 5 0.179 0.014 ---------------------------------------------------------------------------------------------------------------- m 3 --- -- -- -- -- ---- --- --- --- --- --- - F 3 --- -- --- --- -- --- --- ---- - NUMBER IN GROUPHEM: STANDARD DEV: 5 539.3 70.S 5 0.7lS2 0.1209 5 0.1328 0.0166 s 0.3135 0.0524 NUMBER IN GROUP: MM: STANDARD DZV: 5 264.2 31.1 s 0.4512 0.0531 5 0.171 0.012 ---------------------------------------------------------------------------------------------------------------- TABLE 46 Summary of organ Weight Data Week 14 Sacrifice 104-WEM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTMESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WBM=ALL DRATH=3;SUBSET--ALL SPLEEN --- -- --- -- --- -- ---- --- --- --- --- - - -- -- --- ---- --- --- ---- --- TERMINAL ORCM ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO SM DOSE BODY WT WEIGHT BODY WT BRAIN WT SEX DOSE BODY WT WEIGHT BODY Vn GROUP (a) (g) (%) RATIO GROUP (g) (g) (%) ----------------------------------------------------------------------------------------------------------------- x 4 p 4 - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - NUMBER IN GROUP- MEAN: STANDARD DEV: 5 473.3 39.1 5 0.6639 0.0293 5 0.1408 0.0101 5 0.3037 0.0066 --- -- --- --- ---- --- -- ----- NUMBER IN GROUP: HEM: STANDARD DEV: 5 236.9 21.2 s 0.4064 0.0722 5 0.1730 0.035 ---------------------------------------------------------------------------------------------------------------- TABLE 46 summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-BTHYL PB"LUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX--ALL;GROUP=1,2,3,4;WEM=ALL DEATH=3;SUBSET-ALL LEFT TESTIS - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - TERMINAL ORGAN ORGAN-7V- ORGAN-7V- TERMINAL ORGAN ORGM-74 SEX DOSE BODY WT WEICHT BODY WT BRAIN WT SEX DOSE BODY Wr WEIGHT BODY V GROUP (g) (g) (%) RATIO GROUP (4) (a) 1%) ---------------------------------------------------------------------------------------------------------------- u 1 -- --- -- --- -- -- ---- --- -- --- ---- - F I -- -- --- --- ----- -- --- ---- NUMBER IN GROUP: MEAN- STANDARD DEV: 5 535.9 54.S 5 2.6975 0.1684 5 0.3204 0.0570 5 0.7645 0.0789 MMM IN GROUP: MEAN: STANDARD DEV: 5 291.3 46.9 ---------------------------------------------------------------------------------------------------------------- m 2 --- --- -- -- -- ---- -- --- --- --- --- - F 2 -- --- -- ----- --- -- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 531.5 24.6 5 1.7368 0.0912 5 0.3270 0.0161 5 0.7924 0.0251 NUMBER IN GROUPxM : STANDARD DEV: 5 255.2 30.7 ---------------------------------------------------------------------------------------------------------------- x 3 - -- -- --- -- -- -- ---- --- -- --- ---- - F 3 - --- -- ---- ----- -- -- ----- NUMBER IN GROUP: MEM- STANDARD DEV: 5 S39.3 70.5 s 1.GS2$ 0.0711 5 0.3100 0.0367 5 0.7254 0.0433 NUMBER IN GROUP: MEAN: STANDARD DEV.- 5 264.2 31.1 ---------------------------------------------------------------------------------------------------------------- TABLE 46 c summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDD ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WEE:KS=ALL DEATH=3;SUBSET--ALL LEFT TESTIS - --- --- --- -- -- ---- -- --- --- --- --- -- --- -- ---- --- --- ---- ---- - TERMINAL ORGAN ORGAN-TO- ORGAN-70- TERMINAL ORGAN ORCAN-TO- SEX DOSE BODY WT WRIGHT BODY WT BRAIN WT SME DOSE BODY WT WEIGHT BODY WT GROUP (g) (g) (%) RATIO GROUP (g) (g) (%) ------------------------------------------------------------------------------------------------------------------ m 4 F 4 - ---- --- -- --- -- --- --- --- -- --- -- NUMBER IN GROUP: MEAN: STANDARD DEV: s 473.3 39.1 5 1.7151 0.1400 5 0.3629 0.0209 5 0.7841 O.OSOO -- --- -- ---- --- -- ---- ----- NUMBER IN GROUP: MEAN: STANDARD DEV- 5 236.9 21.2 ------------------------------------------------------------------------------------------------------------------ TABLE 46 summary of organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (99.1%) N-VMYL pERFLUoROOCTAKESULPONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL, GROUP=L, 2, 3, 4; WEM=ALL DRATH=3;SUBSET--ALL RIGHT TESTIS - ---- --- -- -- --- ---- -- ---- -- --- -- --- --- --- -- ---- --- ---- --- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN Wr SME DOSE BODY WT WEIGHT BODY wr GROUP (u) (u) (%) RATIO GROUP (a) (g) (%) ----------------------------------------------------------------------------------------------------------------- x 1 --- -- ---- -- - ---- --- --- --- --- -- - F 1 --- --- -- --- ---- --- --- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 535.9 54.5 5 1.7042 0.1307 5 0.3211 0.0473 5 0.7677 0.0648 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 291.3 46.9 ----------------------------------------------------------------------------------------------------------------- m 2 -- --- ---- -- - -- ----- -- --- ---- -- - p 2 -- --- --- --- --- -- ---- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 531.5 24.6 5 1.7733 0.1140 5 0.3339 0.0204 5 0.8097 0.0315 NUMBER IN GROUP: HEM: STANDARD DEV- 5 255.2 30.7 ----------------------------------------------------------------------------------------------------------------- u 3 - ---- -- --- -- -- ---- --- -- --- --- -- p 3 -- -- -- ---- --- -- --- ---- --- NUMBER IN GROUP: 5 5 5 5 NUMBER IN GROUP: 5 MEAN: STANDARD DEV: 539.3 70.5 1.6684 0.0976 0.3131 0.0402 0.7324 0.0561 HEM: STANDARD DEV: 264.2 31.1 ----------------------------------------------------------------------------------------------------------------- TABLE 46 Summary of organ Weight Data week 14 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98-1%) N-ETHYL pMWLUOROOCTAxEsuLPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;%13EKS=ALL DEATH=3;SUBSET--ALL RIGHT TESTIS -- ---- -- --- -- ---- --- --- --- -- --- - - ---- -- --- ---- -- ---- -- --- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-14 SEX DOSE BODY WT WEIGHT BODY WT BRAIN Wr SEX DOSE BODY WT WEIGHT BODY W, GROUP (g) (g) (%) RATIO GROUP fg) (0@ (%) ------------------------------------------------- --------------------------------------------------------------- m 4 F 4 -- ---- -- - --- --- ---- --- -- --- -- -- NUMBER IN GROUP: HEM: STANDARD DEV: 5 473.3 39.1 5 1.7278 0.1665 5 0.3653 0.0253 5 0.7902 0.0681 --- -- ---- --- ---- -- --- -- - NUMBER IN GROUPHEM: STANDARD DEV: 5 236.9 21.2 ---------------------------------------------------------------------------------------------------------------- TABLE 46 SunmiarY Of Organ Weight Data Week 14 Sacrifice 104-WMKIK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.lrs) N-ETHYL PE"LUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;CROUP=1,2,3,4;WBEKS=ALL DRATH=3,SUBSET--ALL IlLwT TNYROID/PAR - --- ---- -- -- --- ---- --- --- --- --- - - -- -- -- ---- ----- --- ---- -- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SWE DOSE BODY Wr WEIGHT BODY WT BRAIN Wr S*EX DOSE BODY WT WEIGHT BODY GROUP (g) (g) (%) RATIO GROUP (if) (a) (%) ---------------------------------------------------------------------------------------------------------------- N 1 - -- --- --- - --- ---- ---- -- --- -- --- p 1 -- -- -- --- ---- ---- --- ---- NUMBER IN GROUP: HEM: s S35.9 s 0.0125 s 0.0023 s 0.0056 NUMBER IN GROUP: MEAN: s 291.3 5 0.0105 s 0.003 STANDARD DEV: 54.5 0.0029 o.ooos 0.0012 STANDARD DEV, 46.9 0.0040 0.001 ---------------------------------------------------------------------------------------------------------------- x 2 -- --- -- -- --- --- --- --- --- --- -- -- p 2 -- -- -- --- ---- ---- --- ---- NUMBER IN GROUP: MEAN: STANDARD DEV.- 5 531.S 24.6 5 0.0114 0.0022 5 0.0021 0.0004 5 O.OOS2 0.0010 NUKBER IN GROUP: MEAN- STANDARD DEV: 5 255.2 30.7 5 0.0076 0.002S 5 0.002 0.000 --------------------------------------------------------------------------------------------------------------- x 3 -- --- --- -- -- --- --- --- -- -- --- --- NUMBER IN GROUP: s 5 s s MEAN: S39.3 0.0132 0.002S o.oose STANDARD DEV: 70.5 0.0023 0.0006 0.0012 F 3 -- -- -- -- --- ----- --- ---- - NUMBER IN GROUPs MEAN: 5 264.2 s 0.0093 5 0.003 STANDARD DEV: 31.1 0.0025 0.000 --------------------------------------------------------------------------------------------------------------- TABLE 4 6 summary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH KMMW RANGE (98"%) N-ETHYL pERpLuoRoOCTMESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES* SMC--ALL;CROUP=1,2,3,4;WEEKS=ALL DRATH=3;SUBSETmALL LEFT TNYROID/PAR - --- -- -- --- --- --- --- --- --- --- --- TERMINAL ORGAN ORGAN-TO- ORGAN-70- SM DOSE BODY WT WEIGHT BODY WT BRAIN Wr GROUP (a) (g) (t) RATIO -----------------------------------------------------7--------- m 4 -- --- -- -- ----- -- ---- ---- TERMINAL ORGAN ORGAN- SEX DOSE BODY Wr WRIGHT BODY GROUP (g) (a) (%) ----------------------------------------------- F 4 - -- --- -- -- --- ---- -- --- --- --- --- NUMBER IN GROUP: MRAN- STANDARD DEV: s 473.3 39.1 5 0.0144 0.0008 5 0.0031 0.0003 5 0.0066 0.0005 ---- -- -- ---- ---- -- --- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 236.9 21.2 5 0.0092 0.0017 5 0.00 0.00 --------------------------------------------------------------------------------------------------------------- TABLE 46 Summary of organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANBSULFONAMIDO B7MML IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;CROUP=1,2,3,4;WEMCS=ALL DEATH=3;SUBSET--ALL RIGHT THYROID/PR -- -- --- --- -- -- --- --- --- ---- --- -- -- --- --- --- --- --- ---- ---- TERMINAL ORGAN ORGM-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO SEX DOSE BODY Wr WRIGHT BODY Wr BRAIN WT SEX DOSE BODY WT WEIGHT BODY Wr GROUP (g) (g) It) RATIO GROUP (a) (g) (t) ----------------------------------------------------------------------------------------------------------------- H 1 - -- --- -- --- -- -- --- ---- ---- -- -- - NUMBER IN GROUP: Nam: STANDARD DEV: 5 535.9 54.5 5 0.0120 0.0021 5 0.0022 0.0003 5 0.0054 0.0009 p 1 - - - - - - - - - - - - - - - - -- - - - - - - - NUMBER IN GROUP: 5 5 5 HEM: 291.3 0.0080 0.0029 STANDARD DEV: 46.9 0.0026 0.0011 ----------------------------------------------------------------------------------------------------------------- x 2 - --- --- --- -- -- -- --- ---- --- --- -- F 2 ----- - --- --- ---- --- ---- -- NUMBER IN GROUP: HEM: s 531.5 5 0.0128 5 0.0024 5 0.0058 NUMBER IN GROUP: MEAN: 5 255.2 5 0.0093 5 0.0037 STANDARD DEV: 24.6 0.0041 0.0008 0.0017 STANDARD DEV: 30.7 0.0033 0.0014 ---------------------------------------------------------------------------------------------------------------- x 3 - --- --- --- - --- -- --- --- ---- --- -- p 3 - - - - - - - - - - - - - - - - - - - - - -- - - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 539.3 70.5 5 0.0138 0.0019 5 0.0026 0.0006 5 0.0061 0.0010 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 264.2 31.1 5 0.0119 0.0042 5 0.0045 0.0013 -------------------------------------------------------------- -------------------------------------------------- TABLE 46 Sumnary of organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: Sn--ALL;GROUP=1,2,3,4;WEEKS=ALL DEATH=3;SUBSET--ALL RIGHT THYROID/PR -- --- ---- -- -- -- --- ---- -- --- --- - --- ---- --- -- --- --- ---- --- TERMINAL ORGAN ORGAN-TO- OROM-TO- TERMINAL ORGAN ORGAN-T SEX DOSE GROUP BODY wr (g) WEIGHT (g) BODY wr (%) BRAIN Wr RATIO SEX DOSE BODY WT WEIGHT BODY W GROUP (g) (g) (%) ---------------------- ------- --------------- -------------------------------------------------------------- x 4 p 4 -- -- --- - --- --- --- --- --- --- -- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 473.3 39.1 5 0.0125 0.0014 5 0.0026 0.0002 5 0.0057 0.0006 - ---- --- --- -- -- ---- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 236.9 21.2 5 0.0092 0.0021 5 0.003 0.000 -------------------------------------------------------------------------------------------------------------- TA13LE 46 summary of organ Weight Data Week 14 Sacrifice 104-%I= DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-SMYL PR"LUOROOCTAKESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WEEKS=ALL DF.ATH=3;SUBSBT=ALL UTERUS - --- --- --- -- -- ---- -- --- ---- -- --- - --- ---- -- ---- --- ---- ---- SEX DOSE TERMINAL BODY Wr ORGAN WRIGHT ORGAN-TOBODY Wr ORGAN-TDBRAIN WT SEX DOSE TERMINAL BODY WT ORGAN WEIGHT ORGAN-74 BODY V? GROUP (g) (g) (%) RATIO GROUP (u) (g) (t) ---------------------------------------------------------------------------------------------------------------- m 1 -- --- -- --- -- --- --- -- ---- --- -- -- NUMBER rU GROUP: MEAN: STANDARD DEV: 5 S35.9 54.5 p 1 NU-MBE-R - -IN -GR-OU-P: - - - - -s- - - -s - - - - - -s - - MEAN: 291.3 0.6337 0.220 STANDARD DEV: 46.9 0.1022 0.044 ---------------------------------------------------------------------------------------------------------------- m 2 -- --- --- -- -- --- -- --- --- ---- -- -- p 2 - --- --- --- -- ---- --- ---- - NUMBER IN GROUP: MEANSTANDARD DEV: 5 S31.5 24.6 NUMBER IN GROUP: MEAN: STANDARD DEV- 5 25S.2 30.7 5 O.S244 0.0677 5 0.205 0.015 ---------------------------------------------------------------------------------------------------------------- m 3 -- --- -- --- - -- ---- -- --- ---- -- --- F 3 - - - - - - - - - - - - - - - - - - - - - -- - NUMBER IN GROUP: MEAN: STANDARD DEV: s S39.3 70.S NUMBER IN GROUPT HEM: STANDARD DEV: 5 264.2 31.1 s 0.6754 0.1666 5 0.2S4 0.051 ---------------------------------------------------------------------------------------------------------------- TABLE 46 Sunnary of Organ Weight Data week 14 sacrifice 104-WMM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98-1t) N-WMYL pMWLuoRoocTANESULFONAMIDO ETHANOL IN RATS --------- --------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WBMr.S=ALL DRATH=3;SUBSBT=ALL UTERUS - ---- --- --- --- -- --- --- --- --- --- - --- --- --- ---- --- ---- ---- - TERMINAL ORGAN ORGAN-70- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN WT SEX DOSE BODY WT WEIGHT BODY GROUP lg) (g) 1%) RATIO GROUP (a) (g) (%) ------------------------------------------------ --------------------------------------------------------------- N 4 F 4 -- --- -- --- -- --- --- --- --- --- --- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 473.3 39.1 -- -- -- ---- --- ---- ---- -- NUMB13R IN GROUP: MEAN: STANDARD DEV: 5 236.9 21.2 5 0.5414 0.0477 5 0.22 0.02 --------------------------------------------------------------------------------------------------------------- TABLE 47 Sunnary of Organ Weight Data Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUPz8,9;WEEKS=ALL DRATH=2;SUBSET--T LIVER -- -- ---- --- -- --- ---- --- ---- -- --- --- -- --- --- ---- ----- ----- SEX DOSE TERMINAL BODY WT ORGAN WEIGHT ORGAN-TOBODY Wr ORCAN-TOBRAIN wr SEX DOSE TERMINAL BODY WT ORGAN WEIGHT ORCANBODY GROUP (g) (g) (%) RATIO GROUP (ii) (g) (%) --------------------------------------------------------------------------------------------------------------- m 8 --- --- --- -- -- ---- ---- --- -- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: s 501.8 59.4 5 14.4950 2.0800 5 2.8829 0.1069 p 8 --- --- -- --- ----- ----- --- NUMBER IN GROUP: MEAN.- STANDARD DEV: 5 270.7 16.9 5 8.0939 0.4382 5 3.00 0.26 --------------------------------------------------------------------------------------------------------------- m 9 --- --- --- -- -- ---- ---- --- -- --- -- NUMBER IN GROUP: MEAN: s 525.2 4 16.6952 4 3.1146 STANDARD DEV: 47.7 2.7892 0.2426 p 9 --- -- --- --- ---- ----- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 254.9 23.0 5 7.5958 0.1717 5 2.99 0.25 --------------------------------------------------------------------------------------------------------------- TABLE 48 c Suimary of Organ Weight Data Week 53 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%1 N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SMC=ALL;GROUP=ALL;WEEKS=ALL DEATH=4;SUBSET--ALL LEFT ADPJKRAL - --- --- -- -- --- --- ---- -- -- --- ---- -- -- ---- --- ---- -- ---- ----- mm DOSE TERMINAL BODY Wr ORGAN WEIGHT ORGAN-TOBODY Wr ORGAN-TOBRAIN WT Sim DOSE TERMINAL BODY.WR ORGAN WEIGHT ORGAN-TVBODY WT GROUP lu) (u) 1%) RATIO GROUP fg) (g) (%) ------------------------------------------------------------------------------------------------------------------ m 1 -- --- -- --- -- ---- --- -- --- --- -- -- F 1 --- -- ---- --- --- -- ---- ---- NUMBER IN GROUP: HE": STANDARD DNV: 5 722.2 58.0 5 0.0350 0.0031 5 0.0049 0.0005 5 0.0147 0.0016 NUMBER IN GROUP: MEAN: STANDARD DUV: 5 406.9 32.2 5 0.0445 0.0140 5 0.0112 0.0043 ------------------------------------------------------------------------------------------------------------------ x 4 -- ---- -- -- --- --- --- --- --- -- --- - F 4 --- -- ----- -- --- ---- ---- -- NUMBER IN GROUP: ME". STANDARD DEV: 10 639.0* 71.5 10 0.0335 0.0057 10 0.0053 0.0011 10 0.0141 0.0025 NUMBER IN GROUP: MM.STANDARD DEV: 10 306.3* 49.7 10 0.0375 0.0061 10 0.0125 0.0030 ------------------------------------------------------------------------------------------------------------------ TABLE 48 Summary of Organ Weight Data Week 53 Sacrifice 104-WEM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-NMYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WBEKSzALL DEATH=4;SUBSBT--ALL RIGHT ADRENAL - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN Wr GROUP (g) (g) ilb) RATIO -------------------------------------------------------------- m 1 - --- -- --- -- -- ---- --- -- ---- -- --- NUMBER IN GROUP: ME": STANDARD DEV: 5 722.2 58.0 5 0.0316 0.0049 5 0.0044 0.0006 5 0.0132 0.0016 -- --- --- ---- --- ---- ---- - TERMINAL ORGAN ORGAN- SEX DOSE BODY Wr WEIGHT BODY GROUP (g) (g) (%) ------------------------------------------------ F 1 - -- -- ---- -7 -- --- --- ----- NUMBER IN GROUP: MEAN: 5 406.9 5 0.0409 5 0.01 STANDARD DEV: 32.2 0.0146 0.00 -------------------------------------------------------------------------------------------------------------- m 4 -- --- -- --- - ---- --- --- -- --- --- -- p 4 - -- --- -- ---- ---- --- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 10 639.0* 71.5 10 0.0324 0.0090 10 O.COS2 0.0016 10 0.0137 0.0039 NUMBER IN CROUP: MEAN: STANDARD DEV; 10 306.3* 49.7 10 0.0347 0.0041 10 0.01 0.00 -------------------------------------------------------------------------------------------------------------- TABLE 48 Sumnary of organ Weight Data Week 53 Sacrifice 104-WMEIK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAWESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;W*EEKS=ALL DF.ATH=4;SUBSET,--ALL BRAIN - --- -- ---- - --- ---- --- --- --- ---- - -- --- -- ---- ---- -- --- ----- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY WT WRIGHT BODY Wr BRAIN WT SEX DOSE ]BODY wr WEIGHT BODY GROUP (a) (0) (%) RATIO GROUP (g) (0) (%) ---------------------------------------------------------------------------------------------------------------- m I -- --- --- -- -- ----- -- --- ---- -- --- p 1 --- -- --- --- ---- --- --- --- NUMBER IN GROUP: NEW: STANDARD DEV: 5 722.2 58.0 5 2.3937 0.1629 5 0.3307 0.0180 s 1.0000 0.0000 NUMBER IN GROUP: MEAN: STANDARD DEV: 5 406.9 32.2 5 2.2100 0.0852 5 0.54S 0.039 --------------------------------------------------------------------------------------------------------------- m 4 - --- -- --- -- -- ---- --- --- --- --- -- p 4 --- -- --- --- ---- --- --- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 639.0* 71.5 10 2.3804 0.1067 10 0.3753* 0.0300 10 1.0000 0.0000 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 306.3* 49.7 10 2.1689 0.1318 10 0.720 0.087 --------------------------------------------------------------------------------------------------------------- TABLE 48 c Sunmry of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-MMYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: MM=ALL;GROUP=ALL;WEEXS=ALL DRATH=4;SUBSET--ALL LEFT KIDNEY --- -- -- -- --- --- --- --- ---- --- ---- - -- --- --- ---- --- --- ----- -- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TD- SEX DOSE BODY wr WRIGHT BODY Wr BRAIN Wr SEX DOSE BODY WT WEIGHT BODY WT GROUP 10) ig) (t) RATIO GROUP (a) 10) (%) ------------------------------------------------------------------------------------------------------------------ m I -- --- - -- --- --- -- ---- --- --- ---- - NUN= IN GROUP-. MRHN: s 722.2 s 2.3249 5 0.3224 s 0.9749 STANDARD DEV: 58.0 0.1910 0.0201 0.0261 F 1 - --- -- ---- --- --- ---- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 406.9 32.2 5 1.3605 0.1412 5 0.3375 0.0587 ---------------------------------------------------------------------------------------------------------------- x 4 -- --- -- -- --- -- ---- -- --- ---- --- - p 4 - ---- -- --- ----- -- --- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 10 639.0* 71.S 10 2.4579 0.3355 10 0.38S6* 0.0421 10 1.0314 0.1225 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 306.3* 49.7 10 1.4508 0.2497 10 0.47Sl 0.0490 ----------------------------------------------------------------------------------------------------------------- TABLE 48 c Summary of Organ weight Data week 53 sacrifice 104-WEEK DIETARY CARCINOGENIC17Y STUDY WITH NARROW RANGE 198-1%) N-EMYL pERFLUOROOCTANSSULpoNAMIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SME=ALL;GROUP=ALL;WEEKS-ALL DEATH=4;SUBSBT--ALL RIGHT KIDNEY --- --- ---- - -- ---- --- --- --- --- --- -- --- -- ---- --- -- ----- ----- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO- SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN WT SEX DOSE BODY WT WEIGHT BODY Wr GROUP (g) (g) (%) PATIO GROUP (g) (o) (%) ------------------------------------------------------------------------------------------------------------------ N I ---- --- --- -- -- --- ----- -- --- --- - F 1 -- --- -- ---- --- --- ---- ---- NUMBER IN GROUP: MM: STANDARD DEV: 5 122.2 58.0 5 2.3397 0.1416 5 0.3247 0.0166 5 0.9821 0.0202 NUMBER IN GROUP: UM: STANDARD DEV: 5 406.9 32.2 5 1.4036 0.1605 5 0.3496 0.0654 ------------------------------------------------------------------------------------------------------------------ m 4 -- ---- - --- -- -- --- ---- --- -- ---- - F 4 -- --- -- ---- --- -- ---- ----- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 639.0* 72.5 10 2.4429 0.3646 10 0.3827* 0.041S 10 1.0246 0.1316 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 306.3* 49.7 10 1.5208 0.2577 10 0.4992* 0.0611 ------------------------------------------------------------------------------------------------------------------ TABLE 48 Summary of organ Weight Data Week 53 Sacrifice 104-WMM DIETARY CARCINOGENICITY STUDY WITH MARROW RANGE 198-194) N-STHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROVP=ALL;WBEKS=ALL DRATH=4;SUBSBT=ALL LIVER --- --- -- --- -- -- --- ---- --- -- ---- - - --- --- -- -- ---- --- ----- -- SEX DOSE TERMINAL BODY WT ORGAN WEIGHT OR(;AN-TC)BODY Wr ORGAN-TOBRAIN Wr SEX DOSE TERMINAL BODY WT ORGAN WEIGHT ORGAN-TO BODY WT GROUP (g) (g) (%) RATIO GROUP (d) (g) (%) ----------------------------------------------------------------------------------------------------------------- x 1 - --- -- --- -- -- --- --- --- -- --- ---- F 1 - --- -- --- -- --- ---- --- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 722.2 58.0 5 20.8522 1.6996 s 2.8910 0.1779 5 8.7696 0.8214 NUMBER IN GROUP: )MAN: STANDARD DEV: 5 406.9 32.2 5 11.1366 0.5964 s 2.7565 0.3325 ----------------------------------------------------------------------------------------------------------------- x 4 - --- -- --- -- -- --- --- --- -- --- ---- r 4 - --- -- -- --- --- ---- --- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 639.0* 71.5 10 30.8941* 5.4082 10 4.8476* 0.7573 10 12.9831* 2.2029 NUMBER IN GROUPT MEAN: STANDARD DEV: 10 306.3* 49.7 la 17.2772* 3.6046 10 5.6SOB 0.8632 ----------------------------------------------------------------------------------------------------------------- TABLE 48 Stwnary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.lt4) N ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP-ALL;WEMKS=ALL DRATH=4;SUBSBT--ALL LUNG - --- --- -- --- -- --- ---- -- -- --- ---- - --- --- --- ---- --- -- ---- -- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-V SEX DOSE BODY wr WRIGHT BODY wr BRAIN Wr SEX DOSE BODY WT WEIGHT BODY W GROUP 10) 10) (%) RATIO GROUP (g) lg) (%) ---------------------------------------------------------------------------------------------------------------- x 1 ---- -- --- - --- --- ---- -- --- -- -- -- NUMBER IN GROUP: 5 5 5. 5 HEM: 722.2 2.1417 0.2979 0.9013 STANDARD DEV: Sa.0 0.2399 0.0401 0.1183 p 1 --- -- --- --- --- ---- --- -- - NUN= IN GROUP: NEW: STANDARD DEV: 5 406.9 32.2 5 1.7049 0.1511 5 0.421 0.049 ---------------------------------------------------------------------------------------------------------------- x 4 -- -- -- --- -- -- --- ---- -- --- -- -- -- F 4 --- -- --- -- ---- --- -- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 10 639.0* 71.5 10 2.2129 0.3222 10 0.3472* 0.0412 10 0.9301 0.1290 NUMBER IN GROUP: NM : STANDARD DEV: 10 306.3* 49.7 10 1.6432 0.1425 10 0.545 0.077 ---------------------------------------------------------------------------------------------------------------- TABLE 48 SummarY of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.141 H-ETHYL PERPLUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP=ALL;WZEKS=ALL DRATH=4,SUBSET--ALL IY.PT OVARY --- -- --- --- -- --- --- --- --- --- --- - -- --- -- ----- --- --- ---- --- SEX DOSE TERMINAL BODY WT ORGAN WRIGHT ORGAN-TOBODY WT ORGAN-TioBRAIN WT SEX DOSE TERMINAL BODY WT ORGAN WEIGHT ORGAN-'D BODY w GROUP 10) 10) It) RATIO GROUP (g) (g) (%) ---------------------------------------------------------------------------------------------------------------- m I - --- --- --- - ---- --- -- --- --- --- -- p I - -- -- --- ----- --- --- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 722.2 58.0 NUMBER IN GROUP: JMW: STANDARD DIKV: 5 406.9 32.2 5 0.0646 0.0121 5 0.015 0.003 ---------------------------------------------------------------------------------------------------------------- m 4 -- -- --- --- - ---- --- -- --- ---- -- -- p 4 - - - - - - - - -- - - - - - - - - - - - - - - NUMB= IN GROUP-. MEAN: STANDARD DEV: 10 639.0* 71.5 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 306.3* 49.7 10 0.0731 0.0139 10 0.024 0.006 ---------------------------------------------------------------------------------------------------------------- TABLE 48 Sununary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PE"LUOROOCTAKESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP-ALL;WEEKS-ALL DFATH=4,SUBSET--ALL RIGHT OVARY - --- --- -- -- --- ---- --- ---- -- --- -- - --- --- --- ---- --- ---- ---- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-74 SME DOSE BODY WT WEIGHT BODY Wr BRAIN Wr SEX DOSE BODY Wr WEIGHT BODY W GROUP (o) (a) (%) RATIO GROUP (a) (a) (%) ---------------------------------------------------------------------------------------------------------------- m 1 -- -- --- -- -- ---- --- ---- -- --- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 722.2 58.0 F I -- -- ---- --- --- -- ----- --- NUMBER IN GROUP: 5 5 5 PMM: STANDARD DEV: 406.9 32.2 0.0607 0.0097 0.015 0.002 ---------------------------------------------------------------------------------------------------------------- m 4 -- -- --- -- -- ---- --- ---- -- --- --- - F 4 - -- ---- --- --- --- ---- --- - NUMBER IN GROUP: MEAN: STANDARD DEV: 10 639.0* 71.5 NUMBER IN GROUP- MM: STANDARD DEV: 10 306.3* 49.7 10 0.0781 0.0242 10 0.026 0.009 --------------------------------------------------------------------------------------------------------------- TABLE 48 Sumary of Organ Weight Data Week 53 Sacrifice 104-WREK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PE"LUOROOCTANESULPONAMIDO BTHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SMC--ALL;GROUP=ALL;WBE==ALL DEATH=4;SUBSRT--ALL SPLEEN --- --- ---- -- -- --- -- ----- -- --- --- -- -- --- ---- -- --- ----- ---- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO SEX DOSE BODY Wr WRICHT BODY WT BRAIN WT SEX DDSH BODY Wr WEIGHT BODY WT CROUP (a) (a) (t) RATIO CROUP fci) (a) (%) ----------------------------------------------------------------------------------------------------------- N 1 --- -- --- -- -- -- ---- --- ---- --- -- - p1 -- --- --- --- --- --- ----- --- NUMBER IN GROUP: MEAN: STANDARD DEV: s 722.2 58.0 5 0.9636 0.1238 5 0.1337 0.0168 s 0.4063 0.0660 NUMBER IN GROUP: HEM: STANDARD DEV: 5 406.9 32.2 5 0.6205 0.0408 5 0.1531 0.0135 ----------------------------------------------------------------------------------------------------------- m 4 --- -- --- --- -- --- -- --- ---- --- -- - F 4 --- -- --- --- --- --- ----- --- NUMBER IN GROUP: MM: STANDARD DEV- 10 639.0* 71.S 10 0.9192 0.3274 10 0.1421 0.0399 10 0.3838 0.1251 NUMBER IN GROUP: HEM: STANDARD DEV: 10 306.3* 49.7 10 O.S425 0.0914 10 0.1792 0.0311 ------------------------------------------------------------------------------------------------------------------ TABLE 48 Summary of Organ Weight Data Week S3 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PB"LUOROOCTANESULPON)LMXDO ETHANOL IN RATS -----------------------------------------------------------------------------------------7-------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WBE"=ALL DEhTH=4;SLIBSET--ALL LM TESTIS --- --- --- --- -- --- --- ---- -- ---- -- -- --- --- --- --- -- ------ --- SEX DOSE T2MDIAL BODY Wr ORGAN WEIGHT ORGAN-TOBODY WT ORGAN-TOBRAIN Wr SEX DOSE TERMINAL BODY wr ORGAN WEIGHT ORGAN-TO BODY Wr GROUP (g) (a) (t) RATIO GROUP (a) (g) (%) ----------------------------------------------------------------------------------------------------------------- N 1 - --- --- --- -- --- --- --- --- --- --- - F 1 --- -- --- --- --- --- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 722.2 58.0 5 1.6043 0.1032 5 0.2228 0.0164 5 0.6747 0.0509 NUMBER IN GROUP: HE": STANDARD DEV: 5 406.9 32.2 ----------------------------------------------------------------------------------------------------------------- m 4 p 4 --- -- -- ---- -- --- ---- ---- - NU-MBE-R - -IN -GR-OU-P: - - - - -10 - - - 1-0 - - - - - -10 - - - - - -10 - - - MEAN: 639.0* 1.7040 0.2710 0.7196 STANDARD DEV: 71.5 0.2865 0.0609 0.1362 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 306.3* 49.7 ----------------------------------------------------------------------------------------------------------------- TABLE 48 Sumary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WERKS=ALL DEKTH=4;SUBSET=ALL RIGHT TESTIS -- --- -- ---- - -- ---- --- -- ---- --- -- ---- -- --- -- ---- --- ---- --- TERMINAL ORGAN ORGAN-TO- ORGAN-70- TERMINAL ORGAN ORGAN-14 SEC DOSE BODY WT WEIGHT BODY WT BRAIN WT sox DOSE BODY WT WEIGHT BODY W. GROUP (g) (g) (%) RATIO GROUP (g) (g) (%) ---------------------------------------------------------------------------------------------------------------- m 1 - --- -- --- --- -- -- ---- --- -- ---- -- NUMBER IN GROUP: MEAN: 5 722.2 s 1.6110 5 0.2237 5 0.6772 STANDARD DEV: 58.0 0.0997 0.0145 0.0428 p 1 -- -- --- --- -- --- --- --- --- NUMBER IN GROUP: s MEAN: STANDARD DEV: 406.9 32.2 ---------------------------------------------------------------------------------------------------------------- x 4 ---- --- -- --- -- --- -- --- --- -- ---- p 4 - - - - - - - - - - - - - - - - - - - - - -- - NUMBER IN GROUP: MEAN: 10 639.0* 10 1.7805* 10 0.2825* 10 0.7506 NUMBER IN GROUP: MEAN*. 10 306.3* STANDARD DEV-. 71.S 0.1392 0.0442 0.0799 STANDARD DEV: 49.7 ---------------------------------------------------------------------------------------------------------------- TABLE 48 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-ALL;WE DEATH=4;SUBSET--ALL M =ALL LEFT THYROID/PAR - -- --- -- --- --- --- -- ---- --- --- --- - --- --- --- ---- -- ---- ---- - SM DOSE TERMINAL BODY Wr ORGAN WEIGHT ORGAN-TOBODY WT ORCAN-TOBRAIN Wr SEK DOSE TERMINAL BODY WT ORGAN WEIGHT ORGAN-TO BODY Wr GROUP (o) (g) (t) RATIO GROUP (g) (g) (%) ----------------------------------------------------------------------------------------------------------------- x I -- -- --- --- --- -- --- --- -- ---- --- - p I -- -- ---- --- ---- --- --- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: s 722.2 58.0 s 0.0151 0.0027 s 0.0021 0.0003 s 0.0063 0.0011 NUMBER IN GROUP: HEMS STANDARD DEV: s 406.9 32.2 s 0.0148 0.0045 5 0.0037 0.0011 ----------------------------------------------------------------------------------------------------------------- m 4 --- -- -- ---- -- --- --- -- --- ---- -- - p 4 -- --- --- ---- --- --- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 639.0* 71.5 10 0.0235* 0.0038 10 0.0037* 0.0004 10 0.0099* 0.0015 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 306.3* 49.7 10 0.0156 0.0053 10 O.OOS2 0.0021 ----------------------------------------------------------------------------------------------------------------- TABLE 48 Summary of organ weight Data Week 53 Sacrifice 104-WMM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-VMYL pERpLuoROOCTANESULPONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: sEX=ALL;GROUP=ALL;WEMM=ALL DEATH=4;SUBSET=ALL RIGHT THYROID/PR - --- -- --- -- -- ---- --- -- ---- --- -- - - -- ---- --- ---- -- ---- ----- TERMINAL ORGAN ORGAN-TO- ORGAN-M- TERMINAL ORGAN ORGAN-7K SEX DOSE BODY wr WRIGHT BODY Wr BRAIN WT SEX DOSE BODY wr WEIGHT BODY Wl GROUP (g) (a) (%) RATIO GROUP (g) (g) (t) ----------------------------------------------------------------------------------------------------------------- N 1 - --- --- -- --- --- -- --- --- --- --- -- p 1 - -- --- ----- --- -- --- ----- NUMBER IN GROUP- MEAN: STANDARD DEV: 5 722.2 58.0 5 0.0189 0.0044 5 0.0026 0.0004 5 0.0079 0.0016 NUMBER IN GROUP: KEAN: STANDARD DEV: 5 406.9 32.2 5 0.0167 0.0044 5 0.004 0.000 ---------------------------------------------------------------------------------------------------------------- m 4 - --- --- -- --- - ---- --- -- --- ---- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 639.0* 71.5 10 0.0250 0.0061 10 0.0039* 0.0006 10 0.0105 0.0024 p 4 --- --- --- ---- -- --- ----- - NUMBER IN GROUP: HEM: STANDARD DEV: 10 306.3* 49.7 10 0.0160 0.0064 10 0.005 0.002 ---------------------------------------------------------------------------------------------------------------- TABLE 48 Summary of Organ Weigrht Data Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PMTFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEhTH=4;SUBSRT=ALL UTERUS --- -- ---- -- -- --- --- ---- --- -- -- -- -- ----- -- ---- -- ---- ----- - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-T SEX DOSE BODY WT WEIGHT BODY Wr BRAIN WT SEX DOSE BODY WT WEIGHT BODY W GROUP (g) (g) (%) RATIO GROUP lg) (g) (%) ---------------------------------------------------------------------------------------------------------------- N 1 - --- --- -- -- --- ---- -- ---- -- --- -- p 1 --- --- ---- --- --- --- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 722.2 58.0 NUMBER IN GROUP: xM : STANDARD DEV: 5 406.9 32.2 5 1.1161 0.4939 5 0.280 0.132 ---------------------------------------------------------------------------------------------------------------- x 4 -- -- --- --- -- -- ---- --- --- -- --- -- NUMBER IN GROUP: 10 MEAN: 639.0* STANDARD DEV: 71.5 F 4 --- --- ---- -- --- ---- ---- - NUMBER IN GROUP: MEAN: 10 306.3* 10 1.1694 10 0.385 STANDARD DEV: 49.7 0.2972 0.098 ---------------------------------------------------------------------------------------------------------------- TABLE 49 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;CROUP=8,9;WEEKS=ALL DRATH=3;SUBSET--ALL LEFT ADRENAL - --- --- --- -- -- ---- ---- --- --- --- - - -- -- ---- --- --- -- ----- --- TERMINAL ORGAN ORGAN-TO- ORGAN-IM- TERMINAL ORGAN ORGAN-T( SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN Wr SEX DOSE BODY WT WEIGHT BODY W@ GROUP (g) (g) (%) RATIO GROUP (d) (0) (%) ---------------------------------------------------------------------------------------------------------------- x a -- ---- -- --- -- --- --- --- ---- --- -- NUMBER IN GROUP: 10 10 10 10 MEAN: 721.2 0.0309 0.0043 0.0128 STANDARD DEV: 89.7 0.0067 0.0007 0.0026 F 8 - -- --- --- --- -- --- ------ - NUMBER IN GROUP: MEAN: STANDARD DEV: 10 412.5 $5.7 10 0.0525 0.0225 10 0.013 0.006 ---------------------------------------------------------------------------------------------------------------- m 9 -- ---- -- -- --- -- ---- --- --- --- --- F 9 --- -- ---- --- -- --- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 725.1 76.6 10 0.0334 0.0053 10 0.0046 0.0007 10 0.0140 0.0021 NUMBER IN GROUP: NM : STANDARD DEV: 10 396.4 49.5 10 0.0435 0.007S 10 0.011 0.002 ---------------------------------------------------------------------------------------------------------------- TABLE 49 Sunnary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PEMPLUORDOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=8,9;WEEXS=ALL DEATH=3,SLIBSET--ALL RIGHT ADRENAL -- -- --- -- -- --- --- --- --- ---- -- --- --- -- --- --- --- --- ---- --- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SME DOSE BODY WT WEIGHT BODY WT BRAIN WT SEX DOSE BODY.WT WEIGHT BODY GROUP (g) (a) (%) RATIO GROUP (g) (g) (%) --------------------------------------------------------------------------------------------------------------- x 8 -- --- --- -- - ---- --- ---- -- --- ---- NUMBER IN GROUP: ME": STANDARD DEV: 10 721.2 89.7 10 0.0320 0.0046 10 0.004S 0.0006 10 0.0132 0.0016 F 8 ---- -- --- --- -- ---- --- --- NUMBER IN GROUP: MEAN: 10 412.5 10 0.0384 10 0.00 STANDARD DEV: 8S.7 0.0086 0.00 --------------------------------------------------------------------------------------------------------------- u 9 --- --- -- -- -- --- --- --- --- --- ---- F 9 --- -- --- --- --- --- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 725.1 76.6 10 0.0286 0.0034 10 0.0040 0.0007 10 0.0120 0.0014 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 396.4 49.5 10 0.0379 0.0072 10 0.00 0.00 --------------------------------------------------------------------------------------------------------------- TABLE 49 Sumnary of organ Weight Data Week 53 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) X-ETHYL PE"LUOROOCTANESULPONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;CROUP=8,9;WEEKS=ALL DRATH=3;SUBSET--ALL BRAIN - ---- --- -- - ---- --- ---- -- -- ---- -- -- --- --- --- ---- --- ---- --- SEX DOSE TERMINAL BODY WT ORGAN WEIGHT ORGAN-TOBODY Wr ORGAN-TOBRAIN WT SME DOSE TERMINAL BODY WT ORGAN WEIGHT ORGAN-TO BODY wr GROUP fg) (g) (%) RATIO GROUP 10) (g) (%) ----------------------------------------------------------------------------------------------------------------- x 8 --- -- --- -- -- ----- -- --- -- --- ---- F a - --- - ---- -- ---- --- ---- --- NUMBER IN GROUP: UM: STANDARD DEV: 10 721.2 89.7 10 2.4158 0.1977 10 0.3385 0.0420 10 1.0000 0.0000 NUMBER IN GROUP: MM: STANDARD DEV: 10 412.5 85.7 10 2.1708 0.1447 10 0.5433 0.0978 ----------------------------------------------------------------------------------------------------------------- m 9 --- --- -- -- -- ---- --- -- --- --- --- - F 9 --- -- --- --- --- ---- --- ---- NUMBER IN GROUP: MEAN- STANDHRD DEV: 10 725.1 76.6 10 2.3887 0.0908 10 0.3324 0.0345 10 1.0000 0.0000 NUMBER IN GROUP: MEAN: STANDARD DILV-. 10 396.4 49.5 10 2.0441* 0.0983 10 0.5221 0.0618 ----------------------------------------------------------------------------------------------------------------- TABLE 49 summary of organ Weight Data Week 53 Sacrifice 104-WE3M DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE IMLUDES: SEX=ALL,GROUP=8,9;WEZKS=ALL DRATH=3;SUBSET=ALL LEFT KIDNEY -- --- -- --- -- --- --- --- -- ---- --- - --- -- --- ---- ---- -- ---- --- SME DOSE TERMINAL BODY WT ORGAN WEIGHT ORGAN-TOBODY Wr ORGAN-TOBRAIN WT SEX DOSE TERMINAL BODY Wr ORGAN WEIGHT ORGAN-TT BODY W. ----G-RO-U-P----------------(-a-)-------(-a-)---------(-%-)-------R-AT-I-O------------G-RO-U-P---------------(-0-)--------(-a-)---------(-%-)---- m 8 --- --- -- --- -- -- ---- -- --- --- ---- F 8 --- -- -- ----- --- --- --- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 721.2 89.7 10 2.3S70 0.2803 10 0.3279 0.0270 10 0.97S4 0.0820 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 412.5 SS.7 10 1.4112 0.2048 10 0.346 0.028 ---------------------------------------------------------------------------------------------------------------- x 9 --- --- -- -- --- -- ---- -- --- -- ---- - F 9 -- --- -- ---- --- --- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 725.1 76.6 10 2.2022 0.3009 10 0.3056 0.0435 10 0.9215 0.1177 NUMBER IN GROUP: MEANSTANDARD DEV: 10 396.4 49.5 10 1.3218 0.1769 10 0.33S 0.039 ---------------------------------------------------------------------------------------------------------------- TABLE 49 suamary of organ Weight Data Week S3 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SMC=ALL,GROUP=8,9;WBEKS=ALL DEATH=3;SUBSET--ALL RIGHT KIDNEY --- -- ---- -- -- --- --- --- --- --- -- -- -- --- ---- ---- --- -- ------ - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-T SME DOSE BODY WT WEIGHT BODY Wr BRAIN Wr SEX DOSE BODY wr WEIGHT BODY W GROUP (0) (g) 1%) RATIO GROUP (a) (a) (%) ---------------------------------------------------------------------------------------------------------------- m 8 - --- --- --- -- -- --- ---- -- --- -- --- p 8 - -- --- ---- --- --- --- ----- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 721.2 89.7 10 2.3234 0.2897 10 0.3234 0.0315 10 0.9622 0.0962 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 412.5 85.7 10 1.4370 0.2720 10 0.350 0.037 --------------------------------------------------------------------------------------------------------------- x 9 -- -- --- --- -- -- --- --- --- -- --- --- NUMBER IN GROUP: MEAN: 10 725.1 10 2.2647 10 0.3144 10 0.9474 STANDARD DEV: 76.6 0.3230 0.0491 0.12S7 p 9 - -- --- ---- --- -- ---- ---- - NUMBER TN GROUP: MM: STANDARD DEV: 10 396.4 49.5 10 1.3601 0.2061 10 0.344 0.048 --------------------------------------------------------------------------------------------------------------- TABLE 49 Sunnary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=8,9;WERKS=ALL DEATH=3;SUBSET--ALL LIVER --- --- ---- - --- --- --- --- --- --- -- - - --- --- --- --- -- ---- ---- -- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY WT WEIGHT BODY wr BRAIN WT SEX DOSE BODY WT WEIGHT BODY GROUP (a) 10) 1%) RATIO GROUP (4) (u) (%) ---------------------------------------------------------------------------------------------------------------- m a -- --- --- -- -- ---- -- ---- --- -- --- - p 8 --- --- -- --- -- ---- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 721.2 89.7 10 20.2343 4.2122 10 2.8067 0.4847 10 8.3464 1.4431 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 412.5 95.7 10 11.3196 2.4S24 10 2.746 0.159 ---------------------------------------------------------------------------------------------------------------- x 9 -- ---- --- - --- --- -- ----- -- -- --- - F 9 --- --- -- --- --- ---- --- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 72S.1 76.6 10 20.3650 2.9205 10 2.8120 0.3074 10 8.5202 1.1115 NUMBER IN GROUP: MRAN: STANDARD DKV: 10 396.4 49.S 10 10.9316 1.4863 10 2.764 0.243 ---------------------------------------------------------------------------------------------------------------- TABLE 49 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE J98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=8,9;WEEKS=ALL DEATH=3,SLTBSBT--ALL LUNG ---- --- -- --- -- ---- --- ---- -- --- -- --- --- -- ---- --- ---- ---- -- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TC SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT SEX DOSE BODY WT WEIGHT BODY m GROUP (a) tg) (%) RATIO GROUP (a) (g) (%) ---------------------------------------------------------------------------------------------------------------- m a -- --- --- -- --- --- --- --- --- --- --- F 8 - -- --- ---- -- --- ---- ---- -- NUMBER IN CROUP: MEAN: STANDARD DEV: 10 721.2 89.7 10 2.1758 0.2190 10 0.3044 0.0381 10 0.9009 0.0625 NUN= IN GROUP: MEAN: STANDARD DEV: 10 412.5 85.7 10 1.6720 0.2500 10 0.421 0.108 ---------------------------------------------------------------------------------------------------------------- x 9 --- --- --- -- -- --- ---- -- --- -- --- - F 9 --- --- -- --- --- ----- -- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 725.1 76.6 10 2.0380 0.1979 10 0.2845 0.0431 10 0.8542 0.0877 NUMBER IN GROUP: HEM: STANDARD DEV: 10 396.4 49.5 10 1.4877 0.1285 10 0.378 0.040 ---------------------------------------------------------------------------------------------------------------- TABLE 49 summary of organ Weight Data Week 53 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.174) N-ETHYL PMTFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDESSEX=ALL;CROUP=8,9;WEEKS=ALL DRATH=3;SUBSET-ALL LEFT OVARY -- --- --- -- --- -- --- ---- --- --- --- - ---- - ---- --- ---- ---- ---- - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-TO SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN WT SEX DOSE BODY wr WEIGHT BODY WT GROUP (g) (a) (%) RATIO GROUP (g) to) (%) ----------------------------------------------------------------------------------------------------------------- m a - --- -- --- -- --- --- -- ---- --- ---- - F 8 -- -- -- ---- --- ---- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 721.2 89.7 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 412.5 SS.7 10 0.0564 0.0161 10 0.0143 0.0053 ----------------------------------------------------------------------------------------------------------------- x 9 -- -- --- -- - ---- --- --- --- --- -- --- p 9 - --- -- --- ----- --- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 72S.1 76.6 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 396.4 49.5 10 0.0611 0.0183 10 0.0155 0.0047 ---------------------------------------------------------------------------------------------------------------- TABLE 49 Sumary of Organ Weight Data Week 53 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=8,9;WEEXS=ALL DEhTH=3;SUBSET=ALL RIGHT OVARY -- -- --- --- --- -- --- --- --- ---- --- - --- --- --- --- --- --- --- ---- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN WT SEX DOSE BODY WT WEIGHT BODY GROUP (g) 10) (%) RATIO GROUP (u) (g) (%) --------------------------------------------------------------------------------------------------------------- m 8 --- -- --- -- -- --- ---- -- --- --- ---- p 8 --- -- ---- --- -- ---- ---- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 721.2 89.7 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 412.5 85.7 10 0.0544 0.0176 10 0.01 0.00 --------------------------------------------------------------------------------------------------------------- x 9 --- -- --- -- -- --- --- --- --- -- ---- - p 9 -- -- ---- --- -- --- ----- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 725.1 76.6 NUMBER IN GROUP: KEAN: STANDARD DRV: 10 396.4 49.5 10 0.0624 o.oios 10 0.01 0.00 --------------------------------------------------------------------------------------------------------------- TABLE 49 suwnary of organ Weight Data Weak 53 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDD ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SM--ALL;GROUP=8,9;WEMM=ALL DEATH=3;SUBSET--ALL SPLEEN - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SU DOSE BODY WT WEIGHT BODY Wr BRAIN WT SEX DOSE BODY WT WEIGHT BODY CROUP fg) (g) (%) RATIO GROUP (a) (g) (%) --------------------------------------------------------------------------------------------------------------- m 8 - -- --- --- - --- --- -- ---- -- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 721.2 89.7 10 1.0371 0.2467 10 0.1430 0.0218 10 0.4265 0.0763 p 8 --- --- --- ---- -- -- ---- --- NUMBER IN GROUPMEAN: STANDARD DEV: 10 412.S 85.7 10 0.5884 0.0964 10 0.14 0.01 --------------------------------------------------------------------------------------------------------------- x 9 - -- --- -- -- --- -- -- --- -- - -- --- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 725.1 76.6 10 1.1631 0.2369 10 0.1618 0.0364 10 0.4862 0.0943 p 9 NU-MB-ER - -IN -GR-OU-P: - - - - -10 - - - -10 - - - - - -10 - - urhm: 396.4 0.5933 0.15 STANDARD DEV: 49.5 0.107S 0.03 --------------------------------------------------------------------------------------------------------------- TABLE 49 Sumary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE igg.lpil N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX--ALL,GROUP=8,9;WEEKS=ALL DRATH=3;SUBSET=ALL LEFT TESTIS - - - - - - - - - - - - - - - - - - - - - I- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT SEX DOSE BODY Wr WEIGHT BODY GROUP 10) (a) (%) RATIO GROUP (.g) (g) (%) --------------------------------------------------------------------------------------------------------------- m 8 - --- -- ---- - -- ---- --- -- --- --- -- - p 8 --- ---- --- -- ---- --- ----- NUMBER IN OROUP-. 10 10 10 10 NUMBER IN GROUP: 10 MEM.STANDARD DEV: 721.2 89.7 1.8105 0.1543 0.2529 0.0240 0.7539 0.0873 MEAN: STANDARD DEV: 412.5 85.7 --------------------------------------------------------------------------------------------------------------- m 9 -- --- --- -- - ---- --- -- --- ---- - --- p 9 - -- ---- --- ---- -- ----- --- NUMBER IN GROUP: ME": STANDARD DEV: 10 725.1 76.6 10 1.7120 0.3999 10 0.2403 0.0685 10 0.7138 0.1556 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 396.4 49.5 -------------------------------------------------------------------------------------------------------------- TABLE 49 Summary of Organ Weight Data Week S3 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-BTHYL PERFLUOROOCTAMSULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SMC=ALL;GROUP=8,9;WBEXS=ALL DRATH=3;SUBSET--ALL RIGHT TESTIS ---- --- -- -- --- ---- --- --- --- -- --- -- --- --- --- --- --- ---- --- TERMINAL ORGAN ORGAN-70- ORGAN-W- TERMINAL ORGAN ORGAN- S= DOSE BODY wr WEIGHT BODY Wr BRAIN WT SEX DOSE BODY WT WEIGHT BODY GROUP (a) (g) (a) RATIO GROUP (g) (g) (%) --------------------------------------------------------------------------------------------------------------- x a -- -- --- --- - ---- ---- --- -- --- -- -- F a -- --- --- --- --- --- ---- --- NUMBER IN GROUPMEAN: STANDARD DEV: 10 721.2 89.7 10 1.8082 0.1769 10 0.2523 0.0226 10 0.7536 0.1006 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 422.5 85.7 --------------------------------------------------------------------------------------------------------------- x 9 --- --- -- --- - --- ---- --- -- --- -- -- p 9 - --- --- --- --- --- --- --- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 725.1 76.6 10 1.8413 0.2307 10 0.2S71 0.0479 10 0.7703 0.0872 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 396.4 49.5 -------------------------------------------------------------------------------------------------------------- TABLE 49 Summary of Organ Weight Data Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 199.1%) N-ETHYL PERFLUOROOCTAKESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SMC=ALL;CROUP=8,9;WBEKS=ALL DEATH=3;SUBSET=ALL LF THYROID/PARA - -- --- --- - ----- --- -- ---- --- -- --- - --- --- --- ---- --- --- ---- - TERMINAL ORGAN ORGAN-7D- ORGAN-TO- TERMINAL ORGAN ORGAN-T SEX DOSE BODY WT WEIGHT BODY Wr BRAIN WT SEX DOSE BODY Wr WEIGHT BODY W GROUP 10) (g) (%) RATIO GROUP (a) (g) (4) ---------------------------------------------------------------------------------------------------------------- m 8 --- -- -- --- -- --- ---- -- --- ---- -- - F a -- -- --- ---- ---- -- ----- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 721.2 89.7 10 0.0232 0.0067 10 0.0032 0.0007 10 0.0096 0.0026 NUMBER IN GROUP: MEAN: STANDARD DEV: 10 412.S 85.7 10 0.0142 0.0032 10 0.003 0.000 ---------------------------------------------------------------------------------------------------------------- x 9 --- -- -- --- -- ---- --- -- ---- --- --- NUMBER IN GROUP: 10 10 10 10 MM: 725.2 0.0202 0.0028 0.0085 STANDARD DEV: 76.6 0.0050 0.0008 0.0021 F 9 -- -- --- ---- ---- -- ---- --- NUMBER IN GROUP-. 10 10 10 HE": 396.4 0.0177 0.004 STANDARD DEV: 49.5 0.0066 0.001 ---------------------------------------------------------------------------------------------------------------- TABLE 49 Summary of Organ Weight Data Week 53 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PZ"LUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=8,9;WEBKS=ALL DEATH=3;SUBSET-ALL RT THYROID/PARA - -- -- --- --- --- --- --- -- ---- ---- -- - --- -- ---- ---- -- ---- ----- SMC DOSE TERMINAL BODY WT ORGAN WRIGHT ORGAN-TOBODY Wr ORGAN-TOBRAIN Wr SEX DOSE TERMINAL BODY wr ORGAN WEIGHT ORGANBODY ----C-R-OU-P----------------(-a-)-------(-a-)---------(-%-)-------R-AT-I-O------------G-RO-U-P---------------(--i-)-------(-g-)---------(%-)----- x a -- --- - -- ---- --- --- --- -- --- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 10 721.2 89.7 10 0.0251 0.0079 10 0.0035 0.0009 10 0.0104 0.0030 p 8 - -- -- ----- --- --- --- ----- NUMBER IN GROUP: 10 10 10 MEAN: STANDARD DEV: 412.5 SS.7 0.0142 0.0025 0.003 0.000 --------------------------------------------------------------------------------------------------------------- N 9 - --- -- - ----- -- --- --- -- --- ---- -- NUMBER IN GROUP: 10 10 10 10 MEAN: STANDARD DEV: 725.1 76.6 0.0242 0.0060 0.0034 0.0009 0.0101 0.0023 F 9 - -- - ---- ----- -- ---- ----- NUMBER IN CROUP: HEM: STANDARD DEV: 10 396.4 49.5 10 0.0147 0.0044 10 0.003 0.001 ---------------------------------------------------------------------------------------------------------------- TABLE 49 summary of Organ Weight Data Week 53 Sacrifice 104-WMM DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE t98.1t) N-WMYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;CROUP=8,9;WEMU=ALL DF.ATH=3; SLQLSET--ALL UTERUS --- -- --- -- -- ---- -- --- ---- --- --- - - --- --- -- --- -- --- ---- ---- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEM DOSE BODY wr WRIGHT BODY Wr BRAIN WT SME DOSE BODY Wr WEIGHT BODY GROUP (g) (o) (%) RATIO GROUP ltr) (a) (t) --------------------------------------------------------------------------------------------------------------- m a -- -- --- -- -- ---- -- --- --- --- --- -- F a -- --- -- --- --- --- -- ------ NUMBER IN GROUP: MEAN: 10 721.2 NUMBER IN GROUP: MEAN: 10 412.5 10 1.0319 10 0.25 STANDARD DEV-. 89.1 STANDARD DEV: 85.7 0.1956 0.063 --------------------------------------------------------------------------------------------------------------- m 9 -- --- -- -- -- ---- -- ---- --- -- --- -- F 9 -- --- -- --- --- --- --- ----- NUMBER IN GROUP: MEAN: STANDARD DEV: 10 725.1 76.6 NUMBER IN GROUP: ME": STANDARD DEV: 10 396.4 49.5 10 1.0749 0.2526 10 0.27 o.o7 --------------------------------------------------------------------------------------------------------------- TABLE 50 Incidence of Macroscopic Observations Week 4 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALI.;GROOP-1,2,3,4,5;WEEKS=ALL DEATH-I;StIBSET-T N U M B ER - 0 F - A N I M A L S - A F SEX: ----------MALE --------- ---------FEMALE--GROUP: -1- -2- -3- -4- -5- -1- -2- -3- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 5 5 5 S. 5 5 5 5 5 ------------------------------------------------------------------------ --- --- - ** TOP OF LIST ** GENERAL COMMENT (GC) ..............................N.UM.B.ER EXAMINED: 5 5 5 5 5 5 5 5 5 NO MACROSCOPIC LESIONS 5 5 5 5 5 5 5 5 5 LIVER (LI) .......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 END OF LIST TABLE 51 c Incidence of Marroscopic Observations Week 4 Sacrifice 104-WEEK DIETARY CARCIIA(.)GENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PER FLUOROOCTANESUL FONAMI DO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GR(X)P-8,9;WEEKS-ALL DEATH-I;SUBSET-T NUM BE R-0 F SEX: --MALE-- -FEMALEGROUP: -8- -9- -8- -9- A N I @iA L S AF ORGAN AND YEYWORD(S) OR PHRASE NUMBER: 5 5 5 5. ------------------------------------------------------------------------ ** TOP OF LIST ** GENERAL COMMENT IGC) ..............................NU.M.BE.R EXAMINED: 5 5 5 5 NO MACROSCOPIC LESIONS 5 5 5 5 LIVER (LI) .......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE-. 5 5 5 5 5 5 5 5 END OF LIST TABLE 52 Incidence of Macroscopic observations Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=I,S;WEEKS=ALL DEATH=2;SUBSET--ALL N UMB BR-0F AN IHA LS A SF.X: --MALE-- -FEMALEGROUP: -1- -5- -1- -5- ORGAN AND KEYWORD(S) OR PHRASE NUMBER.- 5 5 5 5 ------------------------------------------------------------------------- ** TOP OF LIST ** GENERAL COMMENT (GC) ..............................N.UM.B.ER EXAMINED: s s 5 5 NO MACROSCOPIC LESIONS BONE MARROW SHEAR TAKEN 4 0 4 1 5 5 5 5 LUNG (LU) .......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: 5 5 5 5 4 5 5 5 MOTTLED 1 0 0 0 LIVER (LI) ......................................N.U.14.B.ER. EXAMINED: NOT REMARKABLE: 5 5 s 5 5 0 s 2 LIGHT FOCUS(I)/AREA(S) LARGE MOTTLED DIFFUSELY DARK DEPRESSED FOCUS(I)/AREA(S) 0 1 0 0 0 5 0 2 0 0 0 1 0 2 0 2 0 1 0 0 THYMUS (THI ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 5 5 5 s 5 5 5 4 RED FOCUS(I)/AREA(S) 0 0 0 1 TABLE 52 Incidence of Macroscopic observations Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERPLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL:GROUP=1,5;WEEKS=ALL DEATH=2,SUBSET=ALL N U M B E R -0 P A N I M A L S A SEX: --MALE-- -FEMALEGROUP: -1- -5- -1- -5- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 5 5 5 s ----------------------------------------------------------------------=--- -=- -=- -=- ADRENAL, CORTEX (AC) ..............................NU.M.BE.R EXAMINED: NOT REMARKABLE: 5 s s 5 s 4 5 5 DIFFUSELY RED 0 1 0 0 STOMACH, GL (ST) .................................N.U.MB.E.R EXAMINED: NOT REMARKABLE: 5 5 s s 5 3 5 4 DARK FOCUS(I)/AREAIS) RED FOCUS(I)/AREA(S) CECUM ICE) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: 0 1 0 1 0 1 0 0 5 s s s s 4 s s DIFFUSELY RED 0 1 0 0 UTERUS (UT) ......................................NU.M.BE.R. EXAMINED: 0 0 5 5 NOT RENAPICABLE.- 0 0 5 4 LUMEN FILLED WITH FLUID 0 0 0 1 LN, MANDIBULAR INN) ...............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 5 5 5 5 4 5 4 5 DIFFUSELY RED 1 0 1 0 TABLE 52 incidence of Macroscopic observations Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ----------------------------------------------------------------------------------------------------------------- TABLE INCLUDES! SEX=ALL;CROUP=I,S;WEEKS=ALL DRATH=2;SUBSET=ALL N U M B E R -0 F A N I M A L S A SEX: --MALE-- -FEKALEGROUP: -I- -5- -1- -5- ORGAN AND KEYWOPD(S) OR PHRASE NUMBER: 5 5 5 5 ------------------------------------------------------------------------- CAVITY, ABDON (PC) ................................NU.M.BE.R EXAMINED: NOT REMARKHBLE: EDEMA END OF LIST 5 5 5 5 s 4 5 5 0 1 0 0 TABLE 53 Incidence of Macroscopic observations Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN PATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL:GROUP=1,2,3,4;WEEKS=ALL DRATH=3;SUBSET--ALL NU NBER -0F -AN IMAL S-A SEX: -------MALE ------- ------FEMALE -----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 5 5 5 5 5 5 s 5 ------------------------------------------------------------------------- ** TOP OF LIST ** GENERAL COMMENT (GC) ..............................N.UM.B.ER EXAMINED: 5 s 5 5 5 5 5 5 NO MACROSCOPIC LESIONS BONE MARROW SHEAR TAKEN URINARY ELHDDER-SMALL LUKEN 2 2 5 4 3 4 2 4 s 5 5 5 5 5 5 s 0 0 0 0 0 0 1 0 KIDNEY (KD) ......................................NU.M.BE.R. L7JU41NED: 5 5 s 5 5 5 5 s NOT REMARKABLE: 4 5 5 5 5 5 5 5 LARGE PELVIS(ES) 1 0 0 0 0 0 0 0 LIVER (LI) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: s 5 5 5 5 5 5 5 4 5 5 5 5 5 5 5 MOTTLED 1 0 0 0 0 0 0 0 THYMUS (TH) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 5 5 s 5 5 5 5 5 4 5 5 5 5 5 5 5 MOTTLED 1 0 0 0 0 0 0 0 STOMACH, GL (ST) .................................N.U.M.BE.R EXAMINED: NOT REMARKABLE: s s 5 5 s 5 5 5 4 4 5 5 4 5 3 4 DARK FOCUS(I)/AREA(S) RED FOCUS(I)/AREA(S) 0 0 0 0 0 0 1 0 1 1 0 0 1 0 1 1 TABLE 53 Incidence of Macroscopic observations Week 14 Sacrifice 104-wEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (ga.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WEEKS=ALL DRATH=3;SUBSET=ALL N U H B E R -0 F - A N I N A L S - A F SEX: -------MALE ------- ------FEMALE -----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 5 5 s s 5 5 5 5 -----------------------------------------------------------------------=--- -,- -=- -=- -=- -=- -=- -=- SKIN (SK) ............................................ NUMBER EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 5 5 s 4 5 5 4 5 ALOPECIA-FOCAL RED FOCUS(I)/ARF.A(S) 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 PROSTATE (PR) ....................................N.UM.B.ER. EXAMINED: NOT REMARKABLE: 5 5 5 s 0 0 0 0 4 s 5 5 0 0 0 0 LARGE 1 0 0 0 0 0 0 0 SEMINAL VESICLES (SV) .............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 5 5 5 5 0 0 0 0 4 5 5 5 0 0 0 0 LARGE 1 0 0 0 0 0 0 0 UTERUS (UT) ......................................NU.1.4B.E.R EXAMINED: NOT REMARKABLE: 0 0 0 0 s 5 5 5 0 0 0 0 5 5 4 s LUNEN FILLED WITN FLUID 0 0 0 0 0 0 1 0 OVARY (OV) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: 0 0 0 0 5 5 5 5 0 0 0 0 4 5 5 5 CYST(S) 0 0 0 0 1 0 0 0 TABLE 53 incidence of Macroscopic observations Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WEEKS=ALL DEATH=3;SUBSET=ALL NU MBE R-0P -AN INAL S-A SEX: -------HALE ------- ------FEMALE -----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: s 5 5 5 5 5 5 s ------------------------------------------------------------------------- LN, MANDIBULAR (NN) ...............................N.U1.4.BER EXAMINED: NOT REMARKABLE: DIFFUSELY RED RED FOCUS(I)/ARFA(g) END OF LIST 5 5 5 5 5 5 5 5 4 3 5 5 5 4 4 5 1 2 0 0 0 0 1 0 0 0 0 0 0 1 0 0 TABLE 54 Incidence of Macroscopic observations Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-MMYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;CROUP=8,9;WEEKS=ALL DEATH=2;SUBSET=T N U N B E R - 0 P A N IM A L S A P SEX: --MALE-- -FEMALEGROUP: -8- -9- -8- -9- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 5 5 5 5 ------------------------------------------------------------------------- ** TOP OF LIST ** GENERAL COMMENT (GC) ..............................N.UM.B.ER EXAMINED: 5 5 5 5 NO MACROSCOPIC LESIONS LIVER (LI) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 s 5 5 s 5 5 END OF LIST TABLE 55 Incidence of Macroscopic observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAHIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,4;WEEKS=ALL DF.ATH=4;SUBSET--ALL NUK BER -0P AN INALS A P SEX: --KALE-- -FEMALEGROUP: -1- -4- -1- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 5 10 ------------------------------------------------------------------------- ** TOP OF LIST ** GENERAL COMMENT (GC) ..............................NU.M.BE.R EXAMINED: 5 10 5 10 5 10 NO MACROSCOPIC LESIONS BLOOD FILM TAKEN DISCHARGE-OCULAR MALOCCLUSION DONE KARROW SHEAR TAKEN TEETH MISSING/BROKEN/WORN 3 3 5 10 0 1 0 4 5 10 0 3 2 1 s 10 0 0 0 2 5 10 0 1 BRAIN (BR) ......................................N.U.MB.E.R . EXAMINED: NOT REMARKABLE: s 10 5 9 5 10 5 8 COMPRESSED (HYPOTHALAMUS) 0 1 0 2 LUNG (LU) .......................................N.U.MB.E.R . EXAMINED: NOT REMARKABLE: 5 10 5 10 5 10 5 a LIGHT FOCUS(I)/AREA(S) 0 0 0 2 LIVER (LI) ......................................N.U.MB.E.R . EXAMINED: NOT REMARKABLE: 5 10 s 10 5 10 4 9 LIGHT FOCUS(I)/AREA(S) MOTTLED 0 0 0 1 0 0 1 0 TABLE 55 incidence of Macroscopic Observations Week 53 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUORGOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,4;WEEKS=ALL DEATH=4:SUIBSET--ALL NU NBBR -0 P AN IMAL S A SEX: --MALE-- -FEKALEGROUP: -1- -4- -1- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 5 10 5 10 -----------------------------------------------------------------------=--- -=- -=- -='- IN, MESENTERIC (MS) ...............................N.UM.B.ER EXAMINED: NOT REMARKABLE: DIFFUSELY RED ADRENAL, CORTEX (AC) ..............................N.UM.B.ER EXAMINED: NOT REMARKABLE: DARK FOCUS(I)/ARFA(S) PITUITARY (PI) ...................................N.UM.B.ER. EXAMINED: NOT REMARKABLE: HASS(ES) DARK FOCUS(I)/ARPA(S) RED FOCUS(I)/AREA(S) STOMACH, GL (ST) .................................N.U.MB.E.R EXAMINED: NOT REMARKABLE: DARK FOCUS(I)/AREA(S) MAMMARY, FEMALE (MFI ..............................N.UM.B.ER EXAMINED: NOT REMARKABLE: KASS(ES) CYST(S) 5 10 5 10 0 0 5 10 4 10 1 0 s 10 5 8 0 2 0 0 0 0 5 10 5 9 0 1 0 0 0 0 0 0 0 0 5 10 5 9 0 1 5 10 5 10 0 0 5 10 4 7 0 2 1 0 0 1 5 10 4 4 1 6 5 10 4 8 0 1 1 2 TABLE 55 Incidence of Macroscopic Observations Week 53 sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULPONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=1,4;WEEKS=ALL DEATH=4;SUBSET--ALL N UMB ER-0F AN IHAL S A M: --HALE-- -FEMALEGROUP: -1- -4- -1- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 5 10 5 10 -----------------------------------------------------------------------=-- - -=- -=- -=@. UTERUS (UT) ......................................NU.M.BE.R. EXAMINED. NOT REMARKABLE- LUMEN FILLED WITH CYST(S) THICKENED WALL FLUID OVARY (OV) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: CYST(S) IN, MANDIBULAR (NN) ...............................N.UM.B.ER EXAMINED: NOT REMARKABLE: DIFFUSELY RED CAV:RTY, ABWK (PC) ................................NU.M.B.ER EXAMINED: NOT REMARKABLE: HASS(ES) TAIL (TI) .......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: RAISED AREA(S) END OF LIST 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 10 4 9 1 1 5 10 5 10 0 0 5 10 5 10 0 0 5 10 3 8 1 1 1 0 0 1 5 10 5 9 0 1 5 10 4 10 1 0 5 10 5 9 0 1 5 10 5 9 0 1 TABLE 56 Incidence of Macroscopic observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX-ALL;GROUP-8,9;WEEKSmALL DEATH-3;SUBSET-ALL N U M B E R -0 F A N I M A L S A SEX: --HALE-- -FEMALEGROUP: -8- -9- -a- -9- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 10 10 10 10 ------------------------------------------------------------------------ --- --- -- ** TOP OF LIST ** GENERAL COMMENT IGC) ..............................1.4U.K.BER EXAMINED: 10 10 10 10 NO MACROSCOPIC LESIONS MALOCCLUSION ANIMAL OBESE BONE MARROW SMEAR TAKEN TEETH MISSING/BROKEN/WORN BRAIN (BR) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE- 1 4 2 2 0 0 1 1 7 3 0 1 10 10 10 10 0 0 1 0 10 10 10 10 10 10 10 9 COMPRESSED IHYPOTHALAMUS) LUNG (LU) .......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: 0 0 0 1 10 10 10 10 10 10 9 10 LIGHT FOCUS(I)/AREA(S) 0 0 1 0 KIDNEY (KD) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 10 10 10 10 10 9 10 9 LARGE PELVIS(ES) CYST(S) 0 1 0 0 0 0 0 1 TABLE 56 Incidence of Macroscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETIFYL PERFLUOROOCTANESULEKWAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-8,9;WEEKS-ALL DFATH-3;SUBSET-ALL NUM BE R 0 F A N IM A L S A SEX: --HALE-- -FEMALEGROUP: -8- -9- -8- -9- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 10 10 10 10 --------------------------------------------------------------------------- --- --- --7 LIVER (LI) ......................................N.U.MB.E.R . EXAMINED: NOT REMARKABLE: LIGHT FOCUSII)/AREA(S) MOTTLED RED FOCUS(I)/AREA(S) SPLEEN ISP) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: LIGHT FOCUS(I)/AREA(S) ADRENAL, CORTEX (AC) ..............................N.UM.B.ER EXAMINED: NOT REMARKABLE: LARGE PITUITARY (PI) ...................................N.UM.B.ER. EXAMINED: NOT REMARKABLE: DARK FOCUSII)/AREA(S) LARGE DIFFUSELY RED RED FOCUSJI)/AREA(S) 10 10 10 10 8 10 9 10 1 0 0 0 1 0 0 0 0 0 1 0 10 10 10 10 10 9 10 10 0 1 0 0 10 10 10 10 10 10 9 10 0 0 1 0 10 10 10 10 10 9 5 8 0 0 1 0 0 1 4 2 0 0 0 1 0 0 2 1 TABLE 56 Incidence of Macroscopic observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-8,9;WEEKS-ALL DEATH-3;SUBSET-ALL N U M B E R - 0 F A N IM A L S A SEX: --MALE-- -FEMALEGROUP: -8- -9- -8- -9- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 10 10 10 10 ------------------------------------------------------------------------ --- --- -- STOMACH, GL (ST) .................................N.U.M.BE.R EXAMINED: NOT REMARKABLE: DARK FOCUS(I)/AREA(S) SKIN (SK) ............................................ NUMBER EXAMINED: NOT REMARKABLE: CRUSTED ARFA(S) MAMMARY, FEMALE (MF) ..............................N.UM.B.ER EXAMINED: NOT REMARKABLE: MASS(ES) CYST(S) UTERUS (UT) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: CYST(S) TESTIS ITE) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: SMALL 10 10 10 10 10 10 8 10 0 0 2 0 10 10 10 10 10 10 10 9 0 0 0 1 0 0 10 10 0 0 6 5 0 0 1 2 0 0 3 4 0 0 10 10 0 0 10 9 0 0 0 1 10 10 0 0 10 9 0 0 0 1 0 0 TABLE 56 c Incidence of Macroscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.llk) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GR(XJP-8,9;WEEKS-ALL DEATH-3;SUBSET=ALL NU MBE R-0 F SEX: --MALE-- -FEMALEGROUP: -8- -9- -8- -9- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 10 10 10 10 ------------------------------------------------------------------------ --- --- -=. A NIMA LS AF LN, AXILLARY (AX) .................................NU.M.BE.R EXAMINED.- 10 10 10 10 NOT REMARKABLE: 10 10 9 10 DIFFUSELY RED 0 0 1 0 LN, MANDIBULAR (MN) ...............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 10 10 10 10 10 10 8 7 DIFFUSELY RED MOTTLED END OF LIST 0 0 2 2 0 0 0 1 TABLE 57 Incidence of 14icroscopic Observations Wee@. 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1t) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,5;WEEKS-ALL DEATH-2;FIND-ALL;SUBSET=ALL NUM BE R-0 F SEX: --MALE-- -FEMALEGROUP: -I- -5- -I- -5- A N IM A L S AF ORGAN AND FINDING DESCRIPTION NUMBER: 5 5 ------------------------------------------------------------------------ --- ** TOP OF LIST ** EYE (EY) ........................................1.4U.M.BE.R. EXAMINED: NOT REMARKABLE: 5 5 5 5 5 --- 5 5 5 --- 5 5 BRAIN (BR) .......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 SPINAL CORD (SC) .................................N.U.M.BE.R EXAMINED: NOT RE14ARKABLE: KIDNEY (KD) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: --CAST, PR(YREINACEOUS --CYST --MINERALIZATION, TUBULAR --NEPHROPATHY, CHRONIC PROGRESSIVE LIVER (LI) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: --HEMORRHAGE --HYPERTROPHY, HEPATOCELLULAR --INFLAMMATION, CHRONIC --NECROSIS, HEPATOCELLULAR --VACUOLATION, NEPATOCELLULAR 5 5 5 5 5 5 5 5 5 5 5 5 3 4 5 4 1 0 0 0 1 1 0 0 0 0 0 1 0 1 0 0 5 5 5 5 3 0 4 0 0 3 0 1 0 5 1 5 2 0 0 0 0 3 0 1 0 1 0 0 TABLE 57 Incidence c)fMicroscopic Observations Week 8 Sacrifice 104-WEEK DIETARY CARClt4OGENICITY STUDY WITH NARROW RANGE (98.1%) ti-ETHYL PERFLIJOROO(-,TANESULE014P.MIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,5;WEEKS-ALL DEATtl=2;FIND-ALL;SUBSET-ALL NUM BER -0F SEX: GROUP: --MALE--1- -5- -FEMALE-I- -5- A N IM A L S AF ORGAN AND FINDING DESCRIPTION NUMBER: 5 5 5 5. --------------------------------------------------------------------------- --- --- --- THYMUS (TH) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: --HEMORRHAGE LN, MESENTERIC IMS) ...............................NU.M.BE.R EXAMINED: NOT REMARKABLE: --HEMORRHAGE SPLEEN (SP) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 5 5 5 5 4 5 5 3 1 0 0 2 5 5 5 5 4 5 5 5 1 0 0 0 5 5 5 5 5 5 5 5 PITUITARY (PI) ...................................N.UM.B.ER. EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 ADRENAL, CORTEX (AC) ..............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 ADRENAL, MEDULLA (MA) .............................N.U.MB.ER EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 TABLE 57 Tn(-,ider,coef @ticroscopic observations Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RA14GE (98.1%) H-ETIIYL F-ERFLIJOROOCTANESULFONPK.MIDO ETHANOL 114 RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROIJP-1,5;WEEKS-ALL DEATH-2;FIND-ALL;SUBSET-ALL NUM BER-0 F AN IMA LS A SEX: --MALE-GROUP: -I- -5- -FEMALE-I- -5- ORGAN AND FINDING DESCRIPTION NUMBER: 5 5 5 51 ----------------------------------------------------------------------=--- --- -=- --- STOMACH, NONGL (SU) ...............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 STOMACH, GL (ST) .................................N.U.M.BE.R EXAMINED; NOT REMARKABLE: 5 5 5 5 5 5 5 5 DUODENUM (DUI ....................................N.UM.B.E.R EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 JEJUNUM (JE) .....................................N.UM.B.ER. EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 PANCREAS (PA) ....................................N.UM.B.E.R EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 EPIDIDYMIDES (EP) .................................NU.M.BE.R EXAMINED: NOT REMARKABLE: 5 5 0 0 5 5 0 0 TABLE 57 Iriciden::!oef Microscopic Observations Week 0 Sacrifice 104-WEEK DIETARY CARCINOGEtlici,ry STUDY WITH NARROW RANGE (99.1%) N-ETHYL PERFLUOROO(.:TANESULFONAMIDO ETHANOL IN ".TS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GRO(JP-1,5;WEEKS-ALL DEATH-2;FIND--ALL;SUBSET-ALL NUM BER -0 F AN IM LS A F SEX: --MALE-- -FEMALEGROUP: -1- -5- -I- -5- ORGAN AND FINDING DESCRIPTION NUMBER: 5 5 5 5 ------------------------------------------------------------------------ --- --- --- TESTIS (TE) ......................................NU.M.B.ER. EXAMINED: NOT REMARKABLE: 5 5 0 0 5 5 0 0 OVARY (OV) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: 0 0 5 5 0 0 5 5 VAGINA (VA) ......................................NU.M.B.ER. EXAMINED: NOT REMARKABLE: 0 0 5 5 0 0 5 5 UTERUS (UT) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: --DILATATION LN, MANDIBULAR (MN) ...............................N.UM.B.ER EXAMINED: NOT REMARKABLE: --HEMORRHAGE LN, MEDIASTINAL (ML) ..............................N.UM.B.ER EXAMINED: tiCYr REMARKABLE: --HEMORRHAGE CAVITY, ABDOM (PC) ................................NU.M.B.ER EXAMINED: NOT REMARKABLE: --EDEMA END OF LIST 0 0 0 1 0 0 0 0 0 0 0 1 1 0 1 0 0 0 0 0 1 0 1 0 0 0 0 1 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 1 0 0 TABLE 58 Incidence of Microscopic Observations Week 14 Sacrifice 104-WEEK DIETARY CARCINOGEIIICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYI, PERFLUOROOCTA14ESULFONAI-iIDO ETHA140L IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=1,2,3,4;WEEKS-ALL DEATH=3;FIND=ALL;SUBSET=ALL N U H B E R - 0 F -A N I M A LS A F SEX: -------KALE ------- ------FEMALE -----GROUP: -1- -2- -3- -4- -I- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 5 5 5 5. 5 5 5 5 ------------------------------------------------------------------------ ** TOP OF LIST ** EYE (EY) ........................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 BRAIN (BR) .......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: KIDNEY (KD) ......................................NU.M.B.ER. EXAMINED: NOT REMARKABLE: --CAST, PROTEINACEOUS --CYST --DEGENERATION, TUBULAR --DILATATION, PELVIC --HYPERPLASIA, TRANSITIONAL --INFLAMMATION, CHRONIC --MINERALIZATION, TUBULAR --PYELONEPHRITIS CELL LIVER (LI) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: --HEMATOPOIESIS, --HEMORRHAGE --HYPERTROPHY, --INFLAMMATION, --VACUOLATION, EXTRAMEEK)LLARY HEPA-ROCELLULAR CHRONIC HEPATOCELLULAR 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 3 3 5 5 5 5 4 4 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 5 5 5 5 5 5 5 5 3 1 1 0 3 1 3 2 1 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 1 3 5 0 0 0 2 1 1 3 0 1 4 2 0 2 2 1 0 0 0 0 TABLE 58 Incidence of Microscopic Observations Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) H-ETHYL PERFLUOROOCTANESULFONzU41DO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,2,3,4;WEEKS=ALL DEATH=3;FIND--ALL;SUBSET-ALL NUH BER -0F-A NIMA LS-A SEX: -------MALE ------- ------FEMALE -----GROUP: -I- -2- -3- -4- -I- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 5 5 5 5 5 5 5 5 --------------------------------------------------------------------------- --- --- --- -=- -.- -=- -=- LN, MESENTERIC (MS) ...............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 4 5 5 5 5 5 5 5 4 5 4 5 5 5 4 5 --HEMORRHAGE --INFILTRATE, MACROPHAGE, PIGMENTED 0 0 1 0 0 0 1 0 0 0 0 0 0 0 1 0 SPLEEN (SP) ......................................N.UM.B.ER. EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 ADRENAL, CORTEX (AC) ..............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 3 2 4 4 5 5 5 4 --VACUOLATION ADRENAL, MEDULLA (MA) .............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 2 3 1 1 0 0 0 1 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 PANCREAS (PA) ....................................N.UM.B.ER. EXAMINED: NOT REMARKABLE: 5 5 5 5 5 5 5 5 4 5 4 5 5 5 5 5 --FIBROSIS --PIGMENT 1 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 TESTIS (TE) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 5 5 5 5 0 0 0 0 5 5 4 5 0 0 0 0 --ATROPHY/DEGENERATION 0 0 1 0 0 0 0 0 OVARY (OV) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: 0 0 0 0 5 5 5 5 0 0 0 0 5 5 5 4 --HEMORRHAGE END OF LIST 0 0 0 0 0 0 0 1 TABLE 60 Inci,-Jenceof Severity of Microscopic Observations Week. 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (90.1%) N-ETIIYL PERFLk)OROOCTANESULF014AMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP-1,5;WEEKS=ALL DEATH=2;FIND=ALL;SUBSET-T N UM B E R - 0 F A N I M A L S A SEX: --MALE-- -FEMALEGROUP: -I- -5- -I- -5- ORGAN/TISSIJE EXAMINED NUMBER: 5 5 5 5 ------------------------------------------------------------------------ ** TOP OF LIST ** LIVER (LI) .......................................NU.M.BE.R. EXAMINED: 5 5 5 5 --HEMATOPOIESIS, EXTRAMEDULLARY -> 5 5 5 5 TL> 5 5 5 5 MN> 0.0 0.0 0.0 0.0 --HEMORRHAGE -> 5 2 5 4 1> 0 3 0 0 3> 0 0 0 1 TL> 5 5 5 5 MN> 0.0 0.6 0.0 0.6 --HYPERTROPHY, HEPATOCELLULAR -> 5 0 4 0 1> 0 0 1 0 3> 0 5 0 4 4> 0 0 0 1 TL> 5 5 5 5 MN> 0.0 3.0 0.2 3.2 --INFLAMMATION, CHRONIC CONTINUED ON NEXT PAGE -> 3 5 5 5 1> 2 0 0 0 TL> 5 5 5 5 MN> 0.4 0.0 0.0 0.0 TABLE 60 Incidence of Severity of Microscopic Observations Week 8 Sacrifice 104-WEEK DIETARY CARCINO(.;EIIICITY STUDY WITH NARROW RANGE (98.1%) N-ETIIYL PFRFLIJOROO(-'TAtJESULFONAMIDO ETHANOL 114 RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GRO(JP=1,5;WEEKS-ALL DEATH-2;FIND-ALL;SUBSET-T N U M B E R - 0 F A N IM A L S A SEX: --MALE-- -FEMALEGROUP: -1- -5- -I- -5- ORGAN/TISSUE EXAMINED NUMBER: 5 5 ------------------------------------------------------------------------ --- ** FROM PREVIOUS PAGE " LIVER ILI) .......................................NU.M.BE.R. EXAMINED: 5 5 --NECROSIS, HEPATOCELLIJLAR -> 5 2 1> 0 1 3> 0 2 TL> 5 5 MN> 0.0 1.4 5 --- 5 5 0 0 5 0.0 5 --- 5 4 0 1 5 0.6 --VACUOLATION, HEPATOCELLULAR END OF LIST -> 5 4 5 5 1> 0 1 0 0 TL> 5 5 5 5 MN> 0.0 0.2 0.0 0.0 TABLE 61 Incidence of Severity of Microscopic Observations Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) H-ETHYL PERFLUOROr)r-TA14ESULFONAMIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,2,3,4;WEEKS-ALL DEATH=3; FIND=ALL;SUBSET-T N U M B E R - 0 F -A N I M A L S - A F SEX: GROUP: -------MALE ------- ------FEMALE ------I- -2- -3- -4- -I- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 5 5 ------------------------------------------------------------------------ ** TOP OF LIST ** LIVER (LI) .......I ................................NU.M.BE.R EXAMINED: 5 5 --HEMATOPOIESIS, EXTRAMED()LLARY -> 4 5 1> 1 0 TL> 5 5 MN> 0.2 0.0 5 5. 5 5 5 5 - --- --- --- --- - 5 5 5 5 5 5 5 5 5 5 5 5 0 0 0 0 0 0 5 5 5 5 5 5 0.0 0.0 0.0 0.0 0.0 0.0 --HEMORRHAGE -> 4 5 5 5 4 5 5 5 1> 1 0 0 0 0 0 0 0 3> 0 0 0 0 1 0 0 0 TL> 5 5 5 5 5 5 5 5 MN> 0.2 0.0 0.0 0.0 0.6 0.0 0.0 0.0 --HYPERTROPHY, HEPATOCELLULAR -> 5 4 2 0 5 5 5 3 1> 0 1 1 0 0 0 0 0 2> 0 0 1 4 0 0 0 2 3> 0 0 1 1 0 0 0 0 TL> 5 5 5 5 5 5 5 5 MN> 0.0 0.2 1.2 2.2 0.0 0.0 0.0 0.8 --INFLAMMATION, CHRONIC CONTINUED ON NEXT PAGE -> 4 4 2 5 4 1 3 3 1> 0 1 3 0 1 4 2 2 2> 1 0 0 0 0 0 0 0 TL> 5 5 5 5 5 5 5 5 MN> 0.4 0.2 0.6 0.0 0.2 0.8 0.4 0.4 TABLE 61 Ir.,--i,lenocfe Severity of Microscopic observations Week 14 Sacrifice 104-WEE@,' DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) 14-ETHYL PERFLIJOROOCRANESULFONA@IIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLIJUES: SEX-ALL;GR04JP-1,2,3,4;WEEKS-ALL DEATH=3;FIND-ALL;SUBSET-T N U M B E R - 0 F -A N IM A L S -A P SEX: -------MALE ------- ------FEMALE -----GROUP: -I- -2- -3- -4- -I- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 5 5 5 5 5 5 5 ------------------------------------------------------------------------ @* FROM PREVIOUS PAGE ** LIVER (LI) .......................................NU.M.BE.R. EXAMINED: 5 5 5 5 5 5 5 5 --NECROSIS, HEPATOCELLULAR -> 5 5 5 5 5 5 5 5 TL> 5 5 5 5 5 5 5 5 MN> 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 --VACIJOLATION, HEPATOCELLULAR END OF LIST -> 5 3 3 4 5 5 5 5 1> 0 1 1 1 0 0 0 0 2> 0 1 0 0 0 0 0 -0 3> 0 0 1 0 0 0 0 0 TL> 5 5 5 5 5 5 5 5 MN> 0.0 0.6 0.8 0.2 0.0 0.0 0.0 0.0 TABLE 59 Incidence of Microscopic observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROtJP-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL NUM BER -0F A NIMA LS A SEX: --MALE-- -FEMALEGROUP: -1- -4- -I- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 5 ------------------------------------------------------------------------ ** TOP OF LIST ** EYE (EY) ........................................N.UM.B.E.R . EXAMINED- 5 NOT REMARKABLE: 5 10 --- 10 10 5 --- 5 5 10 --- 10 10 BRAIN (BR) ......................................M.L.74.B.ER. EXAMINED: NOT REMARKABLE: --COMPRESSION, VENTRAL LIVER (LI) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: --DEGENERATION, CYSTIC --FOCUS, ALTERED HEPATOCELLULAR, --EDCUS, ALTERED HEPATOCELLULAR, --HYPERPLASIA, BILE DUCT --HYPERTROPHY, HEPATOCELLULAR --INFLAM14ATION, CHRONIC --NECROSIS, HEPATOCELLULAR --STASIS, BILE --VACUOLATION, HEPATOCELLULAR --B-ADENOKA, HEPATOCELLULAR EOSINOPHILIC BASOPHILIC KIDNEY (KD) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: --CAST, PROTEINACEOUS --INFLAMMATION, CHRONIC CONTINUED ON NEXT PAGE ** 5 10 5 10 0 0 5 10 1 0 0 0 0 0 1 0 0 0 0 10 3 1 0 1 0 1 0 9 0 0 5 10 0 7 3 1 0 0 5 10 5 8 0 2 5 10 4 2 0 1 0 1 0 0 0 1 0 1 1 1 0 2 0 2 0 2 0 1 5 10 1 5 0 3 2 0 TABLE 59 Incidence of Microscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.11) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL N U H B E R -0 F A N I M A LS A SEX: --MALE-- -FEMALEGROUP: -1- -4- -1- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 5 10 5 10 ------------------------------------------------------------------ ------ ** FROM PREVIOUS PAGE ** KIDNEY (KD) ...................................NU.M.BE.R..E.X.AMINED: NOT REMARKABLE: 5 10 01 5 10 15 --MINERALIZATION, PELVIC --MINERALIZATION, TUBULAR --NEPHROPATHYF CHRONIC PROGRESSIVE 1 1 2 2 0021 2 1 0 0 SPLEEN (SP) ...................................NU.M.BE.R..E.X.AMINED: NOT REMARKABLE: 5 10 5 10 5 10 5 10 PANCREAS (PA) .................................N.U.MB.E.R ..E.XAMINED: NOT REMARKABLE: --ATROPHYF ISLET CELLS --FIBROSIS --INFLAMATION, CHRONIC --PIGMENT ADRENAL, CORTEX (AC) ............................NU.M.BE.R..EXAMINED: NOT REMARKABLE: --ANGIECTASIS --DEGENERATION, --FIBROSIS CYSTIC, CORTICAL --HYPERTROPHY, --VACUOLATION CORTICAL CELL 5 10 4a 10 01 01 01 5 10 3 9 00 10 00 10 10 11 5 10 5 10 0 0 0 0 00 0 0 5 10 1 8 20 02 01 4 0 00 00 TABLE 59 Incidence of Microscopic observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1t) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS-ALL DFATH-4;FIND-ALL;SUBSET-ALL NUM BER -0 F A N IM A L S A SEX: --MALE-- -FEMALEGROUP: -1- -4- -1- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 5 10 5 10 --------------------------------------------------------------------------- --- --- --- ADRENAL, MEDULLA (MA) .............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 5 10 5 9 5 10 5 10 --HEMORRHAGE --B-PHEOCHROMOCYTCHA LN, MESENTERIC (MS) ...............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 0 1 0 1 5 10 5 9 0 0 0 0 5 10 5 9 --HEMORRHAGE --INFILTRATE, MACROPHAGE, PIGMENTED 0 1 0 1 0 1 0 0 OVARY (OV) ......................................N.U.MB.E.R. EXAMINED-. 0 0 5 10 NOT REMARKABLE: 0 0 5 7 --CYST --HEMORRHAGE TESTIS (TE) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: --ATROPHY/DEGENERATION BONE, FEMUR (FE) .................................N.U.MB.E.R EXAMINED: NOT REMARKABLE: 0 0 0 0 5 10 5 9 0 1 5 10 5 10 0 2 0 2 0 0 0 0 0 0 5 10 5 10 TABLE 59 Incidence of Microscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------7----------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS=ALL DEATH=4;FIND=ALL;SUBSET=ALL N UM B ER -0 F A NIMA LS A SEX: --MALE-- -FEMALEGROUP: -I- -4- -1- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 5 10 5 10 --------------------------------------------------------------------------- MARROW, FEMUR (EN) ..............................NU.M.BE.R..EXAMINED: NOT REMARKABLE: 5 10 5 10 5 10 5 10 MARROW, STERNUM (SE) ............................NU.M.BE.R..EXAMINED: NOT REMARKABLE: 5 10 5 10 5 10 5 10 BONE, STERNUM (SB) ..............................NU.M.BE.R..EXAMINED: NOT REMARKABLE: 5 10 5 10 5 10 5 10 THYMUS (TH) ...................................N.UM.B.ER...EX.AMINED: NOT REMARKABLE: --FIBROSIS --HEMORRHAGE SPINAL CORD (SC) ...............................N.UM.B.ER...EXAMINED: NOT REMARKABLE: 5 9 4 9 0 0 1 0 5 10 5 10 5 10 5 9 01 0 0 5 10 5 10 LN, MANDIBULAR --HEMORRHAGE (MN) .............................NU.M.BE.R..EXAMINED: NOT REMARKABLE: 5 10 4 9 1 1 5 10 4 10 1 0 TABLE 59 Incidence of Microscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.10) H-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP=2,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL N U M B E R - 0 F A N IM A L S A SEX: --MALE-- -FEMALEGROUP: -1- -4- -1- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 5 10 --------------------------------------------------------------------------- 5 10 LUNG (LU) .......................................N.U.MB.E.R . EXAMINED: NOT REMARKABLE: 5 10 4 7 5 10 4 8 --HYPERPLASIA, MEDIAL, ARTERIAL/ARTERIOLRR --MINERALIZATION, VASCULAR --INFILTRATE, MACROPHAGEF ALVEOLAR --INFILTRATE, MACROPHAGE, PIGMENTED HEART (HT) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE-. 0 1 I 1 1 1 0 0 5 10 5 9 0 0 0 0 1 2 0 1 5 10 5 10 --DEGENERATION/NECROSIS 0 1 0 0 MUSCLE, SKELETAL (SM) .............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 5 10 5 10 5 10 5 10 NERVE, SCIATIC (SN) .................................. NUMBER EXAMINED: NOT REMARKABLE: 5 10 5 10 5 10 5 10 THYROID (TY) .....................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: --CYST, FOLLICULAR --CYST, ULTIMOBRANCHIAL --B-ADENOMA, C-CELL --B-ADENOMAf FOLLICULAR CELL 5 10 3 7 0 1 2 2 0 0 0 0 5 10 3 3 0 0 2 6 0 1 0 1 TABLE 59 Incidence of Microscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.11) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROtJP-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL N UM B E R - 0 F A N IM A L S A SEX: --MALE-- -FEMALEGROUP: -1- -4- -I- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 5 10 5 10 --------------------------------------------------------------------------- --- --- --- PARATHYROID (PT) .................................N.U.M.BE.R EXAMINED: NOT REMARKABLE; 5 10 5 9 4 10 5 9 --HYPERPLASIA TRACHEA (TR) .....................................N.UM.B.ER. EXAMINED: NOT REMARKABLE: 1 0 5 10 5 10 0 0 5 10 5 10 ESOPHAGUS (ES) ...................................N.UM.B.ER. EXAMINED: NOT REMARKABLE: 5 10 5 10 5 10 5 10 PITUITARY (PI) ...................................N.U.MB.E.R EXAMINED: NOT REMARKABLE: --CYST --HEMORRHAGE --HYPERPLASIA --B-ADENOMA SALIV GL, MANDIB (SG) ................................ NUMBER EXAMINED: NOT REMARKABLE: 5 10 3 4 0 0 0 2 0 3 2 3 5 10 5 10 5 10 3 5 0 1 0 1 0 0 2 4 5 10 5 10 TABLE 59 Incidence of Microscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH HARROW RANGE (98.1t) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GRO(JP-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL NUM 8ER -0F SEX: --MALE-- -FEMALEGROUP: -1- -4- -1- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 5 10 5 10 ------------------------------------------------------------------------ --- --- --- A N IM A L S AF HARDERIAN GLAND (HG) ..............................N.U1.4.BER EXAMINED: NOT REMARKABLE: --INFLAMMATION, CHRONIC STOMACH, GL (ST) .................................N.U.MB.E.R EXAMINED: NOT REMARKABLE: --EDEMA --EROSION STOMACH, NONGL (SU) .................................. NUMBER EXAMINED: NOT REMARKABLE: 5 10 5 10 0 0 5 10 5 9 0 0 0 1 5 10 5 10 5 10 5 9 0 1 5 10 4 8 1 0 0 2 5 10 5 10 DUODENUM (DU) ....................................N.UM.B.ER. EXAMINED: NOT REMARKABLE: 5 10 5 10 5 10 5 10 JEJUNUM (JE) .....................................N.UM.B.ER. EXAMINED: NOT REMARKABLE: 5 10 5 10 5 10 5 10 ILEUM (IL) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: 5 10 5 10 5 10 5 10 TABLE 59 incidence of Microscopic observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTAKESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-ALL N U M B E R - 0 F A N IM A L S A SEX: GROUP: --MALE--1- -4- -FEMALE-I- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 5 10 5 10 --------------------------------------------------------------------------- --- --- -- CECUM (CE) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: 5 10 5 10 5 10 5 10 COLON (CO) ......................................N.U.MB.E.R . EXAMINED: NOT REMARKABLE: --PARASITISM RECTUM (RE) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: --PARASITISM SKIN (SK) ............................................ NUMBER EXAMINED: NOT REMARKABLE: 5 10 .5 9 0 1 5 10 5 9 0 1 5 10 5 10 5 10 5 10 0 0 5 10 4 10 1 0 5 10 5 10 MAMMARY, FEMALE (MF) ..............................N.UM.B.ER EXAMINED: NOT REMARKABLE: --GALACTOCELE --M-CARCINOMA PROSTATE (PR) ....................................N.UM.B.E.R EXAMINED: NOT REMARKABLE: --INFLAMMATION, CHRONIC CONTINUED ON NEXT PAGE ** 0 0 0 0 0 0 0 0 5 10 3 10 1 0 5 10 4 a 1 1 0 1 0 0 0 0 0 0 TABLE 59 Incidence of Microscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX-ALL;GR(XJP-1,4;WEEKS-ALL DEATH-4;FIND=ALL;SUBSET=ALL NUM BER -0 F A N IM A L S A SFX: --MALE-- -FEMALEGROUP: -1- -4- -1- -4- ORGAN AND FINDING DESCRIPTION NUMBER:. 5 10 ---------------------------------=---= ----------------------------------- ** FROM PREVIOUS PAGE ** PROSTATE (PR) ....................................N.UM.B.ER. EXAMINED: NOT REMARKABLE: 5 10 3 10 5 10 0 0 0 0 --INFLAMMATION, CHRONIC-ACTIVE 1 0 0 0 URINARY BLADDER (UB) ..............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 5 10 5 10 5 10 5 10 EPIDIDYMIDES (EP) ................................N.U.MB.E.R EXAMINED: NOT REMARKABLE-. 5 10 0 0 5 10 0 0 SEMINAL VESICLES (SV) .............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 5 10 0 0 5 10 0 0 VAGINA (VA) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 0 0 5 10 0 0 5 10 CERVIX (CV) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 0 0 5 10 0 0 5 10 TABLE 59 Incidence of Microscopic Observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULF014AMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROt)P-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET=ALL N UM BER -0 F A N IM A L S A SEX: --MALE-- -FEMALEGROUP: -I- -4- -I- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 5 10 ------------------------------------------------------------------------ 5 10 UTERUS (UT) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 0 0 5 10 0 0 3 8 --DILATATION --KYPERPLASIA, CYSTIC, ENDOMETRIAL LN, MEDIASTINAL (ML) ..............................N.UM.B.ER EXAMINED: NOT REMARKABLE-. --HEMORRHAGE --INFILTRATE, MACROPHAGE, PIGMENTED CAVITY, ABDOM (PC) ................................NU.M.BE.R EXAMINED: NOT REMARKABLE: 0 0 2 1 0 0 0 1 0 0 0 2 0 0 0 0 0 0 0 2 0 0 0 2 0 0 0 1 0 0 0 0 --FIBROSIS --NECROSIS, FAT LN, LUMBAR/ILIAC (LJ4) .............................N.U.MB.ER EXAMINED: NOT REMARKABLE: 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 TAIL (TI) .......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: 0 0 0 1 0 0 0 0 --INFLAMMATION, ACUTE --B-KERATOACANTHCMA 0 0 0 1 0 0 0 1 END OF LIST TABLE 60 Incidence of Severity of Microscopic Observations Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,5;WEEKS-ALL DEATH-2;FIND-ALI,;SUBSET-T N UM B E R - 0 F SEX: GROUP: --MALE--I- -5- -FEMALE-1- -5- ORGAN/TISSUE EXAMINED NUMBER: 5 5 --------------------------------------------------------------------------- --- ** TOP OF LIST ** LIVER (LI) .......................................NU.M.BE.R. EXAMINED: 5 5 --HEMATOPOIESIS, EXTRAMEDULLARY -> 5 5 TL> 5 5 MN> 0.0 0.0 5 --- 5 5 5 0.0 5. --- 5 5 5 0.0 --HEMORRHAGE -> 5 2 5 4 1> 0 3 0 0 3> 0 0 0 1 TL> 5 5 5 5 MN> 0.0 0.6 0.0 0.6 --HYPERTROPHY, NEPATOCELLULAR -> 5 0 4 0 1> 0 0 1 0 3> 0 5 0 4 4> 0 0 0 1 Tl> 5 5 5 5 MN> 0.0 3.0 0.2 3.2 --INFLAMMATION, CHRONIC CONTINUED ON NEXT PAGE -> 3 5 5 5 1> 2 0 0 0 TL> 5 5 5 5 MN> 0.4 0.0 0.0 0.0 AN IMA LS AF TABLE 60 Incidence of Severity of Microscopic Observations Week 8 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.11) N-ETHYL PERFLUOROOCTANESULEONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,5;WEEKS-ALL DEATH-2;FIND-ALL;SUBSET-T NUM BER -0 F A N IH A L S A SEX: GROUP: --MALE--I- -5- -FEMALE-I- -5- ORGAN/TISSUE EXAMINED NUMBER: 5 5 ------------------------------------------------------------------------ --- ** FROM PREVIOUS PAGE *- LIVER (LI) .......................................NU.M.BE.R. EXAMINED: 5 5 --NECROSIS, HEPATOCELLULAR -> 5 2 1> 0 1 3> 0 2 TL> 5 5 MN> 0.0 1.4 5 --- 5 5 0 0 5 0.0 5. --- 5 4 0 1 5 0.6 --VACUOLATION, HEPATOCELLULAR END OF LIST -> 5 4 5 5 1> 0 1 0 0 TL> 5 5 5 5 MN> 0.0 0.2 0.0 0.0 TABLE 61 Incidence of Severity of Microscopic observations Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 190.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,2,3,4;WEEKS-ALL DEATH-3;FIND-ALL;SUBSET=T N U M B E R - 0 F - A N I M A L S -,A F SEX: -------MALE ------- ------FEMALE -----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 5 5 5 5. 5 5 5 5 ------------------------------------------------------------------------ - --- --- --- --- ** TOP OF LIST ** LIVER (LI) --HEMATOPOIESIS, EXTRAMEDULLARY NUMBER EXAMINED: 5 5 5 5 5 5 5 5 -> 4 5 5 5 5 5 5 5 1> 1 0 0 0 0 0 0 0 TL> 5 5 5 5 5 5 5 5 MN> 0.2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 --HEMORRHAGE -> 4 5 5 5 4 5 5 5 1> 1 0 0 0 0 0 0 0 3> 0 0 0 0 1 0 0 0 TL> 5 5 5 5 5 5 5 5 MN> 0.2 0.0 0.0 0.0 0.6 0.0 0.0 0.0 --HYPERTROPHY, HEPATOCELLULAR -> 5 4 2 0 5 5 5 3 1> 0 1 1 0 0 0 0 0 2> 0 0 1 4 0 0 0 2 3> 0 0 1 1 0 0 0 0 TL> 5 5 5 5 5 5 5 5 MN> 0.0 0.2 1.2 2.2 0.0 0.0 0.0 0.8 --INFLAMKATION, CHRONIC **.CONTINUED ON NEXT PAGE -> 4 4 2 5 4 1 3 3 1> 0 1 3 0 1 4 2 2 2> 1 0 0 0 0 0 0 0 TL> 5 5 5 5 5 5 5 5 MN> 0.4 0.2 0.6 0.0 0.2 0.8 0.4 0.4 TABLE 61 Incidence of Severity of Microscopic Observations Week 14 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE 198.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS --------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,2,3,4;WEEKS-ALL DEATH-3;FIND-ALL;SUBSET-T NUH B ER-0 F-AN IMA LS A F SEX: -------MALE ------- ------FEMALE -----GROUP: -1- -2- -3- -4- -I- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 5 5 5 5 5 5 5 5 ---------------------=----------------------------------------------------- --- --- --- --- --- - ** FROM PREVIOUS PAGE ** LIVER (LI) .......................................NU.M.BE.R. EXAMINED: 5 5 5 5 5 5 5 5 --NECROSIS, HEPATOCELLULAR -> 5 5 5 5 5 5 5 5 TL> 5 5 5 5 5 5 5 5 MN> 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 --VACUOLATION, HEPATOCELLULAR END OF LIST -> 5 3 3 4 5 5 5 5 1> 0 1 1 1 0 0 0 0 2> 0 1 0 0 0 0 0 0 3> 0 0 1 0 0 0 0 0 TL> 5 5 5 5 5 5 5 5 MN> 0.0 0.6 0.8 0.2 0.0 0.0 0.0 0.0 TABLE 62 Incidence of Severity of Microscopic observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.11) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-T NUM BE R-0 F AN IMA LS A SEX: --MALE-- -FEMALEGROUP: -1- -4- -I- -4- ORGAN/TISSUE EXAMINED NUMBER- 5 ------------------------------------------------------------------------ ** TOP OF LIST ** LIVER (LI) ......................................N.U.MB.E.R. EXAMINED: 5 --DEGENERATION, CYSTIC -> 5 1> 0 TL> 5 MN> 0.0 10 --- 10 10 0 10 0.0 5 --- 5 5 0 5 0.0 10 --- 10 9 1 10 0.1 --E-OCUS, ALTERED HEPATOCELLULAR, EOSINOPHILIC -> 5 10 5 9 4> 0 0 0 1 TL> 5 10 5 10 MN> 0.0 0.0 0.0 0.4 --FOCUS, ALTERED HEPATOCELLULAR, BASOPHILIC -> 4 10 5 10 2> 1 0 0 0 TL> 5 10 5 10 MN> 0.4 0.0 0.0 0.0 --HEMATOPOIESIS, EXTRAMEDULLARY -> 5 10 5 10 TL> 5 10 5 10 MN> 0.0 0.0 0.0 0.0 --HEMORRHAGE CONTINUED ON NEXT PAGE -> 5 10 5 10 TL> 5 10 5 10 MN> 0.0 0.0 0.0 0.0 TABLE 62 Incidence of Severity of Microscopic Observations Week 53 Sacrifice 104-WF.EK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS-ALL DEATH-4;FIND=ALL;SUBSET-T NUM BER -0 F A N IM A L S A SEX: --MALE-- -FEMALEGROUP: -1- -4- -I- -4- ORGAN/TISSUE EXAMINED NUMBER: 5 10 --------------------------------------------------------------------------- 5 10 ** FROM PREVIOUS PAGE ** LIVER (LI) ......................................N.U.MB.E.R. EXAMINED: 5 10 5 10 --HYPERPLJkSIA, BILE DUCT -> 5 10 5 9 1> 0 0 0 1 TL> 5 10 5 10 M> 0.0 0.0 0.0 0.1 --HYPERTROPHY, HEPATOCELLULAR => 5 0 5 3 2> 0 3 0 3 3> 0 2 0 4 4> 0 5 0 0 TL> 5 10 5 10 MN> 0.0 3.2 0.0 1.8 --INFLAMMATION, CHRONIC -> 2 9 4 9 1> 3 1 1 0 2> 0 0 0 1 TL> 5 10 5 10 MN> 0.6 0.1 0.2 0.2 --NECROSIS, HEPATOCELLUIJKR CONTINUED ON NEXT PAGE -> 5 9 5 8 1> 0 1 0 1 3> 0 0 0 1 TL> 5 10 5 10 MN> 0.0 0.1 0.0 0.4 TABLE 62 Incidence of Severity of Microscopic observations Week 53 Sacrifice 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1%) N-ETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX-ALL;GROUP-1,4;WEEKS-ALL DEATH-4;FIND-ALL;SUBSET-T N U M 6 E R - 0 F A N IM A L S A SEX: --MALE-- -FEMALEGROUP: -1- -4- -1- -4- ORGAN/TISSUE EXAMINED NUMBER: 5 10 --------------------------------------------------------------------------- --- ** FROM PREVIOUS PAGE ** LIVER (LI) ......................................N.U.MB.E.R. EXAMINED: 5 10 --STASIS, BILE -> 5 9 1> 0 1 2> 0 0 TL> 5 10 MN> 0.0 0.1 5 --- 5 5 0 0 5 0.0 10 --- 10 8 1 1 10 0.3 --VACUOLATION, HEPATOCELLULAR -> 5 1 5 a 1> 0 3 0 2 2> 0 3 0 0 3> 0 3 0 0 TL> 5 10 5 10 M> 0.0 1.8 0.0 0.2 --B-ADENCMA, HEPATOCELLULAR -> 5 10 +> 0 0 TL> 5 10 5 9 0 1 5 10 --X-HEMATOPOIETIC END OF LIST NEOPLASIA (SEE -HEMATO NEOPLASIA- FOR TYPE) -> 5 10 TL> 5 10 5 10 5 10 Covance 6329-212 3M T-6316.1 Table 63 ResultsofHomogeneity Analyses(ppm) lvfted9/11/97 104-WEEK DIETARY CARCINOGENICrry STUDY WnH NARROW RANGE (98.1-/oN)-ETHYL PERFLUOROOCRANESULFONAMDO EN-IANOL IN RATS Sample Location Replicate 3 T-6316 (ppm) 30 100 300 Top 1 6.28 38.0 95.3 322 2 '6.35 32.2 90.9 277 3 6.24 33.7 93.5 296 Mean 6.29(210)'34.6(115) 93.2(93.2) 298(99.3) Nfiddle 1 2 3 Mean 5.17 5.65 5.89 5.57(186) 33.9 102 34.1 143 34.9 96.8 34.3(114) 114(114) 286 271 266 274(91.3) Bottom 1 2 3 Mean 6.61 5.24 5.37 5.74(191) 32.9 109 35.9 108 32.7 99.4 33.8(113) 105(105) 325 334 278 312(104) a Fach valueinparenthesisisthe percentoftheoretical Covance 6329-212 3M T-6316.1 Table63 (Continued) ResultsofHomogeneity Analyses(ppm) Mixed 9/29/97 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.10/oN)-ETHYL pEy,FLUOROOCTANF ,SUL]FONAMIDO ETHANOL IN RATS T-6316 (ppm) Sample Location RePlicate 3 Top Middle 1 2 3 Mean 1 2 3 Mean 3.98 4.26 30.0 12.7(423Y 4.00 4.14 3.87 4.00(133) Bottom 1 2 3 Mean 4.32 3.98 4.20 4.17(139) a Each valueinparenthesisisthe percentof theoretical. Covance 6329-212 3M T-6316.1 Table63 (Continued) Resultsof Homogeneity Analyses(ppm) NExed 10/15/97 104-WEEK.DIFTARY CARCINOGEMCrry STUDY WrrH NARROW RANGE (98.10/oN)-ETHYL PERFLUOROOCRANESULFONAMIDO ETHANOL IN PATS T-6316 (ppm) Sample Location Replicate 3 Top 1 3.18 2 2.99 3 3.23 Mean 3.13 (104Y Middle 1 2 3 Mean 3.44 3.19 3.32 3.32(111) Bottom 1 2 3 Mean 3.06 3.98 3.34 3.46(115) a Each valueinparenthesisisthepercentof theoretical. Covance 6329-212 3M T-6316.1 Table63 (Continued) ResultsofHomogeneity Analyses(ppm) Mxed 11/7/97 104-WEEK DIFTARY CARCINOGENICrrY STUDY VffM NARROW RANGE (98.1a/aN)-ETHYL pEMUOROOCTANEsULFONAIvMo ETHANOL IN RATS Sample Location Replicate 3 T-6316 (ppm) 300 Top Middle 1 2 3 Mean 1 2 3 Mean 2.73 296 3.19 305 3.53 302 3.15(105)' 301(100) 3.67 2.51 2.83 3.00(100) 304 300 297 300(100) Bottom 1 2 3 Mean 3.12 2.91 3.12 3.05(102) 293 278 328 300(100) a Each valueinparenthesisisthepercentof theoretical. Covance 6329-212 3M T-6316.1 Table63 (Continued) ResultsofHomogeneity Analyses(ppm) Mxed 11/13/97 104-WEEK DIFTARY CARCINOGENICrry STUDY WrrH NARROW RANGE (98.1*/oN)-ETHYL PERFLUOROOCRANESULFONAMEDO ETHANOL IN RATS Sample Location Replicate 3 T-6316 (ppm) 300 Top 1 2.93 290 2 2.86 314 3 2.91 291 Mean 2.90(96.7)' 298(99.3) Middle 1 2 3 Mean 2.65 2.90 2.87 2.81(93.7) 288 302 293 294(98.0) Bottom 1 2 3 Mean 2.66 2.84 3.40 2.97(99.0) 284 269 308 287(95.7) a Each valueinparenthesisisthe percentof theoretical. Covance 6329-212 3M T-6316.1 Table63 (Continued) ResultsofHomogeneity Analyses(ppm) Mxed 1/15/98 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW PERFLUOROOCRANESUIYONAMIDO ETHANOL RANGE (98.1*/oN)-ETHYL IN RATS Sample Location Replicate 3 T-6316 (ppm) 30 100 300 Top 1 2.89 31.8 89.4 275 2 2.54 27.9 93.7 278 3 2.63 29.0 99.2 294 Mean 2.69(89.7)'29.6(98.-7) 94.1(94.1) 282(94.0) Middle 1 2 3 Mean 2.67 28.9 2.66 29.8 2.83 27.2 2.72(90.7) 28.6(95.3) 87.4 280 82.2 300 90.8 289 86.8(86.8) 290(96.7) Bottom Bottom@ 1 2 3 Mean 1 2 3 Mean 3.02 8.49 3.07 4.86(162) 27.9 89.1 291 27.0 101 283 28.0 105 278 27.6(92.0) 98.4(98.4) 284(94.7) 3.68 - - - 2.52 - - - 3.19 - - - 3.13(104) - - - a Each value inparenthesisisthepercentof theoretical. b Reassay. Covance 6329-228 3M T-6316.1 Table 64 Resultsof Homogeneity Analyses(ppm) Nlixed3/30/98 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW PERFLUOROOCTANESULFONAMIDO ETHANOL RANGE (98.10/oN)-ETHYL IN RATS T-6316 (ppm) Sample Location Replicate 1 Top 1 0.824 2 1.01 3 0.906 Mean 0.913 (91.3)9 Nfiddle 1 2 3 Mean 1.02 0.894 0.900 0.938(93.8) Bottom 1 2 3 Mean 0.766 1.28 1.13 1.06(106) a Each valueinparenthesisisthepercentof theoretical. Covance 6329-212 3M T-6316.1 Table 65 Resultsof StabiliAtnyalyses(ppm) Mixed 9/11/97 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (981.-/.N)-ETHYL PERFLUOROOCRANESULFONANMO ETHANOL IN RATS StorageConditions Replicate 3 T-6316(ppm) 300 Initial 19 days,room temperature 1 7.57 271 2 4.70 292 Mean 6.14(205)' 282(94.0) I2 Mean 215 207 211(70.3) a Each valueinparenthesiissthepercentof theoretical. Covance 6329-212 3M T-6316.1 Table65 (Continued) Resultsof StabilitAynalyses(ppm) Nlixed9/29/97 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1*/oN)-ETHYL PERFLUOROOCRANESULFONAMEDO ETHANOL IN RATS T-6316 (ppm) StorageConditions Replicate 3 Initial 1 2 Mean 4.00 4.47 4.24 (141Y a Each valueinparenthesiissthepercentof theoretical. Covance 6329-212 3M T-6316.1 Table65 (Continued) Resultsof StabilitAynalyses(ppm) Mixed 10/15/97 104-WEEK DIF-TARY CARCINOGENICrrY STUDY WrrH NARROW RANGE (98.10/*N)-ETHYL PERFLUOROOCRANESULFONAT%MO ETHANOL IN RATS StorageConditions Replicate 3 T-6316 (ppm) 300 Initiar 1 2 Mean 3.44 302 3.19 292 3.32(11I)b 297(99.0) 19 days,room temperature 1 2 Mean 2.83 250 3.13 270 2.98(99.3) 260(86.7) 34 days,room temperature 1 2 Mean 2.90 266 3.09 266 3.00(100) 266(88.7) 8 weeks, frozen 1 2 Mean 3.12 275 2.79 291 2.96(98.7) 283(94.3) a Resultswere derivedfrom the sample collectefdrom the middleofthe dose preparationsforhomogeneity analysis. b Each valueinparenthesisisthe percentoftheoretical. Covance 6329-212 3M T-6316.1 Table65 (Continued) Resultsof StabilitAynalyses(ppm) Mixed 11/13/97 104-WEEK DIETARY CARCINOGENIC= STUDY WITH NARROW PERFLUOROOCTANESULFONANM)O ETHANOL RANGE (98-lo/'N)-ETHYL IN RATS Storage Conditions Replicate 3 T-6316 (ppm) 300 5 days,room temperature 7 days, animal room conditions 1 2 3 Mean 4.16 3.42 3.00 3.53 (118Y 264 258 267 263(87.7) a Each value in parenthesisisthe percent of theoretical. Covance 6329-228 3M T-6316.1 Table 66 Resultsof StabilitAynalyses(ppm) Nfixed3/30/98 104-V&-EK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.1*/oN)-ETHYL PERFLUOROOCRANESULFONAMIDO ETHANOL IN RATS Interval T-6316 (ppm) Replicate 1 Initiar 1 2 3 Mean 1.02 0.894 0.900 0.938 (93.8@ 21 days,room temperature 1 2 Mean 0.892 0.842 0.867(86.7) 32 days,room temperature 1 2 Mean 1.39 1.20 1.30(130) a Resultswere derivedfrom the sample collectedfrom the middle of thedose preparationsforhomogeneity analysis. b Each valuein parenthesisisthepercent of theoretical. Covance 6329-228 3M T-6316.1 Table66 (Continued) Resultsof StabilitAynalyses(ppm) Nfixed6/5/98 104-WF-EKDIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.10/oN)-ETHYL PERFLUOROOCRANESULFONA?@MO ETHANOL IN RATS Interval T-6316 (ppm) licate I Initial 1 2 Mean 0.966 1.13 1.05 (105@ 32 days,room temperature 1 2 Mean 0.828 0.808 0.818(81.8) 46 days,room temperature 1 2 Mean 1.06 0.902 0.981(98.1) b Each valueinparenthesisisthepercent of theoretical. Covance 6329-212 3M T-6316.1 Table 67 Resultsof Dose PreparationAnalyses(ppm) 104-WEEK DIETARY CARCINOGENICRN STUDY WITH NARROW RANGE (98.10/oN)-ETHYL PERFLUOROOCRANESULFONANMO ETHANOL IN RATS Week Replicate 0 3 T-6316 (ppm) 30 100 300 1-3a I b 2.67 28.9 87.4 280 2 b 2.66 29.8 82.2 300 3 2.83 27.2 90.8 289 Mean 2.72 (90.7)' 28.6(95.3) 86.8(86.8) 290(96.7) ,4-7 4-7 d 1 b 2 b Mean - I - 2 - Mean - 5.64 3.10 4.37(146) 29.0 27.0 28.0(93.3) 90.4 97.5 94.0(94.0) 292 301 297(99.0) 2.81 3.05 2.93(97.7) 8-11 8-lld 1 b 2 b Mean - I - 2 - Mean - 4.53 3.45 3.99(133) 29.9 28.1 29.0(96.7) 84.3 86.5 85.4(85.4) 278 262 270(90.0) 2.66 3.20 2.93(97.7) - - 12-15 1 b 2 b Mean - 3.34 2.67 3.01(101) 26.9 35.6 31.3(104) 98.2 99.1 98.7(98.7) a Resultsforthe 3-13,0-)100-) and 300-ppm levelswere derivedfrom thesample collectedfrom themiddle ofthe dose preparationsforhomogeneity analysis. b Below the limitof quantitation(<2.00 ppm). c Each value in parenthesisis the percent of theoretical. d Reassay. Covance 6329-212 3M T-6316.1 Table67 (Continued) ResultsofDose PreparationAnalyses(ppm) 104-WEEK DIETARY CARCINOGENICITY STUDY WrM NARROW RANGE (98-10/oN)-ETHYL PERFLuoRoocrANEsuL,FONAm[Do ETHANOL IN RATS Week 16-19 16-19" Replicate 0 1 e 2 e Mean - 1 - 2 - Mean - T-6316 (ppm) 3 30 100 300 3.77 3.04 '3.41(114Y 39.3 31.5 35.4(118) 87.2 - 93.0 90.1(90.1) 2.78 21.8 - 2.20 44.6 - 2.49(83.0) 33.2(111) - 16-lV I - 2.62 26.9 - 2 - 2.52 23.3 - Mean - 2.57(85.7) 25.1(83.7) - 20-23 1 e 2.61 27.7 101 2 e 2.41 26.4 92.3 Mean - 2.51(83.7) 27.1(90.3) 96.7(96.7) 20-23' 1 - 2.15 - - 2 - 2.47 - - Mean - 2.31(77.0) - - 20-23f I - 2.14 - - 2 - 1.90 - - Mean - 2.02(67.3) - - c Each valueinparenthesisisthe percentoftheoretical. d Reassay e Below thelimitofquantitatio(n<O.5 ppm) f Retention. Covance 6329-212 3M T-6316.1 Table67 (Continued) ResultsofDose PreparationAnalyses(ppm) 104-WEEK DIETARY CARCINOGENICrrY STLJDY VIRM NARROW PERFLUOROOCRANESULFONAMIDO ETHANOL RANGE (98.1-/.N)-ETHYL IN RATS Week 24-27 Replicate 0 1 e 2 e Mean T-6316 (ppm) 3 30 100 300 2.63 24.1 83.3 - 3.04 26.7 88.4 2.84(94.7)' 25.4(84.7) 85.9(85.9) 24-27' 1 - 2 - Mean - 25.3 24.0 24.7(82.3) 24-27' 1 - 2 - Mean - 22.4 21.4 21.9(73.0) 28-31 28-3 1' 28-3l' 1 e 2.24 26.4 87.5 2 e 2.52 28.4 86.0 Mean - 2.38(79.3) 27.4(91.3) 86.8(86.8) 1 - 3.20 - - 2 - 2.60 - - Mean - 2.90(96.7) - - I - 3.20 - - 2 - 2.73 - - Mean - 2.97(99.0) - - 32-35 1 e 2.92 28.2 83.4 2 e 2.46 29.7 85.9 Mean - 2.69(89.7) 29.0(96.7) 84.7(84.7) c Each valueinparenthesisisthe percentoftheoretical. d Reassay. e Below thelimitof quantitatio(n<0.5ppm) f Retention. Covance 6329-212 3M T-6316.1 Table67 (Continued) ResultsofDose PreparationAnalyses(ppm) 104-WEEK DIFTARY CARCINOGENICrrY STUDY WrrH NARROW RANGE (98.10/.N)-ETHYL PERFLUOROOCRANESULFONAMIDO ETHANOL IN RATS Week 36-39 36-39' 3 6-3 9' 40-43 40-43 d 44-47 44-47d Replicate 0 1 e 2 e Mean - 1 - 2 - Mean - 1 - 2 - Mean - 1 e 2 e Mean - I - 2 - Mean - 1 e 2 e Mean 1 2 Mean T-6316 (ppm) 3 30 100 300 3.36 2.58 2.97 (99.Or 24.9 91.4 - 22.7 87.2 23.8(79.3) 89.3(89.3) 2.53 2.51 2.52(84.0) 23.0 - 22.8 - 22.9(76.3) - 2.82 2.68 2.75(91.7) 27.0 - 29.6 - 28.3(94.3) - 3.01 5.26 4.14(138) 28.9 95.5 28.3 99.5 28.6(95.3) 97.5(97.5) 2.73 2.71 .2.72(90.7) - - 3.97 2.77 3.37(112) 29.3 84.4 27.9 95.8 28.6(95.3) 90.1(90.1) 2.93 2.04 2.49(83.0) 64.0 59.6 61.8(61.8) c Each valueinparenthesisisthe percentoftheoretical. d Reassay. e Below thelimitof quantitatio(n<0.5ppm). f Retention. Covance 6329-212 3M T-6316.1 Table67 (Continued) ResultsofDose PreparationAnalyses.(ppm) 104-WEEK DIETARY CARCINOGENIC= STUDY WITH NARROW RANGE (98.10/oN)-ETHYL PERFLUOROOCRANESULFONAMIDO ETHANOL IN RATS Week Replicate 0 3 T-6316 (ppm) 30 100 300_ 44-47' 1 - 5.30 2 - 2.75 Mean - 4.03(134)c - 60.4 - 58.4 64.4(64.4) 48-51 1 e 2.67 30.2 97.8 2 e 2.59 29.0 94.7 Mean - 2.63(87.7) 29.6(98.7) 96.3(96.3) 52-53 1 e 3.22 25.2 92.5 2 e 3.45 24.0 97.6 Mean - 3.34(111) 24.6(82.0) 95.1(95.1) 52-53' 1 - - 2 - - Mean - - 20.4 21.0 20.7(69.0) 52-53' 1 - - 2 - - Mean - - 19.0 21.5 20.3(67.7) 52-539 1 - - 2 - - Mean - - 88.4 84.5 86.5(86.5) c Each value inparenthesisisthepercentoftheoretical. d Reassay. e Below theEmitofquantitatio(n<0.5ppm). f Retention. g Additionalmix. Covance 6329-228 3M T-6316.1 Table 68 ResultsofDose PreparationAnalyses(ppm) 104-WEEK DIETARY CARCINOGENICITY STLJDY VIM NARROW RANGE (98.1'/oN)-ETHYL PERFLUOROOCTANESULFONAMOO ETHANOL IN RATS Week T-6316 (ppm) Replicate 0 1 I b 2 b 3 Mean 1.02 0.894 0.900 0.938(93.8)' 2-5 1 b 0.782 2 b 0.669 Mean - 0.725(72.5) 2_5d 1 - 1.12 2 - 1.04 Mean - 1.08(108) 6-9 1 0.848 1.48 2 b 1.53 Mean - 1.51(151) 6_gd I b 0.890 2 b 0.858 Mean - 0.874(87.4) a Resultsforthe I ppm levelwere derived from the sample collectedfrom the middle of the dose preparationsforhomogeneity analysis. b Below thelimitof quantitatio(n<0.5ppm). c Each valueinparenthesisisthe percentof the theoretical. d Reassay. Covance 6329-228 3M T-6316.1 Table68 (Continued) Resultsof Dose PreparationAnalyses(ppm) 104-WEEK DIFTARY CARCINOGENICITY STLJDY WrM NARROW RANGE (98.1*/oN)-ETHYL PERFLUOROOCTANESULFONAMU)O ETHANOL IN RATS Week T-6316 (ppm) Replicate 0 1 10-13 1 b 2 b Mean - 0.966 1.13 1.05(105)- 14-17 1 b 2 b Mean - 0.894 0.870 0.882(88.2) 19-21 18-21d 1 b 2 b Mean - 1 - 2 - Mean - 18-2le I - 2 - Mean - 22-25 1 b 2 b Mean - 1.69 1.07 1.38(138) 0.880 1.26 1.07(107) 0.789 0.704 0.747(74.7) 0.798 0.876 0.837(83.7) b Below thelimitofquantitatio(n<0.5ppm). c Each value inparenthesisisthe percentof thetheoretical. d Reassay. e Retention. Covance 6329-228 3M T-6316.1 Table68 (Continued) Resultsof Dose PreparationAnalyses(ppm) 104-WEEK DIETARY CARCINOGENICITY STUDY WITH NARROW RANGE (98.lo/.N)-ETHYL PERFLUOROOCRANESULFONAMDO EIHANOL IN RATS Week T-6316 (ppm) Replicate 0 1 26-29 1 b 2 b Mean 8.81 1.88 5.35(535)' 26-29d 1 2 Mean 0.730 0.786 0.758(75.8) 26-290 1 2 Mean 0.902 0.936 0.919(91.9) 30-33 30-33d 1 b 2 b Mean - I - 2 - Mean - 1.05 1.32 1.19(lig) 0.951 0.955 0.953(95.3) 34-37 1 b 2 b Mean - 1.02 1.00 101(101) b Below thelimitofquantitatio(n<O.Sppm). c Each value inparenthesiissthe percentof the theoretical. d Reassay. e Retention. Covance 6329-228 3M T-6316.1 Table68 (Continued) ResultsofDose PreparationAnalyses(ppm) 104-WEEK DIETARY CARCINOGENICrrY STLJDY WnH NARROW RANGE (98.1-/.N)-ETHYL PERFLUOROOCTANESULFONA.1,@WO ETHANOL IN RATS Week T-6316 (ppm) Replicate 0 1 38-41 1 b 2 b -Mean - 0.836 1.16 0.998(99.8)c 42-45 1 b 2 b Mean - 0.912 0.886 0.899(89.9) 46-49 1 b 2 b Mean - 0.781 0.705 0.743(74.3) 50-53 50-53d 1 b 2 b Mean - I - 2 - Mean - 0.895 2.18 1.54(154) 0.916 0.904 0.910(91.0) b Below thelimitof quantitatio(n<0.5ppm). c Each valueinparenthesiissthepercentof thetheoretical. d Reassay. Covance isan independent,publicinh,eld coiiipan@, o pe ratI*i_i,'i,n o,.,e1r5 countrIiesand L)N-c3r0 t)ffices @vorldividcw,ith headquartersin Princeton,NexNJerse.iU,S,k. Cox,anceisthe marketin,,naiiicforCo%-anceInc. and itssubsidiarieasround the%vorld,theprincipal ones of which arelistedon thisp@i,,TCh.e use of . "Co,,,ancei"n thisreportrefersto (iiioer nioreot theseand othersubsidiaries. THEAMERICAS Princeton 1.800.773.0011 EUROPE Brussels +32.2.773.29.10 ASIA/PACIFIC Singapore +65.7747233 COVANCE LABORATORIES Madison. WI, USA 8B8-541 -LABS (5227) Vienna.VA. USA 800-742-8378 Harrogate.UK Oll 44 1423 500011 Mbnster, Germany Oll 49 251 97980 COV"CE,.-"", THE DEVELOPMENT SERVICES COMPANY Shaping Solutions P.I.TED1. U.S..