Document wa0Q6gOMwLJ645M5DE31mrko

-@ l@@ 1@4 -I----m cov ArgoooCoomE@m THE DEVELOPMENT SERVICES COMPANY DraftReport 13-Week DietaryToxicityStudy withN-Methyl PerfluorooctanesulfonamiEdtohanol(N-MeFOSE, T-6314) inRats PREPARED FOR: 3M St.Paul,Minnesota COVANCE STUDY NUMBER: 6329-225 COVAW-C'E'."'*N THZ MWLOPMEW BEIMCES COMPMY Sponsor: 3M St.Paul,Minnesota AUDITED DRAFR May 25, 1999 FINAL REPORT Study Title: 13-Week DietaryToxicityStudywithN-Methyl Perfluorooctanesulfonamido Ethanol(N-MeFOSE, T-6314)inRats Author: PeterJ.Thomford, PhD Study Completion Date: To be determined Performing Laboratory: Covance LaboratoriesInc. 3301 Kinsman Boulevard Madison,Wisconsin 53704-2595 Laboratory Study Identification: Covance 6329-225 Sponsor Study Identification: Study No. 3M T-6314.1 Page I of 551 QUALrrY ASSURANCE STATEMENT Covance 6329-225 3M T-6314.1 2 Covance 6329-225 ,3M T-6314.1 STUDY I]DENTMCATION 13-Week DietaryToxicityStudywithN-Methyl Perfluorooctanesulfonamido Ethanol(N-MeFOSE, T-6314)inRats TestMaterial N-Methyl Perfluorooctanesulfonarrfido Ethanol(MEFOSE, T-6314) Sponsor 3M ToxicologyServices Building220-2E-02,3M Center St.PauL Minnesota55144-1000 Study Monitor Andrew IVLSeacat,PhD 3M ToxicologyServices 651.575.3161 AlternatSetudy Monitor Study Location Study Director Study Timetable Study InitiatiDoante In-LifeStartDate In-LifeEnd Date Study CompletionDate Marvin T. Case,DVM, PhD 3M ToxicologyServices 651.733.5180 Covance LaboratoriesInc. 3301 Kinsman Boulevard Madison,Wisconsin 53704-2595 PeterJ.Thomford, PhD Covance LaboratoriesInc. P.O. Box 7545 Madison,Wisconsin 53707-7545 608.241.7207 August 27, 1998 September 1,1998 December 2, 1998 To be determined 3 KEY PERSONNEL Covance 6329-225 3M T-6314.1 Study Director Study Toxicologist Study Coordinator SupervisorS,mall Animal Toxicology SupervisorD,ose Formulation SupervisorC,hemistry/ToxSupport SupervisorL,aboratoryAnimal Medicine ClinicaPlathologist Supervisor,ClinicaPlathology AnatomicalPathologist AnatomicalPathologist SupervisorA,natomicalPathology PeterJ.Thomford, PhD Thomas E. Ryan, BS NiiVan Bruce-Konuah Nathan E. Snortum,BA, BT, ALAT DixieBushee,BS, LATG BrianSchoemke, BS Donna J.aenwns, DVM DiplornateA,CLAM RobertL HOL DVK PhD Diplomate,ACVP (Clir@caPlathology) RonaldMarkevitch,BS, MT (ASCP) SandraR. EldridgeP,hD PathologyAssociatesInternational JohnnieL Eighmy,DVK MS Diplomate,ACVP Diplormte,ABT Deborah PirkeLALAT 4 Covance 6329-225 3M T-6314.1 CONTENTS Page ABSTRACT ............................................................8............. PURPOSE .............................................................1.1............ REGULATORY COMPLIANCE ............................................I.I.............. TEST MATERIAL ........................................................I.I............. TestMaterial...........................................................I.I............. Reserve(Archive)Sample ................................................I.I.............. Dispositio.n............................................................I.I............. ANIMALS AND HUSBANDRY ............................................1.2.............. TestAnimal............................................................1.2.............. Identificati.o.n.........................................................1.2.............. Acclimatio.n...........................................................1.2.............. Housing and Maintenance.................................................1.2.............. Justificati.o.n..........................................................1.3.............. PROCEDURES ..........................................................1.3.............. Group Designationsand Dose Levels........................................1.3.............. Dose Preparatio.n.......................................................14.............. RetentionSamples .......................................................1.5............. Method of Administratio.n................................................1.5.............. Dose Analyses..........................................................1.5.............. ClinicaOlbservation.s...................................................1.6.............. Body Weights..........................................................1.6.............. Food Consumption ......................................................1.6.............. Ophthalmology.........................................................1.7.............. ClinicaPlathology.......................................................1.7.............. Serum PerfluorooctanSeulfonicAcid Level(PFOS) Determinatio.n...............18............ Necropsy..............................................................1.8.............. OrcranWeights .........................................................1.9.............. CeU ProliferatiToinssueCollectioannd ImmunohistochemicalEvaluation..........1.9....... PaMtoyl-CoA OxidaseTissueCollectioannd Analyses.........................1.9.............. LiverPFOS Analyses....................................................1.9............... TissuePreservatio.n.....................................................2.0.............. Histopatholog.y........................................................2.0.............. StatisticAanlalyses......................................................2.1.............. RECORD RETENTION ...................................................2.1.............. 5 Covance 6329-225 3M T-6314.1 CONTENTS (Continued) Page RESULTS ...........................................................................2.2................ Dose Analyses ..............................................................2.2............... ClinicalObservations and Survival.............................................2.2............... Ophthalmology ..............................................................2.3.............. Body Weights ...............................................................2.3.............. Food Consumption ..........................................................2.3............... Test MaterialConsumptiorL ...................................................2.4.............. ClinicalPathology...........................................................2.4............... Serum PerfluorooctaneSulfonicAcid Level (PFOS) Determination.................2.4.......... CellProliferatioTnissue Collectionand Immunohistochemical Evaluation...........2.5...... Liver PFOS Determination ...................................................2.5............... Anatomic Pathology .........................................................2.5............... CONCLUSIONS ..............................................................2.6.............. SIGNATURES ...............................................................2.7............... REFERENCES ...............................................................2.8............... OPHTHALMOLOGY REPORT ................................................2.9............... PATHOLOGY REPORT .......................................................3.0............... COMMENTS ON TTIE DATA .................................................3.7............... CODES, ABBREVIATIONS, AND UNITS ......................................4.0............... General Codes and Abbreviations..............................................4.1............... Codes forClinicalPathology ..................................................4.2............... Abbreviationsand Units forClinicalHematology .................................4.5............... Abbreviationsand Units forClinicalChemistry ..................................4.7............... Abbreviationsand Units forClinicalUrinalysi.s..................................4.9............... Codes forAnatomic Pathology................................................5.0............... TABLE I Resultsof Homogeneity Analyses(ppm) .....................................5.3............... 2 Resultsof StabilitAynalyses (ppm) .........................................5.4............... 3 Resultsof Dose PreparationAnalyses (ppm) .................................5.7............... 4 Summary of ClinicalObservations..........................................5.8............... 5 Summary of Ophthalmic Observations ......................................6.0................ 6 Sumniary of Body Weight Data (g).........................................6.1............... 7 Sununary of Body Weight Change Data (g)..................................6.3............... 8 Summary of Food Consumption Data (g)....................................6.5............... 9 Summary of Test MaterialConsumption Data (mg/kg/day).....................6.7............. 6 Covance 6329-225 3M T-6314.1 CONTENTS (Continued) Page TABLE 10 11 12 13 14 15 16 17 18 19 (Continued) Summary of ClinicalHematology Data - Week 5 .............................6.9................ Sununary of ClinicalHematology Data - Week 14 ............................7.3................ Summary of ClinicalChemistry Data - Week 5............................................7..7....... Summary of ClinicalChemistry Data - Week 14...............................8.3............... Summary of ClinicalUrinalysiDsata ........................................8.9................ Summary of Organ Weight Data - Week 5 ...................................9.1............... Summary of Organ Weight Data -'Week 14 ..................................9.3............... Incidenceof Macroscopic Observations....................................I..I.I............... Incidenceof Microscopic Observations.....................................1.1.4............... Incidenceof Severityof SelectedMicroscopic Observations...................1.2.3.......... APPENDIX I................................................................1.2.6............... ProtocolDeviations.........................................................1.2.7............... Protocol...................................................................1.2.9............... ProtocolAmendment No. I..................................................1.4.6............... Protocol Amendment No. 2 ..................................................1.4.8............... Protocol Amendment No. 3 ..................................................1.5.1............... APPENDIX 2................................................................1.5.3............... IndividualAnimal Fate Data ..................................................1.54................ IndividualClinicalObservations...............................................1.5.9............... IndividualOphthalmic Observations...........................................1.7.5................ APPENDIX 3 ................................................................1.91................ IndividualBody Weight Data (g)..............................................19.2................ APPENDIX 4 ...............................................................2.0.3................ IndividuaFlood Consumption Data (g)........................................2.0.4................ IndividuaTlest MaterialConsumption Data (mg/kg/day).........................2.1.5............... APPENDIX 5 ................................................................2.2.5............... IndividualClinicalHematology Data ...........................................2.26................ IndividualClinicalChemistry Data ............................................2.5.0............... IndividualClinicalUrinalysisData ...............................t...................2..7..8............. APPENDIX 6 ...............................................................2.9.0................ IndividualAnatomic Pathology Data ...........................................29.1................ APPENDIX 7 ...............................................................5.4.8................ CellProliferatioTnissue Collectionand InununohistochemicalEvaluation..........5.4.9.... APPENDIX 8 ................................................................5.5.0................ Client-SuppUed Items .......................................................5.5.1............... 7 Covance 6329-225 3M T-6314.1 ABSTRACT The purpose of thisstudy was to assessthetoxicityof thetestniaterial N-Methyl PerfluorooctanesulfonamidoEthanol (N-MeFOSE, T-6314) when administered inthe dietto ratsforat least13 weeks. Four groups of Crl:CI)@(SD)IGS BR ratswere exposed to N-MEFOSE inthe dietforat least13 weeks. Each group contained20 males and 20 females.The dietary concentrationswere 0 (controlgroup),3, 30, and 100 ppm. Food was provided ad libitum,except when anftnalswere fasted.Water was provided ad libitum.The animalswere observed twice daily(a.m.and p.nL) formortalityand moribundity. At leastonce weekly, each animal was removed from itscage and examined forabnormalitiesand signsof toxicity.Body weight data were collectedon the firsdtay of treatmentand weekly thereafter.Food consumption data were collectedweekly. Ophthahnic examinationswere done before initiatioonf treatmentand during Week 14. Blood samples were collectedforhematology and clinicaclhemistry testsduring Weeks 5 and 14. Urine samples forurinalysitsestswere collectedduringWeek 14. During Weeks 5 and 14, blood was collectedfrom fiveanimals/sex/groupfor serum perfluorooctanesulfonicacid(PFOS) analyses.At theWeek 5 sacrifices,amples of the liverwere collectedfrom fiveanimaL-,/sex/groufpor pahT@toyl-CoA oxidase activityand liverPFOS analysis.Animals sacrificeadtWeek 5 were not necropsied. During Week 14, the remaining animals were anesthetized,weighed, exsanguinated,and necropsied. At necropsy, macroscopic observationswere recorded,selectedorgans were weighed, and selectedtissueswere collectedand preserved. Samples of liverwere collectedfrom all survivinganimalsforpah-nitoyl-CoAoxidase activitaynd liverPFOS analysis.Samples of theliverwere collectedfrom fiveanimals/sex/groupforproliferatiocnellnuclearantigen (PCNA) evaluationand microscopicexamination. Microscopic examinationswere done on tissuesfrom each aninialinthecontroland high-dosegroups (terminalsacrificoenly) and from the low-dose animalthatwas sacrificeadt an unscheduled interval.Microscopic examinations were alsodone on the Ever and stomach from each terminalsacrificeanimal in the mid-dose group, and on the Ever from each terminalsacrificaenimal in the low-dose group. 8 Covance 6329-225 3M T-6314.1 One female given 3 ppm N-MEFOSE was sacrificeodn Day 59 due to severe lacerationof the tail.There were no macroscopic or microscopic changes to indicatethatitsmoribund conditionwas testinaterial-relateAdU. other anirmh survivedto thescheduled sacrifice. No clinicaolbservationswere noted thatwere consideredto representprimary effectsof thetestmaterial.Statisticalsliygnificantlyower mean body weights were noted beginning at Week 4 and continuingthrough the end of study for anin-Aalgsiven 100 ppm. Statisticalsliygnificantlyower mean body weights were noted beginningat Week 7 and continuingthrough the end of study for.males given 30 ppm. Body weight changes were statisticalsliygnificantlyower in a sporadicmanner foranftnalsgiven 30 or 100 ppm. Overallbody weight changes (Weeks I-14) were statisticalsliygnificantlloywer forall groups given N-MEFOSE. Although statisticalsliygnificanotnly at Week 13,food consumption was in generallower formales given 100 ppnl For femalesgiven 100 ppni, statisticallloywer food consumption was apparentat Weeks 3, 4, 6, 7, 11, and 12. Dietaryadninistrationof N-MEFOSE was associatedwith lower heniatocriftormales and females fed 100 ppm; higherurea nitrogenfor nialesand females fed 100 ppm; higher albumin formales fed 100 ppm lower globulinformales fed 30 or 100 ppm; lower cholesteroland triglyceridefsormales fed 30 or 100 ppm and females fed 100 ppm; higher alwiineaniinotransferasfeormales fed 100 ppm; and higherhepaticpahnitoylCoA oxidase formales and femalesfed 100 ppm. The effectswere relativelmyild with the exceptionof those on cholesteroland triglyceridefsor the high-dose males;those effects were consideredto be of moderate severity.AR of thetestmaterial-relatecdlinical pathology findingswere more prominent at Week 14 than atWeek 5. Statisticalsliygnificanatnd testmaterial-relatecdhanges interminalbody weights and liver weights were seen in males and/or females inthe two highestdose groups. Statistically significandtecreaseswere seen inthe terminalbody weights of males fed 30 ppm and in both males and females fed 100 ppm of N-MEFOSE. Statisticalsliygnificanitncreases were seen in the mean fiver-to-bodyweight percentage and mean fiver-to-braiwneight ratioin males fed 30 ppm, in mean absoluteliverweight and mean bver-to-body weight percentage in females fed 30 ppm, and in allliverweight parameters inmales and females fed 100 ppnx Test material-relatemdacroscopic findingswere noted at a low incidencein the Ever and glandularstomach of males and fen-,aleisn the 100 ppm dose group only. Liver findings includedorgans thatwere largeand diffuselydark. In theglandularstomach, dark focior 9 areasweresometimes seen in the gastricmucosa. Covance 6329-225 3M T-6314.1 Test material-relatemdicroscopic findingswere seen in the liverof animals fed 30 and 100 ppm of N-MEFOSE and inthe glandularstomach of nialesand females in the 100 ppm group only. No testmaterial-relatecdhanges were seen inanimals fed 3 ppm of N-MEFOSE. In theliver,one or more testniaterial-relatfeidndingsaffectedallanimals fed 100 ppm and includedslight-to-moderatceentrilobulaorr diffusehepatocenular hypertrophy,minimal-to-shghtcoagulativenecrosis,minimal hepatocedularpigment, and mhiimal-to-slighctentrilobulatro rradzonalor dfffusehepatocebularvacuolation.In animals fed 30 ppm, centrilobulahrepatocellularhypertrophy was alsoseen,although the incidenceand severitywas decreased at thisdose. In addition,a low incidenceof minimal hepatocehularvacuolationoccurred in 30 ppm dose group males, and the liverof a single female fed 30 ppm had minimal coagulativenecrosis.A possibletestmaterial-related change in the glandularstomach of animals fed 100 ppm was a relativellyow incidenceof mucosal erosions.The erosionswere of ninirrw to slightseverityand involved a very smallportionof the mucosal surfaceinallcases. Based on the anatomic and clinicaplathology resultsat 30 and 100 ppm and body weight effectsat 3, 30, and 100 ppm, the no-observable-adverse-effecltevelwas determined to be lessthan 3 ppm when N-MEFOSE isadministeredat concentrationsof 0, 3, 30 and 100 ppm to Crl:Ce(SD) IGS BR ratsforatleast13 weeks through dietary administration. 10 PURPOSE Covance 6329-225 3M T-6314.1 The purposeof thisstudywas toassessthetoxicitoyfthetestniaterial N-Methyl PerfluorooctanesulfonamiEdtohanol(N-MeFOSE, T-6314)when administered inthedietto mts foratleast13 weeks. REGULATORY COMPLIANCE Allaspectsofthisstudywere inaccordancewiththeFood and Drug AdministratioGnood LaboratoryPracticeRegulationsassetforthinTitle21 of theUS Code of Federal RegulationsP,art58,issuedDecember 22, 1978 (effectivJeune 20,1979),and withany applicablaemendments. TEST MATERIAL Test Material The testmaterialN,-Methyl PerfluorooctanesulfonaniiEdtohanol(MEFOSE, T-6314), Lot No. To be suppliedby Sponsor,isan offwhitepowder. Itwas receivedat Covance on August 3, 1995. The testmaterialwas storedatroom temperature. Informationon synthesimsethods,stabilitpyu,rityc,omposition,or othercharacteristics thatdefinethetestmaterialison filweith theSponsor. Reserve(Archive)Sample A reservesample (approximatel5y g) ofthetestmateriawlas takenand storedatroom temperature.Thissamplewillbe transferretdo theSponsor afterauthorizatiofnrom the Sponsor. Disposition Remaining testmaterialwillbe returnedafterauthorizatiofnrom theSponsor. II ANIMALS AND HUSBANDRY Covance 6329-225 3M T-6314.1 Test Animal Male and female Crl:CD*(SD) IGS BR ratswere obtained from the Portage, Michigan, facilitoyfCharlesRiverLaboratoriesI,nc.,on August 17, 1998. The animalswere 39 to 45 days old atinitiatiofn treatment.The males weighed from 184 to 236 g,and the femalesweighed from 140 to 179 g atinitiationftreatment. Identification Each animalwas assigneda temporary number upon arrivalBeforeinitiationf treatment,a microchipidentificatidoenvicewas implantedintoeach animal After randomizationforplacement on test,each animalwas assigneda permanent number, and themicrochipwas coded with thatnumber. Alldataforan animalarerecordedunder thesenumbers. Acclimation Ninety-two males and 92 femaleswere receivedon August 17, 1998, and acclimatedin Animal Room 348 for 15 days beforeinitiatiofntreatment.Ingeneralanimalsinthis shipment appeared healthy.During acclimationt,heanimalswere examined for abnormalitieisndicativoefhealthproblems,an ophthalrracexaminationwas done, and body weights were recordedforallanimalsatrandomization. Housing and Maintenance Animal Room 348 was used forthisstudy.Envirorunentaclontrolsfortheanimalroom were setto maintain18 to 26*C, a relativheumidityof 30 to 70%, and a 12-hour light/12-houdrark cycle. The animalswere housed individuall(yexceptforthe firs7t days of acclimationwhen animalswere group-housed) instainlesssteels,creen-bottomcages. 12 Covance 6329-225 3M T-6314.1 Certifierdodent diet#5002 meal, (PNH NutritionInternationalw)as provided (see ProtocolDeviationsforexceptions)ad libitum,except when anftnalswere fasted.Ile dietisroutinelyanalyzed by the manufacturer fornutritionaclomponents and environmentalcontaminants. The resultsareon filewith Covance-Madison. Water was provided ad libitum.Samples of thewater areroutinelyanalyzed forspecified microoraoanism and environmentalcontanifimts.The resultsare on Me with Covance-Madison. There were no known contaminantsinthedietor water at levelsthatwould have interferewdith thisstudy. Animals not selectedforthestudy (12 males and 12 fen-alesw)ere removed from the study room and used for trainingprocedures. Justification Historicallryatshave been used in safetyevaluationstudiesand are recommended by appropriateregulatoryagencies. PROCEDURES This study was conducted in accordance with the Protocol dated August 27, 1998, and Protocol Amendment Nos. I and 2. The protocol,protocolamendments, and protocol deviationsare inAppendix 1. Group Designations and Dose Levels The animals were examined by a laboratoryanimal veterinariaonn August 31, 1998, and found to be suitableforstudy consideration.Selectionof animalsforthe study was based on clinicaolbservations,body weights,ophthaln-dcexaminations,and other data as appropriate.Animals were assignedto treatmentgroups using a computerized blocking procedure designed to achievebody weight balance with respectto treatmentgroup. At the time of randomization,the weight variationof the animalsforeach sex used did not exceed 2 standarddeviationsof the mean weight. Group mean body weights were analyzed using Levene's testfor homogeneity of varianceat the 5.0% probabilityleveland 13 Covance 6329-225 3M T-6314.1 found to be homogeneous. Animals were assignedto thestudy accordingto the following design: Number ofAnimals DietaryLevels Group Male Feniale (ppm MEFOSE)' I (Control)b 20 20 0 2 (Low) 20 20 3 3 (Nd) 20 20 30 4 (High) 20 20 100 a Dose levelswere expressedasppm of MEFOSE. b The controlanbnalsreceivedthebasaldietonly. Dose Preparation Dietaryconcentrationwsere based on the testmaterialas supplied.Before initiationf treatment,dietsof 1,3, 30, 100,and 500 ppm concentrationwsere mixed. Dietswere prepared forstabilitaynalysesatthe I-ppm and 500-ppm concentrationsand for homogeneity analysesatthe 3,30, and 100 ppm concentrations.Dietswere prepared once every4 weeks foruse inthe in-lifpehase. Preparation of Diet for Group 1. The appropriateamount of dietwas weighed intoa labeledcontainerand acetone was added at the same concentrationas the high-dose concentration.The combinationofthedietand acetonewas thenmixed for 15 minutes. Preparation ofDiets for Groups 2 through 3.Each dose levelwas prepared independently.A specifiedamount ofdietwas weighed intoa labeledcontainerand a specifieadmount of dietforGroup 4 was weighed foreach diet.A trenchwas formed in thefeedinthemixing bowl and theamount of dietforGroup 4 was transferretdo the trench.The contentsof the mixingbowl were thoroughlymixed for15 minutes. Preparation of Diet for Group 4. A specifieadmount of dietwas weighed intoa labeled container.The requiredamount of testmaterialwas weighed and transferreidntoa labeledcontainer.Approximately5 mL of acetonewas added to the containerand n-dxed manually. Incrementsof approximately5 mL acetonewere added as necessaryuntilthe testmterial had dissolved.To preparea premix,thedietwas transferreidntoa labeled Hoban* mixing bowl. The testmaterialand acetonewere added to themixing bowl, 14 Covance 6329-225 3M T-6314.1 overlaidwith a portionof dietfrom themixing bowl, and thoroughlymixed. A portionof dietfrom themixing bowl was transferretdo a second mixing bowl, mixed n=uauy to recoverresidualtestmaterialand returnedto the firsmtixing bowl The contentsof the nixing bowl were thoroughlymixed. Samples for dose analyseswere taken directlyfrom the mixing bowl. The prepared testdietswere storedat room temperaturein covered containersuntil dispensed intofeedingjars. Retention Samples During the in-lifpehase, samples (approximately100 g) were taken from each dose preparationfor dose analysesand storedat room temperature.'Mese samples were discardedon May 11, 1999 (seeProtocol Deviationsforexceptions). Method of Administration Dietaryadmixture was used because thepotentialroute of exposure inhumans isoral The dose preparationswere administeredad libitumforat least13 weeks, unless otherwise specified. Dose Analyses Analyses for the concentrationof testmaterialinthe dose preparationswere done by Covance using an analyticamlethod, NT-M324-NIA, suppliedby theSponsor and validatedby Covance. Homogeneity was determined forthe 3-ppm 30-ppm and I00-ppm dose preparations once pretest.One sample (approximately100 g) each from thetop,middle,and bottom of the dose preparationsmixed forhomogeneity analyseswere collected,divided into threesubsamples forextractionand analysisa,nd analyzed fortestmaterialcontent. AU samples were stored at room temperatureuntilanalyzed within7 days of mixing. Four samples (approximately100 g each) were taken from the I-ppm dose level concentrationof dietpreparationsmixed pretest.One sample was analyzed on theday of 15 Covance 6329-225 3M T-6314.1 mixing and used as the baselinevalue. one sample was stored atroom temperature for at least19 days,then analyzed. A thirdsample was storedat room temperature for at least 32 days,then analyzed. The remainingsample was storedina freezersetto maintain -10 to -30*C for 8 weeks, then analyzed. In addition,two samples (approximately100 g each) were taken from the500-ppm dose preparationmixed pretest.One sample was analyzedon the day of mixing. The second sample was storedat room temperature after atleast32 days,then analyzed. Two additionalsamples (approximately100 g each) were taken from the 3-ppm dose preparationmixed forWeeks 9 through 12. One sample was stored atroom temperaturefor at least19 days, then analyzed. The second sample was stored atroom temperature forat least32 days,then analyzed. The sample cobected for dose confirmationanalysiswas used as the baselinesample. During thein-fifpehase,samples (approximately100 g) from alldose preparationswere collectedand analyzed for dose confirmation.AR samples were storedat room temperature untilanalyzed. ClinicalObservations 'ne animals were observed twice daily(a.nLand p.rrl)formortalityand monbundity (see ProtocolDeviationsforexceptions).Signs of poor healthor abnormal behaviorwere recorded as they were observed. At leastonce weekly, each animal was removed from its cage and exan-dned. Any unusual or abnormal findingswere recorded. Body Weights Individualbody weight data were recorded on the firsdtay of treatment,and weekly thereafter. Food Consumption Individualfood consumption datawere recorded weekly duringtreatment.Food consumption was not measured du'ringWeek 5 for animals scheduled for sacrificdeuring Week 5. 16 Covance 6329-225 3M T-6314.1 Ophthabnology Ophthalmic exan-dnations were done before initiationof treatment and during Week 14. The pupilswere dilatedwith 0.5% Mydriacyf, and the eyes were examined by a veterinariawnith an indirectophthalmoscope. ClinicalPathology Blood samples were collectedfrom 10 animaWsex/group during Weeks 5 and 14. Urine samples were collectedfrom 10 animalstsex/groupduringWeek 14. Animals were fasted overnight,(seeProtocolDeviationsforexception)and urinewas collectedchilled (approximately16 hours beforeblood sampling);water was provided ad libitum.Blood was collectedfrom a jugul-ivrein.Potassium EDTA was used as the anticoagulantfor hematology tests.No anticoagulahtwas used fortheclinicaclhemistrysamples. Animals were bled inrandom order. The followingwere evaluated: Hematology red blood cell(erythrocytec)ount hemoglobin hematocrit mean corpuscular volume mean corpuscularhemoglobin mean corpuscularhemoglobin concentration plateletcount white blood cell(leukocyte)count differentibalood cellcount segmented neutrophilcount lymphocyte count monocyte count eosinophilcount basophflcount blood ceH morphology Reticulocytecount smears were made and held forpossiblefutureexamination. glucose urea nitrogen creathiine totalprotein albun-dn globulin totalbilirubin cholesterol triglycerides ClinicalChemistry aspartatean-dnotransferase alanine an-dnotransferase gan-ima glutamyltransferase calcium inorganicphosphorus sodium potassium chloride 17 volume specificgravity pH protein glucose ketones Covance 6329-225 3M T-6314.1 Urinalysis bilirubin blood urobffinogen microscopic examinationof sediment appearance Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination During Weeks 5 and 14, fiveanimaLs/sex/groupwere fastedovernight,(see Protocol Deviationsforexception)anesthetizedwith carbon dioxide,and blood (appmxiniately 4 mL) was collectedfrom a jugularvein. Allsamples were collectedwithout anticoagulanta,llowed to clotat room temperature,and centrifuged.Serum was harvestedand storedin a freezerset to maintain-60 to -80'C untilpacked on dry iceand shipped to the Sponsor foranalyses.The samples were analyzed for PFOS. Results of analyseswillbe reported separatelyby the Sponsor. Necropsy A necropsy was done on the Group 2 female thatwas sacrificeadt an unscheduled interval.During Week 5, fiveanimah;/sex/groupwere fastedovernight(see ProtocoI Deviationsforexception),anesthetizedwith carbon dioxide,bled forserum PFOS samples,weighed, and exsanguinated. These animals were discardedwithout necropsy. The liverwas removed from theseanimals,weighed, and collectedfor palmitoylCoA oxidase and PFOS analysis.During Week 14,theremaining aninmls were fastedovernight,anesthetizedwith carbon dioxide,bled forclinicaplathology tests (10 animaLs/sex/groupwith the exceptionof Group 2 female)and serum PFOS samples (fiveanimals/sex/group)w,eighed, exsanguinated,and necropsied.Uver samples were collectedforpalmitoylCoA oxidase,PCNA, and PFOS analysis.Animals were necropsied inrandom order. The necropsy includeda rmcroscopic examination of the externalfeaturesof the carcass; allexternalbody orificest;he abdominal, thoracic,and cranialcavitieso;rgans; and tissues. Covance 6329-225 3M T-6314.1 Organ Weights After 13 weeks of treatment, the following organs (when present) were weighed; paired organs were weighed together: adrenal(2) brain kidney(2) liver ovary(2) spleen testi(s2) thymus thyroid(2)with parathyroid Organ-to-body weight percentagesand organ-to-brainweight ratioswere calculated. CellProlfferationTissue Collectionand Immunohistochemical Evaluation At the temiinalsacrificer,epresentativesamples of the leftlateralobe of the liverwere collectedfrom fiveanknaLs/sex/groupand preservedin zincforniahm After fixation, samples were embedded in paraffinand shipped to Pathology AssociatesInternational (FrederickM,aryland) forproliferatiocnellnuclearantigen(PCNA) evaluation.In addition,liversectionswere stainedwith hematoxylin and eosin and examined microscopically.Resultsof theevaluationwillbe in Appendix 7. Palrnitoyl-CoA Oiddase Tissue Collectionand Analyses At the scheduled sacrificest,he rightlateralobe of the liverwas collectedfrom each aninial,flash-frozeinn liquidnitrogen,and storedina freezersetto maintain-60 to -800C untilanalyzed by Covance forpalmitoylCoA oxidase activity. Liver PFOS Analyses At thescheduled sacrificesa,portionof the liverfrom each aninml was flash-frozenin liquidr@trogenand stored ina freezersetto maintain-60 to -80*C untilpacked on dry ice and shipped to the Sponsor forPFOS and metabolitesanalyses.Results of these analyses willbe reported separatelyby the Sponsor. 19 Ccyvance6329-225 3M T-6314.1 TissuePreservation The followingtissue(swhen present)from theanimalthatwas sacrificeadtan unscheduledintervalor from each animalsacrificeadttheterminalsacrificweere collecteadnd preservedin 10% neutral-bufferfeodrnmlinu,nlessotherwisespecified: adrenal(2) aorta brain cecum cervix colon duodenum epididyn-i(i2s) esophagus eye(2) femur withbone marrow (articular surface ofthedistaelnd) Harderiangland heart ileumwith Peyer'spatch (lymphoid aggregate) jejunum kidney(2) lesions liver lung with mainstem bronchi lymph nodes (mesenteriacnd mandibular) mammary glands(femalesonly) ovary(2) pancreas pituitary prostate rectum salivargyland[mandibula(r2)] sciatincerve seminalvesicl(e2) skeletamluscle(thigh) skin spinalcord(cervicalm,id-thomcic,and lumbar) spleen sternumwithbone marrow stomach testi(s2) thymus thyroid(2)withparathyroid trachea urinarybladder uterus vagina Zyrnbal'sgland Histopathology Tissues(asappropriatew)ere embedded inparaffins,ectioneds,tainedwithhematoxylin and eosin,and exan-dnedmicroscopicallfyrom each animalinthecontroland high-dose groups and from thelow-doseanimalthatwas sacrificeadtan unscheduledintervalD.ue tomicroscopicfindingnsoted inthehigh-dosegroup,thelivearnd stomach from animals inthemid-dosegroup,and theEverfrom animalsinthelow-dosegroup were also embedded inparaffins,ectioneds,tainedwith hematoxyen and eosin,and examined microscopically. 20 Covance 6329-225 3M T-6314.1 Macroscopic lesionsfrom aninmls inthe low- and mid-dose groups were embedded in paraffins,ectioned,stainedwith hematoxylin and eosin,and exan-dnedmicroscopically. Bone marrow smears from the femur of each animal were prepared at the scheduled sacrificaefter13 weeks of treatment,stainedwith Wright'sstain,and retainedfor possible examinatiorl StatisticaAlnalyses Levene's test(Levene, 1960) was done to testforvariancehomogeneity. In the case of heterogeneityof varianceat p --0@.05,transformationswere used to stabilizethe variance. Comparison teststook varianceheterogeneityintoconsideration. One-way analysisof variance[ANOVA (Winer, 1971a)]was used to analyzebody weights,body weight changes,food consumption, continuous clinicaplathology values; organ weights,organ-to-bodyweight percentages,and organ-to-brainweight ratios.If the ANOVA was significanDtu,nnett'st-test(Dumett, 1964) was used forcontrolversus treatedgroup comparisons. Group comparisons (Groups 2 through 4 versusGroup 1) were evaluatedat the 5.0%, two-tailedprobabilitlyevel.Only data collectedon or afterthefirstday of treatment was analyzed statistically. RECORD RETENTION AR raw data,documentation, records,protocol,and specimens generated as a resultof thisstudy willbe archivedinthe storagefacilitioefs Covance-Madison fora period of at leastI year. At leastI year afterthe submissionof thefinalreport,the Sponsor will determine the finaldispositionof the materials.AU raw data storedon magnetic media, the protocol and protocolwnendments, study correspondence,and an originalcopy of the finalreportwillbe retainedby Covance-Madison. PCNA evaluationdata,paraffinblocks,and tissueslideswillbe retainedby Pathology AssociatesInternational. Liver and serum samples sent to the Sponsor and analysisdata generated from these samples willbe retainedby the Sponsor. 21 RESULTS Covance6329-225 3M T-6314.1 DoseAnalyses Resultosfthehomogeneitsyt,abilaintdyd,osepreparatainoanlysaerseinTableIs through3. Mean valuesof thehomogeneityanalysesrangedfrom 74.0-78.0%,84.0-96.7%,and 77.5-84.2%of thetheoreticacloncentrationfsorthedietscontaining3,30,and 100 ppm N-MEFOSE, respectivelyT.hese resultisndicattehatthemixingprocedureproduced a homogeneous distributiofnthetestmaterialinthedosepreparationsa;lthoughvariability generallyappearedslightlgyreateratthe3 and 30-ppm dietaryconcentrations. Resultsof stabiliatnyalysesofsamplesstoredfor19 and 32 days atroom temperatureand 8 weeks under frozenconditionisndicatetdhatthemean concentrationrsanged from 54.4-62.5%oftheiniticaolncentrationosf I ppm fordietmixed pretest.Samples stored for32 daysatroom temperatureindicatetdhatthemean concentratiownas 98.4% of the initiacloncentrationosf 500 pprrl Resultsof stabiliatnyalysesof samplesstoredfor19 and 32 days atroom temperatureindicatetdhatthemean concentrationrsanged from 93.2-94.0%of theinitiacloncentrationosf I ppm fordietmixed atWeek 4.Samples storedfor19 days atroom temperatureindicatedthatthemean concentratiownas 89.0% of theinitiacloncentrationosf3 ppm. The mean concentrationosf thedose preparatioannalysesforalllevelsrangedfrom 63.7 to 110.0% of thetheoreticcaolncentrationsI.nherentvariabiliatnyd lackof sufficient sensitiviattylow levelsintheanalyticamlethod formeasuringN-MEFOSE resultedin homogeneity,stabiliatnyd routineanalysidsatathatwere inmany casesoutsideof the standardlimitsof +/-15%. These resultwsillbe reevaluateidnconjunctionwiththe analyticarlesultfsrom theblood and livelreveldeterminationwshen theyareprovidedby the sponsor. ClinicalObservations and Survival Clinicaolbservationsaresummarized inTable 4;individuadlata areinAppendix 2. IndividuaalnimalfatedataarealsoinAppendix 2. One femalegiven3 ppm N-MEFOSE was sacrificeodn Day 59 due to severelaceratioonf thetag.There were no macroscopicor microscopicchangesto indicattehatitsmoribund conditionwas testmaterial-relateAdR. otheranimalssurvivedto thescheduledsacrifice. 22 Covance 6329-225 3M T-6314.1 No clinicalobservations were noted that were considered effectsof the testmterial Ophthalmology Ophthahnic observations are summarized in Table 5; individualdata are in Appendix 2. The Ophthalmology Report containsa discussionof the data. Animals selectedforthe study had no lesionsat the prestudy examination. No test material-relateodphthalmic observationswere noted at theWeek 14 exaniimtion. Body Weights Body weight and body weight change data aresummarized in Tables 6 and 7; individual body weight data are in Appendix 3. Test material-relateldower body weights were noted for males given 3 and 30 ppm and fornialesand females given 100 ppm. Statisticalsliygnificantllyower mean body weights were noted beginningat Week 4 and continuingthrough the end of study for males and females given 100 ppm. Statisticalsliygnificantlyower mean body weights were noted beginningatWeek 7 and continuingthrough the end of study formales given 30 pprrl Body weight changes were statisticalsliygnificantlyower ina sporadicnianner fornmles given 30 ppm and foranimalsof both sexes given 100 ppm Overallbody weight changes (Weeks I-14) were statisticalsliygnificantloywer forallgroups given N-MEFOSE. Food Consumption Food consumption data are summarized inTable 8; individuadlata are inAppendix 4. Although statisticalsliygnificanotnly at Week 13 forrmles given 100 ppn-4food consumption was lower fornialesgiven 30 and 100 ppm when compared to those of controlsformost of the study. Females given 100 ppm had statisticalsliygnificantllyower food consumption than those of controlsatWeeks 3, 4, 6, 7, 11,and 12. The overall mean food consumption forfemales fed the I00-ppm concentrationwas significantly lower by 17.5% when compared with thatof the controls. 23 Covance 6329-225 3M T-6314.1 Test Material Consumption Test material consumption data are summarized Appendix 4. in Table 9; individualdata are in Animals were fed dietscontaining3, 30, or 100 ppm N-MEFOSE, T-6314. The mean amounts of testmaterialconsumed by the animals inthesegroups were 0.148 to 0.304 mg/kg/day; 1.390 to 3.094 mglkg/day; and 5.054 to 10.291 mg/kg/day formales, respectively.Values forfemaleswere 0.184 to 0.319 mg/kg/day; 2.204 to 3.395;and 6.494 to 10.378,respectively.The overallmean testmaterialconsumption fornialesfed dietscontaining3, 30, or 100 ppm N-MEFOSE, T-6314 were 0.203 ,2.041,and 6.844 mg/kgtday, respectively.The overallmean testmaterialconsumption for females feddietscontaining3, 30, or 100 ppm N-MEFOSE, T-6314 were 0.240,2.588,and 7.702, respectively. ClinicalPathology Hematology, clinicaclhemistry,and urinalysisdata are sununarized inTables 10 through 14;individualdata arein Appendix 5. The Pathology Report containsa discussionof the data- Dietaryadministrationof N-MEFOSE was associatedwith lower hematocritformales and females fed 100 ppm; higher urea nitrogenfornmles and females fed 100 ppm; higher albumin formales fed 100 ppm; lower globulinformales fed30 or 100 ppm; lower cholesteroland triglyceridefsor males fed 30 or 100 ppm and females fed 100 ppm; higher alanineaniinotransferasfeormales fed 100 ppm; and higherhepaticpalirfitoCyolA oxidase formales and femalesfed 100 ppnl The effectswere relativelmyild with the exceptionof those on cholesteroland triglyceridefsor the high-dosemales; those effects were consideredto be of moderate severity.Allof thetestmaterial-relatecdlinical pathology findingswere more prominent at Week 14 than at Week 5. Serum Perfluorooctane Sulfonic Acid Level (PFOS) Determination Resultsof serum PFOS leveldeterminationwillbe reported separatelyby the Sponsor. 24 Covance 6329-225 3M T-6314.1 Cell Proliferation Tissue Collection and Lmmunohistocheniical Evaluation Results of cellproliferationand inimunohistocherrical evaluation provided by Pathology AssociatesInternationawlillbe inAppendix 7. Resultsof theceH proliferatioenvaluationwillbe provided by Pathology Associates International. Liver PFOS Deterinination Resultsof liverPFOS leveldeterminationwillbe reportedseparatelyby the Sponsor. Anatonlic Pathology Terminal body weights,absoluteorgan weights,organ-to-body weight percentages,and organ-to-brainweight ratiosare sununarizedin Tables 15 and 16; incidencesof macroscopic and microscopic observationsare sununarizedin Tables 17 and 18; the incidenceof severityof microscopicobservationsissummarized in Table 19. Individual data arein Appendix 6. The Pathology Report containsa discussionof thedata. Statisticalsliygnificanatnd testmaterial-relatecdhanges interminalbody weights and liver weights were seen in males and/or females in the two highestdose groups. Statistically significandtecreaseswere seen in the terminalbody weights of males fed 30 ppm and in both males and females fed 100 ppm of N-MEFOSE. Statisticalsliygnificanitncreases were seen in the mean liver-to-bodyweight percentage and mean Ever-to-brainweight ratioin rmles fed 30 ppm in mean absoluteliverweight and mean bver-to-bodyweight percentage in females fed 30 ppm, and inallliverweight parameters inmales and females fed 100 ppn-L Test material-relatemdacroscopic findingswere noted at a low incidencein the Ever and glandularstomach of =Ies and femalesin the 100 ppm dose group only. Liver findings includedorgans thatwere largeand diffuselydark. In theglandularstomach, dark focior areas were sometimes seen in the gastricmucosa. Test material-relatemdicroscopic findingswere seen in the Ever of animals fed 30 and 100 ppm of N-MEFOSE and inthe andular stomach of males and females in the 100 ppm group only. No testmateiial-relatecdhanges were seen inanimals fed 3 ppm of 25 Covance 6329-225 3M.T-6314.1 N-MEFOSE. In the liver,one or more testmaterial-relatefdindingsaffectedaM animals fed 100 ppm and includedslight-to-moderatceentruobularor diffusehepatoceuular hypertrophy,minimal-to-slighctoagulativenecrosis,minimal hepatocellulaprigment, and minimal-to-slighctentrffobulatro niidzonalor diffusehepatocedularvacuolation.In an@@ fed 30 ppm, centrilobulahrepatocehularhypertrophy was alsoseen,although the incidenceand severitywas decreased at thisdose. In addition,a low incidenceof minimal hepatocebularvacuolationoccurred in 30 ppm dose group males, and the liverof a single female fed 30 ppm had mbiinw coagulativenecrosis.A possibletestimterial-reiated change in theglandularstomach of aninws fed 100 ppm was a relativellyow incidenceof mucosal erosions.The erosionswere of minimal to slightseverityand involved a very smallportionof the mucosal surfaceinallcases. CONCLUSIONS Based on the anatozigcand clinicaplathology resultsat 30 and 100 ppm and body weight effectsat 3, 30, and 100 ppm the no-observable-adverse-effecltevelwas determined to be lessthan 3 ppm when N-MEFOSE isadministeredat concentrationsof 0, 3, 30 and 100 ppm to Crl:CI)@(SD)IGS BR ratsforat least13 weeks through dietary administration. 26 SIGNATURES Covance 6329-225 3M T-6314.1 NH van Bruce-Konuah Date Study Coordinator Covance LaboratorieIsnc. PeterJ.Ilomford,PhD Date Study Director Covance LaboratoriesInc. 27 Covance 6329-225 3M T-6314.1 REFERENCES Dunnett,C. W., "New TablesforMultipleComparisonswitha ControL"Biometrics 20:482-491(1964). Levene,H.,"Robust TestsforEqualityof Variances,C"ontributiontsoProbabflLtaynd Statistic(se,ds.)I.OlkinetaL,Ch. 25,pp.278-292,StanfordUniversitPyress:Stanford, Calfforr@(a1960). Winer,B. J.,"Designand Analysisof Single-FactoErxperiments,S"tatisticParlincil2liens ExperimentalDesign Second Ed.,Ch. 3,pp. 149-260,McGraw-Hill: New York, New York (1971a). 28 OPHTHALMOLOGY REPORT Covance 6329-225 3M T-6314.1 Ophthahnic examinationswere done beforeinitiatiofn treatmentand duringWeek 14. Aninmls selectedforthestudyhad no lesionsattheprestudyexamination.No test rmtezial-relatoepdhthabnicobservationswere noted atthe Week 14 examination. Donna 1.Clemons, DVM, MS Date Diplomate,ACLAM 29 PATHOLOGY REPORT Covance 6329-225 3M T-6314.1 SUMMARY The purpose of thisstudy was to assess the toxicityof the testmaterial,N-Methyl PerfluorooctanesulfonamidEothanol(N-MeFOSE), when administeredinthe dietto rats foratleast13 weeks. The testmaterialwas administeredatdose levelsof 3,30, and 100 ppm DietaryadministratioonfN-MEFOSE was associatedwithlower hematocritformales and femalesfed 100 ppm; higherureanitrogenformales and femalesfed 100 ppni;higher albun-dnformales fed 100 ppm; lower globulinfornialesfed 30 or 100 ppm; lower cholesteroalnd triglyceridefsormales fed 30 or 100 ppm and femalesfed 100 ppm; higher alanineaminotransferasfeor males fed 100 ppm; and higherhepaticpalmitoylCoA oxidaseformales and femalesfed 100 ppm. The effectswere relativelmyildwith the exceptionof thoseon cholesteroland triglyceridefsorthemales fed 100 ppm; those effectswere consideredto be ofmoderate severity.Allof the testmaterial-relatceldinical pathologyfindingswere more prominent atWeek 14 than atWeek 5. Statisticalsliygnificanatnd testrmterial-relatcehdanges interminalbody weightsand liver weightswere seen inmales and/orfemalesinthetwo highestdose groups. Statistically significandtecreaseswere seenintheterminalbody weightsof males fed30 ppm and in both males and femalesfed 100 ppm. Statisticalsliygnificanitncreaseswere seen inthe mean fiver-to-bodwyeight percentageand mean liver-to-brawienightratioinnialesfed 30 ppm inmean absoluteliverweight and mean-liver-to-bodwyeightpercentagein femalesfed30 ppm and inallliverweight parametersinnmles and femalesfed 100 ppm. Test rmterial-relatmeadcroscopicfindingswere noted ata low incidenceintheliverand glandularstomach of nialesand femalesinthe 100 ppm dose group only. Liverfindings includedorgansthatwere largeand diffuseldyark. In theglandularstomach,dark focior areaswere someti=s seen inthegastricmucosa. Test material-relatemdicroscopicfindingswere seenintheliverofanimalsfed30 and 100 ppm of N-MEFOSE and intheglandularstomach of nmles and femalesinthe 100 ppm group only. No testrnaterial-relactheadnges were seeninanimalsfed 3 ppm of N-MEFOSE. In the livero,ne or more testmaterial-relatfeidndingsaffectedallanimals 30 Covance6329-225 3M T-6314.1 fed100 ppm, and includedslight-to-modercaetnetrilobuloarrdiffusheepatoceuular hypertrophy,minimal-to-slighctoagulativenecrosis,minimal hepatoceuularpigment, and ninirrW-to-sUghtcentdlobularto midzonal or diffusehepatocehularvacuolation.In animals fed 30 ppm, centrflobulahrepatocebularhypertrophy was alsoseen,although the incidenceand severitywas decreasedatthisdose. In addition,a low incidenceof n*iimal hepatoceuularvacuolationoccurred in30 ppm dose group niales,and the liverof a single female fed 30 ppm had minimal coagulativenecrosis.A possibletestmaterial-related change in the glandularstomach of aninmls fed 100 ppm was a relativellyow incidenceof mucosal erosions.The erosionswere of nii@ to slightseverityand involveda very small portionof the mucosal surfacein allcases. METHODS Four groups of Crl:CD"(SD) IGS BR rats(20 animaLs/sex/group)were fed diets containingthetestmaterialata dose levelof 0 (controlgroup;fed basaldietonly),3, 30, or 300 ppm During Week 5, fiveanimals/sex/groupwere sacrificetdo obtainliver samples fordeterminationof hepaticpalniitoyCloA oxidaseactivity(by Covance) and analysisforPFOS and metabolites(by 3M). One fezimlefed 3 ppm was sacrificedand necropsiedduringWeek 9 because of poor health(unscheduledsacrifice)T.he remaining animalswere sacrificeadnd necropsiedduringWeek 14 (terminalsacrifice). Blood was collectedfor hematology and clinicaclhemistrytestsduring Weeks 5 and 14. Urine was collectedforurinalysitsestsduringWeek 14. At necropsy,macroscopic observationswere recorded,organ weights were obtained(terminalsacrificoenly),and tissueswere placed in fixativaes specifiedby theprotocol. In addition,samples of liver were collectedatthe terminalsacrificfeorevaluationof proliferatiocnellnuclearantigen (PCNA; by Pathology AssociatesInternationalf;iveaninials/sex/groupa)n,d both scheduled sacrificefsordetern-dnatioonf hepaticpaln-@toyCloA oxidase activity(by Covance) and analysisforPFOS and metabolites(by 3M). Mcroscopic examinations were done on protocol-requiredtissuesfrom allcontroland high-doseanirnalssacrificed during Week 14 and the 3 ppm dose group female sacrificeidn a moribund condition duringWeek 9 (unscheduledsacrifice)I.n addition,liverss,tomachs,and macroscopic lesionswere exaniinedfrom allterminalsacrificaenimals fed 30 ppm and macroscopic lesionsand Evers only were examined from animals fed 3 pprrl 31 Covance 6329-225 3M T-6314.1 Statisticalsliygnificandtifferencescitedin the Results and Discussion sectionare based on comparisons between the controland treatedgroups. RESULTS AND DISCUSSION Mortality One female fed 3 ppm (Animal No. C96016) was sacrificeduring Week 9 (Day 59) because of poor health.AllotheraninmIssurvivedto the respectivescheduled sacrifice. CfinicalPathology Weeks 5 and 14. There were severalstatisticalsliygnificanotr otherwisenotable differencesforclinicaplathologyresultsbetween controland treatedanimals. Differences considered to be effectsof the testmaterialwere lower hematocritfor nialesand females fed 100 ppm; higherurea nitrogenfornialesand females fed 100 ppm; higher albumin for males fed 100 ppm, lower globulinformales fed 30 or 100 ppril;lower cholesteroland triglyceridefsor males fed 30 or 100 ppm and females fed 100 ppm; higheralanine aminotransferasefor males fed 100 ppm; and higherhepaticpalniitoyCloA oxidase for males and females fed 100 pprrl The effectswere relativelmyUd with theexception of those on cholesteroland triglyceridefsorthe males fed 100 ppm; those effectswere consideredto be of moderate severity.AR of the testmaterial-relatecdlinicaplathology findingswere more pron-dnentat Week 14 than at Week 5. The mild effectson hematocritand globulinwere consistentwith animals failintgo gain weight appropriately.Although mildlyhigherurea nitrogenand albumin suggested a relativedehydrationfor animalsgiven 100 ppm, therewere no effectson urinevolume or urinespecificgravityconsistentwith dehydration.The mud effecton alanine aminotransferasewas indicativoef the hepatocehulardegeneration,and mildlyhigher hepaticpamtoyl CoA oxidasewas indicativoef peroxisomalproliferationT.he effectson cholesteroland triglyceridewsere the most prominent findingsa,nd suggested lipid metabolism by the liverwas altered. Of uncertainrelationshitpo administrationof the testmaterialwas statisticallloywer mean corpuscularvolume forfemalesfed 100 ppm. The differenceformean corpuscular volume became smallerover time (i.e.f,rom Week 5 to Week 14). Other statistically 32 Covance 6329-225 3M T-6314.1 significadnitfferencewsere consideredincidentaalnd unrelatedto administratioonf the testmaterial. Anatomic Pathology Unscheduled Deaths. The one fenialfeed3 ppm thatwas sacrificeidna moribund conditionon Day 59 (AnimalNo. C96016) had no macroscopicor microscopicchangesto -indicatehatitsmoribund conditionwas testmaterial-related. TenWnal Sacrifice Temdnal Body Weights and Organ Weights. Test niaterial-relactheadngeswere seen intheterminalbody weightsand inabsoluteand relativleiverweightsinanimalsfed 30 and 100 ppm N-MEFOSE. Mean terminalbody weightswere statisticaslilgynificantdleycreasedinmales and females thatwere fed 100 ppm ofN-MEFOSE and inmales onlyfed30 pprrl The decreasedmean body weightsatboth dose levelswere consideredto be testmaterial-related. Statisticalsliygnificanatnd testmaterial-relatiendcreaseswere seen inthemean liver-to-bodwyeightpercentageand themean hver-to-braiwneightratioinmales fed 30 ppm, inmean absoluteliverweightand mean liver-to-bodwyeightpercentagein femalesfed30 pprn,and inallliverweightparametersinn-alesand femalesfed 100 ppm ne liverweightincreasecsorrelatemdacroscopicallwyithlargeEversin3 of 15 males in the 100 ppm dose group and microscopicallwyiththepresenceof hepatocchular hypertrophyinallmales and femalesinthehigh-dosegroup. Additionalstatisticaslilgynificaanbtsoluteor relativoergan weightchangesaffected severalotherorgansinboth sexesand inmultipledose groups.Because therewere no macroscopicor microscopicfindingtshatcorrelatewdiththeweightchanges,the remainingorgan weightvariationwsere consideredto be withintherangeof normal biologivcariatioonr were attributetdo thelower body weightsintreatedversuscontrol animals. Macroscopic Findings. Testniaterial-relamtaecdroscopicfindingwsere notedata low incidenceintheliverand -Iandularstomach of malesand femalesfed 100 ppm 33 CovancL-6329-225 3M T-6314.1 N-MEFOSE. Uvers that were largewere seenin3 of 15 malesand in0 femalesfed 100 pprr4and diff-usedlayrk liverosccurredin2 of 15 nmlesand I of 15 femalesfed 100 ppm. No liverchangesoccurredinanimalsfedthecontrolmaterialor inaninl-:fdesd lower dosesof N-MEFOSE. The largeand diff-usedlayrkliverscorrelatemdicroscopically withhepatoceuulahrypertrophyintheaffectedanimals.In theglandularstomachs,dark focior areasoccurredatan incidencoef 0 of 15,1 of 15,0 of 15,and 2 of 15 inmales, and atan incidenceof 0 of 15,0 of 14,0 of 15,and 3 of 15 infemalesinthecontrol 3 ppm, 30 ppm, and 100 ppm groupsrespectivelyT.he darkfocior areasgenerally correlatemdicroscopicallwyithsznauerosionsinthe glandularmucosa. Diffusereddeningand mottlingofthethymus and mandibularlymph nodes as wen as red focior areasinthethymus were relativelcyommon findingsand frequentlcyorrelated microscopicallwyith hemorrhageintheaffectedorgans.Because thesefindingsdidnot occur ina dose-relatemdanner and becauseratsinmultipledose groups,includincgontrol nialesw,ere sometimes affectedt,hefindingswere consideredtobe agonalchanges that were notassociatedwithtestmateriaaldministrationA.D remainingmacroscopicfindings were consideredto be spontaneousand incidentaalnd not relatedtotestmaterial administration. Microscopic Findings. Test niaterial-relamtiecdroscopicfindingswere seenintheliver of animalsfed30 and 100 ppm of N-MEFOSE and intheglandularstomach of males and femalesinthe 100 ppm group only.There were no testmaterial-relatfeidndingisnthe fiverosf animalsfed3 ppnl Test material-relatfeidndingisntheliverincludedhepatoceuularhypertrophyc,oagulative necrosish,epatoceuularpigment,and hepatocebularvacuolation.The incidenceand severitoyf thesefindingstendedtobe greaterin 100 ppm animals.The incidenceof pertinenltiverfindingsispresentedinText Table 1. 34 Text Table I Covance 6329-225 3M T-6314.1 Incidenceof SelectedNficroscopicFindingsinthe Liver Group Number/Sex Number ExamineA- IM 2M 3M 4M 15 15 15 15 IF 2F 3F 4F 15 14 15 15 Hypertrophy, hepatocerular,diffuse 0 Hypertrophy, hepatoceuular, Centrilobular 0 Necrosis,coagulative 0 Pigment, hepatocehular 0 Vacuolation,hepatocehular, centrilobulatro midzonal 0 Vacuolation,hepatocellulard,iffuse 0 0 0 0 0 14 15 0 0 3 0 0 2 0 2 7 0 2 2 000 1 0 0 7 14 0010 0 007 00 02 00 00 As noted in the above table,hepatoceuularhypertrophy generallyaffectedcentrilobular areasof the liverin animals fed 30 and 100 pprri,but the liverwas more diffusely hypertrophiedinone fenmle fed 100 pprrl The hypertrophichepatocyteswere enlarged with abundant cytoplasm thatoftenhad a granularto globulareosinophilicappearance. In some aninmlsin the high-dosegroup (two males and seven females),the cytoplasm of hepatocytesalsocontained minimal amounts of a brown granularpigment at the periphery of theceR. In addition,livercellsfrequentlywere vacuolated(seeText Table 1), particularliynmales given 100 ppm, with thevacuolationgenerallyaffectinghepatocytes incentrilobulaarnd midzonal areas. Diffusehepatoceuularvacuolationwas alsoseen in two males in each of the 30 and 100 ppm dose groups, but in no other animals. Lastly, minimal to slightcoagulativenecrosisseen in3 of 15 imles fed 100 ppm and I of 15 females fed 30 ppm was likelyrelatedto dietaryadministrationof the testmaterial sinceno controlor 3 ppm dose group animals were similarlayffected. A possibletestmaterial-relatecdhange inthe glandularstomach was the presence of mucosal erosions.The erosionswere of minhnw to slightseverityand involved a very smallportion of the mucosal surfaceinallcases. The erosionswere seen with an incidenceof 0 of 15,0 of 15,and 2 of 15 in males,and atan incidenceof 0 of 15,0 of 15, and 3 of 15 infemales in thecontrol,30 ppm, and 100 ppm groups respectively.The presence of erosionsmicroscopicallygenerallycorrelatedwith the dark focior areas seen 35 Covance 6329-225 3M T-6314.1 in the gastricmucosa at necropsy. One nmle fed 3 ppm alsohad a slightgastricerosion thatwas collectedas a gross lesionat necropsy. Since no erosionswere seen in any of the animals'stomachs examined from animals fed 30 ppn-4the lesioninthe 3 ppm male was considered unlikelyto be testmaterial-related. AU remaining microscopic findingswere considered to be spontaneous and incidental changes and typicalof ratsof thisage and strain. Robert L Hall,DVM, PhD Diplomate,ACVP (CMcal Pathology) JohnnieJ.Eighmy, DVM, MS Diplomate, ACVP Diplomate,ABT Date Date 36 COMMENTS ON THE DATA Covance 6329-225 3M T-6314.1 Variousmodels of calculatorcso,mputers,and computerprograms were used to analyze datainthisstudy.Because differenmtodels round offor truncatenumbers dfferently, valuesinsome tables(e.g.m,eans,standarddeviationso,r individuavlalues)may differ slightlfyrom thoseinothertablesf,rom individuallcyalculateddata,or from statistical analysidsata.Neithertheintegritnyor theinterpretatioofnthedatawas affectedby these differences. The number of animalslisteidntheheadingof thesummary tablesforclinicaolbservations reflecttshenumber of anhii& assignedto eachgroup atthestartof thestudy. The summary tableforclinicaolbservationisndicatethenumber of animalsforwhich a conditionwas observedwithoutregardto thespecifincature,severityr,eversibility, number of incidences/animaolr,thelengthof time theconditionpersisted. Only observationostherthannormalareindicateodn thesununaryclinicaolbservations tables. Each animalwith observationrsecordedas "Normal" throughoutthestudyhas the comment "Animalhas no significafnitndingsi"ndicateodn theindividuacllinical observationstables. The specifidcetailfsorconunentsintheindividuacllinicaolbservationtsablesthatare indicatewdith a "C" can be found attheend of each group foreach sex. The day of initiatioofntreatmentis"Day 1,Week I." Body weightdataareenteredatthe startof a studyweek (e.g.a,body weightrecordedon Day I isconsidereda Week I body weight,a body weightrecordedon Day 8 isconsidereda Week 2 body weight).Body weightchange dataarecalculatefdrom thefirsdtay ofthestudyweek tothefirsdtay of thefollowingstudyweek (e.g.W,eek I valuesarecalculatefdrom Day I through7) and areindicateidnthetableswiththeday beingthefirsdtay of thefollowingweek (e.g., Week I valuesareindicateads "Day 8.").Weekly foodconsumptionand testmaterial consumptionarecalculatefdrom thefirsdtay ofthestudyweek to thefirsdtay of the fouowinc,studyweek (e.g.W,eek I valuesarecalculatefdrom Day I through7). 37 COMMENTS ON THE DATA (Continued) Covance 6329-225 3M T-6314.1 The values for sununary and individualtestmaterial consumption are reported with more significanftiguresthan isappropriateforthedata due to limitationosf the data collection and reportingsoftware. Food consumption values are reportedinwhole numbers; however, PTS carriesfood consumption valuesto one placeto therightof the decirrw forfood efficiencyand test materialconsumption calculations.The'differencesinvaluesgenerated do not influence theinterpretatioonf thecalculation. The comment "SPILI-ED" on individualfood consumption data tablesindicatesthatfood consumption was not recorded due to spillageduringthe interval The comment "NOT TAKEN" on individualfood consumption datatablesindicatesthe animal died beforetheend of thefood consumption interval Differencesin thepopulationsize(N) on thesummary tablesforclinicaalnd anatomic pathology are explained on the individualdata tablesor the codes sheets. 38 COMMENTS ON THE DATA (Continued) Covance 6329-225 3M T-6314.1 The calculatiofnorindividuatlestmaterialconsumptionis: Test materialconsumption = DietConcen=donxFood Consumption Food Consumption Intervaix[FiBrosdty Weight of lnuxval+(DaflyBody Weight C*hL%Day Famr)] where: DailyBody Weight Gain LastBody Weight of lntmvw-FirstBody Weight of bamal Day of LastBody Wei& of hmmw- Day of FastBody Wei& ofInterval and:Day Factor= Food Consumption Interval (Fwd Consumption StartDay- Day of FirstBody Weight of Interval+) 2 and: Food Consumption Interval Food Consumption End Day-FbW Consumption StartDay 39 CODES, ABBREVIATIONS, AND UNITS Covance 6329-225 3M T-6314.1 GeneralCodes and Abbreviations Codes forClinicaPlathology Abbreviationasnd UnitsforClinicaHlematology Abbreviationasnd UnitsforClinicaClhemistry Abbreviationasnd UnitsforClinicaUlrinalysis Codes forAnatomic Pathology Note: The followinglistosf codes,abbreviationasn,d unitsareused by Covance. Some, butnot necessarilaylLof thisinformatiomnay be needed forthisreport. 40 Covance 6329-225 3M T-6314.1 General Codes and Abbreviations )WK N Mean; MEEAN SD; S.D.;STAND DEV; STANDARD DEV; sd NA p c UNSCHED DISPATCH T7BW co Week. Number of measurements Arithmeticmearl Standard deviation. in a group. Group mean issignificantldyifferentfrom themean of the controlgroup (Group 1) atp .50.05. No value;not applicable;not present. Present. Conmient found at the end of each group foreach sex. Unscheduled. Observationsmwferred from the in-life module of the datacollectionsystem to the necropsy module for referenceduring necropsy. Observationsare duplicatesof the lastin-lifoebservations. Terminal body weight. Number. Clinicalobservation. Animal I T m Death Codes: Interimsacrific1e. Terminal sacrifice. Sacrificedat an unscheduled interval. 41 NS QS/QNS NR FS sc SH H SL L si I NF u DT/DOT DB Ti TE RE EE SE PC PD Pi PL PA co HB PLASMO NO AGG FR UTD NO COAG Covanc6e329-225 3M T-6314.1 CodesforCWcal Pathology GENERAL CODES No sample Quantitynot sufficient No repeat(samplevolume not sufficienftorrepeatanalysis) Fibrins=ds Sample clotted. Slightlhyemolyzed Hemolyzed SlightlyUpernic Lipemic Slightliycteric Icteric Animal not fasted Unscheduled/moribund bleed Animal diedon test Died duringbleeding Technicianjudgment to repeattest Technicalerror(instrumentor techniciaenrrorthatresultsin unacceptabledata,e.g.,unacceptableinstrumentoutput,sample spmed, entryof invalidata) Recording error(recordedincorrecdtata,e.g.,wrong number, speffinegrror,incorrectdate) Entryerror(incorreckteyboard entry) Sampling error Plateletcslumped Plateletdsecreased Plateletisncreased Plateletlsarge Plateletasppear adequate Color interferewsithtest Heinz bodiesobserved Plasmodium No aggregation Fractious Unable to determine No coagulation 42 Covance 6329-225 3M T-6314.1 Codes for ClinicalPathology (Continued) RESULTS NOT INCLUDED IN STATISTICAL ANALYSES Hemolyzed clinicaclhemistry or coagulation samples Samples from animalsat unscheduled intervals Prothrombintiznes(PT) greaterthan50 seconds Activatedpartiatlhromboplastintimes(PTT) greaterthan I10 seconds Bleed times(BLETIME) greaterthan30 n-Anutes CODES FOR BLOOD CELL MORPHOLOGY The followingscalewas used to measure the degreeof anisocytosi(sANISO), poikilocytos(iPsOIK),polychromasia(POLY), hypochromasia(HYPO), or basophilic stipplin(gBASTIP) or thepresenceofHoweU-Joilybodies(HJBODY), toxicneutrophils (TOXNEUT), or atypicallymphocytes(ATYPLYM): Scale I 2 3 4 Degree Normal forthe species Slight Moderate Marked Not applicable Presence Not present Rare Few Moderate Many URINE APPEARANCE A Pale B Straw C Yellow D. Dark yellow Color E Amber F Brown G Red H Green I Black P Blue/green Q- Blue R Orange Clarity J Clear K. Hazy L Cloudy Miscellaneous M Debris 0 Feces 43 Codes for Clinical Pathology (Continued) Covance 6329-225 3M T-6314.1 URINE CHEMISTRY MULTISTIX* Urine Glucose - Negative + 100 mg/dL ++ 250 mg/dL i 500 nig/dL 1,000 mg/dL 2!2,000 mg/dL Urine Ketone - Negative + 5 mg/dL ++ 15 mg/dL 40 mg/dL 80 mg/dL i 160 mg/dL STRIP Urine Blood - Negative + Small ++ Moderate i Large (I mg Urine Urobilinogen - 0.2 mg/dL + I nig/dL ++ 2 mg/dL i 4 mg/dL 8 mg/dL approximatelyI Ehrlichunit) Urine Bflirubin - Negative + Small ++ Moderate i Large URINE SEDIMENT CeUs, Crystals,Casts,and Comments A Amorphous urates B Amorphous phosphates C Uric acid D Triplephosphates E Calcium oxalate F Calcium carbonate G Granular casts H Hyahne casts I Cellularcasts J Waxy casts K Unknown crystal P Mucous threads Q Sperm R Fecal contan-dnation S Pinworm ova found T Pinworm larvaefound U Parasiteova found 0 Not present 1 1-5 per field 2 6-10 per field 3 11-20 per field 4 >20 per field Bacteria 0 Not present I Few 2 Moderate 3 Many 44 Covance6329-225 3M T-6314.1 Abbreviationsand UnitsforClinicalHematology Test Red bloodcellcount Hemoglobin Hematocrit Mean corpuscularvolume Mean corpuscularhemoglobin Mean corpuscularhemoglobin concentration Plateletcount Mean plateletvolume Reticulocytecount Absolute reticulocytceount Heinz body count Erythrocytesedimentationrate Prothrombin time Activatedpartialthromboplastintime Thrombin time Activatedcoagulationtime Fibrinogen Fibrin/fibrinogednegradationproducts Plateletaggregation Collagen Adenosine diphosphate Alpha 2-antiplasmin Bleeding time Methemoglobin Plasma hemoglobin Myeloid/erythroidratio Estimated myeloid/erythroidratio VAite blood cellcount Differentiabllood cellcount Nucleated red blood cellcount Corrected white blood cellcount Segmented neutrophflcount Band neutrophilcount Lymphocyte count Monocyte count Eosinophilcount Basophfl count Anisocytosis Polychromasia Abbreviation(Units) RBC (E6/UL or X I06/AL) HGB (G/DL) HCT MCV (FL) MCH (PG) MCHC (%) PLT (E3/UL or XI WIGL) NTV (FL) RETIC (%) or X I03/,OL) RETIC (E3/UL HEINZ (%) ESR (NffvVHR) PT (SEC) PTT (SEC) -fT(SEC) ACT (SEC) FBR (MG/DL) FDP (UGftvlL) PAGG/COL PAGG/ADP ANTIPLAS BLE TIME (%) (SEC) METHGB(%) PLA HGB (MG/DL) M/E RATIO EST M/E RATIO WBC (E3/UL or X I03/,4L) NRBC (/100WBC) X,03 COR WBC (E3/UL or /pL) N-SEG (E3/UL or X103/,uL)and % N-BAND (E3[UL or X103/gL) and % LYMPH (E3/UL X103 or /gL) and % MONO (E3/UL or X103/ML) and % EOSIN (E3/UL X103 or /gL) and % BASO (E3/UL or X103/PL) and % ANISO (-,1,2,3) POLY (-,1,2,3) 45 Covance 6329-225 3M T-6314.1 Abbreviations and Units for ClinicalHematology (Continued) Test Poikilocytosis Hypochromasia HoweU-JoUy bodies Basophilicstippling Toxic neutrophils Atypicallymphocytes Aqueous white blood cellcount (righteye) Aqueous whiteblood cellcount (lefteye) Abbreviation(Units) POIK (-,1,2,3) HYPO (-,1,2,3) HJBODY (-,1,2,3,4) BASTIP (-,1,2,3) TOXNEUT 1,2,3,4) ATYPLYM 1,2,3,4) R EYE (WBCFUL) L EYE (WBCFUL) 46 Covanc6e329-225 3M T-6314.1 Abbreviationasnd UnitsforClinicaClheniistry Test Glucose Urea nitrogen Urea Creathiine Totalprotein Albun-dn Globulin Albumin/globulirnatio Totalbuirubin Directbifimbin Indirecbtilirubin Cholesterol Triglyceride Urea nitrogen/creatinirnaetio TotalLpids Phosphohpids High-densitylipoproteicnholesterol Low-density Upoproteincholesterol Uric acid Aspartatean-dnoaumferase Alanine aminotransferase Alkalinephosphatase Ganum glutamyltransferase Sorbitoldehydrogenase Lactatedehydrogenase Creatinekinase Amylase Lipase PahnitoylCoA oxidase Calcium Ionizedcalcium Inorganicphosphorus Sodium Potassium Chloride Ma-nesium Zinc Strontium Iron Abbreviatio(nUnits) GLU (MG/DL) UN (MG/DL) UREA (MG/DL) CREAT (MG/DL) T PRO (G/DL) ALB (G/DL) GLOB (G/DL) AIG RATIO T BIU (MG/DL) D BILI(MG/DL) I BILI(MG/DL) CHOL (MG/DL) TRIG (MG/DL) UN/CREAT (RATIO) T LEPIDS (MG/DL) P LIPIDS (MG/DL) HDL (MG/DL) LDL (MG/DL) UA (MG/DL) AST/SGOT (IU/L) ALT/SGPT (rU/L) ALK PHOS (IUAL) GGT (IU/L) SDH (IU/L) LDH (IU/L) CK (IU/L) AMYLASE (IU/L) LIPASE (IU/L) PCOAO ([U/G) CA (MG/DL) ION CA (MG/DL) IPHOS (MG/DL) NA (MMOLIL) K (MMOLIL) CL (MMOIJL) MG (NMQ/L orMGIDL) ZN (MG/L orPPM) SR (MG/L or PPM) FE (UG/DL) 47 Covance6329-225 3M T-6314.1 Abbreviationsand UnitsforCffiaicaClheniistry(Continued) Test Excessiron Total ironbindingcapacity Unbound ironbindingcapacity Percent ironsaturation Plasma cholinesterase Red blood cellcholinesterase Brain cholinesterase Caudate putamen Hippocampus Frontalcortex Cerebellum Bicarbonate Serum hemoglobin Serum bileacids Fecal bileacids Average fecalweight Fecalbileacids(calculation) Osmolality Electrophoresis Albumin Alpha- 1-globulin Alpha-2-globulin Beta globulin Ganum globulin High-densitylipoprotein Low-density lipoprotein Very-low-densitylipoprotein Insulin Adrenocorticotropichormone Cortisol Glucagon Triiodothyronine Thyroxine Creatinekinase isoenzymes BB MB mm Abbreviation(Units) EX FE (UG/DL) TIBC (UG/DL) UIBC (UG/DL) FE %SAT (%) CHEP (MU/ML) CHER (MU/M[L) CHEB (MU/M[L) CAUD PUT (UMOLIG) HMPOCAM (UMOIJG) F CORTEX (UMOIJG) CEREBELL (UMOIJG) BICARB (MMOIJL) SER HGB (MG/DL) SBA (UMOLJL or MG/DL) FBA (UG/ML) FCC WGT (G) FBA (MG/Day) OSMO (MOSMIKG) E ALB (GIDL) E A- I (G/DL) E A-2 (G/DL) E BETA (G/DL) E GAMMA (G/DL) E-HDL (%) E-LDL (%) E-VLDL (%) INSULIN (UU/ML) ACTH (PG/ML) CORTISOL (UG/ML) GLUCAGON (PG/ML) T3 (NG/DL) T4 (UG/DL) CK-BB CK-MB CK-MM (UAL) (U/L) (U/L) 48 Ccyvance6329-225 3M T-6314.1 Abbreviations and Units for Clinical Urinalysis Test Urine volume 8 hour urinevolume Specificgravity Urine osmolality Quantitativeurfiwy/cerebrospinal fluidprotein Urine proteinexcretion Urine chemistryMultistix"strip Urine pH Urine protein Urine glucose Urine ketones Urine bffimbin Urine blood Urine urobilinogen Urine reducing substances Microscopic examination of urinesediment Red blood cellsper high-power field V;Wte blood ceus per high-power field Epitheliaclellsper high-power field Bacteriaper high-power field Casts per low-power field Crystalsper low-power field Urine appearance Comments Abbreviation (Units) U VOL (ML) 8 HR VOL (ML) SP GR U OSMO (MOSMIKG) QUAN PRO (MG/DL) PRO EXC (MG) U PH U PRO (MG/DL) U GLU U KET U BILI U BLOOD UROBILI U RE SUB RBC (PER HPF) WBC (PER HPF) EPITH (PER BPF) BACT (PER HPF) CASTS (PER LPF) CRYSTALS (PER LPF1 PER LPF2) URINE APP I or URINE COMMENTS or APP2 Miscellaneous Codes and Abbreviations for ClinicalPathology Fecal occultblood Fecal parasitedetection Hemolytic potential OsmolaUty Not applicable Not applicable Not applicable OSMO (MOSM/KG) 49 Covance 6329-225 3M T-6314.1 Codes for Anatoniic Pathology Code Definition ANIMAL DEATH CODES Interim sacrificesI T Terminalsacrifice m Sacrificeadtan unscheduledinterval EX NOTTAKEN MISSING UNSUITABLE AUTOLYTIC EXCLUDE MACROSCOPIC CODES indicatetshatorgan weightisexcludedfrom calculations Organ weight not taken;explanationgiven innecropsy notes Organ rrussmgor lost Organ technicalluynsuitableforweighing Organ autolyzedand could not be weighed Weight was taken,but was excludedfrom allcalculations MICROSCOPIC CODES Codes BmNIx- Prefacing NeoplasticFindings Primary,benign neoplasm Primary,malignantneoplasm Metastaticneoplasm Locallyinvasiveneoplasm Other neoplasm 50 Covance 6329-225 3M T-6314.1 Codes for Anatomic Pathology (Continued) Code Derniition Distribution of Findings Focal Diffuse Multifocal Grades I 2 3 4 for Severityor Amount Minimal - the leastamount of change thatcan be observed with the lightmicroscope Slight- lessthan average amount of change, but readilydiscernible as abnormal Moderate - the average amount of change thatisexpected for a lesion Moderately severe(marked) - a marked amount of change with possiblelossof functionof the affectedceus or organs 5 Severe - a greatamount of change with probable lossof functionof the affectedcellor organs and frequentlyinvolveslarge'areasof the organ Other Microscopic Codes TL Total p Finding present Finding not present MN Mean 51 Covance 6329-225 3M T-6314.1 Codes for Anatomic Pathology (Continued) TESUE ABBREVUTIONS Abbreviation IN GL STOMACH, GL STOMACH, NONGL SALIV GL, MANDIB IN, ANT MES/PANC AUDITORY LACRIMAL SEB GL GLAND, EX HEMATO NEOPLASIA LACREAAL GI, INT CAVITY, ABDOM SALIV GL,PAROTID LN, TRACHEOBRON Dermition Lymph node Gland Glandular stomach Nonglandular Mandibular salivarygland Anteriormesenteric/pancreatilcymph node Auditory sebaceous gland Exorbitallacrimalgland Heniatopoieticneoplasia Internallacrimalgland Abdominal cavity Parotid salivarygland Tracheobronchiallymph node 52 Covance 6329-225 3M T-6314.1 Table I Resultsof Homogeneity Analyses (ppm) Mixed 8/20/98 13-WEEK DIETARY TOXICITY STUDY WrM N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MeFOSE, T6314) IN RATS Samples Location Replicate 3 T6314 (ppm) 30 100 Top 1 2.19 33.7 79.4 2 2.43 27.8 76.5 3 2.09 25.6 76.7 Mean 2.24(74.7)' 29.0(96.7) 77.5(77.5) Middle 1 2 3 Mean 2.24 2.27 2.14 2.22(74.0) 25.2 25.3 25.1 25.2(84.0) 75.0 79.7 89.5 81.4(81.4) Bottom 1 2 3 Mean 2.03 3.04 1.94 2.34(78.0) 23.7 27.6 29.4 26.9(89.7) 83.2 81.6 87.8 84.2(84.2) a Each value inparenthesisisthe percent of theoretical. 53 Covance 6329-225 3M T-6314.1 Table 2 Resultsof StabilitAynalyses(ppm) Nfixed 8/20/98 13-WEEK DIETARY TOXICrrY STUDY WrrH N-METHYL PERFLUOROOCRANESULFONAMIDO ETHANOL (N-MeFOSE, T6314) IN RATS Storage Conditions, Replicate T6314 (ppm) 1 500 Initial 19 day, room temperature 32 day, room temperature 32 day, room temperature 8 week, frozen 1 2 Mean 1 2 Mean I 2 Mean 1 2 Mean 1 2 Mean 1.88 0.954 1.42(142) 415 468 442 (88.4)a 0.733 - 0.811 0.772 (77.2) - - 444 425 - 435(87.0) 0.709 - 0.850 - 0.780 (78.0) - 0.779 - 0.995 - 0.887 (88.7) - a Each value in the parenthesisisthe percent of theoretical. b Reinjected 54 Table 2 Covance 6329-225 3M T-6314.1 Resultsof StabilitAynalyses (ppm) Mixed 9/24/98 13-WEEK DIETARY TOXICITY STUDY WITH N-MIETHYL PERFLUOROOCRANES,ULFONAMMO ETHANOL (N-MeFOSE, T6314) IN RATS Storage Conditions Replicate 500 T6314 (ppm) 1 Initial I - 2 Mean - 0.788 0.656 0.722 (72.2)" 19 day, room temperature I - 2 - Mean - 0.707 0.651 0.679 (67.9) 32 days, room temperature - 2 - Mean - 0.688 0.657 0.673 (67.3) a Each value in the parenthesisisthe percent of theoretical. 55 Covanoe 6329-225 3M T-6314.1 Table 2 Resultsof StabilitAynalyses(ppm) Mixed 10/22/98 13-WEEK DIETARY TOXICITY STUDY WITH N-MIETHYL PERFLUOROOCTANESULFONANUDO ETHANOL (N-MeFOSE, T6314) IN RATS T6314 (ppm) Storage Conditions Replicate 3 Initial 1 2 Mean 19 day, room temperature 1 2 Mean 2.24 2.49 2.37 (79.0)' 1.89 2.33 2.11(70.3) a Each valuein the parenthesisisthe percent of theoretical. 56 Covance 6329-225 3M T-6314.1 Table 3 Resultsof Dose PreparationAnalyses (ppm) 13-WEEK TO)UCrrY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS Week 1-4 1-4c 1-4d Replicate 0 1 a 2 a Mean - 1 - 2 - Mean - I - 2 - Mean - T-6314 (ppm) -3 30 100 2.16 2.12 2.14 (71.3)b 29.7 27.0 28.4(94.7) 87.3 85.2 86.3(86.3) 1.98 - - 1.84 - - 1.91(63.7) - - 2.48 - - 2.28 - - 2.38(79.3) - - 5-8 9/12 13/14 1 a 2 a Mean a 1 a 2 a Mean a 1 a 2 a Mean a 3.55 3.05 3.30(110) 27.9 27.0 27.5(91.7) 89.3 82.3 85.8(85.8) 2.24 2.49 2.37(79.0) 27.6 26.8 27.2(90.7) 89.7 87.2 88.5(88.5) 2.51 2.42 2.47(82.3) 26.2 26.4 26.3(87.7) 98.1 98.7 98.4(98.4) a Below the Iiiniotfquantitatio(n<0.5 ppm). b Each value inparenthesisisthe percent of theoretical. c Retest. d Retention. 57 Table 4 Summary of Clinical Observations 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-MMMYL ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-93 CATEGORY SEX: GROUP: DOSE: -------MALE ------- 1 2 3 4 0 3 30 100 ------FEMALE ------ 1 2 3 4 0 3 30 100 KEYWORD QUALIFIER NUMBER: 20 20 20 20 20 20 20 20 ------------------------------------------------------------------------------------------------------------------- *** TOP OF LIST APPEARANCE LIMITED USE LIMB-HIND-LEFT MALOCCLUSION MISSING TAIL-DISTAL TEETH SWOLLEN LIMB-HIND-LEFT THIN 0 0 0 0 1 0 0 0 3 6 3 4 1 3 3 1 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 DISCHARGE GENITAL RED IN NASAL RED IN COLOR COLOR 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 EYES RED DISCHARGE EYES 0 0 0 1 0 0 0 0 RESPIRATION AUDIBLE 0 0 0 1 0 0 0 0 58 Table 4 Summary of clinical observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULPONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED DAYS 1-93 CATEGORY SEX: GROUP: DOSE: -------MALE ------- 1 2 3 4 0 3 30 100 ------FEMALE ------ 1 2 3 4 0 3 30 100 KEYWORD QUALIFIER NUMBER- 20 20 20 20 20 20 20 20 ------------------------------------------------------------------------------------------------------------------- SKIN & PELAGE BLACK SKIN TAIL-DISTAL SORE/SCAB MOUTH TAIL YELLOW HAIR COAT PENIS END OF LIST 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 1 0 0 0 0 0 59 Table 5 Summary of ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- NUMBER OF ANIMALS AFFECTED WEEK 14 SEX: -------MALE ------- ------FEMALE ------ GROUP: 1 2 3 4 1 2 3 4 CATEGORY DOSE: 0 3 30 100 0 3 30 100 KEYWORD QUALIFIER NUMBER: 15 15 15 15 15 15 15 15 ------------------------------------------------------------------------------------------------------------------- *** TOP OF LIST CONJUNCTIVA CONJUNCTIVITIS EYES EYE-LEFT 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 0 RETINA RETINAL DEGENERATION-FOCAL EYE-RIGHT END OF LIST 0 0 1 0 0 0 0 0 60 Table 6 Summary of Body Weight Data (g) 13-WEEK DIETARY WXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- SEX: --------------------M-ALE --------------------- -------------------F-EMALE -------------------- GROUP: 1 2 3 4 1 2 3 4 DOSE: 0 3 30 100 0 3 30 100 WEEK UNITS: PPM PPM PPM PPM PPM PPM ppm PPM -------------------------------------------------------------------------------------------------------------------- 1 N 20 MEAN 210 S.D. 11.2 20 211 10.2 2 14 20 MEAN 263 S.D. 16.0 20 263 13.4 3 N 20 MEAN 313 S.D. 21.5 20 314 16.6 4 N 20 MEAN 355 S.D. 25.1 20 355 19.9 5 N 20 20 MEAN 385 382 S.D. 28.6 - 20.5 6 N is MEAN 410 S.D. 24.4 15 401 23.9 7 N is MEAN 435 S.D. 24.5 15 424 26.8 20 211 11.7 20 263 13.8 20 313 17.1 20 351 20.5 20 378 21.6 15 393 21.1 15 414* 23.2 20 208 11.9 20 258 13.1 20 303 15.9 20 335* 18.5 20 359* 21.4 15 378* 19.2 15 403* 21.8 20 159 10.0 20 185 11.9 20 203 16.0 20 224 17.4 20 236 21.7 15 247 22.9 15 255 25.5 20 159 11.6 20 180 15.5 20 200 25.0 20 222 23.3 20 230 23.1 is 237 27.3 is 244 25.3 20 160 9.2 20 183 11.8 20 203 15.2 20 223 14.1 20 233 14.6 is 235 14.7 15 245 14.5 20 158 10.3 20 178 12.6 20 194 17.5 20 207* 16.6 20 215* 16.2 15 223* 21.0 15 229* 21.9 61 Co Table 6 Summary of Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL p PERFLUOROOCTANESULFONAMIDO ETliANOL (N-MEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------------- SEX: --------------------K-ALE ---------------4------ -----1-----------2---F-EMALE ---3------------4 ----- GROUP: 1 DOSE: 0 2 3 3 30 100 0 3 30 100 WEEK UNITS: PPM PPM PPM PPM PPM PPM PPM PPM --------------------------------------------------------------------------------------------------------------------- 8 N is MEAN 452 S.D. 26.9 9 N 15 MEAN 475 S.D. 28.1 10 N is MEAN 490 S.D. 29.7 11 N 15 MEAN 503 S.D. 33.0 12 N 15 MEAN 516 S.D. 34.1 13 N MEAN S.D. is 532 36.1 14 N 15 MEAN S47 S.D. 38.6 is 439 27.0 15 461 25.8 is 475 28.4 15 485 31.9 15 496 30.6 15 sio 30.0 is 521 27.6 15 428* 28.6 15 448* 28.4 15 460* 30.2 15 471* 31.9 is 480* 33.8 15 490* 30.1 is 491* 37.1 15 416* 22.9 15 430* 24.6 is 442* 23.7 15 453* 24.9 15 462* 24.8 is 471* 25.1 is 481* 25.3 15 259 26.8 15 267 26.3 15 275 29.2 15 281 31.3 is 287 33.2 is 293 36.2 is 300 35.9 15 24S 26.5 is 256 26.9 14 259 23.6 14 264 26.9 14 266 25.7 14 273 29.3 14 280 26.7 15 248 14.9 15 257 17.6 is 263 16.8 15 266 16.1 15 270 18.0 is 274 19.6 is 279 19.3 15 231* 22.5 15 238* 22.3 is 241* 22.6 is 245* 23.7 15 246* 24.3 15 250* 24.5 is 254* 24.5 62 c Table 7 Summary of Body Weight Change Data (g) 13-WEEK DIETARY,TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------------- SEX: --------------------M-ALE --------------------- -------------------F-EMALE -------------------- GROUP: 1 2 3 4 1 2 3 4 DOSE: 0 3 30 100 0 3 30 100 WEEK UNITS: PPM PPM PPM PPM PPM PPM PPK PPM --------------------------------------------------------------------------------------------------------------------- 1-2 N MEAN S.D. 2-3 N MEAN S.D. 3-4 N MEAN S.D. 4-S N MEAN S.D. 5-6 N MEAN S.D. 6-7 N MEAN S.D. 7-8 N MEAN S.D. 20 53 6.5 20 49 9.3 20 42 10.4 20 31 7.6 is 19 7.8 15 26 3.3 15 16 4.3 20 S2 5.4 20 51 5.6 20 41 S.5 20 27 3.6 15 17 3.9 is 23 4.4 15 15 4.9 20 53 4.6 20 49 5.0 20 39 S.2 20 26 4.9 15 17 4.7 15 21* 3.6 15 14 8.1 20 50 3.8 20 45* 4.6 20 32* 4.1 20 24* 6.1 15 14 4.9 is 24 6.2 15 13 3.8 20 26 6.7 20 19 8.5 20 21 9.3 20 11 7.6 is 7 6.8 15 9 5.3 15 4 S.1 20 21 11.7 20 20 13.3 20 22 15.9 20 8 7.0 15 12 5.6 is & 5.0 15 2 3.5 20 23 5.7 20 21 8.0 20 19 6.9 20 10 4.6 15 5 4.9 15 10 3.7 is 4 3.5 20 20 6.1 20 16 7.4 20 13* 7.1 20 8 4.9 is 7 4.4 is 6 3.8 15 2 4.6 63 c Table 7 Summary of Body Weight Change Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL p PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ----------- ---------------------------------------------------------------------------------------------------------- SEX: GROUP: --------------------M-ALE --------------------- -------------------F-EMALE 1 2 3 4 1 2 100 0 3 -------------------- 3 4 30 100 DOSE- 0 3 30 PPM PPM PPM PPM PPM PPM PPM W-E-E-K---U-N-IT-S-:- -----P-PM--------------------------------------------------------------------------------------------------- 8-9 9-10 10-11 11-12 12-13 13-14 1-14 N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN s.D. N MEAN S.D. 15 23 3.9 is 16 5.4 is 12 4.7 is 13 5.1 15 16 4.2 is 15 5.0 is 338 35.8 15 22 4.3 15 15 4.9 15 10 19.0 is 10 11.5 15 15 6.3 15 10 5.0 15 307* 27.0 15 20 3.7 15 12 5.7 is 11 4.1 15 9* 4.3 15 io* 10.6 15 1 29.5 15 282* 35.5 15 14* 10.3 15 12 7.5 15 11 3.1 15 9* 2.5 15 9* 4.0 15 10 3.0 15 270* 21.5 15 8 7.1 15 7 6.3 15 6 4.7 15 6 5.9 15 6 7.2 is 6 7.7 15 141 30.7 15 11 3.5 14 5 3.8 14 5 5.5 14 2 4.3 14 8 S.6 14 6 7.7 14 121* 17.8 15 9. 49 is 6 4.4 is 3 5.2 15 4 4.5 15 4 5.7 is 5 5.4 is 120* 14.9 15 7 3.1 is 3 2.5 is 3 2.8 is 2 4.8 15 4 2.8 is 3 4.1 15 96* 17.0 64 Table 8 Summary of Food Consumption Data (g) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- SEX: --------------------M-ALE --------------------- -------------------F-EMALE -------- ----------- GROUP: 1 2 3 4 1 2 3 4 DOSE: 0 3 30 100 0 3 30 100 WEEK UNITS: PPM PPM PPM PPM PPM PPM PPM PPM -------------------------------------------------------------------------------------------------------------------- 1 N 20 MEAN 169 S.D. 12.3 2 N 19 MEAN 176 S.D. 12.9 3 N 20 MEAN 181 S.D. 16.2 4 N 18 MEAN 186 S.D. 14.3 5 N 15 MEAN 177 S.D. 20.5 6 N is MEAN 191 S.D. 14.7 7 N 14 MEAN 191 S.D. 17.7 20 168 9.6 19 177 11.6 19 183 16.5 19 186 13.6 14 176 14.7 15 190 17.5 15 192 1S.4 20 171 13.8 19 178 11.3 20 186 14.6 20 191 15.7 14 172 13.4 15 190 22.8 15 184 23.2 20 168 8.6 20 176 9.1 19 173 8.0 20 176 10.8 15 166 9.4 15 192 9.4 15 182 8.5 19 126 13.5 19 130 15.6 19 138 16.7 17 135 17.7 14 129 16.1 12 138 18.8 12 144 15.1 16 127 16.5 16 124 24.3 16 13S 16.8 16 134 14.6 12 122 17.1 13 131 13.7 12 138 21.1 17 138 24.9 13 137 17.1 16 144 18.7 13 138 10.7 8 122 7.4 12 150 20.5 6 136 6.9 is 122 19.5 16 116 14.3 19 115* 13.3 20 121* 17.2 15 115 15.6 15 121* 14.1 14 117* 13.8 65 c Table 8 Summary of Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------------- SEX: GROUP: DOSE-. --------------------M-ALE --------------------- -------------------F-EMALE 1 2 3 4 1 2 0 3 30 100 0 3 -------------------- 3 4 30 100 WEEK UNITS: ppm PPM PPM PPM PPM PPM PPM PPM --------------------------------------------------------------------------------------------------------------------- 8 9 10 11 12 13 1-13 N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. N MEAN S.D. 13 185 10.9 15 190 20.8 14 187 24.3 14 191 29.7 13 185 14.6 13 187 20.7 9 2397 102.5 12 iss 12.6 is 189 16.6 15 180 27.5 is 183 17.5 is 181 19.4 15 178 12.3 10 2329 115.5 14 179 15.2 15 iso 19.6 15 176 18.8 14 176 22.1 is 175 19.4 is 160 46.1 13 2271 145.8 15 176 10.0 is l*7S 9.2 15 174 10.2 14 173 9.7 is 173 11.3 15 168* 8.9 13 2283 77.0 12 134 19.8 11 130 17.1 13 139 36.5 10 136 22.8 13 137 29.3 11 133 26.4 8 1769 182.0 12 136 12.0 12 131 13.4 13 128 19.2 12 124 11.9 13 129 15.2 11 120 17.2 4 1667 184.7 11 138 11.0 9 146 32.1 12 143 29.6 11 145 32.6 is 146 38.0 13 143 34.8 4 1683 24.1 14 120 15.6 14 118 15.7 14 115 13.9 13 112* 12.5 14 114* 13.3 14 119 26.4 10 1505* 173.4 66 Table 9 Summary of Test Material Consumption Data (mo/kg/day) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL IN-HEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- SEX: ---------------MALE --------------- --------------FEMALE -------------- GROUP: 2 3 4 2 3 4 DOSE: 3 30 100 3 30 100 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. 20 0.304 0.017 19 0.263 0.012 19 0.235 0.015 19 0.216 0.010 14 0.192 0.014 is 0.198 0.017 is 0.191 0.015 20 3.094 0.242 19 2.649 0.125 20 2.394 0.126 20 2.243 0.137 14 1.920 0.132 is 2.017 0.176 is 1.873 0.152 20 10.291 0.471 20 8.941 0.331 19 7.794 0.276 20 7.238 0.335 is 6.399 0.350 15 6.660 0.231 is 6.343 0.186 16 0.319 0.040 16 0.273 0.042 16 0.269 0.027 16 0.252 0.015 12 0.226 0.012 13 0.236 0.030 12 0.247 0.051 17 3.395 0.601 13 3.028 0.512 16 2.861 0.393 13 2.570 0.170 8 2.262 0.188 12 2.662 0.337 6 2.348 0.140 18 10.378 1.400 16 8.867 1.027 19 8.142 0.679 20 8.219 0.997 15 7.464 0.685 15 7.675 0.703 14 7.325 0.627 67 Table 9 Summary of Test Material consumption Data (mg/kg/day) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ SFX: ---------------MALE --------------- --------------FEMALE -------------- GROUP: 2 3 4 2 3 4 DOSE: 3 30 100 3 30 100 WEEK UNITS: PPM PPH PPM PPM PPM PPM ------------------------------------------------------------------------------------------------------------------ 8 N MEAN S.D. 12 0.178 0.010 14 1.764 0.097 15 5.946 0.210 12 0.232 0.023 11 2.335 0.212 14 7.243 0.492 9 N MEAN S.D. 15 0.173 0.014 15 1.694 0.116 15 5.749 0.216 12 0.218 0.016 9 2.394 0.686 14 6.995 0.545 10 N MEAN S.D. 15 0.160 0.023 15 1.618 0.112 is 5.554 0.211 13 0.209 0.021 12 2.310 0.545 14 6.721 0.481 11 N MEAN S.D. 15 0.160 0.014 14 1.582 0.138 14 5.369 0.281 12 0.197 0.016 11 2.274 0.516 13 6.529 0.456 12 N MEAN S.D. 13 N MEAN S.D. 15 0.155 0.015 15 0.148 0.012 15 1.544 0.122 15 1.390 0.387 15 5.301 0.248 is 5.054 0.196 13 0.206 0.022 11 0.184 0.020 15 2.319 0.680 13 2.204 0.601 14 6.494 0.484 14 6.700 1.173 1-13 MEAN 0.203 2.041 6.844 0.240 2.588 7.702 68 13-WEEK DIETARY Table 10 Summary of Clinical Hematology Data males Week 5 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULPONAMIDO ETHANOL (N-MEFOSE. T-6314) IN RATS DOSE ppm MEFOS ------ RPC X10 /,uL -------- HGB G/DL -------- HCT -------- mcv FL -------- MCH PG -------- MCHC PLT X10'/mL -------- -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 8.18 .424 10 8.14 .427 10 8.24 .477 10 7.99 .303 10 16.2 .66 10 16.4 .47 10 16.3 .38 10 15.9 .71 10 47.0 2.04 10 47.5 1.70 10 47.1 1.64 10 46.0 1.71 10 57.4 1.97 10 50.4 1.77 10 57.2 1.93 10 57.6 1.86 10 19.8 .42 10 20.1 .73 10 19.8 .81 10 19.9 .76 10 34.5 .61 10 34.4 .51 10 34.7 .52 10 34.5 .45 10 1173 61.5 10 1151 136.0 10 1038 96.9 10 1081 112.7 10 69 13-WEEK DIETARY Table 10 Summary of Clinical Hematology Data males Week 5 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS DOSE PPM MEFOS ViIBc xio /PL -------- N-SEG X10'/mL -------- LYMPH X10'/,.L -------- MONO X10'/;,L EOSIN XIO'/jAL -------- -------- BASO 3 XIO /,uL -------- N-SEG% -------- LYMPH% -------- MONO% -------- EOSIN ------ 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 9.1 1.96 10 9.1 1.74 10 10.0 2.48 10 10.7 3.51 10 .6 7.9 .14 1.86 10 10 .6 8.0 .10 1.64 10 10 .5 9.0 .15 2.27 10 10 .9 9.0 .40 3.17 10 10 .4 .1 .0 7 87 5 .15 .03 .00 2.1 2.2 1.3 10 10 10 10 10 10 .4 .1 .0 6 88 5 .20 .05 .00 1.6 3.5 1.9 10 10 10 10 10 10 .4 .1 .0 5 90 4 .13 .06 .04 1.4 1.8 1.1 10 10 10 10 10 10 .6 .1 .0 9 84 6 .20 .03 .05 3.6 4.2 1.3 10 10 10 10 10 10 70 13-WEEK DIETARY Table 10 Summary of Clinical Hematology Data Females Week 5 TOXICITY STUDY WITH N-METHYB PERFBUOROOCTANESULFONAMIDO ETHANOB (N-MEFOSE, T-6314) IN RATS DOSE ppm HEFOS ------ RBC Xlol/,UL. -------- HGB G/DL -------- HCT t -------- mcv FL -------- MCH PG -------- MCHC PIT t xiol/,Ul, -------- -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 7.70 .214 10 8.03 .488 10 7.98 .357 10 7.89 .326 10 15.7 .51 10 16.0 .61 10 16.0 .55 10 15.5 .54 10 45.4 1.31 10 46.1 2.08 10 59.1 1.45 10 57.6 1.95 10 45.8 1.91 10 57.4 1.48 10 44.7 1.62 10 - 56.6 1.28 10 20.4 .68 10 20.0 .76 10 20.0 .56 10 19.6 .34 10 34.5 .43 10 34.7 .64 10 35.0 .37 10 34.7 .71 10 1114 104.4 10 1178 82.3 10 1123 121.8 10 1058 217.2 10 71 ZL OT OT OT ol OT C, E' E'Z G't L'E 0 1 s Le L OT OT OT ol OT OT EO' to, LZ' 96'1 et* 60'Z ol t' P*9 S* E'L OT 0' 0 OT E* T ol ol OT B'T V*S P't p L8 a OT OT ol OT OT 00, so* 6T* tz*z 6T* ol I' E' V'9 S* ol zt*z E'L OT OT OT OT OT 0* L* 9*T Olt Z'E 0 1 p 88 L ol OT OT OT OT 00, LO' ZT* ozlz OZ' 0* T' Z' S,9 S* OT TZ*Z P*L 01 OT ol OT OT E* E* S*T SIV T*E OT ol OT OT OT OT 0 T s Le L 00, so* ST' ZE*T 6Z' 65'T ol E* il'S t' E*9 -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- sosvo %HISOH %ONOH %HdHAq %E)2[S-N 'Iyf/,OTX 'Irf/,OTX 'llf/,OTX rlyf/OTX osvia Hisos ONOW lidwxq rlrf/,OTX q?l/,OTX ozs-u -Nam T*PTE9-.L HE SZZ-6ZE9 93u2AOD SIVU MI (PTE9-.L *ZSOASN-N) qoNVHla oaiuvmoarlnsaNVJZWHOnqdH3d QAHIHN-N HIIM Aanis AXIDIXOI AHV13ia MRAM-ET s )loam selemea Blva ABOTOIVMAH TROTUTTD OT alqel JO AleununS 13-WEEK DIETARY Table 11 Summary of Clinical Hematology Data Males Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm NEFOS ------ 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N RPC X10 /,uL -------- 8.56 .463 10 8.42 .657 10 8.68 .535 10 0.25 .273 10 HGB G/DL -------- HCT t -------- mcv FL -------- 15.3 .71 10 15.3 .67 10 15.2 .56 10 14.6 .71 10 47.0 2.00 10 46.7 2.02 10 46.8 1.99 10 44.3 1.92 10 54.9 1.43 10 55.6 2.31 10 54.0 1.79 10 53.7 1.39 10 MCH PG -------- MCHC PLT t X10'/,wL -------- -------- 17.8 .40 10 18.2 .77 10 17.6 .82 10 17.7 .56 10 32.5 .40 10 32.7 .32 10 32.7 .71 10 33.0 .30 10 1122 119.5 10 1060 73.0 10 1000 140.3 10 1011 130.4 10 73 13-WEEK DIETARY Table 11 Summary of Clinical Hematology Data Males Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS DOSE ppm MEFOS ------ WBC XiolwL -------- N-SEG XIO'/,uL -------- LYMPH X10'/,uL -------- MON? X10 ImL -------- EOSIN X10'/,wL -------- BASO X10'/,uL -------- N-SEG% -------- LYMPH% -------- MONO% -------- EOSIP 0 MEAN 6.9 .9 5.4 .5 .1 .0 13 78 7 S.D. N .88 .28 .85 .14 .03 .00 4.0 4.3 1.9 10 10 10 10 10 10 10 10 10 3 MEAN S.D. N 6.7 1.48 10 1.0 .23 10 5.1 1.35 10 .4 .1 .0 is 76 7 .18 .05 .00 3.4 5.6 2.8 10 10 10 10 10 10 30 MEAN S.D. N 7.7 2.68 10 .9 6.2 .24 2.57 10 10 .4 .1 .0 13 80 5 .14 .05 .00 4.7 5.6 2.1 10 10 10 10 10 10 100 MEAN S.D. N 7.2 2.63 10 1.1 .35 10 5.6 2.13 10 .4 .1 .0 16 77 5 .23 .05 .03 2.8 2.9 1.7 10 10 10 10 10 10 74 13-WEEK DIETARY Table 11 Summary of Clinical Hematology Data Females Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MEPOS ------ 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N RPC X10 /,uL -------- 7.76 .178 10 8.07 .330 9 8.09 .343 10 7.69 .289 10 HGB G/DL -------- HCT % -------- mcv PL -------- 14.8 .45 10 15.1 .75 9 15.1 .56 10 14.2 .67 10 45.1 .95 10 46.1 1.97 9 46.2 1.77 10 43.1 1.91 10 58.1 1.13 10 57.1 1.70 9 57.2 1.57 10 56.1 1.26 10 MCH PG -------- MCHC PLT t Xlo'/,wL -------- -------- 19.0 .54 10 18.7 .63 9 18.7 .52 10 18.5 .49 10 32.7 .40 10 32.7 .49 9 32.7 .22 10 33.0 .37 10 1016 103.3 10 1073 108.7 9 980 97.8 10 1056 110.7 10 75 13-WEEK DIETARY Table 11 summary of Clinical Hematology Data Females Week 14 TOXICITY STUDY WITH N-METHYI. PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS DOSE PPM MEFOS iwpc X10 /;4L -------- N-SEG XIO'/;,L -------- LYMPH X10'/,uL -------- MON? X10 /jwL EOSIN Xlol/;4L -------- -------- BASO XlO'ImL -------- N-SEG% -------- LYMPH% -------- MONO% -------- EOSIT ----- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 4.0 .95 10 4.7 1.27 9 5.7 1.08 10 4.7 2.03 10 .8 .47 10 .7 .18 9 1.0 .49 10 .6 .28 10 3.0 .69 10 3.7 1.27 9 4.4 1.10 10 3.8 1.89 10 .2 .1 .0 .12 .03 .00 10 10 10 .3 .1 .0 .05 .00 .00 9 9 9 .3 .1 .0 .10 .00 .03 10 10 10 .2 .1 .0 .09 .04 .00 10 10 10 19 8.5 10 15 5.3 9 17 7.6 10 14 7.0 10 74 8.8 10 77 6.4 9 76 8.0 10 80 8.4 10 5 2.9 10 6 1.3 9 5 1.7 10 4 1.8 10 76 13-WEEK DIETARY Table 12 Summary of Clinical Chemistry Data Males Week 5 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAHIDO ETHANOL (N-MEFOSE. T-6314) IN RATS DOSE ppm MEFOS ------ 0 MEAN S.D. N 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 -------- TRIG MG/D ------ -. 103 11 6 6.9 4.7 2.2 .2 59 5.7 1.9 .07 .39 .23 .26 .00 15.4 10 10 10 10 10 10 10 10 3 MEAN 114 11 ..605 6..923 4..719 2..114 ..200 5182.1 S.D. N 14.1 1.4 10 10 10 10 10 10 10 10 30 MEAN S.D. N 106 15.6 10 12 1.7 10 .6 6.6 4.7 .03 .22 .14 10 10 10 2.0 * .2 .19 .03 10 10 100 MEAN S.D. N 106 17.5 10 13 .6 6.7 4.7 2.0 * .2 1.6 .07 .29 .21 .18 .00 10 10 10 10 10 10 54 10.6 10 44 14.1 10 77 13-WEEK DIETARY Table 12 Summary of Clinical Chemistry Data Males Week 5 TOXICITY STUDY WITH N-HETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm HEFOS ------ 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 KHOL/L -------- 0 MEAN S.D. N 103 18.9 10 32 3.6 10 0 .5 10 10.9 .47 10 9.5 .61 10 147 1.3 10 6.2 .39 10 105 2.3 10 3 MEAN S.D. N 96 16.1 10 33 4.6 10 0 .5 10 10.8 .19 10 9.8 .71 10 147 1.6 10 6.2 .42 10 105 1.6 10 30 MEAN S.D. N 101 18.3 10 32 3.8 10 0 .7 10 10.5 .30 10 9.0 .78 10 148 1.2 10 6.1 .52 10 106 1.2 10 100 MEAN S.D. N 97 12.2 10 40 4.5 10 0 .3 10 10.6 .42 10 9.0 1.02 10 147 2.S 10 6.1 .46 10 105 2.5 10 78 13-WEEK DIETARY Table 12 Summary of Clinical Chemistry Data Females Week 5 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MeFos ---- - 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 -------- TRIG MG/D ------ 0 MEAN 108 12 .7 7.4 5.3 2.1 .2 68 .24 .05 11.9 S.D. 9.2 1.2 .03 .31 .21 10 10 10 10 10 10 N 10 10 3 MEAN 100 12 .7 7.4 5.3 2.1 .2 69 .24 .00 12.0 S.D. 8.9 2.1 .04 1.047 .1039 10 10 10 N 10 10 10 30 MEAN S.D. N 100 MEAN S.D. N 108 10.0 10 95 12.0 10 12 1.5 10 14 1.5 10 .7 7.3 5.3 1.9 .03 .34 .29 .19 10 10 10 10 .6 7.2 5.3 1.9 .07 .41 .28 .23 10 10 10 10 .2 .03 10 .2 .00 10 64 9.7 10 53 21.7 10 79 13-WEEK DIETARY Table 12 Summary of Clinical Chemistry Data Females Week 5 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS DOSE ppm--M-E-FO-S- AST/SGOT IU/L -------- ALT/SGPT IU/L -------- GGT IU/L -------- CA HG/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 99 15.3 10 93 7.5 10 93 14.0 10 93 16.0 10 28 4.8 10 27 4.9 10 28 3.5 10 30 5.8 10 0 .5 10 0 .7 10 1 1.1 10 1 .8 10 10.8 .52 10 10.7 .40 10 10.8 .38 10 10.6 .32 10 7.9 .65 10 8.2 .77 10 7.7 1.07 10 8.2 1.06 10 146 1.3 10 147 1.6 10 146 1.9 10 147 2.0 10 6.0 .31 10 5.8 .39 10 6.0 .60 10 5.8 .52 10 105 1.2 10 105 1.4 10 104 1.9 10 106 2.6 10 80 13-WEEK DIETARY Table 12 summary of Clinical Chemistry Data Males Week 5 TOXICITY STUDY WITH N-METHYL, PERFIUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS DOSE ppm HEFOS ------ PCOAO IU/G -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 12 3.6 5 13 2.1 5 4.3 5 9 1.9 5 81 13-WEEK DIETARY Table 12 Summary of Clinical Chemistry Data Females Week 5 TOXICITY STUDY WITH N-METHYL PERFGUOROOCTANESULFONAMIDO ETHANOL; (N-MEFOSE, T-6314) IN RHTS DOSE ppm NEFOS ------ PCOAO IU/G -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 7 2.5 5 5 2.9 5 7 3.3 5 11 2.7 5 82 13-WEEK DIETARY Table 13 Summary of Clinical Chemistry Data Males week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS DOSE ppm MEFOS ------ 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 -------- TRI MG/ ----- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 117 13 .8 7.2 4.7 2.5 .2 8.2 2.1 .05 .34 .24 .21 .05 10 10 10 10 10 10 10 119 12 .7 7.0 4.7 2.3 .1 7.9 2.1 .05 .34 .20 .21 .05 10 10 10 10 10 10 10 113 14 .8 6.8 4.6 2.1 * .2 9.7 2.0 .07 .57 .35 .30 .05 10 10 10 10 10 10 10 128 11.3 10 15 1.4 10 .7 7.2 5.2 2.0 * .2 .05 .39 .29 .26 .05 10 10 10 10 10 69 15.2 10 57 17.4 10 49 15.1 10 26 12.1 10 83 13-WEEK DIETARY Table 13 Summary of Clinical Chemistry Data males Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULPONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MEFOS ------ 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 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 89 18.4 10 86 9.7 10 91 16.7 10 91 14.3 10 38 5.1 10 41 6.4 10 38 7.0 10 60 21.6 10 2 1.3 10 2 .7 10 2 1.3 10 2 .7 10 10.7 .49 10 10.6 .26 10 10.2 .40 10 10.4 .30 10 6.6 .65 10 6.5 .29 10 6.5 .58 10 6.9 .39 10 150 2.5 10 150 2.2 10 149 2.2 10 150 2.6 10 6.1 .31 10 6.1 .28 10 6.2 .36 10 6.4 .48 10 109 3.4 10 109 3.1 10 108 3.0 10 109 3.8 10 84 13-WEEK DIETARY Table 13 Summary of Clinical Chemistry Data Females Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ptxn MEFOS ------ GIIU 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 -------- TRIG MG/D ------ 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 119 12 .8 7.9 5.8 2.1 10.6 2.0 .07 .50 .41 .31 10 10 10 10 10 10 121 13 .8 7.7 5.6 2.1 8.0 2.1 .07 .53 .42 .24 9 9 9 9 9 9 110 14 .8 8.0 5.8 2.2 7.0 l.B .07 .42 .24 .28 10 10 10 10 10 10 110 9.2 10 17 2.1 10 .8 8.2 6.0 2.1 .06 .50 .36 .23 10 10 10 10 .2 .03 10 .2 .05 9 .2 .03 10 .2 .00 10 73 12.6 10 69 9.4 9 70 9.9 10 51 17.7 10 85 13-WEEK DIETARY Table 13 Summary of Clinical Chemistry Data Females week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MEFOS ------ AST/SG(Yr 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 3 MEAN S.D. N 30 MEAN S.D. N 84 10.1 10 107 32.6 9 128 126.7 10 34 5.7 10 43 20.7 9 64 105.5 10 2 1.2 10 3 1.2 9 3 1.7 10 11.0 .32 10 10.8 .41 9 11.0 .26 10 4.8 .54 10 5.1 .93 9 5.6 .74 10 iso 1.9 10 150 3.6 9 151 2.6 10 5.7 .29 10 6.1 .70 9 6.2 .50 10 ill 2.7 10 ill 3.3 9 109 2.6 10 100 MEAN S.D. N 80 9.3 10 36 6.1 10 3 1.0 10 10.9 .27 10 5.4 .90 10 150 2.7 10 5.7 .43 10 109 3.0 10 86 Table 13 Summary of Clinical Chemistry Data 13-WEEK DIETARY Males Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm MEFOS ------ PCOAO IU/G -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 100 MEAN S.D. N 10 2.3 15 9 2.7 15 9 2.0 15 15 8.1 15 87 13-WEEK DIETARY Table 13 Summary of Clinical Chemistry Data Females Week 14 TOXICITY STUDY WITH N-METHYL, PERFtUOROOCTANESUtFONAMIDO ETHANOU (N-MEFOSE, T-6314) IN RATS DOSE ppm MEFOS ------ PCOAO IU/G -------- 0 MEAN S.D. N 3 MEAN S.D. N 30 MEAN S.D. N 7 2.5 15 7 2.9 14 9 2.8 is 100 MEAN S.D. N 20 6.7 15 88 13-WEEK DIETARY Table 14 Summary of Clinical Urinalysis Data Males Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS DOSE ppm MEFOS ------ 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 9.9 7.15 10 10.6 5.52 10 13.8 13.29 10 21.0 16.52 10 1.036 .0179 10 1.026 .0093 10 1.026 .0162 10 1.024 .0148 10 6.9 .32 10 6.9 .39 10 6.8 .42 10 6.6 .24 10 89 13-WEEK DIETARY Table 14 Summary of Clinical Urinalysis Data Females Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULPONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS DOSE ppm NEFOS ------ U VOL ML SP GR U PH -------- -------- -------- 0 MEAN S.D. N 17.0 14.13 10 1.016 .0112 10 6.7 .26 10 3 MEAN S.D. N 11.4 10.11 9 1.020 .0102 9 6.8 .44 9 30 MEAN S.D. N 100 MEAN S.D. N 16.7 14.62 10 15.7 12.05 10 1.016 .0084 10 1.019 .0113 10 6.8 .26 10 6.6 .21 10 90 TABLE 1S Summary of Organ weight Data Week 5 Sacrifice 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL:GROUP=ALL:WEEKS=ALL DEATH=1;SUBSET=T LIVER -- --- -- --- --- --- -- ---- --- ---- --- TERMINAL ORGAN ORGAN-TO- SEX DOSE BODY WT WEIGHT BODY Wr GROUP (g) (g) (t) --------------------------------------------------- m 1 - -- --- --- -- --- --- --- ---- - NUMBER IN GROUP: 5 5 5 MEAN: STANDARD DEV: 335.2 45.6 10.7554 2.0653 3.1879 0.229S --- -- ----- --- --- ---- ---- TERMINAL ORGAN ORGAN SEX DOSE BODY WT WEIGHT BODY GROUP (g) (g) (% ----------------------------------------------- F 1 --- ---- ---- --- --- ---- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 5 5 5 198.2 6.3023 3.1 13.8 0.5865 0.1 --------------------------------------------------- m 2 -- -- --- -- --- --- --- --- --- - NUMBER IN GROUP: MEAN: STANDARD DEV: s 340.9 18.5 s 10.9504 0.9661 5 3.2077 0.1326 ----------------------------------------------- F 2 ---- --- ---- --- ---- ---- - NUMBER IN GROUP: MEAN: 5 5 5 216.0 7.2592 3.3 STANDARD DEV: 15.1 0.4951 0.0 --------------------------------------------------- m 3 -- -- --- -- --- -- ---- --- --- - NUMBER IN GROUP: MEAN: STANDARD DEV: 5 347.4 26.9 5 13.1250 1.4559 5 3.7790 0.3232 ----------------------------------------------- F 3 - --- --- ---- --- ---- --- -- NUMBER IN GROUP: 5 5 5 1 MEAN: 214.4 7.6187 3.5 STANDARD DEV: 12.S 0.7637 0.2 --------------------------------------------------- ----------------------------------------------- 91 TABLE 15 Summary of organ Weight Data Week 5 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=1;SUBSET=T LIVER -- -- ---- --- -- ---- --- -- ---- ---- -- TERMINAL ORGAN ORGAN-TO- SEX DOSE BODY Wr WEIGHT BODY wr GROUP (g) (g) (%) --------------------------------------------------- m 4 - - - - - - - - - - - - - - - - - - - - -- - - - TERMINAL ORGAN ORGAN-TO SEX DOSE BODY WT WEIGHT BODY WT GROUP (g) (g) (%) -------------------------------------------------- F 4 - -- ---- -- -- ---- -- ---- --- - NUMBER IN GROUP: 5 5 5 MEAN: 311.6 14.7069 4.7214 STANDARD DEV: 22.0 1.1550 0.1919 --------------------------------------------------- -- -- ---- --- --- ---- ------ - NUMBER IN GROUP: 5 5 5 MEAN: STANDARD DEV: 188.1 9.5 8.4256 0.4870 4.4836 0.2373 -------------------------------------------------- 92 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULi'ONAMIDO ETHANOL IN-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ADRENAL - ---- -- --- - --- ---- --- ---- ---- --- --- --- ---- -- ---- --- ------ TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-74 SEX DOSE BODY wr WEIGHT BODY wr BRAIN WT SEX DOSE BODY wr WEIGHT BODY V GROUP (g) (g) 1%) RATIO GROUP (o) (g) (%) ---------------------------------------------------------------------------------------------------------------- m 1 --- --- -- --- - ---- --- ---- --- ---- - F 1 - --- --- --- --- --- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 505.3 35.7 is 0.0562 0.0092 is 0.0112 0.0020 is 0.0258 0.0044 NUMBER IN GROUP: MEAN: STANDARD DEV: is 270.5 33.3 is 0.0709 0.0123 15 0.026 0.005 ---------------------------------------------------------------------------------------------------------------- m 2 --- --- --- -- - ---- --- --- --- ---- -- F 2 - -- ---- --- --- --- --- ----- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 482.1 27.7 is 0.0575 0.0083 15 0.0120 0.0020 15 0.0267 0.0038 NUMBER IN GROUP: MEAN: STANDARD DEV: 14 251.3 24.0 14 0.0675 0.0114 14 0.026 0.003 ---------------------------------------------------------------------------------------------------------------- m 3 ---- -- --- -- - ---- -- ---- --- ---- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 460.1* 31.8 15 O.OS51 0.0088 is 0.0121 0.0022 15 0.0254 0.0040 F 3 --- -7 - --- --- --- ---- ---- - NUMBER IN GROUP: is 15 15 MEAN: 253.4 0.0700 0.027 STANDARD DEV: 17.8 0.0089 0.004 ---------------------------------------------------------------------------------------------------------------- 93 TABLE 16 summary of organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL ADRENAL --- --- -- --- --- ---- --- --- --- ----- --- -- --- ---- ---- --- ----- 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 fg) (g) (%) RATIO CROUP (g) (g) (%) --------------------------------------------------------------------------------------------------------------- m 4 F 4 -- -- --- -- -- ----- --- --- -- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV: is 445.8* 24.4 15 0.0560 0.0073 15 0.0126 0.0014 15 0.0259 0.0039 --- --- --- --- ---- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: is 229.8* 22.7 is 0.0672 0.0113 15 0.02 0.00 --------------------------------------------------------------------------------------------------------------- 94 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-63141 IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T:SUBSET=ALL BRAIN - --- -- --- -- ---- ---- -- --- ---- ---- -- ---- --- ---- ---- --- ---- SF-X DOSE TERMINAL BODY WT ORGAN WEIGHT ORGAN-TOBODY wr ORGAN-TOBRAIN Wr SEX DOSE TERMINAL BODY Wr ORGAN WEIGHT ORGANBODY ----G-R-OU-P----------------(-g-)-------(-g-)---------(-%-)-------R-AT-I-O------------G-RO-U-P---------------(-g-)--------(-g-)---------(-t-)--- m 1 - -- ---- --- ----- ---- -- --- ---- --- p - -1- - - - - - - - --- - - - - - - - - - - - NUMBER IN GROUP: MEANSTANDARD DEV: is 505.3 35.7 15 2.1771 0.0642 15 0.4326 0.0283 15 1.0000 0.0000 NUMBER IN GROUP: MEAN: STANDARD DEV: is 270.5 33.3 is 1.9434 0.1049 15 0.7, 0.07 -------------------------------------------------------------------------------------------------------------- m 2 - -- ---- --- ----- --- --- --- ---- --- F 2 -- ---- --- ---- -- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV, 15 482.1 27.7 15 2.1519 0.0910 15 0.4480 0.0354 is 1.0000 0.0000 NUMBER IN GROUP: MEAN: STANDARD DEV: 14 251.3 24.0 14 1.9678 0.0694 14 0.7 0.0 -------------------------------------------------------------------------------------------------------------- m 3 - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - p 3 - --- ---- --- ---- -- ----- - NUMBER IN GROUP: MEAN: STANDARD DEV: 15 460.1* 31.8 15 2.1680 0.0768 is 0.4731* 0.0323 15 1.0000 0.0000 NUMBER IN GROUP: MEAN: STANDARD DEV: is 253.4 17.8 15 2.0183 0.0826 is 0.7 0.0 -------------------------------------------------------------------------------------------------------------- 95 TABLE 16 sumnary of organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL BRAIN - -- --- -- --- -- ---- --- ---- --- --- -- -- ---- ----- --- --- ---- --- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN Wr SEX DOSE BODY Wr WEIGHT BODY ----G-RO-U-P---------------(-g--)-------(-g-)---------(-t-)-------RA-T-I-O------------G-RO-U-P---------------(-o-)-------(-0--)---------(-t-)--- m 4 p 4 - --- -- --- -- -- ---- ---- --- ---- -- - NUMBER IN GROUP: MEAN: STANDARD DEV: 15 44S.8* 24.4 is 2.1678 0.0884 15 0.4878* 0.0360 is 1.0000 0.0000 --- ---- ---- --- -- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 229.8* 22.7 15 2.0372* 0.1113 15 0.89 0.05 --------------------------------------------------------------------------------------------------------------- 96 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL KIDNEY -- ---- --- -- -- ---- --- ---- --- --- -- --- ---- --- ---- --- ---- --- SEX DOSE TERMINAL BODY Wr ORGAN WEIGHT ORGAN-TOBODY Wr ORGAN-TOBRAIN Wr SEX DOSE TERMINAL BODY WT ORGAN WEIGHT ORGANBODY ----G-RO-U-P---------------(-g--)-------(-g-)---------(-%-)-------RA-T-I-O------------G-RO-U-P---------------(-0-)--------(-g-)---------(%-)---- m 1 -- -- --- -- -- ---- --- --- --- --- ---- p 1 - -- ----- --- ---- --- --- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 505.3 35.7 is 3.8199 0.4337 is 0.7549 0.0520 15 1.7543 0.1893 NUMBER IN GROUP: MEAN: STANDARD DEV: is 270.5 33.3 15 2.1241 0.2283 15 0.78 0.07 --------------------------------------------------------------------------------------------------------------- m 2 -- -- --- --- -- --- --- --- --- --- ---- F 2 ---- ---- --- --- ---- --- --- NUMBER IN GROUP: MEAN: STANDARD DEV: is 482.1 27.7 15 3.7300 0.3858 15 0.7744 0.0762 15 1.7358 0.1924 NUMBER IN GROUP: MEAN: STANDARD DEV: 14 251.3 24.0 14 2.1259 0.2488 14 0.84 0.06 --------------------------------------------------------------------------------------------------------------- m 3 -- --- -- --- - --- ---- -- ---- --- -- -- NUMBER IN GROUP: is is 15 is MEAN: STANDARD DEV: 460.1* 31.8 3.8085 0.3063 0.8308* 0.0819 1.7609 0.1761 F 3 --- ---- ---- --- -- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: is 253.4 17.8 is 2.2559 0.1509 15 0.89 0.07 --------------------------------------------------------------------------------------------------------------- 97 TABLE 16 sumznary of organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL KIDNEY - -- ---- -- -- --- ---- ---- -- ---- ---- -- --- --- ---- --- ---- ---- - 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 (g) fg) (t) RATIO GROUP (g) (g) (t) --------------------------------------------------------------------------------------------------------------- m 4 F 4 -- --- -- --- -- ---- ---- --- ---- -- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 445.8* 24.4 is 4.1850* 0.4lS5 is 0.9389* 0.0787 is 1.9357* 0.232S - -- --- ---- --- --- ----- --- NUMBER IN GROUP: is 15 is MEAN: STANDARD DEV: 229.8* 22.7 2.1993 0.2606 0.95 0.07 --------------------------------------------------------------------------------------------------------------- 98 TABLE 16 Summary of organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LIVER --- --- --- - --- --- ---- --- ---- ---- - - ---- --- ---- -- ---- ---- -- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN Wr SEX DOSE BODY WT WEIGHT BODY GROUP (g) lg) (%) RATIO GROUP (g) (g) it) -------------------------------------------------------------------------------------------------------------- m 1 -- -- --- --- - ----- -- --- ---- ---- -- p 1 --- --- --- --- ---- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 505.3 35.7 is 14.5017 1.6903 is 2.8663 0.2214 is 6.6577 0.7163 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 270.5 33.3 15 8.0512 1.3405 15 2.97 0.34 --------------------------------------------------------------------------------------------------------------- m 2 - --- -- --- -- -- ---- --- -- ----- -- -- F 2 ---- --- --- ---- --- --- ---- NUMBER IN GROUP: MEAN: 15 482.1 15 14.3465 15 2.9903 is 6.6774 NUMBER IN GROUP: MEAN: 14 251.3 14 7.8673 14 3.12 STANDARD DEV: 27.7 1.3494 0.2896 0.6795 STANDARD DEV: 24.0 0.9141 0.20 --------------------------------------------------------------------------------------------------------------- m 3 -- -- --- -- -- --- ---- --- -- ---- ---- F 3 -- --- -- ---- ---- -- --- ---- NUMBER IN GROUP: 15 15 15 15 NUMBER IN GROUP: 15 is 15 MEAN: STANDARD DEV: 460.1* 31.8 15.9014 1.5170 3.4572* 0.2312 7.3423* 0.7472 MEAN: STANDARD DEV: 253.4 17.8 9.2512* 0.7652 3.66 0.32 --------------------------------------------------------------------------------------------------------------- 99 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYB ETHANOL (N-MEPOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL:GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL LIVER --- --- --- -- --- ---- -- ---- --- ---- - -- --- --- ---- ---- -- ----- - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY wr WEIGNT BODY Wr BRAIN WT SEX DOSE BODY Wr WEIGHT BODY GROUP (g) (g) (%) RATIO GROUP (g) (g) (t) --------------------------------------------------------------------------------------------------------------- m 4 F 4 - --- -- --- -- ---- --- --- --- --- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 445.8* 24.4 15 24.5652* 2.7276 15 5.5083* 0.4975 15 11.3342* 1.1828 -- --- --- --- ---- --- ------ NUMBER IN GROUP: 15 15 15 MEAN: 229.8* 12.2021* 5.33 STANDARD DEV: 22.7 1.4877 0.62 --------------------------------------------------------------------------------------------------------------- 100 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL JN-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SF-X=ALL;GROUP=ALL;WEEKS=ALL DFATH=T;SUBSET=ALL OVARY -- -- --- --- -- --- --- --- ---- --- --- - -- ---- --- ---- --- --- ----- - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-T SEX DOSE BODY wr WEIGHT BODY wr BRAIN WT SEX DOSE BODY wr WEIGHT BODY W GROUP (g) (g) (%) RATIO GROUP (g) (g) (%) ---------------------------------------------------------------------------------------------------------------- m 1 -- --- -- --- -- ---- --- --- --- ---- -- F 1 --- --- ---- ---- --- --- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 505.3 35.7 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 270.5 33.3 is 0.1280 0.0205 is 0.048 0.009 ---------------------------------------------------------------------------------------------------------------- m 2 --- -- --- --- --- --- --- --- --- ---- - F 2 --- ---- --- ---- --- ---- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 482.1 27.7 NUMBER IN GROUP: MEAN: STANDARD DEV: 14 251.3 24.0 14 0.1225 0.0227 14 0.048 0.008 ---------------------------------------------------------------------------------------------------------------- m 3 --- --- --- -- --- -- ---- --- --- --- -- F 3 --- ---- --- ---- --- --- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 460.1* 31.8 NUMBER IN GROUP: MEAN: STANDARD DEV: is 253.4 17.8 is 0.1221 0.0215 15 0.048 0.010 ---------------------------------------------------------------------------------------------------------------- 101 TABLE 16 summary of organ weight Data Week 14 Sacrifice 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL OVARY -- ---- --- -- -- ---- --- ---- -- ----- - --- ---- ---- -- ----- ---- --- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY WT WEIJGHT BODY Wr BRAIN WT SEX DOSE BODY Wr WEIGHT BODY ----G-RO-U-P---------------(-g--)-------(-g-)---------(-%-)-------RA-T-I-O------------G-RO-U-P---------------(-g-)-------(-g--)---------(%-)----- m 4 F 4 - -- ---- -- -- -- ---- --- ---- ---- -- - NUMBER IN GROUP: MEAN: STANDARD DEV: 15 445.8* 24.4 - --- ---- --- --- --- ------ - NUMBER IN GROUP: MEAN: STANDARD DEV: 15 229.8* 22.7 15 0.1206 0.0239 is 0.052 0.009 ---------------------------------------------------------------------------------------------------------------- 102 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN-MEPOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL SPLEEN -- --- -- ---- ----- --- ---- -- ---- --- -- ---- ---- --- ---- ---- ---- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-74 SEX DOSE BODY WT WEIGHT BODY WT BRAIN WT SEX DOSE BODY WT WEIGHT BODY VF GROUP IV) (g) (t) RATIO GROUP lg) (g) (%) ---------------------------------------------------------------------------------------------------------------- m 1 --- ---- -- - --- ----- -- --- --- --- -- p 1 --- --- ---- ---- -- ----- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 505.3 35.7 is 0.8041 0.0904 15 0.1592 0.0149 is 0.3691 0.0371 NUMBER IN GROUP: MEAN: STANDARD DEV: is 270.5 33.3 is 0.5153 0.1324 15 0.190 0.040 ---------------------------------------------------------------------------------------------------------------- m 2 --- ---- -- - ---- ---- -- ---- --- --- - F 2 - - - - - - - - - - - - - - - - - - - - - -- - NUMBER IN GROUP: MEAN: STANDARD DEV: 15 482.1 27.7 15 0.7666 0.1431 15 0.1597 0.0332 15 0.3558 0.0604 NUMBER IN GROUP: MEAN: STANDARD DEV: 14 251.3 24.0 14 0.5235 0.0643 14 0.209 0.023 ---------------------------------------------------------------------------------------------------------------- m 3 - --- --- -- - ---- ---- -- --- --- --- -- F 3 --- --- ---- --- --- ----- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 460.1* 31.8 15 0.7341 0.0802 15 0.1602 0.0203 15 0.3390 0.0390 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 253.4 17.8 15 0.5166 0.0506 15 0.204 0.025 ---------------------------------------------------------------------------------------------------------------- 103 TABLE 16 summary of organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN-MEFOSE, T-6314) IN RhTs ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL SPLEEN --- -- ---- -- -- ----- --- --- ---- ---- -- --- --- --- ---- --- ------ - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN Wr SEX DOSE BODY WT WEIGHT BODY GROUP (g) (g) (t) RATIO GROUP (g) (g) (t) ---------------------------------------------------------------------------------------------------------------- m 4 p 4 -- -- --- -- -- ---- ---- --- ---- --- -- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 445.8* 24.4 15 0.6707* 0.1266 is 0.1501 0.0251 is 0.3101* 0.0620 -- --- ---- -- ----- ---- ---- NUMBER IN GROUP: MEAN: STANDARD DEV: is 229.8* 22.7 15 0.4675 0.0678 15 0.203 0.023 ---------------------------------------------------------------------------------------------------------------- 104 TABLE 16 Summary of organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DF-ATH=T;SUBSET=ALL TESTIS - ---- -- --- -- ---- --- ---- --- ---- -- - -- ----- -- ---- --- ---- ---- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN-'A SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN Wr SEX DOSE BODY WT WEIGHT BODY W. GROUP (g) (g) (t) RATIO GROUP lg) (g) (%) ---------------------------------------------------------------------------------------------------------------- m 1 -- ---- -- -- -- ---- --- --- ----- --- - F- - -1 - - - - - - - - - - - - - - - - - - - - - NUMBER IN GROUP: MEAN: STANDARD DEV: is 505.3 35.7 is 3.3907 0.2211 is 0.6733 0.0559 15 l.S579 0.0976 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 270.5 33.3 ---------------------------------------------------------------------------------------------------------------- m 2 -- --- --- -- -- ---- --- --- --- ---- -- F 2 --- ---- --- --- --- ----- --- NUMBER IN GROUP: MEAN: STANDARD DEV: 15 482.1 27.7 15 3.3852 0.3024 is 0.7028 0.0565 15 1.5752 0.1496 NUMBER IN GROUP: MEAN: STANDARD DEV: 14 251.3 24.0 ---------------------------------------------------------------------------------------------------------------- m 3 -- --- -- -- --- ---- -- --- ---- -- ---- F 3 NUMBER IN GROUP: MEAN: STANDARD I)EV: 15 460.1* 31.8 is 3.4481 0.3067 15 0.7535* 0.0874 15 1.5922 0.1509 NU-MB-ER - -IN -GR-OUP-: - - - - -is - - - - - - - - - - - - MEAN: 253.4 STANDARD DEV: 17.8 ----------------------------------------------------------------------7 ----------------------------------------- 105 TABLE 16 Surmiary of organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATii=T;SUBSET=ALL TESTIS - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- 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 Vfi GROUP (g) (g) (%) RATIO GROUP lg) (0) (%) ----------------------------------------------------------------------------------------------------------------- m 4 F 4 - --- --- -- -- ---- --- --- ---- --- --- NUMBER IN GROUP: MEAN: STANDARD DEV: is 445.8* 24.4 15 3.4789 0.2974 is 0.7824* 0.0756 15 1.6042 0.1126 --- ---- -- --- -- ---- ------ NUMBER IN GROUP: MEAN: STANDARD DEV: is 229.8 22.7 ---------------------------------------------------------------------------------------------------------------- 106 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T:SUBSET=ALL THYMUS -- -- --- --- -- --- --- ---- -- ----- -- - -- ---- --- ---- --- ---- ---- - TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY WT WEIGHT BODY Wr BRAIN WT SEX DOSE BODY WT WEIGHT BODY ----G-RO-U-P---------------(-g--)-------(-g-)---------(-%-)-------R-AT-I-O------------G-RO-U-P---------------(-g-)--------10-)----------(%-)----- m 1 F 1 - - - - - - - - - -- - - - - - - - - - - - - - NU-MBE-R - -IN -GR-OUP-: - - - - -15 - - - -15 - - - - - -is - - - - - -is - - - MEAN: 505.3 0.3454 0.0684 0.1586 STANDARD DEV: 35.7 0.0847 0.0160 0.0383 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 270.5 33.3 is 0.2814 0.0627 is 0.105 0.025 ---------------------------------------------------------------------------------------------------------------- m 2 -- --- --- -- -- ---- --- --- ---- -- --- F 2 -- ----- --- --- ---- -- ----- NUMBER IN GROUP: MEAN-. STANDARD DEV: 15 482.1 27.7 15 0.3117 0.0630 15 0.0651 0.0152 15 0.1451 0.0301 NUMBER IN GROUP: MEAN: STANDARD DEV: 14 251.3 24.0 14 0.2951 0.0491 14 0.117 0.017 ---------------------------------------------------------------------------------------------------------------- m 3 - --- --- --- -- --- --- --- --- ---- --- F 3 -- --- ---- --- --- --- ----- - NUMBER IN GROUP: MEAN: STANDARD DEV: 15 460.1* 31.8 is 0.2725* 0.0678 is 0.0592 0.0147 15 0.1260* 0.0324 NUMBER IN GROUP: MEAN: STANDARD DEV: 15 253.4 17.8 is 0.2978 0.0627 is 0.117 0.02 --------------------------------------------------------------------------------------------------------------- 107 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=T;SUBSET=ALL THYMUS --- -- ---- -- - ----- ---- -- --- ---- -- - --- ---- --- ---- --- ----- -- SEX DOSE TERMINAL BODY Wr ORGAN WEIGHT ORGAN-TOBODY WT ORGAN-TOBRAIN WT SEX DOSE TERMINAL BODY Wr ORGAN WEIGHT ORGAN-74 BODY w ----G-RO-U-P ---------------(-g--)-------(-g-)---------(-%-)-------RA-T-I-O ------------G-RO-U-P ---------------(-g-)-------(-u--)--------(-%-)----- m 4 F 4 -- --- -- -- -- --- ---- --- -- ---- --- - NUMBER IN GROUP: MEAN: STANDARD DEV: 15 445.8* 24.4 15 0.2610* 0.0515 is O.D586 0.0115 15 0.1206* 0.0246 - --- ---- --- --- ----- ---- - NUMBER IN GROUP: MEAN: STANDARD DEV: 15 229.8* 22.7 is 0.2654 0.0525 15 0.115 0.019 ---------------------------------------------------------------------------------------------------------------- 108 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DF-ATH=T;SUBSET=ALL THYROID/PARATHYR -- --- -- --- --- ---- -- ----- -- --- --- -- --- ---- ----- --- ----- -- SEX DOSE TERMINAL BODY wr ORGAN WEIGHT ORGAN-TOBODY Wr ORGAN-TOBRAIN WT SEX DOSE TERMINAL BODY WT ORGAN WEIGHT ORGANBODY GROUP (g) (g) (%) RATIO GROUP (u) (0) (%) --------------------------------------------------------------------------------------------------------------- m 1 - -- --- --- -- --- ---- --- --- --- --- - F 1 - --- --- ---- ---- --- ----- - NUMBER IN GROUP: MEAN: STANDARD DEV: 15 505.3 35.7 15 0.0255 0.0063 is 0.0051 0.0013 15 0.0117 0.0029 NUMBER IN GROUP: MEAN: STANDARD DEV: is 270.5 33.3 15 0.0203 0.0062 15 0.00 0.00 --------------------------------------------------------------------------------------------------------------- m 2 -- -- --- -- -- ----- --- -- ---- --- --- F 2 - --- --- ---- ---- --- ----- - NUMBER IN GROUP: MEAN: STANDARD DEV: 15 482.1 27.7 15 0.0254 0.0078 is 0.0053 0.0017 15 0.0118 0.0034 NUMBER IN GROUP: KEAN: STANDARD DEV: 14 251.3 24.0 14 0.0180 0.0066 14 0.00 0.00 --------------------------------------------------------------------------------------------------------------- m 3 F 3 - --- --- ----- --- --- --- --- NU-MBE-R - -IN -GR-OU-P: - - - - -15 - - - -is - - - - - -15 - - - - - -is - - - MEAN: 460.1* 0.0244 0.0053 0.0112 STANDARD DEV: 31.8 0.0048 0.0010 0.0019 NUMBER IN GROUP: MEAN: STANDARD DEV: is 253.4 17.8 is 0.0190 0.0046 15 0.00 0.00 --------------------------------------------------------------------------------------------------------------- 109 TABLE 16 Summary of Organ Weight Data Week 14 Sacrifice 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-ML"RHYL ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DF-ATH=T:SUBSET=ALL THYROID/PARATHYR -- --- --- -- -- ----- -- ---- ---- ----- - --- -- ----- ---- --- --- --- TERMINAL ORGAN ORGAN-TO- ORGAN-TO- TERMINAL ORGAN ORGAN- SEX DOSE BODY Wr WEIGHT BODY Wr BRAIN Wr SEX DOSE BODY WT WEIGHT BODY GROUP fg) (g) (%) RATIO GROUP (o) (g) (%) --------------------------------------------------------------------------------------------------------------- m 4 F 4 --- --- --- - ---- ---- --- --- ----- -- NUMBER IN GROUP: MEAN: STANDARD DEV: is 445.8* 24.4 15 0.0252 0.0033 15 0.0057 0.0009 15 0.0117 0.0017 - - - - - - - - - - - - - - - - - - - - - -- - NUMBER IN GROUP: MEAN: STANDARD DEV: 15 229.8* 22.7 15 0.0203 0.0052 is 0.00 0.00 --------------------------------------------------------------------------------------------------------------- 110 TABLE 17 Incidence of Macroscopic Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL,GROUP=ALL;WEEKS=ALL DEATH=ALL;SUBSET=ALL N U N B E R - 0 F - A N IM A L S -A SEX: GROUP: -------MALE -------I- -2- -3- -4- ------FEMALE ------I- -2- -3- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 20 20 20 20 20 20 20 20 ------------------------------------------------------------------------- ** TOP OF LIST ** GENERAL COMMENT (GC) ..............................N.UM.B.ER EXAMINED: 20 20 20 20 20 20 20 20 BONE MARROW SHEAR TAKEN MALOCCLUSION NO MACROSCOPIC LESIONS TAIL - BENT/MISSING STAINS-PERINEUM/PERIANAL 15 15 15 15 15 14 15 15 1 4 2 2 0 1 1 0 8 7 7 6 13 9 11 8 0 0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 LIVER (LI) .......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 20 20 20 20 20 20 20 20 20 20 20 16 20 20 20 19 LIGHT FOCUS(I)/AREA(S) LARGE DIFFUSELY DARK 0 0 0 1 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 2 0 0 0 1 KIDNEY (KD) .........I.............................N.U.MB.ER EXAMINED: NOT REMARKABLE: 20 20 20 20 20 20 20 20 19 19 20 18 20 20 20 20 LARGE PELVIS(ES) GRANULAR 14ATERIAL 1 1 0 2 0 0 0 0 0 1 0 0 0 0 0 0 SPLEEN (SP) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 20 20 20 20 20 20 20 20 20 20 20 20 19 20 20 20 ADHESION(S) 0 0 0 0 1 0 0 0 TABLE 17 incidence of Macroscopic Observations 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;SUBSET=ALL N U M B E R - 0 F -A N IH A L S -A SEX: ------- MALE ------- ------FEMALE -----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 20 20 20 20 20 20 20 20 -----------------------------------------------------------------------=--- -=- -=- -=- -=- -=- -=- -=- THYMUS (TH) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 20 20 20 20 20 20 20 20 17 18 16 18 20 19 19 20 RED FOCUS(I)/AREA(S) DIFFUSELY RED MOTTLED PITUITARY (pi) ...................................N.UM.B.ER. EXAMINED: NOT REMARKABLE: 2 1 3 1 0 0 1 0 0 1 1 1 0 1 0 0 1 0 0 0 0 0 0 0 20 20 20 20 20 20 20 20 20 20 20 20 19 20 20 20 LARGE STOMACH, GL (ST) .................................N.U.MB.E.R EXAMINED: NOT REMARKABLE: DARK FOCUS(I)/AREA(S) LIGHT FOCUS(I)/AREA(S) LN, MANDIBULAR (HN) ...............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 0 0 0 0 1 0 0 0 20 20 20 20 20 20 20 20 20 18 20 18 20 20 19 17 0 1 0 2 0 0 0 3 0 1 0 0 0 0 1 0 20 20 20 20 20 20 20 20 16 18 15 16 20 20 17 20, DIFFUSELY RED MOTTLED 3 2 4 3 0 0 2 0 1 0 1 1 0 0 1 0 112 TABLE 17 Incidence of Macroscopic Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;SUBSET=ALL N UH BER -0P -AN IMA LS SEX: GROUP: -------MALE -------1- -2- -3- -4- ------FEMALE ------1- -2- -3- -4- ORGAN AND KEYWORD(S) OR PHRASE NUMBER: 20 20 20 20 20 20 20 20 -----------------------------------------------------------------------=-- - -=- -=- -=- -=- -=- -=- -=- UTERUS (UT) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 0 0 0 0 20 20 20 20 0 0 0 0 19 17 19 19 LUMEN FILLED WITH FLUID OVARY (OV) .......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: DIFFUSELY RED TAIL (TI) ........................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 0 0 0 0 1 3 1 1 0 0 0 0 20 20 20 20 0 0 0 0 20 20 19 18 0 0 0 0 0 0 1 2 20 20 20 20 20 20 20 20 20 20 20 20 20 19 20 20 LACERATION(S) END OF LIST 0 0 0 0 0 1 0 0 113 TABLE 18 Incidence of Microscopic Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE. T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL,FIND=ALL;SUBSET=ALL N U M B E R - 0 F - A N IM A L S SEX: -------MALE ------- ------FEMALE -----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 20 20 20 20 20 20 20 20 ------------------------------------------------------------------------- ** TOP OF LIST ** DONE, FEMUR (FE) .................................N.U.MB.E.R EXAMINED: is 0 0 is is 1 0 is NOT REMARKABLET 15 0 0 15 15 1 0 15 NARROW, FEMUR (FM) ................................NU.M.BE.R EXAMINED: 15 0 0 15 15 1 0 is NOT REMARKABLE: 15 0 0 15 15 1 0 15 MARROW, STERNUM (SE) ..............................N.UM.B.ER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 is 15 1 0 is BONE, STERNUM (SB) ................................NU.M.B.ER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 is is 1 0 15 EYE (EY) ........................................N.U.MB.E.R. EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 is BRAIN (BR) .......................................NU.M.BE.R. EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 14 --INFILTRATE, LYMPHOHISTIOCYTIC 0 0 0 0 0 0 0 1 SPINAL CORD (SC) .................................N.U.MB.E.R EXAMINEDI 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 114 TABLE 18 incidence of microscopic observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL N U M B B R - 0 P - A N I H A LS SEX: ------- MALE ------- ------FEMALE -----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 20 20 20 20 20 20 20 20 ------------------------------------------------------------------------- LUNG (LU) .......................................N.U.MB.E.R. EXAMINED: 15 0 0 is is 1 0 15 NOT REMARKABLE: 6 0 0 7 12 1 0 12 --HEMORRHAGE --INFILTRATE, HACROPHAGE, --INFLAMMATION, SUBACUTE --MINERALIZATION, VASCULAR ALVEOLAR 1 0 0 0 0 0 0 0 4 0 0 5 1 0 0 2 1 0 0 0 0 0 0 1 5 0 0 3 2 0 0 0 TRACHEA (TR) .....................................NU.NMO.BTE.R.REMEAXRAKMAIBNLEED:: 1155 00 00 1155 1155 11 00 1i5s ESOPHAGUS (ES) ...................................N.UM.B.ER. EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 is 1 0 15 LIVER (LI) ......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: --FIBROSIS, CAPSULAR --HYPERTROPHY. HEPATOCELLULAR, DIFFUSE --HYPERTROPHY, HEPATOCELLULAR, CENTRILOSULAR --INFILTRATE, LYMPHOHISTIOCYTIC --NECROSIS, COAGULATIVE --NECROSIS, INDIVIDUAL HEPATOCYTE --PIGMENT, HEPATOCELI.ULAR --VACUOLhTION, HEPATOCELLULAR, CENTRILOBULAR --VACUOLATION, HEPATOCELLULAR, DIFFUSE CONTINUED ON NEXT PAGE TO MIDZONAL 15 15 15 15 15 15 15 15 5 0 1 0 5 4 2 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 14 15 0 0 7 14 10 15 13 10 10 11 12 9 0 0 0 3 0 0 1 0 6 9 5 6 3 6 4 5 0 0 0 2 0 0 0 7 0 0 2 7 0 a 0 2 0 0 2 2 0 0 0 0 115 TABLE 18 Incidence of Microscopic Observations 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL N U N B E R - 0 F - A N IM A L S SEX: -------HALE ------- ------FEMALE -----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 20 20 20 20 20 20 20 20 ------------------------------------------------------------------------- ** FROM PREVIOUS PAGE ** LIVER (LI) .......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 15 15 15 15 15 15 15 15 5 0 1 0 5 4 2 0 --VACUOLATrON, HEPATOCELLULAR, PERIPORTAL 0 0 1 0 2 3 0 0 KIDNEY (KD) ......................................NU.M.BE.R. EXAMINED: 15 1 0 15 15 1 0 is NOT REMARKABLE: 11 0 0 12 14 1 0 12 --BASOPHILIC TUBULES, CORTEX --DILATATION, PELVIC --INFLAMMATION, CHRONIC --MINERALIZATION, TUBULAR --THICKENING, BASEMENT MEMBRANE 2 0 0 0 0 0 0 0 1 1 0 2 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 1 1 0 0 2 1 0 0 0 0 0 0 0 HEART (HT) .......................................NU.M.BE.R. EXAMINED: 15 NOT REMARKABLE: 12 0 0 15 15 0 0 12 15 1 0 15 1 0 14 --DEGENERATION/NECROSIS 3 0 0 3 0 0 0 1 MUSCLE, SKELETAL (SM) .............................N.U.MB.ER EXAMINED: 15 NOT REMARKABLE: 15 0 0 is is 1 0 15 0 0 15 15 1 0 15 NERVE, SCIATIC (SN) ...............................N.UM.B.ER EXAMINED: 15 0 0 15 15 1 0 is NOT REMARKABLE: 15 0 0 is is 1 0 15 116 TABLE 18 Incidence of microscopic observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL N UM BER -0F -AN INA LS SEX: -------MALE ------- ------FEMALE -----GROUP; -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 20 20 20 20 20 20 20 20 -----------------------------------------------------------------------=-- - -=- -=- -=- -=- -=- -=- -=- SPLEEN (SP) ......................................NU.M.BE.R. EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 is 14 1 0 is --INFLAMMATION, CHRONIC, CAPSULAR 0 0 0 0 1 0 0 0 THYMUS (TH) ......................................NU.M.BE.R. EXAMINED: 15 2 4 15 15 2 1 15 NOT REMARKABLE: 9 0 0 6 11 1 0 10 --HEMORRHAGE --INVOLUTION 6 2 4 9 4 1 1 4 0 0 1 1 1 1 0 2 LN, HESENTERIC (MS) ...............................N.UM.B.ER EXAMINED: 15 0 0 15 15 1 0 is NOT REMARKABLE: 15 0 0 13 15 1 0 15 --HEMORRHAGE 0 0 0 2 0 0 0 0 THYROID (TY) .....................................N.UM.B.ER. EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 4 0 0 8 6 1 0 9 --CYST, ULTIMOBRANCHIAL --ECTOPIC THYMUS --INFILTRATE, LYMPHOHISTIOCYTIC --ONE EXAMINED 9 0 0 7 9 0 0 6 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 PARATHYROID (PT) .................................N.U.M.BE.R EXAMINED: 15 0 0 15 15 1 0 is NOT REMARKABLE: 13 0 0 15 15 1 0 14 --CYST CONTINUED ON NEXT PAGE 1 0 0 0 0 0 0 0 117 TABLE 18 Incidence of Microscopic Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL N UH BER -0F -AN IHA LS SEX: -------KALE ------- ------FEMALE -----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 20 20 20 20 20 20 20 20 ------------------------------------------------------------------------- ** FROM PREVIOUS PAGE ** PARATHYROID (PT) .................................N.U.MB.E.R EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 13 0 0 15 15 1 0 14 --ONE EXAMINED 1 0 0 0 0 0 0 1 ADRENAL, CORTEX (AC) ..............................N.UM.B.ER EXAMINED: 15 0 0 15 15 1 0 is NOT REMARKABLE: 15 0 0 14 15 1 0 15 --INFILTRATE. LYMPHOHISTIOCYTIC 0 0 0 1 0 0 0 0 ADRENAL. MEDULLA (MA) .............................N.U.MB.ER EXAMINED: 15 0 0 15 15 1 0 is NOT REMARKABLE: 15 0 0 15 15 1 0 15 AORTA (AO) .......................................NU.M.BE.R. EXAMINED: 15 NOT REMARKABLE: 15 0 0 15 15 0 0 15 15 1 0 15 1 0 is PITUITARY (pj) ...................................N.UM.B.ER. EXAMINED: 15 a 0 is is 1 0 15 NOT REMARKABLE: 14 0 0 14 14 1 0 15 --CYST --HYPERPLASIA 1 0 0 1 a 0 0 0 0 0 0 0 1 0 0 0 STOMACH, GL (ST) .................................N.U.MB.E.R EXAMINED: 14 NOT REMARKABLE: 14 2 15 15 15 1 15 13 15 1 15 15 1 15 12 --EROSION 0 1 0 2 0 0 0 3 TABLE 18 incidence of Microscopic observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYU PERFUUOROOCTANESULPONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL:SUBSET=ALL NU HBE R-0 F-AN IHA LS SEX: -------MALE ------- ------FEMALE -----GROUP: -I- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 20 20 20 20 20 20 20 20 -----------------------------------------------------------------------=--- -=- -,- -=- -=- -=- -=- -=- STOMACH, NONGL (SU) ...............................N.UM.B.ER. EXAMINED: 14 NOT REMARKABLE: 14 0 15 15 15 0 15 15 .15 1 15 15 1 15 15 PANCREAS (pA) ....................................N.UM.B.ER. EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 11 0 0 13 14 1 0 13 --ATROPHY, ACINAR --INFILTRATE, LYMPHOMISTIOCYTIC --INFLAMMATION, CHRONIC-ACTIVE --PIGMENT, BROWN 0 0 0 1 1 0 0 1 2 0 0 0 1 0 0 2 1 0 0 2 0 0 0 0 2 0 0 2 0 0 0 0 DUODENUM (DU) ....................................N.UM.B.ER. EXAMINED: 14 0 0 is is 1 0 15 NOT REMARKABLE: 14 0 0 15 15 1 0 is JEJUNUM (JE) .....................................N.UM.B.ER. EXAMINED: 15 0 0 15 15 1 0 is NOT REMARKABLE: 15 0 0 15 15 1 0 15 ILEUM (IL) .......................................NU.M.BE.R. EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 is 15 1 0 15 CECUM (CE) .......................................NU.M.BE.R. EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 is 119 TABLE 18 Incidence of Microscopic Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL:GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL:SUBSET=ALL NUH BER -0 F-AN IMA LS A SEX: GROUP: -------MALE -------1- -2- -3- -4- ------FEMALE ------I- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 20 20 20 20 20 20 20 20 ------------------------------------------------------------------------- COLON (CO) ......................................N.U.MB.E.R. EXAMINED: 15 0 0 15 15 1 0 is NOT REMARKABLE: 15 0 0 is 15 1 0 15 RECTUM (RE) ......................................NU.M.BE.R. EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 13 0 0 15 it 1 0 is --PARASITISM 2 0 0 0 1 0 0 0 LN, MANDIBULAR (MN) ...............................N.UM.B.ER EXAMINED: 15 NOT REMARKABLE: 11 2 5 15 15 0 0 7 12 1 3 15 1 0 14 --HEMORRHAGE --HYPERPLASIA. PLASMACYTIC 4 2 5 8 2 0 3 1 0 0 0 0 1 0 0 0 SALLV GL, HANDIB (SG) .............................N.U.MB.ER EXAMINED: 15 0 0 is is 1 0 15 NOT REMARKABLE: 15 0 0 15 15 1 0 15 HARDERIAN GLAND (HG) ..............................N.UM.B.ER EXAMINED: 15 0 0 15 15 1 0 15 NOT RE14ARKABLE: 14 0 0 13 15 1 0 14 --INFILTRATE. LYMPHOHISTIOCYTIC 1 0 a 2 0 0 0 1 AUDITORY SEB GL (AS) ..............................N.UM.B.ER EXAMINED: 15 0 0 is is 1 0 is NOT REMARKABLE: 15 0 0 12 11 1 0 13 --ONE EXAMINED 0 0 0 3 4 0 0 2 120 TABLE 18 Incidence of Microscopic observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL N UH BER -0F -AN INA LS SEX: -------KALE ------- ------FEMALE -----GROUP: -1- -2- -3- -4- -I- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 20 20 -----------------------------------------------------------------------=-- - -=- 20 -=- 20 -=- 20 -=- 20 -=- 20 -=- 20 -=- SKIN (SK) .......................................N.U.MB.E.R. EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 14 0 0 15 15 1 0 15 --EXUDATE, EPIDERMAL SURFACE --INFLAMMATION, SUBACUTE MAHKARY, FEMALE (MF) ..............................N.UM.B.ER EXAMINED: NOT REMARKABLE: 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 15 1 0 is 0 0 0 0 15 1 0 15 URINARY BLADDER (UB) ..............................N.UM.B.ER EXAMINED: 15 0 0 15 15 1 0 15 NOT REMARKABLE: 15 0 0 13 15 1 0 is --INFILTRATE, LYMPHOHISTIOCYTIC UTERUS (UT) ......................................NU.M.BE.R. EXAMINED: NOT REMARKABLE: 0 0 0 2 0 0 0 0 0 0 0 0 is 4 1 15 0 0 0 0 14 1 1 10 --DILATATION CERVIX (CV) ......................................NU.M.BE.R. EXAMINED: NOT REMRKABLE3 0 0 0 0 1 3 0 5 0 0 0 0 15 1 0 15 0 0 0 0 15 1 0 is OVARY (OV) .......................................NU.M.BE.R. EXAMINEDI NOT REMARKABLE: 0 0 0 0 15 1 1 is 0 0 0 0 15 1 1 15 121 TABLE 18 Incidence of Microscopic Observations 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=ALL N UM BER -0P -AN IHA LS-A SEX: -------MALE ------- ------FEMALE -----GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN AND FINDING DESCRIPTION NUMBER: 20 20 20 20 20 20 20 20 -----------------------------------------------------------------------=-- - -=- -=- -=- -=- -=- -=- -=- VAGINA (VA) ......................................NU.M.BE.R. EXAMINEDNOT REMARKABLE: 0 0 0 0 15 1 0 is 0 0 0 0 15 1 0 is PROSTATE (PR) ....................................N.UM.B.E.R EXAMINED: 15 0 0 15 0 0 0 0 NOT REMARKABLE: 3 0 0 9 0 0 0 0 --INFILTRATE, LYMPHOHISTIOCYTIC --INFLAMMATION, CHRONIC-ACTIVE 12 0 0 6 0 0 0 0 0 0 0 1 0 0 0 0 SEMINAL VESICLES (SV) .............................N.U.MB.ER EXAMINED: 15 0 0 15 0 0 0 0 NOT REMARKABLE: 15 0 0 15 0 0 0 0 TESTIS (TE) ......................................NU.M.BE.R. EXAMINED: 15 0 0 15 0 0 0 0 NOT REMARKABLE: 15 0 0 15 0 0 0 0 EPIDIDYMIDES (EP) .................................NU.M.BE.R EXAMINED: 15 0 0 is 0 0 0 0 NOT REMARKABLE: 15 0 0 15 0 0 0 0 TAIL (TI) .......................................N.U.MB.E.R. EXAMINED: NOT REMARKABLE: --HEMORRHAGE --ULCERATION END OF LIST 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 1 0 0 122 TABLE 19 incidence of Severity of Selected microscopic Observations 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=T N U M B E R - 0 F -A N I NA LS SEX: ------- MALE ------- ------FEMALE -----GROUP: -I- -2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 20 20 20 20 20 20 20 20 ------------------------------------------------------------------------- ** TOP OF LIST ** LIVER (LI) ......... --FIBROSIS, CAPSUU'R''*'*''***''*'**'* ..... NUMBER EXAMINED: 15 15 15 15 15 15 15 15 -> 15 15 14 15 14 15 15 15 1> 0 0 1 0 1 0 0 0 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.1 0.0 0.1 0.0 0.0 0.0 --HYPERTROPHY, HEPATOCELLULAR, DIFFUSE -> 15 15 15 15 15 15 15 14 2> 0 0 0 0 0 0 0 1 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.1 --HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR -> 15 15 1 0 1S 15 8 1 1> 0 0 11 0 0 0 7 0 2> 0 0 3 1 0 0 0 7 3> 0 0 0 14 0 0 0 7 TL> 15 15 15 15 15 15 15 15 mN> 0.0 0.0 1.1 2.9 0.0 0.0 0.5 2.3 --INFILTRATE, LYMPHOHISTIOCYTIC CONTINUED ON NEXT PAGE -> 5 0 2 5 5 4 3 6 1> 10 14 13 10 10 11 12 9 2> 0 1 0 0 0 0 0 0 TL:- 15 15 15 15 15 15 15 15 MN> 0.7 1.1 0.9 0.7 0.7 0.7 0.8 0.6 123 TABLE 19 Incidence of severity of Selected microscopic observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=T SEX: GROUP: N U H B E R - 0 F - A N IN A L S -------MALE ------- ------FEMALE ------I- -2- -3- -4- -I- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 20 20 20 20 20 20 20 20 ------------------------------------------------------------------------- ** FROM PREVIOUS PAGE ** LIVER (LI) ......... --NECROSIS, COAGUU@i@i*''"''''''*''*''*''***'' NUMBER EXAMINED: 15 15 15 15 15 15 15 15 ... -> 15 15 15 12 15 15 14 15 1> 0 0 0 2 0 0 1 0 2> 0 0 0 1 0 0 0 0 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.0 0.3 0.0 0.0 0.1 0.0 --NECROSIS, INDIVIDUAL HEPATOCYTE -> 9 1> 6 2> 0 6 10 9 5 0 0 9 12 5 3 1 0 9 11 10 6 4 5 0 0 0 TL> 15 15 15 15 15 15 15 15 HN> 0.4 0.6 0.3 0.5 0.2 0.4 0.3 0.3 --PIGMENT, HEPATOCELLULAR -> 15 15 15 13 15 15 15 8 1> 0 0 0 2 0 0 0 7 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.0 0.1 0.0 0.0 0.0 0.5 --VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR TO MIDZONAL CONTINUED ON NEXT PAGE -> 15 IS 13 1> 0 0 2 8 15 15 15 13 5 0 0 0 2 2> 0 0 0 2 0 0 0 0 TL> 15 15 15 15 15 15 15 15 HN> 0.0 0.0 0.1 0.6 0.0 0.0 0.0 0.1 124 TABLE 19 Incidence of Severity of Selected Microscopic Observations 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- TABLE INCLUDES: SEX=ALL;GROUP=ALL;WEEKS=ALL DEATH=ALL;FIND=ALL;SUBSET=T NUM BER -0P -AN IMA LS SEX: -------MALE ------- ------FEMALE ------ GROUP: -1- -2- -3- -4- -1- -2- -3- -4- ORGAN/TISSUE EXAMINED NUMBER: 20 20 ------------------------------------------------------------------------- 20 20 20 20 20 20 ** FROM PREVIOUS PAGE ** LIVER (LI) ......................................N.U.MB.E.R. EXAMINED: 15 15 15 15 15 15 15 15 --VACUOE.ATION, HEPATOCELLULAR, DIFFUSE -> 15 15 13 13 15 15 15 15 1> 0 0 2 0 0 0 0 0 2> 0 0 0 2 0 0 0 0 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.1 0.3 0.0 0.0 0.0 0.0 --VACUOLATION, HEPATOCELLULAR, PERIPORTAL -> 15 15 14 15 13 12 15 15 1> 0 0 1 0 2 3 0 0 TL> 15 15 15 15 15 15 15 15 MN> 0.0 0.0 0.1 0.0 0.1 0.2 0.0 0.0 STOMACH, GL (ST) .................................N.U.M.BE.R EXAMINED: 14 --EROSION -> 14 2 15 15 15 1 15 13 15 2 15 Is 1 15 12 1> 0 0 0 1 0 0 0 2 2> 0 1 0 1 0 0 0 1 TL> 14 2 15 15 15 1 is 15 END OF LIST MN> 0.0 1.0 0.0 0.2 0.0 0.0 0.0 0.3 125 APPENDIX 1 ProtocolDeviations Protocol ProtocolAmendment No. 1 ProtocolAmendment No. 2 ProtocolAmendment No. 3 Covance 6329-225 3M T-6314.1 126 Covance 6329-225 3M T-6314.1 Protocol Deviations Protocol. Housing. Diet. "CertifiedRodent Diet#5002, meal (PNU Nutrition Internationaald) libitun4unlessotherwisespecified." Actual Procedure. The animalswere givenTeklad 8728C pelletedfood from August 17, 1998 to August 23, 1998. Protocol. Dose Preparation.RetentionSamples. "During the in-lifpehase,samples (approximately100 g) willbe taken from each dose preparationsampled fordose analyses and stored at room temperature. Unless used foranalyses,thesesamples willbe discarded approximately I month aftercompletion of thein-lifpehase." Actual Procedure. Retentionsamples were discardedafterapproximatelyI month of the completion of the in-lifpehase. Protocol. Observationof Ani=N. ClinicaOlbservations."Each animal willbe observed twicedaily(arrland p.rrl)formortalityand moribundity,recordingfindingsas theyare observed." Actual Procedure. On Days 16 through 30, thea.nL and p.m mortalityand moribundity checks were not documented. Protocol. Temiination. Scheduled Sacrifices."Afterat least4 weeks of treatment, fiveanin"sex/group willbe fastedovernight,bled forserum samples,anesthetizedwith carbon dioxide,weic0hed, and exsanguinated." Actual Procedure. Fastingof animalsatthe Week 5 scheduledsacrificweas not documented. ProtocoL ExperimentalDesign. Postmortem Procedures. "The followingtissues(when present)or representativseamples willbe collectedfrom each animal and preserved in 10% phosphate-bufferedformaun, unlessotherwise specified." 127 Covance 6329-225 3M T-6314.1 Actual Procedure. Some tissuesr,equiredby theprotocol were not availablefor histopathologicexamination. Nlissingtissuesarelistedwith appropriatecomments in the pathology data sheetsforindividualanfimls. Summary tablesdo not includethem as having been examined. "fbesedeviationsare not expected to have affectedthe resultsof the study. 128 CIOHVEAAt'C'E.'-\ mzwpm"T sumca CONP"ff Sponsor: 3M St.Paul,Minnesota PROTOCOL Study Title: 13-Week DietaryToxicitSytudywithN-MethylPerfluorooctanesuIfonamido Ethanol(N-MeFOSE, T-6314)inRats Date: August 27, 1998 PerfomiingLaboratory: Covance UboratoriesInc. 3301 KinsnianBoulevard Madison,Wisconsin.53704-2595 LaboratoryStudy Identification: ProposalNo. 90545D Covance 6329-225 Sponsor ProjectIdentification: 3M T-6314.1 129 Covanc6e329-225 Page2 Study 13-WeekDietarTyoxicitSytudywithN-MethylPerfluorooctanesulfonEatmhiadnool (N-MeFOSE, T-6314) inRats Purpose To assessthetoxicityof thetestmaterialwhen administeredinthe diettoratsforat least 13 weeks Sponsor 3M Toxicology Services Building220-2E-02,3M Center St.Paul,Minnesota 55144-1000 Study Monitor Andrew M. Seacat,PhD 3M ToxicologyServices Telephone No.:651-575.3161 FacsimileNo.: 651.733.1773 AlternateStudy Monitor Marvin T. Case,DVM, PhD 3M ToxicoloO-Y Services Telepbone No.: 651.733.5180 FacsimileNo.: 651.733.1773 Study Location Covance Uboratories Inc. 3301 Kinsman Boulevard Madison, Wisconsin 53704-2595 MaiUna Address: PO Box 7545 Madison, Wisconsin 53707-7545 130 StudyDirector PeterJ.Ilomford,PhD Covance LaboratoriesInc. Telephone No.: 608.241.7207 FacsimileNo.: 608.242.2736 Covanc6e329-225 Page3 To@dcologist Thomas E. Ryan, BS Covance LaboratoriesInc. Proposed Study Timetable In-LifeStartDate: September 1,1998 In-LifeEnd Date: December 3, 1998 Audited DraftReport Date: May 26, 1998 Regulatory Compliance Thisstudy willbe conducted incompliance withthe Food and Drug AdministrationGood LaboratoryPracticeRegulationsas setforthinTitle21 of theUS Code ofFederal Regulations,Part58, issuedDecember 22, 1978 (effectivJeune 20, 1979),and with any applicableamendments. Animal Care and Use Statement AU proceduresinthisprotocolare incompliancewiththe Animal WelftieAct Re-0ulations,9 CFR 1-4. Inthe opinionof theSponsor and studydirectort,he studydoes not unnecessarilyduplicateany previouswork. Quality Assurance ne protocol,studyconduct,and finalreportwillbe auditedby the Covance Quality AssuranceUnit(QAU). The proliferaticoenU nuclearantigen(PCNA) evaluationd,ata, and reportwiU be auditedby theQAU of PathologyAssociatesInternational.iverand serum analyses,data,and reportwillbe auditedby the QAU of3M Environmental Technolo-c,Yand SafetyServices. 131 TestMaterial Comee 6329-225 Page4 Identification N-MethylPerfluorooctanesulfonEatmhiadnool(MEFOS, T-6314) Lot Number The lotnumbers willbe maintainedintheraw data. Puzity Responsibilitoyf theSponsor Stability Responsibilitoyf theSponsor Storage Conditions At room temperature Characteristics Informationon synthesismethods,composition,or othercharacteristitchsatdefinethe testmaterialison filewith theSponsor. Reserve (Archive)Samples A reservesample (approxfimtel5yg) of eachlotwillbe takenand storedatroom temperature.These samples willbe transferretdo the Sponsor aftercompletionof the in-lifpehase. DispositionofTest Material Afterauthorizatiofnrom the Sponsor,any remainingtestmaterialwillbe returnedto: Andrew M. Seacat,PhD 3M Toxicology Services ]@ufldin2g20-2E-02, 3M Center St.Paul,Minnesota 55144- 1000 Telephone No.: 651.575.3161 FacsimileNo.: 651.733.1773 132 Animals Covance 6329-225 Page 5 Species Rat Strain Crl:CD*(SD) IGS BR Source Charles River Laboratories, Inc.,Portage, Mchigan Age at Initiation of Treatment Preferably lessthan 6 weeks of age but not more than 8 weeks of age Weight at Initiation of Treatment 100 to 300 g Number and Sex 80 niales and 80 females identification Implantablemicrochipidentificatidoenvice Husbandry Housing Individua(lrmy be group-housedduringaccliznationA)n.inmls willbe housed in suspended, stainlessteelcages. Diet CertifieRdodent Diet#5002,meal (PNIINutritioInnternationaald)libitumu,nless otherwisespecified.The dietisroutinelyanalyzedby themanufacturerfornutritional components and environmentalcontanifimts.Specifiednutrienatnd contanihmt analysesareon fileat Covance-Madison. 133 Covance 6329-225 Page 6 Water Ad libitum. Samples of the water are routinely analyzed for specified znicroorganisnis and environmentalcontaminants.The resultsare on Me atCovance-MadisorL Contaminants There areno known contaminantsinthedietor water atlevelsthatmight interferweith thisstudy. Environment Envirorunentalcontrolsfortheanimalroom willbe setto maintain18 to 26*C, a relativheuzniditoyf 30 to 70%, and a 12-hourlight/12-houdrark cycle.The light/dark cyclemay be interruptedto accommodate in-lifperocedures. Accfimation At least1 week Randomization Selectionofanfiriaflosrthestudy willbe based on clinicaolbservationso,phthahnic examinations,and otherdataas appropriate.Aninmls willbe assignedto treatment groups usinga computerizedblockingprocedure designedto achievebody weight balancewithrespecttotreatmentgroups. At the timeofrandomization,theweight variationofthe anin@ ofeach sex used willnot exceed 2 standarddeviationsof the mean weight,and themean body weight foreach group of each sex willnot be statisticadlilfyferenattthe5.0% probabilitlyevel. justi:rication Rats historicalhlayve been used insafetyevaluationstudiesand arereconunended by appropriateregulatoryagencies. 134 Covance6329-225 Page7 Group Designationsand DietaryLevels Number ofAnimals Dietary Levels Group NWe 1 (Controlb) 20 Feinale 20 (ppm MEFOS)* 0 2 (Low) 20 20 3 3 (Nhd) 20 20 30 4 (High) 20 20 100 a Dose levelsare expressed as ppm of MEFOS. b The controlaninmlswillreceivethebasaldietonly. Dosing Procedures Method of Adniinistration Dietary,7 daystweek forat least13 weeks. Treatment willcontinuethrough theday beforenecropsy. Reason for Dosing Route The potentialrouteof exposure in humans isoral Dose Preparation AU dose preparationswillbe mixed according to the study-specifimcixing procedure developed by Covance. Dose concentrationswillbe based on the MEFOS content as supplied.AD dose preparationswillbe storedat room temperature. Before initiationf treatment,dose preparationsof I ppm, 3 ppm 30 ppm 100 ppm and 500 ppm willbe mixed. Dose preparationswillbe mixed at leastonce every 4 weeks during the in-lifpehase. Retention Samples During thein-lifpehase,samples (approximately100 g) willbe taken from each dose preparationsampled for dose analysesand stored at room temperature. Unless used for analyses,thesesamples willbe discardedapproximately I month aftercompletion of the in-lif-ephase. 135 Covance 6329-225 Page 8 Dose Analyses By Covance, using a method suppliedby the Sponsor and validatedby Covance Homogeneity Homogeneity willbe determined for 3-ppm, 30-ppni,and 100-ppm dose preparations once pretest.One san4,)I(eapproximately 100 g) each from the top,middle, and bottom of the dose preparationsmixed forhomogeneity analyseswillbe collected,dividedinto threesubsamples forextractionand analysis,and analyzed fortestmaterialcontent. All samples willbe storedatroom temperature untilanalyzedwithin 7 days aftermixing. Homogeneity analysiswillbe repeatedifbatch sizechanges by more than 30%. Stability Four samples (approximately 100 g each) willbe taken from the I-ppm dose level concentrationof dietpreparationsmixed pretest.One &wnple willbe analyzedon the day of mixing and used as the baselinevalue. One sample willbe storedat room temperatureforat least19 days,then analyzed. A thirdsample willbe storedatroom temperatureafteratleast32 days,then analyzed. The remaining sample willbe stored ina freezersetto maintain-10 to -30 *C for 8 weeks, then analyzed. In addition,two samples (approximately100 g each) willbe taken from the500-ppm dose preparationmixed pretest.One sample willbe analyzed on the day of mixing. The second sample willbe willbe stored at room temperature afterat least32 days, then analyzed. Dose Confirmation During the in-lifpehase, samples (approximately 100 g) from alldose preparationswill be analyzed. All samples willbe storedat room temperature untilanalyzed. 136 ObservatioonfAnimals Covanc6e329-225 Page9 ClinicaOlbservations Eachanimalwillbeobservetdwicedail(yarrlandp.m) fbrmortaliatnydmoribundity, recordingfindingsastheyare observed. At leastonce weekly, each animalwillbe observed(cagewillbe opened,and theanimalwillbe removed);abnomial findingsor an indicatioonf normal willbe recorded.Additionalfindingswillbe recordedas they are observed. Body Weights Each animalwillbe weighed atleastonce priorto treatment,on thefirsdtay of treatment,and weekly thereafter. Food Consumption Food consumption willbe recordedweekly duringtreatment.Food consumption will not be measured duringWeek 5 foranimalsscheduledforsacrificdeuringWeek 5. Ophthabuic Examinations Ophthalmic examinationswillbe done foreach anfiiwbeforeinitiatiofn treatmentand beforethe Week 14 scheduledsacrificen.e eyesof each animalwillbe examined by a veterinariaunsingan indirecotphthalmoscope. A mydriaticagentwillbe insti.Ueidnto theeyes priorto examination. ClinicalPathology Frequency Heniatolo0cyand clinicaclhemistryduringWeeks 5 and 14-,urinalysidsuringWeek 14 Number of Animals Ten aninWstsex/group(thesame animalswillbe used ateach intervali,fpossible) Method ofCollection Aninmls willbe fastedovernight;bloodwillbe collectedfrom a jugularvein.'Me anticoagulanwtillbe potassiumEDTA forhematology tests.Urinewillbe collected chilleodvernight(approxftmtely16 hours). 137 Covance 6329-225 Page 10 Tests Hematology red bloodcell(erythrocytec)ount hemoglobin hermtocrit mean corpuscularvolume mean corpuscularhemoglobin mean corpuscularhemoglobin concentration platelectount whiteblood cell(leukocytec)ount differentiballood cellcount blood cellmorphology reticulocytsemear (made, but not examined) glucose urea nitrogen creatinine totalprotein albumin globulin cholesterol triglycerides totalbwmbin ClinicalChemistry alanineaminommferase gamma glutamyluansferase aspartateaniinotransferase calcium inorganicphosphorus sodium potassium chloride appearance volume specifigcravity pH protein urobilinogen Urinalysis glucose ketones buirubin blood microscopicexaminationof sediment Serum PerfluorooctaneSulfonicAcid (PFOS) Analyses Frequency and Number of Animals FiveanimaWsex/group afteratleast4 and 13 weeks of treatment.Samples after 4 weeks of treatmentwillbe collectedfrom anbnalsselectedfortheinterim sacrifice. 138 Covance6329-225 PageII MethodofCoHection Animalswillbe fastedoveniightb;lood(approximatel4ymL) willbecollected fromajugularvein.Sampleswillbe collectewdithoutanticoagulant. Sample Handling Blood sampleswillbe allowedto clotatroom temperaturaend centrifuged. Serum samples willbe harvested and storedin a freezersetto maintain -60 to -80*C. Samples willbe packed on dry iceand shipped to: KrisJ.Hansen, PhD 3M Environmental Technology and Safety Services 935 Bush Avenue Building2-3E-09 St. PauL N@ffimesota55133-3331 Telephone No.: 651.778.6018 FacsimileNo.: 651.778.6176 Serum samples willbe analyzed for PFOS and metabolitesby the Sponsor. Results willbe reportedseparatelyby the Sponsor. Temiination Unscheduled Sacrificeasnd Deaths Necropsieswillbe done. Anbnals to be sacrificewdillbe anesthetizewdith carbon dioxide,weighed, and exsanguinated. Scheduled Sacrijrices Afterat least4 weeks of treatment,fiveanimals/sex/.o-rowuipllbe fastedovernight,bled forserum samples,anesthetizedwith carbon dioxide,weighed, and exsanguinated. The abdon-dnalcavityof each animal willbe opened, the liverwillbe removed and weighed, and Ever samples willbe collectedforpaliniitoyCloA and PFOS analysis.Animals will be discardedafterlivercollection. 139 Covance6329-225 Page12 Afteratleast13 weeks oftreatmenta,llsurvivinagninmlswillbefastedovernightb,led forserum samples (fiveanimaL-Jsex/group)and clinicaplathology tests(IOlsex/group), anesthetizedwith carbon dioxide,weighed, exsanguinated,and necropsied. liver samples willbe collectedforpaffinitoyCloA, PCNA, and PFOS analysis. Postmortem Procedures Necropsy The necropsy willincludean examination of the externalfeaturesof the carcass;all externalbody orificest;he abdominal thoracic,and cranialcavitieso;rgans;and tissues. Organ Weights At the scheduledsacrificaefter13 weeks of treatment,the followingorgans (when present)willbe weighed; pairedorgans willbe weighed together adrenal(2) brain kidney(2) liver ovary(2) spleen testi(s2) thymus thyroid(2)withparathyroid Organ-to-body weight percentagesand organ-to-brainweight ratioswillbe calculated. Bone Marrow Smear From the femur of each animal at the scheduled sacrificaefter13 weeks of treatment only;made but not examined CellProliferatioTnissue Collectionand Immunohistocheniical Evaluation At the scheduled sacrificaefter13 weeks of treatment ,representativesamples of left laterallobeof the liverfrom each animal willbe collectedand preserved in zinc fomialin. After fixatione,ach sample of liverwillbe embedded inparaffina,nd theparaffm blocks willbe shipped to: 140 Covance6329-225 Page13 SandraR.EldridgeP,hD Pathology AssociatesInternational 15 Wormes MiU Court, SuiteI FTederick,Maryland 21701 Telephone No.: 301-663.1644, ext.2201 FacsimileNo: 301.663.8994 ProliferatiocneR nuclearantigen(PCNA) evaluationwillbe done on thesamples. Resultswillbe provided forinclusionin thefinalreport. Palmitoyl-CoA Oiddase Tissue CoUection and AnWyses At the scheduledsacrificest,herightlateralobeof theliverwillbe collectedfrom each animal and flash-frozeinn liquidnitrogen.The livertissuewillbe storedin a freezerset to maintain-60 to -80*C untilanalyzed by Covance forpahnitoyl-CoA oxidaseactivity. Liver PFOS Analysis At scheduled sacrificest,herenmbiingportionof theliverfrom each anbiw afterother requiredcollectionwsillbe storedina freezersetto maintain-60 to -80*C. Samples willbe packed on dry iceand shipped to KrisJ.Hansen, PhD, 3M Environmental Technology and SafetyServices. Liver samples willbe analyzed forPFOS and metabolitesby the Sponsor. Results willbe reportedseparatelyby the Sponsor. Tissue Preservation The followingtissues(when present)from each animal thatisfound dead, sacrificeadt an unscheduled intervalo,r sacrificeadt the scheduled sacrificaefter13 weeks of treatmentwillbe preservedinlo% neutral-bufferefdormahn: 141 Covance 6329-225 Page 14 adrenal(2) aorta brain cecum cervix colon duodenum epididymis(2) esophagus eye (2) femur with bone marrow (articulasrurface of the of the distalend) Harderian gland heart ileumwith Peyees patch (lymphoid aggregate) jejunum kidney(2) lesions liver lung with mainstem bronchi lymph nodes (mesentericand mandibular) mammary glands(femalesonly) ovary(2) pancreas pituitary prostate rectum salivarygland [mandibular(2)] sciaticnerve seminalvesicle(2) skeletamluscle (thigh) skin spinalcord (cervicaln-dd-thoracica,nd lumbar) spleen sternum with bone marrow stomach testi(s2) thymus thyroid(2)with parathyroid trachea urinarybladder uterus vagina Zyrnbal'sgland Histopathology Tissues(asappropriate)from each animal inthe controland high-dosegroups and each animal thatdiesor issacrificedat an unscheduled intervalwillbe embedded inparaffin, sectioned,stainedwith hematoxylin and eosin,and examined microscopically. Macroscopic lesionsfrom aninmls in the low- and rnid-dosegroups willbe embedded in paraffins,ectioned,stainedwith hematoxylin and eosin,and examined microscopically. Suspected targetorgans noted at the high dose willbe examined microscopicallyfrom each aninial(atthe Sponsor'srequestand added by amendment). Reports One copy of thedraftreportwillbe sentto the Sponsor. The reportwillincludethe followinginfomiation: 142 Experimental Design and Methods Covance 6329-225 Page 15 Results dose analyses mortality clinicaolbservations body weights body weight changes food consumption testmaterialconsumption ophthalmic findings clinicaplathology results pahnitoylCoA oxidaseactivities rmcroscopic observations microscopic observations ceU proliferatioanssessments(providedby the Sponsor's designee) StatisticalEvaluation Levene'stestwillbe done to testfor variancehomogeneity. In the case of heterogeneity of varianceat p -s0.05,transformationswillbe used to stabiliztehe variance. Comparison testswilltake varianceheterogeneityintoconsideration. One-way analysisof variance(ANOVA) willbe used (ifapplicable)to analyzebody weights,body weight changes,food consumption, continuous clinicaplathology values, and organ weight data.IftheANOVA issignificantD,umett's t-testwillbe used for control versustreatedgroup comparisons. Ifthe ANOVA shows significancfeorbody weights at Week 1,one-way analysisof covariance(ANCOVA) willbe used to analyzebody weights,with initiablody weights as thecovariate.IftheANCOVA issignificantc,ovariate-adjustemdeans willbe used for control versustreatedgroup comparisons. Group comparisons (Groups 2 through 4 versusGroup 1) willbe evaluatedat the 5.0%, two-tafledprobabilitlyevel.Only data collectedon or afterthe firsdtay of treatment wW be analyzed statistically. 143 Covanoe6329-225 Page16 At theend ofI yearafterissuanceoftheauditeddraftreporti,fno requestedrevisionosr instructiontso finalizehave been communicated by the Sponsor, then the audited draft reportwiR be considered '&W' and issuedas the finalreport,signed by the study director, and submitted to the Sponsor. Any modificationsor changes to the auditeddraftreportrequested I yearafterissuance willbe performed at additionalcostto the Sponsor. Two copiesof the signedfmalreport(one unbound and one bound) willbe sentto the client. Record Retention AU raw data,documentation, records,protocol,specimens, and finalreportgenerated as a resultof thisstudy willbe archivedin thestoragefacilitioefsCovance-Madison fora periodof I yearfouowing submissionof thefinalreportto theSponsor. One year after subn-dssionof the finalreport,the aforementioned materialswillbe sentto the Sponsor, and a returnfeewillbe charged;allraw data stored on magnetic media, protocol,study correspondence,and the originalfinalreport wiU be retainedby Covance. The Sponsor may electto have the materialsretainedin the Covance archivesfor an additionalperiod of time,and Covance willcharge a storagefee. Ifthe Sponsor chooses to have Covance dispose of the materials,a disposalfee willbe charged. PCNA anti0cenevaluationdatawillbe retainedby Pathology AssociatesIntemationaL Liver and serum samples sent to the Sponsor and analysisdata wM be retainedby the Sponsor. 144 PROTOCOL APPROVAL Covance 6329-225 page 17 19Ai i Di- -e9l.41@. rew M. Seacat,PhD Date Study Monitor 3M Prigr1. rd,Ptl@ b Study Dk&tor t *.,001 Covance LaboratoriesInc. Date 145 COVAM'C-E'."%\ MEDMWPURMTSMCU=MPAMY PROTOCOL AMENDMENT NO. I Covance6329-225 13-Week DietaryToxicityStudywithN-Methyl Perfluorooctanesulfonamido Ethanol(N-MeFOSE, T-6314)inRats Sponsor: 3M, St.PauL Minnesota StudyMonitor: Andrew M. SeacaL PhD TestingFacility: Covance LaboratorieIsnc.,Madison,Wisconsin Study Director- PeterJ.Thomford, PhD Thisamendment modifiesthefollowingportionof theprotocol: EffectiveAugust 27,1998 1. Page 3, Proposed Study Timetable. To correcttheauditeddraftreportdate, deletethetextinthissectionand replacewiththefollowing: In-LifeStartDate: September 1,1998 In-LifeEnd Date: December 3, 1998 AuditedDraftReportDate: May 26, 1999 EffectiveOctober 1,1998 2. Page 12,Postmortem Procedures,CeH ProliferatioTnissueCollectionand lxnmunohistochemicalEvaluation,Paragraph 1. To reflectthedecisionto performproliferaticoenU nuclearantigenevaluatiofnorfiveanimaLs/sex/group only,deletethisparagraphand replacewith thefollowing: At thescheduledsacrificaefter13 weeks of treatmentr,epresentativseamplesof theleftlaterallobeof theliverfrom fiveanirrWstsex/grouwpillbe collecteadnd preservedinzincfommlin. 146 AMENDNIENT APPROVAL Covance 6329-225 Protowl Amendment No. I ]@aite2 Ancrmw M. Seacat,PhD StudyMonitor 3M t AV-,VZ 1 I@,nn VOrr-d-,PhD StudyD' r Covance boratorieIsnc. Date /0 Eate 147 C 0 V AA'C-E-.--'@ Tme DmLopmzxT sarmn compaw PROTOCOL AMENDMENT NO. 2 Covance6329-225 13-Week DietaryToxicityStudy withN-Methyl Perfluorooctanesulfonamido Ethanol(N-MeFOSE, T-6314)inRats Sponsor: 3M, St.PauL Minnesota StudyMonitor: Andrew M. Seacat,PhD TestingFacility: Covance LaboratorieIsnc.,Madison,Wisconsin Study Director: PeterJ.Tbomford, PhD TI@swnendment modifiesthefollowingportionof theprotocol: EffectiveOctober 21,1998 1. Page 8,Dose Preparation,Dose Analysis,Stabiuty.To reflectthedecisionto performadditionasltabiliatnyalysisa,dd thefollowingto thissection: Two additionaslamples(approximatel1y00 g each)willbe takenfrom the3-ppm dose preparatiomnixed forWeek 9 through 12. One samplewillbe storedat room temperatureforatleast19 days,thenanalyzed.The secondsample willbe storedatroom temperatureforatleast32 days,thenanalyzed.The sample collectedfordose confirmatioannalysiswillbe used as thebaselinesample. 148 Covance6329-225 ProtocoAlmendmentNo.2 Page2 EffectiDveecember4,1998 2. Page13,PostmortePmrocedureLsi,verPFOS AnalysiSse,ntenc1e.To clarify collectioonf liversectionsforPFOS analysisd,eletethissentenceand replacewith thefollowing: At scheduledsacrificetsh,erenuiininpgortionoftheliverfrom eachanimalafter otherrequiredcollectionwsillbe flash-frozeinnliquidnitrogenand storedina freezersettomaintain-60 to -80*C. EffectiveDecember 15,1998 3. Page 13,Postmortem Procedures,CeH ProliferatioTnissueCollectionand Immunohistochemical Evaluation,Paragraph 3. To includeexaminationof liversectionswillbe stainedwith hernatoxyliannd eosinas partof thecell proliferatieovnaluationd,eletethisparagraphand replacewiththefollowing: Prolfferaticoenllnuclearantigen(PCNA) evaluatiownillbe done on thesamples. In additionl,ivesrectionswillbe stainedwithhematoxylinand eosinand examinedmicroscopicallyR.esultswillbe providedforinclusioinnthefinal report. EffectivJeanuary 25, 1999 4. Page 14,Postmortem Procedures,Histopathology,Paragraph 3. Liverand stomach were identifieads targetorgansinanimalsinthehigh-dosegroup and will be examined inanimalsfrom themid-dosegroup. Thereforedeletethisparagraph and replacewiththefollowing: Liverand stomach from each animalinthe mid-dosegroup willbe embedded in paraffins,ectioneds,tainedwith hematoxyhn and eosin,and examined microscopically. 149 Covance 6329-225 ProtocoAlmendinent No.2 Page 3 Effective February St 1999 5. Page 14, Postmortm Procedures, Histopathology, ParAgmph 3. Liver and was identifiedas target organ in anifnsllin the mid-dose group and will be examined in anim-gi from the low-dose group. Therefore delete this paragraph and replacewiththe following: Liverand stomach from each anirnalinthe mid-dose group and liverfrom each anitn:ilnthelow-dose group willbe embedded inparaffins,ectioned,stainedwith hematoxybn and eosin,and examined microscopically. ANMNDNW,NT APPROVAL Andrew M. Seacat,PhD Study Monitor 3M Pet@rJ.nywrd, PhD Study Dir6Cor Covance LaboratoriesInc. Date Date 150 C 0 V A-N -C'E-.N'- PROTOCOL AMENDMENT NO. 3 Covance 6329-225 DRAFT 13-Week DietaryToxicityStudywithN-Methyl Perfluorooctariesulfonaniido Ethanol(N-MeFOSE, T-6314)inRats Sponsor. 3M, St.PauL Minnesota StudyMonitor Andrew M. Seacat,PhD TestingFacility: Covance LaboratorieIsnc.,Madison,WLwonsin Study Director: PeterJ.Thomford, PhD Thisamendment modifiesthefollowingportionof theprotocol: EffectivAeugust 28,1"8 I Page 4. To includethevehicleused to dissolvtehetestmateriableforemixing withthedieta,dd thefollowingsection. Vehicle Identification Acetone Lot Numbers The lotnumbers willbe maintainedintheraw data. Purity On filewiththemanufacturer Stability On filweiththemanufacturer 151 Covance6329-225 ProtocoAlmndment No.3 Page2 StorageConditions At room temperature Characteristics idonmtion on synthesinsxthods,compositiono,rothercharacteristtihcast definethe vehicleison filewith the manufacturer. AMENDMENT APPROVAL Andrew M. Seacat,PhD Study Monitor 3M PeterJ.nomford, PhD Study Director Covance LaboratoriesInc. Date Date 152 - @-w APPENDIX 2 IndividuaAlnimal FateData IndividuaCllinicaOlbservations IndividuaOlphthahnicObservations Covanoe 6329-225 3M T-6314.1 I 153 APPENDIX 2 Individual Animal Fate Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-63141 IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER ------ C95901 c959O2 c95903 c95904 C95905 C95906 C95907 C95908 C95909 C95910 C95911 C95912 C95913 C95914 C95915 C95916 C95917 C95918 C95919 c95920 C95921 C95922 C9S923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95931 C95932 C95933 C95934 DOSE GROUP ----- 1 1 I 1 1 1 I 1 1 1 1 1 1 1 1 1 I 1 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 SEX ------ KALE KALE MALE MALE MALE MALE MALE MALE MALE MALE 14ALE MALE KALE MALE KALE MALE KALE MALE HALE MALE MALE MALE KALE MALE HALE MALE MALE MALE KALE MALE 14ALE MALE MALE KALE DEATH CODE ----- T T T T T T T T T T 1 1 I 1 1 T T T T T T T T T T T T T T T I 1 1 I TYPE OF DEATH ----------- SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED DESCRIPTION OF DEATH ------------------------- TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIPICE TERMINAL SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE DATE OF DEATH -------- 12/02/98 12/02/98 12/02/98 12/02/98 12/02/90 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 10/01/98 10/01/98 10/01/98 10101198 10/01/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 10/01/98 10/01/98 10/01/98 10/01/98 DAY OF STUDY ------- 93 93 93 93 93 93 93 93 93 93 31 31 31 31 31 93 93 93 93 93 93 93 93 93 93 93 93 93 93 93 31 31 31 31 WEEK OP STUDY ------- 14 14 14 14 14 14 14 14 14 14 5 5 5 5 5 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 5 5 5 5 154 APPENDIX 2 c individual Animal Fate Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERPLUOROOCTANESULPONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER ------ C95935 C95936 C95937 C95938 C95939 c9S940 C95941 c95942 C95943 c95944 c95945 c95946 C95947 C95948 C95949 C95950 C95951 C95952 C95953 C95954 C95955 C95956 C95957 C95958 C95959 C95960 C95961 C95962 C95963 C95964 C95965 C95966 C95967 c9s968 DOSE GROUP ----- 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 SEX ------ MALE MALE MALE MALE MALE MALE MALE MALE 14ALE MALE MALE KALE MALE MALE 14ALE MALE MALE MALE MALE MALE MALE KALE MALE IIALE MALE MALE 14ALE 14ALE MALE MALE MALE MALE KALE KALE DEATH CODE ----- 1 T T T T T T T T T T T T T T T I 1 I 1 1 T T T T T T T TT T T T T TYPE OF DEATH ----------- SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED DESCRIPTION OF DEATH ------------------------- FIRST INTERIM SACRIFICE TERMINAL TERMINAL TERMINAL SACRIFICE SACRIFICE SACRIFICE TERMINAL TERMINAL SACRIFICE SACRIFICE TERMINAL SACRIFICE TERMINAL TERMINAL SACRIFICE SACRIFICE TERMINAL TERMINAL TERMINAL TERMINAL SACRIFICE SACRIFICE SACRIFICE SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE TERMINAL TERMINAL TERMINAL TERMINAL SACRIFICE SACRIFICE SACRIFICE SACRIFICE TERMINAL SACRIFICE TERMINAL TERMINAL SACRIFICE SACRIFICE TERMINAL TERMINAL SACRIFICE SACRIFICE TERMINAL TERMINAL TERMINAL SACRIFICE SACRIFICE SACRIFICE TERMINAL SACRIFICE DATE OF DEATH -------- 10/01/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 10/01/98 10/01/98 10/02/98 10/01/98 10/01/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 DAY OF STUDY ------- 31 93 93 93 93 93 93 93 93 93 93 93 93 93 93 93 31 31 31 31 31 93 93 93 93 93 93 93 93 93 93 93 93 93 WEEK OF STUDY ------- 5 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 5 5 5 5 5 14 14 14 14 14 14 14 14 14 14 14 14 14 155 APPENDIX 2 Individual Animal Fate Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER ------ C95969 C95970 c9s971 C95972 C95973 C95974 C95975 C95976 C95977 C95978 C95979 C95980 C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 C95991 C95992 C95993 C95994 C95995 C95996 C95997 c9s998 C95999 C96000 C96001 c96002 DOSE GROUP ----- 4 4 4 4 4 4 4 4 4 4 4 4 1 I I 1 1 1 1 1 I 1 1 1 I 1 1 1 1 1 1 1 2 2 SEX ------ MALE KALE MALE KALE MALE KALE MALE MALE MALE KALE MALE MALE FEMALE FEMALE FEMALE FEMALE FE14ALE FEMALE FE14ALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE PEKKLE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE DEATH CODE ----- T T 1 1 I 1 1 T T T T T T T T T T T T T T T I 1 I 1 1 T T T T T T T TYPE OF DEATH ----------- SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED DESCRIPTION OF DEATH ------------------------- TERMINAL SACRIFICE TERMINAL SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE DATE OF DEATH -------- 12/02/98 12/02/98 10101198 10/01/98 10/01/98 10/01/98 10/01/98 12/02/98 12/02/99 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 10/01198 10/01/98 10/01/98 10/01/98 10/01/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 DAY OF STUDY ------- 93 93 31 31 31 31 31 93 93 93 93 93 93 93 93 93 93 93 93 93 93 93 31 31 31 31 31 93 93 93 93 93 93 93 WEEK OF STUDY ------- 14 14 5 5 5 5 5 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 5 5 5 5 5 14 14 14 14 14 14 14 156 APPENDIX 2 Individual Animal Fate Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANI14AL NUMBER ------ C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 C96011 C96012 C96013 c96014 c96015 c96016 C96017 C96018 c96019 C96020 C96021 c96022 c96023 C96024 c96025 c96026 C96027 c96028 C96029 C96030 c96031 c96032 c96033 C96034 c96035 c96036 DOSE GROUP ----- 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 SEX ------ FEMALE FEMALE FEMALE FEMALE FEMALE FE14ALE FEMALE FEMALE FE14ALE FEMALE FE14ALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FE14ALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FE14ALE FEMALE FEMALE FEMALE FEMALE FEMALE DEATH CODE ----- T T T T T T T T 1 1 1 1 I m T T T T T T T T T T T T T T 1 1 1 1 I T TYPE OF DEATH ----------- SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED UNSCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED DESCRIPTION OF DEATH ------------------------- TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE UNSCHEDULED DEATH TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE TERMINAL SACRIFICE DATE OF DEATH -------- 12/02/98 12/02/98 12/02/98 12/02/98 12/02/99 12/02/98 12/02/98 12/02/98 10/01/98 10/01/98 10/01/98 10/01/98 10/01/98 10/29/98 12/02198 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 10/01/98 10/01/98 10/01/98 10/01/98 10/01/98 12/02/98 DAY OF STUDY ------- 93 93 93 93 93 93 93 93 31 31 31 31 31 59 93 93 93 93 93 93 93 93 93 93 93 93 93 93 31 31 31 31 31 93 WEEK OF STUDY ------- 14 14 14 14 14 14 14 14 5 5 5 5 5 9 14 14 14 14 14 14 14 14 14 14 14 14 14 14 5 5 5 5 5 14 157 APPENDIX 2 individual Animal Fate Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER ------ C96037 C96038 c96039 C96040 C96041 C96042 C96043 C96044 c96045 c96046 C96047 C96048 C96049 C96050 c96051 C96052 c96053 C96054 C96055 C96056 C96057 C96058 c96059 C96060 DOSE GROUP ----- 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 SEX ------ FEMALE FE14ALE FEMALE FEMALE FEMALE FEMALE FE14ALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FEMALE FE14ALE FEMALE FEMALE DEATH CODE ----- T T T T T T T T T T T T T T 1 1 1 1 1 T T T T T TYPE OF DEATH ----------- SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED SCHEDULED DESCRIPTION OF DEATH ------------------------- TERMINAL SACRIFICE TERMINAL TERMINAL SACRIFICE SACRIFICE TERMINAL TERMINAL SACRIFICE SACRIFICE TERMINAL TERMINAL TERMINAL TERMINAL SACRIFICE SACRIFICE SACRIFICE SACRIFICE TERMINAL SACRIFICE TERMINAL TERMINAL SACRIFICE SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE FIRST INTERIM SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE TERMINAL SACRIFICE DATE OF DEATH -------- 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 10/01/98 10/01/98 10/01/98 10/01/98 10/01/98 12/02/98 12/02/98 12/02/98 12/02/98 12/02/98 DAY OF STUDY ------- 93 93 93 93 93 93 93 93 93 93 93 93 93 93 31 31 31 31 31 93 93 93 93 93 WEEK OF STUDY ------- 14 14 14 14 14 14 14 14 14 14 14 14 14 14 5 5 5 5 5 14 14 14 14 14 158 Appendix 2 Individual Clinical observations 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL IN-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: Ml DOSE: 0 PPM ANIMAL DEATH WK OF KEYWORD DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSERV@ -------------------------------------------------------------------------------------------------7------------------ c95901 T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS C95902 T c9S903 T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 29, 36 SKIN & PELAGE BLACK SKIN TAIL-DISTAL 50, 57, 64, 71 C95904 T C95905 T C95906 T c95907 T C95909 T C95909 T 14 DISCHARGE GENITAL RED IN COLOR 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 92 71, 78, 85, 92-93 159 Appendix 2 Individual Clinical observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ CATEGORY ANIMAL DEATH WK OF KEYWORD GROUP: Ml DOSE: 0 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BEL NUMBER CODE DEATH QUALIFIER IC, - COMMENTS LISTED AT END OF OBSE ------------------------------------------------------------------------------------------------------------------ C95910 T C95911 1 C95912 1 c95913 1 C95914 1 C95915 1 c95916 T C95917 T C95918 T C95919 T c95920 T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL, HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 APPEARANCE MALOCCLUSION 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 22, 29, 31 160 Appendix 2 individual Clinical Observations 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEPOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: M2 DOSE: 3 PPM ANIMAL DEATH WK OF KEYWORD DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOV 'C' - COMMENTS LISTED AT END OF OBSE N-U-M-BE-R---CO-D-E----DE-A-TH--------QU-A-L-I-FI-E-R------------------------------------------------------------------------------------ C95921 T c95922 T c95923 T C95924 T C95925 T c95926 T c95927 T C95928 T C95929 T c95930 T C95931 1 14 APPEARANCE MALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION THIN 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 22, 29 71, 78, 85, 92-93 71 64, 71, 78 161 Appendix 2 Individual clinical observations 13-WEEK DIETARY TOXICITY STUDY WITH N-MVMYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: M2 DOSE: 3 PPM ANIMAL DEATH WK OF KEYWORD DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSE ------------------------------------------------------------------------------------------------------------------- C95932 1 C95933 1 c95934 1 C95935 1 C95936 T C95937 T C9S938 T c95939 T C95940 T 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 14 APPEARANCE MALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 78, 85, 92-93 78, 85, 92-93 29, 36, 43, 50, 57, 64, 71, 78, 85, 92-93 162 c Appendix 2 Individual Clinical observations 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYI, ETHANOL (N-MEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: M3 DOSE: 30 PPM ANIMAL DEATH WK OF KEYWORD DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; NUMBER CODE DEATH QUALIFIER IC, - COMMENTS LISTED AT END OF OBSERV) -------------------------------------------------------------------------------------------------------------------- C95941 T C95942 T c95943 T C95944 T C95945 T C95946 T C9S947 T C95948 T c95949 T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE 14ALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION SKIN & PELAGE YELLOW HAIR PENIS COAT 50, S7, 64, 71, 78, 85, 92-93 43, 50, 57, 64, 71 85, 92-93 92-93 163 Appendix 2 individual Clinical observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M3 DOSE: 30 PPM ANIMAL DEATH WK OF KEYWORD DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELO' NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSE ------------------------------------------------------------------------------------------------------------------ c9S950 T c95951 1 C95952 1 c95953 1 c95954 1 C95955 1 C95956 T C95957 T c95959 T c95959 T c95960 T 14 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS 164 Appendix 2 Iiidividualclinical observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: M4 DOSE: 100 PPM ANIMAL DEATH WK OF KEYWORD DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSE ------------------------------------------------------------------------------------------------------------------- C95961 T C95962 T C95963 T C95964 T C95965 T C95966 T C95967 T C95968 T 14 ANI14AL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 APPEARANCE MALOCCLUSION MISSING TEETH DISCHARGE NASAL RED IN COLOR FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS 55, 57, 64, 71, 78, 85, 92-93 55 55 EYES RED DISCHARGE EYES 55 RESPIRATION AUDIBLE 55 165 Appendix 2 Individual Clinical observations 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYT ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: M4 DOSE: 100 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; ANIMAL DEATH WK OF KEYWORD IC, - COMMENTS LISTED AT END OF OBSE N-U-M-BE-R---C-OD-E----DE-A-T-H-------Q-UA-L-I-FI-E-R--------------------------------------------------------------------------------------- C95969 T C95970 T C95971 1 C95972 1 c95973 1 C95974 1 c95975 1 c9s976 T c95977 T c95978 T c95979 T c95980 T 14 ANIMAL HAS NO SIGNIFICANT 14 APPEARANCE MALOCCLUSION 5 APPEARANCE MALOCCLUSION 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 APPEARANCE KALOCCLUSION FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS 64, 71, 78, 8S, 92-93 29, 31 29, 36 166 Appendix 2 Individual Clinical observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYI, PERFI,uoRoocTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS --------- --------------------------------------------------------------------------------------------------------- CATEGORY GROUP: Fl DOSE: 0 PPM ANIMAL DEATH WK OF KEYWORD DAYS 1-93 - OBSERVED DURING IC, COMMENTS NUMBER CODE DEATH QUALIFIER --------------------------------------------------------------------------- THE DAYS LISTED AT LISTED END OF BELOW OBSE C95981 T c95982 T C95983 T C95984 T c95985 T c95986 T C95987 T C95988 T C95989 T C95990 T 14 APPEARANCE LIMITED USE LIMB-HIND-LEFT SWOLLEN LIMB-HIND-LEFT 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 AN114AL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANI14AL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 64 64 85, 92-93 167 Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ CATEGORY, GROUP: Fl DOSE: 0 PPM ANIMAL DEATH WK OF KEYWORD DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOI NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSE ------------------------------------------------------------------------------------------------------------------ c95991 1 c95992 1 C95993 1 C95994 1 C95995 1 C95996 T C95997 T C95998 T C95999 T C96000 T 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 AN114AL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS 168 Appendix 2 individual clinical observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYI, PERFI,UOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: F2 DOSE: 3 PPH ANIMAL DEATH WK OF KEYWORD DAYS 1-93 - OBSERVED DURING THE DAYS ]LISTED BELOI NUMBER CODE DEATH QUALIFIER IC, - COMMENTS LISTED AT END OF OBSE ------------------------------------------------------------------------------------------------------------------ c96001 T C96002 T C96003 T C96004 T C96005 T C96006 T c96007 T C96008 T C96009 T C96010 T C96011 1 C96012 1 C96013 1 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS No SIGNIFICANT 14 ANIMAL HAS No SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS No SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS 169 Appendix 2 Individual Clinical observations 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: F2 DOSE: 3 PPH ANIMAL DEATH WK OF KEYWORD DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW: NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSE -------------------------------------------------------------------------------------------------------------------- C96014 1 C96015 1 c96016 m C96017 T C96018 T C96019 T C96020 T 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 9 APPEARANCE MALOCCLUSION SKIN & PELAGE SORE/SCAB TAIL 14 APPEARANCE MALOCCLUSION 14 APPEARANCE MALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 22, 29 59 78, 85, 92-93 170 Appendix 2 individual clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: F3 DOSE: 30 PPM ANIMAL DEATH WK OF KEYWORD DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; NUMBER CODE DEATH QUALIFIER 'C' - COMMENTS LISTED AT END OF OBSE ------------------------------------------------------------------------------------------------------------- C96021 T C96022 T C96023 T C96024 T C96025 T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 ANI14AL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 78, 85, 92-93 C96026 T C96027 T C96028 T 14 APPEARANCE MALOCCLUSION 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 14 APPEARANCE MALOCCLUSION 57, 64 78, 85, 92-93 SKIN & PELAGE SORE/SCAB MOUTH 78 C96029 T 14 ANIMAL HAS NO SIGNIFICANT FINDINGS 171 c Appendix 2 Individtial Clinical observations 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: F3 DOSET 30 PPM ANIMAL DEATH WK OF KEYMRD DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW; NUMBER CODE DEATH QUALIFIER --.Cl - COMMENTS LISTED AT END OF OBSERVA ------------------------------------------------------------------------------------------------------------------- C96030 T C96031 1 C96032 1 C96033 1 C96034 1 c96035 1 c96036 T C96037 T C96038 T C96039 T c96040 T 14 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIKAL HAS NO SIGNIFICANT 14 AN414AL HAS No SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS 172 Cov Appendix 2 Individual Clinical Observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYI, p PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: F4 DOSE: ANIMAL DEATH WK OF KEYWORD NUMBER CODE DEATH QUALIFIER ---------------------------------------------------- C96041 T c96042 T C96043 T c96044 T c96045 T C96046 T C96047 T 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS C96048 T 14 APPEARANCE MALOCCLUSION C96049 T 14 APPEARANCE MISSING TAIL-DISTAL C96050 T C96051 1 14 ANX14AL HAS NO SIGNIFICANT FINDINGS 5 ANIMAL HAS NO SIGNIFICANT FINDINGS 100 PPM DAYS 1-93 OBSERVED DURING THE DAYS LISTED BELOW; -C- - COMMENTS LISTED AT END OF OBSERVAT ---------------------------------------- so 36, 43, 50, 57, 64, 71, 78, 85, 92-93 173 c Appendix 2 Individual clinical observations 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------- ------------ -------------------------------------------------------------------------------------------- CATEGORY GROUP: F4 DOSE: 100 PPM DAYS 1-93 - OBSERVED DURING THE DAYS LISTED BELOW: ANIMAL DEATH WK OF KEYWORD IC, - COMMENTS LISTED AT END OF OBSERVA N-U-M-BE-R---C-OD-E----DE-A-T-H-------Q-UA-L-I-FI-E-R--------------------------------------------------------------------------------------- C96052 1 c96053 1 C96054 1 C96055 1 C96056 T C96057 T C96058 T C96059 T c96060 T 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 5 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANI14AL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT 14 ANIMAL HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS 174 c Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL CATEGORY KEYWORD GROUP: Ml DOSE: 0 PPM WEEK 14 N-U-MB-E-R -------------------QU-A-L-I-FI-E-R-------------------------------------------------------------------------------------- c95901 C95902 C95903 C9S904 C95905 C95906 C95907 c95908 C95909 c95910 C95916 C95917 C95918 AN114AL HAS No SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANI14AL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS 175 Co Appendix 2 Individual Ophthalmic observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL p PERFLUOROOCTANESULFONAMIDO ETHANOL IN-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: Ml DOSE: 0 PPM ANIMAL KEYWORD WEEK 14 NUMBER QUALIFIER ---------------------------------------------------------------------------------------------------------------------- c9s9l9 C95920 ANIMAL ANIMAL HAS NO SIGNIFICANT HAS NO SIGNIFICANT FINDINGS FINDINGS 176 c Appendix 2 individual Ophthalmic observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: M2 DOSE: 3 PPM ANI14AL KEYWORD WEEK 14 NUMBER QUALIFIER --------------------------------------------------------------------------------------------------------------------- C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95936 c95937 ANIMAL HAS No SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS AN114AL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS CONJUNCTIVA CONJUNCTIVITIS EYES 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANI14AL HAS NO SIGNIFICANT FINDINGS ANI14AL HAS NO SIGNIFICANT FINDINGS 177 Appendix 2 Individual Ophthalmic observations Week 14 13-WEEK DIETARY PERFLUOROOCTANESULPONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL CATEGORY KEYWORD GROUP: m2 DOSE: 3 PPM WEEK 14 N-U-MB-E-R -------------------QU-A-L-I-FI-E-R--------------------------------------------------------------------------------------- C95938 C95939 C95940 ANIMAL ANIMAL ANIMAL HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS 178 Appendix 2 Individual ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUoRoOCTANESULFONAMIDO ETHANOL IN-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL CATEGORY KEYWORD croup: M3 DOSE: 30 PPM WEEK 14 N-U-MB-E-R------ ------------ Q-U-A-LI-F-I-ER-------------------------------------------------------------------------------------- C95941 C95942 C95943 C95944 C95945 C95946 C95941 c95948 C95949 C95950 c9s956 C95957 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT ANI14AL HAS NO SIGNIFICANT FINDINGS FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL ANIMAL ANIMAL ANIMAL ANIMAL HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS No SIGNIFICANT FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS RETINA RETINAL DEGENERATION-FOCAL EYE-RIGHT 14 ANIMAL HAS No SIGNIFICANT FINDINGS 179 c Appendix 2 individual Ophthalmic observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUORooCTANESULPONAMIDO ETHANOL TN-MEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: M3 DOSE: 30 PPM WEEK 14 ANIMAL KEYWORD NUMBER QUALIFIER -------------------------------------------------- ---------------------------------------- c959SO c9s9s9 C95960 ANIMAL HAS No SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS 180 Appendix 2 Individual ophthalmic Observations Week 14 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ CATEGORY GROUP: M4 DOSE: 100 PPM ANIMAL KEYWORD WEEK 14 NUMBER QUALIFIER ------------------------------------------------------------------------------------------------------------------ c95961 C95962 C95963 C95964 C95965 C95966 C95967 ANIMAL ANIMAL ANIMAL ANIMAL ANIMAL ANIMAL ANIMAL HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS C95968 c9s969 C95970 C95976 C95977 CONJUNCTIVA CONJUNCTIVITIS EYE-LEFT 14 ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS ANIMAL HAS NO SIGNIFICANT FINDINGS 181 Appendix 2 Individual Ophthalmic observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: M4 DOSE: 100 PPM ANIMAL KEYWORD WEEK 14 NUMBER QUALIFIER -------------------------------------------------------------------------------------------------------------------- C95978 C95979 C95980 ANIMAL ANIMAL ANIMAL HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS 182 Appendix 2 Individual ophthalmic observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: Fl DOSE: 0 PPM ANIMAL KEYWORD WEEK 14 NU14BER QUALIFIER ------------------------------------------------------------------------------------------------------------------- C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 c95996 C95997 C95998 ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT AN114AL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANI14AL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS No SIGNIFICANT ANIMAL HAS No SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS 183 c Appendix 2 Individual ophthalmic observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------------- ANIMAL CATEGORY KEYWORD GROUP: Fl DOSE: 0 PPM WEEK 14 N-U-M-BE-R-------------------Q-UA-L-I-FI-E-R-------------------------------------------------------------------------------------- C95999 C96000 ANIMAL ANIMAL HAS No SIGNIFICANT HAS NO SIGNIFICANT FINDINGS FINDINGS 184 Appendix 2 Individual Ophthalmic Observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULPONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL CATEGORY KEYWORD GROUP: F2 DOSE: 3 PPM WEEK 14 N-U-MB-E-R-----------------Q-U-AL-I-F-IE-R----------------------------------------------------------------------------------------- C96001 C96002 c96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 C96016 C96017 C96018 ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIKAL HAS NO SIGNIFICANT ANIMAL HAS No SIGNIFICANT ANI14AL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS No SIGNIFICANT ANIMAL HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS 185 c Appendix 2 Individual Ophthalmic observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL TN-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: F2 DOSE: 3 PPM WEEK 14 ANI14AL KEYWORD N-U-MB-E-R-------------------Q-UA-L-I-FI-E-R------------------------------------------------------------------------------------- C96019 C96020 ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT FINDINGS FINDINGS 186 c Appendix 2 Individual ophthalmic observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METNYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314@ IN RATS --------------------------------------------------------------------------------------------------------------------- ANIMAL CATEGORY KEYWORD GROUP: F3 DOSE: 30 PPM WEEK 14 N-U-M-BE-R-------------------Q-UA-L-I-F-IE-R------------------------------------------------------------------------------------- C96021 C96022 c96023 C96024 C96025 c96026 C96027 C96028 C96029 C96030 C96036 c96037 C96038 ANIMAL ANIMAL ANIMAL ANIMAL ANIMAL ANIMAL ANIMAL ANIMAL ANIMAL ANIMAL ANIMAL ANIMAL ANIMAL HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS 187 Appendix 2 Individual Ophthalmic observations Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- CATEGORY GROUP: F3 DOSE: 30 PPM ANIMAL KEYWORD WEEK 14 NUMBER QUALIFIER ------------------------------------------------------------------------------------------------------------------- C96039 c96040 ANIMAL ANIMAL HAS NO SIGNIFICANT HAS NO SIGNIFICANT FINDINGS FINDINGS 188 Appendix 2 Individual ophthalmic observations week 14 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL CATEGORY KEYWORD GROUP: F4 DOSE: 100 PPM WEEK 14 N-U-MB-E-R----- ------------ QUALIFIER ----------------------------------------------------------------- C96041 C96042 C96043 C96044 C96045 C96046 C96047 c96048 C96049 c96050 C96056 C96057 C96058 ANIMAL HAS NO SIGNIFICANT AN114AL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS No SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANI14AL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL ANIMAL HAS NO SIGNIFICANT HAS NO SIGNIFICANT ANIMAL HAS No SIGNIFICANT ANIMAL HAS NO SIGNIFICANT ANIMAL HAS NO SIGNIFICANT FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS FINDINGS 189 c Appendix 2 Individual ophthalmic observations week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------------- ANIMAL CATEGORY KEYWORD GROUP: F4 DOSE: 100 PPM WEEK 14 N-U-M-BE-R-------------------Q-U-A-LI-F-I-ER-------------------------------------------------------------------------------------- C96059 C96060 ANIMAL ANIMAL HAS NO SIGNIFICANT HAS NO SIGNIFICANT FINDINGS FINDINGS 190 Irz _-v APPENDIX 3 IndividuaBlody Weight Data (g) Covance 6329-225 3M T-6314.1 191 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS I -------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WE N-U-M-BE-R------------1------------2 -----------3 -----------4----------------------------------------------------------- GROUP: C95901 c95902 C95903 c95904 c959O5 c95906 c95907 C95908 C95909 c95910 C95911 c95912 C95913 C95914 C95915 C95916 C95917 C95918 c95919 C95920 GROUP: C95921 c95922 C95923 C95924 C95925 C95926 c95927 c95928 MALE 1 208 216 204 206 204 197 208 202 203 215 225 222 234 202 185 226 205 209 213 216 HALE 2 215 207 201 232 227 206 202 199 0 PPM 261 271 254 259 257 250 253 262 2S4 272 273 281 299 256 219 284 264 262 270 267 3 PPH 267 2S6 253 281 282 250 251 257 314 321 308 315 303 304 298 316 288 326 304 334 345 302 245 342 324 321 326 317 312 301 306 327 334 294 299 314 352 362 355 361 341 355 342 364 319 377 337 389 353 349 276 389 370 371 370 360 350 345 346 360 376 324 336 359 380 392 374 395 376 391 366 399 352 415 361 411 402 377 293 425 400 395 405 397 372 374 374 388 402 350 359 391 391 407 398 409 386 411 383 417 359 429 462 428 418 427 422 389 389 390 406 418 366 373 404 420 433 4 24 436 411 445 406 442 384 457 487 454 438 452 443 411 413 418 427 439 380 397 429 430 444 437 453 433 461 417 461 395 477 506 474 458 465 464 422 421 437 445 461 401 417 447 455 473 459 472 453 485 438 480 417 505 531 502 476 491 481 449 453 46 46 48 42 43 46 192 Appendix 3 Individual Body Weight Data fg) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYI, ETKANOL TN-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEE 7 8 9 N-U-M-BE-R-------------1 -----------2-----------3 -----------4-----------5-----------6----------------------------------------- GROUP: c95929 C95930 C9S931 C95932 C95933 C95934 C95935 C95936 C95937 C95938 C95939 C95940 GROUP: C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95951 C95952 C95953 C95954 C95955 c9S956 MALE 2 - 3 PPM 208 259 220 275 210 2S8 203 2S2 206 260 191 238 208 261 224 290 217 273 221 283 209 255 214 263 MALE 3 30 PPM 199 245 203 248 230 283 209 263 205 261 204 253 202 252 216 265 219 276 215 268 236 297 205 250 207 258 225 279 198 259 209 264 311 329 316 303 308 283 318 355 321 335 299 311 284 294 331 307 315 294 299 316 332 323 351 294 308 332 314 318 351 374 367 342 3S3 322 361 408 357 380 341 350 318 325 371 347 35S 336 337 358 383 364 392 329 342 374 350 366 377 398 398 365 381 352 392 436 378 406 363 383 342 347 397 366 385 369 368 380 413 389 416 347 362 404 381 396 393 413 46S 395 426 384 398 357 360 408 382 395 386 381 397 428 407 42S 418 441 496 412 451 404 418 373 380 429 404 418 410 397 419 4S7 431 448 436 449 511 421 466 413 432 387 372 452 413 443 425 415 433 478 445 469 461 472 528 444 486 433 455 403 400 466 430 462 450 433 457 502 463 489 193 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------- ------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK 6 7 WEEK WEEK 8 9 N-U-MB-E-R----- -------1-----------2------------3 -----------4-----------5---------------------------------------------------- GROUP: MALE 3 - 30 PPH c95957 226 279 326 367 389 411 427 440 420 460 438 c9s9s8 205 261 308 343 323 369 353 389 372 406 392 401 421 cC9955996509 129104 224644 239107 348 383 399 420 426 446 GROUP: MALE 4 100 PPM C95961 227 284 334 373 402 417 442 456 397 476 412 C95962 205 252 292 321 343 345 369 356 389 381 412 427 452 cC9955996643 221272 226646 332118703 331531 333832 338494 437118 433842 434973 360 386 405 426 cC9955996656 119975 224455 284 331374 336439 374 399 408 423 C95967 204 206 256 258 301 310 349 377 390 422 437 417 C95968 317 351 377 386 417 427 432 434 451 453 C95969 219 C95970 232 277 281 329 362 385 394 C95971 203 252 298 336 340 C95972 200 253 304 341 367 C95973 184 234 271 295 311 c9S974 197 246 293 320 343 C95975 214 262 306 283 334 312 357 332 350 361 367 380 C95976 200 244 256 299 330 358 376 400 416 432 c95977 209 C95978 212 268 313 344 367 391 410 398 422 407 439 419 204 255 300 334 342 359 369 379 382 397 409 429 c9S979 C95980 219 269 313 194 Appendix 3 Individual Body Weight Data lg) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANI14AL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 1 2 3 4 5 6 7 8 9 ------------------------------------------------------------------------------------------------------------------- GROUP: FEMALE 1 0 PPM C95981 156 191 220 240 256 260 273 287 286 C95982 142 175 213 216 224 234 241 246 256 C95983 146 173 186 195 214 211 224 219 229 C95984 169 192 215 241 247 243 251 254 263 C95985 162 195 213 234 240 254 262 267 270 c9s986 169 190 218 230 236 247 260 262 262 C95987 146 173 182 213 211 218 220 229 240 C95988 150 171 182 215 217 232 239 234 250 C95989 153 189 204 228 249 252 254 262 286 C95990 172 208 225 256 280 279 292 301 302 C95991 168 193 214 219 240 C95992 148 167 177 203 213 C95993 iss 180 184 207 218 C95994 172 194 217 229 245 C95995 152 162 181 201 207 C95996 165 194 210 237 244 258 260 264 271 C9S997 152 176 192 211 219 223 233 238 249 C95998 167 194 202 226 237 241 241 246 244 C95999 173 194 222 260 286 300 318 318 332 C96000 161 180 206 22S 232 248 261 261 268 GROUP: FEMALE 2 3 PPM c96001 143 161 187 204 201 214 224 228 243 C96002 142 160 176 178 200 20S 209 209 222 c96003 153 168 190 201 196 207 217 215 219 C96004 176 153 124 198 218 236 243 239 251 C96005 165 187 205 221 224 232 236 241 252 c96006 ISO 170 187 210 218 220 232 234 244 c96007 164 188 202 226 234 245 244 250 260 C96008 168 186 217 229 238 246 261 260 277 195 Appendix 3 Individual Body Weight Data ig) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEPOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 1 2 3 4 5 6 1 8 ------------------------------------------------------------------------------------------------------------------- GROUP: FE14ALE 2 - 3 PPH C96009 140 156 166 170 181 190 200 198 205 C96010 162 184 209 216 232 240 249 249 265 C96011 149 184 203 246 250 C96012 149 167 193 213 223 C96013 169 195 217 239 250 C96024 167 193 214 245 260 C96015 15S 178 205 228 236 C96016 177 206 232 245 252 266 271 273 284 C96017 164 194 224 257 271 291 287 287 29S C96018 160 189 224 239 243 247 265 272 264 271 275 280 283 289 C96019 178 203 228 245 224 237 239 242 252 C96020 154 184 193 222 GROUP: FEMALE 3 30 PPM C96021 144 162 182 211 222 225 227 234 242 C96022 167 193 221 232 250 234 249 234 256 243 261 244 271 255 C96023 167 189 210 219 237 243 255 252 269 CC9966002245 117741 119946 219270 222335 232 235 243 250 251 C96026 150 168 188 206 213 211 228 230 232 C96027 165 194 222 245 258 266 277 280 297 c96028 168 178 217 224 237 240 248 227 236 258 266 236 245 c96029 151 173 191 206 223 220 223 236 241 251 C96030 151 169 189 211 C96031 159 182 191 219 230 C96032 158 177 195 220 230 C96033 160 190 210 233 240 C96034 167 193 220 246 262 C96035 169 203 227 240 245 C96036 164 185 206 226 231 238 249 254 261 196 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETNANOL IN-HEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WE NUMBER 1 2 3 4 5 6 7 8 ----------------------------------------------------------------------------------------------------------------- GROUP: FEMALE 3 30 PPM C96037 158 190 202 226 228 238 242 248 260 C96038 161 178 203 221 228 244 256 261 263 c96039 156 181 201 225 233 243 254 254 267 C96040 140 162 170 lea 198 208 219 219 224 GROUP: FEMALE 4 100 PPM C96041 140 164 180 194 200 201 205 215 223 C96042 163 184 200 213 216 224 229 231 239 C96043 151 170 188 202 209 211 219 222 226 C96044 169 198 217 236 241 253 259 2SB 268 C96045 164 182 207 218 222 234 244 250 255 C96046 170 190 211 226 238 249 258 263 269 c96047 160 171 185 198 200 206 209 214 219 C96048 157 188 199 215 221 227 231 227 239 C96049 144 158 163 180 188 189 187 189 199 C96050 150 165 187 199 205 205 212 214 216 C96051 153 163 185 199 199 C96052 179 192 208 223 228 C96053 152 169 176 206 218 C96054 156 174 180 198 209 c960S5 155 169 172 193 198 c96056 155 174 190 194 206 215 222 214 222 C96057 166 196 218 222 237 248 256 258 262 c96058 169 193 224 228 230 241 246 251 257 C96059 141 164 176 174 193 199 210 206 218 C96060 165 188 213 221 233 245 243 247 258 197 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS ------- -------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK N-U-MB-E-R--- --------1-1 ----------1-2----------1-3-----------14-------------------------------------------------------------- GROUP: C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 C9S916 C95917 c9s9l8 C95919 C95920 MALE 1 481 505 484 501 478 525 468 508 430 550 561 529 493 520 511 0 PPM 492 514 493 516 488 539 481 517 448 579 570 542 505 532 526 Soo 523 533 542 510 518 S31 539 495 509 561 Sol 501 511 526 543 459 475 596 623 588 601 559 577 520 53S ssi 567 545 557 GROUP: MALE 2 3 PPM C95921 483 494 Soo 512 c95922 480 494 510 527 C95923 499 505 529 531 C95924 494 503 520 527 C95925 438 474 498 510 C95926 447 457 468 479 C95927 468 485 497 511 C95928 495 501 sis 524 C95929 502 517 540 549 C95930 490 502 519 525 C95936 568 575 577 585 C95937 463 444 459 482 C95938 517 515 532 544 C95939 451 465 474 483 198 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK NUMBER 11 12 13 14 ------------------------------------------------------------------------------------------------------------------- CROUP: KALE 2 - 3 PPM C95940 487 504 518 524 GROUP: HALE 3 - 30 PPM C95941 419 426 435 448 c9S942 421 427 449 454 c95943 501 509 529 S34 C95944 444 452 466 475 C95945 486 501 513 524 C95946 476 480 492 502 C95947 457 458 463 471 C95948 478 493 504 515 C95949 534 542 517 413 c95950 473 482 495 502 C95956 518 534 543 SSB C95957 479 487 499 516 C95958 471 485 Soo 502 C95959 448 458 467 476 C95960 460 466 477 481 GROUP: MALE 4 100 PPM c9S961 497 509 513 522 C95962 434 443 457 468 C95963 478 488 Sol 511 c9S964 466 474 485 499 C95965 422 430 443 453 C95966 451 461 468 482 C95967 449 460 472 480 C95968 458 468 485 494 C95969 475 481 485 Soo 199 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL IN-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK NUMBER 11 12 13 14 ------------------------------------------------------------------------------------------------------------------ GROUP: HALE 4 - 100 PPM C95970 460 462 468 473 C95976 393 404 408 418 C95977 458 469 479 490 C95978 465 475 485 490 C95979 441 4S2 459 469 C95980 442 450 458 465 GROUP: FEMALE 1 0 PPM C95981 292 313 307 331 C95982 262 267 271 275 C95983 240 241 241 246 C95984 280 285 284 299 C95985 293 297 296 312 C95986 281 285 290 297 C95987 251 256 264 272 C95988 264 261 276 283 C95989 284 299 311 310 C95990 330 332 349 341 C95996 278 281 292 291 C95997 256 266 271 277 C95998 257 262 266 267 C95999 362 372 388 394 C96000 286 292 290 298 GROUP: FEMALE 2 3 ppm C96001 245 253 253 263 C96002 236 237 243 251 c96003 234 231 232 244 C96004 267 268 279 298 200 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK NUMBER 11 12 13 14 ------------------------------------------------------------------------------------------------------------------ GROUP: FEMALE 2 - 3 PPM C96005 257 261 266 269 C96006 251 258 266 274 C96007 268 271 280 292 C96008 289 296 300 305 C96009 216 218 226 231 C96010 274 275 283 292 C96017 303 301 318 303 C96018 299 292 307 306 C96019 300 298 313 321 C96020 257 261 260 267 GROUP: FEMALE 3 30 PPM C96021 247 254 258 262 C96022 274 284 283 292 c96023 265 26S 274 277 C96024 271 273 278 283 C96025 273 274 265 275 c96026 247 249 257 255 c96027 300 312 322 323 C96028 280 279 290 295 C96029 252 252 257 26S C96030 254 258 262 262 c96036 270 270 276 275 C96037 261 273 269 283 C96038 282 290 291 304 C96039 274 276 285 284 C96040 239 241 239 251 201 Appendix 3 Individual Body Weight Data (g) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDD TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK NUMBER 11 12 13 14 ------------------------------------------------------------------------------------------------------------------- GROUP: FEMALE 4 100 PPM C96041 222 C96042 242 C96043 232 C96044 276 c96045 269 C96046 279 C96047 224 C96048 248 C96049 203 C96050 225 c96056 228 C96057 270 C96058 256 c96059 227 C96060 267 231 234 236 246 249 247 239 242 239 282 283 287 271 273 280 283 294 290 226 227 231 243 247 259 207 208 213 228 233 239 224 226 229 267 276 279 262 269 271 219 228 232 269 275 271 202 -.-iw --- - -V -- W- @ t APPENDIX 4 Covance 6329-225 3M T-6314.1 IndividuaFlood Consumption Data (g) IndividuaTlestMaterialConsumption (mg/kglday) 203 Appendix 4 Individual Food Consumption Data lg) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 1 2 3 4 s 6 7 8 9 -------------------------------------------------------------------------------------------------------------------- GROUP: MALE 1 0 PPM C95901 C95902 C95903 C95904 C9590S C95906 c95907 C95908 C95909 C95910 C95911 C95912 C95913 C95914 C95915 C95916 C95917 C95918 C95919 C95920 165 168 171 183 159 172 174 179 190 178 160 173 176 187 162 176 182 191 202 177 164 165 175 182 166 161 166 182 199 168 156 158 169 174 157 177 183 192 202 172 152 151 154 SPILLED 147 175 179 191 198 176 172 165 162 172 187 191 194 198 lei 179 169 174 164 272 180 187 136 SPILLED 163 142 176 188 191 192 192 187 185 284 185 189 168 181 186 187 184 178 207 231 SPILLED 233 164 168 179 190 192 179 181 181 176 197 187 187 192 190 182 181 182 203 202 208 213 182 SPILLED SPILLED 214 199 195 188 183 iso 177 167 166 197 199 192 190 170 164 165 160 194 200 193 208 194 190 186 185 187 189 186 178 180 182 lei 178 233 242 SPILLED 240 185 189 184 188 GROUP: MALE 2 3 PPM C95921 162 C95922 163 C95923 159 C95924 171 c95925 185 C95926 164 C95927 161 c95928 187 170 168 175 168 176 168 175 179 158 175 170 175 178 163 iss 177 179 184 164 186 195 SPILLED 214 187 206 162 167 168 157 171 168 165 170 155 172 189 188 202 SPILLED 201 185 SPILLED 187 176 183 178 186 191 187 186 186 183 211 215 203 177 167 167 177 175 173 206 201 197 204 Appendix 4 Individual Food Consumption Data fg) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEP NUMBER 1 2 3 4 5 6 7 8 9 ------------------------------------------------------------------------------------------------------------------- GROUP: KALE 2 - 3 PPM C95929 175 186 191 195 191 237 c95930 177 194 218 195 176 208 c95931 155 SPILLED 21S SPILLED c95932 160 165 166 173 c95933 165 172 176 172 C95934 156 161 164 169 C9593S 183 195 197 197 C95936 171 189 203 197 192 191 C95937 163 172 175 178 184 184 C95938 177 189 197 204 186 194 c95939 163 174 187 191 199 185 C95940 165 171 176 184 179 178 GROUP: KALE 3 30 PPM C95941 C95942 c95943 C95944 c95945 C95946 c95947 C95948 c95949 C95950 c95951 C95952 C95953 C95954 C95955 c95956 154 159 158 156 162 161 178 184 190 174 179 183 168 184 191 169 168 180 isi 161 166 166 179 200 172 186 197 168 180 189 181 185 193 155 161 167 178 186 192 184 197 202 194 197 200 208 SPILLED 214 166 152 162 166 152 170 197 162 186 186 164 189 193 179 198 189 173 186 171 IS2 168 188 176 185 201 181 207 188 168 200 192 174 187 216 210 228 SPILLED 259 234 SPILLED 235 190 186 186 194 188 189 186 SPILLED 198 197 199 197 194 180 168 187 185 189 159 153 145 145 153 158 189 183 185 180 178 169 197 187 187 184 189 179 162 155 157 183 185 182 209 204 200 191 189 190 246 SPILLED 226 205 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 1 2 3 4 5 6 7 8 9 ------------------------------------------------------------------------------------------------------------------- GROUP: KALE 3 - 30 PPM C95957 166 179 188 189 184 lal 182 180 176 C95958 168 175 180 182 181 194 176 183 188 c95959 163 176 178 193 185 193 189 190 188 C95960 168 181 181 200 192 175 175 178 167 GROUP: KALE 4 100 PPM C95961 183 189 191 194 171 200 194 192 188 C95962 159 168 165 167 154 179 178 171 171 C95963 172 171 171 171 165 184 179 180 183 C95964 172 191 181 194 171 185 190 185 179 C95965 159 168 168 172 157 177 172 165 169 C9S966 ise 167 171 173 154 180 179 178 180 C95967 170 178 175 179 157 179 183 176 179 c9s968 188 184 191 197 171 195 194 159 iss C9S969 181 179 178@ 180 iss 183 183 181 178 C95970 171 198 SPILLED 187 170 195 187 187 174 C95971 159 166 170 152 C95972 160 169 172 172 C95973 165 170 164 167 C95974 162 175 170 172 C95975 164 168 169 173 c95976 162 167 164 165 161 163 162 157 155 C95977 163 174 169 177 173 182 186 181 184 C95978 166 171 165 170 171 172 173 174 180 C95979 170 175 177 176 183 175 179 170 171 C95980 174 182 178 177 180 181 184 182 180 206 Appendix 4 Individual Food Consumption Data lg) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 1 2 3 4 5 6 7 8 9 ------------------------------------------------------------------------------------------------------------------- GROUP: C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 C95991 C95992 C95993 C95994 C95995 C95996 C95997 C95998 C95999 C96000 GROUP: C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 FE14ALE 1 138 127 127 126 135 137 124 124 135 162 131 ill 121 129 ill 122 ill 120 98 SPILLED FEMALE 2 SPILLED 103 106 169 125 SPILLED 119 148 0 PPM 150 143 139 130 128 152 123 114 134 147 126 101 108 133 SPILLED 126 107 112 144 145 3 PPM SPILLED 106 113 45 120 SPILLED 122 SPILLED 153 123 SPILLED 145 133 132 163 127 144 165 135 116 119 138 162 127 114 119 145 158 SPILLED 104 110 127 122 SPILLED 133 144 IS3 116 SPILLED 137 137 138 130 125 SPILLED 170 159 116 125 146 118 127 115 119 163 SPILLED SPILLED 121 107 SPILLED 125 SPILLED 137 148 129 115 108 125 132 121 113 SPILLED 137 135 121 119 126 166 156 SPILLED 106 105 125 119 112 SPILLED 113 161 126 120 138 137 SPILLED 128 130 SPILLED 156 119 SPILLED 113 171 ls6 121 109 106 138 125 SPILLED 132 145 159 134 SPILLED 148 137 130 151 119 SPILLED 158 121 SPILLED 161 157 151 176 ill 106 134 127 SPILLED 149 137 129 120 102 iso 135 127 129 126 SPILLED 140 113 SPILLED SPILLED 163 171 SPILLED 119 SPILLED 140 161 123 137 146 104 119 SPILLED 141 136 132 132 125 SPILLED 147 109 SPILLED 119 163 SPILLED SPILLED 113 109 144 129 SPILLED 133 135 207 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 1 2 3 4 5 6 7 8 9 -------------------------------------------------------------------------------------------------------------------- GROUP: C96009 C96010 C96011 C96012 c96013 C96014 C96015 C96016 C96017 c96018 C96019 C96020 GROUP: C96021 C96022 c96023 C96024 c96025 C96026 C96027 C96028 C96029 C96030 C96031 C96032 C96033 C96034 C96035 C96036 FEMALE 2 - 3 PPM 115 117 133 113 SPILLED 131 124 122 136 140 131 SPILLED SPILLED 122 128 143 152 135 129 131 131 144 143 120 FEMALE 3 30 PPM SPILLED 131 117 129 133 SPILLED 208 124 129 131 135 124 124 162 149 117 178 SPILLED 125 126 123 SPILLED SPILLED 137 SPILLED 130 SPILLED 140 129 139 151 118 SPILLED 127 148 SPILLED 167 144 132 130 153 158 137 126 140 149 131 129 135 SPILLED 188 132 159 138 163 128 137 139 136 122 108 137 153 128 150 ISO 137 127 151 SPILLED 137 126 142 150 137 134 135 SPILLED SPILLED 13S 135 139 SPILLED 131 133 164 142 118 99 124 131 157 SPILLED 147 126 134 SPILLED 113 117 120 SPILLED SPILLED 120 115 130 SPILLED 147 141 131 140 SPILLED 145 120 152 141 154 132 137 155 181 128 SPILLED 139 159 171 SPILLED 128 141 SPILLED 149 128 SPILLED 140 131 SPILLED 129 SPILLED SPILLED 138 SPILLED 146 SPILLED 125 139 130 137 SPILLED 146 125 127 127 138 131 134 SPILLED SPILLED 137 158 130 138 119 151 NOT TAK 138 139 142 117 SPILLED 131 131 121 139 SPILLED 164 139 SPILLED 133 SPILLED 208 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 1 2 3 4 5 6 7 8 9 ------------------------------------------------------------------------------------------------------------------- GROUP: C96037 C96038 C96039 c96040 GROUP: C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96051 C96052 C96053 C96054 c96055 C96056 C96057 C96058 C96059 C96060 FEMALE 3 130 120 185 SPILLED FEMALE 4 135 100 107 136 118 SPILLED 108 128 101 133 101 149 113 SPILLED 105 109 175 124 lie 129 30 PPM 127 161 SPILLED SPILLED 100 PPM 110 92 104 127 128 SPILLED 107 ill SPILLED SPILLED 107 126 109 SPILLED 100 108 133 133 143 123 178 SPILLED SPILLED SPILLED 109 96 103 137 124 127 105 102 99 124 101 140 118 SPILLED 104 110 130 124 107 116 SPILLED SPILLED SPILLED SPILLED 120 99 105 1-42 145 130 99 ill 102 120 106 128 121 151 108 116 159 121 121 120 125 SPILLED SPILLED SPILLED 106 99 102 132 124 128 102 100 94 104 112 149 127 121 122 130 194 SPILLED SPILLED 125 107 109 142 148 136 106 110 105 117 ill 137 125 124 115 129 SPILLED SPILLED SPILLED 117 106 105 129 142 SPILLED 104 102 98 114 103 132 129 125 125 136 SPILLED 159 S.PZLLED 113 109 102 141 140 isi 109 ill 106 109 127 SPILLED SPILLED 225 ill 104 104 135 146 149 103 114 108 ill 107 133 124 SPILLED 121 101 124 121 SPILLEI 123 209 Appendix 4 Individual Food Consumption Data (9) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK NUMBER 11 12 13 -------------------------------------------------------------------------------------------------------------------- GROUP: C95901 C95902 c95903 C95904 C95905 C95906 c95907 C95908 c95909 C95910 C95916 C95917 C95918 C95919 C95920 GROUP: C95921 C95922 C95923 C95924 c95925 C95926 c95927 c95928 c9S929 C95930 c95936 C95937 C95938 C95939 MALE I - 0 PPM 167 171 ISO 184 176 182 216 213 244 SPILLED 192 199 163 168 194 195 157 157 SPILLED 198 182 184 179 183 179 191 260 SPILLED 187 186 MALE 2 3 PPM 208 204 174 176 188 iss 184 188 190 199 158 153 177 176 194 197 221 207 177 184 179 161 ls4 140 195 199 168 168 172 180 179 198 177 190 SPILLED 194 157 208 182 SPILLED 173 241 181 203 171 169 184 193 154 167 178 189 177 172 181 188 166 210 Appendix 4 Individual Food Consumption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK NUMBER 11 12 13 ------------------------------------------------------------------------------------------------------------------- GROUP: MALE 2 - 3 PPM c95940 184 184 175 GROUP: HALE 3 - 30 PPM c95941 147 145 139 c95942 166 169 181 c95943 175 181 171 C95944 162 163 158 C95945 183 182 188 C9S946 SPILLED 174 167 C95947 143 141 138 C95948 182 178 182 C95949 192 175 7 c95950 184 190 188 c95956 233 224 207 C95957 164 167 165 C95958 184 182 173 C95959 183 185 178 c95960 161 166 156 GROUP: MALE 4 100 PPM C95961 177 178 178 c95962 159 164 157 C95963 182 183 175 C95964 177 178 178 C95965 163 169 168 C95966 175 172 164 c95967 177 177 166 C95968 197 199 175 C95969 169 170 170 211 Appendix 4 Individual Food Conswnption Data (g) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK NUMBER 11 12 13 ------------------------------------------------------------------------------------------------------------------ GROUP: c9S970 C95976 C95977 C95978 C95979 c95980 GROUP: c9s981 C95982 C95983 C95984 c95985 C95986 C95987 C95988 C95989 C95990 C95996 c95997 C95998 C95999 C96000 GROUP: C96001 C96002 C96003 c96004 MALE 4 - 100 PPM 163 SPILLED 178 170 165 174 FEMALE 1 163 146 175 175 172 174 0 PPM 175 116 SPILLED 139 134 130 125 117 SPILLED 139 ill SPILLED SPILLED 176 SPILLED 123 109 165 124 131 125 117 131 SPILLED 148 ill 213 122 168 SPILLED FEMALE 2 3 PPM 110 104 112 114 ill 114 134 138 157 147 171 169 173 176 182 109 171 128 135 ill 122 114 SPILLED 117 109 SPILLED SPILLED 160 SPILLED 101 105 107 137 212 Appendix 4 individual Food Consumption Data (g) 13-WEEK DIETARY PERFLUORGOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL WEEK WEEK WEEK NU14BER 11 12 13 ------------------------------------------------------------------------------------------------------------------ GROUP: C96005 c96006 c96007 C96008 C96009 c96010 C96017 c96018 C96019 c96020 GROUP: c96021 C96022 C96023 C96024 C96025 c96026 C96027 C96028 C96029 c96030 C96036 c96037 c96038 C96039 C96040 FEMALE 2 120 SPILLED 141 132 SPILLED 135 Ila 123 139 110 FEMALE 3 195 132 125 123 125 SPILLED 193 116 SPILLED 122 SPILLED 128 139 197 SPILLED 3 PPM 116 SPILLED 149 130 129 150 127 147 143 119 30 PPM 127 121 121 123 107 250 183 120 177 123 129 128 134 172 174 113 SPILLED 136 126 SPILLED 130 97 SPILLED 150 113 125 126 121 118 115 220 148 124 SPILLED 125 212 134 130 162 SPILLED 213 Appendix 4 Individual Food Consumption Data 19) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN-HEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK N-U-MB-E-R -----------1-1-----------12-----------13------------------------------------------------------------------------------ GROUP: c96041 C96042 c96043 C96044 C96045 C96046 c96047 C96048 C96049 C96050 C96056 C96057 c96058 C96059 C96060 FEMALE 4 108 97 103 131 133 123 97 118 106 107 97 SPILLED 119 SPILLED lie 100 PPM 106 99 99 129 131 122 100 118 105 112 96 132 120 SPILLED 116 103 96 96 129 137 128 105 125 103 106 101 131 197 SPILLED 112 214 Appendix 4 Individual Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 1 2 3 4 5 6 7 8 9 ------------------------------------------------------------------------------------------------------------------- GROUP: C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95931 C95932 c95933 C95934 C95935 C9S936 C95937 C95938 C95939 c9S940 GROUP: C95941 C95942 C95943 C95944 C95945 C95946 C95947 c95948 KALE 2 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.4 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 3 PPM 0.3 0.3 0.3 0.2 0.3 0.3 0.3 0.3 0.3 0.3 SPILLED 0.3 0.3 0.3 0.3 0.3 0.2 0.3 0.3 0.3 M)KLE 3 3.0 3.0 3.0 3.2 3.1 3.2 2.9 3.0 30 PPM 2.6 2.6 2.6 2.7 2.7 2.6 2.5 2.6 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 0.3 0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.3 0.2 2.2 2.2 2.3 2.4 2.4 2.4 2.2 2.5 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.2 o.2 0.2 0.2 0.2 0.2 0.2 2.2 2.1 2.2 2.2 2.2 2.3 2.1 2.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.3 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 SPILLED 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 o.2 0.2 0.2 0.2 NOT TM NOT TAI NOT TAI NOT TA) NOT 0. 0. 0. 0. 0. 1.9 1.9 1.8 1.7 1. 1.8 2.0 1.7 1.7 1. 1.7 1.9 1.8 1.7 1. 1.9 2.1 1.9 1.8 1. 2.0 2.1 2.0 1.8 1. 2.0 2.0 1.9 1.9 1. 1.7 1.9 1.7 1.6 1. 1.9 1.9 1.8 1.8 1. 215 c Appendix 4 Inclividual Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 1 2 3 4 5 6 7 8 9 -------------------------------------------------------------------------------------------------------------------- GROUP: C95949 C95950 c959Sl C95952 c95953 C95954 C95955 C959S6 C95957 C95958 C95959 C95960 GROUP: c95961 C95962 c95963 c95964 C95965 c95966 C95967 C95968 c95969 c95970 C95971 C95972 C95973 C9S974 C95975 C95976 MALE 3 - 30 PPM 3.0 2.6 3.0 2.6 2.9 2.4 2.9 2.S 3.3 2.8 3.1 2.8 3.6 2.9 3.8 SPILLED 2.8 2.5 3.1 2.6 3.2 2.8 3.0 2.7 MALE 4 - 100 PPM 10.2 8.7 9.9 8.8 10.2 8.5 10.1 9.4 10.3 9.1 10.2 9.0 10.6 9.1 11.6 9.3 10.4 8.6 9.5 9.3 10.0 8.6 10.1 8.7 11.3 9.6 10.4 9.3 9.8 8.5 10.4 9.1 2.4 2.4 2.2 2.3 2.5 2.5 2.6 2.7 2.3 2.4 2.S 2.3 7.7 7.7 7.5 7.7 8.1 8.1 7.9 8.3 7.6 SPILLED 7.7 7.6 8.3 7.9 7.5 7.9 2.2 2.1 2.0 2.2 2.3 2.4 2.S 2.6 2.1 2.2 2.4 2.3 7.2 7.2 6.9 7.6 7.6 7.4 7.3 7.8 7.1 7.2 6.4 6.9 7.9 7.4 7.2 7.3 1.8 1.8 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SPILLED 2.0 2.0 2.2 2.1 2.0 2.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.5 1.9 2.1 2.2 1.8 1.9 1.9 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.3 1.8 1.8 2.0 1.8 1.8 1.8 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SPILLED 1.7 1.8 2.0 1.7 1.7 1.8 NOT TAKE NOT TAKE NOT TAKE NOT TAKE NOT TAKE 1.9 1.6 1.8 1.9 1.6 6.0 6.3 6.2 6.3 6.6 6.2 6.1 6.4 S.8 6.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.7 6.7 6.9 6.6 .6.5 7.1 6.9 6.6 6.9 6.5 6.8 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.6 6.2 6.5 6.1 6.4 6.5 6.5 6.5 6.5 6.2 6.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.4 5.9 6.0 5.9 6.0 6.1 6.1 6.1 5.3 5.9 6.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.0 5.6 5.9 5.7 5.7 6.0 6.0 5.9 5.2 5.6 S.5 NOT TAK NOT TAKE NOT TAK NOT TAKE NOT TAKE 5.8 216 Appendix 4 Individual Test Material consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYI, PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 1 2 3 4 5 6 7 8 ------------------------------------------------------------------------------------------------------------------- GROUP: c95977 c95978 C95979 c95980 GROUP: c96001 C96002 c96003 C96004 c96005 c96OO6 c96007 c96008 c96009 C96010 C96011 c96012 c96013 c96014 c96015 C96016 c96017 c96018 c96019 C96020 KALE 4 - 100 PPM 10.0 9.0 9.9 8.4 10.6 9.0 10.2 8.9 FEMALE 2 3 PPM SPILLED 0.3 0.3 0.4 0.3 SPILLED 0.3 0.4 0.3 0.3 0.3 0.3 SPILLED 0.3 0.3 0.3 0.3 0.3 0.3 SPILLED SPILLED 0.3 0.3 0.1 o.3 SPILLED 0.3 SPILLED SPILLED 0.3 0.3 o.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 7.7 7.2 8.0 7.8 SPILLED 0.3 0.2 0.3 0.2 SPILLED 0.3 0.3 SPILLED 0.3 o.3 SPILLED 0.3 0.3 0.3 0.2 0.3 0.3 0.2 0.3 7.4 6.8 7.3 7.1 SPILLED 0.3 0.2 SPILLED 0.2 SPILLED 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.2 0.2 SPILLED 0.2 0.2 6.7 6.7 6.5 6.1 6.0 6.4 6.1 5.9 5.8 5.8 7.1 6.4 6.4 5.9 5.8 6.8 6.6 6.S 6.2 5.9 SPILLED 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 o.2 o.2 0.2 SPILLED 0.2 0.2 0.3 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 SPILLED 0.2 0.2 0.3 0.2 0.2 0.2 0.2 SPILLED 0.3 0.2 0.4 SPILLED NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 SPILLED 0.2 0.2 SPILLED 0.2 SPILLED 0.2 0.3 0.2 0.2 0.2 0.3 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 SPILLED 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 NOT TAK NOT TAK NOT TAK NOT TAK NOT TAK NOT TAK 0.2 0.2 0.2 0.2 217 Appendix 4 individual Test Material consumption Data lmg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK NUMBER 1 2 3 4 5 6 7 8 9 ------------------------------------------------------------------------------------------------------------------- GROUP: C96021 C96022 c96023 C96024 C96025 C96026 C96027 C96028 C96029 c96030 c96031 C96032 c96033 C96034 c96035 C96036 C96037 C96038 C96039 c96040 GROUP: C96041 C96042 C96043 C96044 C96045 C96046 c96047 C96048 FEMALE 3 SPILLED 3.1 2.8 3.0 3.1 SPILLED 5.0 3.1 3.4 3.5 3.4 3.2 3.0 3.9 3.4 2.9 3.2 3.0 4.7 SPILLED FEMALE 4 12.7 8.2 9.5 10.6 9.7 SPILLED 9.3 10.6 30 PPM 4.4 SPILLED 2.7 2.6 2.7 SPILLED SPILLED 3.0 SPILLED 3.1 SPILLED 3.2 2.8 2.9 3.0 2.6 2.8 3.6 SPILLED SPILLED 100 PPM 9.1 6.8 8.3 8.7 9.4 SPILLED 8.6 8.2 3.1 2.8 2.6 2.4 2.8 SPILLED 3.5 2.6 3.4 3.0 3.4 2.6 2.7 2.6 2.5 2.4 3.6 SPILLED SPILLED SPILLED 8.3 6.6 7.5 8.6 9.3 8.3 7.8 7.0 2.8 2.7 2.6 2.4 2.5 SPILLED SPILLED 2.5 2.7 2.8 SPILLED 2.5 2.4 2.8 2.5 2.2 SPILLED SPILLED SPILLED SPILLED 8.7 6.6 7.3 8.5 9.4 8.0 7.1 7.3 2.6 SPILLED 2.1 2.1 2.2 SPILLED SPILLED 2.2 2.2 2.5 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SPILLED 2.3 SPILLED SPILLED SPILLED 2.9 2.4 2.8 2.3 2.5 3.0 2.9 2.2 SPILLED 2.6 TAKEN NOT NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.8 2.3 3.3 SPILLED SPILLED SPILLED 2.3 2.3 SPILLED 2.2 SPILLED SPILLED 2.3 SPILLED 2.6 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SPILLED 2.3 SPILLED SPILLED SPILLED 2.3 2.0 2.4 2.2 2.3 SPILLED SPILLED 2.2 2.8 2TA.K3EN MT NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.3 2.3 SPILLED 2.6 SPILLED SPILLED 2.1 2.2 1.9 2.3 SPILLED 2.4 2.2 SPILLEE 2.3 NOT TM NOT TAI NOT TAJ NOT TAJ NOT TAk SPILLEI 2.1 SPILLE SPILLE 4. 7.6 8.8 8.0 7.4 7. 6.4 6.7 6.6 6.6 6. 6.9 7.2 6.8 6.5 6. 7.6 7.9 7.1 7.7 7. 7.8 8.8 8.2 7.9 B. 7.5 7.7 SPILLED 8.1 7. 7.2 7.3 7.0 7.2 6. 6.4 6.9 6.4 6.8 6. 218 Appendix 4 Individual Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ---------- ------------ -------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK WEEK WEEK 5 WEEK 6 WEEK WEEK WEEK 7 8 9 N-U-MB-E-R ------ ------1------ 2 3 4 -------------------------------------------------------------------------------------------- GROUP: c96049 C96050 c96051 C96052 C96053 C96054 c96055 C96056 C96057 C96058 C96059 c96060 FEMALE 4 9.6 12.1 9.1 11.5 10.1 SPILLED 9.3 9.5 13.8 9.9 11.1 10.4 100 PPM SPILLED SPILLED 8.8 9.0 8.9 SPILLED 8.4 8.5 9.2 9.1 12.0 8.8 8.2 9.2 7.5 9.3 8.8 SPILLED 8.1 8.2 8.4 7.8 8.7 7.6 7.9 8.5 7.6 8.1 8.2 10.6 7.9 8.3 9.9 7.5 9.4 7.6 7.1 7.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.6 8.8 7.7 8.8 7.3 8.0 8.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.3 7.8 7.3 8.7 6.7 7.4 7.6 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.7 7.3 7.4 8.6 7.3 7.8 7.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 7.o 7.3 7.0 SPILLED 6.8 7.7 7.3 NOT TAKE NOT TAKE NOT TAK NOT TAK NOT TAK 6.4 6.7 6.7 SPILLED 6.8 219 Appendix 4 Individual Test Material Consumption Data lmg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK NUMBER 11 12 13 ------------------------------------------------------------------------------------------------------------------- GROUP: C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95931 C95932 C95933 C95934 C95935 C9S936 C95937 C95938 C95939 C95940 GROUP: C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 MALE 2 - 3 PPM 0.2 0.2 0.2 0.2 0.2 0.1 0.2 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.1 0.1 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.1 0.2 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.1 0.1 0.2 0.2 0.2 MALE 3 - 30 PPM 1.5 1.4 1.7 1.7 1.5 1.5 1.5 1.5 1.6 1.5 SPILLED 1.5 1.3 1.3 1.6 1.5 0.2 0.1 0.1 0.2 0.2 0.1 0.1 0.1 0.1 0.1 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.1 0.2 0.1 0.1 0.1 1.3 1.7 1.4 1.4 1.6 1.4 1.3 1.5 220 c Appendix 4 individual Test Material consumption Data (mg/ko/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK N-U-MB-E-R ------------1-1-----------12-----------13------------------------------------------------------------------------------ GROUP: C95949 C95950 c9s951 C95952 c95953 C95954 C95955 C95956 C95957 C95958 C95959 C95960 GROUP: C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95971 C95972 C95973 c9S974 c95975 c95976 KALE 3 - 30 PPM 1.5 1.7 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 1.9 1.5 1.6 1.7 1.5 1.4 1.7 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 1.8 1.5 1.6 1.7 1.5 KALE 4 100 PPM 5.0 5.2 5.4 5.4 5.5 5.5 5.6 6.1 5.1 5.1 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SPILLED 5.0 5.2 5.3 5.3 5.5 5.3 5.4 6.0 5.0 5.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 5.1 0.1 1.6 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 1.6 1.4 1.5 1.6 1.4 4.9 4.8 4.9 5.2 5.4 4.9 5.0 5.1 4.9 4.8 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 5.1 221 c Appendix 4 individual Test Material Consumption Data (mg/kg/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PEP,FLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK NUMBER 11 12 13 --------------------------------------------------------------------------------------------------------------------- GROUP: c95977 C95978 C95979 C95980 GROUP: c96001 c96002 C96003 C96004 c9600S C96006 c96007 C96008 C96009 C96010 C96011 C96012 C96013 C96014 C96015 c96016 C96017 C96018 C96019 C96020 KALE 4 - 100 PPM 5.5 5.3 5.2 5.2 5.3 5.4 5.6 5.5 FEMALE 2 3 PPH 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 SPILLED 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 0.2 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.2 0.2 0.2 0.2 5.0 5.0 S.3 5.4 0.2 0.2 0.2 0.2 0.2 SPILLED 0.2 0.2 SPILLED 0.2 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 0.1 SPILLED 0.2 0.2 222 Co Appendix 4 iiidivicltiaTlest Material consuniption Data fmg/ko/day) 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL p PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK N-U-MB-E-R ------------1-1-----------1-2----------1-3----------------------------------------------------------------------------- GROUP: c96021 c9GO22 C96023 c96024 C9602S c96026 c96027 c96028 c96029 c96030 C96031 C96032 C96033 c96034 c96035 c96036 C96037 c96038 c96039 C96040 GROUP: c96041 c96042 C96043 c96044 c96045 c96046 c96047 c96048 FEMALE 3 - 30 PPM 3.3 2.0 2.0 1.9 2.0 SPILLED 2.7 1.8 SPILLED 2.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN SPILLED 2.1 2.1 3.1 SPILLED 2.1 1.8 1.9 1.9 1.7 4.2 2.5 1.8 3.0 2.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 2.0 2.0 2.0 2.6 3.1 FEMALE 4 6.8 5.7 6.2 6.7 7.0 6.3 6.2 6.9 100 PPM 6.5 5.) 5.9 6.5 7.2 6.1 6.3 6.9 2.1 1.9 1.9 1.8 1.8 3.7 2.0 1.8 SPILLED 2.0 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 3.3 2.1 1.9 2.4 SPILLED 6.3 5.5 5.7 6.5 7.1 6.4 6.6 7.1 223 Appendix 4 Individual Test Material Consumption Data fmg/kg/day) 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH H-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL WEEK WEEK WEEK N-U-MB-E-R----- 11 12 13 ---------------------------------------------------------------------------------------------------------- GROUP: C96049 C96050 C96051 C96052 C96053 C960S4 C96055 C96056 C960S7 C96058 C96059 C96060 FEMALE 4 7.4 6.7 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.1 SPILLED 6.6 SPILLED 6.3 100 PPM 7.2 6.9 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.1 6.9 6.5 SPILLED 6.1 7.0 6.4 NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN NOT TAKEN 6.3 6.7 10.4 SPILLED 5.9 224 APPENDIX 5 individuaCllinicaHlematology Data IndividuaCllinicaClhemistryData IndividuaCllinicaUlfinalysiDsata Covanoe 6329-225 3M T-6314.1 225 Appendix 5 individual Clinical Hematology Data males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ RBC XIO'/,uL -------- HGB G/DL -------- HCT % -------- mcv FL -------- MCH PG -------- MCHC t -------- PLT X10'/,uL -------- Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 MEAN S.D. N Group: 2 C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95920 C95929 C95930 MEAN S.D. N Dose Level: 0 8.89 8.64 8.23 7.52 7.92 7.90 8.18 7.86 8.63 8.06 17.3 16.6 16.4 15.3 15.3 15.7 16.3 16.0 17.0 16.1 8.18 .424 10 16.2 .66 10 Dose Level: 3 8.38 7.84 8.57 7.55 8.09 8.29 8.07 8.99 7.76 7.89 16.B 15.6 17.0 16.3 16.2 16.0 16.2 17.1 16.1 16.4 8.14 .427 10 16.4 .47 10 Dosage Unit: ppm MEFOS 50.1 48.1 47.5 45.5 42.7 46.2 46.7 47.4 49.1 46.3 56.4 55.7 57.6 60.5 54.0 58.5 57.1 60.3 56.9 57.4 19.4 19.2 19.9 20.4 19.3 19.8 19.9 20.4 19.7 20.0 47.0 2.04 10 57.4 1.97 10 19.8 .42 10 Dosage Unit: ppm MEFOS 49.2 45.6 48.6 46.8 46.7 46.2 47.9 51.1 46.0 47.1 58.7 58.2 56.8 61.9 57.7 55.8 59.3 56.8 59.3 59.7 20.0 19.9 19.9 21.5 20.1 19.3 20.0 19.0 20.8 20.7 47.5 1.70 10 50.4 1.77 10 20.1 .73 10 34.5 34.6 34.6 33.7 35.7 33.9 34.9 33.7 34.7 34.7 34.5 .61 10 34.1 34.2 35.0 34.7 34.8 34.6 33.8 33.5 35.0 34.7 34.4 .51 10 1186 1223 1208 1227 1235 1221 1084 1006 1099 1162 1173 61.5 10 1136 1297 1400 1177 1108 1172 1166 1143 917 993 1151 136.0 10 226 Appendix 5 Individual Clinical Hematology Data males week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ RBC xio 6 /jwL -------- HGB G/DL -------- HCT t -------- mcv FL -------- MCH PG -------- MCHC t -------- PLT X10'/jAL -------- Group: 3 C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 MEAN S.D. N Dose Level: 30 8.09 9.02 8.19 8.23 8.17 7.68 8.10 8.37 9.01 7.56 16.1 16.9 15.9 16.7 16.2 16.2 16.0 16.6 16.7 15.8 8.24 .477 10 16.3 .38 10 Dose Level: 100 7.59 8.16 8.03 7.64 8.33 8.11 8.32 7.57 7.90 8.29 15.7 16.0 16.1 16.1 16.9 15.3 16.1 14.9 14.8 16.9 7.99 .303 10 15.9 .71 10 Dosage Unit: ppm MEFOS 45.9 49.9 45.9 48.2 46.5 46.0 45.3 47.7 49.4 45.8 56.7 55.3 56.1 58.6 56.9 59.9 55.9 56.9 54.8 60.6 19.9 18.7 19.4 20.2 19.8 21.1 19.8 19.9 18.6 20.9 47.1 1.64 10 57.2 1.93 10 19.8 .81 10 Dosage Unit: ppm MEFOS 46.0 46.4 46.9 46.1 48.7 44.6 46.9 43.2 43.9 47.7 46.0 1.71 10 60.6 56.9 58.5 60.3 58.5 55.0 56.3 57.1 55.6 57.5 57.6 1.86 10 20.7 19.6 20.1 21.1 20.2 18.9 19.4 19.7 18.7 20.3 19.9 .76 10 35.1 33.9 34.6 34.5 34.9 35.2 35.4 34.9 33.9 34.4 34.7 .52 10 34.1 34.5 34.4 34.9 34.6 34.4 34.4 34.4 33.6 35.3 34.5 .45 10 1130 1133 1027 891 1074 893 1151 1027 958 1098 1038 96.9 10 1141 1097 1177 996 1166 948 1001 1296 1032 970 1081 112.7 10 227 ANIMAL NUMBER ------ Group; 1 C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 MEAN S.D. N Group: 2 C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 MEAN S.D. N Appendix 5 Individual Clinical Hematology Data Males Week 5 WBC XIO'/,wL -------- 13-WEEK DIETARY N-SEG LYMPH XIO'/,uL X10'/,wL -------- -------- TOXICITY STUDY WITH N-METHYL,PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS MON? X10 /ML -------- EOSIN XlO'ImL -------- BASQ XIO ImL -------- N-SEGW -------- LYMPH% -------- MONO% -------- EOSIN ------ Dose Level: 0 Dosage Unit: ppm NEFOS 8.6 .5 7.7 .4 .1 .0 6 89 4 9.7 .6 8.6 .4 .0 .0 6 89 5 6.7 .8 5.7 .2 .1 .0 11 85 3 11.9 .4 10.7 .7 .1 .0 3 90 6 8.4 .6 7.3 .3 .1 .0 8 87 4 6.9 .5 6.0 .3 .1 .0 7 87 4 B.1 .5 7.1 .4 .1 .0 6 88 5 12.7 .8 11.4 .4 .1 .0 6 90 3 8.1 .7 6.8 .5 .1 .0 9 84 6 9.5 .7 8.1 .6 .1 .0 7 85 7 9.1 1.96 10 .6 7.9 .14 1.86 10 10 .4 .1 .0 .15 .03 .00 7 87 5 2.1 2.2 1.3 10 10 10 10 10 10 Dose Level: 3 Dosage Unit: ppm MEFOS 6.4 .5 7.5 .4 .1 .0 6 Be 4 7.9 .6 6.6 .5 .2 .0 7 84 6 9.3 .6 8.2 .5 .1 .0 6 88 5 8.5 .6 7.2 .5 .1 .0 8 85 6 9.8 .5 8.9 .3 .1 .0 5 91 3 12.6 .7 10.9 .9 .1 .0 5 86 7 @8.6 .7 7.2 .5 .1 .0 8 84 6 7.3 .4 6.8 .1 .0 .0 5 93 1 7.4 .7 6.2 .4 .1 .0 9 84 6 11.5 .5 10.6 .4 .1 .0 4 92 3 9.1 1.74 10 .6 8.0 .10 1.64 10 10 .4 .1 .0 .20 .05 .00 10 10 10 6 1.6 10 88 3.5 10 5 1.9 10 228 ANIMAL NUMBER ------ Group: 3 C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 MEAN S.D. N Appendix 5 Individual Clinical Hematology Data males Week 5 IMFIBC xio /,uL -------- 13-WEEK DIETARY N-SEC: Xlo,/,UL ------ - LYMI>H X 1 0'/,u L -------- TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAHIDO ETHANOL (N-HEFOSE, T-6314) IN RATS MONO X10'/,uL -------- EOSIN xiol/,Ub -------- BASQ X10 /)AL -------- N-SEG% -------- I.YMPH% -------- MONO% -------- EOSIN ------ Dose Level: 30 14.3 .8 8.4 .4 6.6 .4 10.1 .5 7.3 .6 9.8 .3 12.0 .7 13.2 .6 9.1 .5 9.5 .5 10.0 .5 2.48 .15 10 10 Dose Level: 100 14.4 .5 10.2 1.0 10.1 .5 9.8 .8 6.4 .7 14.0 1.4 4.2 .5 14.7 1.1 13.4 1.5 9.B 1.4 10.7 .9 3.51 .40 10 10 Dosage Unit: ppm MEFOS 12.8* .5 .2 7.6 .3 .0 5.8 .3 .1 9.2 .4 .1 6.4 .3 .1 9.1 .3 .1 10.7 .4 .1 12.0 .4 .1 8.2 .3 .0 B.3 .7 .1 9.0 2.27 10 .4 .1 .13 .06 10 10 Dosage Unit: ppm MEFOS 13.2 8.4 B.9 8.5 5.2 11.6 3.3 12.7 10.8 7.8 .6 .1 .7 .1 .6 .1 .4 .1 .4 .1 .8 .2 .3 .1 .7 .1 .9 .1 .4 .1 9.0 .6 .1 3.17 .20 .03 10 10 10 .0 .0 .0 .0 .0 .1 .1 .0 .0 .0 .0 .04 10 .1 .1 .0 .0 .0 .0 .0 .1 .0 .0 .0 .05 10 6 5 7 5 8 3 6 4 5 5 5 1.4 10 3 10 5 8 11 10 12 7 12 15 9 3.6 10 89 90 87 91 88 92 89 92 90 87 90 1.8 10 92 82 88 86 82 83 79 86 80 79 84 4.2 10 4 4 5 4 4 3 4 3 4 7 4 1.1 10 4 7 6 4 6 6 8 5 7 5 6 1.3 10 229 13-WEEK DIETARY ANlt4AL NUMBER ------ Group: I C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 Group: 2 C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 Appendix 5 Individual Clinical Hematology Data Males Week 5 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Dose Level: 0 - - - - - - - - - - - - - - - - - - - - Dosage Unit: ppm HEFOS - - - - - - - - - - - - - - - - - - - - - - - - Dose Level: 3 - - - - - - - - - - - - - - - - Dosage Unit: ppm NEFOS - - - - - - - - - - - - - - - - 230 13-WEEK DIETARY ANIMAL NUMBER ------ Group: 3 C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 Group: 4 C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 Appendix 5 Individual Clinical Hematology Data Males week 5 TOXICITY STUDY WITH N-METHYT PERFTUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Dose Level: 30 - - - - - - - - - - - - - - - - - - - - Dosage Unit: ppm MEFOS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Dose Level: 100 - - - - - - - - - - - - - - - - - - - - Dosage Unit: ppm NEFOS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 231 Appendix 5 individual clinical Hematology Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ RBC X10'/,pL -------- HGB G/DL -------- HCT t -------- mcv FL -------- MCH PG -------- MCHC t -------- PLT X10'/,uL -------- Group: 1 C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95980 C95989 C95990 MEAN S.D. N Group: 2 C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 MEAN S.D. N Dose Level: 0 7.36 7.74 7.53 7.56 7.75 8.17 7.75 7.67 7.63 7.82 15.2 15.7 16.2 14.5 15.8 15.9 15.8 15.5 15.7 16.3 7.70 .214 10 15.7 .51 10 Dose Level: 3 8.35 0.59 8.09 6.82 8.04 8.26 7.89 7.97 7.86 8.42 15.9 16.2 16.3 14.3 16.3 16.1 16.3 16.3 16.1 16.2 8.03 .488 10 16.0 .61 10 Dosage Unit: ppm MEFOS 44.3 45.1 46.0 42.6 45.9 47.0 45.5 44.8 46.1 46.9 60.3 58.3 61.1 56.4 59.3 57.5 59.8 58.4 60.4 60.0 20.7 20.3 21.5 19.1 20.4 19.5 20.4 20.2 20.6 20.9 45.4 1.31 10 59.1 1.45 10 20.4 .68 10 Dosage Unit: ppm NEFOS 45.1 47.2 47.7 40.9 47.4 46.7 46.5 45.6 46.1 48.3 54.0 54.9 58.9 60.0 59.0 56.5 59.0 57.3 58.7 57.4 19.1 18.8 20.2 21.0 20.3 19.5 20.7 20.4 20.5 19.2 46.1 2.08 10 57.6 1.95 10 20.0 .76 10 34.3 34.8 35.2 33.9 34.4 33.9 34.7 34.5 34.1 34.9 34.5 .43 10 35.3 34.3 34.2 35.1 34.5 34.5 35.1 35.7 34.9 33.5 34.7 .64 10 1230 1254 1094 1137 1012 1085 913 1190 1056 1171 1114 104.4 10 1297 lial 1107 1267 1139 1166 1106 1303 1083 1129 1170 82.3 10 232 Appendix 5 Individual clinical Hematology Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ RBC xio 6 /,uL -------- HGB G/DL -------- HCT t -------- mcv FL -------- MCH PG -------- MCHC t -------- PLT xlo,/,UL -------- Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 MEAN S.D. N Group: 4 C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 MEAN S.D. N Dose Level: 30 8.61 7.97 7.34 8.01 8.17 7.78 7.86 7.66 8.04 8.36 16.6 16.0 15.2 16.2 15.7 16.0 16.3 15.3 15.6 16.9 7.98 .357 10 16.0 .55 10 Dose Level: 100 7.44 7.66 8.63 7.63 8.13 7.84 7.91 7.76 7.95 7.95 14.5 15.1 16.5 15.3 15.7 15.7 15.8 15.1 15.2 15.7 7.89 .326 10 15.5 .54 10 Dosage Unit: ppm HEFOS 48.3 45.7 43.4 46.3 45.2 45.2 46.6 43.5 44.5 49.3 56.1 57.4 59.1 57.8 55.4 58.2 59.3 56.8 55.4 58.9 19.3 20.1 20.7 20.2 19.2 20.6 20.7 20.0 19.5 20.2 45.8 1.91 10 57.4 1.48 10 20.0 .56 10 Dosage Unit: ppm NEFOS 41.9 43.1 47.5 44.9 45.9 46.0 43.4 44.1 44.9 44.8 56.4 56.2 55.1 58.8 56.5 58.7 54.9 56.8 56.4 56.3 19.5 19.7 19.1 20.1 19.3 20.0 19.9 19.5 19.2 19.8 44.7 1.62 10 56.6 1.28 10 19.6 .34 10 34.4 35.0 35.1 35.0 34.8 35.5 35.0 35.3 35.1 34.3 35.0 .37 10 34.6 35.1 34.6 34.2 34.2 34.0 36.3 34.4 34.0 35.2 34.7 .71 to 1199 1084 1037 1029 1082 1124 1057 1414 1199 1007 1123 121.8 10 1007 1191 1235 1059 1091 535 1151 1333 942 1032 1058 217.2 10 233 ANIMAE, NUMBER ------ Group: 1 C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 MEAN S.D. N Group: 2 C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 MEAN S.D. N Appendix 5 Individual Clinical Hematology Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS WBC X10'/,uL -------- N-SEG xi Oj/,uL -------- LYMPH XIO'IML -------- MONO I xio ImL -------- EOSIN X10'/,uL -------- BASQ N-SEG% X10 /,uL -------- -------- LYMPH% -------- MONO% -------- EOSIN% ------- Dose Level: 0 Dosage Unit: ppm HEFOS 8.2 1.1 6.4 .6 .1 .0 14 77 a 7.6 .7 6.3 .5 .1 .0 9 83 6 5.3 .4 4.6 .2 .0 .0 7 Be 5 7.3 .2 6.8 .3 .0 .0 3 93 4 7.6 .5 6.6 .4 .1 .0 7 87 5 6.8 .2 6.3 .2 .0 .0 4 92 3 3.3 .2 2.9 .1 .0 .0 7 89 3 6.9 .5 5.9 .3 .1 .0 7 87 5 5.2 .3 4.5 .3 .0 .0 7 87 5 4.6 .2 4.1 .3 .0 .0 4 89 6 6.3 1.59 10 .4 5.4 .29 1.32 10 10 .3 .0 .0 7 87 5 .15 .05 .00 3.1 4.5 1.5 10 10 10 10 10 10 1 Dose Level: 3 Dosage Unit: ppm HEFOS 5.7 .5 5.1 .1 .1 .0 9 88 1 3.5 .3 3.0 .1 .0 .0 9 86 4 7.6 .7 6.3 .4 .2 .0 10 83 5 7.2 .3 6.5 .4 .1 .0 4 90 5 11.1 .3 10.6 .2 .0 .0 2 96 1 5.8 .4 5.0 .3 .0 .0 6 Be 5 10.4 .4 9.7 .3 .1 .0 4 93 3 7.0 .4 6.2 .3 .1 .0 5 09 5 7.9 .8 6.6 .3 .1 0 10 84 4 7.4 .8 6.4 .1 .0 :0 11 66 2 7.4 2.21 10 .5 6.5 .20 2.20 10 10 .2 .1 .0 7 Be 4 .12 .07 .00 3.2 4.0 1.6 10 10 10 10 10 10 1 234 ANIMAL NUMBER ------ Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 MEAN S.D. N Group: 4 c96041 C96042 C96043 C96044 C96045 C96046 c96047 C96048 C96049 C96050 MEAN S.D. N Appendix 5 Individual Clinical Hematology Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS wpc Xio /ML -------- N-SEG X10'/mL -------- LYMPH XIO'/,uL -------- MON? EOSIN BASG N-SEG% X10 /,uL Xlo'/,uL X10 /;4L -------- -------- -------- -------- LYMPH% -------- MONO% -------- EOSIN ------ Dose Level: 30 Dosage Unit; ppm MEFOS 7.7 .3 7.0 .2 .1 .0 4 92 3 6.2 .3 5.6 .3 .0 .0 4 90 4 5.1 .8 3.8 .4 .1 .0 16 74 a 5.9 .4 5.2 .2 .1 .0 7 88 3 5.7 .3 5.2 .2 .1 .0 5 90 3 9.7 .5 8.8 .2 .1 .0 6 91 2 10.9 .6 9.6 .7 .1 .0 5 Be 6 6.7 .4 5.9 .3 .0 .0 6 88 5 4.4 .7 3.6 .1 .0 .0 15 81 3 11.1 .7 9.6 .6 .1 .0 7 87 5 7.3 2.42 10 .5 6.4 .19 2.24 10 10 .3 .1 .0 8 87 4 .19 .05 .00 4.4 5.4 1.8 10 10 10 10 10 10 Dose Level: 100 Dosage Unit: ppm MEFOS 10.2 .3 9.6 .3 .1 .0 3 94 2 6.7 .4 5.9 .3 .1 .0 7 Be 4 8.9 .5 7.9 .4 .1 .0 6 88 5 6.6 .8 5.4 .3 .1 .0 12 82 4 10.8 .4 9.1 1.1 .1 .1 4 84 10 5.7 .2 5.2 .2 .0 .0 3 92 4 6.6 .4 5.8 .3 .1 .0 6 88 4 5.7 .7 4.8 .2 .1 .0 12 84 3 7.3 .4 6.7 .2 .0 .0 5 91 3 4.2 .5 3.4 .3 .1 .0 12 80 7 7.3 2.09 10 .5 6.4 .18 1.96 10 10 .4 .1 .0 7 87 5 .27 .04 .03 3.7 4.5 2.3 10 10 10 10 10 10 235 13-WEEK DIETARY ANIMAL NUMBER ------ Group: 1 C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 Group: 2 C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 Appendix 5 Individual Clinical Hematology Data Females Week 5 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS ANISO POLY POIK HYPO TOXNEUT -------- -------- -------- -------- -------- Dose Level: 0 - - - - - - - - - - - - - - - - - - - Dosage Unit; ppm MEPOS - - - - - - - - - - - - - - - - - - - - - Dose Level: 3 - - - - - - - - - - - - - - - - - - - Dosage Unit: ppm MEFOS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 236 13-WEEK DIETARY ANIMAL NUMBER ------ Group: 3 C96021 C96022 C96023 c96024 C96025 C96026 c96027 C96028 C96029 C96030 Group: 4 C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 Appendix 5 Individual Clinical Hematology Data Females Week 5 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-63141 IN RATS ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Dose Level: 30 Dosage Unit: ppm MEFOS - - - Dose Level: 100 - - - - - - - - - - - - - - - - - - - - Dosage Unit: ppm NEFOS - - - - - - - - - - - - - - - - - - - - - 237 Appendix 5 Individual Clinical Hematology Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ RBC XIO'/mL -------- HGB G/DL -------- HCT -------- mcv FL -------- MCH PG -------- MCHC -------- P%,7 X10 /,uL -------- Group: I C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95919 C95919 C95920 MEAN S.D. N Group: 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 MEAN S.D. N Dose Level: 0 9.37 8.66 9.11 7.96 8.19 8.16 8.63 8.25 8.36 8.96 16.2 15.1 16.1 14.8 14.3 14.4 15.7 14.8 15.3 16.1 8.56 .463 10 15.3 .71 10 Dose Level: 3 8.71 8.33 7.14 8.57 8.91 9.13 9.29 8.05 8.34 7.72 15.4 15.3 14.2 15.4 15.4 16.5 16.0 15.0 14.9 14.5 8.42 .657 10 15.3 .67 10 Dosage Unit: ppm MEFOS 49.4 46.4 49.9 45.9 43.7 45.5 48.0 45.7 46.3 49.0 52.7 53.5 54.7 57.6 53.3 55.7 55.6 55.4 55.4 54.7 17.3 17.5 17.6 18.5 17.4 17.7 18.2 17.9 18.3 17.9 47.0 2.00 10 54.9 1.43 10 17.8 .40 10 Dosage Unit: ppm HEFOS 47.4 46.0 43.1 47.6 47.1 50.0 49.2 45.8 45.9 44.9 54.4 55.2 60.4 55.6 52.9 54.8 53.0 57.0 55.0 58.1 17.7 18.3 19.B 17.9 17.3 18.1 17.2 18.7 17.9 18.7 46.7 2.02 10 55.6 2.31 10 18.2 .77 10 32.9 32.6 32.2 32.2 32.7 31.7 32.7 32.3 33.0 32.8 32.5 .40 10 32.5 33.2 32.9 32.3 32.7 33.0 32.5 32.8 32.5 32.2 32.7 .32 10 1131 1142 1001 1130 1174 1148 935 1072 1095 1390 1122 119.5 10 1019 1225 1042 1038 1115 1124 1028 988 1003 1019 1060 73.0 10 238 Appendix 5 Individual Clinical Hematology Data Malea Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYU PERFTUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ RBC XIO'/,uL -------- HGB G/DL -------- HCT % -------- mcv FL -------- MCH PG -------- MCHC % -------- PLT X10'/,uL -------- Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980 MEAN S.D. N Dose Level: 30 0.33 9.62 8.89 8.53 9.15 9.24 8.68 8.26 8.07 8.03 14.7 16.0 15.4 15.5 15.2 16.1 14.6 15.4 14.4 15.2 8.68 .535 10 15.2 .56 10 Dose Level: 100 8.07 8.58 8.15 7.96 0.54 8.41 8.44 7.75 8.14 8.42 14.7 14.9 14.6 14.4 15.8 14.9 14.3 13.0 14.6 15.0 8.25 .273 10 14.6 .71 10 Dosage Unit: ppm MEFOS 44.1 50.5 47.2 47.5 47.1 49.0 46.3 45.6 44.2 46.1 53.0 52.5 53.2 55.7 51.5 53.0 53.4 55.2 54.8 57.5 17.7 16.6 17.4 18.2 16.6 17.4 16.8 18.7 17.9 18.9 46.8 1.99 10 54.0 1.79 10 17.6 .82 10 Dosage Unit: ppm MEFOS 44.6 45.4 44.6 43.4 47.0 45.2 43.6 39.7 43.8 45.3 44.3 1.92 10 55.3 52.9 54.8 54.6 55.1 53.7 51.7 51.2 53.8 53.9 53.7 1.39 10 18.3 17.4 17.9 18.1 18.5 17.7 17.0 16.7 17.9 17.8 17.7 .56 10 33.3 31.6 32.7 32.7 32.3 32.9 31.6 33.9 32.6 33.0 32.7 .71 10 33.0 32.8 32.7 33.3 33.6 33.0 32.8 32.7 33.3 33.1 33.0 .30 10 1015 1065 1109 932 1107 1006 636 986 1100 1045 1000 140.3 10 957 992 1153 1014 1104 907 1306 902 878 897 1011 138.4 10 239 ANIMAL NUMBER ------ Group: C95901 C95902 C95903 C95904 C95905 c959O6 C95909 C95918 C95919 C95920 MEAN S.D. N Group; 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 MEAN S.D. N Appendix 5 Individual Clinical Hematology Data Males Week 14 13-WEEK DIEI'ARY TOXICITY STUDY WITH N-METHYU PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS WBC N-SEG Xlo,/),L X10'/mL -------- -------- LYMPH X10'/mL -------- MONO X10'/pL ------- EOSIN X10'/,uL -------- BASG N-SEG% X10 /ML -------- -------- LYMPH% -------- MONO% -------- EOSIN% ------- Dose Level: 0 7.5 .8 6.0 .9 6.8 1.2 6.0 .7 6.4 .6 6.0 1.0 6.9 1.0 7.0 .6 8.8 .8 7.4 1.5 6.9 .9 .88 .28 10 10 Dose Level: 3 4.8 .8 7.0 1.1 7.7 .9 6.1 1.4 8.0 1.3 6.4 .8 6.0 1.0 7.2 .9 4.3 .7 9.2 1.1 6.7 1.48 10 1.0 .23 10 Dosage Unit: ppm MEFOS 6.0 .6 .1 4.8 .2 .0 4.9 .6 .1 4.8 .5 .1 5.3 .3 .1 4.4 .5 .1 5.2 .6 .1 5.7 .6 .1 7.4 .4 .1 5.4 .4 .1 5.4 .5 .1 .85 .14 .03 10 10 10 Dosage Unit; ppm MEFOS 3.6 .3 .1 5.0 .6 .2 6.4 .4 .1 4.2 .4 .1 5.9 .6 .2 5.1 .3 .2 4.0 .8 .1 5.7 .4 .2 3.2 .2 .1 7.5 .5 .1 5.1 1.35 10 .4 .1 .18 .05 10 10 .0 .0 .0 .0 .0 .0 .0 .0 .0 .0 .0 .00 10 .0 .0 .0 .0 .0 .0 0 :0 .0 .0 .0 .00 10 11 80 7 15 81 4 17 72 9 11 79 8 10 82 5 16 74 8 15 75 9 8 82 8 10 84 5 21 73 5 13 78 7 4.0 4.3 1.9 10 10 10 1 16 16 12 23 16 12 17 13 17 12 is 3.4 10 76 72 83 69 73 80 66 80 75 al 76 5.6 10 6 9 5 6 8 5 14 5 5 6 7 2.8 10 240 ANIMAL NUMBER ------ Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980 MEAN S.D. N Appendix 5 individual Clinical Hematology Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS WBC XIO'/ML -------- N-SEG X10'/;,L -------- LYMPH X10'/,uL -------- MONO X10'/,uL ------ EOSIN X10'/,uL -------- BASG N-SEG% X10 /jAL -------- -------- LYMPH% -------- MON01i -------- EOSIN% ------- Dose Level: 30 Dosage Unit: ppm MEFOS 10.8 1.2 9.0 .4 .1 .0 11 84 3 3.7 .7 2.8 .1 .0 .0 20 76 3 7.9 .8 6.4 .5 .1 .0 10 82 7 6.1 .7 4.9 .4 .1 .0 11 81 6 12.0 .9 10.6 .3 .1 .0 8 88 3 10.8 .7 9.5 .5 .1 .0 6 88 4 7.4 1.3 5.3 .6 .1 .0 18 72 9 5.9 .9 4.5 .4 .1 .0 is 76 7 6.2 1.1 4.6 .3 .2 .0 18 74 5 6.0 .6 4.9 .4 .1 .0 10 82 6 7.7 .9 6.2 .4 .1 .0 13 so 5 2.68 .24 2.57 .14 .05 .00 4.7 5.6 2.1 10 10 10 10 10 10 10 10 10 1 Dose Level: 100 Dosage Unit: ppm MEFOS 5.0 .8 3.9 .2 .1 .0 17 77 4 5.9 1.0 4.6 .3 .1 .0 16 77 5 8.6 1.0 7.4 .3 .1 .0 11 84 3 6.7 1.2 5.0 .4 .1 .0 18 74 6 5.4 1.1 4.0 .2 .1 .0 20 74 4 4.4 .7 3.3 .4 .0 .0 15 75 8 12.7 1.6 10.0 1.0 .2 .1 12 78 8 10.3 1.8 7.8 .4 .1 .0 18 76 4 5.9 .8 4.6 .3 .1 .0 14 79 6 6.6 1.1 5.0 .4 .1 .0 16 76 6 7.2 2.63 10 1.1 .35 10 5.6 2.13 10 .4 .1 .0 16 77 5 .23 .05 .03 2.8 2.9 1.7 10 10 10 10 10 10 1 241 13-WEEK DIETARY ANI14AL NUMBER ------ Group; I C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920 Group: 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 Appendix 5 Individual Clinical Hematology Data Males Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANISO POLY POIK HYPO TOXNEUT -------- -------- -------- -------- -------- Dose Level: 0 - Dosage Unit: ppm NEFOS Dose Level: 3 - - - - - - - - - - - - - - - - Dosage Unit: ppm MEFOS_ - - - - - - - - - - - - - - - - - 242 13-WEEK DIETARY ANIMAL NUMBER ------ Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C959BO Appendix 5 Individual Clinical Hematology Data Males Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULPONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Dose Level: 30 - - - - - - - - - - - - - - - - - - - - Dosage Unit: ppm NEFOS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Dose Level: 100 - - - - - - - - - - - - - - - - Dosage Unit: ppm MEFOS - - - - - - - - - - - - - - - - - - - 243 Appendix 5 Individual Clinical Hematology Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ RBC (I xio /;AL -------- liGB G/DL -------- HCT t -------- mcv FL -------- MCH PG -------- MCHC t -------- PLT X10'/,uL -------- Group: 1 C95983 C959B4 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000 MEAN S.D. N Group: 2 C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 MEAN S.D. N Dose Level: 0 7.70 8.09 7.55 7.54 7.59 7.77 7.85 7.00 7.78 7.96 15.1 14.8 14.6 14.2 14.6 14.7 14.6 14.3 14.8 15.8 7.76 .17B 10 14.8 .45 10 Dose Level: 3 8.33 8.06 7.54 7.77 8.34 7.73 8.55 8.13 8.18 14.6 14.9 14.4 14.5 16.6 14.3 15.8 15.1 15.3 8.07 .330 9 15.1 .75 9 Dosage Unit: ppm NEFOS 46.1 45.7 44.9 43.4 44.9 44.7 45.0 44.5 45.0 46.9 59.9 56.5 59.4 57.6 59.1 57.6 57.4 57.0 57.6 58.9 19.7 18.2 19.3 18.8 19.2 18.9 18.6 18.3 19.0 19.8 45.1 .95 10 58.1 1.13 10 19.0 .54 10 Dosage Unit: ppm NEFOS 45.4 44.6 44.8 44.3 49.0 43.9 48.0 46.8 46.9 54.5 55.4 59.4 57.0 59.7 56.8 56.1 57.6 57.4 17.5 18.5 19.1 18.7 19.9 18.5 18.5 19.5 18.7 46.1 1.97 9 57.1 1.70 9 18.7 .63 9 32.8 32.3 32.5 32.6 32.5 32.9 32.5 32.2 32.9 33.6 32.7 .40 10 32.1 33.4 32.1 32.8 33.3 32.6 33.0 32.2 32.5 32.7 .49 9 940 1026 894 1107 848 1087 1098 1163 951 1049 1016 103.3 10 1176 1045 938 965 1108 1055 1142 1263 969 1073 108.7 9 244 Appendix 5 Individual Clinical Hematology Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULPONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ RBC HGB HCT mcv MCH MCHC PLT X10'/IL G/DL t FL PG t XIO'/,wL -------- -------- -------- -------- -------- -------- -------- Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 MEAN S.D. N Group: 4 C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060 MEAN S.D. N Dose Level: 30 8.56 8.45 7.78 7.76 8.49 7.62 8.33 8.05 7.86 7.99 15.4 15.9 15.0 14.5 15.3 14.6 15.7 15.6 14.2 15.1 8.09 .343 10 15.1 .56 10 Dose Level: 100 7.74 7.55 8.20 @7.75 7.33 7.47 8.10 7.41 7.52 7.80 13.9 14.0 15.1 15.0 13.0 14.0 14.7 13.7 13.8 14.8 7.69 .289 10 14.2 .67 10 Dosage Unit: ppm MEFOS 47.5 48.2 45.5 44.2 46.7 44.9 48.4 47.8 43.3 45.7 55.5 57.1 58.5 57.0 55.1 58.9 58.2 59.4 55.1 57.2 18.0 18.9 19.3 18.6 18.1 19.1 18.8 19.4 18.0 18.9 46.2 1.77 10 57.2 1.57 10 18.7 .52 10 Dosage Unit: ppm MEFOS 42.7 43.3 45.7 44.7 39.9 42.3 44.6 41.4 41.5 45.3 55.1 57.4 55.7 57.7 54.4 56.6 55.1 55.9 55.2 58.1 18.0 18.6 19.5 19.4 17.7 18.7 18.1 18.6 18.4 19.0 43.1 1.91 10 56.1 1.26 10 18.5 .49 10 32.4 33.0 32.9 32.7 32.8 32.5 32.4 32.7 32.7 33.0 32.7 .22 10 32.6 32.4 33.1 33.6 32.6 33.1 32.9 33.2 33.3 32.8 33.0 .37 10 931 1017 1047 915 1079 918 1059 809 905 1117 980 97.8 10 1203 945 965 1049 1088 1189 988 925 1210 995 1056 110.7 10 245 ANIMAL NUMBER ------ Group: I C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000 MEAN S.D. N Group: 2 C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 MEAN S.D. N Appendix 5 Individual Clinical Hematology Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS WBC xio ]/ML -------- N-SEG X10'1,wL -------- LYMPH XIO'/mL -------- MONO X10'/,uL -------- EOSIN X10'/,uL -------- BASG N-SEG% X10 /,uL -------- -------- LYMPH% -------- MONO% -------- BOSIN ------ Dose Level: 0 Dosage Unit: pg)m MEFOS 4.2 1.0 3.1 .0 .1 .0 24 74 1 2.3 .3 1.9 .1 .0 .0 12 82 4 4.9 1.9 2.6 .3 .1 .0 39 53 7 4.8 .7 4.0 .0 .1 .0 15 82 0 3.6 .4 2.9 .2 .1 .0 11 81 6 5.6 1.1 4.2 .2 .1 .0 19 75 4 3.1 .5 2.4 .1 .1 .0 15 78 4 4.1 .9 2.7 .3 .1 .0 22 67 7 3.6 .4 2.8 .3 .1 .0 11 77 9 4.2 .8 3.0 .2 .1 .0 20 72 5 4.0 .8 3.0 .2 .1 .0 19 74 5 .95 .47 .69 .12 .03 .00 8.5 8.8 2.8 10 10 10 10 10 10 10 10 10 Dose Level: 3 Dosage Unit: ppm MEFOS 3.6 .4 2.9 .3 .1 .0 10 80 7 3.1 .6 2.1 .2 .1 .0 19 70 8 4.0 .7 2.9 .2 .1 .0 19 72 6 4.0 1.0 2.7 .3 .1 .0 24 67 7 6.7 .5 5.8 .3 .1 .0 0 86 4 6.6 .8 5.4 .3 .1 .0 12 82 5 5.0 .7 4.0 .3 .1 .0 13 80 5 4.3 .8 3.3 .2 .1 .0 18 75 5 5.3 .6 4.4 .2 .1 .0 11 82 5 4.7 1.27 9 .7 3.7 .18 1.27 9 9 .3 .1 .0 15 77 6 .05 .00 .00 5.3 6.4 1.3 9 9 9 9 9 9 246 ANIMAL NUMBER ------ Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 MEAN S.D. N Group: 4 C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060 MEAN S.D. N Appendix 5 Individual Clinical Hematology Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS wpc Xio /i4L -------- N-SEG LYMPH xio'/,UL Xlo,/PL -------- -------- MONO X10'/,wL -------- EOSIN XlO'ImL -------- BAS.9 X10 ImL -------- N-SEG% -------- LYMPH% -------- MONO% -------- EOSIN ------ Dose Level: 30 Dosage Unit: ppm MEFOS 6.9 5.1 5.1 4.9 4.5 6.6 5.4 7.8 6.0 4.8 5.7 1.08 10 .6 .8 .8 .9 .5 1.9 .9 .6 1.8 .8 1.0 .49 10 6.1 3.9 3.8 3.5 3.8 4.2 4.1 6.7 3.9 3.6 4.4 1.10 10 .1 .1 .0 a 89 2 .3 .1 .0 15 77 6 .4 .1 .0 16 74 8 .3 .1 .0 19 72 6 .2 .1 .0 10 83 4 .3 .1 .0 29 65 5 .4 .1 .0 16 75 7 .4 .1 .1 7 86 5 .2 .1 .0 29 65 4 .3 .1 .0 17 7S 6 .3 .1 .0 17 76 5 .10 .00 .03 7.6 8.0 1.7 10 10 10 10 10 10 Dose Level: 100 Dosage Unit: ppm MEFOS 2.9 .4 2.3 .1 .0 .0 14 81 4 3.6 .6 2.0 .2 .1 .0 17 76 4 9.7 1.0 8.4 .2 .1 .0 10 86 2 6.4 .6 5.5 .3 .1 .0 9 85 4 3.9 .3 3.4 .0 .1 .0 a 89 0 4.0 1.1 2.6 .2 .1 .0 28 65 5 4.7 .4 4.1 .2 .0 .0 7 88 4 3.8 .9 2.6 .3 .1 .0 24 67 7 3.0 .4 2.5 .1 .1 .0 13 82 3 4.8 .5 4.0 .2 .1 .0 11 84 4 4.7 2.03 10 .6 3.8 .28 1.89 10 10 .2 .1 .0 14 so 4 .09 .04 .00 7.0 8.4 1.8 10 10 10 10 10 10 247 13-WEEK DIETARY ANIMAL NUMBER ------ Group: 1 C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000 Group: 2 C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 Appendix 5 Individual Clinical Hematology Data Females Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ANISO -------- POLY -------- POIK -------- HYPO -------- TOXNEUT -------- Dose Level: 0 - - - - - - - - - - - - - - - - - - - - Dosage Unit: ppm MEFOS - - - - - - - - - - - - - - - - - - - - - - - - - - - - Dose Level: 3 - - - - - - - - - - - - - Dosage Unit: pga NEFOS - - - - - - - - - - - - - 248 13-WEEK DIETARY ANIMAL NUMBER ------ Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 Group: 4 C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060 Appendix 5 individual Clinical Hematology Data Females Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETIIANOL (N-MEFOSE, T-6314) IN RATS ANISO POLY POIK HYPO TOXNEUT -------- -------- -------- -------- -------- Dose Level: 30 Dosage Unit: ppm NEFOS Dose Level: 100 - - - - - - - - - - - - - - - - - - - - Dosage Unit: ppm NEFOS - - - - - - - - - - - - - - - - - - - - 249 ANIMAL NUMBER ------ Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 MEAN S.D. N Group: 2 C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 MEAN S.D. N Appendix 5 Individual Clinical Chemistry Data males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS 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 -------- TRIG MG/DL ------- Dose Level: 0 101 9 98 11 109 id 107 12 96 11 100 9 107 9 110 13 94 12 105 9 103 5.7 10 11 1.9 10 Dose Level: 3 116 10 109 11 117 10 107 14 148 9 108 12 104 12 103 10 103 10 127 11 114 14.1 10 11 1.4 10 Dosage Unit: ppm MEFOS .7 7.3 4.8 .7 7.3 4.8 .6 7.0 4.5 .7 6.5 4.4 .6 7.0 4.8 .6 7.4 5.0 .5 6.3 4.3 .7 7.1 4.9 .6 6.5 4.7 .7 6.7 4.8 .6 6.9 4.7 .07 .39 .23 10 10 10 Dosage Unit: ppm MEFOS .7 7.1 5.1 .6 6.5 4.5 .6 7.0 4.8 .7 6.6 4.5 .7 7.1 4.7 .6 7.0 4.7 .6 6.9 4.7 .6 6.9 4.9 .6 6.6 4.6 .7 7.1 4.9 .6 6.9 4.7 .05 .23 .19 10 10 10 2.5 2.5 2.5 2.1 2.2 2.4 2.0 2.2 1.8 1.9 2.2 .26 10 2.0 2.0 2.2 2.1 2.4 2.3 2.2 2.0 2.0 2.2 2.1 ..14 10 .2 .2 .2 .2 .2 .2 .2 .2 .2 .2 .2 .00 10 .2 .2 .2 .2 .2 .2 .2 .2 .2 .2 .2 .00 10 60 4 57 3 76 3 50 4 56 4 83 9 32 3 76 3 54 4 47 4 59 4 15.4 1 10 1 50 51 54 88 62 50 59 45 60 63 58 12.1 10 250 ANIMAL NUMBER ------ Group: 3 C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95946 C95949 C95950 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 MEAN S.D. N Appendix 5 Individual Clinical Chemistry Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 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 -------- TRIG MG/DL ------ Dose Level; 30 Dosage Unit: ppm MEFOS 93 12 114 10 129 11 91 10 ill 10 104 15 116 14 124 11 84 11 90 11 .6 6.5 4.8 1.7 .6 7.1 4.8 2.3 .6 6.5 4.6 1.9 .6 6.8 4.7 2.1 .6 6.5 4.5 2.0 .6 6.9 4.8 2.1 .6 6.4 4.6 1.8 .6 6.6 4.9 1.7 .6 6.7 4.6 2.1 .5 6.5 4.5 2.0 .2 51 .2 48 .2 46 .2 67 .2 42 .2 58 .1 73 .2 57 .2 54 .2 40 106 12 .6 6.6 4.7 2.0 .2 54 15.6 1.7 .03 .22 .14 .19 .03 10.6 10 10 10 10 10 10 10 10 Dose Level: 100 Dosage Unit: ppm MEPOS 152 17 90 11 97 12 102 13 94 12 110 13 99 13 ill 12 105 13 98 13 .7 6.4 4.4 2.0 .6 6.6 4.7 1.9 .7 6.8 4.8 2.0 .6 6.4 4.8 1.6 .6 7.0 4.9 2.1 .5 6.3 4.4 1.9 .6 6.9 4.8 2.1 .6 7.1 4.8 2.3 .5 6.5 4.5 2.0 .6 7.0 5.0 2.0 .2 26 .2 25 .2 60 .2 64 .2 41 .2 34 .2 55 .2 54 .2 35 .2 51 106 13 .6 6.7 4.7 2.0 .2 44 17.5 1.6 .07 .29 .21 .18 .00 14.1 10 10 10 10 10 10 10 10 251 Appendix 5 Individual Clinical Chemistry Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ 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 -------- Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95907 C95908 C95909 C95910 MEAN S.D. N Group: 2 C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 MEAN S.D. N Dose Level: 0 90 86 71 99 97 143 114 100 ill 109 103 18.9 10 Dose Level: 3 92 115 95 86 79 108 74 123 83 103 96 16.1 10 34 35 25 31 34 35 26 33 33 30 32 3.6 10 33 35 39 26 29 41 35 32 30 30 33 4.6 10 Dosage Unit; ppm NEFOS 1 11.7 10.2 0 11.3 9.9 1 11.0 9.0 0 10.4 10.5 0 10.4 8.5 0 11.6 9.6 1 10.5 8.9 0 11.0 9.7 0 10.7 9.3 0 10.8 9.3 0 .5 10 10.9 .47 10 9.5 .61 10 Dosage Unit: ppm MEFOS 0 11.1 11.1 1 10.6 9.0 0 10.7 10.3 1 11.0 0 10.7 10.3 9.0 0 10.9 9.5 0 11.1 9.6 0 10.9 10.5 0 10.7 9.7 1 10.6 9.1 0 .5 10 10.8 .19 10 9.8 .71 10 149 149 145 146 148 146 147 147 147 146 147 1.3 10 6.6 6.8 6.1 5.7 6.1 6.8 6.4 6.1 6.0 5.8 6.2 .39 10 150 145 147 147 145 147 146 149 147 148 147 1.6 10 7.0 6.0 7.0 61 5:9 6.1 5.9 6.2 5.9 6.3 6.2 .42 10 107 107 102 103 107 101 106 104 103 106 105 2.3 10 108 102 105 106 105 104 104 105 103 105 105 1.6 10 252 ANIMAL NUMBER ------ Group: 3 C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 MEAN S.D. N Appendix 5 individual Clinical Chemistry Data Males Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 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 HMOL/L -------- Dose Level: 30 Dosage Unit: ppm MEFOS 131 33 109 36 95 32 113 32 76 27 82 31 90 36 88 34 125 38 105 26 0 10.5 9.0 147 0 10.8 9.0 150 2 10.1 8.7 147 0 10.9 9.9 147 0 10.6 9.0 146 0 10.3 7.7 147 0 10.1 8.2 147 1 10.6 10.4 148 1 10.4 8.9 149 0 10.9 9.5 147 6.6 106 6.5 107 6.3 105 6.6 105 5.4 104 5.2 108 5.6 107 6.0 107 6.3 105 6.5 106 101 18.3 10 32 3.8 10 0 .7 10 10.5 .30 10 9.0 .78 10 148 1.2 10 6.1 .52 10 106 1.2 10 Dose Level- 100 Dosage Unit: ppm MEFOS 86 36 113 41 93 35 122 41 103 41 91 41 94 50 88 40 90 41 86 34 0 10.2 11.4 146 5.8 103 0 10.2 8.9 148 6.0 107 0 10.9 9.6 148 6.5 106 1 10.8 9.0 149 6.5 109 0 10.6 9.3 148 6.5 104 0 10.0 7.9 143 5.1 104 0 11.2 9.2 ISO 6.1 108 0 10.9 9.1 146 6.5 103 0 10.0 7.8 142 6.1 102 0 10.7 8.3 146 5.7 102 97 12.2 10 40 4.5 10 0 .3 10 10.6 .42 10 9.0 1.02 10 147 2.5 10 6.1 .46 10 105 2.5 10 253 ANIMAL NUMBER ------ Group: 1 C95981 C95982 C95983 C95984 C95985 C959B6 C95987 C95988 C95989 C95990 MEAN S.D. N Group: 2 C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 MEAN S.D. N Appendix 5 Individual Clinical Chemistry Data 13-WEEK DIETARY Females Week 5 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS CLU 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 -------- TRIG MG/DL ------ Dose Level: 0 Dosage Uniti ppm NEFOS 101 13 119 11 117 13 ill 13 110 14 92 12 105 11 99 13 120 12 ill 10 .7 8.1 5.6 2.5 .7 7.3 5.5 1.8 .7 7.3 4.9 2.4 .7 7.7 5.4 2.3 .7 7.4 5.5 1.9 .7 7.3 5.3 2.0 .7 7.2 5.3 1.9 .7 7.3 5.2 2.1 .7 7.0 5.1 1.9 .6 7.6 5.4 2.2 .2 80 .2 76 .2 67 .3 56 .3 93 .2 64 .2 61 .2 50 .2 55 .3 66 108 12 .7 7.4 5.3 2.1 .2 68 9.2 1.2 .03 .31 .21 .24 .05 11.9 10 10 10 10 10 10 10 10 Dose Level: 3 Dosage Unit: ppm HEFOS 99 9 .6 7.3 5.4 1.9 .2 53 99 11 .7 7.6 5.8 1.8 .2 54 107 10 .7 7.0 4.9 2.1 .2 87 95 9 .6 6.9 5.0 1.9 .2 70 115 14 .7 7.4 5.0 2.4 .2 81 116 14 .7 6.9 4.8 2.1 .2 68 103 10 .7 7.5 5.3 2.2 .2 54 116 11 .7 8.5 6.0 2.5 .2 75 105 14 .7 7.2 5.2 2.0 .2 78 121 13 .7 7.2 5.4 1.8 .2 69 108 12 .7 7.4 5.3 2.1 .2 69 8.9 2.1 .04 .47 .39 .24 .00 12.0 10 10 10 10 10 10 10 10 254 ANIMAL, NUMBER ------ Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 MEAN S.D. N Group: 4 C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 MEAN S.D. N Appendix 5 individual Clinical Chemistry Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 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 -------- TRIG MG/DL ------ Dose Level: 30 102 10 116 13 113 12 95 12 ill 13 94 12 105 10 123 11 117 13 99 15 108 10.0 10 12 1.5 10 Dose Level: 100 89 12 98 15 75 13 96 12 105 11 90 15 84 14 117 15 89 is 104 13 95 12.0 10 14 1.5 10 Dosage Unit: ppm MEFOS .7 7.6 5.5 .7 7.1 5.3 .7 7.9 5.9 .6 7.1 5.3 .7 7.7 5.. 4 .7 6.9 4 .9 .7 7.1 5 .3 .7 7.0 4 .9 .7 7.0 5 .3 .7 7.2 54 .7 7.3 5.3 .03 .34 .29 10 10 10 Dosage Unit: ppm MEFOS .6 7.1 5.4 .6 7.5 5.5 .6 7.5 5.4 .6 7.5 5.4 .6 6.8 5.0 .6 6.6 4.7 .8 7.1 5.4 .7 8.0 5.7 .6 7.0 5.4 .7 7.3 5.2 .6 7.2 5.3 .07 .41 .28 10 10 10 2.1 1.8 2.0 1.8 2.3 2.0 1.8 2.1 1.7 1.8 1.9 .19 10 1.7 2.0 2.1 2.1 1.8 1.9 1.7 2.3 1.6 2.1 1.9 .23 10 .2 .2 .2 .2 .2 .2 .2 .2 .2 .1 .2 .03 10 .2 .2 .2 .2 .2 .2 .2 .2 .2 .2 .2 .00 10 62 52 75 73 69 53 76 53 58 71 64 9.7 10 46 100 43 86 50 38 48 37 39 45 53 21.7 10 255 ANI14AL NUMBER ------ Group: 1 C95981 C95982 C95983 C95984 C95985 C95986 C959B7 C95988 C95989 C95990 MEAN S.D. N Group: 2 C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 MEAN S.D. N Appendix 5 Individual Clinical Chemistry Data Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYI, PERFUUOROOCTANESULFONAHIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 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 -------- Dose Level: 0 71 91 85 120 91 99 99 101 ill 119 99 15.3 10 Dose Level: 3 91 99 81 95 105 83 94 97 89 100 93 7.5 10 31 24 23 34 25 25 36 24 28 33 28 4.8 10 30 25 22 25 36 23 30 21 23 31 27 4.9 10 Dosage Unitt ppm NEFOS 1 12.0 8.5 0 10.8 8.0 1 10.6 7.0 0 10.7 7.8 0 11.2 8.1 1 10.4 8.1 0 10.3 7.1 0 10.5 8.0 1 10.5 7.4 0 11.2 9.2 0 .5 10 10.8 .52 10 7.9 .65 10 Dosage Unit: ppm MEFOS 0 10.4 7.9 0 10.9 8.7 1 10.9 0.2 0 10.6 8.8 0 11.3 9.8 1 10.3 7.9 0 10.8 8.3 0 11.3 8.3 2 10.2 7.3 0 10.4 7.1 0 .7 10 10.7 .40 10 8.2 .77 10 147 148 148 147 144 146 145 146 146 146 146 1.3 10 6.0 6.5 6.2 6.0 6.3 5.8 5.5 5.9 5.7 6.3 6.0 .31 10 144 149 146 145 149 147 147 147 146 147 147 1.6 10 5.4 5.9 6.4 5.5 6.1 5.5 5.8 6.s 5.5 5.7 5.8 .39 10 105 107 105 106 103 104 105 104 104 104 105 1.2 10 105 104 106 105 105 107 105 102 106 106 105 1.4 10 256 Appendix 5 Individual Clinical Chemistry Data ANIMAL NUMBER ------ Females Week 5 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 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 -------- Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 MEAN S.D. N Group: 4 C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 MEAN S.D. N Dose Level: 30 91 30 99 29 86 25 lis 25 83 28 80 21 97 31 73 31 112 26 93 32 93 14.0 10 28 3.5 10 Dose Level: 100 96 26 119 23 106 31 82 34 67 28 88 36 113 39 86 26 91 34 80 22 93 16.0 10 30 5.8 10 Dosage Unit: ppm MEFOS 0 11.4 9.4 1 10.6 8.0 3 10.7 6.2 0 10.9 8.8 0 11.0 6.9 2 10.5 8.3 0 11.1 8.6 1 10.7 7.2 1 10.0 6.4 2 10.8 7.4 1 1.1 10 10.8 .38 10 7.7 1.07 10 Dosage Unit: ppm MEFOS 1 10.4 8.2 0 11.2 8.4 1 10.7 8.2 0 11.2 9.6 1 10.7 8.6 0 10.6 B.9 0 10.4 9.2 2 10.3 6.8 2 10.5 8.5 1 10.5 6.1 1 .8 10 10.6 .32 10 8.2 1.06 10 150 146 145 144 145 146 146 145 145 149 146 1.9 10 7.2 6.0 5.1 6.4 5.8 5.6 6.4 5.7 5.4 6.0 6.0 .60 10 149 143 149 146 148 146 147 147 iso 147 147 2.0 10 5.6 6.3 5.7 6.7 5.9 5.9 5.8 5.0 5.8 5.0 5.8 .52 10 107 102 103 103 104 107 104 104 103 107 104 1.9 10 107 101 108 103 107 107 104 109 109 106 106 2.6 10 257 13-WEEK Appendix 5 Individual Clinical Chemistry Data males Week 5 DIETARY TOXICITY STUDY WITH N-METHYB PERFbUOROOCTANESU16FONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ Group: 1 PCOAO IU/G -------- Dose Level: 0 Dosage Unit: ppm NEFOS C95911 11 C95912 9 C95913 13 C95914 10 C95915 18 MEAN S.D. N Group: 2 12 3.6 5 Dose bevel: 3 Dosage Unit: ppm HEFOS C95931 12 C95932 15 C95933 13 C95934 11 C95935 16 MEAN S.D. N Group: 3 C95951 C95952 C95953 C95954 C95955 13 2.1 5 Dose Level: 30 14 7 2 B 9 Dosage Unit: ppm MEFOS MEAN a S.D. 4.3 N 5 258 13-WEEK Appendix 5 Individual Clinical Chemistry Data males Week 5 DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ PCOAO IU/G -------- Group: 4 Dose Level: 100 Dosage Unit: ppm MEFOS C95971 7 C95972 8 C95973 9 C95974 12 C95975 9 MEAN 9 S.D. 1.9 N 5 259 13-WEEK Appendix 5 Individual clinical Chemistry Data DIETARY Females Week 5 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULPONAMIDO ETHANOL (N-MEFOSE, T-6314@ IN RATS ANIMAL NUMBER ------ PCOAO IU/G -------- Group: 1 Dose Level: 0 Dosage Unit: ppm NEFOS C95991 6 C95992 9 C95993 3 C95994 7 C95995 9 MEAN S.D. N Group: 2 C96011 C96012 C96013 C96014 C96015 MEAN S.D. N Group: 3 7 2.5 5 Dose Level: 3 6 3 9 3 2 5 2.9 5 Dose Level: 30 Dosage Unit: ppm NEFOS Dosage Unit: ppm NEFOS C96031 C96032 C96033 C96034 C96035 MEAN S.D. N 7 6 5 5 13 7 3.3 5 260 13-WEEK Appendix 5 Individual Clinical Chemistry Data Females Week 5 DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ PCOAO IU/G -------- Group: 4 C96051 C96052 C96053 C96054 C96055 MEAN S.D. N Dose Level: 100 8 9 11 10 15 11 2.7 5 Dosage Unit: ppm MEFOS 261 ANIMAL NUMBER ------ Group: I C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95910 C95919 C95920 MEAN S.D. N Group: 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 MEAN S.D. N Appendix 5 Individual Clinical Chemistry Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS CLU MG/DL -------- UN MG/DL -------- CREAT MG/DL -------- T PRO G/DL -------- ALB G/DL -------- GLOB G/DL -------- T BTLI MG/DL -------- CHOL MG/DL -------- TRIG MG/DL -------- Dose Level: 0 125 12 123 13 107 14 120 17 106 11 120 11 106 14 115 13 126 10 125 11 117 8.2 10 13 2.1 10 Dose Level: 3 115 10 129 15 121 15 126 10 lie 13 125 14 115 12 105 10 109 10 126 13 119 7.9 10 12 2.1 10 Dosage Unit: ppm MEFOS .8 7.5 4.8 .8 7.5 4.6 .8 7.3 4.7 .8 6.8 4.5 .7 6.8 4.6 .7 7.6 5.1 B 6.7 4.4 .8 7.3 4.9 .7 7.5 5.1 .7 7.2 4.7 .8 7.2 4.7 .05 .34 .24 10 10 10 Dosage Unit: ppm MEFOS .7 6.9 4.8 .8 6.7 4.6 .7 6.5 4.4 .7 7.1 4.6 .8 7.1 4.7 .8 7.3 4.9 .8 7.1 5.0 .7 6.8 4.5 .7 7.6 4.9 .7 6.6 4.5 .7 7.0 4.7 .05 .34 .20 10 10 10 2.7 2.9 2.6 2.3 2.2 2.5 2.3 2.4 2.4 2.5 2.5 .21 10 2.1 2.1 2.1 2.5 2.4 2.4 2.1 2.3 2.7 2.1 2.3 .21 10 .2 54 .1 71 .2 69 .2 80 .1 53 .2 100 .1 54 .1 82 .1 64 .2 60 76 34 61 61 64 ill 53 5( 4 3 .2 69 5 .05 15.2 2 10 10 1 .2 37 4 .1 44 8 .1 87 4 .1 60 4 .2 41 4 .2 56 8 .1 38 7 .1 61 8 .1 69 2 .1 79 3 .1 57 5 .05 17.4 2 10 10 1 262 ANI14AL NUMBER ------ Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95966 C95969 C95977 C95980 MEAN S.D. N Appendix 5 individual Clinical Chemistry Data males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 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 -------- TRIG MG/DL ------- Dose Level: 30 Dosage Unit: ppm MEFOS 122 14 .7 6.6 4.8 1.8 .1 39 3 119 12 .8 7.6 5.1 2.5 .2 45 3 124 11 .7 6.7 4.7 2.0 .2 33 5 100 12 .7 6.7 4.6 2.1 .2 59 3 115 16 .8 6.6 4.5 2.1 .1 71 3 108 12' .9 7.0 4.7 2.3 .2 57 4 94 15 .7 5.4 3.8 1.6 .2 36 2 119 15 .7 6.7 4.8 1.9 .1 31 2 117 13 .8 7.0 4.5 2.5 .1 72 3 114 17 .0 7.2 4.9 2.3 .2 50 3 113 14 .8 6.8 4.6 2.1 .2 49 3 9.7 2.0 .07 .57 .35 .30 .05 15.1 1 10 10 10 10 10 10 10 10 1 Dose Level: 100 Dosage Unit: ppm NEFOS 131 16 .7 7.3 5.1 2.2 .2 13 1 121 13 .7 6.5 4.9 1.6 .3 11 1 153 16 .8 7.5 5.6 1.9 .2 39 2 140 16 .8 7.4 5.6 1.8 .2 37 2 120 14 .7 7.3 5.3 2.0 .2 25 1 123 15 .7 7.5 5.3 2.2 .2 46 2 120 13 .8 7.7 5.2 2.5 .2 31 1 123 17 .7 6.8 4.7 2.1 .2 15 116 14 .7 6.7 4.9 1.8 .1 19 1 131 15 .7 7.1 5.1 2.0 .2 20 1 128 15 .7 7.2 5.2 2.0 .2 26 1 11.3 1.4 .05 .39 .29 .26 .05 12.1 10 10 10 10 10 10 10 10 1 263 ANIMAL NUMBER ------ Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920 MEAN S.D. N Group: 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 MEAN S.D. N Appendix 5 Individual Clinical Chemistry Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS AST/SGOT IU/L -------- ALT/SGPT IU/L -------- GGT IU/L -------- CA MG/DL -------- I PHOS MG/DL -------- NA 14HOL/L -------- K MMOL/L -------- CL MMOL/L -------- Dose Level: 0 101 95 87 107 110 87 109 59 68 70 89 18.4 10 Dose Level: 3 86 80 83 95 94 69 91 100 75 92 86 9.7 10 44 3B 35 42 39 38 47 29 35 36 38 5.1 10 49 44 36 43 50 39 44 30 34 39 41 6.4 10 Dosage Unit: ppm MEFOS 3 11.3 7.8 3 10.6 6.0 1 10.8 7.6 0 10.-3 7.0 3 9.9 6.2 3 11.3 6.2 3 10.2 6.2 2 11.2 6.2 0 11.0 6.4 1 10.6 6.2 2 1.3 10 10.7 .49 10 6.6 .65 10 Dosage Unit: ppm MEFOS 2 10.3 6.7 2 10.8 6.7 2 10.3 6.7 3 10.2 6.2 3 10.6 6.1 2 10.9 6.9 3 10.8 6.5 3 10.3 6.1 3 10.7 6.4 1 10.7 6.7 2 .7 10 10.6 .26 10 6.5 .29 10 154 148 152 149 147 146 148 150 151 151 150 2.5 10 6.2 6.4 6.5 6.1 6.1 5.7 5.9 5.9 6.3 5.5 6.1 .31 10 150 151 146 149 152 148 150 147 152 152 150 2.2 10 5.9 6.2 6.1 6.1 6.3 6.1 6.4 5.5 5.8 6.4 6.1 .28 10 113 107 110 109 106 102 107 109 ill 113 109 3.4 10 ill 110 105 106 ill 105 110 105 112 112 109 3.1 10 264 ANIMAL NUMBER ------ Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980 MEAN S.D. N Appendix 5 Individual Clinical Chemistry Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS AST/SGOT ALT/SGPT IU/L IU/L -------- -------- GGT IU/L -------- CA MG/DL -------- I PHOS MG/DL -------- NA MMOL/L -------- K MMOL/L -------- CL MMOL/L -------- Dose Level: 30 Dosage Unit: ppm MEPOS 96 44 111 45 82 31 74 3B 75 36 84 45 126 49 94 34 Be 28 78 34 3 10.3 6.3 150 6.5 112 1 10.3 6.2 151 6.4 ill 3 10.0 6.8 149 6.1 109 3 10.6 7.5 150 6.5 ill 1 10.1 6.4 145 5.4 104 3 10.6 7.2 150 6.3 105 0 9.2 5.5 145 5.8 104 2 10.3 6.8 150 6.1 108 3 10.4 6.0 151 6.2 110 4 10.4 6.6 150 6.5 110 91 16.7 10 38 7.0 10 2 1.3 10 10.2 .40 10 6.5 .58 10 149 2.2 10 6.2 .36 10 108 3.0 10 Dose Level: 100 Dosage Unit: ppm MEFOS 73 46 83 48 63 33 100 64 99 65 95 57 108 70 86 36 99 70 102 108 3 10.6 6.6 152 6.9 112 2 10.0 6.9 150 6.5 108 2 10.9 7.1 154 6.4 112 1 10.6 7.3 152 7.0 112 3 10.6 7.3 153 6.7 109 2 10.6 6.7 147 5.6 102 3 10.5 7.3 147 6.6 103 2 10.0 6.2 147 6.3 100 1 10.1 6.4 150 5.6 ill 2 10.5 7.0 151 6.5 112 91 14.3 10 60 21.6 10 2 .7 10 10.4 .30 10 6.9 .39 10 150 2.6 10 6.4 .48 10 109 3.6 10 265 ANIMAL NUMBER ------ Group: 1 C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000 MEAN S.D. N Group: 2 C96001 c96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 MEAN S.D. N Appendix 5 Individual Clinical Chemistry Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS 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 -------- TRIG MG/DL ------- Dose Level: 0 Dosage Unit: ppm MEFOS 123 137 125 133 115 114 107 120 114 104 119 10.6 10 Dose Level: 3 120 123 124 113 138 125 ill 116 123 121 8.0 9 14 11 15 9 11 15 12 13 11 13 12 2.0 10 10 11 13 17 13 11 14 14 12 13 2.1 9 .9 8.3 5.9 .9 8.5 5.9 .9 8.1 6.2 .8 7.5 5.7 .8 7.9 6.1 .9 8.0 5.7 .9 8.7 6.4 .7 7.2 5.4 .8 7.5 5.6 .9 7.4 5.0 .8 7.9 5.8 .07 .50 .41 10 10 10 Dosage Unit: ppm MEFOS .7 7.6 5.6 .8 7.6 5.9 .8 7.1 5.0 .7 7.0 5.0 .9 8.6 6.0 .7 8.3 6.1 .8 7.3 5.2 .8 7.9 5.7 .6 7.7 5.7 .8 7.7 5.6 .07 .53 .42 9 9 9 2.6 1.9 1.8 1.8 2.3 2.3 1.8 1.9 2.4 2.1 .31 10 2.0 1.7 2.1 2.0 2.6 2.2 2.1 2.2 2.0 2.1 .24 9 .2 69 5 .2 68 4 .2 101 3 .2 60 3 .2 66 3 .2 68 2 .3 90 8 .2 70 4 .2 71 3 .2 66 3 .2 73 4 .03 12.6 1 10 10 1 .1 52 1 .2 57 2 .2 78 3 .1 69 3 .1 70 3 .2 67 9 .2 73 2 .2 76 4 .1 80 3 .2 69 3 .05 9.4 2 9 9 266 ANIMAL NUMBER ------ Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 MEAN S.D. N Group: 4 C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060 MEAN S.D. N Appendix 5 Individual Clinical Chemistry Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS 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 -------- TRIG MG/DL ------- Dose Level: 30 Dosage Unit: ppm MEFOS 109 13 ill 16 97 13 105 12 116 13 122 12 103 13 113 17 113 16 ill 13 .8 7.7 5.6 2.1 .9 7.8 5.9 1.9 .8 8.3 6.1 2.2 .7 7.8 5.6 2.2 .9 8.8 6.0 2.8 .7 7.6 5.5 2.1 .8 7.6 5.7 1.9 .8 7.7 5.7 2.0 .9 8.2 5.7 2.5 .8 8.5 6.2 2.3 .2 57 3 .2 58 3 .2 74 2 .2 66 3 .2 75 2 .2 59 3 .2 78 6 .2 70 2 .2 74 4 .1 86 3 110 14 .8 8.0 5.8 2.2 .2 70 3 7.0 1.8 .07 .42 .24 .28 .03 9.9 1 10 10 10 10 10 10 10 10 1 Dose Level: 100 Dosage Unit: ppm MEFOS 100 15 .8 9.0 6.6 2.4 .2 84 3 116 14 .9 8.6 6.4 2.2 .2 65 2 125 15 B 7.6 5.6 2.0 .2 45 2 116 18 .9 7.8 5.6 2.2 .2 56 2 109 17 .8 8.1 6.2 1.9 .2 50 1 120 18 .9 8.6 6.1 2.5 .2 30 2 ill 1B .8 7.7 5.9 1.8 .2 35 2 104 20 .7 7.9 5.7 2.2 .2 34 2 95 19 .8 8.7 6.4 2.3 .2 42 2 109 14 .8 7.8 5.9 1.9 .2 71 2 110 17 .8 8.2 6.0 2.1 .2 51 2 9.2 2.1 .06 .50 .36 .23 .00 17.7 10 10 10 10 10 10 10 10 1 267 Appendix 5 Individual Clinical Chemistry Data Females Week 14 ANIMAL NUMBER ------ 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL, PERFFUOROOCTANESUGFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS AST/SCOT 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 -------- Group: 1 C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 c95997 C96000 MEAN S.D. N Dose Level: 0 74 92 79 77 79 101 88 78 75 99 84 10.1 10 27 34 31 31 35 35 4B 37 30 33 34 5.7 10 Dosage Unitt ppm MEFOS 4 11.0 4.2 3 10.9 4.2 2 11.0 4.6 3 10.7 4.4 1 11.0 5.0 3 11.1 5.6 1 11.7 5.4 3 11.2 5.0 1 10.9 5.5 4 10.5 4.4 2 1.2 10 11.0 .32 10 4.8 .54 10 152 153 149 151 149 148 152 150 149 147 150 1.9 10 6.1 5.7 5.4 5.3 5.8 5.5 6.2 5.6 5.6 5.9 5.7 .29 10 113 113 110 114 110 107 112 113 ill 106 ill 2.7 10 Group: 2 C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 MEAN S.D. N Dose Level: 3 91 100 190 89 101 81 101 94 114 107 32.6 9 36 31 96 30 44 30 42 35 40 43 20.7 9 Dosage Unit: ppm MEFOS 1 10.7 5.3 1 10.6 4.3 3 10.6 4.3 3 10.4 5.0 3 11.7 7.3 4 10.7 4.3 3 10.5 5.0 1 11.1 5.3 4 11.1 5.4 3 10.8 1.2 .41 9 9 5.1 .93 9 iso 149 150 147 159 147 149 150 151 150 3.6 9 6.0 5.8 5.9 5.8 7.7 5.1 6.2 6.1 6.4 6.1 .70 9 115 109 ill 109 114 105 110 114 113 ill 3.3 9 268 69Z T'tTE9-1 HE SZZ-6ZE9 sOuRA03 ot O*E 601 tiT SOT oil ZTT oil BOT OTT tot ITT Oil OT Et' L'S GIs t*s t's S,9 T'S 8*S Z*9 S*s 019 0*9 ol L*Z OST EST Lti 6PT SST ist 6VT IST LPT tsT OST ot 06' t*s ot LE' 6'01 OT oll E L't 6'OT E 9*E O*OT E t's B'OT e E*9 6*01 E e't L*OT e 819 6*01 1 a's O'TT E 6*S 9*OT s 9,S E'TT E E'S SITT E SodeR wdd :ltun abesoa OT 1*9 9E OT E*6 08 it ZB GE 06 ic 99 Bt T6 ic 6L ZE 6L it 8L El OL TE SL OE S6 ooi :IaAariagoa N '13-S NY3H 090963 9SO963 OS0963 6VO963 8t0963 Lt0963 9tO963 St0963 1,00960 Zt0960 t :dno:rd OT 9,Z 601 ol os* Z*9 ol 9*Z IST ol tL* 9*S OT 9z, 0*11 ol L'T E 01 S'SOT t9 OT L*9zl BZT cl.xs NV3K TIT S*9 IST 6*9 T'TT s LOT a's 6tT EIS 6*01 E OTT E*9 IST G*9 6'OT z 901 P*9 6PT z's 6*01 t 60T E*S evi L't 9'OT z 601 Z*9 EST S,9 9*TT z ITT 9*S OST 9*G OITT I Sol 6'S LPT E*p 0111 1 ETT L*9 9ST Z*9 Z*TT p zil 6'9 EST 0*9 Z'll 9 t9E set tE OET EE BL PE 90T 6Z 9L SE LB zz S9 01 Be 6Z 18 OE te OP0963 8E0960 010963 LZ0963 9ZO963 SZ0963 PZ096Z) EZ0960 ZZ0963 IZO963 SO,49H wdd :ltun obesocl OE :IaAariagoa -------- -------- -------- -------- -------- -------- -------- -------- ri/qOHN rl3 ri/rIONH x q/riomm VN IU/DH SOND I Ila/E)N V3 ri/ni LDD ri/ni ri/ni LdDs/.LIV JIODS/.LSV E :dno3f) -----uauwnn QVWINV S.LV'DNI (PTE9-1 '3SOA3K-N) qONVH.L3 OaIKVNOA'InSZNVI-)OOHOnIJHSd QAHISW-N HIIM AGNIS AIIDIXOI AHV13IU M33M-El pi Naam saluwad elea AilaTwaqO TeaTuTID lenpTATpui S xtpuaddv 13-WEEK Appendix 5 Individual Clinical Chemistry Data Males Week 14 DIETARY TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) PERFLUOROOCTANESULFONAMIDO IN RATS ANIMAL NUMBER ------ PCOAO IU/G -------- Group: 1 Dose Level: 0 Dosage Unit: ppm MEFOS C95901 4 C95902 11 C95903 11 C95904 10 C9590'5 11 C95906 12 C95907 8 C95908 10 C95909 10 C95910 8 C95916 11 C95917 11 C95918 13 C95919 8 C95920 7 MEAN S.D. N 10 2.3 15 270 13-WEEK DIETARY Appendix 5 Individual Clinical Chemistry Data Males Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ PCOAO IU/G -------- Group: 2 C95921 C95922 C95923 C95924 C95925 C95926 C95927 C95928 C95929 C95930 C95936 C95937 C95938 C95939 C95940 MEAN S.D. N Dose Level: 3 10 10 7 11 10 11 12 12 12 12 10 4 9 8 4 9 2.7 15 Dosage Unit: ppm MEFOS 271 Appendix 5 Individual Clinical Chemistry Data 13-WEEK males Week 14 DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ PCOAO IUIG -------- Group: 3 C95941 C95942 C95943 C95944 C95945 C95946 C95947 C95948 C95949 C95950 C95956 C95957 C95958 C95959 C95960 MEAN S.D. N Dose Level: 30 10 9 a 10 7 9 9 12 6 12 5 11 10 9 9 9 2.0 15 Dosage Unit: ppm HEFOS 272 13-WEEK Appendix 5 Individual Clinical Chemistry Data males Week 14 DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS AN114AL NUMBER ------ PCOAO IU/G -------- Group: 4 C95961 C95962 C95963 C95964 C95965 C95966 C95967 C95968 C95969 C95970 C95976 C95977 C95978 C95979 C95980 MEAN S.D. N Dose Level: 100 17 11 12 11 5 12 38 13 19 22 22 5 12 15 16 15 8.1 15 Dosage Unit: ppm NEFOS 273 13-WEEK Appendix 5 Individual Clinical Chemistry Data Females Week 14 DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULPONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS ANIMAL NUMBER ------ PCOAO IU/G -------- Group: 1 C95981 C95982 C95983 C95984 C95985 C95986 C95987 C95988 C95989 C95990 C95996 C95997 C95998 C95999 C96000 MEAN S.D. N Dose Level: 0 10 11 5 5 9 4 4 5 7 a 3 8 10 7 7 7 2.5 15 Dosage Unit: ppm MEFOS 274 13-WEEK Appendix 5 Individual Clinical Chemistry Data Females Week 14 DIETARY TOXICITY STUDY WITH N-METHYG PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ PCOAO IU/G -------- Group: 2 C96001 C96002 C96003 C96004 C96005 C96006 C96007 C96008 C96009 C96010 C96017 C96018 C96019 C96020 MEAN S.D. N Dose Level: 3 6 4 10 5 8 3 4 5 10 10 4 8 11 10 7 2.9 14 Dosage Unit: ppm MEFOS 275 13-WEEK DIETARY Appendix 5 Individual Clinical Chemistry Data Females Week 14 TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ PCOAO IU/G -------- Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96028 C96029 C96030 C96036 C96037 C96038 C96039 C96040 MEAN S.D. N Dose Level: 30 4 11 14 5 8 11 7 9 11 12 9 10 10 10 5 9 2.8 15 Dosage Unit: ppM HEFOS 276 13-WEEK Appendix 5 Individual Clinical Chemistry Data Females Week 14 DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ PCOAO IU/G -------- Group: 4 C96041 C96042 C96043 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96057 C96058 C96059 C96060 MEAN S.D. N Dose Level: 100 27 22 16 20 17 12 36 11 20 23 19 22 21 19 8 20 6.7 15 Dosage Unit: ppm MEFOS 277 13-WEEK Appendix 5 Individual Clinical Urinalysis Data Males Week 14 DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ U VOL SP GR U PH ML -------- -------- -------- Group; I C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920 MEAN S.D. N Group: 2 C95921 C95922 C95924 C95925 C9@926 C95927 C95928 C95936 C95937 C95939 MEAN S.D. N Dose Level: 0 18.0 7.6 12.5 6.4 4.0 7.7 B 12.0 24.7 5.0 1.018 1.034 1.026 1.044 1.039 1.030 1.074 1.025 1.013 1.052 9.9 7.15 10 1.036 .0179 10 Dose Level: 3 10.2 6.4 10.6 19.6 2.6 4.7 17.5 8.0 15.3 11.2 1.023 1.026 1.030 1.016 1.040 1.043 1.016 1.030 1.020 1.021 10.6 5.52 10 1.026 .0093 10 Dosage Unit: ppm MEFOS 7.0 7.0 7.0 6.5 7.0 7.0 6.5 7.0 7.5 6.5 6.9 .32 10 Dosage Unit: ppm NEFOS 7.5 7.0 7.0 7.0 6.5 6.5 7.0 6.5 7.5 6.5 6.9 .39 10 278 13-WEEK Appendix 5 Individual Clinical Urinalysis Data Males Week 14 DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 MEAN S.D. N Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C95980 MEAN S.D. N Dose Level: 30 9.1 21.1 17.1 3.5 10.4 13.6 47.5 a 6.0 1.3 8.0 1.022 1.013 1.021 1.037 1.024 1.014 1.002 1.037 1.060 1.030 13.8 13.29 10 1.026 .0162 10 Dose Level: 100 38.5 6.3 14.4 5.6 10.0 19.0 48.2 a 45.2 a 14.5 8.3 1.010 1.042 1.024 1.047 1.031 1.019 1.007 1.004 1.023 1.037 21.0 16.52 10 1.024 .0148 10 Dosage Unitt ppm MEFOS 7.5 6.5 7.0 7.0 7.0 7.0 6.0 6.5 6.5 7.0 6.8 .42 10 Dosage Unit: ppm MEFOS 7.0 6.5 6.5 6.5 6.5 7.0 6.5 7.0 6.5 6.5 6.6 .24 10 a Sample was overflowing at the time of collection. 279 Appendix 5 individual Clinical Urinalysis Data males week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ u PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: I C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920 Group: 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 Dose Level: 0 30 - 30 - 30 - 300 - 30 - 30 - 100 - 30 - 30 - 30 - Dose Level: 3 30 - 30 - 30 - 30 - 30 - 30 - 30 - 30 - 30 - 10 - Dosage Unit: ppm MEPOS + + ++ + + + Dosage Unit: ppm MEFOS 280 Appendix 5 Individual Clinical UrinalySia Data males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ u PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 Dose Level: 30 30 - 10 - 10 - 30 - 30 - 10 - 0 - 30 - 30 - 30 - Dosage Unit: ppm MEFOS + + + ++ + + Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 c95980 Dose Level: 100 10 - 30 - 10 - 30 - 30 - 30 - 10 - 10 - 10 - 10 - Dosage Unit: ppm MEFOS ++ ++ + + 281 ANIMAL NUMBER ------ Group: 1 C95901 C95902 C95903 C95904 C95905 C95906 C95909 C95918 C95919 C95920 Group: 2 C95921 C95922 C95924 C95925 C95926 C95927 C95928 C95936 C95937 C95939 Appendix 5 Individual Clinical Urinalysis Data Males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS CRYSTALS PER LPF PER LPFI -------- -------- URINE APP1 -------- C014MENTS -------- Dose Level: 0 Dosage Unit: ppm NEFOS 0 0 0 3 0 IB4D BJ p 1 1 1 3 0 4D Bi PQ 0 0 1 3 0 4D Bi PQ 0 0 1 2 0 2B4D SK PO 0 0 1 3 0 0 Bi p 0 0 1 2 0 4D ai PQ 0 0 0 1 0 3D ci 4 1 1 3 0 4D BJ PQ 0 1 1 2 0 2BID BJ QR 0 1 2 0 4D ci Q Dose Level: 3 Dosage Unit: ppm MEFOS 0 1 1 2 0 4D BKM P() 0 0 1 2 0 3D Bi Q 0 0 1 2 0 3D Bi PQ 0 0 1 2 0 4D Bi p 0 1 0 2 0 3D Di p 0 0 1 3 0 4D BJ 0 1 1 2 0 lB4D Bi 0 0 1 3 0 4D Bi PQ 0 0 1 3 0 4D Bi PQ 0 1 1 2 0 2D BJ 282 ANI14AL NUMBER ------ Group: 3 C95941 C95942 C95943 C95944 C95947 C95948 C95949 C95950 C95958 C95960 Group: 4 C95961 C95962 C95963 C95964 C95965 C95967 C95968 C95969 C95977 C959BO Appendix 5 individual Clinical Urinalysis Data males Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYI, PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- URINE APP1 -------- COMMENTS -------- Dose Level: 30 Dosage Unit: ppm MEFOS 0 0 0 3 0 2B3D ai QR 0 1 1 1 0 4D Bi PQ 0 1 0 2 0 3D Bi Q 0 0 0 2 0 4D Bi PQ 0 0 1 2 0 4D Bi PQ 0 0 1 2 0 4D Bi PQ 0 1 a 1 0 0 AJ 0 1 1 3 0 4D Bi PQ 0 0 1 1 0 4D ci PQ 0 0 1 2 0 3D BJ PQ Dose Level: 100 Dosage Unit: ppm NEFOS 0 1 0 1 0 0 AJ Q 0 0 1 2 0 4D BJ Q 0 0 1 2 0 2D BJ Q a 0 1 1 0 4D Bi PQ 0 0 1 3 0 4D Bi PQ 2 0 1 2 0 4D Bi Po 0 0 1 3 0 4D AJ 4 0 0 0 0 0 AJ 0 0 1 2 0 40 Bi PO 0 1 1 2 0 3D BJ Q 283 13-WEEK Appendix 5 individual Clinical urinalysis Data Females Week 14 DIETARY TOXICTTY STUDY WITH N-METHYL PERFE.UOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ U VOL ML -------- SP GR -------- U PH -------- Group: 1 Dose Level: 0 Dosage Unit: ppm NEFOS C95983 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000 4.3 1.027 6.5 17.5 1.010 7.0 25.6 1.006 7.0 36.0 1.005 6.5 4.3 1.027 6.5 41.0 1.002 6.5 2.6 1.034 6.5 24.3 1.008 7.0 5.8 1.023 6.5 8.2 1.017 7.0 MEAN S.D. N 17.0 14.13 10 1.016 .0112 10 6.7 .26 10 Group: 2 Dose Level: 3 Dosage Unit: ppm MEFOS C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 3.1 1.027 6.5 8.2 1.022 6.5 2.3 1.036 6.5 7.6 1.022 7.5 30.4 1.006 6.5 26.1 1.006 7.5 12.2 1.015 6.5 3.8 1.028 6.5 9.1 1.014 7.0 MEAN S.D. N 11.4 10.11 9 1.020 .0102 9 6.8 .44 9 284 13-WEEK Appendix 5 individual Clinical urinalysis Data Females Week 14 DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS ANIMAL NUMBER ------ U VOL HL -------- SP GR -------- U PH -------- Group: 3 Dose Level: 30 Dosage Unit: ppm NEFOS C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 9.0 1.021 7.0 9.9 1.019 6.5 22.1 1.009 6.5 41.5 1.004 7.0 2.4 1.030 6.5 43.8 1.006 6.5 6.3 1.025 7.0 7.6 1.020 6.5 11.3 1.016 7.0 12.8 1.013 7.0 MEAN S.D. N Group: 4 C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060 16.7 14.62 10 1.016 .0084 10 Dose Level: 100 7.0 2.4 19.0 7.2 18.7 10.0 5.3 9.1 40.5 29.5 1.029 1.039 1.014 1.026 1.010 1.012 1.024 1.026 1.004 1.007 6.8 .26 10 Dosage Unit: ppm MEFOS 6.5 6.5 6.5 6.5 6.5 6.5 6.5 6.5 7.0 7.0 MEAN S.D. N 15.7 12.05 10 1.019 .0113 10 6.6 .21 10 285 Appendix 5 individual Clinical Urinalysis Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANI14AL NUMBER ------ U PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: I C959B3 C95984 C95985 C95986 C95987 C95988 C95990 C95996 C95997 C96000 Dose Level: 0 30 - 0 - 0 - 0 - 10 - 0 - 30 - 0 - 10 - 10 - Dosage Unit: ppm MEFOS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Group: 2 C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 Dose Level: 3 10 - 10 - 10 - 10 - 0 - 10 - 10 - 10 - 0 - Dosage Unit: ppm HEFOS - - - - - - - - - - - - - - - - - - - - 286 Appendix 5 Individual Clinical Urinalysis Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULPONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ANIMAL NUMBER ------ u PRO MG/DL -------- U GLU -------- U KET -------- U BILI -------- U BLOOD -------- UROBILI -------- Group: 3 Dose Level: 30 Dosage Unit: pipm MEFOS C96021 10 C96022 0 - - - - C96023 10 - - - - - C96024 0 - - - - - C96025 10 - - - - - C96026 10 - - - - - C96027 10 - - - - - C96030 10 - - - - - C96038 10 - - - - - C96040 0 - - - - - Group: 4 Dose Level: 100 Dosage Unit: ppm MEPOS C96042 10 - - - - C96044 30 - - - - - C96045 10 - - - - - C96046 10 - - - - - C96047 0 - - - - - C96048 10 - - - - - C96049 10 - C96050 10 - C96056 0 - C96060 0 - 287 ANIMAL NUMBER ------ Group: 1 C95983 C95984 C95905 C95986 C95987 C95988 C95990 C95996 C95997 C96000 Group: 2 C96001 C96002 C96003 C96006 C96007 C96008 C96010 C96019 C96020 Appendix 5 Individual Clinical Urinalysis Data Females week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER LPF -------- CRYSTALS PER LPF1 -------- URINE APPI -------- COMMENTS -------- Dose Level: 0 Dosage Unit: ppm MEFOS 0 1 1 2 0 2D Bi - 0 0 1 1 0 1D AJ - 0 0 0 1 0 0 AJ - 0 1 1 1 0 0 AJ - 0 1 1 2 0 4D Bi p 0 0 1 3 0 4D AJ 0 0 1 1 0 2D Bi p 0 0 0 1 0 2D AJ 0 0 1 3 0 4D BJ p 0 0 1 1 0 4D BJ Dose Level: 3 Dosage Unit: ppm MEFOS 0 0 1 1 0 4D Bi p 0 0 1 2 0 4D Bi p 0 0 1 3 0 4D Bi p 0 1 1 2 0 4D BJ p 0 0 0 1 0 0 AJ 0 0 1 3 0 1D AJ 0 1 1 2 0 0 Bi p 0 0 1 1 0 4D Bi 0 0 0 1 0 2D Bi 288 ANI14AL NUMBER ------ Group: 3 C96021 C96022 C96023 C96024 C96025 C96026 C96027 C96030 C96038 C96040 Group: 4 C96042 C96044 C96045 C96046 C96047 C96048 C96049 C96050 C96056 C96060 Appendix 5 Individual Clinical urinalySiS Data Females Week 14 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYB PERFLUOROOCTANESULPONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS RBC PER HPF -------- WBC PER HPF -------- EPITH PER HPF -------- BACT PER HPF -------- CASTS PER GPF -------- CRYSTALS PER LPF1 -------- URINE APP1 -------- COMMENTS -------- Dose Level: 30 Dosage Unit: ppm NEFOS 0 1 1 2 0 4D BJ p 0 0 0 1 0 3D Bi - 0 0 1 1 0 0 AJ - 1 0 1 1 0 0 AJ - 0 0 1 1 0 0 Bi - 0 0 1 1 0 1B AJ - 0 1 1 2 0 4D BJ p 0 1 1 1 0 0 Bi 0 0 1 2 0 0 Bi 0 0 1 1 0 0 BJ p DoSe Level: 100 Dosage Unit: pjpm NEFOS 0 0 1 1 0 2D Bi 0 1 0 2 0 1D BJ 0 0 1 2 0 0 AJ 0 1 1 2 0 4D BJ p 0 1 1 1 0 IB AJ 0 0 1 1 0 0 BJ p 0 0 1 2 0 4D Bi p 0 1 1 2 0 4D BJ 0 0 0 2 0 0 AJ 0 0 1 1 0 0 AJ 289 --v APPENDIX 6 IndividualAnftnalPathology Data -- 'k-@ Covance 6329-225 3M T-6314.1 I 290 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95901 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: MALE STUDY DAY OF 12/02/98 12:16 DOSE GROUP: 1 DEATH: 93 STUDY WEEK PROSECTOR: LAURIE J. SACRIFICE OF DEATH: SCHULLER STATUS: 14 SCHEDULED, TERMINAL SACRIFI TERMINAL BODY WEIGHT: 477 RECORDER: TERRI L. WILL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0RG ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ------ ADRENAL (AD) .0507 .0106 t .0234 WEIGHT BRAIN (SR) KIDNEY (KD) 2.1637 3.6235 .4520 t .7582 t 1.0000 1.6747 WEIGHT WEIGHT LIVER SPLEEN TESTIS (LI) (SP) (TE) 13.2353 .6399 3.0353 2.7695 t .1339 t .6351 t 6.1170 .2957 1.4028 WEIGHI WEIGHI WEIGHI THYMUS (TH) .3522 .0737 % .1628 WEIGin THYROID/PARATHYR (TT) .0353 .0074 % .0163 WEIGHI ------------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------------------------------------------------- LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIHAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL HEART (HT) : -DEGENERATION/NECROSIS,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PANCREAS (PA) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) -BONE KARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS ------ -------------------------------- 291 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95901 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI( DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 477. DATE AND TIME OF NECROPSY: 12/02/98 12:16 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. WILLI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD -------------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), HARROW, FEMUR (FM), HARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, SKE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE). LN, MANDIBULAR SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTAT SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYNIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAHRNATION: BONE, FEMUR (FE), HARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA) AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV). TESTIS (TE), EPIDIDYMIDES (EP ------------------------------------------------------------------------------------------------------------------- 292 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95902 DATE OF DEATH: 12/02/98 SEX: MALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 500 DATE AND TIME OF NECROPSY: 12/02/90 10:38 PROSECTOR: JODI THIEREN RECORDER: TERRI L. WILL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0RG ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST A ------ ADRENAL (AD) .0754 .0151 t .0353 WEIGHT BRAIN (BR) 2.1335 .4262 t 1.0000 WEIGHT KIDNEY (KD) 4.1240 .8238 t 1.9330 WEIGHT LIVER (LI) 15.9820 3.1926 % 7.4910 WEIGHT SPLEEN (SP) B310 .1660 t .3895 WEIGHT TESTIS (TE) 3.5597 .7111 t 1.6685 WEIGHT THYMUS (TH) .2540 .0507 t .1191 WEIGHT THYROID/PARATHYR (TT) .0190 .0040 t .0093 WEIGHT ------------------------------------------------------------------------------------------------------------------- 0BS ERVA T 10N S NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------------------------------------------------- LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL KIDNEY (KD) ; THYMUS (TH) -MOTTLED; BILATERAL: RED AND TAN LN, MANDIBULAR (NN) : -DIFFUSELY RED; BILATERAL: DARK RED -MINERALIZATION, TUBULAR,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINI14AL LN, MANDIBULAR (NN) -HEMORRHAGE,-SLIGHT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN - - -- - - - - -- - -- - - - - -- - - - - -- - -- - - - - - - - - - - - 293 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95902 SEX: 14ALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 500 DATE AND TIME OF NECROPSY: 12/02/98 10:38 PROSECTOR: JODI THIEREN RECORDER: TERRI L. WILL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), NARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKE NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC) ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE). SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UB). PROSTATE (PR), SEMINAL VESICLE TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNRE14ARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), HEART (HT). MUSCLE, SKELETAL (SM), NERVE, SCIAT SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA ( AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU). JEJUNUH (J ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, KHNDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB SKIN (SK), URINARY BLADDER (UB). SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) ------------------------------------------------------------------------------------------------------------------- 294 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95903 SEX: KALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 40 DATE AND TIME OF NECROPSY: 12/02/98 11:07 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST A ADRENAL (AD) .0585 .0121 t .0273 WEIGH BRAIN (BR) 2.1393 .4431 t 1.0000 WEIGH KIDNEY (KD) 3.4896 .7228 t 1.6312 WEIG LIVER (LI) 13.3362 2.7623 t 6.2339 WEIGH SPLEEN (SP) .8041 .1665 t .3759 WEIG TESTIS (TE) 3.5494 .7352 t 1.6591 WHIG THYMUS (TH) .2730 .0565 t .1276 WEIGH THYROID/ PAFLATHYR (TT) .0280 .0058 % .0131 WEIGH ----------------------------------------------------------------------------------------------------------------- 0B SE RVA T10N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LUNG (LU) : -HEMORRHAGE,-MINIMAL -INFILTRATE, KACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIHAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYROID (TY) : LN, MANDIBULAR (MN) -MMTLEDI BILATERAL: RED AND TAN -ECTOPIC THYMUS,-PRESENT LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL SKIN (SK) : -EXUDATE, EPIDERMAL SURFACE,-MINIMAL GENERAL COMMENT (GC) -INFLAMMATION, SURACUTE,-MINIKAL -BONE MARROW SMEAR TAKEN ------- ------------------------------- 295 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95903 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/99 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 48 DATE AND TIME OF NECROPSY: 12/02/98 11:07 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, KAN HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SX), URINARY BLADDER (UB). PROSTATE (PR). SEMINAL VESICL TESTIS (TE), EPIDIDYNIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC). TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCI SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (K AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM ( ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV). TESTIS (TE), EPIDIDYMIDES (EP) ------------------------------------------------------------------------------------------------------------------ 296 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95904 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT. 502 DATE AND TIME OF NECROPSY: 12/02/98 12:07 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R G STA ------ ADRENAL (AD) .0551 .0110 t .0249 WEIGHT BRAIN (BR) 2.2087 .4393 t 1.0000 WEIGHT KIDNEY (KD) 4.1957 .8345 t 1.8996 WEIGHT LIVER (LI) 14.9025 2.9639 t 6.7472 WEIGHT SPLEEN (SP) .8734 .1737 % .3954 WEIGHT TESTIS (TE) 3.4791 .6919 t 1.5752 WEIGHT THYMUS (TH) .3279 .0652 t .1485 WEIGHT THYROID/PARATHYR (TT) .0119 .0024 % .0054 WEIGHT ------------------------------------------------------------------------------------------------------------------- 0BS ERVA T10N S NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL KIDNEY (KD) : HEPATOCYTE,-MINIMAL -BASOPHILIC TUBULES, CORTEX,-MINIMAL -THICKENING, BASEMENT HEMERANE,-KINIHAL HEART (HT) : THYROID (TY) >NOTE:>TRIN COMMENT: PARATHYROID (PT) : >NOTE:>TRIM COMMENT: ONE MISSING ONE MISSING AT TIME OF TRIMMING AT TIME OF TRIMMING -DEGENERATION/NECROSIS,-MINIMAL THYMUS (TH) : HEMORRHAGE,-MINIKAL THY-ROID (TY) : -ONE EXAMINED.-PRESENT PARATHYROID (PT) : -ONE EXAMINED.-PRESENT PROSTATE (PR) t -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL 297 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95904 SEX: MALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 5 DATE AND TIME OF NECROPSY: 12/02/9B 12:07 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 1 0 N S (CONTINUED) NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, S NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO). PITUITARY (PI). STOMACH. GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM IDU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UH), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), MUSCLE, SKELETAL (SM). NERVE, SCIATIC (SN), SP LN, HESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECT LN, MANDIBULAR (MN), SALIV GL. MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB). SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) ----------------------------------------------------------------------------------------------------------------- 298 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH H-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN PATS --------------------------------------------------------------------------------------------------------------- ANT14AL NUMBER: C95905 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 10:03 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFE --------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO s ---------------------- -------- -------- -------- ADRENAL (AD) .0413 .0086 t .0188 WE BRAIN (BR) KIDNEY (KD) 2.1962 3.2242 .4596 t .6748 t 1.0000 WE 1.4681 WE LIVER SPLEEN TESTIS (LI) (SP) (TE) 13.4331 .0531 3.1958 2.8114 t .1785 t .6689 t 6.1165 WE .3884 WE 1.4551 WE THYMUS (TH) .3319 .0695 % .1511 WE THYROID/PARATHYR (TT) .0209 .0044 t .0095 WE --------------------------------------------------------------------------------------------------------------- 0B SER VAT 10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------ LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MININAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYMUS (TH) : -HEMORRHAGE.-MINIHAL PROSTATE (PR) : GENERAL COMMENT (GC) -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS -- - - - - - - -- - - - - -- - - - - - - - -- - - - - -- - -- - - - 299 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95905 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 10:03 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFE --------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH). LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL. CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NON PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIB SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). URINARY BLADDER (UB). PRO SEMINAL VESICLES (SV), TESTIS (TE). EPIDIDYNIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM). NARROW. STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (S NERVE, SCIATIC (SN). SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU). PANCREAS (PA) DUODENUM (DU), JEJUNUM (JE). ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB). SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYNIDES (EP) --------------------------------------------------------------------------------------------------------------- 300 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95906 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SA DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 10:06 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CH POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORN -------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO s ---------------------- -------- -------- -------- ADRENAL (AD) .0596 .0112 t .0270 W, BRAIN (BR) 2.2070 .4146 t 1.0000 w KIDNEY (KD) 3.6715 .6897 t 1.6636 w@ LIVER (LI) 17.6850 3.3224 t 8.0131 w SPLEEN (SP) .9226 .1733 t .4180 W, TESTIS (TE) 3.5489 .6667 t 1.6080 W. THYMUS (TH) .2941 .0553 t .1333 w THYROID/PARATHYR (TT) .0273 .0051 t .0124 w -------------------------------------------------------------------------------------------------------------- 0B SERV AT 10N S NECROPSY HISTOPATHOLOGY ----------------------------------------------------------------------------------------------------------- LUNG (LU) : -MINERALIZATION, VASCULAR.-MINIMAL THYROID -CYST, PANCREAS (TY) : ULTIMOBRANCHIAL,-PRESENT (PA) : -PIGMENT, BROWN.-MINIKAL GENERAL COMMENT (GC) -BONE HARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - -- - - - - - - - - - - -- - - - - - - - - - - -- - - - - - 301 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL TN-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95906 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SAI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 10:06 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CH POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORN -------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNRE14ARKABLE AT NECROPSY: BONE, FEMUR (FE), t4ARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM tSB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD). HEART (HT), MUSCLE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC tMS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST). STOMACH, NO] PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM tIL), CECUH (CE). COLON (CO), RECTUM (RE), LN, MANDI SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG@, AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PR SEMINAL VESICLES (SV), TESTIS tTE), EPIDIDYMIDES (EP), TAIL tTI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE). 14ARROW, FEMUR tFM), MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC). TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS tTH), LN, MESENTERIC (HS), PARATHYROID (PT), ADRENAL, CORTEX ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU). DUODENUM (DU JEJUNUM tJE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB ( HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VE TESTIS (TE), EPIDIDYMIDES (EP) -------------------------------------------------------------------------------------------------------------- 302 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95907 SEX. HALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE AND TIME OF NECROPSY: 12/02/98 7:56 PROSECTOR; TODD ACKER RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST ---- ADRENAL (AD) .0456 .0097 t .0216 WEIG BRAIN (BR) 2.1146 .4507 t 1.0000 WEIG KIDNEY (KD) 3.3900 .7225 % 1.6031 WEIG LIVER (LI) 12.7160 2.7101 % 6.0134 WEI( SPLEEN (SP) .6803 .1450 % .3217 WEI( TESTIS (TE) 3.1705 .6757 % 1.4993 WEI( THYMUS (TH) .3000 .0639 % .1419 WEI( THYROID/PARATHYR (TT) .0298 .0064 % .0141 WEI( ----------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOL#OGY ------------------------------------------------------------------------------------------------------------- THYROID (TY) : -CYST, ULTIMOBRANCHIAL.-PRESENT PANCREAS (PA) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -PIGMENT, BROWN,-MINIMAL RECTUM (RE) : -PARASITISM.-PRESENT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - 303 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95907 SEX: HALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC DATE OF DEATH: 12/02/96 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 7:56 PROSECTOR: TODD ACKER RECORDER: WENDY CHE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNE --------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), NARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, OL (ST), STOMACH, NON PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), IN, MANDIB SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PRO SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE. STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT). MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX ( ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST). STOMACH, NONGL (SU), DUODENUM (DU) JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), LN, MANDIBULAR (NN), SALIV GL. MANDIB (SG). HARDERIAN AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES --------------------------------------------------------------------------------------------------------------- 304 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------- ANIKAL NUMBER: C95908 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 7:36 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: LYNN HORNE --------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO s ---------------------- -------- -------- -------- ADRENAL (AD) .0571 .0113 t .0269 WE BRAIN (BR) 2.1256 .4209 t 1.0000 WE KIDNEY (KD) 3. 4 9Q@4@ .6915 % 1. 64@9 WE LIVER (LI) 13.0677 2.5877 t 6.1',11 8 WE SPLEEN TESTIS ISP) (TE) .8254 3.3149 .1634 t .6564 t .3883 WE 1.5595 WE THYMUS (TH) .5078 .1006 t .2309 WE THYROID/PARATHYR (TT) .0193 .0038 t .0091 WE --------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------ THYROID (TY) : LN, MANDIBULAR (MN) -DIFFUSELY RED; BILATERAL -CYST, ULTIMOBRANCHIAL.-PRESENT LN, MANDIBULAR (NN) : -HEMORRHAGE.-MINIMAL PROSTATE (PR) : -INFILTRATE. LYMPHOHISTIOCYTIC.-SLIGHT GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- 305 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95908 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 7:36 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (OR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL. MEDULLA (MA), AORTA (AD), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), SALIV GL, HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESI TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE). HARROW. FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH). LN, MESENTERIC (MS). PARATHYROID (PT). ADRENAL,' CORTEX (A ADRENAL, MEDULLA (KA). AORTA (AO), PITUITARY (PI). STOMACH, GL (ST). STOMACH. NONGL (SU), PANCREAS.(PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). URINARY BLADDER (UB), SEMINAL VESICLES (SV). TEST EPIDIDYMIDES (EP) ---------------------------------------------------------------------------------------------------------------- 306 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95909 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH; 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 10:29 PROSECTOR: JOHN S. HALFORD RECORDER; WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0 ST --- ADRENAL (AD) .0629 .0145 % .0287 WEI BRAIN (BR) 2.1932 .5053 t 1.0000 WEI KIDNEY (KD) 3.1195 .7188 % 1.4224 WEI LIVER (LI) 11.3174 2.6077 % 5.1602 WEI SPLEEN (SP) .6744 .1554 t .3075 WEI TESTIS (TE) 3.6084 .8314 t 1.6453 WEI THYMUS (TH) .3922 .0904 t .1788 WEI THYROID/PARATHYR (TT) .0256 .0059 t .0117 WEI ---------------------------------------------------------------------------------------------------------------- 0 BS ERVA T10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- LUNG (LU) : -INFILTRATE, HACROPHAGE, LIVER (LI) : ALVEOLAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE.-MINIMAL THYMUS (TH) : -HEMORRHAGE.-HINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT HARDERIAN GLAND (HG) : -INFILTRATE, LYMPHOHISTIOCYTIC.-HINIKAL PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOMIC.-MINIKAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS - - - - - - - - - - - -- - -- - -- - - - - -- - -- - -- - -- - - - - 307 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL IN-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95909 SEX: MALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT; DATE AND TIME OF NECROPSY: 12/02/98 10:29 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), IN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYNIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SH). NERVE, S SPLEEN (SP), LN, NESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA ( PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM CECUM (CE). COLON (CO). RECTUM (RE), LN, MANDIBULAR (MN)o SALIV GL, MANDIB (SG), AUDITORY SEB GL (AS), S URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYNIDES (EP) ---------------------------------------------------------------------------------------------------------------- 308 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS ------ --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95910 SEX- MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 12/02/98 7:54 PROSECTOR: NANCY DIEDRICH TERMINAL BODY WEIGHT: RECORDER: STEVE VAN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: TONY HANFEL ------ --------------------------------------------------------------------------------------------------------- ------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST --- ---------------------- .0412 .0072 % .0183 WEI ADRENAL (AD) 2.2483 .3918 t 1.0000 WEI BRAIN (BR) KIDNEY (KD) 4.4547 16.2577 .7764 % 2.8333 t 1.9814 WEI 7.2311 WEI LIVER (LI) SPLEEN (SP) .8328 .1451 % .3704 WEI TESTIS THYMUS (TE) (TH) 3.6513 .5244 .0345 .6363 t .0914 % .0060 t 1.6240 WEI .2332 WEI .0153 WEI T-H-YR-O-I-D/-P-A-RA-T-H-YR-------(-T-T-)------------------------------------------------------------------------------------ 0 BSE RVAT 10N S HISTOPATHOLOGY NECROPSY ---- ------------ --------------------------- ---------------------------------------------------------------- LUNG (LU) : -INFILTRATE, 14ACROPHAGE, ALVEOLAR,-MINIMAL -MINERKLIZATION, VASCULAR,-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL KIDNEY (KD) : -BASOPHILIC TUBULES, CORTEX,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL.-PRESENT -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIHAL GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - -- - - 309 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------- ------------------------------------------------------------------------------- ANIMAL NUMBER: C95910 SEX- MALE DOSE GROUP: 1 SACRIFICE STATUS: STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACR TERMINAL BODY WEIGHT: RECORDER: STEVE VAN DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/98 7:54 PRO@ECTOR: NANCY DIEDRICH WEIGHER: TONY HANFEL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY ---------------------------------------------------------------------------------------------- -------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE. NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO). PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UB). PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYHIDES (EP). TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: , STERNUM (SB), EYE (EY), BRAIN (BR), BONE, FEMUR (FE), t4ARROW. FEMUR (FM), MARROW, STERNUM (SE), BONE SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SH), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU). JEJUNU ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYNIDES ----------------------------------------------------------------------------------- -------------------------- 310 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-NETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95911 SEX: KALE DOSE GROUP.- I SACRIFICE STATUS: SCHEDULED, FIRST INTERIM DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 10/01/98 11:59 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZI ---------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- sI --- -------- -------- -------- NOI ADRENAL (AD) -------- -------- -------- NOI BRAIN (BR) KIDNEY (KD) -------- -------- -------- NOI LIVER (LI) 9.9529 3.0671 % -------- WEI SPLEEN (SP) -------- -------- -------- NOI TESTIS (TE) --------------- --------------- --------------- m N(M THYMUS (TH) -------- -------- -------- NOI -------T-H-Y-R-O-I-D-/-P-A-R-A-T-H-Y-R---(-T-T-)----------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD). HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NON PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIB SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PRO SEMINAL VESICLES (SV). TESTIS (TE), EPIDIDYNIDES (EP), TAIL (TI). GENERAL COMMENT (GC) --------------------------------------------------------------------------------------------------------------- 311 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE. T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95912 SEX: HALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 3 DATE AND TIME OF NECROPSY: 10/01/98 11:31 PROSECTOR: MATTHEW AXTHAN RECORDER: KEVIN BILLI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) KIDNEY (KD) --------------- --------------- -------- NOT -------- NOT LIVER (LI) 12.7772 3.3955 t -------- WEIG SPLEEN (SP) -------- -------- -------- NOT TESTIS (TE) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT THYROID/PARATHYR (TT) -------- -------- -------- NOT ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (HA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST). STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK). URINARY BLADDER (UB). PRO SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYNIDES (EP), TAIL (TI), GENERAL COMM" (GC) ----------------------------------------------------------------------------------------------------------------- 312 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95913 SEX: 14ALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 10/01/98 11:45 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHKY WEIGHER: MICHELE ZI ---------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST --- ADRENAL BRAIN KIDNEY LIVER SPLEEN (AD) (BR) (KD) (LI) (SP) ---------------------- 11.6383 -------- ---------------------- 3.1703 t -------- -------- NOT -------- NOT -------- NOT -------- WEI -------- NOT TESTIS (TE) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT THYROIDIPARATHYR (TT) -------- -------- -------- NOT ---------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS.(ES), LIVER (LI), KIDNEY (KD). HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO). PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO). RECTUM (RE). LN, MANDIBU SALIV GL. KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYNIDES (EP), TAIL (TI), GENERAL COMMENT (GC) ---------------------------------------------------------------------------------------------------------------- 313 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95914 DATE OF DEATH: 10/01/98 DATE AND TIME OF NECROPSY: SEX: MALE STUDY DAY OF 10'/01/98 11:36 DOSE GROUP: I SACRIFICE DEATH: 31 STUDY WEEK OF DEATH: PROSECTOR: MATTHEW AXTMAN STATUS: 5 SCHEDULED, FIRST INTERI TERMINAL BODY WEIGHT: RECORDER: KEVIN BIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZI --------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO s ---------------------- -------- -------- -------- ADRENAL (AD) -------- -------- -------- N(Y BRAIN (BR) -------- -------- -------- N(Y KIDNEY (KD) -------- -------- -------- Nor LIVER (LI) 11.8655 3.4274 t -------- WE SPLEEN (SP) -------- -------- -------- NCY TESTIS (TE) -------- -------- -------- N(Y THYMUS (TH) -------- -------- -------- NCV THYROID/PARATHYR (TT) -------- -------- -------- NCY --------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). 14ARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (DR). SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AD), PITUITARY (PI), STOKACH, GL (ST), STOMACH, NON PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBI SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UB), PRO SEMINAL VESICLES (SV), TESTIS (TE). EPIDIDYHIDES (EP), TAIL (TI), GENERAL COMMENT (GC) --------------------------------------------------------------------------------------------------------------- 314 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYT ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95915 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 10/01/98 11:42 PROSECTOR; WENDY CHERRY RECORDER: KEVIN BILL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZI ---------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST --- ---------------------- ADRENAL (AD) --------------- --------------- --------------- NOI NOI BRAIN (BR) KIDNEY (KD) -------- -------2.8791 t --------------- NOI WEI LIVER (LI) 7.5432 -------- -------- -------- NOI SPLEEN (SP) -------- -------- -------- NOI TESTIS (TE) -------- -------- -------- W(M THYMUS (TH) -------- -------- ---------- NOI -------T-HY-R-O-I-D/-P-A-R-A-TH-Y-R-----(-T-T-)-------------------------------------------------------------------- ------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FH), MARROW, STERNUM (SE), BONE, STERNUM (SH), EYE (EY). BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NON( PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), LN. MANDIBI SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS)., SKIN (SK), URINARY BLADDER (UB), PRO SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) GENERAL COMMENT (GC) --------------------------------------------------------------------------------------------------------------- 315 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE. T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER-. C95916 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: 14ALE STUDY DAY OF 12/02/98 8:32 DOSE GROUP: 1 SACRIFICE DEATH: 93 STUDY WEEK OF DEATH: PROSECTOR: NANCY DIEDRICH STATUS: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 55 RECORDER: STEVE VAN A[ POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT -------- WEIGHT RATIO -------- ST ----- ADRENAL (AD) .0570 .0102 t .0246 WEIG BRAIN (BR) 2.3125 .4145 t 1.0000 WEIG KIDNEY (KD) 4.2219 .7567 1.8257 WEIG LIVER (LI) 15.3513 2.7516 6.6384 WEIG SPLEEN (SP) .8545 .1532 t .3695 WEIG TESTIS (TE) 3.7162 .6661 t 1.6070 WEIG THYMUS (TH) .3622 .0649 t .1566 WEIG THYROID/PARATHYR (TT) .0252 .0045 t .0109 WEIG ----------------------------------------------------------------------------------------------------------------- 0 BS ERVAT 10N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LUNG (LU) : -INFLAMMATION, SURACUTE,-HININAL KIDNEY (KD) -LARGE PELVIS(ES); RIGHT THYMUS (TH) : -RED FOCUS(I)/AREA(S); DIFFUSE: MULTIPLE DARK RED AREAS, UP KIDNEY (KD) : -DILATATION, PELVIC,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL To 3 X 2 MM STOMACH, GL (ST) >NOTE:>TRIMMING COMMENT: STOMACH, NONGL (SU) : >NOTE:>TRIMMING COMMENT: STOMACH STOMACH NOT FOUND NOT FOUND IN WET TISSUE IN WET TISSUE STOMACH, GL (ST) >TISSUE MISSING STOMACH, NONGL (SU) >TISSUE MISSING PANCREAS (PA) : -INFLAMMATION, CHRONIC-ACTIVE.-SLIGHT DUODENUM (DU) >NOTE:>TRIMMING COMMENTs DUODENUM NOT FOUND IN WET TISSUE DUODENUM (DU) t >TISSUE MISSING PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT 316 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95916 SEX: MALE STUDY DAY OF DEATH: DOSE GROUP: 1 93 STUD Y WEEK SACRIFICE OF DEATH: STATUS: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 55 RECORDER: STEVE VAN AD DATE OF DEATH: 12/02/98 PROSECTOR: NANCY DIEDRICH DATE AND TIME OF NECROPSY: 12/02/98 POST-FIX WEIGHER: NOT AVAILABLE 8:32 PATHOLOGIST: JOHN - EIGHMY -------------------W-EI-G-H-ER-:---T-O-N-Y --H-A-NF-E-L-D --- ------------------------------------------------------------- ------ 0 B S E R V A T 1 0 N S (CONTINUED) HISTOPATHOLOGY NECROPSY ---------------------------------------------- ---------------------------------------------------------------- GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN - - -- - -- - - - - -- - - - THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: STERNUM (SB), EYE (EY), BRAIN (BR), BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW. STERNUM (SE), BONE, SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (, ES), LIVER (LI), HEART (HT), MUSCLE, SKELETAL (SM), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS) . ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE). LN MANDIBULAR (NN), SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTA SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY). BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), HEART (HT), MUSCLE, SKELETAL (SH). NERVE, SCI SPLEEN (SP), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID JPT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA AORTA (AO), PITUITARY (PI), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK). URINARY BLADDER (US), --------S-E-M-IN-A-L---VE-S-I-C-L-ES---(-S-V-)-.--TE-S-T-I-S---(T-E-)-,--E-PI-D-I-D-Y-MI-D-E-S---(-E-P-)-------------------------------------------------------- 317 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95917 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: MALE STUDY DAY OF 12/02/98 7:37 DOSE GROUP: 1 SACRIFICE DEATH: 93 STUDY WEEK OF DEATH: PROSECTOR: JERALD W. JOHNSON STATUS: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 5 RECORDER: WENDY CHERRI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) .0545 2.0848 4.3299 13.8740 .0102 t .3920 t .8140 t 2.6084 % .0261 1.0000 2.0769 6.6548 WEIG WEIG WEIG WEIG SPLEEN TESTIS (SP) (TE) .7099 3.4976 .1335 t .6576 % .3405 1.6777 WEIG WEIG THYMUS (TH) .3380 .0635 % .1621 WEIG THYROID/PARATHYR (TT) .0278 .0052 1 .0133 WRIG ----------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCWIC.-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT RECTUM (RE) : -PARASITISM.-PRESENT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - 318 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95917 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 SCHEDULED. TERMINAL SACRIF TERMINAL BODY WEIGHT: 53 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/98 7:37 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW. FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH). LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UB), PROST SEMINAL VESICLES (SV). TESTIS (TE), EPIDIDYNIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW. FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SC SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA ( AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA). DUODENUM (DU), JEJUNUM ILEUM (IL), CECUM (CE). COLON (CO). LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE). EPIDIDYNIDES ( ----------------------------------------------------------------------------------------------------------------- 319 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCT,KNESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95919 SEX: MALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/90 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 49 DATE AND TIME OF NECROPSY: 12/02/98 10:56 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ADRENAL (AD) .0547 .0111 t .0261 WEIG BRAIN (BR) 2.0931 .4231 t 1.0000 WEIGH KIDNEY (KD) 3.6402 .7358 t 1.7391 WEIGH LIVER (LI) 14.9341 3.0188 t 7.1349 WEIG SPLEEN (SP) .7976 .1612 t .3811 WEIG TESTIS (TE) 3.2582 .6586 t 1.5566 WEIG THYMUS (TH) .2806 .0567 % .1341 WEIGH THYROID/PARATHYR (TT) .0265 .0054 t .0127 WEIG ------------------------------------------------------------------------------------------------------------------ 0 BSE RVAT 10N S NECROPSY HISTOPATHOL.OGY --------------------------------------------------------------------------------------------------------------- LUNG (LU) : -INFILTRATE, MACROPHAGE, LIVER (LI) : ALVEOLAR.-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC.-MIN114AL THYMUS (TH) -RED FOCUS(I)/AREA(S); TO 3 X 2 KH DIFFUSE: MULTIPLE DARK RED AREAS, UP THYMUS (TH) : -HEMORRHAGE,-MINIHAL GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN ------ -------------------------------- 320 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95918 DATE OF DEATH: 12/02/96 SEX: MALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIP STUDY DAY OF DEATH: 93 STUDY WEEK OF DEJKTH% 14 TERMINAL BODY WEIGHT: 49 DATE AND TIME OF NECROPSY: 12/02/98 10:58 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FH), MARROW, STERNUM (SE). BONE, STERNUM (SB). EYE (EY). BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), LN. MESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), LN, MANDIBULAR (NN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (US). PROSTA SEMINAL VESICLES (SV). TESTIS (TE), EPIDIDYMIDES (EP). TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (PH), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA ITR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SH), NERVE, SCI SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (NN), SALIV GL. MANDIB (SG). HARDERIAN GLA AUDITORY SES GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR). SEMINAL VESICLES (SV). TESTIS (TE), EPIDIDYNIDES (EP) ------------------------------------------------------------------------------------------------------------------ 321 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULPONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95919 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: 14ALE STUDY DAY OF 12/02/98 11:30 DOSE GROUP: 1 SACRIFICE DEATH: 93 STUDY WEEK OF DEATH: PROSECTOR: NANCY DIEDRICH STATUS: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 5 RECORDER: TERRI L. Wl POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST ---- ADRENAL (AD) .0603 .0115 t .0267 WEIG BRAIN (BR) 2.2555 .4305 t 1.0000 WEIG KIDNEY (KD) 4.1905 .7999 t 1.8579 WEIG LIVER (LI) 16.3018 3.1116 t 7.2276 WEIG SPLEEN (SP) .9470 .1606 t .4199 WEIG TESTIS (TE) 3.1638 .6039 % 1.4027 WEIG THYMUS (TH) .2340 .0447 % .1037 WEIG THYROID/PARATHYR (TT) .0308 .0059 % .0137 WEIG ------------------------------------------------------------------------------------------------------------------ 0B SER VAT 10N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LIVER (LI) : LN, MANDIBULAR (MN) -DIFFUSELY RED; RIGHT: DARK RED GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -INFILTRATE, LYMPROHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL HEART (HT) : -DEGENERATION/NECROSIS,-MINIMAL THYROID (TY) : -CYST, ULTIHOBRANCHIAL,-PRESENT PARATHYROID (PT) -CYST,-PRESENT PITUITARY (PI) -CYST,-PRESENT LN, MANDIBULAR (HN) -HEMORRHAGE,-MINIMAL PROSTATE (PR) i -INFILTRATE, LYMPHORISTIOCWIC,-mibirMAL 322 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95919 SEX: 14ALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 52 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 RECORDER: TERRI L. WIL DATE AND TIME OF NECROPSY: 12/02/90 11:30 PROSECTOR: NANCY DIEDRICH PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-V-A-I-LA-B-L-E------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD). HEART (HT). MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MAN HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICL TESTIS (TE). EPIDIDYMIDES (EP). TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), MUSCLE, SKELETAL (SH), NERVE, SCI SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (KA), AORTA (AO), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL). CECUM (CE). COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYKIDES (EP) ---------------------------------------------------------------------------------------------------------------- 323 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS --------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95920 SEX: MALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 514 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY DATE AND TIME OF NECROPsy: 12/02/98 11:35 PATHOLOGIST: JOHN EIGH14Y WEIGHER: LYNN HORNER P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-V-AI-L-A-B-LE------------------------------- ---------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ----- ADRENAL (AD) .0685 .0133 t .0314 WEIGH WEIGH BRAIN (BR) 2.1808 4.1319 .4241 t .8036 t 1.0000 1.0947 WEIGH KIDNEY (KD) LIVER (LI) 15.1321 2.9428 t .1587 t 6.9388 .3743 WEIGH WEIGH SPLEEN (SP) .8162 3.1121 .6052 % 1.4270 WEIGH TESTIS THYMUS (TE) (TH) .4094 .0796 t .1877 WEIGtr THYROID/PARATHYR (TT) .0193 .0038 t .0088 WEIGH ------------------------------------------------------------------------------------------------------------------ 0 B S E R V A T 10 N S HISTOPATHOLOGY NECROPSY ----------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIHAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL GENERAL C014MENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - -- - 324 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYB PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95920 SEX: MALE DOSE GROUP: 1 SACRIFICE STATUS: DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 DATE AND TIME OF NECROPsy: 12/02/98 11:35 PROSECTOR: JOHN S. HALFORD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST-. JOHN EIGHHY -------------------------------------------------------------------------- SCHEDULED, TERMINAL SACRIFI TERMINAL BODY WEIGHT: 514 RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER ------------------ ------ THE FBOOLNLEO,WINFGEMURORGA(NFSE),WEKRAERROUWN,REMAFREKMAUBRLE (FMA)T, NMEACRRROOPWSY,: STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGB PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTJV SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYKIDES (EP), TAIL (TI) THE FBOOLNLEO,WINFGEMURTISS(UFEES), W1E4RAERROUWN,REMFAERMKUARBLE(FM),AT NMAIRCRROOWS,COPSITCERNUEMXAMI(NSAET)I,ON:BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT). MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL. CORTEX (AC) ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGB (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN). SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB). SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) ----------------------------------------------------------------------------------------------------------------- 325 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYI, PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95921 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF TERMINAL, BODY WEIGHT: 47 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 11:11 PROSECTOR: JOHN S. HABFORD PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-VA-I-L-A-BL-E-------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO -------- ST A ----- ---------------------- -------- -------.0107 t .0226 WEIGH ADRENAL (AD) BRAIN (BR) .0513 2.2655 .4736 t .7120 t 1.0000 1.5036 WEIG WEIG KIDNEY (KD) LIVER (LI) 3.4063 13.6319 .7113 2.0495 t .1487 t 6.0172 .3140 WEIG WEIGH SPLEEN (SP) 3.1045 .6489 % 1.3703 WEIG TESTIS (TE) .2703 .0565 t .1193 WEIG THYMUS (TH) .0315 .0066 % .0139 WEIGH -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-) ----------------------------------------------------------------------------------- 0B SER VAT 10N S HISTOPATHOLOGY NECROPSY ---------------------------------------------- -------- ------------ --------------------------------------- LIVER (1,I): -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAI, THYMUS (TH) -DIFFUSELY RED; LEFT LOBE: DARK RED THYMUS (TH) : -HEMORRHAGE,-SLIGHT GENERAL COMMENT (GC) : -BONE 14ARROW SMEAR TAKEN ------- ------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (bI). KIDNEY (KD), HEART (HT), MUSCI.E, S NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (Al ADRENAL, MEDULLA (t4A), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST). STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROST SEMINAL VESICLES (SV), TESTIS (TE). EPIDIDYMIDES (EP)o TAIL (TI) ------------------------------------------------------------------------------------------------------------- 326 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95922 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: MALE STUDY DAY OF 12/02/98 11:30 POST-FIX WEIGHER: NOT AVAILABLE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI TERMINAL BODY WEIGHT: 486 DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: TERRI L. WILL PROSECTOR: LAURIE J. SCHULLER WEIGHER: TONY HANFELD PATHOLOGIST: JO-H-N--E-I-G-HM-Y-------------------------------------------- ---------------------------------- ABSOLUTE ORGAN ORGAN NAME (GRAMS) WEIGHT ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) ORGAN TO BRAIN WEIGHT RATIO 0 RC S_T_A ---------------------- ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR (TT) .0448 2.1727 3.4077 13.7456 .7358 3.6580 .2339 .0446 .0092 t .0206 WEIGHI .4463 t 1.0000 WEIGH .7000 t 1.5684 WEIGH 2.8237 t 6.3265 WEIGW. .1512 t .3387 WEIGH .7514 t 1.6836 WEIGW .0480 t .1077 WEIGW .0092 % .0205 WEIGH ----------------------------------------------------------------- NECROPSY -------- ------------ -------------------------- 0 B S E RV A T HISTOPATHOLOGY ----------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE.-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS --- - - - - - - - - - - - - - - - -- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: STERNUM (SB), EYE (EY), BRAIN (BR). BONE, FEMUR (FE), MARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN). SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS). THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE). LN, MANDIDULA SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB). PROST SEMINAL VESICLES (SV). TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) -------------------------------------------------------------------------------------------------------------- 327 APPENDIX 6 Individual Ainatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI ANlt4AL NUMBER: C95923 SEX: MALE DOSE GROUP: 2 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 491 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY DATE AND TIME OF NECROP sy: 12/02/98 8:47 PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER POST-FIX WEIGHER: NOT AVAILABLE -------------- --------------------------------- ------------- ---------------------------------------------------- ORGAN To BRAIN 0RG ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE TO BODY WEIGHT WEIGHT RATIO S_T A ORGAN NAME (GRAMS) ---------------------- --- .0101 % .0232 WEIGHT ADRENAL (AD) .0499 2.1488 .4370 t 1.0000 WEIGHT WEIGHT BRAIN (BR) KIDNEY (KD) 4.0171 .8170 % 2.8214 t 1.8695 6.4562 WEIGHT LIVER (LI) 13.8730 .1279 t .2926 WEIGHT SPLEEN TESTIS (SP) (TE) .6287 3.6620 .3346 .7448 % .0680 t 1.7042 .1557 WEIGHT WEIGHT WEIGHT THYMUS (TH) THYROID/PARATHYR (TT) .0122 .0025 t .0057 ------------ ---------------------------------------------------- 0B SERV NECROPSY ------------------------------------------------------------- AT I LIVER (LI) -INFILTRATE, HISTOPATHOLOGY LYMPHOHISTIOCYTIC.-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (RA), AORTA (AID), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBULA SALIV GL, HANDIB (SG). HARDERIAN GLAND (HG), AUDITORY , SEB GL (AS), SKIN (SK), URINARY BLADDER (UB). PROSTJV SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) TAIL (TI) -------------------------------------------------------------------------------------------------------------- 328 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL, PERFLUOROOCTANESUBFONAMIDO ETHANOL (N-MEFOSE, T-6314@ IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95924 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE AND TIME OF NECROPSY: 12/02/98 9;45 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. Wl POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) ------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST ---- ADRENAL (AD) .0561 .0113 t .0258 WEIG BRAIN (BR) 2.1774 .4367 % 1.0000 WEIG KIDNEY (KD) 3.7379 .7497 t 1.7167 WEIG LIVER (LI) 13.9536 2.7986 t 6.4084 WEIG SPLEEN (SP) .9245 .1854 % .4246 WEIG TESTIS (TE) 3.5483 .7117 t 1.6296 WEIG THYMUS (TH) .3028 .0607 t .1391 WEIG THYROID/PARATHYR (TT) .0248 .0050 t .0114 WEIG ----------------------------------------------------------------------------------------------------------------- 0 BSE RVAT 10N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-HINIHAL GENERAL COMMENT (GC) -BONE NARROW SHEAR TAKEN -NECROSIS, INDIVIDUAL HEPATOCYTE,-MININAL -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - THE FOLLOWING ORGANS WERE UNRE14ARKABLE AT NECROPSY: BONE, FEMUR (FE), HARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYRorD (PT), ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUH (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBUU SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYNIDES (EP). TAIL (TI) ----------------------------------------------------------------------------------------------------------------- 329 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95925 SEX: KALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT-. 468 DATE AND TIME OF NECROPSY: 12/02/98 10:10 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHERT TONY HANFELD ------------------------------------------------------------------------------------------------------------------- ORGAN NAME - ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WRIGHT RATIO -------- 0RG ST A ------ ADRENAL (AD) .0629 .0134 t .0283 WEIGHT BRAIN (BR) 2.2194 .4739 t 1.0000 WEIGHT KIDNEY (KDI 3.9763 .8491 t 1.7916 WEIGHT LIVER (LI) 14.6970 3.1384 % 6.6221 WEIGHT SPLEEN (SP) .6523 .1393 t .2939 WEIGHT TESTIS ITE) 3.1815 .6794 t 1.4335 WEIGHT THYMUS (TH) .2829 .0604 t .1275 WEIGHT THYROID/PARATHYR (TT) .0261 .0056 t .0118 WEIGHT ------------------------------------------------------------------------------------------------------------------- 0BS ERVA T 10NS NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-miNrHAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL STOMACH, GL (ST) -LIGHT FOCUS(I)/AREA(S); SINGLE WHITE. SLIGHTLY MUCOSA, NEAR ESOPHAGEAL GROVE: RAISED AREA. 1 MM IN DIAMETER STOMACH, GL (ST) >UNREMARKABLE LN, MANDIBULAR iMN) : -DIFFUSELY RED; BILATERAL: GENERAL COMMENT (GC) : DARK RED LN, MANDIBULAR (MN) -HEMORRHAGE,-SLIGHT -BONE HARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS - - - - - - - - -- - -- - - - - - - - - - - - - - - - - -- - -- - - - -- 330 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95925 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRZFI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 466 DATE AND TIME OF NECROPSY: 12/02/98 10:10 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY RANFELD ------------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), HARROW, FEMUR (FM), t4ARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AD), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA) DUODENUM (DU). JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL JAS), SKIN (SK). URINARY BLADDER (UB), PROSTATE (PR). SEMINAL VESICLE TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) ------------------------------------------------------------------------------------------------------------------- 331 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95926 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE AND TIME OF NECROPSY: 12/02/98 11:19 PROSECTOR: KEVIN BILLINGS RECORDERT WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST ---- ADRENAL (AD) .0518 .0118 t .0261 WEIG BRAIN (BR) 1.9876 .4531 t 1.0000 WEIG KIDNEY (KD) 2.8500 .6496 t 1.4339 WEIG LIVER (LI) 11.7726 2.6835 t 5.9230 WEIG SPLEEN (SP) .6868 .1566 t .3455 WEIG TESTIS (TE) 2.7873 .6354 t 1,4023 WEIG THYMUS (TH) .3553 .0810 t .1788 WEIG THYROID/PARATHYR (TT) .0163 .0037 % .0082 WEIG ----------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER ILI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL GENERAL COMMENT (GC) -NECROSIS, INDIVIDUAL HEPATOCYTE.-MINIKAL -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS ------ -------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), XIDNEY JKD), HEART JHT), MUSCLE, S NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (HS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AD), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBUL SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB). PROST SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) ----------------------------------------------------------------------------------------------------------------- 332 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYG PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- AN114AL NUMBER: C95927 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE AND TIME OF NECROPSY: 12/02/98 9:50 PROSECTOR: JODI THIEREN RECORDER: TERRI L. Wl POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGH14Y WEIGHER: TORY HANFELD ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST ---- ADRENAL (AD) .0504 .0107 t .0239 WEIG BRAIN (BR) KIDNEY (KD) 2.1110 4.0122 .4497 % .8548 t 1.0000 1.9006 WEIG WRIG LIVER (LI) 14.9670 3.1865 t 7.0900 WEIG SPLEEN (SP) .6945 .1480 % .3290 WEIG TESTIS (TE) 3.0365 .6469 % 1.4384 WEIG THYMUS (TH) .3438 .0732 % .1629 WEIG THYROID/PARATHYR (TT) .0230 .0049 % .0109 WEIG ----------------------------------------------------------------------------------------------------------------- 0 BS ERVAT 10N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INPILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL STOMACH, GL (ST) -DARK FOCUS(I)/AREA(S); AREA, 3 X 1 MM GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN MUCOSA: SINGLE DARK BROWN LINEAR STOMACH, GL (ST) -EROSION,-SLIGHT - -THE- FO-LLOW-ING - -ORGAN-S -WER-E -UNRE-MARK-ABLE- -AT -NECR-OPS-Y: - - - - - - - - - - - - - - - - - - - BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY IKD), HEART (HT), MUSCLE, I NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL. CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI), STOMACHO MONGL (SU), PANCREAS DUODENUM (DU). JEJUNUM (JE). ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, HHNDIB (SG). HARDERIAN GLAND (RGI. AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSI SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) ----------------------------------------------------------------------------------------------------------------- 333 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER% C95928 SEX: 14ALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH% 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 11:23 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0 ST --- ADRENAL (AD) .0537 .0110 1 .0259 WEI BRAIN (BR) 2.0720 .4262 % 1.0000 WEI KIDNEY (KD) 3,6794 .7569 t 1.7758 WEI LIVER (LI) 14.1057 2.9018 % 6.8078 WEI SPLEEN (SP) .5995 .1233 % .2893 WEI TESTIS (TE) 3.4858 .7171 t 1.6823 WEI THYMUS (TH) .2143 .0441 % .1034 WEI THYROID/PARATHYR (TT) .0300 .0062 % .0145 WEI ---------------------------------------------------------------------------------------------------------------- 0 BSE RVA T10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-HINIt4AL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS -- - - - - - -- - - - - - - - - - - - - - -- - - - - -- - - - - - - - THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS). THYROID ITY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH. GL (ST). STOMACH, NONG PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PRO SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) --------------------------------------------------------------------------------------------------------------- 334 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95929 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 5 DATE AND TIME OF NECROPSY: 12/02/98 8:20 PROSECTOR: JOHN S. HALFORD RECORDER.- WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST ---- ADRENAL (AD) .0687 .0136 t .0317 BRAIN (BR) 2.1644 .4282 % 1.0000 KIDNEY IKD) 3.1590 .6249 t 1.4595 LIVER (LI) 13.3939 2.6496 % 6.1883 SPLEEN (SP) .8459 .1673 t .3908 TESTIS (TE) 3.7218 .7363 t 1.7196 THYMUS (TH) .2340 .0463 t .1081 THYROID/PARATHYR (TT) .0298 .0059 & .0138 ----------------------------------------------------------------------------------------------------------------- WHIG WEIG WEIG WEIG WEIG WEI WEIG WEIG 0 BSE RVAT 10N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- THYMUS (TH) -RED FOCUS(I)IAREA(S); RIGHT LOBE: SINGLE DARK RED AREA, 6 X 3 MM GENERAL COMMENT (GC) -BONE NARROW SHEAR TAKEN LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-SLIGHT -NECROSIS, INDIVIDUAL HEP)LTOCYTE,-MININAL THYMUS (TH) : -HEMORRHAGE,-SLIGHT - -THE- FO-LLOW-ING- O-RGAN-S -WER-E -UNRE-MARK-ABLE- -AT -NEC-ROPS-Y: - - - - - - - - - - - - - - - - - - - BONE. FEMUR (FE), NARROW, FEMUR (FM). NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY JKD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX ( ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBULAR (MN). SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SX), URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 335 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYU ETHANOL (N-NEFOSE, T-6314) IN RATS -------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95930 DATE OF DEATH: 12/02/98 SEX: MALE STUDY DAY OF DEATH: DOSE GROUP: 2 SACRIFICE STATUS: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 48 DATE AND TIME OF NECROPSY: 12/02/98 8:59 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY P-O-S-T--F-I-X-- W-E-I-G-HE-R-:---N-OT-- A-V-A-I-LA-B-L-E------------------P-AT-H-O-LO-G-I-ST-:----J-OH-N---EI-G-H-MY---------------------WE-I-G-HE-R-:---L-Y-N-N --H-OR-N-E-R--------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ----- ---------------------- ADRENAL (AD) .0711 .0147 % .0350 WEIGI BRAIN (BR) 2.0340 3.8914 .4202 % .8040 t 1.0000 1.9132 7.5644 WEIGI WEIG WEIG KIDNEY (KD) LIVER (LI) 15.3859 .8442 3.1709 % .1744 % .4150 WEIG SPLEEN TESTIS (SP) (TE) 3.4684 .4143 .7166 t .0856 % 1.7052 .2037 WEIG WEIG THYMUS (TH) THYROID/PARATHYR (TT) .0169 .0035 t .0083 WEIG --------------------------------------------------------------------------------------------------------------- 0 BS E RVAT 10N S HISTOPATHOLOGY NECROPSY ---------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIKAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL KIDNEY (KD) -LARGE PELVIS(ES), -GRANULAR KATERIAL; LEFT LEFT, WITHIN PELVIS: MULTIPLE TAN, KIDNEY (KD) : -DILATATION, PELVIC,-SLIGHT PINPOINT GRANULES GENERAL COMMENT (GC) - -B-ONE - 14-ARRO-W S-HEA-R T-AKEN- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 336 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERPLUOROOCTANESULPONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIt4AL NUMBER: C95930 DATE OF DEATH: 12/02/98 SEX: 14ALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT- 4 DATE AND TIME OF NECROPSY: 12/02/98 8:59 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE. STERNUM (SB), EYE (EY), BRAIN (BR) SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), HEART (HT), MUSCLE, SKELETAL ,(sm), NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (RA), AORTA (AO), PITUITARY (PI), STOMACH. GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL). CECUM (CE,), COLON (CO), RECTUM (RE), LN, MANDIBULI SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROST SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) ----------------------------------------------------------------------------------------------------------------- 337 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95931 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 3 DATE AND TIME OF NECROPSY: 10/01/98 11:47 PROSECTOR.- MATTHEW AXTMAN RECORDER. KEVIN BILLI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZINA ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO ST ---------------------- -------- -------- -------- ---- ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) KIDNEY (KD) --------------- --------------- -------- NOT -------- NOT LIVER (LI) 11,8205 3.2590 t -------- WEIG SPLEEN (SP) -------- -------- -------- NOT TESTIS (TE) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- m(yr THYROID/PARATHYR (TT) -------- -------- -------- NOT ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW. STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT). MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PKRATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL. MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (BE), LM, 14ANDIBUL SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROST SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) ----------------------------------------------------------------------------------------------------------------- 338 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DINTARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95932 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 10/01/99 11:42 PROSECTOR: 14ATTHEW AXTMAN RECORDER: KEVIN BILL POST-FIX WEIGHER: NOT A"ILABLE PATHOLOGIST: JOHN RIGHMY WEIGHER: MICHELE ZIK ---------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WRIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME ---------------------- (GRAMS) -------- TO 13ODY WEIGHT (t) -------- WEIGHT RATIO -------- ST --- ADRENAL BRAIN KIDNEY LIVER SPLEEN (AD) (BR) (KD) (LI) (SP) ---------------------- 9.9205 -------- ---------------------- 3.0144 -------- -------- --------------- --------------- NOT NOT NOT WEI NOT TESTIS (TE) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT THYROID/PARATHYR (TT) -------- -------- -------- NOT ---------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (RD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO). PITUITARY (PI), STOMACH, OL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE). LN, MANDIBU SALIV GL, HANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK). URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE). EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) ---------------------------------------------------------------------------------------------------------------- 339 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUDROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95933 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM DATE OF DEATH: 10/01/99 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 3 DATE AND TIME OF NECROPSY: 10/01/98 11:44 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIHA ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ADRENAL (AD) BRAIN (BR) KIDNEY (KD) --------------- -------- --------------- -------- -------- NOT -------- bw -------- NOT LIVER (LI) 11.2465 3.2952 t -------- WEIG SPLEEN (SP) -------- -------- -------- mm TESTIS (TE) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT THYROID/PARATHYR (TT) -------- -------- -------- NOT ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH). LN, HESENTERIC (MS). THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH. GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO). RECTUM (RE), LN, MANDIBUL SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SED GL (AS), SKIN (SK), URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYKIDES (EP). TAIL (TI), GENERAL COMMENT (GC) ----------------------------------------------------------------------------------------------------------------- 340 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYI, PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95934 SEX: KALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM TERMINAL BODY WEIGHTT 3 DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 RECORDER: KEVIN BILLI DATE AND TIME OF NECROPSY: 10/01/98 11;58 PROSECTOR: WENDY CHERRY PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA P-O-S-T--F-I-X- -W-E-I-GH-E-R-:---NO-T---AV-A-I-LA-B-L-E------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ---------------------- -------- -------- -------- NOT ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) -------- -------- -------- NOT KIDNEY (KD) 9.9286 3.1321 t -------- WEIG LIVER (LI) -------- -------- -------- NOT SPLEEN (SP) -------- -------- -------- NOT TESTIS (TE) -------- -------- -------- NOT THYMUS (TH) ----- -------- -------- NOT -------TH-Y-R-OI-D-/-P-AR-A-T-H-YR------(-TT-)--------------------------------------------------------- --------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH. , GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO) RECTUM (RE), LN, KANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE). EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) ------- --------------------------------------------------------------------------------------------------------- 341 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH H-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95935 SEX: 14ALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 3 DATE AND TIME OF NECROPSY: 10/01/98 12:07 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZITO ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 01 ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) -------- -------- -------- NOT KIDNEY (KD) -------- -------- -------- NOT LIVER (LI) 11.8361 3.3379 t -------- WEIG SPLEEN (SP) -------- -------- -------- NOT TESTIS (TE) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT THYROID/PARATHYR (TT) -------- -------- -------- NOT ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP),, THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGT PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE). LN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK). URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV?, TESTIS (TE), EPIDIDYMIDES (EP)o TAIL (TI). GENERAL COMMENT (GC) ----------------------------------------------------------------------------------------------------------------- 342 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95936 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 9:51 PROSECTOR: J:ERALD W. JOHNSON RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST JOHN EIGHMY WEIGHER: LYNN HORNER --------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT -------- WEIGHT RATIO -------- ST --- ADRENAL (AD) .0484 .0088 t .0234 WEI BRAIN (BR) 2.0694 .3756 t .7474 % 1.0000 WEI 1.9898 WEI KIDNEY (KD) LIVER (LI) 4.1177 15.6498 2.8408 t 7.5625 WEI SPLEEN (SP) .7959 .1445 % .3846 WEI TESTIS (TE) 3.1581 .5733 % 1.5261 WEI THYMUS (TH) .3262 .0592 % .1576 WEI THYROID/PARATHYR (TT) .0188 .0034 % .0091 WEI ---------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE. LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -MALOCCLUSION; LEFT, UPPER INCISOR - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), IN, KANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE). EPIDIDYMIDES (EP), TAIL (TI) ---------------------------------------------------------------------------------------------------------------- 343 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- AN114AL NUMBER: C95937 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY WEEK OF DEATH. 14 TERMINAL BODY WEIGHT: 4 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: STUDY DAY OF DEATH: 93 12/02/98 11:10 PROSECTOR: TODD ACKER RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME (GRAMS) ----- TO BODY WEIGHT -------- WEIGHT RATIO -------- ST --- --------- ------------- ADRENAL (AD) .0662 .0149 t .0293 WEI BRAIN (BR) 2.2591 .5082 % .0437 % 1.0000 WEI 1.6601 WEI KIDNEY (KD) LIVER (LI) 3.7504 16.6721 3.7508 % .1899 % 7.3800 WEI .3736 WEI SPLEEN TESTIS (SP) (TE) .8440 3.2365 .7291 % 1.4327 WEI THYMUS (TH) .3431 .0772 % .0065 % .1519 WEI .0128 WEI -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-)--------------.-0-28-9-------------------------------------------------------------------- 0 BSE RVAT 10N S HISTOPATHOLOGY ---------------------------N-E-C-R-O-P-S-Y--------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS - -THE- FO-LLOW-ING- -ORGAN-S -WER-E -UNRE-MARK-ABLE- -AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (BS), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, MONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL, 14ANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SES GL (AS). SKIN (SK). URINARY BLADDER (UB). PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYNIDES (EP). TAIL (TI) ---------------------------------------------------------------------------------------------------------------- 344 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCI'ANESULFONAMIDO ETHANOL (N-MEFOSE. T-63141 IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95938 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE AND TIME OF NECROPSY: 12/02/98 7:59 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGH14Y WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ADRENAL (AD) .0579 BRAIN KIDNEY LIVER (BR) (KD) (LI) 2.1368 4.1230 16.5589 SPLEEN (SP) TESTIS (TE) THYMUS (TH) THYROID/PARATHYR ----------------------- .5647 3.6229 .3002 (TT) 0272 ------------------------ ORGAN WEIGHT RELATIVE TO BODY WEIGHT -------- .0116 t .4294 t .8286 t 3.3278 % .1135 t .7281 t .0603 t 0055 t ----- - ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST ---- .0271 WEIG 1.0000 1.9295 7.7494 WEIG WEIG WEIG .2643 1.6955 .1405 WEIG WEIG WEI 0127 WEIG ---------------------- NECROPSY NS HISTOPATHOLOGY ---------------------------------------------- LIVER (LI) : GENERAL C014MENT (GC) -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -BONE HARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - -- - - -- - -- -- - - -- - - - - - - - - - - - - - - THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM), HARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY). BRAIN (HR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN). SPLEEN ISP), THYMUS (TH). LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH. NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLOt4 (CO). RECTUM (RE), LN, MANDIBU SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK). URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP). TAIL (TI) ----------------------------------------------------------------------------------------------------------------- 345 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO STHANOL, (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95939 SEX: MALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE AND TIME OF NECROPSY: 12/02/96 12:23 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WRIGHT RATIO -------- 0R ST ---- ADRENAL (AD) .0634 .0142 t .0213 WEIG BRAIN (BR) 2.3237 .5199 t 2.0000 WEIG KIDNEY (KD) 3.6350 .0117 t 1.5643 WEIG LIVER (LI) 12.6033 2.8145 t 5.4236 WEIG SPLEEN (SP) 1.1088 .2476 t .4772 WEIG TESTIS (TE) 3.2465 .7254 t 1.3980 WEIGT THYMUS (TH) .4355 .0973 t .1874 WEIGI THYROrD/PARATHYR (TT) .0289 .0065 t .0124 WEIG ------------------------------------------------------------------------------------------------------------------ 0 BS ERVAT 10N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LIVER ILI) : GENERAL COMMENT (GC) -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -BONE t4ARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - -- - - THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: DONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), DONE, STERNUM (SB), EYE (EY), BRAIN (DR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJLINUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, K4NDIBULA SALIV GL, HANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY SLADDRR (UB), PROSTA SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) ------------------------------------------------------------------------------------------------------------------ 346 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95940 SEX: KALE DOSE GROUP: 2 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 48 DATE AND TIME OF NECROPSY: 12/02/98 8:10 PROSECTOR: KIMBERLY DURLAND RECORDER: STEVE VAN AD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ----- ADRENAL BRAIN KIDNEY LIVER (AD) (BR) (KD) (LI) .0659 2.1363 4.1869 14.1874 .0136 t .4422 t .8667 t 2.9367 t .0308 1.0000 1.9599 6.6411 WEIGH WEIGH WEIGH WEIGH SPLEEN (SP) .8620 .1784 % .4035 WEIGH TESTIS (TE) 3.8586 .7987 t 1.8062 WEIGH, THYMUS (TH) .2849 .0590 t .1334 WEIGH THYROID/PARATHYR (TT) .0224 .0046 t .0105 WEIGH ----------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY ---------------------------------------------------------------- HISTOPATHOLOGY 7 ---------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL LN, MANDIBULAR (MN) -DIFFUSELY RED; BILATERAL: DARK RED -NECROSIS, INDIVIDUAL LN, MANDIBULAR (MN) -HEMORRHAGE.-SLIGHT HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -MALOCCLUSION: BILATERAL UPPER INCISORS - -- - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - -- - - THE FOLLOWING ORGANS WERE UNREKARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM). MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SX NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (HA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO). RECTUM (RE), SALIV GL, MAN HARDERIAN GLAND (HG), AUDITORY SED GL (AS), SKIN (SK), URINARY BLADDER (UH). PROSTATE (PR), SEMINAL VESICL TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) 347 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL JN-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95941 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 41 DATE AND TIME OF NECROPSY: 12/02/90 11:42 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ----- ADRENAL (AD) .0457 .0111 % .0216 WEIGH BRAIN (BR) 2.1186 .5148 1 1.0000 WEIGH KIDNEY (KD) 3.5249 .8566 % 1.6638 WEIGW. LIVER (LI) 13.6671 3.3213 t 6.4510 WEIGW. SPLEEN (SP) .8387 .2038 % .3959 WEIGH TESTIS (TE) 3.2827 .7977 16 1.5495 WEIGH THYMUS (TH) .3528 .0057 % .1665 WEIGW. THYROID/PARATHYR (TT) .0182 .0044 t .0086 WEIGH ------------------------------------------------------------------------------------------------------------------ 0 B S E RV A T 1 0 N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LIVER (LI) : -FIBROSIS, CAPSULAR.-HINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -HYPERTROPHY, HEPATOCELLULAR, CENTRILODULAR,- -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIKAL -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - 348 A-PENDI@ Individual Anatomic Pathology Data 13-WEEK DIE'L@ARY TOXICITY STUDY WITH N-METHYL PERFLUC)ROOCTAIJESULFONAMIL)O ETHANOL (N-MEFOSE, T-6314) IN PATS ------ ------------------------------------------------------------------------------------------------------- M@'I!4.b,LNUMBERI C9'-941 DATE OF DEATH: 12/02/98 SEX- MALE STUDY DAY OF DEATH: DOSE GROUP: 1 93 STUD@ WEEK SA-RIFI-E STATUSOF 'DEATH-. 14 PROSECTOR: KEVIN BILLINGS SCHEDULED, TERMINAL SA TERMINAL BODY WEIGHT: RECORDER: WENDY CH '-)ATEAND TIME OF NECROPSYT 12/02/98 11:42 PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORN POST-F'IX WEIGHER: NOT AVAILABLE -------------------------------------------------------------------------------------------------------------- I"IE Fc)[,LOWING ORGANS WERE UNREMARKABLE AT NECROPSY: B014F, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE. STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERTC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (14A), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NO PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDI SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PR SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES tv-Pi,TAIL i-i-ii THE FOLLOWING TISSUES WERE LJNREIAARKABLE AT Mil-ROSI-C)PIC EXAMINATION: STOMACH. GL (ST). STOMACH, NONGL (StJ) -------------------------------------------------------------------------- 349 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBERZ C95942 SEX. HALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIPI DATE OF DEATHT 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 418 DATE AND TIME OF NECROPSY: 12/02/98 10:58 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0 RG STA ------ ADRENAL (AD) .0694 .0166 t .0335 WEIGHT BRAIN (BR) 2.0705 .4945 t 1.0000 WEIGHT KIDNEY (KD) LIVER (LI) 4.1159 14.8588 .9830 t 3.5480 % 1.9879 7.1764 WEIGHT WEIGHT SPLEEN TESTIS (SP) (TE) .6815 3.5997 .1628 t .8597 1 .3291 1.7386 WEIGHT WEIGHT THYMUS (TH) .2560 .0613 t .1240 WEIGHT THYROID/PARATHYR (TT) .0174 .0042 t .0084 WEIGHT ------------------------------------------------------------------------------------------------------------------- 0B SERV AT 10N S NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-ML LN, MANDIBULAR (MN) -DIFFUSELY RED; BILATERAL: GENERAL COMMENT (GC) t -BONE HARROW SHEAR TAKEN DARK RED -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-MINI LN. MANDIBULAR (NN) -HEMORRHAGE.-SLIGHT -MALOCCLUSION; BILATERAL, UPPER INCISORS - -- - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 350 individual APPENL)IX t) Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METtiYl@ ETHANOL (N-MEFOSE, T-6314) IN RATS ------ ------- ------------ ------------------------------------------------------------------ ANIMAL, tj[JMBER: C95942 L)AI'EOF DEATH: 12/02/98 SEX: MALE s,ruDY DAY DOSE GRCUP. 3 SACRIFICE OF DEATH: 93 STUDY WEEK OF DEATH: PROSEC-TOR: JERALD W. JOHNSON STATUS, 14 SCHEDULED, TERMINAL SAC TERMINAL BODY WEIGHT: RECORDER: WENDY CHE [)A'PE AND TIME OF 14ECROPSY, 12/0'@/96 PATHOLOGIST: JOHN EIGHMY P-O-S-T---FI-X- -W-E-I-G-HE-R-:----N-OT---A-VA-I-L-AB-L-E------------------------------------------------------- WEIGHER: LYNN HORNE --------------------------- I'liFFBOOLNLEO,WINGFEMURORGA(NFSE), WERRAERROUWN,REMAFREKMAUBLRE (FM)A,T NMEACRRROOPWS,Y: STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU@, TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC) , ADRENAL, MEDULLA (MA) , AORTA (AO) , PITUITARY (PI) , ST014ACH, GL (ST) , STOMACH, NON PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, HARDERIAN GI,AND (IIC;,) AU')!'I'ORYSEB C-1-(Aq) , QKTN (SK) , URINARY BLADDER (UB) , PROSTATE (PR) , SEMINAL VES TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNRE14ARKABLE AT MICROSCOPIC EXAMINATION: ---------S'-I-U-M--A-C-i-i,--6*1-1-k-.'-;-!-,)--ST-U-M-A-CI-I,--q-l-)-N-,3-L------------------------------------- -------------------------- 351 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95943 SEX: 14ALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIPI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 500 DATE AND TIME OF NECROPSY: 12/02/98 11:21 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0 RG STA ------ ADRENAL (AD) .0531 .0106 t .0251 WEIGHT BRAIN (BR) 2.1128 .4225 t 1.0000 WEIGHT KIDNEY (KD) 4.1504 .8299 t 1.9644 WEIGHT LIVER (LI) 19.4681 3.8928 t 9.2144 WEIGHT SPLEEN (SP) .6715 .1343 % .3178 WEIGHT TESTIS (TE) 3.5995 .7198 t 1.7037 WEIGHT THYMUS (TH) .3527 .0705 % .1669 WEIGHT THYROID/PARATHYR (TT) .0275 .0055 t .0130 WEIGHT ------------------------------------------------------------------------------------------------------------------- 0 8S ERVA T10N S NECROPSY HISTOPATHOT.OGY ---------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY. HEPATOCELLULAR, CENTRILOBULAR.-S GENERAL COMMENT (GC) -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION. HEPATOCELLULAR, DIFPUSE,-MINIMAL -BONE MARROW SHEAR TAKEN -No MACROSCOPIC LESIONS - - - - - - - - - -- - - - - - - - - - - - - - -- - - - - -- - -- - - - - 352 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYT ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95943 SEX: MALE DOSE STUDY DAY OF DEATH: 93 GROUP- 3 SACRIFICE STATUS: STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 50 RECORDER: WENDY CHERRY DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/98 11:21 PROSECTOR: JERALD W. JOHNSON WEIGHER: LYNN HORNER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNRE14ARKABLE AT NECROPSY: BONE. FEMUR (FE). HARROW, FEMUR (FM). HARROW. STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE. SCIATIC (SN). SPLEEN (SP), THYMUS ITH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL, MNDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UB), PROSTN SEMINAL VESICLES (SV), TESTIS (TE). EPIDIDYMIDES (EP). TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: --------S-T-OM-A-C-H-, --G-L---(S-T-)-,--S-T-OM-A-C-H-.--N-O-N-G-L --(-S-U-) ----------------------------------------------------------------------- 353 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFGUOROOCTANESUGFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER. C95944 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: MALE DOSE GROUP: 3 SACRIFICE STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 12/02/98 11:31 PROSECTOR: TODD ACKER STATUS: 14 SCHEDULED, TERMINAL SACR TERMINAL BODY WEIGHT: RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO ST ---------------------- -------- -------- -------- ADRENAL (AD) .0511 .0118 t .0235 WEI BRAIN (BR) 2.1737 .5018 t 1.0000 WEI KIDNEY (KD) 3.9789 .9185 t 1.8305 WEI LIVER (LI) 15.6049 3.6022 t 7.1790 WEI SPLEEN (SP) .6847 .1581 % .3150 WEI TESTIS (TE) 3.4797 .8033 t 1.6008 WEI THYMUS (TH) .2276 .0525 % .1047 WEI THYROID/PARATHYR (TT) .0265 .0061 t .0122 WEI ---------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- LIVER (LI) : LN, MANDIBULAR (MN) -DIFFUSELY RED; BILATERAL: GENERAL COMMENT (GC) : DARK RED -HYPERTROPHY, HEPATOCELLULAR, LN, MANDIBULAR (MN) -HEMORRHAGE,-SLIGHT CENTRILOBUGAR -BONE MARROW SHEAR TAKEN ------ -------------------------------- 354 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEPOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95944 SEX, HALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 11:31 PROSECTOR,. TODD ACKER RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER% LYNN HORNER ---------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MRSENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, PANCREAS CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AD), PITUITARY (PI). STOMACH, (;L (ST), STOMACH. RON(; (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE). SALIV GL, HARDERIAN GLAND (HG), AUDITORY SEB GL IAS), SKIN (SX), URINARY BLADDER TESTIS (TE), EPIDIDYNIDES (EP), TAIL (TI) (US), PROSTATE (PR), SEMINAL VESI THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST). STOMACH, NONGL (SU) ---------------------------------------------------------------------------------------------------------------- 355 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYT PERFLUOROOCT@KNESULFONAMIDO ETHANOL (N-MEFOSE, 7-6314) in RATS --------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95945 SEX. MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERmrNAL SAC DATE OF DEATH: 12102/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 6:17 PROSECTOR: KEVIN BILLINGS RECORDER; WENDY CHE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNE ---------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0 sI --- ADRENAL (AD) .0502 .0102 t .0232 WEI BRAIN (BR) 2.1630 .4403 t 1.0000 WEI KIDNEY (KD) 4.1701 .8488 t 1.9279 WEI LIVER (LI) 17.2249 3.5060 t 7.9634 WEI SPLEEN (SP) .6713 .1366 t .3104 WEI TESTIS (TE) 3.8878 .7913 t 1.7974 WEI THYMUS (TH) .2839 .0578 t .1313 WEI THYROID/PARATHYR (TT) .0216 .0044 t .0100 WEI ---------------------------------------------------------------------------------------------------------------- 0 BSE RVAT 10N S ---------------------------N-E-C-R-O-P-S-Y------------------------------------------------------H-I-S-T-O-P-A-T-H-O-L-O-O-G-Y------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULikR -INFILTRATE, LYMPHOHISTIOCYTIC,-MININAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) -VACUOLATION, HEPATOCELLULAR, DIFFUSE.-MINI -DONE MARROW SMEAR TAKEN -No MACROSCOPIC LESIONS - - - - - - - -- - - - - -- - - - - -- - -- -- - - - -- - - - -- - - 356 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYT ETHANOL (N-NEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95945 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL, SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 8:17 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). HARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE. STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL, (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: . STOMACH, GL (ST), STOMACH, NONGL (SU) ---------------------------------------------------------------------------------------------------------------- 357 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95946 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE AND TIME OF RECROPSY: 12/02/96 7:59 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST ---- ADRENAL (AD) .0648 .0138 % .0273 WEIG BRAIN (BR) KIDNEY (KD) 2.3771 3.3029 .5068 t .7042 % 2.0000 1.3895 WEIG WEIG LIVER (LI) 15.7438 3.3569 & 6.6231 WEIG SPLEEN TESTIS (SP) (TE) .7863 3.5286 .1677 % .7524 t .3308 1.4845 WEIG WEIG THYMUS (TH) .1989 .0424 % .0837 WEIG THYROID/PARATHYR (TT) .0365 .0078 % .0154 WEIG ----------------------------------------------------------------------------------------------------------------- 0 BS ERVA T10N S NECROPSY HISTOPATHOLOOGY -------------------------------------------------------------------------------------------------------------- LIVER ILI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) -BONE 14ARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - 358 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUORDOCTANESULFC)NAMIDO ETHANOI, (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95946 SEX: t4ALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL S DATE OF DEATH: 12/02/98 STUDY DAY OF DEATHT 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 7:59 PROSECTOR: JOHN S. NALFORD RECORDER: WENDY C POST-@'LX WEIGHER-. NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER. LYNN HO ------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG ILU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (liT),MUSCL NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX JAC), ADRENAL, MEDULLA (t4A), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, N PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MAND SALIV GL, mANVrB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), P SEMINAL VESICLES (SV). TESTIS (TE). EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STORACH. NONGL (SU) ------------------------------------------------------------------------------------------------------------- 359 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95947 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 44 DATE AND TIME OF NECROPSY: 12/02/98 9:45 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. Wl POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ----- ADRENAL (AD) .0507 .0113 % .0231 WEIG BRAIN (BR) 2.1942 .4877 t 1.0000 WEIG KIDNEY (KD) 3.2317 .7183 % 1.4728 WEIG LIVER (LI) 15.1188 3.3605 % 6.8903 WEIG SPLEEN (SP) .8297 .1844 % .3781 WEIG TESTIS (TE) 3.2832 .7298 t 1.4963 WEIG THYMUS (TH) .3773 .0839 t .1720 WEIG THYROID/PARATHYR (TT) .0232 .0052 % .0106 WEIG ----------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIKAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MININAL THYMUS (TH) -RED FOCUS(I)/AREA(S), DIFFUSE: MULTIPLE DARK RED PINPOINT THYMUS (TH) : -HEMORRHAGE,-MINIMAL FOCI IN, MANDIBULAR (HN) -MOTTLED; BILATERAL: DARK RED AND TAN IN, MANDIBULAR (MN) -HEMORRHAGE,-MINIMAL GENERAL COMMENT (GC) : -BONE NARROW SHEAR TAKEN - - - - - - - - -- - - - - - - - - - - - - - - - - - - -- - - - - -- - - 360 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYI, P@RFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSS, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95947 DATE OF DEATH: 12/02/98 SEX: MALE STUDY DAY OF DEATH: DOSE GROUP: 3 SACRIFICE STATUS: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SAC TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 9:45 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. POST-FIX WEIGHER: NOT AVAILABIE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANPH --------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNRE14ARKABIE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, OL (ST), STOMACH, NONGL (SU), PANCREAS (PA) DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VES TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) --------------------------------------------------------------------------------------------------------------- 361 APPENDIX Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95948 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02196 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 9:44 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0 ST --- ADRENAL (AD) .0458 .0096 t .0214 WEI BRAIN (BR) 2.1430 .4499 t 1.0000 WEI KIDNEY (KD) 3.6102 .7580 1 1.6846 WEI LIVER (LI) 13.4487 2.8236 t 6.27S6 WEI SPLEEN (SP) .8221 .1726 t .3836 wEr TESTIS (TE) 3.2511 .6826 t 1.5171 WEI THYMUS (TH) .3464 .0727 t .1616 WEI THYROID/PARATHYR (TT) .0202 .0042 % .0094 WEI ---------------------------------------------------------------------------------------------------------------- 0 BS ERVAT 10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOSULAR -INFILTRATE, LYMPHOHISTIOCYTIC.-MININAL THY14US (TH) THYMUS (TH) - -DIFFUSELY RED: DARK RED -HEMORRHAGE,-SLIGHT L,N, MANDIBULAR (NN) : LN. MANDIBULAR (MN) -DIFFUSELY RED; BILATERAL: DARK RED -HEMORRHAGE,-SLIGHT GENERAL COMMENT (GC) ; -BONE MARROW SHEAR TAKEN GENERAL INFORMATION (XX) >NOTE:>ANIMAL IDENTIFICATION TRANSPONDER DAMAGED AT NECROPSY - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - -- - 362 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95948 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS; SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE AND TIME OF NECROPSY: 12/02/98 9:44 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHER POST-FIX WEIGHER% NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD). HEART (HT), MUSCLE, I NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL. CORTEX ( ADRENAL, MEDULLA JHA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH. NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESI( TESTIS (TE). EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) ---------------------------------------------------------------------------------------------------------------- 363 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-HETHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- AN114AL NUMBER: C95949 SEX: MALE DOSE GROUPT 3 SACRIFICE STATUS: STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 4 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 RECORDER: WENDY CHERR DATE AND TIME OF NECROPSY: 12/02/98 11:44 PROSECTOR: JILL PAUS PATHOLOGIST: JOHN EIGHHY WEIGHER: LYNN HORNER POST-FIX ------- -W-E-I-GH-E-R-:---NO-T---AV-A-I-L-AB-L-E------------------------------------- ----------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- --------------------- .0562 .0133 t .0274 WEIG ADRENAL (AD) 2.0546 .4879 % 1.0000 WEIG BRAIN (BR) KIDNEY (KD) 3.9393 14.9562 .9355 % 3.5517 % 1.9173 7.2794 WEIG WEIG LIVER ILI) .7402 .1758 % .3603 WEIG SPLEEN TESTIS (SP) (TE) 3.5816 .1584 .850S % .0376 % 1.7432 .0771 WEIG WEIG THYMUS (TH) THYROID/PARATHYR (TT) .0219 .0052 % .0107 WEIG ------------- ----------------------------------------------------------------------------------------------- 0 HISTOPATHOLOGY NECROPSY ---------------------------------------------- ------- -------------------------------------------------------- GENERAL COMMENT (GC) : -BONE 14ARROW SHEAR TAKEN -t4ALOCCLUSION; BILATERAL, UPPER INCISORS -STAINS-PERINEUM/PERIANAL; YELLOW AND MOIST ----- ----------- - - - - - - - - - - - - - -- 364 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYT ETHANOL (N-NEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95949 DATE OF DEATH: 12/02/98 SEX: MALE STUDY DAY DOSE GROUP: 3 OF DEATH: 93 STUDY WEEK PROSECTOR: JILL PAUS SACRIFICE OF DEATH: STATUS: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 4 RECORDER: WENDY CHERR DATE AND TIME OF NECRopsy: 12/02/90 11:44 PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER P-O-S-T--F-I-X- -W-E-I-GH-E-R-:---NO-T- -A-V-A-IL-A-B-LE------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: (SE), BONE, STERNUM (SB). EYE (EY). BRAIN (BR). BONE, FEMUR (FE). MARROW, FEMUR (FH), MARROW, STERNUM SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), IN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI),.STONACH. GL (ST). STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE). LN, MANDIBU SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SED GL (AS). SKIN (SK), URINARY BLADDER (UB), PRO SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATIONT ------- L-I-V-E-R--(-L-I-)-,--ST-O-M-A-C-H,---G-L--(-S-T-).--S-T-O-M-AC-H-.---NO-N-G-L---(S-U-)---------------------------------------------------------- 365 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANI14AL NUMBER: C95950 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 4 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: STUDY DAY OF DEATH: 93 12/02/98 10:29 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. Wl POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD --------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 01 ST ---- ADRENAL (AD) .0593 .0127 t .0267 WEI( BRAIN (BR) 2.2213 .4750 t 1.0000 WEI( KIDNEY (KD) LIVER (LI) 3.8346 15.5750 .8201 t 3.3308 % .1413 t 1.7263 7.0117 .2975 WEI( WEI( WEI SPLEEN TESTIS (SP) (TE) .6608 3.4323 .7340 t 1.5452 WEI THYMUS (TH) .2306 .0493 t .1038 WEI THYROID/PARATHYR (TT) .0259 .0055 % .0117 WEI ---------------------------------------------------------------------------------------------------------------- 0B SERV AT 10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYMUS *(TH) -RED FOCUS(I)/AREA(S); UP TO 5 KH IN DIAMETER BOTH LOBES: MULTIPLE DARK RED AREAS, THYMUS (TH) : -HEMORRHAGE,-SLIGHT -INVOLUTION,-MINIMAL GENERAL C014MENT (GC) : -BONE MARROW SHEAR TAKEN - - - - - - - - - - - - - - -- - -- - - - - -- - -- - - - - -- - - - - 366 Individual APPENDIX Anatomic 6 Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFL[IOROOC'PANESUI,F(3NAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95950 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL S DATE OF DEATH: 12/02/98 STUDY DAY OF DEATII: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY; 12/02/98 10:29 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L P-O-S-T-F-I-X----WE-I-G-H-ER-:----N-O-T --A-V-AI-L-A-B-LE---------------------P-A-TH-O-L-OG-I-S-T:-----J-O-H-N --E-I-G-HM-Y-----------------------W-E-IG-H-E-R:----T-O-N-Y--HAI 'I'liEFOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), HARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSC NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORT ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS DUODENUM (DU), JFJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (RE), LN, MANDIBULAR (MN), (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP). TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST). STOMACH, NONGL (SU) ---- ------------------------------------------------------------------------------------------------------- 367 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95951 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM S DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 381 DATE AND TIME OF NECROPSY: 10/01/98 12:06 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLIN( POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZINA ------------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT -------- WEIGHT RATIO -------- STA ----- ---------------------- -------- ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) --------------- --------------- --------------- NOT TA NOT TJ KIDNEY (KD) LIVER (LI) 13.6836 3.5840 -------- WEIGW, SPLEEN (SP) --------------- --------------- --------------- NOT T@ NOT TJ TESTIS (TE) -------- -------- -------- NOT T THYMUS (TH) THYROID/PARATHYR (TT) -------- -------- -------- NOT T@ ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC). LUNG (LU). TRACHEA (TR). ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD). HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), E.N, MANDIBULA SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UB), PROSTN SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) ----------------------------------------------------------------------------------------------------------------- 368 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYT ETHANOL (N-HEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95952 SEX: MALE DOSE GROUP; 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAE, BODY WEIGHT: 3 DATE AND TIME OF NECROPSY: 10/01/98 11:25 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILII POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIHA ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) -------- -------- -------- NOT KIDNEY (KD) -------- -------- -------- NOT LIVER (LI) 11.6980 3.6961 t -------- WHIG SPLEEN (SP) -------- -------- -------- NOT TESTIS (TE) -------- -------- -------- NM THYMUS (TH) -------- -------- -------- m(yr THYROID/PARATHYR (TT) -------- -------- -------- NOT ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW. STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (tI), KIDNEY (KD). HEART (HTI, MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (HS), THYROID (TY), PAMTHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), LN, MANDIBUL SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SED GL (AS), SKIN (SK), URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV). TESTIS (TE), EPIDIDYMIDES (EP). TAIL (TI). GENERAL COMMENT (GC) ----------------------------------------------------------------------------------------------------------------- 369 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYT PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95953 SEX: KALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM TERMINAL BODY WEIGHT: 3 DATE OF DEATH: 10/01/98. STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 RECORDER: KEVIN BIILI DATE AND TIME OF NECR opsy: 10/01/98 11:13 PROSECTOR: TONY HANFELD PATHOLOGIST: JOHN EIGHHY WEIGHER: MICHELE ZIIU POST-FIX WEIGHER: NOT AVAILABLE -------- --- - ------ ----- ------ -------- -------- ----- ------------- ---------------------------------ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN-TO BRAIN 0 ORGAN NAME (GRAMS) TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST --- ---------------------- -------- -------- -------- NOT -------- ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) ------- ------ -------- NOT KIDNEY (KD) LIVER (LI) 11.6552 3.5700 % -------- -------- WEI -------- NOT SPLEEN (SP) -------- -------- NOT TESTrs (TE) -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R------(T-T-)------------------------------------------------------------------------------------ THE ------ FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, STERNUM (SB). EYE (EY), BRAIN (BR). BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD). HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (KA). AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), LM, HMDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND IHG), AUDITORY ,SEE GL (AS). SKIN (SK), URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) TAIL (TI), GENERAL COMMENT (GC) -------------------------------------------------------------------------------------------------------- 370 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH H-METJIYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95954 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 3 DATE AND TIME OF NECROPSY: 10/01/98 11:38 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIN) ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 01 ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ADRENAL (AD) -------- -------- -------- NOT BRAIN (OR) -------- -------- -------- NOT KIDNEY (KD) -------- -------- -------- NOT LIVER (LI) 13.5081 3.6968 t -------- WEI( SPLEEN (SP) -------- -------- -------- NOT TESTIS (TE) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT THYROID/PARATHYR (TT) -------- -------- -------- NOT ---------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AD). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO). RECTUM (RE). LN, MANDIBU SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SX). URINARY BLADDER (UB), PRO!27 SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) ---------------------------------------------------------------------------------------------------------------- 371 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE. T-6314) IN RATS ------- ------------ -------------------------------------------------------------------------------------------- ANI14AL NUMBER: C95955 SEX: MALE STUDY DAY OF DEATH: DOSE GROUP: 3 31 STUDY WEEK SACRIFICE STATUS: OF DEATH: 5 SCHEDULED, FIRST INTERIM TERMINAL BODY WEIGHT: 3 RECORDER: KEVIN BILLI DATE OF DEATH: 10/01/98 DATE AND TIME OF NECROPSY: 10/01/98 11:55 PROSECTOR: TONY HANFELD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: MICHELE ZIKA ------- ------------ ------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ---------------------- -------- -------- -------- NOT ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) -------- -------- -------- NOT KIDNEY (KD) LIVER (LI) 15.0803 -------- 4.3472 -------- --------------- WEIG NOT SPLEEN TESTIS (SP) (TE) --------------- --------------- -------- NOT -------- NOT THYMUS (TH) -------- -------- -------- NOT -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-)-------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD). HEART (HT). MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH). LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (HA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), IN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) ------------------------------------------------------------------------------------------------- -------------- 372 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95956 DATE OF DEATH: 12/02/98 SEX: MALE DOSE GROUP-. 3 SACRIFICE STATUS: STUDY DAY OF DEATH-. 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 52 DATE AND TIME OF NECROPSY: 12/02/98 8:27 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST A ----- ---------------------- -------- ADRENAL (AD) BRAIN (BR) .0526 2.1420 .0101 % .4093 t .7374 t .0246 1.0000 1.8014 WEIGW. WEIGtr WEIGW KIDNEY (KD) 3.8506 17.4646 3.3374 % 8.1534 WEIGW LIVER (LI) SPLEEN (SP) .7985 .1526 t .3728 WEIGH TESTIS (TE) 2.7847 .5321 t .0598 % 1.3000 .1462 WEIGW WEIGtr THYMUS (TH) .3131 .0268 .0051 t .0125 WEIGR -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-) ------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S HISTOPATHOLOGY ---------------------------N-E-C-R-O-P-S-Y----------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,- -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL GENERAL C014MENT (GC) -BONE MARROW SMEAR TAKEN - -N-O M-ACRO-SCO-PIC - L-ESI-ONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 373 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95956 SEX-. HALE DOSE GROUP: 3 SACRIFICE STATUS: STUDY WEEK OF DEATHI 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 5 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHER DATE AND TIME OF NECROPSY; 12/02/98 8:27 PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-V-AI-L-A-B-LE----------------------------------------- ---------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE fEY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, I NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBU SALIV GL, 14ANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SX). URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE). EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) ---------------------------------------------------------------------------------------------------------------- 374 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-HETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95957 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 4 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: WENDY CHERIC DATE AND TIME OF NECROPSY: 12/02/98 8:54 PROSECTOR: JILL PAUS WEIGHER: LYNN HORNER PATHOLOGIST: JOHN EIGHMY P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-VA-I-L-A-BL-E------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT It) -------- WEIGHT RATIO -------- ST ---- ---------------------- -------- .0112 t .0243 WEIG ADRENAL (AD) .0530 2.1797 .4592 t 1.0000 WEIG BRAIN (BR) 4.2081 .8865 % 1.9306 WEIG KIDNEY (KD) LIVER (LI) 16.5473 .8376 3.4858 % .1764 % 7.5915 .3843 1.7819 WEIG WEIG WRIG SPLEEN TESTIS (SP) (TE) 3.8841 .8182 % .0502 % .1094 WEIG THYMUS (TH) .2384 .0268 .0056 % .0123 WEIG -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-)------------------ ----------------------------------------------------------------- 0 B S E RV A T 1 0 N S HISTOPATHOLOGY NECROPSY ------- ---------------------------------------------------- --------------------------------------------LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILODULAR, -INFILTRATE, LY14PHOHISTIOCYTIC,-MINIHAL -VACUOLATION, HEPATOCELLULHR. CENTRILOBULAR MINIMAL GENERAL COMMENT (GC) -BONE 14ARROW SHEAR TAKEN - -N-O M-ACRO-SCO-PIC - L-ESI-ONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 375 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------- ------------ ------------------------------------------------------------------ ANIMAL NUMBER: C95957 SEX: KALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 4 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: WENDY CHERR DATE AND TIME OF NECROPSY: 12/02/98 8:54 PROSECTOR: JILL PAUS WEIGHER: LYNN HORNER PATHOLOGIST: JOHN EIGHMY P-O-S-T--F-I-X---W-EI-G-H-E-R:---N-O-T--A-V-AI-L-A-B-LE----------------------------------------------------------------------------------- THE FBOOLNLEO,WINFGEMURORGA(NFSE),WEKRAERROUWN,REMAFREKMAUBRLE (FMA)T, NMEACRRROOPWS,YT STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR)t SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD). HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBU SALIV GL. RANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROST SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: --------S-T-OM-A-C-H-, --G-L---(S-T-)-,--S-T-OM-A-C-H-,--N-O-N-GL---(-S-U-) --------------------------------------------------------------------- 376 APPENDIX 6 Individual Anatomic PatholOgY Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95958 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH% 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 10:40 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0 ST --- ADRENAL (AD) .0509 .0108 1 .0238 WEI BRAIN (BR) 2.1388 .4538 t 1.0000 WEI KIDNEY (KD) 3.6164 .7673 t 1.6909 WEI LIVER (LI) 16.8594 3.5772 t 7.8826 WEI SPLEEN (SP) .7451 .1581 t .3484 WEI TESTIS (TE) 3.0781 .6531 t 1.4392 WEI THYMUS (TH) .2885 .0612 t .1349 WEI THYROID/PARATHYR (TT) .0212 .0045 t .0099 WEI ---------------------------------------------------------------------------------------------------------------- 0 8S ERVA T10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- LIVER ILI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOOriLAR -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -NECROSIS. INDIVIDUAL HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -No MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - 377 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE. T-6314) IN RATS ........... --------------------------------------------------------------------------------------------------I ANIMAL NUMBER: C95958 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: HALE STUDY DAY OF 12/02/98 10:40 DOSE GROUP: 3 SACRIFICE DEATH: 93 STUDY WEEK OF DEATH: PROSECTOR: KEVIN BILLINGS PATHOLOGIST: JOHN EIGHMY STATUS: 14 SCHEDULED, TERMINAL SACRII TERMINAL BODY WEIGHT: 47 RECORDER. WENDY CHERRI WEIGHER: LYNN HORNER P-O-S-T-F-I-X---WE-I-G-H-ER-:---N-O-T--A-V-AI-L-A-B-LE---------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LUI),TRACHEA (TR), ESOPHAGUS (ES), LIVER (L,I), KIDNEY (KD), HEART (HT), MUSCLE, S THYROID (TY), PARHTHYROID (PT), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS) ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE). ILEUM (IL) CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBUL. SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY iEB GL (AS). SKIN (SK), URINARY BLADDER (UB). PROST SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: --------S-T-OM-A-C-H-, --G-L---(S-T-)-,--S-TO-M-A-C-H,----N-O-N-G-L --(-S-U-)-- ---------------------------------------------------------------- 378 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (M-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- AN114AL NUMBER: C95959 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE AND TIME OF NECROPSY: 12/02/96 7:39 PROSECTOR: KIMBERLY DURLAND RECORDER: STEVE VAN A POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHKY WEIGHER: TONY HANFELD ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WRIGHT RATIO -------- ST ---- ADRENAL (AD) .0479 .0108 t .0214 WEIG BRAIN (BR) 2.2347 .5040 t 1.0000 WEIG KIDNEY (KD) 3.6999 .8344 t4 1.6557 WEIG LIVER (LI) 15.7371 3.5492 t 7.0422 WEIG SPLEEN (SP) .6008 .1355 t .2689 WEIG TESTIS (TE) 3.2245 .7272 t 1.4429 WEIG THYMUS (TH) .2848 .0642 t .1274 WEIG THYROID/PARATHYR (TT) .0286 .0065 % .0128 WEIGI ----------------------------------------------------------------------------------------------------------------- 0 BS ERVA T10N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR. CENTRILOSULAR. LN, MANDIBULAR (MN) -DIFFUSELY RED; BILATERAL: DARK RED -INFILTRATE. LYMPHOHISTIOCYTIC,-MINIMAL LN, MANDIBULAR (MN) -. -HEMORRHAGE,-MINIMAL GENERAL COMMENT (GC) : -BONE MARROW SHEAR TAKEN - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- 379 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95959 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE AND TIME OF NECROPSY: 12/02/98 7:39 PROSECTOR: KIMBERLY DURLAND RECORDER: STEVE VAN A POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SU). SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JF.JUNUM (JE), ILEUM (IL). CECUK (CE), COLON (CO), RECTUM (RE), SALIV CL, HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). URINARY BLADDER (UB). PROSTATE (PR), SEMINAL VESIC TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, OL (ST). STOMACH, NONGL (SU) ----------------------------------------------------------------------------------------------------------------- 380 APPENDIX 6 individual AnatomiC Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIRAL NUMBER: C95960 SEX. MALE STUDY DAY OF DEATH: DOSE GROUP: 3 SACRIFICE STATUS: 93 STUDY WEEK OF DEATH: 14 SCHEDULED. TERMINAL SACRIF TERMINAL BODY WEIGHT: 44 RECORDER: WENDY CHERRY DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/98 11:43 PROSECTOR: MICHELE ZIMA PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-V-A-IL-A-B-LE------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME - -------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- .0169 t WEIGHT RATIO -------- .0346 STA ----- WEIG ADRENAL (AD) .0760 .4863 % 1.0000 WEIG BRAIN (BR) 2.1953 3.8855 .8642 % 1.7699 WEIGH KIDNEY (KD) LIVER (LI) 16.2467 3.6136 t 7.4007 .2929 WEIG WEIG SPLEEN (SP) .6429 3.8243 .1430 t .8506 76 1.7420 .0906 WEIG WRIG TESTIS THYMUS (TE) (TH) .1769 .0393 t .0054 % .0111 WEIGH -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-)--------------.-0-24-3- ----------------------------------------------------------------- 0 BS ERVA T 10NS HISTOPATHOLOGY NECROPSY ------ ---------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY. HEPATOCELLULAR, CENTRILOBULAR, -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULPLR, CENTRILOBULAR MINIMAL THYMUS (TH) -RED FOCUS(I)/AREA(S); BOTH LOBES: MULTIPLE DARK RED, THYMUS (TH) -HEMORRHAGE,-SLIGHT PINPOINT FOCI GENERAL COMMENT (GC) - -B-ONE - MA-RROW- S-MEAR- T-AKEN- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 381 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONA,MIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ------- --------------------------------------------------------------------------------------------------------- AN114AL NUMBER: C95960 SEX: MALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 RECORDER: WENDY CHERR DATE AND TIME OF NECROPSY: 12/02/98 11:43 PROSECTOR: MICHELE ZIKA PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER P-O-S-T--F-I-X---W-EI-G-H-E-R:---N-O-T--A-V-AI-L-A-B-LE-------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (HR). SPINAL CORD (SC). LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP). LN, NESENTERIC (HS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), IN, MANDIBULAR (NN). SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SX), URINARY BLADDER (UB), PRO SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) ---------------------------------------------------------------------------------------------------------------- 382 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE. T-6314) IN RATS ------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95961 DATE OF DEATH: 12/02/98 SEX: KALE DOSE GROUP: 4 SACRIFICE STATUS: STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 PROSECTOR: LAURIE J. SCHULLER SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 4 RECORDER: TERRI L. Wl DATE AND TIME OF NECROPSY: 12/02/98 11:53 POST-FIX WEIGHER:.NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HHNFELD ------- --------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ---------------------- ADRENAL (AD) .0572 .0118 % 02t8 WEIG BRAIN (SR) KIDNEY (KD) 2.3075 4.4633 27.5733 .4776 t .9239 t 5.7076 t 1.0000 1.9343 11.9494 WEIG WEIG WEIG LIVER (LI) .7101 .1470 t .3077 WEIG SPLEEN TESTIS (SP) (TE) 3.9981 .8276 t 1.7327 WEIG THYMUS (TH) THYROID/PARATHYR (TT) .3288 .0241 .0681 t .0050 % .1425 .0104 WEIG WEIG ----------------------------------------------------------------------------------------------------------------- 0B SERV NECROPSY --------------------------------------------------------------- AT 10N S HISTOPATHOLOGY ---------------------------------------------- LUNG (LU) : -INFILTRATE, HACROPHAGE, ALVEOLAR,-MTNIMAL LIVER (LI) -LARGE; ALL LOBES, MARGINS ROUNDED LIVER (LI) : -HYPERTROPHY, -"CUOLATION, HEPATOCELLULAR, HEPATOCELLULAR, CENTRILOBULAR, CENTRILOBULAR SLIGHT THYMUS (TH) -HEMORRHAGE.-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT LN, MANDIBULAR (MN) -DIFFUSELY RED; BILATERAL: DARK RED LN, MANDIBULAR (NN) i -HEMORRHAGE.-MINIMAL GENERAL COMMENT (GC) : - -B-ONE- KA-RROW- S-MEA-R T-AKEN- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 383 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95961 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: MALE STUDY DAY OF 12/02/98 11:53 DOSE GROUP: 4 DEATH: 93 STUDY WEEK PROSECTOR: LAURIE J. SACRIFICE OF DEATH: SCHULLER STATUS: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 4 RECORDER: TERRI L. Wl POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), NARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (HR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT). MUSCLE, SKELETAL (SM) NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AD), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUN (JE), ILEUM (IL), CECUM (CE). COLON (CO). RECTUM (RE), SALIV GL. HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). URINARY BLADDER -(UB). PROSTATE (PR), SEMINAL VESIC TESTIS (TE), EPIDIDYNIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), NARROW, FEMUR (FM), MARROW, STERNUM (SE). DONE. STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD). HEART (HT), MUSCLE. SKELETAL (SH), NERVE, SC SPLEEN (SP), LN, HESENTERIC (MS). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (A PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE). ILEUM CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). S URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) ----------------------------------------------------------------------------------------------------------------- 384 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95962 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL B'ODY WEIGHT-. DATE AND TIME OF NECROPSY: 12/02198 10:31 PROSECTOR: TODD ACKER RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST --- ADRENAL (AD) .0573 .0134 t .0263 WEI BRAIN (BR) 2.1762 .5083 t 1.0000 WEI KIDNEY (KD) 3.9386 .9200 t 1.8099 WEI LIVER (LI) 21.3603 4.9896 t 9.8154 WEI SPLEEN (SP) .6749 .1577 % .3101 WEI TESTIS (TE) 3.5204 .8223 t 1.6177 WEI THYMUS (TH) .2975 .0695 t .1367 WEI THYROID/PARATHYR (TT) .0265 .0062 % .0122 WEI -------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR CENTRILOBULAE -VACUOLATION, MINIMAL REPATOCELLULAR: CENTRILOBULPJ LN, MANDIBULAR (MN) -HEKORRHAGE,-MINIMAL HARDERIAN GLAND (HG) -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - -- - -- - -- - -- - -- - - - - - - - - - - - - - - 385 Individual APPENDIX Anatomic 6 Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95962 SEX: HALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH; 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE AND TIME OF NECROPSY: 12/02/98 10:31 PROSECTOR: TODD ACKER RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MAX, AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (Jiflt ILEUM (IL), CECUM (CE). COLON (CO), RECTUM",JM), LN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HGi, AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB). PROST SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYNIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE. SKELETAL (SH) NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), IN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC). ADRENAL. MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), SALIV GL, MA AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) ----------------------------------------------------------------------------------------------------------------- 386 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-HETHYL ETHANOL (M-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95963 SEX: 14ALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH; 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT- 4 DATE AND TIME OF NECROPSY: 12/02/98 12;30 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST; JOHN EIGHHY WEIGHER: TONY HANFEL ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT -------- WEIGHT RATIO -------- ST --- ADRENAL (AD) .0519 .0110 % .0250 WEI BRAIN (BR) 2.0730 .4381 t 1.0000 WEI KIDNEY (KD) 3.9593 .8367 % 1.9099 WEI LIVER (LI) 26.0579 5.5067 % 12.5701 WEI SPLEEN (SP) .6285 .1328 t .3032 WEI TESTIS (TE) 3.4019 .7189 % 1.6411 WEI THYMUS (TH) .2799 .0592 % .1350 WEI THYROID/PARATHYR (TT) .0246 OOS2 t .0119 WEI ---------------------------------------------------------------------------------------------------------------- 0 BSE RVA T10N S NECROPSY HISTOPATHOLOGY ----------------------------------------------------------------------------------------------------------- LUNG (LU) ; -MINERALIZATION, VASCULAR,-NINIMAL LIVER (LI) -LARGE: ALL LOBES THICKENED, MARGINS ROUNDED -DIFFUSELY DARK; ALL LOBES: DARK BROWN STOMACH, GL (ST) : -DARK FOCUS(I)/AREA(S); MUCOSA: SINGLE DARK BROWN FOCUS, 1 LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL STOMACH, GL (ST) -EROSION.-SLIGHT MM IN DIAMETER PANCREAS (PA) -ATROPHY, ACINAR,-MINIMAL -INFLAMMATION, CHRONIC-ACTIVE,-SLIGHT -PIGMENT, BROWN,-MINIMAL HARDERIAN GLAND (HG) : -INFILTRATE, LYMPHOHISTIOCYTIC,-HINIKAL PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT 387 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6114) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95963 SEX: KALE DOSE GROUP-. 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 12:30 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. W POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFEL ---------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 1 0 N S (CONTINUED) HISTOPATHOLOGY ---------------------------NE-C-R-OP-S-Y ----------------------------------------------------------------------------- GENERAL COMMENT (GC) : -BONE MARROW SHEAR TAKEN - - - - -- - - - - - THE FOL.LOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), t4ARROW, FEMUR (FM), KARROW, STERNUM (SE), BONE, STERNUM - - - - - - -- (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SH NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA ,(AO). PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE) COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: . STERNUM (SB), EYE (EY), BRAIN (BR), BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), DONE SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCL.E, SKELETAL (SM). NERVE, S SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS). THYROID (TY), PARATHYROID (PT) ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI). STOMACH, NONGL (SU), DUODENUM (DU). JEJUNUM (JE), ILE CECUM (CE). COLON (CO). RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), AUDITORY SEE GL (AS). S URINARY BLADDER (UB). SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) ---------------------------------------------------------------------------------------------------------------- 388 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95964 SEX: HALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT-. 4 DATE AND TIME OF NECROPSY: 12/02/98 12:07 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST --- ADRENAL (AD) .0554 .0120 t .0243 WEI BRAIN (BR) 2.2840 .4934 t 1.0000 WEI KIDNEY (KD) 4.5315 .9789 t 1.9840 WEI LIVER (LI) 30.5553 6.6008 t 13.3780 WEI SPLEEN (SP) .7488 .1618 t .3276 WEI TESTIS (TE) 3.8137 .8239 t 1.6697 WEI THYMUS (TH) .2714 .0586 t .1108 WEI THYROID/PARATHYR (TT) .0220 .0048 % .0096 WEI ------------------------7--------------------------------------------------------------------------------------- 0 BSE RVAT 10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- LUNG (LU) -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULHR -NECROSIS, COAGULATIVE,-MINI14AL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL LN, HESENTERIC (MS) : -HEMORRHAGE.-MINIMAL IN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL URINARY BLADDER (UB) -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIHAL PROSTATE (PR) : -INPILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT 389 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95964 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: KALE STUDY DAY OF 12/02/98 12:07 DOSE GROUP: 4 SACRIFICE DEATH: 93 STUDY WEEK OF DEATH: PROSECTOR: KEVIN BILLINGS STATUS: 14 SCHEDULED, TERMINAL SACR TERMINAL BODY WEIGHT: RECORDER: WENDY CHEE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: LYNN HORNEF ---------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 1 0 N S (CONTINUED) NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- GENERAL COMMENT (GC) : -BONE MARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT). ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NON PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBI SALIV GL. KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS)t SKIN (SK). URINARY BLADDER (UB), PRO SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNRE14ARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD). HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SPLEEN (SP), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AD), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE). ILELN CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) --------------------------------------------------------------------------------------------------------------- 390 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95965 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 11:04 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. W POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFEL ---------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST --- ADRENAL (AD) .0569 .0135 t .0271 WEI BRAIN (BR) 2.1026 .4984 t 1.0000 WEI KIDNEY (KD) 4.2312 1.0029 t 2.0124 WEI LIVER (LI) 24.8958 5.9009 t 11.8405 WEI SPLEEN (SP) .5544 .1314 t .2637 WEI TESTIS (TE) 3.5478 .8409 t 1.6873 WEI THYMUS (TH) .2759 .0654 t .1312 WEI THYROID/PARATHYR (TT) .0214 .0051 t .0102 WEI ---------------------------------------------------------------------------------------------------------------- 0 BSE RVAT 10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- LIVER (LI) : -LARGE; ALL LOBES: THICKENED -DIFFUSELY DARK; ALL LOBES: DARK BROWN LIVER (LI) : -HYPERTROPHY. -INFILTRATE, -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR LYMPHOHISTIOCYTIC,-MINIMAL HEPATOCELLULAR, CENTRILOBULAR MINIMAL KIDNEY (KD) -MINERALIZATION, TUBULAR,-MINIKAL HEART (HT) : -DEGENERATION/NECROSIS.-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL.-PRESENT JEJUNUM (JE) : >UNREMARKABLE >N(YrE: >ON SLIDE 13. GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - 391 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFI,UOROOCTANESUI,FONAMIDO ETHANOL, (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER-. C95965 DATE OF DEATH: 12/02/96 SEX: MALE STUDY DAY OF DEATH: DOSE GROUP.- 4 SACRIFICE STATUS: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 4 DATE AND TIME OF NECROPSY: 12/02/98 11:04 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI I.. W POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFEL ---------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), NARROW. STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM) NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH). LN. NESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), LN, KANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UB). PROS SEMINAL VESICLES (SV). TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE). NARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), S THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (MA), AORTA PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), ILEUM (IL), CECUM COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GE., MANDIS (SG), HARDERIAN GLAND (HG), AUDITORY SES SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE). EPIDIDYNIDES (EP) ---------------------------------------------------------------------------------------------------------------- 392 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYB PERFLUOROOCTANESULFONAMIDO ETHANOL @N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95966 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRII DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 44 DATE AND TIME OF NECROPSY: 12/02/98 7:53 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERR) POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT -------- WEIGHT RATIO -------- ST ---- ADRENAL (AD) .0524 .0118 .0257 WEIG BRAIN (BR) 2.0426 .4597 1.0000 WEIG KIDNEY (KD) 4.8321 1.0876 2.3657 WEIG LIVER (LI) 20.9821 4.7225 10.2723 WEIG SPLEEN (SP) .7381 .1661 .3614 WEIG TESTIS (TE) 3.0674 .6904 1.5017 WEIG THYMUS (TH) .3532 .0795 .1729 WEIG THYROID/PARATHYR (TT) .0227 .0051 .0111 WEIG ----------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LUNG (LU) : -MINERALIZATION, VASCULAR,-MINI14AL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE.-MINIMAL THYMUS (TH) : -HEMORRRAGE.-MINIMAL IN, MESENTERIC (MS) : -HEMORRHAGE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL.-PRESENT URINARY BLADDER (UB) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) -BONE KARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS 393 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95966 SEX: MAIE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE AND TIME OF NECROPSY: 12/02/98 7:53 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD). HEART (HT), MUSCLE, S NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUH (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL. MANDIB (SC), HARDERIAN GLAND (HG), AUDITORY SES GL (AS). SKIN (SK), URINARY BLADDER (UB), PROST SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP). TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), KARROW, FEMUR (FM), NARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SC SPLEEN (SP), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE) COLON (CO), RECTUM (RE), LN, MANDIBULAR (NN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB G SKIN (SK), PROSTATE (PR), SEMINAL VESICLES (SV). TESTIS (TE), EPIDIDYNIDES (EP) ----------------------------------------------------------------------------------------------------------------- 394 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYE, PERFLUOROOCTANESUBFONAMIDO ETHANOE, (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAE, NUMBER: C95967 SEX: HABE DOSE GROUP- 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 9:54 PROSECTOR: MICHELE ZINA RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST --- ADRENAL (AD) .0473 .0106 % .0221 WEI BRAIN (BR) 2.1399 .4778 t 1.0000 WEI KIDNEY (KD) 4.1495 .9266 t 1.9392 WEI LIVER (LI) 25.0600 5.5962 t 11.7114 WEI SPLEEN (SP) .4205 .0939 t .1965 WEI TESTIS (TE) 3.2710 .7305 t 1.5286 WEI THYMUS (TH) .1537 .0343 % .0718 WEI THYROID/PARATHYR (TT) .0278 .0062 t .0130 WEI --------------------------------------------------------------------------------------------------------------- 0B SERV AT 10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------ LUNG (LU) : -INFILTRATE, KACROPRAGE, ALVEOLAR.-MINIHAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULA -PIGMENT, HEPATOCELLULAR,-MINIMAL -VACUOLATION, HEPATOCELLULAR, DIFFUSE,-SLI >NOTE:>PIGMENT IS CONCENTRATED IN THE CYTO CENTRILOBULAR HEPATOCYTES NEAR BILE KIDNEY (KD) -LARGE PELVIS(ES)s LEFT THYMUS (TH) : -DIFFUSELY REDI RIGHT LOBE KIDNEY (KD) t -DILATATION, PELVIC,-SLIGHT THYMUS (TH) : -HEMORRHAGE.-MINIMAL -INVOLUTION,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PITUITARY (PI) -CYST.-PRESENT 395 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAHIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95961 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 9:54 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 1 0 N S (CONTINUED) NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL: DARK RED IN, MANDIBULAR (MN) -HEMORRHAGE,-SLIGHT AUDITORY SEB GL (AS) -ONE EXAMINED,-PRESENT PROSTATE (PR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINI14AL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN - - - - - - - - - - - - - - - - - - - -- - -- - - - - -- -- - - - - - THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), HARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), HEART (HT), MUSCLE, SKELETAL (SM) NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX ( ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH. NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESI TESTIS (TE), EPIDIDYMIDES (EP), TAIL ITI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE). MARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SH), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS). PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA STOMACH. OL (ST), STOMACH, NONGL (SU). PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE). ILEUM (IL), CECUM (CE COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), SKIN (SK), URINARY BLADDER (UB). SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) ---------------------------------------------------------------------------------------------------------------- 396 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTA,NESULPONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95968 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: MALE STUDY DAY OF 12/02/98 9:58 DOSE GROUP: 4 SACRIFICE DEATH: 93 STUDY WEEK OF DEATH: PROSECTOR: KEVIN BILLINGS STATUS: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 45 RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ----- ADRENAL (AD) BRAIN (BR) .0730 2.1136 .0159 t .4600 % .0345 1.0000 WEIGH WEIGH KIDNEY (KD) LIVER (LI) 4.2887 24.0192 .9333 t 5.2272 t 2.0291 11.3641 WEIGH WEIG SPLEEN (SP) .947B .2063 t .4484 WEIG TESTIS (TE) 2.6087 .6113 t 1.3289 WEIGH THYMUS (TH) .2901 .0631 % .1373 WEIG THYROID/PARATHYR (TT) .0236 .0051 t .0112 WEIGH ------------------------------------------------------------------------------------------------------------------ 0B SERVA T 10N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LUNG (LU) : -INFILTRATE, HACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR.- -INFILTRATE, LYMPHOHISTIOCYTIC,-MINI14AL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR T MINIMAL ADRENAL, CORTEX (AC) -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL. PROSTATE (PR) : -INFILTRATE. LYMPHOHISTIOCYTIC.-SLIGHT GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL, UPPER INCISORS - - - - - - - - - - - - - - -- - -- - - - - - - - - - - - - - - - - -- - 397 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95968 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE AND TIME OF NECROPSY: 12/02/98 9:58 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FH), NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (14A), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK). URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR). ESOPHAGUS (ES). KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SH), NERVE, S SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, MEDULLA (MA), AO PITUITARY (PI), STOMACH, GL (ST). STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM CECUM (CE). COLON (CO), RECTUM (RE). LN, MANDIBULAR (NN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG) AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV). TESTIS (TE). EPIDIDYMIDis ---------------------------------------------------------------------------------------------------------------- 398 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95969 SEX: t4ALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 DATE AND TIME OF NECROPSY: 12/02/98 11:41 PROSECTOR: JERALD W. JOHNSON TERMINAL BODY WEIGHT: RECORDER: WENDY CHE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNE --------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO s ---------------------- -------- -------- -------- ADRENAL (AD) .0691 .0140 t .0334 WE BRAIN (BR) 2.0668 .4437 t 1.0000 WE KIDNEY (KD) 5.0360 1.0812 t 2.4366 WE LIVER (LI) 22.5076 4.9320 t 10.8901 WE SPLEEN TESTIS (SP) (TE) .7573 3.3886 .1626 t .7275 t .3664 WE 1.6395 WE THYMUS (TH) .2489 .0534 t .1204 WE THYROID/PARATHYR (TT) .0252 .0054 t .0122 WE --------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------ LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULA -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIKAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULA KIDNEY (KD) -LARGE PELVIS(ES); RIGHT MINIMAL KIDNEY (KD) -DILATATION, HEART (HT) : PELVIC,-MODERATE -DEGENERATION/NECROSIS,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL STOMACH, GL (ST) -DARK FOCUS(I)/AREA(S); MUCOSAT MULTIPLE DARK BROWN AREAS, STOMACH, GL .(ST) : -EROSION,-MINIMAL UP To 2 X 1 MM PROSTATE (PR) -INFILTRATE, LYMPHOHISTIOCYTIC,-SLIGHT 399 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95969 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 4 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: STUDY 12/02/98 DAY OF DEATH: 93 11:41 PROSECTOR: JERALD PATHOLOGIST: JOHN W. JOHNSON EIGHMY RECORDER: WENDY CHER WEIGHER: LYNN HORNER P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-VA-I-L-A-BL-E----------------------------------------- --------------------------------------- 0 B S E R V A T 1 0 N S (CONTINUED) NECROPSY HISTOPATHOLOGY --------------------------------------------- ---------------------------------------------------------------- PROSTATE (PR) : -INFLAMMATION. CHRONIC-ACTIVE,-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN THE FOLLOWING ORGANS WERE UNRE14ARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB). EYE (EY). BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), HEART (HT). MUSCLE, SKELETAL (SM) NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE ------ FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE. STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), MUSCLE, SKELETAL (SH), NERVE, SCIATIC (SN). S LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (14A), AORTA PITUITARY (PI). STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) ------------------------------------------------------------------------------------------ ------------- 400 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95970 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/90 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 43 DATE AND TIME OF NECROPSY: 12/02/98 B:47 PROSECTOR: GREGORY CODDINGTON RECORDER: STEVE VAN AD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ----- ADRENAL (AD) .0560 .0127 t .0249 WEIGW BRAIN (BR) 2.2490 .5115 % 1.0000 WEIGH KIDNEY (KD) 3.7296 .8482 t 1.6583 WEIGIV LIVER (LI) 23,2250 5.2820 % 10.3268 WEIGW SPLEEN (SP) .6436 .1464 t .2862 WEIGW TESTIS (TE) 3.5189 .8003 t 1.5647 WEIGtr THYMUS (TH) .2718 .0618 t .1209 WEIGH THYROID/PARATHYR (TT) .0230 .0052 t .0102 WEIGR ------------------------------------------------------------------------------------------------------------------ 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,- -INFILTRATE. LYMPHOHISTIOCYTIC.-MINIMAL -NECROSIS, COAGULATIVE.-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -PIGMENT, HEPATOCELLULAR,-MINIMAL THYMUS (TH) : -HEMORRHAGE,-MINIMAL PANCREAS (PA) -INFLAMMATION, CHRONIC-ACTIVE,-MINIMAL -PIGMENT, BROWN.-MINIMAL LN, MANDIBULAR (MN) -MOTTLED; BILATERAL: DARK RED AND TAN LN, MANDIBULAR (MN) t -HEMORRHAGE,-MINIMAL GENERAL COMMENT (GC) : -BONE HARROW SMEAR TAKEN -MALOCCLUSION; BILATERAL UPPER INCISORS - - - - - - -- - - - - - - - - - - - - - - - - -- - -- - - - - - - - -- 401 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER. C95970 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 43 DATE AND TIME OF NECROPSY: 12/02/98 8:47 PROSECTOR: GREGORY CODDINGTON RECORDER: STEVE VAN AD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (HA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MAN HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICL TESTIS (TE). EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM). NERVE, SCIATIC (SN). SPLEEN (SP), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG) AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB). PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYHIDES (EP) --------------------------------------------------------------------------------------------------- ------------- 402 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANI14AL NUMBER: C95971 DATE OF DEATH: 10/01/98 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM S STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 30 DATE AND TIME OF NECROPSY: 10/01/98 11:57 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST; JOHN EIGHMY WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST I ----- ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) -------- -------- -------- NOT KIDNEY (KD) -------- -------- -------- NOT LIVER (LI) 14.5443 4.7054 t -------- WEIG SPLEEN (SP) -------- -------- -------- NOT TESTIS (TE) -------- -------- -------- NOT I THYMUS (TH) THYROID/PARATHYR (TT) --------------- --------------- -------- NOT -------- NOT ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL. CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), I.N, MANDIBULJ SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROS SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYNIDES (EP), TAIL (TI), GENERAL COMMENT (GC) ----------------------------------------------------------------------------------------------------------------- 403 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYI, ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95972 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SA DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 333 DATE AND TIME OF NECROPSY: 10/01/98 12:06 PROSECTOR: MATTHEW AXTMAN RECORDER: KEVIN BILLING POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIHA ------------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 RG ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ------ ADRENAL (AD) -------- -------- -------- NOT TA BRAIN (BR) -------- -------- -------- NOT TA KIDNEY (KD) -------- -------- -------- NOT LIVER (LI) 14.9723 4.4921 t -------- WEIGHT SPLEEN (SP) -------- -------- -------- NOT TA TESTIS (TE) -------- -------- -------- NOT TA THYMUS (TH) -------- -------- -------- NOT TA THYROID/PARATHYR (TT) -------- -------- -------- NOT TA ------------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKE NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), IN, MANDIBULAR SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTAT SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI). GENERAL COMMENT (GC) ------------------------------------------------------------------------------------------------------------------- 404 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95973 DATE OF DEATH: 10/01/98 DATE AND TIME OF NECROPSY: SEX.- 14ALE STUDY DAY OF 10/01/98 11:48 DOSE GROUP: 4 SACRIFICE DEATH: 31 STUDY WEEK OF DEATH: PROSECTOR: WENDY CHERRY STATUS: 5 SCHEDULED, FIRST INTERIM SA TERMINAL BODY WEIGHT: 276 RECORDER: KEVIN BILLING POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0RC ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ------ ADRENAL (AD) -------- -------- -------- NOT T) BRAIN (BR) -------- -------- -------- NOT T) KIDNEY (KD) -------- -------- -------- NOT T) LIVER (LI) 13.1995 4.7703 % -------- WEIGHI SPLEEN (SP) -------- -------- -------- NOT V TESTIS (TE) -------- -------- -------- NOT V THYMUS (TH) -------- -------- -------- NOT Ti THYROID/PARATHYR (TT) -------- -------- -------- NOT T ------------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (HS). THYROID (TY), PARATHYROID (PT). ADRENAL. CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST). STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), IN, MANDIBULA SALIV GL, HANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTA SEMINAL VESICLES (SV), TESTIS (TE). EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) ------------------------------------------------------------------------------------------------------------------ 405 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95974 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM SA( DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 311 DATE AND TIME OF NECROPSY: 10/01/98 11:22 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLING POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0RG ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO STA ---------------------- -------- -------- -------- ------ ADRENAL (AD) BRAIN (BR) KIDNEY (KD) -------- --------------- -------- --------------- --------------- -------- NOT TA NOT TA NOT TA LIVER (LI) 14.4142 4.6288 t -------- WEIGHT SPLEEN (SP) -------- -------- -------- NOT TA TESTIS (TE) -------- -------- -------- NOT TA THYMUS 4TH) -------- -------- -------- NOT TA THYROID/PARATHYR (TT) -------- -------- -------- NOT TAI ------------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), NARROW, FEMUR (FM), NARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART IHT), MUSCLE, SKE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL. PANCREAS CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), LN, MANDIBULAR SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTAT SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI), GENERAL COMMENT (GC) ------------------------------------------------------------------------------------------------------------------- 406 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95975 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM S DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 32 DATE AND TIME OF NECROPSY; 10/01/90 11:53 PROSECTOR: MATTHEW AXTHAN RECORDER: KEVIN BILLI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIHA ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ----- ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) -------- -------- -------- NOT KIDNEY (KD) -------- -------- -------- NOT T LIVER (LI) 16.4042 5.0104 t -------- WEIG SPLEEN ISP) -------- -------- -------- NOT TESTIS (TE) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT THYROID/PARATHYR (TT) -------- -------- -------- NOT T ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW. FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI)t KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, NESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, KMDIBULA SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). URINARY BLADDER (UB), PROSTA SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP). TAIL (TI), GENERAL COMMENT (GC) ------------------------------------------------------------------------------------------------------------------ 407 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------7--------------------------------------------------------------------------- ANIMAL NUMBER: C95976 SEX: KALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 3 DATE AND TIME OF NECROPSY: 12/02/98 8:23 PROSECTOR: JILL PAUS RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ADRENAL (AD) .0447 .0117 t .0203 WEIG BRAIN (BR) 2.1994 .5746 t 1.0000 WEIG KIDNEY (KD) 3.5516 .9278 t 1.6148 WEIG LIVER (LI) 21.3634 5.5808 t 9.7133 WEIG SPLEEN (SP) .4872 .1273 t .2215 WEIG TESTIS (TE) 3.4775 .9004 t 1.5811 WEIG THYMUS (TH) .2380 .0622 t .1082 WEIG THYROID/PARATHYR (TT) .0300 .0078 t .0136 WEIG ----------------------------------------------------------------------------------------------------------------- 0BS ERVA T 10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------ LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -INFILTRATE, LYMPHOHISTIOCYTIC,-HINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR MINIMAL THYMUS (TH) -HEMORRHAGE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT LN, MANDIBULAR (HN) -HEMORRHAGE.-SLIGHT GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - -- - - -- - - 408 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95976 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 38 DATE AND TIME OF NECROPSY; 12/02/98 8:23 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). KARROW, FEMUR (FH), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (14A), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). URINARY BLADDER (UB). PROSTA SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), HARROW. FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM). NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (HS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, HE AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM ( ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE). SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP) ------------------------------------------------------------------------------------------------------------------ 409 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95977 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 10:58 PROSECTOR: MICHELE ZIHA RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO ST ---------------------- -------- -------- -------- ADRENAL (AD) .0587 .0129 t .0280 WEI( BRAIN (BR) 2.0929 .4604 t 1.0000 WEI KIDNEY (KD) 4.2673 .9387 t 2.0389 WEI LIVER (LI) 25.0541 5.5112 t 11.9710 WEI SPLEEN (SP) .7871 .1731 t .3761 WEI( TESTIS (TE) 3.4440 .7576 t 1.6456 WEI( THYMUS (TH) .2202 .0484 t .1052 WEI( THYROID/PARATHYR (TT) .0339 .0075 t .0162 WEI ---------------------------------------------------------------------------------------------------------------- 0 BS ERVA T10N S NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------------------------------------------- LUNG (LU) : -INFILTRATE, HACROPTIAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -HYPERTROPHY, -VACUOLATION, HEPATOCELLULAR, HEPATOCELLULAR. CENTRILOBULAR, DIFFUSE,-SLIG HEART (HT) -DEGENERATION/NECROSIS.-MINIMAL THYMUS (TH) -RED FOCUS(I)IAREA(S); BOTH LOBES: 14ULTIPLE DARK RED, THYMUS (TH) : -HEMORRHAGE,-MINIMAL PINPOINT FOCI LN, MANDIBULAR (NN) LN, MANDIBULAR (NN) -DIFFUSELY RED; BILATERAL -HEMORRHAGE.-MINIMAL GENERAL COMMENT (GC) ; -BONE MARROW SHEAR TAKEN --- ----------------------------------- 410 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-HETHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95977 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 4 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: STUDY DAY OF DEATH: 93 12/02/98 10:58 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX ( ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU). PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR). SEMINAL VESIC TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), MUSCLE, SKELETAL (SH), NERVE, SCIATIC (SN), SPLEEN (SP). LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY S SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYNIDES (EP) ---------------------------------------------------------------------------------------------------------------- 411 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYU PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95978 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUSI SCHEDULED, TERMINAL SACRIF STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 45 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/99 8:40 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) -------- TO 13ODY WEIGHT -------- WEIGHT RATIO -------- STA ----- ---------------------- ADRENAL (AD) .0568 .0125 .0266 WEIGH BRAIN (BR) 2.1377 3.6874 .4707 .8118 1.0000 1.7249 WEIGH WEIG KIDNEY (KD) LIVER (LI) 28.4115 6.2553 t 13.2907 WEIG SPLEEN (SP) .6243 3.BB68 .1375 % .8557 t .2920 1.8182 WEIG WEIGH TESTIS (TE) THYMUS (TH) .1836 .0404 t .0859 WEIGH THYROID/PARATHYR (TT) .0245 .0054 % .0115 WEIG ---------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY ---------------------------------------------- ---------------------------------------------------------------- LUNG (LU) : -MINERALIZATION, VASCULAR,-MINIMAL LIVER (LI) -LIGHT FOCUS(I)/AREA(S); DIAPHRAGMATIC SURFACE OF LEFT LATERAL LOBE: MULTIPLE TAN AREAS, PINPOINT AND UP TO 1 MM IN DIAMETER; COLLECTED ON ROUTINE SECTION LIVER (LI) : -HYPERTROPHY, HEPATOC ELLULAR, CENTRILOBULAR.-INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -NECROSIS, COAGULATIVE,-SLIGHT -VACUOLATION, HEPATOCELLULAR, CENTRILOBULAR SLIGHT THYMUS (TH) i -HEMORRHAGE,-MINIKAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PROSTATE (PR) a -INFILTRATE, LYHPHOHISTIOCYTIC.-MINIHAL GENERAL COMMENT (GC) t - -1-3ONE- MA-RROW- S-HEA-R T-AKE-N - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 412 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOITOOCTANESULFONAMIDO ETHANOL (N-MEFOSE. T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95978 DATE OF DEATH: 12/02/98 SEX: MALE STUDY DAY OF DOSE GROUP: 4 SACRIFICE DEATH: 93 STUDY WEEK OF DEATH: PROSECTOR: KEVIN BILLINGS STATUS: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 45 RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 POST-FIX WEIGHER: NOT AVAILABLE 8:40 PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER --------------------------------- ------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), KIDNEY (KD), HEART (HT). MUSCLE, SKELETAL (SH), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (HS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY , (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE) COLON (CO), RECTUM (RE), LN, KANDIBULA SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), PROST SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE. FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD). HEART (HT), MUSCLE, SKELETAL (SM), NERVE, Sci SPLEEN (SP). LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU). PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE). ILEUM CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (NN), SALIV GL, MANDIS (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), URINARY BLADDER (UB), SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYNIDES (I ------------------------------------------------------------------------------------------------------------------ 413 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95979 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 43 DATE AND TIME OF NECROPSY: 12/02/98 8:16 PROSECTOR: LAURIE J. SCHULLER RECORDER: STEVE VAN AD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ----- ADRENAL (AD) .0499 .0115 t .0221 WEIGH BRAIN (BR) 2.2608 .5197 t 1.0000 WEIGH KIDNEY (KD) 3.8911 .8945 t 1.7211 WEIGH LIVER (LI) 23.2324 5.3408 t 10.2762 WEIG SPLEEN (SP) .6649 .1529 t .2941 WEIG TESTIS (TE) 3.4924 .8029 t 1.5448 WEIGI THYMUS (TH) .2278 .0524 t .1008 WEIG THYROID/PARATHYR (TT) .0253 .0058 t .0112 WEIG ------------------------------------------------------------------------------------------------------------------ 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, -INFILTRATE, HEPATOCELLULAR, CENTRILOBULAR, LYMPHOHISTIOCYTIC,-MINIHAL -NECROSIS, INDIVIDUAL HEPATOCYTE.-SLIGHT THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT AUDITORY SEB GL (AS) : -ONE EXAMINED.-PRESEMT GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - 414 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95979 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 DATE AND TIME OF NECROPSY: 12/02/98 8:16 PROSECTOR: LAURIE J. SCHULLER TERMINAL BODY WEIGHT: 43 RECORDER: STEVE VAN AD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD -------- --------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (L, I), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS) THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), URINARY BLADDER (UB), PROST SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD). HEART (HT), MUSCLE, SKELETAL (SH), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH). LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC) ADRENAL, MEDULLA (HA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN). SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), SKIN (SK), URINARY BLADDER (UB), PROSTATE (PR), SEMINAL VESIC --------T-ES-T-I-S---(-TE-)-,--E-P-I-D-ID-Y-M-I-D-ES----(-EP-)---------------------------------- --------------------------------------- 415 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAHIDO ETHANOL CN-MEFOSE, T-6314) IN RATS ------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95980 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 4 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: STUDY DAY OF DEATH: 93 12/02/98 12:24 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY -------------------W--E-I-GH-E-R-: -- L-Y-N-N - H-O-R-NE-R-- ------------------------------------------------------------- ------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME --------- ------------- (GRAMS) ----- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ADRENAL (AD) .0539 .0124 % .0237 WEIG WEIG BRAIN (BR) 2.2717 4.2176 .5234 % .9718 t 1.0000 1.8566 WEIG KIDNEY (KD) LIVER (LI) 24.1794 .6736 5.5713 % .1552 t 10.6437 .2965 WEIG WEIG SPLEEN TESTIS (SP) (TE) 3.5469 .2741 .8173 t .0632 t 1.5613 .1207 WEIG WEIG THYMUS (TH) THYROID/PARATHYR (TT) .0237 .0055 % .0104 WEIG ------- -------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S HISTOPATHOLOGY ---------------------------N-E-C-R-O-P-S-Y---------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY. HEPATOCELLULAR, CENTRILOBULAR, -INFILTRATE, LYHPHOHISTIOCYTIC.-MINIHAL IN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL AUDITORY SEB GL (AS) -ONE EXAMINED.-PRESENT GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS ------ ----- ---- - - -- - -- - - - - -- - - - 416 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULPONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAI, NUMBER: C95980 SEX: MALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 43 DATE AND TIME OF NECROPSY: 12/02/98 12:24 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGISTI JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), IN, NESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA JAO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL). CECUM (CE). COLON (CO), RECTUM (RE), LN, MANDISULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SX), URINARY BLADDER (US), PROSTA SEMINAL VESICLES (SV), TESTIS (TE), EPIDIDYMIDES (EP), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE). MARROW, FEMUR (FM). MARROW, STERNUM (SE). DONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR). ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SH), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE) , SALIV GL. RAN HARDERIAN GLAND (MG), SKIN (SX), URINARY BLADDER (UB). PROSTATE (PR), SEMINAL VESICLES (SV), TESTIS (TE). EPIDIDYMIDES (EP) ------------------------------------------------------------------------------------------------------------------ 417 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95981 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 29 DATE OF D EATH: 12/02/98 STUDY DAY OF DEATH: 93 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY DATE AND TIME OF NECROpsy: 12/02/98 9:39 PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER POST-FIX WEIGHER: NOT A-V-A-IL-A-B-LE------------------------------------------------------------------------------------- --------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ----- ---------------------ADRENAL (AD) -------.0884 .0298 t .6713 t .0444 1.0000 WEIG WEIG BRAIN (BR) 1.9910 2.5928 .8742 t 1.3023 WEIG KIDNEY (KD) LIVER (LI) 11.3754 .0971 3.8353 t .0327 % 5.7134 .0488 WEIG WEIG OVARY (OV) SPLEEN (SP) .9631 .3247 t .0984 t .4837 .1466 WEIG WEIG THYMUS (TH) THYROID/PARATHYR (TT) .2919 .0246 .0083 % .0124 WEIG ------------------------------------------------------------------------------------------------------------- 0B S HISTOPATHOLOGY NECROPSY ------ --------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL SPLEEN (SP) -ADHESION(S); SURROUNDING ENTIRE SPLEEN ADIPOSE TISSUE: ADHESIONS; COLLECTED INTACT ADHERED MULTIPLE TO PANCREAS AND GRAY AND TAN FIBROUS PITUITARY (PI) -LARGE; 6 X 5 X 3 KH; APPEARS SWOLLEN SPLEEN (SP) : -INFLAMMATION, CHRONIC, CAPSULAR,-MODERATE >NOTE:>THERE ARE NUMEROUS PIGMENT-CONTAINING THE AREAS OF CHRONIC INFLAMMATION. THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PITUITARY (PI) : -HYPERPLASIAO-MODERATE PANCREAS (PA) : -ATROPHY, ACINAR,-MINIHAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINI14AL RECTUM (RE) : -PARASITISM,-PRESENT LN, MANDIBULAR -HYPERPLASIA, (MN) * PLAS14ACYTIC.-HODERATE 418 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95981 DATE OF DEATH: 12/02/98 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACR TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 8:39 PROSECTOR: JOHN S. NALFORD RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILA13LE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 1 0 N S (CONTINUED) NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). t4ARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KO), HEART (UT). MUSCLE, NERVE, SCIATIC (SN), THYMUS (TH), LN. MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX ADRENAL, MEDULLA (MA). AORTA (AO), STOMACH, GL (ST), STOMACH, NONGL (SU). PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), LN, MANDIBULAR (NN), SALIV GL, MANDIB (SG HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERU CERVIX (CV), OVARY (OV). VAGINA (VA). TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE). HARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), SPAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY IKD), HEART (HT), MUSCLE, SKELETAL (SM) NERVE, SCIATIC (SN), THYMUS (TH). LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, AORTA (AO), STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DUI, JEJUNUM (JE). ILEUM (IL), CECUM (CE). SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY. FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV). OVARY (OV), VAGINA (VA) ----------------------------------------------------------------------------------------------------------------- 419 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95982 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 25 DATE AND TIME OF NECROPSY: 12/02/96 8:38 PROSECTOR: TODD ACKER RECORDER, WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOL4GIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ----- ADRENAL (AD) BRAIN (BR) .0501 1.7308 .0199 t .6887 t .0289 1.0000 WEIG WEIG KIDNEY (KD) LIVER (LI) 1.8839 7.3455 .7497 t 2.9230 t 1.0885 4.2440 WEIG WEIGH OVARY SPLEEN THYMUS (OV) (SP) (TH) .1041 .4764 .3310 .0414 t .1896 t .1317 t .0601 .2752 .1912 WEIG WEIG WEIG THYROID/PARATHYR (TT) .0135 .0054 t .0078 WEIGH ------------------------------------------------------------------------------------------------------------------ 0B SE RVAT 10N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - -- - - - - - - - - - - - - - - - - -- - -- - - -- - - 420 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95982 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 2 DATE AND TIME OF NECROPSY: 12/02/98 8:38 PROSECTOR: TODD ACKER RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD). HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBUL SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE. STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDISU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV). OVARY (OV), VAGINA (VA) ----------------------------------------------------------------------------------------------------------------- 421 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95983 DATE OF DEATH: 12/02/98 SEX: FEMALE STUDY DAY OF DOSE GROUP: I SACRIFICE DEATH: 93 STUDY WEEK OF DEATH: PROSECTOR: TODD ACKER STATUS: 14 SCHEDULED, TERMINAL SACRII TERMINAL BODY WEIGHT: 22 RECORDER: WENDY CHERR DATE AND TIME OF NECROPSY: 12/02/90 12:35 PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-V-AI-L-A-B-LE-------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) -------- TO BODY WEIGHT -------- WEIGHT RATIO -------- ST ---- ---------------------- ADRENAL (AD) .0677 1.8357 .0303 t .8206 t .0369 1.0000 WEIG WRIG BRAIN (BR) KIDNEY (KD) 2.1211 7.7858 .9482 % 3.4805 % 1.1555 4.2413 WEIG WEIG LIVER (LI) OVARY (OV) .1169 .4244 .0523 % IB97 % .0637 .2312 WEIG WEIG SPLEEN (SP) .2297 .1027 % .1251 WEIG THYMUS (TH) THYROID/PARATHYR (TT) .()160 .0072 % .0087 WEIG ------- ------------ -------------------------------------------------------------------------------------------- 0 BS ERVAT 10N S HISTOPATHOLOGY NECROPSY ------ --------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -FIBROSIS, CAPSULAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL.-MI THYMUS (TH) : -HEMORRRAGE.-HINIMAL -INVOLUTION,-MINIHAL THYROID (TY) ; -CYSTI ULTIMOBRANCHIAL,-PRESENT GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN - -N-O M-ACRO-SCO-PIC - L-ESIO-NS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 422 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN PATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95983 SEX: FEMALE STUDY DAY OF DEATH: DOSE GROUP: 1 SACRIFICE STATUS: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 22 RECORDER: WENDY CHERRY DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/98 12:35 PROSECTOR: TODD ACKER WEIGHER: LYNN HORNER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH). LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER JUB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SH). NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, HE AORTA (AO). PITUITARY (PI). STOMACH. GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU). JEJUNUM ( ILEUM (IL). CECUM (CE), COLON (CO). RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLA AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (KF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVA --------V-A-GI-N-A---(-V-A)----------------------------------------------------------------------------------------------- 423 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95984 SEX: FEMALE DOSE GROUPT 1 SACRIFICE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: DATE AND TIME OF NECROPSY: 12/02/98 12:26 PROSECTOR: JERALD W. JOHNSON POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY --------------------------------------------------------------------- STATUS: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 2 RECORDER: WENDY CHERR WEIGHER: LYNN HORNER -------- ---- ------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ---------------------- ADRENAL (AD) .0689 .0258 t .7894 t .0327 1.0000 WEIG WEIG BRAIN (BR) 2.1061 2.2832 .8558 & 1.0841 WEIG KIDNEY (KD) LIVER (LI) 8.6507 3.2424 t 4.1074 WEIG OVARY (OV) SPLEEN (SP) .1184 .5182 .2544 .0444 % .1942 t .0954 t .0562 .2460 .1208 WEIG WEIG WEIG THYMUS (TH) .0185 .0069 t .0088 WRIG -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-)----------------------------------------- ---------------------------------------- 0B SERV AT 10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT UTERUS (UT) -LUNEN FILLED WITH FLUID; BILATERAL: CLEAR FLUID UTERUS (UT) : >UNREMARKABLE GENERAL COMMENT (GC) : - -B-ONE - HA-RROW- S-MEA-R T-AKEN- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 424 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANlt4AL NUMBER: C95984 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 26 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 12:26 PROSECTOR: JERALD W. JOHNSON PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-V-A-IL-A-B-LE------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), HARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (14A), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST). STOMACH, NONGL PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), IN, KANDIBULA SALIV GL. KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAHMARY, FEMALE (MF), URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN. MESENTERIC (MS). PARATHYROID (PT), ADRENAL. CORTEX (AC) ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN). SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (KF), URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA) -------- --------------------------------------------------------------------------------------------------------- 425 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-HETHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95985 DATE OF DEATH: 12/02/98 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 2 DATE AND TIME OF NECROPSY: 12/02/98 11:20 PROSECTOR: JILL PAUS RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHKY WEIGHER: LYNN HORNER ------- -------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT -------- WEIGHT RATIO -------- ST ---- ---------------------- -------- .0785 .0277 t .0397 WEIG ADRENAL (AD) 2.0288 .7169 t 1.0000 WEIG BRAIN (BR) KIDNEY (KD) 2.1159 8.9903 .7477 t 3.1768 t 1.0429 4.4313 WEIG WEIG LIVER (LI) .1524 .0539 % .0751 WEIG OVARY (OV) SPLEEN (SP) .5420 .2466 .1915 % .0871 t .2672 .1215 WEIG WEIG THYMUS (TH) THYROID/PARATHYR (TT) .0227 .0080 % .0112 WEIG ----------------------------------------------------------------------------------------------------------------- 0 B S E RV A T 1 0 N S NECROPSY HISTOPATHOLOGY ------- ----------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-HINIMAL LN, MANDIBULAR (NN) : -HEMORRHAGE.-MINIMAL AUDITORY SEB GL (AS) -ONE EXAMINED,-PRESENT GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - 426 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-63141 IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95985 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY'OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 28 DATE AND TIME OF NECROPSY: 12/02/98 11:20 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (.LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS) THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJLINUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), "GINA ("), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD). HEART (HT), MUSCLE, SKELETAL (SH), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH)t LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). SALIV GL, MAN HARDERIAN GLAND (HG), SKIN (SK), KAMHARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVA VAGINA (VA) ----------------------------------------------------------------------------------------------------------------- 427 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFI,UOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE. T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95986 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI TERMINAL BODY WEIGHT: 264 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH. 93 STUDY WEEK OF DEATH: 14 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI G. WILL DATE AND TIME OF NECROPSY: 12/02/98 12-.34 PATHOLOGIST: JOHN EIGHHY WEIGHER: TONY RANFEGD P-O-S-T--F-L-X---W-EI-G-H-ER-:---N-O-T--A-V-AI-L-A-BL-E------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0RG ORGAN NAME (GRAMS) TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ------ ---------------------ADRENAL (AD) -------.0824 .0312 % .7526 % .0414 1.0000 WEIGHI WEIGHI BRAIN (BR) KIDNEY (KD) 1.9090 2.1350 7.8859 .8078 % 2.9837 t 1.0734 3.9648 WEIGtn WEIGHI LIVER (LI) .1421 .0538 % .0714 WEIGHI OVARY SPLEEN (OV) (SP) .5597 .3403 .2118 % .1288 t t .2814 .1711 .0078 WEIGHI WEIGH! WEIGW, THYMUS (TH) THYROID/PARATHYR (TT) .0156 .0059 -------------------------------------------------------------------------- --------------------------------------- 0 B S E R V A T 10 N S HISTOPATHOLOGY NECROPSY ---------------------------------------------- ---------------------------------------------------------------- GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN - -N-O M-ACR-OSCO-PIC - L-ESI-ONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 428 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95986 SEX: FEMALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 26 DATE AND TIME OF NECROPSY: 12/02/96 12z3d PROSECTOR; GREGORY CODDINGTON RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGISTT JOHN EIGHMY WEIGHER: TONY HHNFELD ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (PH), MARROW, STERNUM (SE), DONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN. MANDIBULA SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT). CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNRE14ARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX JAC), ADRF-NALO MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, OL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), LN, HANDIBULA SALIV GL, HANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB). UTERUS (UT), CERVIX (CV), OVARY (OV), "GINA (VA) ------------------------------------------------------------------------------------------------------------------ 429 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95987 DATE OF DEATH: 12/02/98 SEX: FEMALE STUDY DAY OF DEATH: DOSE GROUP: 1 93 STUDY WEEK SACRIFICE STATUS: OF DEATH: 14 SCHEDULED, TERMINAL SACRIFI TERMINAL BODY WEIGHT: 244 DATE AND TIME OF NECROPSY: 12/02/98 10:51 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHERT LYNN HORNER ------------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0RG ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST A ------ ADRENAL (AD) .0980 .0401 % .0519 WEIGHT BRAIN (BR) 1.8897 .7741 % 1.0000 WEIGHT KIDNEY (KD) 1.9180 .7857 % 1.0150 WEIGHT LIVER (LI) 7.2576 2.9732 t 3.8406 WEIGHT OVARY (OV) .1316 .0539 % .0696 WEIGHT SPLEEN (SP) .4780 .1958 % .2530 WEIGHT THYMUS (TH) .3293 .1349 % .1743 WEIGHT THYROID/PARATHYR (TT) .0233 .0095 t .0123 WEIGHT ------------------------------------------------------------------------------------------------------------------- 0 BSE RVAT 10N s NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------------------------------------------------- LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR.-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MIN114AL THYROID (TY) ; -CYST, ULTIMOBRANCHIAL,-PRESENT LN, MANDIBULAR (NN) : -t]EMORRHAGE,-MINIMAL UTERUS (UT) : -DILATATION.-MINIMAL GENERAL COMMENT (GC) -DONE MARROW SMEAR TAKEN -No MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - -- - 430 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERF[,UOROOCTANESUt,FONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95987 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 24 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 10:51 PROSECTOR: JOHN S. HALFORD WEIGHER: LYNN HORNER POST-FLX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY -------------------------------------- ------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: (EY). BRAIN (BR). BONE, FEMUR (FE). MARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE HEART (HT). MUSCLE, St SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, HANDIDUEJ SAUIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FBOOLNLEO,WINFGEMURTISS(UFEES), WMEARREROWU,NREFMEAMRKUARBLE(FM).AT MAMRIRCROOWS,COPSITCERNUEMXAMI(NSAET)I.ON:BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SH), NERVE, SC SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU). PANCREAS (PA), DUODENUM (DU), JEJUNUM ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SE SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB). CERVIX (CV), OVARY (OV), VAGINA (VA) ------- -------------------------------------------------------------------------------------------------- 431 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95988 DATE OF DEATH: 12/02/98 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 25 DATE AND TIME OF NECROPSY: 12/02/98 10:22 PROSECTOR: KEVIN BILLINGS PATHOLOGIST: JOHN EIGHMY RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER P-O-S-T--F-I-X-- W-E-I-GH-E-R-:---NO-T-- A-V-A-I-LA-B-L-E------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- S TA ----- -- --------- ADRENAL (AD) .0716 .0283 t .7329 % .0387 1.0000 WEIGH WEIGH BRAIN (BR) 1.8513 1,0853 .7464 t 1.0184 WEIGH KIDNEY (KD) LIVER (LI) 7.0591 2.7946 lb .0472 t 3.8131 .0644 WEIGH WEIGH OVARY (OV) .1193 .4753 .1882 t .2567 WEIGH SPLEEN THYMUS (SP) (TH) .3660 .1449 t .1977 WEIG THYROID/PARATHYR (TT) .0136 .0054 t .0073 WEIGH -------------------------------------------------------------------------------------------------------------- 0 HISTOPATHOLOGY -------- ------------------N-E-CR-O-PS-Y-------------------------------------- ---------------------------------------LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL KIDNEY (KD) : -MINERALIZATION, TUBULAR.-MINIMAL THY14US (TH) : -HEMORRHAGE,-MINI14AL THYROID (TY) : -CYST, ULTIMOBRHNCHIAL,-PRESENT GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS ----- ----------- -------------- 432 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE. T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95988 SEX: FE14ALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT.* 25 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 10:22 PROSECTOR: KEVIN BILLINGS PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-V-A-I-LA-B-L-E----- ------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), 14ARROW, FE.MUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU) TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), IN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK). MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FBOOLNLEO,WINFGEMURTIS(SUFEES). WMEARREROWU,NREFMEAMRKUARBLE(FM)A,T MAMRIRCROOWS,COPSITCERNUEMXAMI(NSAET)I,ON:BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES). HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIAT SPLEEN (SP), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, HANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (HF), URINARY BLADDER (UB), UTERUS (UT). CERVIX (CV), OVA --------V-AG-I-N-A---(-VA-)----------------------------------------------------------------------------------------------- 433 APPENDIX 6 Individual Anatomic Pathology Data 13-WEgK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95989 SEX: FEMALE STUDY DAY OF DEATH: DOSE 93 GROUP-. I STUDY WEEK SACRIFICE OF DEATH: STATUS: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 2 RECORDER: STEVE VAN A DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/98 8:40 PROSECTOR: LAURIE J. SCHULLER WEIGHER: TONY HANFELD PATHOLOGIST: JOHN EIGHMY P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-V-AI-L-A-B-LE------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO ST -------- ---------------------ADRENAL (AD) -------.0673 .0243 % .6878 % .0353 1.0000 WEIG WEIG BRAIN (BR) 1.9052 1.9871 .7174 t 1.0430 WEIG KIDNEY (KD) 7.3952 2.6697 % 3.8816 WE IG LIVER (LI) .1033 .0373 t .0542 WEIG OVARY (OV) .5285 .1908 t .2774 WEIG SPLEEN (SP) .2674 .0965 t .1404 WEIG THYMUS (TH) THYROID/PARATHYR (TT) .0121 .0044 % .0064 WEIG --------------------- ------------------------------------------------------------------------------------- 0B SERVA T I HISTOPATHOLOGY NECROPSY --------------------------------------------- ------- ------------------------------------------------------- LUNG (LU) : -MINERALIZATION, VASCULAR.-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC, -MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MININAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL.-PRESENT AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESEW GENERAL COMMENT (GC) -BONE 14ARROW SMEAR TAKEN - -N-O M-ACRO-SCO-PIC - L-ESI-ONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 434 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, V-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFIC . ANI14AL NUMBER: C95989 SEX: FEMALE DOSE GROUP: 1 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHR, 271 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 PROSECTOR: LAURIE J. SCHULLER RECORDER: STEVE VAN ADES WEIGHER: TONY HANFELD DATE AND TIME OF NECROPSY: 12/02/98 8:40 PATHOLOGIST: JOHN EIGHMY P-O-S-T-F-I-X---WE-I-G-H-ER-:---N-O-T--A-VA-I-L-A-BL-E-------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE. FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM JSE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD). HEART (HT), MUSCLE, SKE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESEN', RERIC (MS), THYROID ('rY), PARATHYROID (PT). PITUITARY (PI), STOMACH, GL (Sr). STOMACH, NONGL ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (14A). AORTA (AO) PANCREAS (PA). DUODENUM (DU) JEJUNUM (JE), ILEUM (IL) CECUM (CE), COLON (CO), iEL-rUM (RE). LN, MANDIBULAR SALIV GL, MANDIB (SG), HARDEKIAN GLAND (HG), AUDITORY @EB GL (AS), SKIN (SK), MAMMARY, FEMALE (HF). URINARY BLADDER (UB). UTERUS (UT), CERVIX (CV), OVARY (OV). "GINA (VA), TAIL (TI) FOLLOWING TISSUES WERE UNRE14ARKABLE AT MICROSCOPIC EXAMINATION: THE BONE. FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM). NERVE, SCIK SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA AORTA (AO), PITUITARY (PI), STOMACH, GL (ST). STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU). JEJUNUt4 (J ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (HN), SALIV GL, MANDIB (SG). HARDERIAN GLAN SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (") ----------------------------------------------------------------------------------------------------------------- 435 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95990 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 313 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WILL DATE AND TIME OF NECROPsy: 12/02/98 12:30 PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD -PO-S-T---FI-X---W-EI-G-H-E-R:---N-O-T--A-V-AI-L-A-B-LE--------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 RG (GRAMS) TO BODY WEIGHT WEIGHT RATIO STA ORGAN NAME ---------------------- -------- -------- -------- ------ ADRENAL (AD) .0642 .0205 % .0338 WEIGHT WEIGHT BRAIN (BR) 1.8999 2.3886 .6070 t .7631 % 1.0000 1.2572 WEIGHT KIDNEY (KD) LIVER (LI) 8.8406 2.8270 % .0446 % 4.6574 .0735 WEIGHT WEIGHT WEIGHT OVARY (OV) SPLEEN (SP) .1396 .4933 .1576 t .0650 % .2596 .1071 WEIGHT THYMUS (TH) THYROID/PARATHYR (TT) .2034 .0280 .0089 % .0147 WEIGHT - ------------------------------------------------------------------------------------------------------------------- 0 HISTOPATHOLOGY NECROPSY ------------------------------------------------ ---------------------------------------------------------------- LUNG (LU) : -MINERALIZATION, VASCULAR.-MINIMAL LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL GENERAL C014MENT (GC) -BONE KARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS ----- -------------- 436 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ AN114AL NUMBER: C95990 SEX: FEMALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 31 DATE AND TIME OF NECROPSY: 12/02/98 12:30 PROSECTOR: KIM13ERLY DURLAND RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (14A), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, KMDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), "GINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), t4ARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR), ESOPHAGUS (ES). KIDNEY (KD). HEART (HT), MUSCLE, SKELETAL (SH), NERV9. SCI SPLEEN (SP). THYMUS (TH), LN. MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), liARDERIAN GLAND (HG)o AUDITORY SEB GL (AS), SKIN (SK)o MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV). VAGINA (VA) ------------------------------------------------------------------------------------------------------------------ 437 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95991 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM S, DATE OP DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 20 DATE AND TIME OF NECROPSY: 10/01/98 11:32 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLIN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT -------- WEIGHT RATIO -------- S TA ----- ADRENAL BRAIN KIDNEY LIVER (AD) (BR) (KD) (LI) ---------------------- 6.8351 ---------------------- 3.3326 --------------- --------------- NOT T NOT T, NOT T, WEIGW OVARY (OV) -------- -------- -------- NOT T SPLEEN THYMUS (SP) (TH) --------------- --------------- --------------- NOT T, NOT T@ THYROID/PARATHYR (TT) -------- -------- -------- NOT T ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM). MARROW, STERNUM (SE), DONE, STERNUM ISB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN). SPLEEN (SPI, THYMUS (Til), LN, HESENTERIC (MS). THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE). ILEUM (IL). CECUM (CE). COLON (CO), RECTUM (RE), LN, MANDIBUL*V SALIV GL, HANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), MAMMARY, FEMALE (HP). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) ------------------------------------------------------------------------------------------------------------------ 438 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHY[I PERFLUOROOCTANESUBFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAB NUMBER: C95992 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM S STUDY WEEK OF DEATH: 5 TERMINAL, BODY WEIGHT: 18 DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 DATE AND TIME OF NECROPSY: 10/01/98 11:51 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ) ----- -------- -------- -------- NOT ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) KIDNEY (KD) -------- -------3.2449 t --------------- NOT WEIG LIVER (LI) 5.8602 -------- -------- -------- NOT OVARY (OV) -------- -------- -------- NOT SPLEEN (SP) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-) ----------------------------------------------------------------------- ------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), HARROW, FEMUR (FM), HARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JFJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (US), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) ----------------------------------------------------------------------------------------------------------------- 439 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314@ IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95993 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED. FIRST INTERIM S STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 20 DATE OF DEATH: 10/01/98 DATE AND TIME OF NECROPSY: STUDY DAY OF DEATH: 31 10/01/90 11:38 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLIN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA -------- --------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ----- ADRENAL (AD) --------------- --------------- --------------- NOT NOT BRAIN (BR) KIDNEY (KD) -------- -------2.9896 --------------- NOT WEIGH LIVER (LI) 6.0180 -------- -------- -------- NOT OVARY (OV) -------- -------- -------- NOT SPLEEN (SP) -------- -------- -------- NOT T THYMUS (TH) THYROID/PARATHYR (TT) -------- -------- -------- NOT --------------------------------------------------------------------- ---------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), 14ARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL, 14ANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) ------------------------------------------------------------------------------------------------------------------ 440 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUORC)OCTANESULFONAMIDO ETHANOL IN-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95994 SEX: FEMALE DOSS GROUP: 1 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM S DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 21 DATE AND TIME OF NECROPSY; 10/01/98 11:25 PROSECTOR: MATTHEW AXTHAN RECORDER: KEVIN BILLIN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST A ----- ADRENAL (AD) -------- -------- -------- NOT T BRAIN (BR) -------- -------- -------- NOT KIDNEY (KD) -------- -------- -------- NOT T LIVER (LI) 7.0305 3.2624 t -------- WEIGH NOT OVARY (OV) --------------- --------------- -------- -------- NOT SPLEEN (SP) THYMUS (TH) -------- -------- -------- NOT T THYROID/PARATHYR (TT) -------- -------- -------- NOT T ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), RARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (NS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC). ADRENAL. MEDULLA (RA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MMDIBULA SALIV GL, KHNDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), MAMMARY, FEMALE (HP), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA). TAIL (TI). GENERAL COMMENT (GC) ------------------------7----------------------------------------------------------------------------------------- 441 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95995 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: STUDY WEEK OF DEATH: 5 SCHEDULED, FIRST INTERIM S TERMINAL BODY WEIGHT: 18 DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLI DATE AND TIME OF NECROPSY: 10/01/98 12:01 PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIKA P-O-S-T--F-I-X-- W-E-I-GH-E-R-:---NO-T--A-V-A-IL-A-B-LE-------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ----NOT -------- -------- -------- ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) -------- -------- -------- NOT KIDNEY (KD) 5.7678 3.0598 t -------- WEIGH LIVER (LI) -------- -------- -------- NOT T OVARY (OV) -------- -------- -------- NOT SPLEEN (SP) -------- -------- -------- NOT T THYMUS (TH) -------- -------- -------- NOT T -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-) ------------------------------------------------------------------------------------- THE FBOOLNLEO,WINFGEMURORGA(NFSE),WEHRAERROUWN,REMAFREKMAUBRLE (FMA)T, NHEACRRROOPWSY,: STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY JKD), HEART (HT), MUSCLE, St NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (HS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, HANDISUEJ SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB). UTERUS (UT), CERVIX (CV), OVARY (OV). VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) ---------------------------------------------------------------------------------------------------------------- 442 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C95996 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI) DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 26 DATE AND TIME OF NECROPSY: 12/02/98 12.35 PROSECTOR: JILL PAUS RECORDER: WENDY CHERRI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT -------- WEIGHT RATIO -------- STI ----- ADRENAL (AD) .0538 .0200 t .0269 WEIG BRAIN (BR) 2.0029 .7448 t 1.0000 WEIG KIDNEY (KD) 2.2491 .8364 % 1.1229 WEIG LIVER (LI) 7.1747 2.6682 % 3.5822 WEIGE OVARY (OV) .1609 .0598 % .0803 WEIG SPLEEN (SP) .4536 .1687 % .2265 WEIGF THYMUS (TH) .2401 .0893 % .1199 WEIG THYROID/PAPATHYR (TT) .0251 .0093 % .0125 WEIG ------------------------------------------------------------------------------------------------------------------ 0 BS ERVA T10N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LIVER (LI) ; -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIHAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MININAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL.-MI THYMUS (TH) ; -HEMORRHAGE,-MINIMAL GENERAL COMMENT (GC) -BONE 14ARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - -- - - - - - - - - -- -- - -- - - - - -- - - - - - - - 443 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUORUUCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEPOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95996 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: FEMALE DOSE GROUP: 1 STUDY DAY OF DEATH: 93 STUDY WEEK 12/02/98 12:35 PROSECTOR: JILL PAUS SACRIFICE OF DEATH: STATUS: 14 SCHEDULED, TERMINAL SACRIFIC TERMINAL BODY WEIGHT: 268. RECORDER.- WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER -------------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE. SKEI NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH). LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (I PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), IN, MANDIBULAR SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV). OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FH), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC) ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL. MANDIB (SG). HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB). UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) ------------------------------------------------------------------------------------------------------------------- 444 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY SRUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFIC ANIMAL NUMBER: C95997 SEX: FEMALE DOSE GROUP: 1 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 247. DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 PROSECTOR: KEVIN BILLINGS RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 11:02 PATHOLOGIST: JOHN EIGH14Y WEIGHER: LYNN HORNER P-O-S-T-F-I-X---WE-I-G-H-ER-:---N-O-T--A-VA-I-L-A-BL-E--------------------- ------------ -------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0RG STAT (GRAMS) TO BODY WEIGHT WEIGHT RATIO -------- ------- ORGAN NAME ---------------------- -------- ------- .0377 WRIGHT ADRENAL (AD) .0693 .0280 t .7429 t 1.0000 WEIGHT BRAIN (BR) 1.0393 2.0840 .8417 % 1.1330 WEIGHT WEIGHT KIDNEY LIVER (KD) (LI) 6.13198 2.7544 % .0514 % 3.7078 .0692 WEIGHT OVARY (OV) SPLEEN (SP) .1272 .4192 .2108 .1693 t .0851 t .2279 .1146 WEIGHT WEIGHT WEIGHT THYMUS (TH) .0177 .0071 t .0096 -------T-HY-R-O-I-D/-P-A-R-AT-H-Y-R-----(-T-T-) ----------------------------------------------------------------------------------- 0 B S E RV A T 1 0 N S HISTOPATHOLOGY NECROPSY ----------------------------------------------- --------- -----------------------------------------------------THYMUS (TH) : -HEMORRHAGE,-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL.-PRESENT GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN - -N-O M-ACRO-SCO-PIC - L-ESIO-NS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 445 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- AN114AL NUMBER: C95997 DATE OF DEATH: 12/02/98 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFIC STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 247. DATE AND TIME OF NECROPSY: 12/02/99 11:02 PROSECTOR: KEVIN BILLINGS RECORDERT WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER -------------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE. SKEL NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AD), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (S PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SES GL (AS), SKIN (SK), MAMMARY, FEMALE IMF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (SR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKEL NERVE, SCIATIC (SN). SPLEEN (SP), LN, MESENTERIC (MS). PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, NEDU AORTA (AO), PITUITARY (PI), STOMACH, GL (ST). STOMACH, NONGL (SU). PANCREAS (PA). DUODENUM (DU). JEJUNUM (JE ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBULAR (MN). SALIV GL. MANDIB (SG), HARDERIAN GLAND AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY VAGINA (VA) -------------------------------------------------------------------------------------------------------------------- 446 c APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFICE ANIMAL NUMBER: C95998 SEX: FEMALE DOSE GROUP: I STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 240.2 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 PROSECTOR: KIMBERLY DURLAND RECORDER: STEVE VAN ADEST DATE AND TIME OF NECROPSY: 12/02/98 8:40 PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD---- P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--AV-A-I-L-AB-L-E--------------------------------------------------------------------------- ----0--R- G A ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN WEIGHT RATIO STAT ORGAN NAME (GRAMS) TO BODY WEIGHT (t) -------- -------- -------- ---------------------- -------- .0267 t .0316 WEIGHT T ADRENAL (AD) .0641 .8447 t 1.0000 WEIGHT T BRAIN (BR) 2.0289 1.8478 .7693 t .9107 WEIGHT T WEIGHT T KIDNEY (KD) 6.0936 2.5369 t 3.0034 WEIGHT T LIVER (LI) OVARY (OV) .1647 .0686 % .0812 .2132 WEIGHT SPLEEN (SP) .4325 .1801 % .1447 % .1713 WEIGHT T THYMUS (TH) .3476 .0142 % .0168 WEIGHT T -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-) ---------------.-0-3-41--------------------------------------------------------------------- 0 BSE RVAT 10N S HISTOPATHOLOGY NECROPSY --------- ---------------------------------------- -------------------------------------------------------------THYROID (TY) - -CYST, ULTIMOBRANCHIAL,-PRESENT AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT GENERAL COMMENT (GC) -"E MARROW SHEAR TAKEN -NO 14ACROSCOPIC LESIONS - -- - - - - - - - - - - - - - - - - - - 447 Individual APPENDIX Anatomic 6 Pathology Data ---------------------- 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------- ANIMAL NUMBER: C95998 SEX: FEMALE STUDY DAY OF DEATH: DOSE 93 GROUP: 1 SACRIFICE STUDY WEEK OF DEATH: STATUS: 14 SCHEDULED, TERMINAL SACRIFI TERMINAL BODY WEIGHT: 240 RECORDER: STEVE VAN ADE DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/98 8:40 PROSECTOR: KIMBERLY DURLAND WEIGHER: TONY HANFELD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY --------- --------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), 14ARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, SKE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FE14ALE (HF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL. CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST). STOMACH. NONGL (SU), PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), IN, MANDIBULAR (MN), SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS CERVIX (CV), OVARY (OV), VAGINA (VA) ------------------------------------------------------------- 448 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYT ETHANOL (N-NEFOSE, T-6314) IN RATS ---------------------------------- ------------------------------------------------------------------------------- ANIMAL NUMBER: C95999 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI TERMINAL BODY WEIGHT: 358 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: WENDY CHERRY DATE AND TIME OF NECROP sy: 12/02/98 8:25 PROSECTOR: JERALD W. JOHNSON PATHOLOGIST: JOHN EIGHNY WEIGHER: I.YNN HORNER P-O-S-T--F-I-X---W-EI-G-H-E-R:---N-O-T--A-V-AI-L-A-B-LE--------------- ----- ------ - --- ----- ------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 RG ORGAN NAME --------- (GRAMS) ----- TO BODY WEIGHT (t) -------- WEIGHT RATIO ----- --.0359 STA ------ WEIGHT -- ---------- ADRENAL (AD) .0752 .0210 t 1.0000 WEIGHT BRAIN (BR) 2.0931 .5840 t .6829 % 1.1693 WEIGHT KIDNEY (KD) 2.4475 9.9107 2.7653 t 4.7349 WEIGHT LIVER JLI) .1232 .0344 t .0589 WEIGHT OVARY (OV) .5403 .1508 t .2581 WEIGHI SPLEEN (SP) .3750 .1046 t .1792 WEIGHI THYMUS (TH) THYROID/PARATHY R (TT) .0228 .0064 t .0109 WEIGIN -------------------------- 0 BS E NECROPSY -------------------------------------------------------------------------- ------- HISTOPATHOLOGY LIVER (LI) -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT GENERAL COMMENT (GC) -BONE 14ARROW SMEAR TAKEN - -N-O M-ACRO-SCO-PIC - L-ESI-ONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 449 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------ ------------------------------------------------------------------ ANIMAL NUMBER: C95999 SEX: FEMALE STUDY DAY OF DEATH: DOSE GROUP: 1 93 STUDY WEEK SACRIFICE STATUS: OF DEATH% 14 SCHEDULED, TERMINAL SACRIFIC TERMINAL BODY WEIGHT: 358. RECORDER: WENDY CHERRY DATE OF DEATH: 12/02/98 PROSECTOR: JERALD W. JOHNSON DATE AND TIME OF NECROPSY: 12/02/98 8:25 PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-VA-I-L-A-BL-E-------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKEL NERVE, SCIATIC (SN). SPLEEN (.SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT). MEDULLA (MA), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL (S ADRENAL, CORTEX (AC), ADRENAL JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR PANCREAS (PA). DUODENUM (DU). SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), KAMMARY, FEMALE (MF). URINARY BLADDER (UB). UTERUS (UT). CERVIX (CV). OVARY (OV). "GINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD). HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS). SKIN (SK). MAMMARY, FEMALE (HF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), "GINA (") ---------------------------------------------------------------------------------------------------------------- 450 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96000 SEX: FEMALE DOSE GROUP: I SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFIC TERMINAL BODY WEIGHT: 269. DATE OF DEATH: 12/N0E2C/R9O8PSY: 12/0S2T/U9D8Y D1A0Y:11OF DEATH:PRO9S3ECTOR: STTOUDDDY WACEKEEKR OF DEATH: 14 RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER DATE AND TIME OF POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY --------------------------------------- ------------------------------------------------ ------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R G (GRAMS) TO BODY WEIGHT WEIGHT RATIO -------- S_T A T - ----- ORGAN NAME ---------------------- -------- -------- .0330 WEIGHT ADRENAL (AD) .0647 .0240 t .7266 t 1. 0000, -foil WEIGHT 'BRAIN (BR) 1.9596 .7128 % .9810 WEIGHT KIDNEY (KD) LIVER (LI) 1.9224 8.1750 .1191 3.0311 t .0442 t 4.1718 .0608 WEIGHT WEIGHT OVARY (OV) SPLEEN (SP) .4243 .1879 .1573 t .0697 % .2165 .0959 WEIGHT WEIGHT WEIGHT THYMUS (TH) .0169 .0063 t .0086 -------T-H-Y-RO-I-D-/-PA-R-A-T-HY-R-----(-T-T-)------------------------------------------------------------------------------------ 0B SERV AT 10N S HISTOPATHOLOGY NECROPSY -------- --------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL AUDITORY SEB GL (AS) : -ONE EX&MINED,-PRESENT GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN - -N-O M-ACRO-SCO-PIC - L-ESI-ONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 451 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96000 SEX: FEMALE DOSE GROUP: 1 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFIC STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 269. DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: STUDY DAY OF DEATH: 93 12/02/98 10:11 PROSECTOR: TODD ACKER RECORDER- WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER -------------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), t4ARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKEL NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL. CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (S PANCREAS (PA). DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO). RECTUM (RE), LN, MANDIBULAR SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA ("), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE. FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), KIDNEY (KD), HEART (HT). MUSCLE, SKELETAL (SM), NERVEO SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY) PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH: r.L (ST), STOMACH, NONGL (S PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE). LN, MANDIBULAR SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS CERVIX (CV), OVARY (OV), "GINA (VA) -------------------------------------------------------------------------------------------------------------------- 452 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96001 SEX: FEMALE STUDY DAY OF DEATH; DOSE GROUP: 2 SACRIFICE STATUS: 93 STU DY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT! 2 RECORDER: WENDY CHERR DATE OF DEATH: 12/02/98 DATE AND TIME OF NECRopsy: 12/02/98 12:11 PROSECTOR: JILL PAUS WEIGHER: LYNN HORNER PATHOLOGIST: JOHN EIGHHY POST-FIX WEIGHER: NOT AVAILABLE ------------------------------------------------------------------ ------------------------------------------ ---ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE TO BODY WEIGHT ORGAN TO BRAIN WEIGHT RATIO 0R ST ORGAN NAME (GRAMS) -------- ---------------------- .0246 t .0314 WEIG ADRENAL (AD) BRAIN (BR) .0574 1.8284 2.1472 .7834 % .9200 % 1.0000 1.1744 WEIG WEIG KIDNEY (KD) LIVER (LI) 7.2356 .1433 3.1001 % .0614 % 3.9573 .0784 WEIG WEIG WEIG OVARY (OV) SPLEEN (SP) .5303 .3077 .2272 % .1318 % .2900 .1683 .0167 WEIG WEIG THYMUS (TH) THYROID/PARATHYR (TT) .0305 .0131 --% ------------------------------------- ------- ---------------------------------------------------------------- 0 BS ERVAT 10N HISTOPATHOL.OGY NECROPSY --------------------------- LIVER (LI) : -INFILTRATE, -VACUOLATION. LYMPHOHISTIOCYTIC.-MINI14AL HEPATOCELLULAR, PERIPORTAL.-M GENERAL COMMENT (GC) -BONE KARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS ------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY). BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE. NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, HESENTERIC (HS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH. NONG PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL) CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY @EB GL (AS), SKIN (SK), MAMMARY, FEMALE (HF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) ------------------------------------------------------------------------------------ ----------- -------------- 453 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96002 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATHT 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 22 DATE AND TIME OF NECROPSY: 12/02/98 10:25 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------7 ------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT -------- WEIGHT RATIO -------- STA ADRENAL (AD) .0630 .0276 t .0311 WEIGtr BRAIN (BR) 2.0244 .8863 t .8355 % 1.0000 .9426 WEIGH WEIGTP KIDNEY LIVER (KD) (LI) 1.9083 7.1598 3.1340 % 3.5368 WEIGH OVARY (OV) .1099 .0481 t .0543 WEIGtr SPLEEN (SP) .4890 .2141 % .1223 % .2416 .1380 WEIGH WEIGH THYMUS (TH) THYROID/PARATHYR (TT) .2793 .0179 .0078 % .0088 WEIGH ------------------------------------------------------------------------------------------------------------------ 0 BS ERVAT 10N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS. INDIVIDUAL HEPATOCYTE,-MINIMAL UTERUS (UT) -LUMEN FILLED WITH FLUID; BILATERAL; CLEAR FLUID UTERUS (UT) : -DILATATION,-SLIGHT GENERAL COMMENT (GC) : - -B-ONE - MARROW -- SMEAR TAKEN - --- - - - - - - - - - - - - - - - -- - - - - - - - - -- - - THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), HARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY , (PI), STOMACH, GL (ST). STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE) COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF)o URINARY BLADDER (UB), CERVIX (CV). OVARY (OV), VAGINA (VA), TAIL (TI) ------------------------------------------------------------------------------------------------------------------ 454 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS -------- ------------ -------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96003 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 21 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 10:50 PROSECTOR: TODD ACKER WEIGHER: LYNN HORNER P-O-S-T--F-I-X-- W-E-I-G-HE-R-:---N-OT---AV-A-I-L-AB-L-E------------------P-A-TH-O-L-OG-I-S-T:----J-O-HN---EI-G-H-K-Y ---------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- .0275 t WEIGHT RATIO -------- .0301 STA ----- WEIG ADRENAL (AD) .0590 .9127 t 1.0000 WEIGT BRAIN (BR) 1.9851 1.7313 .7960 t .8721 WEIG KIDNEY (KD) LIVER (LI) 6.5350 .1142 3.0046 t .0525 t 3.2920 .0575 WEIG WEIG OVARY (OV) .5506 .2531 t .2774 WEIG SPLEEN THYMUS (SP) (TH) .2760 .1269 t .1390 WEIG THYROID/PARATHYR (TT) .0194 .0089 t .0098 WEIG ------------- --------------------------------------------------------------------------------------------------- 0 BS ERVA T10N S HISTOPATHOLOGY NECROPSY ---------------------------------------------- ---------------------------------------------------------------- UTERUS (UT) : -LUMEN FILLED WITH FLUID; BILATERAL-. CLEAR FLUID UTERUS (UT) -DILATATION,-MODERATE GENERAL COM14ENT (GC) : - -B-ONE- MA-RROW- S-MEAR- T-AKE-N - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 455 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96003 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 2 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: STUDY DAY OF DEATH: 93 12/02/98 10:50 PROSECTOR: TODD ACKER RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS). THYROID (TY). PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI). STOMAC,H, GL (ST). STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO) RECTUM (RE), LN, MANDIBU SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). MAMMARY, FEMALE (MF), URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: --------L-I-V-E-R--(-L-I-)------------------------------------------------------------------------------------------------ 456 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE. T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF ANIMAL NUMBER: C96004 DATE OF DEATH: 12/02/98 SEX: FEMALE DOSE GROUP* 2 STUDY DAY OF DEATH : 93 STUDY WEEK OF DEATH: 14 PROSECTOR: TODD ACKER TERMINAL BODY WEIGHT: 26 RECORDER: WENDY CHERRY WEIGHER: LYNN HORNER DATE AND TIME OF NECROpsy: 12/02/90 7:34 PATHOLOGIST; J O-H-N--E-I-GH-M-Y------------------------------------------- POST-FIX WEIGHER: NOT AVAILABLE ----------- ------ ------ -- ORGAN To BRAIN 0R -------------------------------ABSOLUTE ORGAN WEIGHT ---- ORGAN WEIGHT RELATIVE WEIGHT RATIO STA ORGAN NAME (GRAMS) TO BODY WEIGHT (t) -------- -------- ----- ---------------------- -------- .0265 WEIGH ADRENAL (AD) .0516 1.9505 .0196 % .7399 % 1.0000 1.1576 WEIGH WEIG BRAIN (BR) KIDNEY (KD) 2.2579 .8566 % 3.1487 t 4.2554 WEIGH LIVER (LI) 8.3001 .0467 % .0631 WEIG OVARY (OV) .1230 .1899 % .2566 WEIG SPLEEN (SP) 5005 .2900 .1100 % .1487 .0073 WEIG WEIG THYMUS (TH) THYROID/PARATHYR (TT) .0143 .0054 % ---------------------------------------------------------------- 0 BS ERVA T 10N S HISTOPATHOLOGY NECROPSY --------------------------------------------------------- --------------------------------------- GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS ----- ------- - -- - - - - -- - -- - - - - - - - - - - 457 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUDROOCI'ANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------- ANIMAL, NUMBER: C96004 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL Sl DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 7:34 PROSECTOR: TODD ACKER RECORDER: WENDY Cf POST-f'IX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HOIU ----- -------------------------------------------------------------------------------------------------------- TtlE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR fFM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCL NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (Til), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, N PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MAND SALLV CL, MANDIB (SG) , HARDERIAN GLAND (HG) , AUDITORY SEB GL (AS) , SKIN (SK) , KAHt4ARY, FEMALE (MF) , URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI) ------------------------------------------------------------------------------------------------------------- 458 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: c96005 DATE OF DEATH: 12/02/98 SEX: FEMALE STUDY DAY OF DEATH: DOSE GROUP: 2 SACRIFICE STATUS: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRIFX TERMINAL BODY WEIGHT: 243 DATE AND TIME OF NECROPSY: 12/02/98 8:05 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER --------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 RC ORGAN NAME (GRAMS) TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ----- ---------------------- -------- ADRENAL (AD) .0702 .0288 t .0370 WEIGH WEIGH BRAIN (BR) 1.8993 2.2248 .7794 % .9129 % 1.0000 1.1714 WEIGH KIDNEY (KD) LIVER (LI) 0.2448 3.3832 t .0453 % 4.3410 .0581 WEIGH WEIGH OVARY (OV) SPLEEN (SP) .1103 .4497 .1845 % .2368 WEIGW. THYMUS (TH) .3365 .1381 % .1772 WEIGW THYROID/PARATHYR (TT) .0162 .0066 t .0085 WEIGH ------------------------------------------------------------------------------------------------------------------ 0 NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE.-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (BY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH). LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY . (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE) COLON (CO), RECTUM (RE), LN, KANDIBULA SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (HP), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) ------------------------------------------------------------------------------------------------------------------ 459 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96006 SEX: FEMALE STUDY DAY OF DEATH: DOSE GROUP: 2 93 STUDY WEEK SACRIFICE STATUS: OF DEATH: 14 SCHEDULED, TERMINAL SACRIPI( TERMINAL BODY WEIGHT: 249 RECORDER: WENDY CHERRY DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/98 10:36 PROSECTOR: MICHELE ZIKA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0RG ORGAN NAME (GRAMS) TO BODY WEIGHT -------- WEIGHT RATIO -------- ST A ------ ---------------------- ADRENAL (AD) -------.0512 .0205 .7927 .0259 1.0000 WEIGHT WEIGHT BRAIN (BR) KIDNEY (KD) 1.9754 1.8567 7.3435 .7451 2.9468 t .9399 3.7175 WEIGHT WEIGHT LIVER (LI) .1079 .0433 % .0546 WEIGHT OVARY SPLEEN (OV) (SP) .4943 .1984 t .2502 .1130 WEIGHT WEIGHT THYMUS (TH) .2233 .0896 % .0013 % .0016 WEIGHT -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-)--------------.-0-03-2------------------------------------------------------------------- 0 BS ERVAT 10N S HISTOPATHOLOGY ---------------------------N-E-C-R-O-P-S-Y----------------------------- -----------------------------------------------LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR). SPINAL CORD (SC) , LUNG (LU) , TRACHEA (TR) , ESOPHAGUS (ES) , LIVER (LI) , KIDNEY (KD) , HEART (HT). MUSCLE, SKE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (,MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), LN, MANDIBULAR SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA ("). TAIL (TI) ----------------------------------------------------------------------------------------------------------------- 460 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6114) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96007 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 252 DATE AND TIME OF NECROPSY: 12/02/98 12:06 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0RG STA ------ ADRENAL (AD) .0765 .0303 .0379 WEIGHT BRAIN (BR) 2.0179 .7992 1.0000 WEIGHT KIDNEY (KD) LIVER (LI) 2.2417 8.5804 .8878 3.3982 1.1109 4.2521 WEIGHT WEIGHT OVARY (OV) SPLEEN (SP) .1210 .6280 .0479 .2487 t .0600 .3112 WEIGHT WEIGHT THYMUS (TH) .3639 .1441 % .1803 WEIGHT THYROID/PARATHYR (TT) .0251 .0099 t .0124 WEIGHT ------------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 1 0N S NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-MINI GENERAL COMMENT (GC) -ROME NARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS - - - -- - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - -- - THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE. FEMUR 4FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORT) (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), LN, MANDIBULAR SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SX), MAMMARY, FEMALE (HP), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) ------------------------------------------------------------------------------------------------------------------- 461 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEPOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96008 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/90 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 27 DATE AND TIME OF NECROPSY: 12/02/98 10:19 PROSECTOR: MICHELE ZIMA RECORDER; WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ----- ADRENAL (AD) BRAIN (BR) KIDNEY (KD) LIVER (LI) .0821 1.9908 2.4080 9.2167 .0296 t .7171 t .8674 % 3.3201 t .0412 1.0000 1.2096 4.6296 OVARY SPLEEN THYMUS (OV) (SP) (TH) .1217 .6382 .3024 .0438 % .2299 t .1089 t .0611 .3206 .1519 THYROID/PARATHYR (TT) .0224 .0081 t .0113 ------------------------------------------------------------------------------------------------------------------ WEIGtr WEIGW WEIGH WEIGW WEIGif WEIGH WEIGtr WEIGH 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------ LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL GENERAL COMMENT (GC) -BONE 14ARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS GENERAL INFORMATION (XX) >NOTE:>ANIMAL IDENTIFICATION TRANSPONDER DAMAGED AT NECROPSY - -THE- FO-LLOW-ING - -ORGA-NS -WER-E -UNREM-ARK-ABLE- -AT -NEC-ROPS-Y: - - - - - - - - - - - - - - - - - - - BONE, FEMUR (FE), NARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE. STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (HA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM ICE), COLON ICO), RECTUM (RE), LN, MANDIBULA SALIV GL. MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SES GL (AS), SKIN (SK). MAMMARY, FEMALE (MF). URINARY BLADDER (US). UTERUS (UT), CERVIX (CV), OVARY (OV). VAGINA (VA), TAIL (TI) ------------------------------------------------------------------------------------------------------------------ 462 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONA,MIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96009 SEX; FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 8:20 PROSECTOR: TODD ACKER RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHKY WEIGHERT LYNN HORNER ---------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0 ST --- ADRENAL (AD) .0564 .0270 t .0293 WEI BRAIN (BR) 1.9241 .9219 t 1.0000 WEI KIDNEY (KD) 1.8706 .8963 t .9722 WEI LIVER (LI) 5.9471 2.8496 t 3.0908 WEI OVARY (OV) .1006 .0482 t .0523 WEI SPLEEN (SP) .4206 .2015 t .2186 WEI THYMUS (TH) .1966 .0942 t .1022 WEI THYROID/PARATHYR (TT) .0090 .0043 t .0047 WEI ---------------------------------------------------------------------------------------------------------------- 0B SER VAT 10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS ------ -------------------------------- 463 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANlt4AL NUMBER: C96009 DATE OF DEATH: 12/02/98 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 2 DATE AND TIME OF NECROPSY: 12/02/98 8:20 PROSECTOR: TODD ACKER RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SEI, BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT). ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (14A), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST). STOMACH. NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUH (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), IN, M"DIBUL SALIV GL. HANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA). TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI) ----------------------------------------------------------------------------------------------------------------- 464 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96010 SEX: FE14ALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/99 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 2 DATE AND TIME OF NECROPSY: 12/02/98 10:35 PROSECTOR: LAURIE J. SCHULLER RECORDER: TERRI L. Wl POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER% TONY HAMPELD ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST ---- ADRENAL (AD) .0658 .0250 t .0317 WEIG BRAIN iBR) 2.0743 .7887 % 1.0000 WEIG KIDNEY (KD) 2.0370 .7745 t .9020 WEIG LIVER (LI) 8.2431 3.1343 t 3.9739 WEIG OVARY (OV) .0965 .0367 % .0465 WEIG SPLEEN (SP) .5076 .2234 t .2833 WEIG THYMUS (TH) .3850 .1464 t .1856 WEIG THYROID/PARATHYR (TT) .0181 .0069 t .0087 WEIG ----------------------------------------------------------------------------------------------------------------- 0 BSE RVAT 10N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE.-MINIMAL -VACUOLATION, HEPATOCELLULAR, PERIPORTAL,-ML GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - -- - - - - - - -- - - -- - - - - - - - - - - - - - - THE FOLLOWING ORGANS WERE UNRE14ARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM). MARROW. STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS IPA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE). LN, KANDIBU SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY. FEMALE (MF), URINARY BLAL)DER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA IVA), TAIL (TI) ----------------------------------------------------------------------------------------------------------------- 465 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96011 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT-. 2 DATE AND TIME OF NECROPSY: 10/01/98 12:09 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: MICHELE ZIMA ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ADRENAL (AD) BRAIN IBR) KIDNEY (KD) ---------------------- ---------------------- -------- NOT -------- NOT -------- NOT LIVER OVARY SPLEEN THYMUS (LI) (OV) (SP) (TH) 7.5294 -------- -------- -------- 3.3198 t -------- --------------- -------- WEIG -------- NOT -------- NOT -------- NOT THYROID/PARATHYR (TT) -------- -------- -------- NOT ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE. FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (LI), KIDNEY (KO), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (Kh), AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DUI, JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), IN, MANDIBUL SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SED GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB). UTERUS (UT), CERVIX (CV), OVARY (OV). VAGINA (VA). TAIL (TI), GENERAL COMMENT (GC) ----------------------------------------------------------------------------------------------------------------- 466 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYB PERFLUOROOCTANESUBFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ AN114AL NUMBER: C96012 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM S STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 19 DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 PROSECTOR: TONY HANFEI.D RECORDER: KEVIN BILLIN DATE AND TIME OF NECROPSY: 10/01/98 11:05 POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIHA ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- IGRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST A ----- -------- -------- -------- NOT T ADRENAL (AD) -------- -------- -------- NOT T BRAIN (BR) -------- -------- -------- NOT KIDNEY (KD) LIVER (1.1) 6.5011 -------- 3.3878 t -------- --------------- WEIG NOT OVARY (OV) -------- -------- -------- NOT T SPLEEN (SP) THYMUS (TH) --------------- --------------- --------------- NOT NOT -------T-H-Y-R-O-I-D-/-P-A-R-A-T-H-Y-R---(-T-T-)------------------------------- ----------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA). AORTA (AO), PITUITARY . (PI). STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE) COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SER GL (AS), SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) ------------------------------------------------------------------------------------------------------------------ 467 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------- ------------ -------------------------------------------------------------------------------------------- ANIKAL NUMBER: C96013 SEX: FE14ALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 2 DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 RECORDER: KEVIN BILLI DATE AND TIME OF NECROPSY: 10/01/98 11:31 . PROSECTOR: WENDY CHERRY PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIHA P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-V-AI-L-A-B-LE-------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) -------- TO BODY WEIGHT -------- WEIGHT RATIO -------- ST ---- ---------------------- -------- -------- -------- NOT ADRENAL (AD) -------- -------- NOT BRAIN (BR) -------- ------7--------- -------- NOT KIDNEY (KD) LIVER (LI) 7.7373 -------- 3.4681 t -------- --------------- WEIG NOT OVARY (OV) -------- -------- -------- NOT SPLEEN (SP) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT -------T-H-YR-O-I-D-/-PA-R-A-T-HY-R------(T-T-)-------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC). LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI). KIDNEY (KD), HEART (HT). MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH. NONGL PANCREAS (PA), DUODENUM (DU), JF.JUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), IN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SX). MAMMARY. FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV). OVARY (OV), VAGINA (VA), TAIL (TI). GENERAL COMMENT (GC) ----------------------------------------------------------------------------------------------------------------- 468 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTA.NESULPONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96014 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM DATE OF DEATH: 10/01/98 DATE AND TIME OF NECROPSY: STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 10/01/98 11:07 PROSECTOR-. MATTHEW AXTMAN TERMINAL BODY WEIGHT: 2 RECORDER: KEVIN BILLI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIM) ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 01 ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- 9T ---- ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) -------- -------- -------- NOT KIDNEY (KD) -------- -------- -------- NO@ LIVER (LI) 7.4920 3.2903 % -------- WEI OVARY (OV) -------- -------- -------- NOT SPLEEN (SP) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT THYROID/PARATHYR (TT) -------- -------- -------- NOT ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM). MARROW. STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD). HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LM, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (t4A). AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON ICO), RECTUM (RE), IN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERUS IUT), CERVIX ICV), OVARY (OV). VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) ----------------------------------------------------------------------------------------------------------------- 469 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEPOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96015 SEX: FE14ALE DOSE GROUP: 2 SACRIFICE STATUS% SCHEDULED, FIRST INTERIM S) DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATHI 5 TERMINAL BODY WEIGHT: 210 DATE AND TIME OF NECROPSY: 10/01/98 11:14 PROSECTOR: MATTHEW AXTKAN RECORDER: KEVIN BILLIN( POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 RC ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO STA ---------------------- -------- -------- -------- ------ ADRENAL (AD) --------------- --------------- --------------- NOT T) NOT TJ BRAIN (SR) KIDNEY IKD) -------- -------- -------- NOT TJ LIVER (LI) 7.0360 3.3441 t -------- WEIGHI OVARY (OV) -------- -------- -------- NOT TJ SPLEEN (SP) -------- -------- -------- NOT Ti NOT T THYMUS (TH) -------- -------- -------- THYROID/PARATHYR (TT) -------- -------- -------- NOT T ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM). MARROW. STERNUM (SE), BONE, STERNUM (SB). EYE (EY). BRAIN (BRI, SPINAL CORD (SC). LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE. SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS). THYROID ITY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AD), PITUITARY (PI), STOMACH. GL (ST), STOMACH, N014GL PANCREAS (PA), DUODENUM IDU), JEJUNUM (JE). ILEUM (IL). CECUM (CE). COLON (CO), RECTUM (RE). LN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, PEKALS (KF), URINARY BLADDER (UB), UTERUS JUT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI). GENERAL COMMENT (GC) ------------------------------------------------------------------------------------------------------------------ 470 Individual APPENDIX Anatomic 6 Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS --------------------------------------------- ----------------------------------------------------------------- SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: UNSCHEDULED (M) HNIMAL NUMBER: C96016 STUDY DAY OF DEATH: 59 STUDY WEEK OF DEATH: 9 TERMINAL BODY WEIGHT: DATE OF DEATH: 10/29/98 PROSECTOR: JAMES T. CALLEN RECORDER: JAMES T. DATE AND TIME OF NECROPSY: 10/29/98 15:09 WEIGHER: JAMES T. l'OST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY --------------------------- ------------------------------- -------------------------------------------------- ... ORGAN WEIGHTS WERE NOT RECORDED ... -------------------------------------------- ----------------------------------------------------------------- 0 B SE RVA T 10N S HISTOPATHOLOGY NECROPSY - ------------ ------------------------------------ ------ ---------------------------- -------------- LIVER (LI) -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE.-MINIMA TAIL (TI) -LACERATION(S); 20 MM FROM BASE OF TAIL: SINGLE LACERATION, 20 x 10 MM; SURROUNDING TISSUE APPEARS SWOLLEN AND EXUDES A TAIL (TI) : -HEMORRHAGE,-SLIGHT -ULCERATION,-MINIMAL DARK RED SEMIFLUID; COLLECTED ------ --- ---- ---- -- 471 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAHIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96016 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: UNSCHEDULED (M) DATE OF DEATH*. 10/29/98 STUDY DAY OF DEATH: 59 STUDY WEEK OF DEATH: 9 TERMINAL BODY WEIGHT: 27 DATE AND TIME OF NECROPSY: 10/29/98 15:09 PROSECTOR: JAMES T. CALLEN RECORDER: JAMES T. CAL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: JAMES T. CALL ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD). HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), IN, MANDIBULA SALIV GL, KMDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), GENERAL C014MENT (GC) THE FOLLOWING TISSUES WERE UNRE14ARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), RARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM). NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), LN, MANDIBUIJ SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT). CERVIX (CV), OVARY (OV), VAGINA (VA) ------------------------------------------------------------------------------------------------------------------ 472 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANEsubFoNAmrDo TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL, NUMBER: C96017 SEX: FEMALE DOSE GROUP- 2 SACRIFICE STATUS: SCHEDULED, TERNINAti SACRIFI DATE OF DEATH: 12/02198 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT- 277 DATE AND TIME OF NECROPSY: 12/02/98 7:41 PROSECTOR: JODI THIEREN RECORDER: STEVE VAN ADE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WRIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0 RG STA ------ ADRENAL (AD) .0693 .0250 t .0342 WEIGHT BRAIN (HR) KIDNEY (KD) 2.0282 2.2400 .7311 t .8075 % 1.0000 1.1044 WEIGHT WRIGHT LIVER (LI) 8.0588 2.9051 t 3.9734 WEIGHT OVARY (OV) .1886 .0680 t .0930 WEIGHT SPLEEN (SP) .5476 .1974 t .2700 WEIGHT THYMUS (TH) .3084 .1112 t .1521 WRIGHT THYROID/PARATHYR (TT) .0200 .0072 t .0099 WEIGHT ------------------------------------------------------------------------------------------------------------------- 0 8 S E R V A T 10 N S NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------------------------------------------------- LIVER (LI) : GENERAL C014MENT (GC) -BONE KARROW SHEAR TAKEN -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -MALOCCLUSION; BILATERAL UPPER INCISORS - - - - - - - - - - - - - - -- - -- - - - - - - - - - - - - - - - - - - - - THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). KARROW, FEMUR (FM), MARROW. STERNUM (BE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, SKE NERVE, SCIATIC (SK). SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (14A), AORTA (AOJ. PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (VU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO). RECTUM (RE), LN, MANDIBULAR SALIV GL, MANDIB (SG), HARDERIAN GLAND (HGI, AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT). CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) ------------------------------------------------------------------------------------------------------------------- 473 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-63141 IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96018 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATHT 14 TERMINAL BODY WEIGHT: 2 DATE AND TIME OF NECROPSY: 12/02/98 8:50 PROSECTOR: MICHELE ZIMA RECORDER-. WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHERs LYNN HORNER ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ADRENAL (AD) .0805 .0288 t .0423 WEIG BRAIN (BR) 1.9028 .6803 t 1.0000 WEIG KIDNEY (KD) 2.0616 .7371 t 1.0835 WEIG LIVER (LI) 8.0095 2.8636 % 4.2093 WEIG OVARY (OV) .1174 .0420 % .0617 WEIG SPLEEN (SP) .5094 .1821 t .2677 WEIG THYMUS (TH) .2793 .0999 t .1468 WRIG THYROID/PARATHYR (TT) .0175 .0063 t 0092 WRIG ----------------------------------------------------------------------------------------------------------------- 0 B S E RV A T 1 0 N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL THYMUS (TH) -DIFFUSELY RED; DARK RED -NECROSIS, INDIVIDUAL THYMUS (TH) ; -HEMORRHAGE,-SLIGHT -INVOLUTION,-MINIMAL HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) -BONE HARROW SMEAR TAKEN - -THE- FO-LLOW-ING- O-RGAN-S -WER-E U-NREM-ARK-ABLE- -AT -NEC-ROPS-Y: - - - - - - - - - - - - - - - - - - - BONE. FEMUR (FE). 14ARROW. FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD). HEART (UT). MUSCLE. S NERVE, SCIATIC ISN), SPLEEN (SP), LN, MESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX ( ADRENAL, MEDULLA (RA), AORTA IAO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS IPA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR INN), SALIV GL, HANDIS (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK). MAMMARY, FEMALE IMF), URINARY BLADDER (US), UTERUS (UT), CERVIX (CV), OVARY (OV). VAGINA (VA), TAIL (TZ) 474 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ AN114AL NUMBER: C96019 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 28 DATE AND TIME OF NECROPSY: 12/02/98 12il2 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ----- ADRENAL (AD) .0860 .0304 t .0420 WEIGH BRAIN (BR) 2.0462 .7225 % 1.0000 WEIGH' KIDNEY (KD) 2.6887 .9494 % 1.3140 WEIGH LIVER (LI) 8,9464 3.1590 t4 4.3722 WEIGH OVARY (OV) .1290 .0456 t .0630 WEIGH SPLEEN (SP) .5329 .1882 t .2604 WEIGff THYMUS (TH) .3098 .1094 t .1514 WEIGER THYROID/PARATHYR (TT) .0209 .0074 % .0102 WEIGH ------------------------------------------------------------------------------------------------------------------ 0B SERV AT 10N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- UTERUS (UT) : UTERUS (UT) : -LUNEN FILLED WITH FLUID; BILATERAL: CLEAR FLUID -DILATATION,-SLIGHT GENERAL COMMENT (GC) : -BONE MARROW SHEAR TAKEN - - - - - - - - - -- - - - - - - - -- - -- - - - - - - - - - - - - - - - 475 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96019 SEX-. FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 2 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: TERRI L. WI DATE AND TIME OF NECROPSY: 12/02/98 12:12 PROSECTOR: NANCY DIEDRICH WEIGHER: TONY HANFELD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY ---------------------------------------- ----------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: STERNUM (SB), EYE (EY). BRAIN (BR), BONE, FEMUR (FE). t4ARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE. S NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN. MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL. CORTEX (AC), ADRENAL, MEDULLA (14A), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL . DUODENUM (DU). JEJUNUM (JE), ILEUM (IL). CECUM (CE). COLON (CO), RECTUM (RE). LN, MANDIBU SPAALNICRVEAGSL, (PMAA)NDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). MAMMARY, FEMALE (MF). URINARY BLADDER (UB). CERVIX (CV), OVARY (OV). VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: --------L-I-V-E-R--(-L-I)----------------------------- ------------ ----------------------------------------------------- 476 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96020 SEX: FEMALE DOSE GROUP: 2 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 23 DATE AND TIME OF NECROPSY: 12/02/98 12:06 PROSECTOR: JOHN S. HALFORD RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ----- ADRENAL (AD) .0746 .0311 t .0392 WEIGH BRAIN (BR) 1.9018 .7927 t 1.0000 WEIGH KIDNEY (KD) 2.0893 .8709 t 1.0986 WEIGH LIVER (LI) 8.3210 3.4685 t 4.3753 WEIGH OVARY (OV) .1320 .0550 t .0694 WEIGH SPLEEN (SP) .4508 .1879 % .2370 WEIGH THYMUS (TH) .2735 .1140 t .1438 WEIGH THYROID/PARATHYR (TT) .0172 .0072 t .0090 WEIGH ------------------------------------------------------------------------------------------------------------------ 0 BSE RVAT 10N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINI14AL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) -BONE KARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - -- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FH), MARROW, STERNUM (SE), DONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD). HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN). SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL. MANDID (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). MAMMARY. FEMALE (KF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL ITI) ------------------------------------------------------------------------------------------------------------------ 477 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96021 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUST SCHEDULED, TERMINAL SACRIP DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 23 DATE AND TIME OF NECROPSY: 12/02/98 10:36 PROSECTOR: JERALD W. JOHNSON RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST; JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ----- ADRENAL (AD) .0599 .0250 % .0302 WEIG BRAIN (BR) 1.9833 .8274 t 1.0000 WEIG KIDNEY (KD) 2.1418 .8935 t 1.0799 WEIGH LIVER (LI) 7.9743 3,3268 t 4.0207 WEIG OVARY (OV) .1125 .0469 t .0567 WEIG SPLEEN (SP) .5182 .2162 1 .2613 WEIGH THYMUS (TH) .2110 .0880 % .1064 WEIGH THYROID/PARATHYR (TT) .0159 .0066 t .0000 WEIGF ------------------------------------------------------------------------------------------------------------------ 0 BSE RVAT 10N S NECROPSY HISTOPATHOL#OGY --------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIHAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - -- - - - -- - - - - - -- - - - - - -- - - 478 APPENDIX 6 Individual AnatomiC PathologY Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ---- ---- ------- ------------ ------------------------------------------------------------ ANI14AL NUMBER: C96021 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: FEMALE STUDY DAY OF 12/02/98 10:36 POST-FIX WEIGHER: NOT AVAILABLE ----------------------------------- DOSE GROUP: 3 DEATH: 93 STUD Y WEEK PROSECTOR: JERALD W. SACRIFICE OF DEATH: JOHNSON STATUS: 14 SCHEDULED, TERMINAL SACRIFI TERMINAL BODY WEIGHT: 239 RECORDER. WENDY CHERRY WEIGHER: LYNN HORNER PATHOLOGIST: JOHN EIGHMY -------------------------- --------------------------------------- THE FOLLOWING ORGANS WEMRAERROUWN,RE14FAERMKUARBLE (FHA)T, NMEACRRROOPWS,Y: STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). BONE, FEMUR (FE), (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, SKI SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS NERVE, SCIATIC (SN). SPLEEN (SP). THYMUS (TH). LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), ST014ACH GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL) CECUM (CE). COLON (CO). IECTUM (RE), LN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY @EB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT). CERVIX (CV). OVARY (OV). VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: --------S-T-OM-A-C-H-, --G-L---(S--T)-.--S-T-O-M-AC-H-,- -N-O-N-GL---(-S-U-) --------------------------------------------------------------------- 479 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBERT C96022 SEX: FEMALE DOSE GROUP. 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH% 12/02/99 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 2 DATE AND TIME OF NECROPSY: 12/02/98 12:09 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. Wl POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TORY HANFELD ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (ti) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST ---- ADRENAL (AD) .0765 .0289 t .0367 WEIG BRAIN (BR) 2.0837 .7881 % 1.0000 WEIG KIDNEY (KD) 2.1627 .8180 % 1.0379 WEIG LIVER (LI) 8.7642 3.3147 t 4.2061 WEIG OVARY (OV) .1119 .0423 t .0537 WEIG SPLEEN (SP) .5033 .1904 % .2415 WEIG THYMUS (TH) .2463 .0932 t .1182 WEIG THYROID/PARATHYR ITT) .0279 .0106 % .0134 WEIG ----------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : GENERAL COMMENT (GC) -HYPERTROPHY, NEPATOCELLULAR, CENTRILOBULAR, INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -BONE MARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - 480 APPENDIX 6 Individual AnatomiC Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-KEPOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI TERMINAL BODY WEIGHT: 264 ANIMAL NUMBER: C96022 SEX: FEMALE STUDY WEEK OF DEATH: 14 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WIL WEIGHER: TONY HANFELD DATE AND TIME OF NECROPSY: 12/02/98 12:09 PATHOLOGIST: JOHN EIGHMY - ----- ------- P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-VA-I-L-A-BL-E-------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), t4ARROW. FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY). BRAIN (BR), . TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI) KIDNEY (KD). HEART (HT). MUSCLE, SK SNPEIRNVAEL, CSOCRIDATI(CSC)(,SNL)U,NGSPL(ELEUN) (SP), THYMUS (TH), LN, MESENTERIC (MS), T4yROID (TY) PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (t4A), AORTA (AO), PITUITARY (PI), STOMACH: GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU). JEJUNUM (JE), ILEUM (IL) CECUM (CE), COLON (CO). RECTUM (RE), LN, MANDIBULA SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY @EB GL (AS). SKIN (SK). MAMMARY, FEMALE (HF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV). VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC STOMACH, GL (ST), STOMACH, NONGL (SU) ---------------------------------------------- EXAMINATION: 481 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96023 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 253 DATE AND TIME OF NECROPSY: 12/02/90 10:06 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WILL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY RANFELD ------------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- .ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0RG STA ------ ADRENAL (AD) BRAIN (BR) KIDNEY (KD) .0695 2.0599 2.5238 .0275 t .8142 t .9975 t .0337 1.0000 1.2252 WEIGHT WEIGHT WEIGHT LIVER (LI) OVARY (OV) 10.5886 .1184 4.1852 t .0468 % 5.1403 .0575 WEIGHT WEIGHT SPLEEN (SP) .5279 .2087 t .2563 WEIGHT THYMUS (TH) .3996 .1579 % .1940 WEIGHT THYROID/PARATHYR (TT) .0150 .0059 t .0073 WEIGHT ------------------------------------------------------------------------------------------------------------------- 0 BS ERVA T10N S NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,-M -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIHAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-NINIMAL GENERAL COMMENT (GC) -BONE HARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS -- - - - - - - -- - -- - - - - -- -- - -- - - -- - - - - - - - -- - 482 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF ANIMAL NUMBER: C96023 SEX: FEMALE DOSE GROUP: 3 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 25 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WIL DATE AND TIME OF NECROPSY: 12/02/98 10;06 PATHOLOGIST. JOHN EIGHMY WEIGHER: TONY HANFELD -------------------------------------- P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-VA-I-L-A-BL-E----------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (DR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY . (PI), STOMACH, GL (ST). STOMACH, NONGL COLON (CO), RECTUM (RE). LN, VAANDIBULA PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE) SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FE14ALE (KF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: --------S-T-OM-A-C-H-, --G-L---(S-T-)-,--S-T-OM-A-C-H-,--N-O-N-GL---(-S-U-) --------------- ----------- ----------------------------------------- 483 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96024 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 25 DATE AND TIME OF NECROPSY: 12/02/98 l2tl2 PROSECTOR: JODI THIEREN RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGISTI JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ----- ADRENAL (AD) .0753 .0292 t .0350 WEIGH BRAIN (BR) 2.1505 .8345 t 1.0000 WEIGH KIDNEY (KD) 2.5361 .9841 t 1.1793 WEIGH LIVER (LI) 8,6565 3.3591 1 4.0253 WEIGH OVARY (OV) .1361 .0528 t .0633 WEIG SPLEEN (SP) .4379 .1699 t .2036 WEIG THYMUS (TH) .2907 .1128 t .1352 WEIGH THYROID/PARATHYR (TT) .0183 .0071 % .0085 WEIG ------------------------------------------------------------------------------------------------------------------ 0B SERV AT 10N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LIVER (LI) : GENERAL COMMENT (GC) -HYPERTROPHY, HEPATOCELLULAR, CPNTRILOBULAR.- -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS -- - -- - - - - - - - - - - - - - - - - - - -- - -- - -- - - - - -- - 484 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96024 SEX: FEMALE DOSE GROUPZ 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 25 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: TERRI L. WIL DATE AND TIME OF NECROPSY: 12/02/98 12:12 PROSECTOR: JODI THIEREN WEIGHER: TONY HANFELD PATHOLOGIST: JOHN EIGHMY P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-V-A-IL-A-B-LE------ ----------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), LIVER (L,I), KIDNEY (KD). HEART (HT), MUSCLE, SK THYROID (TY), PARATHYROID (PT). NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS) ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST). STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULJ SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: ------- S-T-O-M-AC-H-,---G-L --(-S-T)-.--S-T-O-M-AC-H-,---N-ON-G-L---(S-U-)---------------------------------------------------------------------- 495 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96025 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT. 25 DATE AND TIME OF NECROPSY: 12/02/90 11:33 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ----- ADRENAL (AD) .0780 .0310 t .0395 WEIGW. BRAIN (BR) KIDNEY (KD) 1.9934 2.3465 .7851 t .9242 t 1.0000 1.1771 WEIGH WEIGH LIVER (LI) 9.8976 3.8982 % 4.9652 WEIGH OVARY (OV) .1407 .0554 % .0706 WEIGH SPLEEN (SP) .5995 .2361 t .3007 WEIGfr@ THYMUS (TH) .2171 .0855 % .1089 WEIGW. THYROID/PARATHYR (TT) .0268 .0106 t .0134 WEIGtr. ------------------------------------------------------------------------------------------------------------------ 0 BSE RVAT 10N S . NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- STOMACH, GL (ST) -LIGHT FOCUS(I)/AREA(S); MUCOSA, NEAR SINGLE WHITE PINPOINT SLIGHTLY RAISED ESOPHAGEAL FOCUS GROOVE: LIVER (LI) : -INFILTRATE, LYHPHOHISTIOCYTIC,-MIN114AL STOMACH, GL (ST) - >UNREMARKABLE >NOTE:>THERE IS A FOCAL AREA OF NORMAL-APPEAR MUSCLE IN THE TUNICA HUSCULARIS IN THE LIMITING RIDGE. IN, MANDIBULAR (MN) -MOTTLED; BILATERAL: RED AND TAN OVARY (OV) : -DIFFUSELY RED; BILATERAL LN, MANDIBULAR (MN) : -HEMORRHAGE,-MINIMAL OVARY (OV) : >UNREMARKABLE GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - 486 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96025 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 25 DATE AND TIME OF NECROPSY: 12/02/98 11:33 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: TONY RANFELD ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL. MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB). UTERUS CERVIX (CV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOKACH, NONGL (SU) ------------------------------------------------------------------------------------------------------------------ 487 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96026 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 2 DATE AND TIME OF NECROPSY: 12/02/98 11:08 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ADRENAL (AD) .0700 .0301 t .0353 WEIG BRAIN (SR) 1.9824 .8526 t 1.0000 WEIG KIDNEY (KD) 2.0111 .8650 % 1.0145 WEIG LIVER (LI) 8.3034 3.5714 t 4.1886 WEIG OVARY (OV) .1165 .0501 % .0588 WEIG SPLEEN (SP) .4610 .1983 % .2325 WEIG THYMUS (TH) .2781 .1196 t .1403 WEIG THYROID/PARATHYR (TT) .0139 .0060 t .0070 WEIG ---------------------------------------------------------------------------------------------------------------- 0B SERV AT 10N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIHAL GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 488 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYE, ETHANOL (N-MEFOSE, T-6314) IN RATS -------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96026 DATE OF DEATH: 12/02/90 SEX: FEMALE STUDY DAY OF DEATH: DOSE GROUP: 3 SACRIFICE STATUS: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 23 DATE AND TIME OF NECROPSY: 12/02/98 11:08 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUH (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULJ SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (HF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV). "GINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) ----------------------------------------------------------------------------------------------------------------- 489 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96027 SEX: FEMALE STUDY DAY OF DEATH: DOSE GROUP: 3 93 STUDY WEEK SACRIFICE OF DEATH: STATUS: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 2 RECORDER: TERRI L. WI DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/98 10:10 PROSECTORT LAURIE J. SCHULLER WEIGHER: TONY HANFELD PATHOLOGIST: JOHN EIGHMY P-O-S-T--F-I-X---W-EI-G-H-E-R:---N-O-T--A-V-AI-L-A-B-LE---------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT -------- WEIGHT RATIO -------- ST ---- ---------------------- -------- .0222 t .0340 WEIG ADRENAL (AD) .0659 .6527 % 1.0000 WEIG BRAIN (BR) 1.9373 .7787 % 1.1929 WEIG KIDNEY (KD) 2.3111 9.8850 3.3305 % 5.1025 WEIG LIVER (LI) .1046 .0352 % .0540 WEIG OVARY (OV) SPLEEN (SP) .5319 .3779 .1792 % .1273 % .0060 % .2746 .1951 .0091 WEIG WEIG WEIG THYMUS (TH) -------T-HY-R-O-I-D/-P-A-R-AT-H-Y-R-----(-T-T-)--------------.-0-17-7----------------------------------------------------------------- 0B SERVA T10N S HISTOPATHOLOGY NECROPSY -------------------------------------------- --------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MIN114AL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS ---- -------------------- - - - - - - - - - -- - - 490 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96027 SEX: FEMALE -DOSE GROUP: 3 SACRIFICE STATUS: STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACR TERMINAL BODY WEIGHT: RECORDER: TERRI L. W DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/98 10:10 PROSECTOR: LAURIE J. SCHULLER WEIGHER: TONY HANFEL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY ------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: . STERNUM (SB), EYE (EY), BRAIN (HR). BONE, FEMUR (FE), MARROW, FEMUR (FM), KARROW, STERNUM (SE), BONE SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN. HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE). LN, HMDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: ------ -S-T-O-MA-C-H-,---G-L--(-ST-)-,--S-T-O-MA-C-H-,--N-O-N-G-L--(-S-U-)------------------------------------------------------------------ 491 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96028 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: FEMALE STUDY DAY OF 12/02/98 9:00 DOSE GROUP- 3 SACRIFICE DEATH: 93 STUDY WEEK OF DEATH: PROSECTOR: LAURIE J. SCHULLER STATUS% 14 SCHEDULED, TERMINAL SACRIF TER14INAL BODY WEIGHT: 25 RECORDER: STEVE VAN A POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGISTT JOHN EIGHKY WEIGHER: TONY HANFBLD ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ----- ADRENAL (AD) .0628 .0242 % .0315 WEIG BRAIN KIDNEY LIVER (BR) (KD) (LI) 1.9952 2.0909 8.7646 .7686 t .8054 % 3.3762 t 1.0000 1.0480 4.3928 WEIG WEIG WEIG OVARY SPLEEN THYMUS (OV) (SP) (TH) .1106 .5702 .3955 .0426 t .2196 t .1523 t .0554 .2858 .1982 WEIG WEIGH WEIG THYROID/PARATHYR (TT) .0193 .0074 t .0097 WEIGH ------------------------------------------------------------------------------------------------------------------ 0 BSE RVAT 10N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -KALOCCLUSION; BILATERAL UPPER INCISORS - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - 492 APPENDIX individual AnatoMiC Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFI,UOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI ANIMAL NUMBER: C96028 SEX: FE14ALE DOSE GROUP: 3 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 2 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 PROSECTOR: LAURIE J. SCHULLER RECORDER: STEVE VAN A DATE AND TIME OF NECROPSY: 12/02/98 9:00 PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD - - P-O-S-T--F-I-X---WE-I-G-HE-R-:---N-O-T--A-VA-I-L-A-BL-E------------------------------------------------------------------------ ------- FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: THE BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL , DUODENUM (DU), JEJUNUM (JE). ILEUM (IL). CECUM (CE). COLON (CO), RECTUM (RE). LN, MANDIBU PSAANLCIRVEASGL, (PMAA)NDIB (SG), HARDERIAN GLAND (HG), AUDITORY SED GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: --------S-T-OM-A-C-H-, --G-L---(S-T-)-,--S-T-OM-A-C-H-,--N-O-N-GL---(-S-U-) --------------------------------------------------------------------- 493 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFI,UOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96029 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 2 DATE AND TIME OF NECROPSY: 12/02/98 7:41 PROSECTOR: NANCY DIEDRICH RECORDERT STEVE VAN A POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (ft) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST ---- ADRENAL (AD) .0617 .0341 t .0412 WEIG BRAIN (BR) 1.9819 .8275 t 1.0000 WEIG KIDNEY (KD) 2.1671 .9048 t 1.0934 WEIG LIVER (LI) 8.7181 3.6401 t 4.3989 WEIG OVARY (OV) .1243 .0519 t .0627 WEIG SPLEEN (SP) .5235 .2186 t .2641 WEIG THYMUS (TH) .2626 .1096 t .1325 WEIG THYROID/PARATHYR (TT) .0179 .0075 ts .0090 WEIG ----------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - -- - -- - - - - - - -- - - - - - -- - -- - - - - - - - - - 494 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------- ------------------------------------------------------------------ ANIMAL NUMBER: C96029 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIP TERMINAL BODY WEIGHT: 23 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: STEVE VAN AD DATE AND TIME OF NECROPSY: 12/02/98 7:41 PROSECTORI NANCY DIEDRICH WEIGHER: TONY HANFELD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY -------------------------- -------- ------------------------------------------------------------------------------ THE FBOOLNLEO,WINFGEMURORGA(NFSE),WEMRAERROUWN,REMAFREKMAUBRLE (FMA)T, NMEACRRROOPWS,Y: STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (14A), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), LN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNRE14ARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) -------------------------------------------------------------------7 ------------------------------------------- 495 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE. T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96030 SEX: FEMALE STUDY DAY OF DEATH: DOSE GROUP: 3 SACRIFICE STATUS: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 24 RECORDER: TERRI L. WIL DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/98 11:22 PROSECTOR: JODI THIEREN WEIGHER: TONY HANFELD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY -------- ------------ ------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ----- - -------------------- -------- ADRENAL (AD) .0640 2.0259 .0263 t .8317 % .0316 1.0000 WEIGH WEIGH BRAIN (BR) 2.1625 .8877 t 1.0674 WEIG KIDNEY (KD) 10.3610 4.2533 % 5.1143 WEIG LIVER (LI) .1272 .0522 % .0628 WEIG OVARY (OV) SPLEEN (SP) .5984 .2458 .2456 % .1009 % .2954 .1213 WEIG WEIG THYMUS (TH) THYROID/PARATHYR (TT) .0121 .0050 % .0060 WEIG --------------------------------------------------------------------------------------------------------------- 0B SERVA T10N S HISTOPATHOLOGY NECROPSY ------ ------------ --------------------------- -------- ------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR.- -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, COAGULATIVE.-MINIMAL THYMUS (TH) -RED FOCUS(I)/AREA(S); RIGHT LN, MANDIBULAR (MN) : -DIFFUSELY RED; BILATERAL LOBE: MULTIPLE PINPOINT FOCI THYMUS (TH) : -HEMORRHAGE,-MINIMAL LN. MANDIBULAR (HN) : -HEMORRHAGE,-MINIMAL GENERAL COMMENT (GC) : -BONE HARROW SMEAR TAKEN ------ ----- 496 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFDUOROOCTANESULFONANIDO TOXICITY STUDY WITH N-METHYR, ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96030 SEX: FE14ALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACA DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 11:22 PROSECTOR: JODI THIEREN RECORDER: TERRI L. W POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST.- JOHN EIGHMY WEIGHER. TONY HANFEL ---------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE. FEMUR (FE), HARROW, FEMUR (FM), t4ARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART IHT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (P'r), ADRENAL, CORTEX ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS IPA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUH (RE), SALIV GL, MANDID (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERU CERVIX (CV). OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH. GL (ST), STOMACH, NONCL (SU) ---------------------------------------------------------------------------------------------------------------- 497 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96031 DATE OF DEATH: 10/01/98 DATE AND TIME OF NECROPSY: SEX: FEMALE STUDY DAY OF jolol/ge 11:34 DOSE GROUP: 3 SACRIFICE DEATH: 31 STUDY WEEK OF DEATH: PROSECTOR: WENDY CHERRY STATUS: 5 SCHEDULED, FIRST INTERIM TERMINAL BODY WEIGHT: 2 RECORDER: KEVIN BILLI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO ST ---------------------- -------- -------- -------- ---- ADRENAL (AD) --------------- --------------- -------- NOT -------- NOT BRAIN (BR) KIDNEY (KD) -------- -------- -------- NOT LIVER (LI) 7.4421 3.6215 & -------- WEIG OVARY (OV) -------- -------- -------- NOT SPLEEN (SP) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT THYROID/PARATHYR (TT) --- ---- -------- -------- NOT ------------- --------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNRE14ARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE. SCIATIC (SN). SPLEEN (SP), THYMUS (TH). IN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH. NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), LN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB). UTERUS (UT). CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TZ), GENERAL COMMENT (GC) ----------------------------------------------------------------------------------------------------------------- 498 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- AN114AL NUMBER: C96032 SEX: FEMALE STUDY DAY OF DEATH: DOSE GROUP: 3 SACRIFICE STATUS: 31 STUDY WEEK OF DEATH: 5 SCHEDULED, FIRST INTERIM TERMINAL BODY WEIGHT: 2 RECORDER: KEVIN BILLI DATE OF DEATH: 10/01/98 DATE AND TIME OF NECROPSY: 10/01/98 11:09 PROSECTOR: WENDY CHERRY WEIGHER: MICHELE ZINA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ---------------------- --------------- -------- -------- NOT ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) -------- -------- -------- NOT KIDNEY (KD) 6.7736 3.3302 % -------- WEIG LIVER (LI) -------- -------- -------- NOT OVARY (OV) -------- -------- -------- NOT SPLEEN THYMUS (SP) (TH) --------------- --------------- --------------- NOT NOT -------TH-Y-R-O-ID-/-P-A-R-AT-H-Y-R-----(-T-T)------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, , GL (ST). STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO) RECTUM (RE), LN. MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAN14ARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) ------- -------------------------------------------------------------------------------------------------------- 499 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96033 DATE OF DEATH: 10/01/98 DATE AND TIME OF NECROPSY: SEX: FE14ALE STUDY DAY OF 10/01/98 11:15 DOSE GROUP: 3 SACRIFICE DEATH: 31 STUDY WEEK OF DEATH: PROSECTOR: WENDY CHERRY STATUS: 5 SCHEDULED, FIRST INTERIM TERMINAL BODY WEIGHT: RECORDER: KEVIN BILL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMJ ---------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST --- ADRENAL (AD) --------------- --------------- -------- NOT -------- NOT BRAIN (BR) KIDNEY (KD) -------- -------- -------- NOT LIVER (LI) 7.7835 -------- 3.7011 1 -------- -------- WEI -------- NOT OVARY (OV) SPLEEN (SP) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT THYROID/PARATHYR (TT) -------- -------- -------- NOT --------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR IFM), MARROW, STERNUM ISE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR). SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH). LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO). PITUITARY (Pl), STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA). DUODENUM (DU). JEJUNUM (JE). ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (14F), URINARY BLADDER (UB). UTERUS (UT). CERVIX (CV). OVARY (OV), "GINA ("), TAIL (TI), GENERAL COMMENT (GC) ---------------------------------------------------------------------------------------------------------------- 500 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96034 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM S TERMINAL BODY WEIGHT: 23 DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 RECORDER: KEVIN BILLIN DATE AND TIME OF NECROPSY: 10/01/98 12:01 PROSECTOR: MATTHEW AXTHAN WEIGHER: MICHELE ZIMA POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY -------------------------- ------------ ------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) ORGAN TO BRAIN WEI-GH-T---R-AT-I-O 0R ST A ORGAN NAME (GRAMS) -------- -------- ----- ---------------------- -------- -------- -------- NOT ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) -------- -------- -------- NOT KIDNEY (KD) LIVER (LI) 8.8195 3.7690 t -------- --------------- WEIG NOT T OVARY (OV) -------- -------- NOT SPLEEN THYMUS (SP) (TH) --------- --------------- -------- NOT -------- NOT -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-) -------------------------------------------------------------------------------------------- THE FBOOLNLEO,WINFGEMURORGA(NFSE), WEMRAERROUWN,REMAFREKMAUBRLE (FMA)T, NMEACRRROOPWS,Y: STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S) NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, HANDIBULJ SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF)l URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) --------------------------------------------------------------------------------------------------------------- 501 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL IN-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96035 DATE OF DEATH: 10/01/98 SEX; FEMALE STUDY DAY OF DEATH: DOSE GROUP: 3 SACRIFICE STATUS: 31 STUDY WEEK OF DEATH: 5 SCHEDULED. FIRST INTERIM S TERMINAL BODY WEIGHT: 21 DATE AND TIME OF NECROPSY: 10/01/98 11:21 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLIN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ADRENAL BRAIN KIDNEY LIVER OVARY SPLEEN (AD) (BR) (KD) (LI) (OV) (SP) ABSOLUTE ORGAN WEIGHT (GRAMS) --------------- -------- -------- 7.2747 --------------- -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- --------------- -------- 3.3248 -------- --------------- ORGAN TO BRAIN WEIGHT RATIO --------------- -------- --------------- -------- --------------- 0R S TA ----- NOT T NOT T NOT TJ WEIGH NOT T NOT T, NOT T, THYMUS (TH) -------- -------- -------- NOT T -------T-HY-R-O-ID-/-P-A-RA-T-H-Y-R-----(-TT-)--------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB). UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) -------- ------------------------------------------------------------------------------------------------------- 502 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLIJOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE. T-6314) IN RATS ------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96036 DATE OF DEATH: 12/02/98 SEX: FEMALE STUDY DAY OF DEATH: DOSE GROUP: 3 SACRIFICE STATUS: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT- 2 DATE AND TIME OF NECROPSY: 12/02/98 7:45 PROSECTOR: GREGORY CODDINGTON RECORDER: STEVE VAN A POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO -------- ST ---- ---------------------- -------- -------- ADRENAL (AD) .0611 .0241 % .0287 WEIG BRAIN (BR) 2.1326 .8416 % 1.0000 WEIG WEIG KIDNEY (KD) 2.3286 9.7463 .9189 % 3.8462 % 1.0919 4.5701 WEIG LIVER (LI) OVARY (OV) .1035 .0408 t .1930 % .0485 .2293 WEIG WEIG SPLEEN THYMUS (SP) (TH) .4891 .3725 .1470 % .1747 WEIG THYROID/PARATHYR (TT) .0205 .0081 % .0096 WEIG ----------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S HISTOPATHOLOGY ---------------------------N-E-C-R-O-P-S-Y----------------------------------- ------------ --------------------------- LIVER *(LI): -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN - -N-O M-ACR-OSCO-PIC - L-ESI-ONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 503 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL JN-NEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96036 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT. 2 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: STEVE VAN A DATE AND TIME OF NECROPSY: 12/02/90 7:45 PROSECTOR: GREGORY CODDINGTON WEIGHER: TONY HANFELD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY ---------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SH), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA.(TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, S NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (t4A). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM fRE), LN, HANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY. FEMALE (HP). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV). VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST). STOMACH, NONGL (SU) -------------------------------------------------------------------- --------------------------------------- 504 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESUL,FONAMIDO ETHANOL, (N-MEFOSE, T-6314 ) IN RATS --------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96037 SEX: FEMALE DOSE GROUP- 3 SACRIFICE STATUS: SCHEDUBED, TERMINAB SACRIF TERMINAL BODY WEIGHT: 25 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: WENDY CHERR) DATE AND TIME OF NECROPSY: 12/02/98 7:37 PROSECTOR: MICHELE ZIMA WEIGHER: LYNN HORNER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY -------- ----- ------ ----- ------ -------- --------------------------- ---------------------------------ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R (GRAMS) TO BODY WEIGHT WEIGHT RATIO S_T_ ORGAN NAME ---------------------- -------.0804 -------- .0320 t .7408 t .0432 1.0000 WEIG WEIG ADRENAL (AD) BRAIN (BR) 1.8602 .9465 % 1.2777 WEIG KIDNEY (KD) 2.3767 8.8940 3.5420 t 4.7812 WEIG LIVER (LI) .0918 .0366 % .0493 WEIG OVARY (OV) SPLEEN (SP) .5405 .2792 .2153 t .1112 % .2906 .1501 .0105 WEIG WEIG WEIG THYMUS (TH) THYROID/PARATHYR (TT) .0196 .0078 t ---------------------------------------------------------------------------------------------------------------- 0 BS ERVAT I NECROPSY ------------------------------------------------------------ HISTOPATHOLOGY -------------- GENERAL COMMENT (GC) : -BONE 14ARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS ------ ---------- ------------------- 505 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96037 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 2 DATE AND TIME OF NECROPSY: 12/02/98 7:37 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), LN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV). OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI), STOMACH, GL (ST). STOMACH, NONGL (SU) ----------------------------------------------------------------------------------------------------------------- 506 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96038 DATE OF DEATH: 12/02/90 SEX: FEMALE DOSE GROUP, 3 SACRIFICE STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: PROSECTOR: JERALD W. JOHNSON STATUS: 14 SCHEDULED, TERMINAL SACRIFI TERMINAL BODY WEIGHT: 275 RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 10:14 POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 RG ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT -------- WEIGHT RATIO -------- STA ------ ADRENAL (AD) BRAIN (BR) .0554 2.1428 .0201 % .7784 t .7875 % .0259 1.0000, 1.0118 WEIGHT WEIGHT WEIGHT KIDNEY (KD) LIVER (LI) 2.1681 9.8295 3.5705 t 4.5872 WRIGHT .1411 .0513 % .0658 WEIGHT OVARY (OV) SPLEEN (SP) .4874 .1770 % .2275 WEIGHT THYMUS (TH) .2831 .1028 % .1321 WEIGHT THYROID/PARATHYR (TT) .0153 .0056 t .0071 WEIGHT ------------------------------------------------------------------------------------------------------------------- 0 BS ERVA T10N S NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL LN, MANDIBULAR (MN) -DIFFUSELY RED; BILATERAL UTERUS (UT) '. -LUMEN FILLED WITH FLUID; LEFT: CLEAR FLUID LN, HANDIBULAR (NN) -HEMORRHAGE,-SLIGHT UTERUS (UT) : >UNREMARKABLE GENERAL COMMENT (GC) : -BONE MARROW SHEAR TAKEN ----- --------------- - - - - - - - - - - -- - 507 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96038 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 27 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDER: WENDY CHERRY DATE AND TIME OF NECROPSY: 12/02/98 10:14 PROSECTOR: JERALD W. JOHNSON PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER POST-FIX WEIGHER: NOT AVAILABLE ------------------------------------------------------------------------------ --------------------------------- THE FBOOLNLEO,WINFGEMURORGA(NFSE), WEtR4EARRUONWR,E14FAERMKUABRLE (FMA)T, NMEACRRRO,OPWS,Y: STERNUM (SE), BONE. STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR) ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, ME SENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO). PITUITARY (PI), STOMACH. GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU). JEJUNUH (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), SALIV GL. MAN HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). MAMMARY, FEMALE (MF), URINARY BLADDER (UB). CERVIX OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST). STOMACH, NONGL (SU) ------------------------------------------------------------------------ 508 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96039 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 8:13 PROSECTOR: NANCY DIEDRICH RECORDER: STEVE VAN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFE --------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT -------- WEIGHT RATIO s -------- ADRENAL (AD) .0835 .0324 % .0415 WE BRAIN (BR) 2.0098 .7805 t .8579 % 1.0000 WE 1.0992 WE KIDNEY (KD) LIVER (LI) 2.2091 9.1522 3.5543 % 4.5538 WE OVARY (OV) .1115 .0433 t .0555 WE SPLEEN (SP) .4315 .1676 t .1280 % .2147 we .1640 WE THYMUS (TH) THYROID/PARATHYR (TT) .3296 .0199 .0077 % .0099 WE --------------------------------------------------------------------------------------------------------------- 0B SERV AT 10N S NECROPSY HISTOPATHOLOGY ----------------------------------------------------------------------------------------------------------- LIVER (LI) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIHAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN - -N-O M-ACR-OSCO-PIC - L-ESI-ONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 509 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFI,UOROOCTANESULFONAMIDO ETHANOL JN-MEFOSE, T-6314) IN RATS ------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER- C96039 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 2 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 RECORDERT STEVE VAN A DATE AND TIME OF NECROPSY: 12/02/9B 8rl3 PROSECTOR: NANCY DIEDRICH PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD P-O-S-T--F-I-X- -W-E-I-GH-E-R-:---NO-T---AV-A-I-L-AB-L-E------------------------------------------------------------------------------------ THE FBOOLNLEO,WINFGEMURORGA(NFSE), WEMRAERROUWN,RE14FAERMKUARBLE (FM)A,T NMEACRRROOPWS,Y: STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN. HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY IPI), STOMAC.H, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO) RECTUM (RE), LN, MANDIBU SALIV GL. KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT). CERVIX (CV). OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: STOMACH, GL (ST), STOMACH, NONGL (SU) ----------------------------------------------------------------------------------------------------------------- 510 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96040 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT-. DATE AND TIME OF NECROPSY: 12/02/98 12:04 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. W POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFEL ---------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 ORGAN NAME (GRAMS) TO BODY WEIGHT (t) WEIGHT RATIO ST ---------------------- -------- -------- -------- ADRENAL (AD) .0650 .0292 fs .0336 WEI BRAIN (BR) 1.9359 .8693 t 1.0000 WEI KIDNEY (KO) 2.3025 1.0339 % 1.1894 WEI LIVER (LI) 9.2333 4.1461 t 4.7695 WEI OVARY (OV) .1810 .0813 t .0935 WEI SPLEEN (SP) .5292 .2376 % .2734 WEI THYMUS (TH) .2778 .1247 t .1435 WEI THYROID/PARATHYR (TT) .0253 .0114 t .0131 WEI ---------------------------------------------------------------------------------------------------------------- 0B SER VAT 10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - 511 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS --------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96040 SEX: FEMALE DOSE GROUP: 3 SACRIFICE STATUS: SCHEDULED, TERMINAL SAC DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 12:04 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST; JOHN EIGHMY WEIGHER: TONY HANFE --------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW. FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NON, PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), LN, MANDIB SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), MAMMARY, FE14ALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV). OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: LIVER (LI), STOMACH, GL (ST), STOMACH, NONGL (SU) --------------------------------------------------------------------------------------------------------------- 512 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96041 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH- 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 8:59 PROSECTOR: TODD ACKER RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST.- JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0 ST --- ADRENAL (AD) .0654 .0308 t .0363 WEI BRAIN (BR) 1.8020 .8500 t 1.0000 WEI KIDNEY (KD) 1.8605 .8776 t 1.0325 WEI LIVER (LI) 10.2446 4.8324 t 5.6851 WEI OVARY (OV) .1083 .0511 t .0601 WEI SPLEEN (SP) .4309 .2033 t .2391 WEI THYMUS (TH) .2212 .1043 t .1228 WEI THYROID/PARATHYR (TT) .0158 .0075 t .0088 WEI ---------------------------------------------------------------------------------------------------------------- 0 BSE RVAT 10N S NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR CENTRILOBULAR -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MIN114AL AUDITORY SEB GL (AS) : -ONE EXAMINED,-PRESENT GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS ------- ----------------- 513 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96041 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 8:59 PROSECTOR: TODD ACKER RECORDER: WENDY CHER POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ---------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW. FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH). LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AD), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SX), MAMMARY, FEMALE (MF), URINARY BLADDER (UB). UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA ("), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR). ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SH), NERVE, S SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST). STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), IN, MANDIBULAR (MN), SALIV GLt HANDIB (SG), HARDERIAN GLAND (HG), SKIN (SK), MAMMARY, FEMALE (KF), URINARY BLADDER (UB), UTER CERVIX (CV), OVARY (OV), VAGINA (VA) ---------------------------------------------------------------------------------------------------------------- 514 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96042 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 2 DATE AND TIME OF NECROPSY: 12/02/98 12:00 PROSECTOR: TODD ACKER RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHKY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO-BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST ---- ADRENAL BRAIN KIDNEY LIVER OVARY JAD) (BR) (KD) (LI) (OV) .0619 2.0530 2.2573 13.7996 .1247 .0271 % .8973 % .9866 % 6.0313 % .0545 % .0302 1.0000 1.0995 6.7217 .0607 WEIG WEIG WEIG WEIG WEIG SPLEEN (SP) .4886 .2135 % .2380 WEIG THYMUS (TH) .2500 .1093 t .1218 WEIG THYROID/PARATHYR (TT) .0203 .0089 t .0099 WEIG ----------------------------------------------------------------------------------------------------------------- 0 BS E RVAT 10N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -PIGMENT, HEPATOCELLULAR,-MINI14AL KIDNEY (KD) : -INFLAMMATION, CHRONIC,-MINIMAL THYMUS (TH) : -HEMORRHAGE.-MINIHAL STOMACH, GL (ST) : -EROSION,-MINIMAL GENERAL COMMENT (GC) -BONE HARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS ------ --------------------------- ---- 515 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- AN114AL NUMBER: C96042 SEX: FE14ALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED. TERMINAL SACRIFI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT; 228 DATE AND TIME OF NECROPSY: 12/02/98 12:00 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FLX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNRE14ARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO). RECTUM (RE), LN, KANDIBULAI SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA ("), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD ISC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES). HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIAT SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, 14ANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SES GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVA VAGINA (VA) ------------------------------------------------------------------------------------------------------------------ 516 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96043 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 21 DATE AND TIME OF NECROPSY: 12/02/98 B:54 PROSECTOR: NANCY DIEDRICH RECORDER: STEVE VAN AD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT It) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ----- ADRENAL (AD) .0754 .0345 t .0314 WEIGH BRAIN (BR) 2.0160 .9235 t 1.0000 WEIGH KIDNEY (KD) 2.1708 .9944 t 1.0768 WEIGH LIVER (LI) 9.1440 4.1887 t 4.5357 WEIG OVARY (OV) .1120 .0513 % .0556 WEIGT SPLEEN (SP) .4212 .1929 % .2089 WEIGT THYMUS (TH) .2302 .1055 t .1142 WEIGI THYROID/PARATHYR (TT) .0191 .0087 % .0095 WEIG ---------------------------------------------------------------------------------------------------------------- 0BS ERV AT 10N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -INFILTRATE, LYMPHOHISTIOCYTIC,-HINIKAL THYROID (TY) : -CYST, ULTIHOBRANCHIAL,-PRESENT STOMACH, GL (ST) -DARK FOCUS(I)/AREA(S); MUCOSA.- MULTIPLE DARK BROWN AREAS, STOMACH. GL (ST) : -EROSION,-MINIHAL UP TO 4 X 2 MM GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - 517 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULPONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96043 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIP DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 21 DATE AND TIME OF NECROPSY: 12/02/98 8:54 PROSECTOR: NANCY DIEDRICH RECORDER: STEVE VAN AD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES). LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, SK NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (14A), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), LN. MANDIBULAR (MN), SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). MAMMARY, FE14ALE (MP). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV). VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), HARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES). KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SH), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC) ADRENAL, MEDULLA (14A), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA). DUODENUM (DU), JEJ ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIS (SG), HARDERIAN GLJ AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (HF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVA "GINA (VA) ------------------------------------------------------------------------------------------------------------------ 518 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONA,MIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96044 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 26 DATE AND TIME OF NECROPSY: 12/02/98 12:19 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R STA ----- ADRENAL (AD) .0833 .0319 t .0381 WEIGH BRAIN (BR) 2.1839 .8367 t 1.0000 WEIG KIDNEY (KD) 2.4878 .9532 t 1.1392 WEIGH LIVER (LI) 14.4761 5.5472 t 6.6295 WEIGH OVARY (OV) .1201 .0460 t .0550 WEIGH SPLEEN (SP) .5592 .2143 t .2561 WEIGH THYMUS (TH) .2968 .1137 t .1359 WEIGH THYROID/PARATHYR (TT) .0194 .0074 t .0089 WEIG ------------------------------------------------------------------------------------------------------------------ 0B SE RVAT 10N S NECROPSY HISTOPATHOEOGY --------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,- -INFILTRATE. LYMPHOHISTIOCYTIC,-MINIMAL HEART (HT) : -DEGENERATION/NECROSIS,-MINIKAL THYMUS (TH) : GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN -HEMORRRAGE,-MININAL -NO MACROSCOPIC LESIONS - - - - - - - - - - - -- - -- - - -- - - - -- - -- - -- - - - -- - - 519 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96044 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: FEMALE STUDY DAY OF 12/02/90 12:19 DOSE GROUP: 4 SACRIFICE DEATH: 93 STUDY WEEK OF DEATH: PROSECTOR: TODD ACKER STATUS: 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 2 RECORDER: WENDY CHERR POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), IN, MANDIBUU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FE14ALE (MF), URINARY BLADDER (UB), UTERUS (UT). CERVIX (CV), OVARY (OV). VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB)o EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), MUSCLE, SKELETAL (SH), NERVE, SCI SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LoN, MANDIBULAR (NN), SALIV GL, MANDIB (SG), HARDERIAN G AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT). CERVIX (CV), OVi VAGINA (VA) ----------------------------------------------------------------------------------------------------------------- 520 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYI. PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ AN114AL NUMBER: C96045 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 25 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROpsy: STUDY DAY OF DEATH: 93 12/02/98 9:47 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WIL POST-FIX WEIGHERI NOT AVAILABLE . PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ----- ---------------------- ADRENAL (AD) .0862 .0343 t .0416 WEIG BRAIN (BR) 2.0735 .8248 % 1.0589 t 1.0000 1.2839 WEIGH WEIGH KIDNEY (KD) LIVER (LI) 2.6621 11.5067 4.5770 t 5.5494 WEIG OVARY (OV) .1738 .0691 % .0838 WEIGH SPLEEN (SP) .5999 .2386 t .2893 WEIG THYMUS (TH) .2968 .1181 % .1431 WEIGH THYROID/PARATHYR (TT) .0316 .0126 % .0152 WEIGH ----------------------------------------------------------------------------------------------------------------- 0 BSER VAT 10N S NECROPSY HISTOPATHOLOGY ----------------------------------------------------------------------------------------------- -------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR.- -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIHAL PANCREAS (PA) : -ATROPHY, ACINAR,-MINIMAL -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL AUDITORY SEB GL (AS) :' -ONE EXAMINED,-PRESENT UTERUS (UT) : -DILATATION,-SLIGHT OVARY (OV) i -DIFFUSELY RED; BILATERAL OVARY (OV) t >UNREMARKABLE GENERAL COMMENT (GC) i -BONE MARROW SHEAR TAKEN ----- --------------------------------- 521 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96045 SEX: FE14ALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 2 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WI DATE AND TIME OF NECROPSY: 12/02/98 9:47 PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD P-O-S-T--F-I-X- -W-E-I-GH-E-R-:---NO-T---AV-A-I-LA-B-L-E------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). HARROW, FEMUR (FM), MARROW, STERNUM ISE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH. GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FE14ALE (MF), URINARY BLADDER (UB), UTERUS (UT). CERVIX (CV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (BY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM) NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH). LN. NESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (14A), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGI DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (NN), SALIV GL, HANDIB (SG), HARDERIAN GLAND (HG), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), CERVI --------V-A-GI-N-A---(-VA-)--------------------------- ------------------------------------------------------------------ 522 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANI14AL NUMBER: C96046 SEX-. FE14ALE STUDY DAY OF DEATH; DOSE GROUP: 4 SACRIFICE STATUS: 93 STUDY WEEK OF DEATH: 14 SCHEDULED. TERMINAL SACRIF TERMINAL BODY WEIGHT: 26 RECORDER: TERRI L. WIL DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: 12/02/98 10:42 PROSECTOR: NANCY DIEDRICH WEIGHER: TONY HANFELD POST-FLX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY ------------------------------------------------------------------------------- -------- ------------------------ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) To BODY WEIGHT -------- WEIGHT RATIO -------- STA -- -- - ---------------------ADRENAL (AD) -------.0612 .0229 % .7865 % .0292 1.0000 WEIG WEIG BRAIN (BR) 2.0991 2.2050 .8262 t 1.0505 WEIG KIDNEY (KD) 11.8714 4.4479 % 5.6555 WEIG LIVER (LI) .1311 .0491 % .0625 WEIG OVARY (OV) .5352 .2005 t .2550 WEIG SPLEEN THYMUS (SP) (TH) .3266 .1224 t .1556 .0089 WEIG WEIG -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-)--------------.-0-18-6--------------------.-0-0-70---t--------------------------------------- 0 BSE RV NECROPSY --------------------------------------------------------------- A HISTOPATHOLOGY ------ -------------------------------------- LIVER (LI) -HYPERTROPHY, -INFILTRATE, HEPATOCELLULAR, CENTRILOBULAR, LYMPHOHISTIOCYTIC,-MINIKAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS ------ ---------------------- --------- 523 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESUI,FONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96046 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: SEX: FEMALE STUDY DAY OF 12/02/98 10:42 DOSE GROUP: 4 SACRIFICE DEATH: 93 STUDY WEEK OF DEATH: PROSECTOR: NANCY DIEDRICH STATUS; 14 SCHEDULED, TERMINAL SACRI TERMINAL BODY WEIGHT: 2 RECORDER: TERRI L. WI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ----------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA). AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBUL SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS). SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE). MARROW, FEMUR (FM), NARROW. STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM) NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST)o STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT). CERVIX (CV), OVARY (OV), VAGINA (VA) ----------------------------------------------------------------------------------------------------------------- 524 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYG PERFLUOROOCTANESUI,FONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANI14AL NUMBER: C96047 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 21 DATE AND TIME OF NECROPSY: 12/02/98 11:53 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT -------- WEIGHT RATIO -------- STA ----- ADRENAL (AD) .0586 .0275 % .0281 WEIGH BRAIN (BR) 2.0822 .9762 % 1.0000 WEIG KIDNEY (KD) 2,3414 1.0977 t 1.1245 WEIG LIVER (LI) 12.2355 5.7363 t 5.8762 WEIGH OVARY (OV) .1156 .0542 'k .0555 WEIGH SPLEEN (SP) .4873 .2285 % .2340 WEIG THYMUS (TH) .33B8 .1588 % .1627 WEIGH THYROID/PARATHYR (TT) .0191 .0090 % .0092 WEIG ------------------------------------------------------------------------------------------------------------------ 0 BSE RVAT 10N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LUNG (LU) : -INFILTRATE, MACROPHAGE, ALVEOLAR,-MINIMAL LIVER (LI) -DIFFUSELY DARK; ALL LOBES: DARK BROWN LIVER (LI) : -HYPERTROPHY, -INFILTRATE, HEPATOCELLULAR, CENTRILOBULAR.- LYMPHOHISTIOCYTIC,-MINIMAL -PIGMENT, HEPATOCELLULAR,-MINIHAL THYROID (TY) : -CYST, UGTIMOBRANCHIAL,-PRESENT UTERUS (UT) -LUNEN FILLED WITH FLUID; BILATERALT CLEAR FLUID UTERUS (UT) : -DILATATION,-SLIGHT GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN - - - - - - - - -- - -- - -- -- - - - -- -- - - - - - - - - - -- - 525 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE. T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96047 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIE DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 21 DATE AND TIME OF NECROPSY: 12/02/98 11:53 PROSECTOR: NANCY DIEDRICH RECORDER: TERRI L. WI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), t4ARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SH), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL. MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBULJ SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MP), URINARY BLADDER (UB), CERVIX (CV), OVARY (OV). VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), TRACHEA (TR). ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SH), NERVE, SC SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), PARATHYROID (PT), ADRENAL. CORTEX (AC), ADRENAL, MEDULLA AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE). LN. MANDIBULAR (MN), SALIV GL, HANDIB (SG), HARDERIAN G AUDITORY SEB GL (AS), SKIN (SK), MAMMARY. FEMALE (HF). URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAG ----------------------------------------------------------------------------------------------------------------- 526 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFGUOROOCTANESUGFONAMIDD TOXICITY STUDY WITH N-METHYL ETHANOI, (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96048 SEX- FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 22 DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. WIL DATE AND TIME OF NECROPSY: 12/02/98 10:40 PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-V-AI-L-A-B-LE-------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT (ft) -------- WEIGHT RATIO -------- STA ----- ---------------------- -------- ADRENAL (AD) .0851 .0380 t .9416 t .0404 1.0000 WEIGH WEIGH BRAIN (BR) KIDNEY (KD) 2.1074 2.3036 1.0293 t 1.0931 WEIG LIVER (LI) 13.9635 6.2393 t .0777 t 6.6259 .0825 WEIG WEIG OVARY (OV) SPLEEN (SP) .1738 .5093 .2276 t .1328 t .2417 .1410 WEIG WEIGH THYMUS (TH) .2971 .0252 .0113 t .0120 WEIG -------T-H-YR-O-I-D-/P-A-R-A-TH-Y-R-----(-T-T-) ------------------------------------------------------------------------------------ 0B SE RVAT 10N S NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------- ---------------------------------------- BRAIN (BR) : -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIHAL LUNG (LU) : -INFLAMMATION, SUBACUTE.-MINIKAL LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR. CENTRILOBULAR,- -PIGMENT, HEPATOCELLULAR,-MINIHAL -VACUOLATION, HEPATOCELLULAR, CENTRILODULAR MINIMAL KIDNEY (KD) -MINERALIZATION, TUBULAR.-HINIHAL THYROID (TY) : -CYST. ULTIMOBRA14CHIAL,-PRESENT HARDERIAN GLAND (HG) : -INFILTRATE, LYHPHOHISTIOCYTIC,-MINIMAL OVARY (OV) -DIFFUSELY RED; BILATERAL: DARK RED OVARY (OV) : >UNREMARKABLE 527 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96048 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE kND TIME OF NECROPSY: 12/02/98 10:40 PROSECTOR: KIMBERLY DURLAND RECORDER: TERRI L. W POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFEL ------------------------------------------------------------------------------------ -------------------------- 0 B S E R V A T 1 0 N S (CONTINUED) NECROPSY HISTOPATHOLOGY ------------------------------------------------------------------------------------------------------------- GENERAL COMMENT (GC) : -BONE KARROW SMEAR TAKEN - -THE- FO-LLO-WING- O-RGAN-S -WER-E -UNRE-MARK-ABLE- -AT -NEC-ROPS-Y: - - - - - - - - - - - - - - - - - - - BONE, FEMUR (FE), HARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC). ADRENAL, MEDULLA (KA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE). LN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (US), UTERUS (UT), CERVIX (CV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: . BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE STERNUM (SB), EYE (EY). SPINAL CORD (S TRACHEA (TR), ESOPHAGUS (ES), HEART (HT). MUSCLE. SKELETAL (SM), NERVE, SCIATIC (SN). SPLEEN (SP), THYMU LN, HESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITAR STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE COLON (CO). RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), AUDITORY SEB OL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), VAGINA (VA) ---------------------------------------------------------------------------------------------------------------- 528 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYT PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96049 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 19 DATE AND TIME OF NECROPSY: 12/02/98 10:55 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WIL POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY RANFELD ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT -------- WEIGHT RATIO -------- STA ----- ADRENAL (AD) .0539 .0282 t .0297 WEIGIV BRAIN (BR) 1.8149 .9482 % 1.0000 WEIGH KIDNEY (KD) 1.7670 .9232 % .9736 WEIGH LIVER (LI) 10.6923 5.5864 % 5.8914 WEIGH OVARY (OV) .0973 .0508 % .0536 WEIGH SPLEEN (SP) .4078 .2131 % .2247 WEIGH THYMUS (TH) .2422 .1265 % .1335 WEIGH THYROID/PARATHYR (TT) .0173 .0090 % .0095 WEIGH ---------------------------------------------------------------------------------------------------------------- 0B SE RVAT 10N S NECROPSY HISTOPATHOLOGY --------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR.- -PIGMENT, HEPATOCELLULAR.-HINIMAL STOMACH, GL (ST) -DARK FOCUS(I)/AREA(S); MUCOSA: MULTIPLE DARK BROWN AREAS, STOMACH, GL (ST) -EROSION,-SLIGHT UP TO 5 X 1 MM GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -TAIL - BENT/MISSING; TIP: MISSING; REMAINING PORTION COLLECTED - - - - - - - - - -- - - - - - - - -- - - - - - - - - - - - - - -- - - 529 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOITOOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBERT C96049 DATE OF DEATH: 12/02/98 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 10:55 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. W POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFEL ---------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE. FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI). STOMACH, NONGL (SU), PANCREAS DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, KANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV). OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: . BONE, FEMUR (FE), MARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN. MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN. MANDIBULAR (MN), SALIV GL, MANDIB (SG). HARDERIAN GliAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV). OVARY (OV), VAGINA (VA) ---------------------------------------------------------------------------------------------------------------- 530 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MtFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANI14AL NUMBER: C96050 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRI STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 2 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: STUDY DAY OF DEATH: 93 12/02/98 11:40 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. WI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ----------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT -------- WEIGHT RATIO -------- ST ---- ---------------------- -------- ADRENAL (AD) .0634 .0292 .0313 WEIG BRAIN (BR) KIDNEY (KD) 2.0287 1.9598 .9357 .9040 5.9174 1.0000 .9660 6.3237 WEIG WEIG WEIG LIVER (LI) 12.8289 .0985 .0454 t .0486 WEIG OVARY (OV) .3976 .1834 % .1960 WEIG SPLEEN THYMUS (SP) (TH) .1845 .0851 % .0909 WEIG THYROID/PARATHYR (TT) .0195 .0090 t .0096 WEIG --------------------------------------------------------------------------------------------------------------- 0B SERV AT 10N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -INFILTRATE, LYMPHOHISTIOCYTIC,-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -PIGMENT, HEPATOCELLULAR,-MINIMAL GENERAL COMMENT (GC) -BONE 14ARROW SMEAR TAKEN - -N-O M-ACRO-SCO-PIC - L-ESI-ONS - - - - -- - - - - - - --- -- -- - -- - - - - - - - - - 531 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-HETHYL PERFI.UOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ---------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96050 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACR DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH- 14 TERMINAL BODY WEIGHT: DATE AND TIME OF NECROPSY: 12/02/98 11:40 PROSECTOR: GREGORY CODDINGTON RECORDER: TERRI L. W POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFEL ---------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (KA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL). CECUM (CE), COLON (CO), RECTUM (RE), IN, MANDIBU SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FE14ALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), DONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SH NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS). THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONG PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBU SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) ---------------------------------------------------------------------------------------------------------------- 532 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL JN-NEFOSE, T-6314) IN RATS ----------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96051 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 1 DATE OF DEATH: 10/01/98 DATE AND TIME OF NECROPSY: STUDY 10/01/98 DAY OF DEATH: 31 11:19 PROSECTOR: MATTHEW PATHOLOGIST: JOHN AXTMAN HIGHMY RECORDER: KEVIN BILLI WEIGHER: MICHELE ZIMA P-O-S-T--F-I-X---W-EI-G-H-E-R:---N-O-T--A-V-AI-L-A-B-LE-------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST ---- ---------------------- --------------- -------- -------- NOT ADRENAL (AD) -------- -------- -------- NOT BRAIN (BR) -------- -------- -------- NOT KIDNEY (KD) LIVER (LI) 8.8661 -------- 4.8904 -------- --------------- WEIG NOT OVARY (OV) -------- -------- -------- NOT SPLEEN (SP) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT -------TH-Y-R-O-ID-/-P-A-RA-T-H-Y-R-----(-TT-)-------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, S NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, NESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU). JEJUNUM (JE), ILEUM (IL), CECUM (CE). , COLON (CO), RECTUM (RE), LN, MANDIBU SALIV GL, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS) SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT). CERVIX (CV), OVARY (OV). VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) ------- ------------------------------------------------------------------------------------------------------- 533 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE. T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96052 DATE OF DEATH: 10/01/98 SEX: FEMALE STUDY DAY OF DEATH: DOSE GROUP: 4 31 STUDY WEEK SACRIFICE STATUS: OF DEATH: 5 SCHEDULED, FIRST INTERIM S) TERMINAL BODY WEIGHT: 20 DATE AND TIME OF NECROPSY: 10/01/98 11:52 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLIN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIHA ------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ----- ---------------------- -------- -------- -------- NOT T ADRENAL (AD) -------- -------- -------- NOT TJ BRAIN (BR) KIDNEY (KD) -------- -------4.4248 t --------------- NOT TJ WEIGH LIVER (LI) 8.9691 -------- -------- -------- NOT TA OVARY (OV) -------- -------- -------- NOT T SPLEEN (SP) -------- -------- -------- NOT T, THYMUS (TH) THYROID/PARATHYR (TT) -------- -------- -------- NOT T ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). t4ARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP). THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY). PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), "GINA (VA), TAIL (TI), GENERAL COMMENT (GC) ---------------------------------------------------------------------------------------------------------------- 534 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYT ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96053 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM S) STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 191 DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 PROSECTOR: WENDY CHERRY RECORDER: KEVIN BILLIN( DATE AND TIME OF NECROPSY: 10/01/98 11:55 PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA P-O-S-T--F-I-X---WE-I-G-H-ER-:---N-O-T--A-V-AI-L-A-B-LE--------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT (t) -- ----- WEIGHT RATIO ----- --- STA ----- ---------------------- --------------- -------- -------- NOT T ADRENAL (AD) -------- -------- -------- NOT T BRAIN (BR) -------- -------- NOT T KIDNEY (KD) 8.3894 4.3924 % -------- WEIGW LIVER (LI) -------- ------ -------- NOT TJ OVARY (OV) -------- -------- -------- NOT Ti SPLEEN (SP) -------- -------- -------- NOT TA THYMUS (TH) -------- NOT T THYROID/PARATHYR (TT) ----------------------------------------------------------------- -------- --------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM). MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC). LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, SK NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH). LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY , (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE). ILEUM (IL), CECUM (CE) COLON (CO). RECTUM (RE). LN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (HF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA). TAIL (TI), GENERAL COMMENT (GC) -------- ------------ -------------------------------------------------------------------------------------------- 535 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-HEFOSE, T-6314) IN RATS --------------------------------------7--------------------------------------------------------------------------- ANIMAL NUMBER: C96054 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, FIRST INTERIM S DATE OF DEATH: 10/01/98 STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 18 DATE AND TIME OF NECROPSY: 10/01/98 11:16 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLIN POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIMA ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STA ----- ADRENAL (AD) -------- -------- -------- NOT T BRAIN (BR) -------- -------- -------- NOT T KIDNEY (KD) -------- -------4.2946 --------------- NOT WRIG LIVER (LI) OVARY (OV) 8.0181 -------- -------- -------- NOT SPLEEN (SP) -------- -------- -------- NOT THYMUS (TH) -------- -------- -------- NOT THYROID/PARATHYR (TT) -------- -------- -------- NOT --------------------------------------:---------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN). SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS). THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), IN, HANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (KF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV). OVARY (OV), VAGINA (VA), TAIL (TI). GENERAL COMMENT (GC) ------------------------------------------------------------------------------------------------------------------ 536 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96055 DATE OF DEATH: 10/01/98 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS% SCHEDULED, FIRST INTERIM SAC STUDY DAY OF DEATH: 31 STUDY WEEK OF DEATH: 5 TERMINAL BODY WEIGHT: 178. DATE AND TIME OF NECROPSY: 10/01/98 11:28 PROSECTOR: TONY HANFELD RECORDER: KEVIN BILLINGI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: MICHELE ZIKA -------------------------------------------------------------------------------------------------------------------- ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0 RG ORGAN NAME ---------------------- (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- STAI ------- ADRENAL (AD) -------- -------- -------- NOT TA) BRAIN (BR) -------- -------- -------- NOT TAI KIDNEY (KD) -------- -------- -------- NOT TA LIVER (LI) 7.0851 4.4075 t -------- WEIGHT OVARY (OV) -------- -------- -------- NOT TA SPLEEN (SP) -------- -------- -------- NOT TA THYMUS (TH) -------- -------- -------- NOT TA THYROID/PARATHYR (TT) -------- -------- -------- NOT TA ------------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT). MUSCLE, SKE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE), LN, MANDIBULAR SALIV GL, HANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI), GENERAL COMMENT (GC) ------------------------------------------------------------------------------------------------------------------- 537 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESUUFONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ AN114AL NUMBER; C96056 DATE OF DEATH: 12/02/9B SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 20 DATE AND TIME OF NECROPSY; 12/02/98 9:49 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT -------- WEIGHT RATIO -------- STA ----- ---------------------- ADRENAL (AD) .0720 .0344 % .0368 WEIGH WEIGir BRAIN (BR) 1.9559 1.9486 .9345 t .9310 t 1.0000 .9963 WEIGif KIDNEY (KD) 12.3563 5.9036 t 6.3175 WEIGW LIVER (LI) .1065 .0509 t .0545 WEIGtr OVARY (OV) SPLEEN (SP) .4034 .1927 % .2062 WEIGtf THYMUS (TH) THYROID/PARATHYR (TT) .2087 .0187 .0997 % .0089 % .1067 .0096 WEIGH WEIGH ------------------------------------------------------------------------------------------------------------------ 0 B S E RV A T 1 0 N S HISTOPATHOLOGY ---------------------------N-E-C-R-O-P-S-Y----------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR,- -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIKAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -VACUOLATION, HEPATOCELLULAR, CENTRILOSULAR MINIMAL THYMUS (TH) -HEMORRHAGE.-MINIMAL UTERUS (UT) : -DILATATION.-SLIGHT GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN -NO MACROSCOPIC LESIONS ------ ----- ---- 538 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96056 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 20 DATE AND TIME OF NECROPSY: 12/02/98 9:49 PROSECTOR: TODD ACKER RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE). MARROW, FE.MUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR). SPINAL CORD (SC), LUNG (LU) TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (HA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE). LN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG). AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV). OVARY (OV), VAGINA (VA). TAIL (TI) THE FOLLOWING TISSUES WERE UNRE14ARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), HARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB) EYE (Ek). BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART *(HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, MESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU). PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN), SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY. FEMALE (HP). URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (VA) ------------------------------------------------------------------------------------------------------------------ 539. APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96057 SEX: FE14ALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 25 DATE AND TIME OF NECROPSY: 12/02/98 8:39 PROSECTOR: GREGORY CODDINGTON RECORDER: STEVE VAN Al POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0R ST ----- ADRENAL (AD) .0614 .0245 t .0280 WEIG BRAIN (BR) 2.1920 .8750 t 1.0000 WEIG KIDNEY (KD) 2.2779 .9093 t 1.0392 WEIG LIVER (LI) 13.2419 5.2862 % 6.0410 WEIG OVARY (OV) .1134 .0453 t .0517 WEIG SPLEEN (SP) .3561 .1422 % .1625 WEIG THYMUS (TH) .2704 .1079 % .1234 WEIG THYROID/PARATHYR (TT) .0195 .0078 % .0089 WEIG ----------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S NECROPSY HISTOPATHOLOGY -------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, CENTRILOBULAR, -INFILTRATE, LYMPHOHISTIOCYTIC.-MINIMAL -NECROSIS, INDIVIDUAL HEPATOCYTE,-MINIMAL -PIGMENT, HEPATOCELLULAR,-MINIMAL KIDNEY (KD) : -MINERALIZATION, TUBULAR,-MINIMAL THYMUS (TH) : -INVOLUTION.-MIN114AL STOMACH, GL (ST) -DARK FOCUS(I)/AREA(S); MUCOSA: MULTIPLE BROWN AREAS, UP TO STOMACH, GL (ST) >UNRE14ARKABLE 3 X 1 MM UTERUS (UT) -DILATATION,-MINIMAL GENERAL COMMENT (GC) -BONE MARROW SMEAR TAKEN - - - - - - - - - -- -- - - - - - - - - - -- - - - - -- - -- - -- - - 540 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOC,RANESUI@FONAMIDO ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96057 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIPI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 250 DATE AND TIME OF NECROPSY: 12/02/98 8:39 PROSECTOR: GREGORY CODDINGTON RECORDER: STEVE VAN ADE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), NARROW, STERNUM (SE), BONE, STERNUM (SB) EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI). KIDNEY !KD), HEART (HT), MUSCLE, SKE NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH)t LN, MESENTERIC (MS)t THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA) DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (MN). SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FE14ALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE). BONE, STERNUM (SB), EYE (EY). BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATI SPLEEN (SP). LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL. CORTEX (AC), ADRENAL, MEDULLA AORTA (AO), PITUITARY (PI), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR (NN), SALIV GL, HANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), CERVIX (CV), OVARY (OV). VAGIN ------------------------------------------------------------------------------------------------------------------- 541 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS -------- --------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96058 DATE OF DEATH: 12/02/98 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 SCHEDULED, TERMINAL SACRIF TERMINAL BODY WEIGHT: 24 DATE AND TIME OF NECROPSY: 12/02/98 7:55 PROSECTOR: LAURIE J. SCHULLER RECORDER: STEVE VAN AD POST-FIX WEIGHER. NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) -------- TO BODY WEIGHT (t) -------- WEIGHT RATIO -------- ST A ----- ---------------------- ADRENAL (AD) .0527 .0214 t .0253 WEIG BRAIN (BR) 2.0848 .8451 t 1.0000 WEIGH KIDNEY (KD) 2.0803 .8433 t .9978 WEIGH LIVER (LI) 11.7380 4.7580 t 5.6303 WEIG OVARY (OV) .0992 .0402 t .0476 WEIG SPLEEN (SP) .5123 .2077 t .1106 t .2457 .1309 WEIGH WEIG THYMUS (TH) THYROID/PARATHYR (TT) .2728 .0157 .0064 % .0075 WEIG --------------------------------------------------------------------- ---------------------------------------- 0B SERVA T 10N S NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------- ---------------------------------------- LIVER (LI) - -HYPERTROPHY, HEPATOCELLULHR. DIFFUSE,-SLIGHT THYMUS (TH) : -HEMORRHAGE.-MINIMAL -INVOLUTION,-MINI14AL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT PANCREAS (PA) : -INFILTRATE, LYMPHOHISTIOCYTIC.-MIMIMAL LN, MANDIBULAR (NN) : -HEMORRHAGE,-MINIHAL GENERAL C014MENT (GC) -BONE MARROW SMEAR TAKEN GENERAL INFORMATION (XX) >NOTE:>ANIKAL NECROPSIED OUT OF ORDER DUE TO MORIBUND CONDITION FOLLOWING BLOOD COLLECTION - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - -- - 542 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-HEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C9605B SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 24 DATE AND TIME OF NECROPSY: 12/02/98 7:55 PROSECTOR: LAURIE J. SCHULLER RECORDER: STEVE VAN AD POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHHY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------ THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (SR), SPINAL CORD (SC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SK NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, HESENTERIC (MS), THYROID (TY), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (14A), AORTA (AO). PITUITARY (PI), STOMACH, GL (ST), STOMACH. NONGL PANCREAS (PA). DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL, MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (HP), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA). TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR). ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM), NERVE, SCIATIC (SN), SPLEEN (SP), LN, NESENTERIC (MS), PARATHYROID (PT), ADRENAL, CORTEX (AC), ADRENAL, Mi AORTA (AO), PITUITARY (PI). STOMACH, GL (ST), STOMACH, NONGL (SU), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL) CECUM (CE), COLON (CO), RECTUM (RE), SALIV Gl,, MANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), S MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA) ---------------------------------------------------------------------------------------------------------------- 543 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYI, ETHANOL IN-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96059 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI DATE OF DEATH: 12/02/98 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 207 DATE AND TIME OF NECROPSY: 12/02/98 8:25 PROSECTOR: JODI THIEREN RECORDER: STEVE VAN ADE POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------- ORGAN NAME ---------------------- ABSOLUTE ORGAN WEIGHT (GRAMS) -------- ORGAN WEIGHT RELATIVE TO BODY WEIGHT (t) -------- ORGAN TO BRAIN WEIGHT RATIO -------- 0 RG STA ------ ADRENAL (AD) .0551 .0265 t .0275 WEIGHT BRAIN (BR) 2.0062 .9650 t 1.0000 WEIGHT KIDNEY (KD) 2.0576 .9897 t 1.0256 WEIGHT LIVER (LI) 11.4068 5.4867 t 5.6858 WEIGHT OVARY (OV) .1254 .0603 t .0625 WEIGHT SPLEEN (SP) .4387 .2110 t .2187 WEIGHT THYMUS (TH) .1931 .0929 t .0963 WEIGHT THYROID/PARATHYR (TT) .0137 .0066 t .0068 WEIGHT ------------------------------------------------------------------------------------------------------------------- 0 BS ERVA T10N S NECROPSY HISTOPATHOLOGY ---------------------------------------------------------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY, HEPATOCELLULAR, -PIGMENT, HEPATOCELLULAR.-MINIMAL THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT UTERUS (UT) : -DILATATION,-SLIGHT CENTRILOBULAR.-M GENERAL COMMENT (GC) -BONE MARROW SHEAR TAKEN -NO MACROSCOPIC LESIONS - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - -- - - - - - 544 Individual APPENDIX Anatomic 6 Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-NEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------- ANIMAL NUMBER: C96059 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFI DATE OF DEATH: 12/02/9B STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 207 DATE AND TIME OF NECROPSY: 12/02/98 8:25 PROSECTOR: JODI THIEREN RECORDER: STEVE VAN ADI POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: TONY HANFELD ------------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY; BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR). SPINAL CORD ISC), LUNG (LU). TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKI NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (HS). THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULA SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FE14ALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA (VA), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE). KARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SM) NERVE. SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (HS), PARATHYROID (PT). ADRENAL, CORTEX (AC; ADRENAL, MEDULLA (HA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE). COLON (CO), RECTUM (RE). LN, MANDIBULAR (MN). SALIV GL. MANDIB (SG), HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FE14ALE (MF), URINARY BLADDER (UB), CERVIX (CV), OVARY (OV), VAGINA (") ------------------------------------------------------------------------------------------------------------------ 545 APPENDIX 6 Individual Anatomic Pathology Data 13-WEEK DIETARY TOXICITY STUDY WITH N-METHYL PERFLUOROOCTANESULFONAMIDO ETHANOL (N-MEFOSE, T-6314) IN RATS ------------------------------------------------------------------------------------------------------------------ ANIMAL NUMBER: C96060 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIF STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 24 DATE OF DEATH: 12/02/98 DATE AND TIME OF NECROPSY: STUDY DAY OF DEATH: 93 12/02/98 12:19 PROSECTOR: MICHELE ZIHA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER ------------------------------------------------------------------------------------------------------------------ ABSOLUTE ORGAN WEIGHT ORGAN WEIGHT RELATIVE ORGAN TO BRAIN 0R ORGAN NAME (GRAMS) TO BODY WEIGHT -------- WEIGHT RATIO -------- STA ----- ---------------------- -------- ADRENAL (AD) BRAIN (BR) .0718 2.0579 2.5943 .0288 t .8245 t 1.0394 t .0349 1.0000 1.2607 WEIGtf WEIGH WEIGH KIDNEY (KD) LIVER (LI) 13.5240 5.4183 t 6.5717 WEIGH .1100 .0441 t .0535 WEIGH OVARY (OV) SPLEEN (SP) .4646 .1861 t .2258 WEIGH THYMUS (TH) .3518 .1409 t .0125 % .1710 .0152 WEIG WEIG THYROID/PARATHYR (TT) .0313 ---------------------------------------------------------------------------------------------------------------- 0 B S E R V A T 10 N S HISTOPATHOLOGY NECROPSY ----------------------------------------------- ---------------------------------------------------------------- LIVER (LI) : -HYPERTROPHY. HEPATOCELLULAR, CENTRILOBULAR.- THYROID (TY) >NOTE:>TRIMMING COMMENT: ONE WET TISSUE AT TRIMMING PARATHYROID (PT) : >NOTE:>TRIMMING COMMENT: ONE THYROID/PARATHYROID THYROID/PARATHYROID NOT FOUND IN NOT FOUND IN THYROID (TY) : -CYST, ULTIMOBRANCHIAL,-PRESENT -ONE EXAMINED.-PRESENT PARATHYROID (PT) : -ONE EXAMINED,-PRESENT WET TISSUE AT TRIMMING GENERAL COMMENT (GC) : -BONE MARROW SMEAR TAKEN - -N-O M-ACRO-SCO-PIC - L-ESI-ONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 546 APPENDIX 6 individual Anatomic Pathology Data 13-WEEK DIETARY PERFLUOROOCTANESULFONAMIDO TOXICITY STUDY WITH N-METHYL ETHANOL (N-MEPOSE, T-6314) IN RATS -------------------------------------------------------------------------------------------------------------------- ANI14AL NUMBER: C96060 SEX: FEMALE DOSE GROUP: 4 SACRIFICE STATUS: SCHEDULED, TERMINAL SACRIFIC DATE OF DEATH: 12/02/90 STUDY DAY OF DEATH: 93 STUDY WEEK OF DEATH: 14 TERMINAL BODY WEIGHT: 249. DATE AND TIME OF NECROPSY: 12/02/98 12:19 PROSECTOR: MICHELE ZIMA RECORDER: WENDY CHERRY POST-FIX WEIGHER: NOT AVAILABLE PATHOLOGIST: JOHN EIGHMY WEIGHER: LYNN HORNER -------------------------------------------------------------------------------------------------------------------- THE FOLLOWING ORGANS WERE UNREMARKABLE AT NECROPSY: BONE, FEMUR (FE), MARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB), EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), LIVER (LI), KIDNEY (KD), HEART (HT), MUSCLE, SKEL NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, MESENTERIC (MS). THYROID (TY), PARATHYROID (PT). ADRENAL, CORTEX (AC), ADRENAL, MEDULLA (MA), AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (S PANCREAS (PA), DUODENUM (DU), JEJUNUM (JE), ILEUM (IL), CECUM (CE), COLON (CO), RECTUM (RE), LN, MANDIBULAR SALIV GL, KANDIB (SG). HARDERIAN GLAND (HG), AUDITORY SEB GL (AS), SKIN (SK). MAMMARY, FE14ALE (MF). URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY (OV), VAGINA ("), TAIL (TI) THE FOLLOWING TISSUES WERE UNREMARKABLE AT MICROSCOPIC EXAMINATION: BONE, FEMUR (FE), KARROW, FEMUR (FM), MARROW, STERNUM (SE), BONE, STERNUM (SB). EYE (EY), BRAIN (BR), SPINAL CORD (SC), LUNG (LU), TRACHEA (TR), ESOPHAGUS (ES), KIDNEY (KD), HEART (HT), MUSCLE, SKELETAL (SH), NERVE, SCIATIC (SN), SPLEEN (SP), THYMUS (TH), LN, NESENTERIC (MS), ADRENAL, CORTEX (AC), ADRENAL, MEDULLA AORTA (AO), PITUITARY (PI), STOMACH, GL (ST), STOMACH, NONGL (SU), PANCREAS (PA), DUODENUM (DU), JEJUNUH (JE ILEUM (IL), CECUM (CE), COLON (CO). RECTUM (RE), LN, 14ANDIBULAR (MN), SALIV GL. MANDIS (SG), HARDERIAN GLAND AUDITORY SEB GL (AS), SKIN (SK), MAMMARY, FEMALE (MF), URINARY BLADDER (UB), UTERUS (UT), CERVIX (CV), OVARY "GINA (") -------------------------------------------------------------------------------------------------------------------- 547 APPENDEK7 Covance 6329-225 3M T-6314.1 CeU ProliferatiToinssueCollectionand InununohistochemicaElvaluation NOTE: Thisappendixof thereportcontainsinfomiatiosnuppuedby Pathology AssociatesInteniationalnd hasbeen reviewedby theQualityAssuranceUnit of PathologyAssociatesIntemationaL 548 Ccyvance6329-225 3M T-6314.1 CeU ProliferatioTnissue Collectionand InununohistochemicalEvaluation (tobe provided by Pathology AssociatesInternational) 549 APPENDEK8 Client-SupplieIdterrL% Covance 6329-225 3M T-6314.1 Note: Thisappendixcontainsinfonmtion suppliedby theSponsor and hasbeen reviewedby theQualityAssuranceUnit of [inserctlientname]. 550 CHent-SuppHed Items ---. --v -W-@ Covance 6329-225 3M T-6314.1 I 551 Covance isan independent,publicINh-eld compan%, operatingin over 15 countriesand over 30 offices worldwide,with headquartersin Princeton,New Jerse%*U,SA. Covance isthe markctln,-name forCovance Inc. and itssubsidiarieasround theworld,the principal ones of which arelisteodn thispacreT.he use of "Co-,,ancei"n thisreportrefersto one or more of theseand other subsidiaries. THEAMERICAS Princeton 1.800.773.0011 EUROPE Brussels +32.2.773.29.10 ASIA/PACIFIC Singapore +65.7747233 COVANCE LABORATORIES Madison, Wl. USA 888-541 -LABS (5227) Vienna.VA, USA 800-742-8378 Harrogate.UK Oil 44 1423 500011 Monster.Germany Oil 49 251 97980 c 0 V &NROOEC@O. THE DEVELOPMENT SERVICES COMPANY pol.rIeNUo.$ Shaping Solutions