Document z61VDnJqzy0722zB8aG25B1g

H sS pen a Mem, ARG-0253 TWO YEAR ORAL (DIET) TOXICITY / CARCINOGENICITY STUDY OF FLUOROCHEMICAL FM-3924 IN RATS (RIKER Experiment No. 0281CRO012) Conducted During April, 1981 - - May, 1983 Volume 2 of RIKER Laboratories, Inc. / 3M Company St. Paul, Minnesota 55144-1000 U.S.A. 01i338 InividSuusslnrRiazcerdoSsicnogple aTndabMliactreodsciopniaclOhRseaproarttions 3920: Tun YeRarikeOrralLbTaoaitcoirtiye-sG,neToicg.ici1ty Study in Rats Tate 2 fFaitne:d ONeasbteer:108() TTeHrainal SSeaxc:rifMiaclee Grow: (1 PII 0 pn MacrSostcionpic Bhservations: Piittuoirtary Wicrosrceopailc Observations: LEsiovheages PaPraantcrheyarsoid PiSatluiivtaarryySlant TShiynroid Trachen "RaSiusleldraciisrceudladrarlkesrieosn,, both hing feet. Fale ares, soe 98 of right kidhey. "oCotrtiscxaalnivnadc,wlsaitsisoinn,g local ares, aild ZrPaorrttaall obnilaenidculcetarprcleifleriantfiiolnt,ratsei,daild oeitnavrasaitnroep,hy,isasiilndg r "tiegm e-- l"aottoderaanaitniet,is,aisuslicnegrative, bilateral, sirked "tpt, submconal TShpeleefno,lloKeiidnngey,tisHseuaerst,wLrieng,fouTnedsttios/bEeiwdiitdhpians,noPrroastaltien,itsS:tomach, Urinary Bladder. Ffiotea:l GNeoetkbsert108R)7T6er2aiml SSeaxc:rifailcee Brot (3) PAYEE 30 pa WacSroiscnapic Ghservations: NicroHsecaarptic Ghserations: Liver Piutnugitary FrParesptttieal Slang Sle Inhfelaalsimneg,d esseiroona,l 1arceos.dia, parently "Wwpictairftoictails,, aclhdronic nonsppurtive, oHretpaatlocsystmeonvuaccloelaarticoenl,l sinlftiilftraactle,, saiinlidnal ""fraoscnlsar sineralization, ild J"rPorsetpattiiatlisa,dmwiatties,, ssocder,atewoderate "Hessigeross, iniasl TKhiefnefyo,lloTneisntgist/iEsisduiedsyawiesr,e fSotuonudcht,o bUeriwniatrhyinBlnaodrewral, Lhiiirtesm:l, Thyroid, Parathyroid, Trache, Esophages, Salivary Blane, Puneres. Psrpoejceiecst:ushahter: O28ICHNT2 001839 Suanrized STH Pages 163 354 SInudainvairdiuzaeld NiancgrloescoTpaibclaatneddMiMcnriossalcoRpaipc serv(caotnitoinnused FE: Tuo YeRairkeOrralLibTooriactiatryie-sG,ncIocg,eici3t0y Stdy in Fats Table: 2 nFiatees:] (Neabeetr:108I)RTTIeErSaiml SSeaxc:riMfailcee Grow: (1 FI-IF24 30 pn NacrPoisctoupiitcarDyiservations: Ricrohsacroepniacl Oservations: Heart LKiivterrey Lng pPaunrcartheyarsoid TFhiytriotiadry Trachea "sual dark are, ""PHhpecsacrhdriotnicsc,ytocnhsr,onbiecnisgonn,swupnuirlaattievrael, ~Cwhirtainfioccaplr,ogr1edssive nephropathy, anterate "FHeerptaatlocaytweomvcalcseoalraticoenl,l sinuflitlitfroactae,, wiilldd "VPaesrciuvlaasrculsairnesraolnioznactlieoanr, ianlfdiltrate, ald "Hheeitnaerxanaitnreodp,hy,notaadinerpaltaene of section Wdteinacoanranchial cyst "Tracheitis, chronic, wild TShpeleefna,lloTneisntgistEipsisudeisdpearse, fProousntatLeo,beStwoimatchhi,n UnorrimnaalryLiBnliatdse:r, Esophagus, Salivary Gland, fFantiee:al eNeabker:1083) 6Te4rminal SSaecs:rifMiaclee row (1 FIFA 30 pn MacrSosicnopic Goserationst PTihtyuaiutsary MieraMsacroepniacl Observations: heart Liver TM harathyroid Cifrocautlpaards.raised lesion, right and eit hind P"oSsuslibldyarkenlaarrig.ed "WSeitnusloliadrayl ceecltlashiyap,erscloarstiea,, lwoactailfoacraelas,, wwiilldd "Hwyistciafrotciatlis,, aclheronic novspurative, "FFoorrttaall abislmeondccletarprcoellilfeirnaftiilotnr,ataei,idwild ~Nieagsaclleacyrtossiinse,raillizdation wild Parledusons, interstitial, chronic, witifocal, PHeyrpbevrapslcaasliaar, sseopntoaalclceelwl,ifnofciallt,rawtieldinisal ot exaioed, not in plane of section sPpreocjieecst:NRaastbr: Z8ICHOL2 001840 355 Sumnarized STAR Page: 164 ISnudsiuvriidnuaeld RSainrgolsecoTpiaclaandticdrioascnopRieeprOtbse(rcvoanttiionnused) FARE Too YekrefralLaTboorsactiotryi-eGs,cogTecn,ici3t8y Stdy i Rats Tale: 2 Feaatel: tNhaebeir:10167T0er0sioal SSeaactriWfailcee Seow (9) PHST24 30 pn MicrosPciotpuiictaBryservations (antinued: PrSokisntate Toys Thyroid rpodsntoantsitis, scte, sorte JFottateerunaiiet,is,ntulicneraltaivne,ofbisleactteiroanl, marked erSpecltaiosniaof, veCscseall,1dfoaadli,posae16Liss. Wtitoraschial ost SThteeefno,loKniidnnegy,tsTseastssEwepriedfpoanid,toStbeonwciht,hinUrisnaoryalLaidmitrs,: Traches, Esohagus, Salivary land, Pacres. Fvietea:lhWeaers925 ) SacrificeSien eMxaltreesisrot (9 PI 30 pon -- Paitin Sin WicrLosicvoepric erations: frrese LGiivner Paucnrgess PaFriaatihtyirroyid tin Tetisfpidionis F Jair thingT in dorsal area. SlUiegrhstltyedpaLleesions, bath hind fotgas. oSitnussoxisdeailnnde,ctsisss,incguter, diffuse, soferate voarrticbpirloegrseastsivperomligfheorsaatitohny,, aanlimdal pFeerriavlascsulearnsonroncclelelwinifniflitlrtartaet,e,ssiniienl IJsoltetmacenlle,steanansdn plane of section "Fomtoodnssraatitis, ulcerative, sare rLeosps ,of iharratfeollicle snd piernal Hotthicnksenoineg,, faoirsaingkin, TShpeleefnl,loHseirntg,tiSstsouweisch,weinaforuyndBtloadbee,witPhrionstastoe,usThLyirmoiitds,: Traces, Slivary land. PSroocjieocst:aasthe: CZBICROIZ 001841 Sunriaed STH Page: 145 . 356 SIuabnividsuel SRTriionkseecpLTiabucslaawttdoerdNibee,iraolsncc,pBecar3Bt0.se(rattiionnes) Pat To Yeu BalTact Dcqeicity Stuy in ats Toe: 2 iFult Geeres106T) TTran SSaecirifilcee eos (9) AA 30 pa [e---- Ao vile esos. WcroVwiicotrsec thartion: rFoarntesrogrrssoioecsalefpilttr,atei, niod clytotlcdobidlse p,dctmasi,drlifarctli,on1, 616 Tryaiatnshoid JASarttacwshtoiinsnt,d,aariosnss,inggald hSSoetiefnon,loFiiannrgs,tiLsPnstu,iestTrwyr,eofPtureesst.o,be wPiraisast,rwtonmiet,s:Urinary adr, ren, Essphies, Feiie: tThasret109B) TTerwinal SScoifMclee Gag (3 PHT 0 pn [---- 2a visible sions, Wroscrmeic Darton: GWateilcallyccalltipoenr,aiaacl, wwietsi,ocwill,d hort [wiitrir el, pwild -- tiiennee DFPoorrrttai)l sbirloge rdnsciipnrctseseernatiittnr,a,teat,irlwaitde ng SePesaraloaeorctesanaelsstetoraeastntieoinlo,enn,weitlrdtast,e,s1i4d Prsiyreid Aeosrwhagnen,a,i2ti0s,har1e4of section pTShheienfvo,allTwSsianEgn,ipPsicutt,wye,e fFcroaeussest,o.bSetioukhh, WoirnaelyLSiatse:r, Troi, Trach, ssh, poeets:Waetr: CELE 001842 Sriot sti rue 16" . 557 Sussarized Single Tabulated Anisal Report (continued) F32In8di:vidTuoalYeMaakrceroDrsrcaoUpbiTocorvaaitnidatiMyvi-scn,rcoosIpceom,piicci3tO0ybseSrtvuaytioinnshts Tae: 2 fFaotei:l vWatters1061)7T6er8inal SSeccriWiaclee rou: (1 PRIA 30 on NroSsicpnic Bseration: Ncroascraepacl Burvations: HEoxrothages idney liver ung Ptiinrated Slee "aise, crcalr Lesion, bath hid ftps. SJiontusaoindiaolna,ctwsiisas,incgorte, atifcal, ald Swpistcirfdaictls,, wirloe se ronupurstive, hGranlailcus,repgerlevsiscive oepeapathy, aininl "ypsattuoidrtgeenawltaetraitnio,n,wavlitcisfloactle,,wimlidtifocs, "wsocearliatre sineralizatios, ild Flndeaona, interstitial, cheonic, ultifocal, oNtinreaxtaiianteido,n,noftocianl,plpanreeaafcsheyct,ioanild TFuetnstdeeoriastsiitiss,, nutlrcaesraetuilvlei,ryb,ilaitnecrraeli,edu,rked sid TTehsetifsoElodwiintgsti,ssuPersoswtaartee,fouSntdomatcoh,beUrwiintahriyn Doardee,HiTnhtysr:oid, Traces Salivary Gland, Pituitary, Pancras. rFaien:drWkesr:1069) T6erainal SScerxifMiaclee Grout (3 F450 on [I -- Wcr[os7copic Bserations: Eroprhtages Ho visible Lesions. "Sairntuiscoaildalaceslcattsio,n,Colrotceasl, waelgs, seerate hKooctarwaistiinse,d, chsriosnsiocnsnspurative, wit, wild Kidney Live ""CCshatrloacnuiildcus,pgreopngeerlrevasitsciivoen,nepwhartoipfaotchayl,, siwlidld ng "HLosecpcaaltaocaryrteewsi,anlestaoeldrieatrziatotineo,n,vaciulodlated, eorrhage, local ares, sodrste SPpreocjieecst:NRuabter: CRICROIZ 001843 Samar STR Pug: 167 358 SInudminvriidzuaeld MSaicnrgolsecoTpaibcalaatndedNimcirnoaslcoRiecporhts.e(rcaotnitionnused) PRI24: Tao YeaHrikearlLiTbnoriactiotiye-sO,coIgnec.nci3t1y Stody in ts Tle: 2 Fmiitnea:l eMsustteer:1081)R-T3e7r6m9inal SSaecx:rifMiaclee Group: ( 3) F-3924 30 pou MicroPsicrosptihcyrOobisdervations (eantined): PiTtesutiitsalrEypidienis Thyroid ""hHaitereoxansined, not in plane of section ""Htastc,alacrolalioniedralization, ald TShpeleefno,llPorroisgtattei,ssuSetsoawaacrhe, fUroiunnartyoBbleattweirt,hinTrmacahremal, LSianliitvsa:ry Gland, Pancreas. Ffiotei:lttahskesrs102R)SSTucOrificedSeni:n MeaxlternisGrow (31 FOI 0 pn Nacroscapic Obsernations: NicrPoistcuapiitcarOybservations: renal hEesaorpthagus tLiidvneery ng Fituitary "Large ass, 153 08 cn, "CSoirntsiociadlalvacescotlaastiiao,n,Cofrotceasl,, fmoocdaelr,ataeild "oMytocaardniitids,,chariosnsiicngnnsuppurative, diffuse, ~Owhiaenriacteprogressive nephropathy, wild PPoorrttaal bsialneondculcetarproclelilferiantfiiolnt,ratwei,ldsoderate Hepatocyte alteration, vacwlated, mitifocal, "ssicdalar sineralization, wild Faruscnia, interstitial, chronic, mitifecal, Haelsdorrbage, local areas, woderate "Hieron SThpeleefna,lloTneisntgist/iEspsiudeisdyvaesr,e fParuonsdtatteo,beStwoiwtahcihn, nUorrimnaalryliBnliatdse:r, Thyroid, Parathyroid, Triche, Silivry Blan, Pancreas. Ffaitnea:l GMeoeskhser:108R) ITeLrainal SSaecx:rifWiaclee Seay (3) PRI 30 pon WacroTshayprioicd Observations: Hicrosapic Observations: Mire! Fossibly slightly enlarged. Cortical vacwlation, focal, sodeate sPpreocjieets:ufsahter: O2ICKIL2 001844 Suanarized STH Page: 148 - 359 SInudmiavriidzuaeld SaicnrgolsecoTpaibculaatndedMiMcirossacopRiecpoOrbtse(rcvoanttiionnused) F394 Tuo YeaRrikeOrralLiTbooxriatcoirtiye-sO,ncoIgnecn.ici3t%y Study in Rats Table: 2 fniaal Fate: Mheaenkdesr:104R)-ITTe7r1ainal SSeanctriMfailcee Group: Microscopic Observations (continued): Esophagus Heart Kidney Liver PLuuncgreas Parathyroid PPirtousittaatrey 3) PION 30 pou ""MNyootcaerxdaimtiinse,d,chsriosnsiicngaorsuppurative, witifocal, ald "Chronic progressive nephropathy, soderate ~NHeagtaalccyyttoesivsa,cusoilantiinoln, aultifocal, aild V"Hayspceurlpalarsiaai,neirsalleitzatceiloln,, sil focal, moderate ""Nhoetroenxsanined, not in plane of section "Prostatitis, acute, nrked The folloving tissues vere Spleen, Testis/Epididyais, found to Stonach, be within normal Urinary Bladder, linits: Thyroid, Trachea, Salivary Gland. AFantei:lWNeoenkbser:101R)-SSTa7cr2ificedSexi:n MexatlreenisGroupi (3) FA-I30Spo4n Macroscopic Observations: MicrPoistcuopiitcarOybservations: AEdsroepnhaalgus Kidoey Liver Lung Pituitary PrSoasltivaatrey Bland StToessatcish/Epidiynis Thyroid "haised wass, | cn dia. ""CNoorttiecxaalninveadc,wolwaitsisoinn,g multifocal, aild ""CPhorrotnailc spornoognruecslseiarvecenlelphrionpfaitlhtyr,atew,ildail "vAalsvceuollaarr aiancerroaplhiazgaetsi,ons,iletiilfdocal, aild Perivascalar sononuclear infiltrate, il "hNeortoenxsavined, wissing ""EKdoetnse,xasniunbemdu,coswails,sianogderate "bTiulbaatelraalt,ropahiyl, asperaatogenesis, diffuse, "FUotlilsiocburlaanrchhiyaplerpclyasstia, cystic, wnilateral, aid STphleeefno,llHoewairntg, tUirsisnuaersyvBelraeddfeoru,ndPatoratbehyrwoiithdi,nTrsaocrhaeaal, lPiasnictrse:as. SPpreocjieecst: NRuastber: CZ0ICR0I2 a + 001845 - 360 Sunarized STAR Page: 169 SInudairviidzueald NSaicnrgolsecoTpaibculaatndedMiMcironsacopRiecpoOrbtse(rcvoanttiionnused) P3924 Tuo YeaRrikGeeralLiTbooxriatcoirtiye-sD,ncoIgnec.nici3t%y Stady in Rats Table: 2 nial Fate: (Whuessdkeer:108I)R-TSeTr7a5inal SSeaxc:rifMiaclee Groups (3) F-39430 pp Macroscopic Observations: Nicroscapic Observations: renal HEsaorpthagus Kidney Liver LPuanrgathyroid Pituitary "Xo visible lesions. "CWoerdtuilclaalryvacceulollahtyipoenr,plamslitai,fofcoacla,l, asiilniml ""MHyootcaerxdaiatiinse,d,chirsoniincgnonsappurative, witifocal, ld "Chronic progressive nephropathy, marked "Hpeorptaatlocyitleealdtuecrtatpiroonl,ifvearcautsiloant,eda,ildfocal, Nweigladlocytosis, winisal Hepatocyte alteration, basophilic, focal, "avalsdcolar aineralization, siniml "Kot exanined, nat in plane of section -hdenons The follosing tissues vere Spleen, Testis/Epidiynis, found to be within Prostate, Stosach, norsal lisits: Urinary Blader, Thyroid, Traches, Salivary Gland, Pancreas. Aoinal Nosbers RSA Se: Male Group (3) FA-3924 30 pon Fate: Weeks 104) Found Dead Macroscopic Observations: Skin Pituitary WicrosKciodpniecy Observations: MKirdenneyl Liver Lung Pancreas PPairtautihtyarroyid "Circular, ulcerated lesion, 0.3 ca dia, in dorsal "Enlarged area, with hesorrhagic area, 0.8 ca dia. ~Hgpear pitted ""SCihnruosnoiicdaplrocgtreasssiiav,e cnoerptherro,patwhuyl,tifsoacrakle,d aild "pPoorrttaall sbiolneonudculcetarprcoellilderiantfiiolnt,rataei,ldald Cystaid degeneration, mitifocal, wild "Aslcvaeollaarr aacirneorpahlaigzeast,ionm,itaifiolcal, wild F"Hiybpreorspilsa,sias,odeirsalteet cell, focal, soderate "Merona - 001846 PSrpoejceicets:bufsabter: OZBICROOIE i - i 361 Suanarized STAR Page: 170 Sriunwda SNiloe irettt4se,lrilrie.eRedtecmoamiinn 32: Te To ol TocoSpicy tt ots te 1 oFi r eYrts10ISnTHd bna ale eo 3 FHA rsaS4iiecw Batis cotinad: Sawiirts,,vnice, aie ehSeireeelBeiatpsbeas wePfoetnds,3Sascithiovsrnl BLiitr:, Tre, Trichs, Eas oeevaas10BTErl uSocs os 5 RT [------ [-- 5 visible tion. HfeTarvtr Mneyorctasrdtiaerl fiibwroosis,namultwifhiocafle,alws,intiwsaeel l [Hurniert SlHMeevigmaalinoitcyttsows,iasw,slastiiena,isia1sl0, ale rVeinn mtr eyieti dvan, alrite hSeeuwlTnaoirssrw,re dSuoch0, bMerish,oTsori,irsst, Scabies, Siva oeeetres1)BeTwe Srecasle [fH--eestar--y -- Joy [ prrise) -- ot ros | 9 FL aeipdey,taeue,t0F4earsyn. on act ret ifreeitnid i, Hd Siryiitstschia,i corte, ise, tion, rat iil, nie 001847 HSpoeceiess:aRaet : icon : Sussarized STAR Page: 171 362 Suarized Single Tabulated Mniaal Report (continued) Individual Nacroscopic and Wicroscopic Observations FI-3024 Too YeaRrikerralLisToorraitcoirtiye-sO,ncoIgnec.nici$t8y Study in Rats Table: 2 nial Nasber: 1R-TT76 Sex: Male Grow: ( 3) PN-3S0N 0 pp Fate: Weekes 106) Tersinal Sacrifice Wicroscpic Observations (continued): [2 Lung Parathyroid Pituitary Skin "CPherlovniiccapirsoegrraelsisziavteionn,ephsriolpdathy, ail vAalsvceuollaarr asaicnreorpahlaigzeast,ionw,iltaiiflocal, soderate Perivascular sosonuclear infiltrate, witifocal, soderate "Kot exanined, wissing "Menona "Podoteraatitis, ulcerative, bilateral, marked Basal cell tusor, benign, bick The following Spleen, Liver, tissues were found Testis/Epididyais, to be within norual Prostate, Stowach, lisits: Urinary Bladder, Thyroid, Trachea, Salivary Gland, Pancreas, Eye. Ffantieo:al (MWaesekhser:1061)R-TTe7r7ainal Sex: Male Sacrifice Groups (3) FR-IG2 30 ope Macroscopic Observations: Microscopic Observations: adrenal KiEdsonpehyagus Liver Lung TPraraactkhsyroid "Ko visible lesions. ""CHoorttiecxaalvinveadc,usleastsiionn,g focal, wininal ""PFyoerltiatliss,onaacnuutcel,eaurniclealtlerianlf,ilwtiraltde, wininal Portal bile duct proliferation, sirisal Hepatocyte vacuolation, centrilobular, sMoedgearlaatcertosis, soderate Hielpeatacyte alteration, vacuolated, wiltifocal, VHaesscourlrahargea,inleorcaallizaarteiaosn,, aoderate ild "Not examined, not in plane of section "Tracheitis, conic, wild The following Spleen, Heart, tissues were found Testis/Epididyais, to be within rorual Prostate, Stonach, lisits: Urinary Bladder, Thyroid, Salivary land, Pituitary, Pancreas. SPrpoejceicets:WaRsabter: 0Z810R0012 Suni sre" - 363 STaufinvrideadl RSicntglsecTpaiulnteddWlrioascloRpietB.er(vcaottiioounnt) PEA To YouRrikeBralLTabooratcorieGsc, oIencc.it3y Stay i ats Tole: 2 rFlle lNeahr168I) TTeEwial SSeciafiie eo) FT 50 om PHSrdr-- y Morornein Barations: Huse, 0.7 cn din, bearhaic Lesion. Sivas setsia cote, dius, ald breratpes itver wy Jatrnos Tiraeit SoPokhmeoecrhrriionenocseytoanasn,sisbeyntign,iuvnileate,ral Sthirailg,eaets e egret, sete CTaiccuussmepsetantiobnil,atmwals, tawied uPasuasorni,seinatlersstittiiaol, oalsec, sltifecl, Bwieela wcrophge, foal, ail ePruiarseal,arsmteaaitoamiidttrate, ald "eelntoncolt aro SJprraains --cel, foal, wile Osh colo GTihevef,elToentnigfEipdsiuasw,rePrfaostdateL,o Sbehowiwth,inisnaarly SLliatse:r, Paths, Trachs, Salivary lad. FiintelNNeasbee:08BTTerai eSurrtitailcee Gro 5 LSTA Tp WcrocBarpiactessrations: [iryen -- Ersoepnmtass Kir ler LSeuil,re0.a3tcareea,t,bewrrhgic ein, Jmoetscrviaossincety,onw,ssibniggs, wilateral "Pvroencesprospsetis sh0odps, wild uCrlaelancviio, W8ri1tefiltrate, aint rCotedditiegrfuactkiornl.ifrfoactail,onw,ldadil Hepatocyte alteration, vacuolated, focal, K . ore SiEh LIGr VIL o veri Megalocytesis, winisal SPpaegcieets:NRaabter: OBIHOLZ 001849 Swing spe 3" . 564 STuasbsvairidzueld BSionksgelcepTLiaabvcuolrnastdaedrciArsn,oissanclco.pRecpo3srter(vcaotnitionnused) PETA: Tas ear BalToxicity Dregeicity Sod in ats Tie: 2 Faaitentdhnek 108T ) TeraiS ml Sifiaclee Group: 5) ARSE 50 pn Wcroscapic Osrvtisn (continued: Pucres "psrpaltaasisisnrsleistticoenl,, aslidtios, soderate kita at rine sssing SThleeefo,llfwairng, tTiessstuiesEwdrietfaoru,n tPorobsetawtiet,hiSntracmh], Uiiwnie:y later, Thyroid, Paratha, Sitar lad, Triches FoatwesltNhastve10R) TToriml SSwurtifailcee Grog (5) ASR 50 po [---- Wcroscmpitc Bsrvations: Eitpres lnery Ho visible lesions. SCJiohtnraoenniitnrlaepc,ehsasssaiisnsscpartees,tyfo,al,aianinsdlre vSFeapelranact,ownntew,asltiliztadtiiaoln,, saihdosc, sltifacl, aRiveetar scrphges, stil, ld Perbascalar wonscion infiltrate, slg STTteaetefonsllHoaSwrtitni,vtaTiyessstuEieslsE,wprdeiFdifatottusen,rt,PbroFesatcawtrieet,hsi,tn onomree) Uniintsr:y Blatter, Thyroid, Farathyrd, rFaetenewasve108T1 THerwial SSucsiaflie rot 3) OT 0 pon NacroSsicnpic stration: FicroPthoiitcirsysrations: Erepnat art trey STaeihd0a.f35la0e7dcIasic Let ind Fant, SJaivaananndc,tamsiisss,iocnorte, diffuse, ald Swiytsistal,, uclreane rorsamrative oinvii naerrgrneastiiveons,ebarlp6aty, isial Cilclus, pelvic, soerte SFprecaigees: NRart : CRLHOLZ 001850 | sured srs 565 SInudairviidzueald NSaicnrgolsecaTpaibculaantdedWiMcnrioasaclopRiecpoOrbtse(rcvoanttiionnused) FI-3924: Too YeaRrikBeeralLabToorraitcoirtiye-sD,ncoIgnec,nici3t0y Study in Rats Table: 2 Ania Fate: MMeoeskbser:108()RTTerDsinal SSaecx:rifMiaclee Group: (3) FA-3920 30 pou Microscopic Observations (continued): Liver tung Pancreas. Parathyraid Pituitary Skin ~VHaesgcaullaacyrtoasiinse,rasliiznaitmilon, ail Alveolar aacrophages, multifocal, wild ""NAotcieexanaitnreodp,hy,notaoidnerpaltaene of section "-Pboddeontoenraaatitis, ulcerative, unilateral, wirked STphleeefno,llToessitnigs/tEipsisduiecsyawiesr,e Pfroousntdatteo, bSetowniatchhi,n UnroirnmaarlylBilmaidtdse:r, Thyroid, Trachea, Salivary land. AFratiee:l (NMoesetkesr: 82R)3S8ac2rificeSdeitn Male Group extrenis (3) F-92030 poe Macroscopic Observations: skin Splem StLyosmsahchNode (esenteric) Nicroscopic Observations: EHseoaprhtagus Kidney Liver Lung Lyssh Kode (aesenteric) Pancreas. Parathyroid Prostate skin Splem Stomach Urinary Blagder "Ulcerated, circular lesion, left hind "Enfloaortgpaedd.with multiple raised circular "UlLecseiroantsi,onrainngipnyglorfirconva0l.v2e-ar1eac.a dia. "Enlarged "HNaoltigeuxaasstineldy,mphiosnssi,ngied NaPlroitgenianntreslyosrpphtoinoan,drnoixpeldets, aild ""VHaaslciuglnaarntwilnyemrpaholniaz,atinoinx,edaild Malignant Lywhons, sired "Malignant "Halignant Iysphona, Iysphoss, aired sixed ""pKrootsteaxtaimtiinse,d,acnuotte,insopdlearnaeteof section "Pododermatitis, ulcerative, wilateral, wirked malignant ysphons, sixes ""UElpcietrh,elisaalderhaytpeerplasia, sisple, diffuse, aild The following tissues vere found to be within Testis/Epididyais, Adrenal, Thyroid, Traches, nSoarlaiavlarlyisGiltasn:d, Pituitary, PSrpoejceicets:sRtaetr: G10R0012 . 366 001851 Susmarized STAR Pages 175 STonemriinze RSiotgesecTLaa.oelra3taednMMc,irss1lcc.nRcegeBrar(caotnotinnsued PRS: Tee Yeu Bal Tuircamcity Sat in ats Table: 2 Fae thats 55) Saritced in trena [I titr-- y Liiever WerTsSecmtntuirsistiroaptiison: eSrreatnats fpor Ha its StSTonleeyrstSlaints EE TY aanrilke, rpaiettdedaas, en0l.8arcges.din. cSheeestteswapranrrshralls. PJeectrioetscynteo,nsa,ssbirmie, wilatera vr"ecepatcurtdpereHvraoeasolisante,iaolnorcaadl ttauhr,a,, swiordtkedsadte S"reperpnasa, wried JSSittmeewaaisantotreis,hzye,simssspiienrgmits,poessiitse, ilteal, si hoeaonloLsinngg Fsruoesst,wrneefesndBtaoieber,witThrionts,aaTraLceis,tPaces. oFirtel tohenrk,104S) TTeaioal SSewcsifailcee Gt 3) 0 0 an [-- Werosrcoopnc wsaratians: fsettags ilvtey je Tetsuttsairbyitiamis re-- GSaitnuiscoiadalvasuleaatsioan,orftecoanl, iiules, ald TJrowcaariitnint,,cmreasnoegrosmeative, eSineircfoeclp,nre,salseisvne ostropathy, ainial eYverarlgha,memreikstar, ile loneiatrhy, sprsategneis, bilateral, jones theeefnollPvoivntattiessSuetsewee,re Ufroiunnarytolbaetewrit,hiTn nrormaal Pwairtast:hrrd, riches, Salivary land, SPpaecgieets: NRaahtr: 8IcHO12 . 001852 Sunwise sre: 18. -567 Suid Sige Tate al port (ction) PHInLdividTuoaleMraacroBscloLpiTic oaandroMiS,crcosonceop,piec sObseSrtvaetyionnshts ie 2 aFe eener10T) ToTrsionSSrlie rot (9 FR 0 PThaerliiso,snsendsOrratwrieontn(cn1i0nbotntssi sr Lt contin rien toeeer10I) TTorso SSormie Got 3 FR Wirsonic Suration: Wraspic Baration: -- Newt f--- SAiienruioeintld,cassai,encrt, local srs, tr FNTateealhpseeomnce,tlotawiodnH,L isniiftatt,, w1ildd wPHsreas ciocoitnnsssnmr,asai4on, wid hPeereifsolneo,rgyHtaiscbseute,s wSTrheinfayodfinto,b,e withrinssar,ltiwit,: Oray der, red, Feed toheee0)ITRae Srl c r (3 FR WWeerrsTscwcnnc uration mratiens: Burk ein, 0.3 ch dai ation Loe, re rt SAiirnteaiitas,atvei,crotomsmgwatiilvet, ite rWPaeinieeelraosastleeosn,opsttye, sina nr FpTreaacestwi,sodaenitsec,al iisste, id I ATHenevaslrthogswee,eraoalsnieiosln,, wwialete frre Species: Rat 001853 Sanarined STR Page: 17 368 SInudsisvairdiuzaald RSaicnrgolsecoTpaibculnatdedMiAcnriossaclopRiecpoOratse(rcvoanttiionnused) F928: Too YeairterralLaTboosriactiotryi-eDsn,coTgneen,ici3t0y Study in Rats Tle: 2 fFnaitne:al (KMoebekesr:10160-T5e1r8simal SSeaxc:riWfailcee Grow (3 P20 0 gn Nicroscopic Observations (continued): TSphleeefno,llToevsitnigs/tEipsisduiedsynwiesr,e Pfroousntdatteo, bSetowmiatchhi,n nUorrimnaalryLBilmaidtdse:r, Thyroid, Parathyroid, Traches, Esophagus, Salivary Gland, Pituitary, Pancreas. Ffaitnea:lGNeosebker:1081)R-TTe0r6m7inal SSaecx:rifMiaclee Group: ( 3) FAIT24 30 poe Macroscopic Observations: Wicrbosacroepniacl Dservations: tiEdsonpehyagus Liver Lung ko visible lesions. "oCotrtiecxaalinveadc,wlaaitsisoinn,g focal, aild ~CPhyrlnitiics,proagcrees,sivweilnaetsehrraolp,athsya,dewrialtde "PPoorrttaall sboinloenadculcetarprcoellilferiantfiiolnt,rataei,ldsild "Rpeergiavlaystcoulsairs,sosndoenrcalteear infiltrate, wild Heserhage, local areas, moderate The falloving Spleen, Heart, tissues were found Testis/Epididyn, tPorobsetawtiet,hinStonnoarcmha,l Ulriisnitasr:y Bladder, Thyroid, Parathyroid, Teaches, Salivary Bland, Pituitary, Pancreas. fFaitnea:l HNeacskbeer:106R) 7T6er0minal SSaecx:rifMiaclee Brow ( 3) FA-3S2A 30 pou WacroSskcionpic Observations: RicroEsscoopphiacguOsbservations: LXiivdeery sPtarnathyroid Trachea Circular inflasmed Lesion, 1eft hind foctpad. o~Cthaneixcaipnreodg,reasissisviengneghropathy, winisal "PPoorrttaall sbiolneondculcetarprcoeliilferiantfiilotnr,ataei,nisaailnisal Negalacytois, "Not exanined, ostodeiratpelane of section . "Proidoedderaatitis, ulcerative, wilateral, "Trachetis, conic, wild TShpeleefno,lloHweiarntg,tiLsusnuge,sTveesrteiaf/oEupniddidtyoaibse,wiPtrhoisntatneo,rsSatoslaicsht,s:Urinary Bladder, hrenal, Thyroid, Species: Rat Project Musber: 0281CR0012 001854 Sunarized STH Page: 18" 369 STaoriitd Sciigrte TLwaals4aotora,ecnoeonr3uta(ticotn) PL Ta or a Tosi Scopcitr Sty fn ats oie 2 aFs tehanse 00T) ETToran SSewxrifWicle rs (3 Fn hSe vflSll,saHa trtyrwy,r PJrouon1:0--bn sin srl its ctinnts Fiiswhbaek:e)IrTtesec mleesrows 9) PLA [IWarsnoniitc yB-- urts: Sale tu to 11 07 cw. rt Kise AvWpeicnkiiitars,e,sariennscsopnsiantat,ivae,so p= Senapatoloceetsa,itaeiitnidohnl, smiitlse,, 1m04 ng raters AJAtllaeariaanwrapi,1thiaenigoaF ,sitwled PSiiewty Srooo s TSTherefyostlthnagistsaFseePsonswt,ratee,fuRndonsitbswaitrhiyn sBardlr,iKirsen, Tors, Traces, Exsbs Feeas taheee100I) aTia Stilc r 5 Fn [roTenmr -- BEiastt spleiidee1i5n1s,1 5ch0iidcouttt, Wrssraneic Burton: on Gort valatio, tfc, id oinnwthri coFteranianctf,eonrsaas,,eeas,nlsisi ine foelonouurctreatcon I AownenatrywreissAti,on, ailec, stil, Perks wie AS wld Alveolar macrophages, multifocal, sild LSpeciaes: mRat iep 001855 ism 370 SInusimvairdiuzaeld MSaicnrgolsecoTpaibculaantdedMiMcnriossaclopRiecpoDrhtse(rcvoanttiionnused) FI-3924: Teo YeaRrikeDralLaTboorriatcoirtiye-sO,ncoIgnecn,ici2t0y Study in Rats Table: 2 fFaotie:l (Mhuesetkesr:106()R5Te9r0ninal Sex: Male Sacrifice Group: (3) FA-3924 30 poe Nicroscapic Observations (continued): Skin TTheysrtoiisd/Epididyis "Podoermatitis, ulcerative, B2ilateral, marked "Vascular sineralization, aild <C cell adenoma Follicular adesons The follosing tissues vere Spleen, Prostate, Stouich, found to be within normal limits: Urinary Bladder, Parathyroid, Trachea, Salivary Gland, Pituitary, Pancreas. final Nusbert (R-T791 Sex: Male Grow: ( 31 PR-ISZA 30 phe Fate: (beste 108) Terainal Sacrifice Macroscopic Osservations: MicroTsecosptiics/EOpbisdeirdvyantiiosns: [i Esophagus Heart Kidney Liver Lung Testis/Epididynis Trachea "Right testis small. "Cortical vacuolation, multifocal, sild ""MHyootcaerxdaivtiinse,d,chwriosnsiicngnansuppurative, "Clhorcoanlicarperaos,gremsosdievreatneephropathy, ail Pelvic sineralization, sinimal Calculus, pelvic, soderate "Portal ile duct proliferation, ild Hepatocyte vacuolation, centrilobular, woderate CHyesptaatiodcydteegeanletreartaitoino,n,fovcaaclu,alawtieldd, focal, sNielgdaloctosis, soderate "vascular sineralization, wild Alveolar sacrophages, asltifocal, aild "Tubule atrophy, asperaatogenesis, unilateral, rk "Tracheitis, chronic, ild The follouing tissues vere Spleen, Prostate, Stowich, found to be within normal Urinary Bladder, Thyroid, lisits: Parathyroid, Salivary Gland, Pituitary, Pancreas. PSrpoejceiecst:NaRsabter: G2810R0012 . 001856 Suanirized STH Pages 120" 371 SInudainvriidauasld SMaicnrgolsecoTpaibcalaatndedWiicrsasacopRiecpoOrbtse(rcvoanttiionnused) FI: Tao YeRrikeOrralLioTroaitcairtiye-sG,ncloigca.ici3t0y Stdy in Rts Tae: 2 fFaotie:l (Mhaetser1031)0-S9ac2rificeSdexi:n MeaslterenisGroup (3) F-39200 pn Macroscopic sermons: WicrLoixvaepric Ohserations: hEexaorptages tur lng Pirathyrold -Possibly slightly pale. opctarwdaiitviesd,, cahirsosniincg ensigpurative, Pwoirttiaflecsaeln,onwuiclldear cell infiltrate, wild sPcoratlalarbilienedruacltizpartoiloinfe,raatiilodn, wild oStransaslaonni,nem,ultnioftocianl,plwainledof section TShpeleefna,lloKriidnngey,tisTseusetsis/wEepriedifdoyuunids,toPbreostwaitteh,inSntoornmaaclh,liUnriitnsa:ry Blatter, Adrenal, Thyroid, Trache, Salivary Bland, Pituitary, Pancreas. JFaotei:nhaebseer:106S) TSerminal SSaecx:rifWiaclee Brow (3 FIT 0 pn Nacrosspic Observations: PSiitnuitary HicroLscyopnicoOdbeser(vaaetsinotnesr:ic) hEexacrpthagus rt LiLvger HLyiwth tNote (pester) Sin Thyroid inary Hatter --ihsaiesedd caisrsc,ula0r.7Lecsaiodni,a.Left hind footpad, topes Desorrhagic ""Ntoytscaerxdaimailnedf,ibariosssiis,nglocal areas, wild "CPherlovniiccipnreorgarleisnsaitvieonn,epshirlodathy, sderate "vassecgulloacrytsaisnse,ralaiiznaitniaoln, aild APevrievsrcalsaarcrsoopnhaogssc,iearltiinffoiclatlr,atew,iladil "Hehseorernhage, soderate "woitroeddrasitis, slcerative, wiliteral, pUeirtpislcarsainach,ial cceylslt, mitifocal, wild CEapilthaelsial hyperslasia siple, diffuse, aild STphleeefno,llToensitgist/iEspsiudeisdasiesr,e Pfroousntdatteo,bSetowwiitchhi,n nAdorremnaall,liPnairtast:hyroid, Traches, Salivary Bland, SPpreocjieecst: MRuaath: 0281CR012 001857 Sorin st ges". 372 STauniriidzuaeld NSicnrglsecTpaielaattediirnaasltoRppBter(vcaotnitoinnu PHI To Yevu eGalLTieactritcoemeeic3tr Stay in ats Tate: 2 iFaatel eNerk,160I) TDerwiSal sSurifailcee Get (5) AIA 0 0 The f[elronrEs-- tos w--r fo-- nd 10--be a0 somal nits (ction Frale tNhonkes108B) TTerminal SSweifailces Gri (3) 0 5 0 [A ---- [A ron -- Eerpt s ilotw y we PTaToraratataysoid Yo visible lesions. STfnrwiycanriatis,ectraasina,ecsorotsep,riadteinv,e seats DFiurrioalnfsr,apreaslidiveeehtrmaitlhrya,tea,ldald ppaitaocies ischaearttiioonn, hiatltoerd,,suarteis friee---- aVewrhrhges,mtpoicantaireos,, sidleeate rJteeastsoarmt,iatrsh,iwaatre,tsin TShteefeanloTing to Eipssuehsb rawetr,e Sfotnwdcht,e breawrityhislsieeu,l TLaicsh:a, Salivary Ging, Pititarr, FiiatelNoeeser,100) T%erai SSuerilicee Rucrsosarpic Oserations: Wcrscrpeic Besrations: hort Bron (3) FA 50 pn Fierae,.slihly raised mss, cada 108 ACeosrttitcarlydceeplelerpatrioan,cafo,ci,fowall, wile AGeorfcararnesat ssgprtine, ital, wit SPcrieotn ahbtr: OIRO 001858 siwsmnm 373 Snairnias RiaincgrtloesLTcpaialhardttWeiresacropBieear3rt.atCcitoinuse) P52 Tu ter al Tce capri Stay in Rats Tie: 2 iPie tres106) Tessa SSoicaihe Gro 1 FTE 30 pn [TeAer ------ tr StlAv-- wnaier el -- alate, ile Ppepritst)oapbeivsfeurciksiorotnin,friacmiailoantt,ecdayhittaligfa wfe re---- un SAPeerstilaeasswtcoresoahignotei,oanT,cwlfilidarrese,ysfierdite -- reste aeoshwtaeh,t woatte,1spohraaof ein SSohnen FSoernedners, ite FhTeiefsolnloibnPgtantni,sessueSsoewre,futrni d to BSe iwitehinTsorcsmd,iTtacshes, Estas, Slivey Sad, Fiite ante s9IrTtdse1s arensGrogs (9 PRE pn Aith---- Srienal Ncprosrepee Oserations: ent riotwer wy [Hit-- on SSaserenatpewdes,rih0grbsc.o.dd6ao,an. Smiensroiidtl,cacsonaccsrtm,adritfs,e marked TDieoipnroercpi,iweissliieaneissnebrwopaatihyt, eald1d ATieauprectisvtr, itntcilonid erweare--a--rs--e--Sn--es mite, tParvieasitn swatnciniophnoninoffisneicttieonaid eptnait, icerativ, wilson, po ae Yer Species: Rat OBEN 001859 Sanrio sre ws" 3 S547 Susearized Single Tabulated Anisal Report (continued) rn et Species: Rat 0018600 sme wm" 375 SIannrianed RSaagceiTsmu1tMiiacrlosRceputraCtcitoinae PSA To Yuir wBalLiTccsiotryisO,cgened,city tay in ats Tie: 2 oFlrel Neesres104) Trail GSuerflien Geom (9) FR 50 oa WicosTcnopc Susrvations (ation: sAcvtaarr aiscrrliensti,ons, titad , ils Pintuaitthyirrsis TNPerepyriitanircsatdcsostlalniristerateinfra, id restae Siem rJst, drone, ifose, Seopieis, tralia, inwsitital, incrsset, yrs Liaeirarco wisiry Baste EOtth,licaallobd res, sole, dius, wire ysita, orc, itd ohuet,oSotunns,tiMssuresawrerafhede LSo bee wvithlinns,arParLeist,:Sul Intestine, Lrg Ttstine, Tiss iFinl:l eekres1089 ) Torso SSueriflicee Grog (9 FR 3 pn [---- Wicoursesnct thertiss: rt Ktonwe ao visible sins, Saapicdainratdisa,abcrctauritao, csoLrotoce,aairrleeas, ,itd DWrioinieeapli,esmsldine shop, wile "Fara sami cal ltrs, ald TM Fpauresned CJHyesesttoisddrtdsegeanheerrattiioonn,,eivlidcalted, sitifoca, AeMetvgalraocayt,omsiase,ialwsinoiemenaln,, 1il6a oFamesiistis,, vatva0.,laTnoeulofsvetsi,onwish SThteenf,loTwinEtisdusaewr,e Pfroosmtatteo, bSetowiitchhi,n srraw!yLBiatke:r, hid, Trach, Eben, Pnaigeest:Maetr: QAICHOLE 001861 Swnicet st rage 65 576 Seuinvriiauaad RSktitegsrecoTLniairat4teorMiicernolnsec,nRecgratrattiionnt PUS28 To Yur al TcScoecity tay ats Tate 2 rFitee Naerset10ITTerai SSewrrfWiicee frost (3 FE 0 TSielioaWreynrsSlooapnti,tciPststesirestriawrtri,eonesad(cn6tibneati)tis sara Lit (contin: Feirtael eNsaaer,00SaridSeicn nBtlreenisGet | 9) AA 50 pn [ Hits-- Kits uSaihrtgtas ,sae1.3wdcnidited crorwen Ossi: ier Sirionntprotgarssitnye cAortge, racl awreiens, il f Sw[ eipetcr-- e ste-- aton, isla, stifocs, ny Nnercga,waLinltwieesn, swdieeate arTeartteitssessidomis rSFaeirntteueisittaei,pwaatite,e eie hSSheheifnno,yloHSienhrgot,tiSPstsouunetsshawe,rterifnouanBtasdbeer,witThoiostss,rwFaTsittess:t, Trach Exghges oFirtee tYeeer,10 8 SacridicedSein xmtlreentsGros (5 F390 50 pn [eAtn-- WersTrteeinailisiedroamiiosns: pe itor Liver any HTieotrhvataitcsnnwspe,err1s1a0nw8h.iap,s, vSoieosonftpapirapterissoimiat csoerrteo,swar,iedaid HSeweipsuaettoacctyteesisvnakcteuirotnliattoiinoosnn,,amcuilaltleiftoecadl,astildta, Peerrvaest,alr1w0nsnacrleean, (snfietartaete wild SPrpojoecnt hbatber: OBICROLZ 001862 `Sussarized STAR Page: 186 377 `ISnudaiavirdiuzaeld SMaicnrgolsecoTpaibculaantdedMiMcaroisacopRiecpoOrbtse(rcvoanttiionnused) F324: Tuo YeaRrikeOrralLaTboonriatcoirtiye-sD,ncoIgnecn.ici3t8y Study in Rats Tle: 2 foinal Fate: (NMuesebkesr: 76R)-ISBa0c1rificeSdesi:n Male Group: eitreais (31 PA-IS430 pra MicrosPcaonpcirceaOsbservations (continued): PPirtousittaatrey SpTleesetnis/Epididynis ""Ahcdinnoanrsatrophy, wild ""HNeostoseixdaesrionseids,, iwsiildng "Tubule atrophy, aspersatogenesis, unilateral, warked HTehaertf,olSltoowuiancgh,tiUsrsiuneasryveBrleadfdoeurn,d Tthoyrboeidw,itPhairnatnhoyrrmoaild,liTsrtasc:hea, Esophagus, Salivary Gland. frinal Fate: (WMueaebkesr:106()R-3T4e0r2minal SSeaxc:riMfailcee Group: ( 31 PA-IR24 0 ppm Macroscopic Observations: Thorax (intersal) Splemn Liver Lyssh Node (sesenteric) Lyagh Node (abdouinal) Testis/Epididyais MicrAodsrceopniacl Observations: adrenal Kidney Liver Lung Lysoh Node (abdoninal) PPriotsutiattaery Spleen "Filled with pale yellow Greatly enlarged; pale fluid. raised lesions, 0.6 ca "pdoita.ted with irregalar surface. ""SRleingalhtlLyysegnhlanrogdeeds asnldighhetslayrrehnalgaircg.ed and hesorrhagic. ""CBlielaartecryasltl,y 1sncaaildia., right adrenal. "COonretiocfalpaivracuporleasteinotn, meltifocal, sild "CFhrreolnoicngprriotgirse,ssiavceuten,eparnpdaetrhatye, aild "PHoerptaatlocbyitlee vdauccutolaptrioolni,fercaetnitorni,lobwuilldar, wderate Halignant Iyiphona, histiocytic sRcaalilganarnt aTiyneeprhaolnisz,atihoins,tioaciyltic Hesorrhage, multifocal, wild "KSailniugsnoaindtalIyescpthaasnisa,, hiirskteidocytic Hesorrhige, ild ""HPortosteaxtaintiinse,d, acwuitses,ingmrked "Halignant Iysshoms, histiocytic PSrpoejceicetstMaRaabter: OZBICR001Z 001863 Sumarized STAR Page: 197 378 Seuinde rSiioegrecaLaaleaswtadarirefn,ilnse,Bornta(tinotns 528 To Yow Bl Toi icity Stat i ats nie2 oFave eehr0)ITEose SSeeree r (3) FE 0m [SiIosus-------- Wey nttr rEtieoten, tsaate,ii,d sila ise, rrwirtn, sate, ried TThetfeTloonrseusn,weoares,toPbao tirha,oErvaint,salive Sun, res, oied tronse 10H ) TorsS o Surtaicee So (9) A WarsHroensitycateDurations: ATetutoenin, 0.5 8 di, [Koiarne -- ive cTermti aaraedisvnass,ckaLlolinrn,nf, srwteatss og AMtnaicllabioslohdrgttspi,reti,atriWtogfn,,ad16 PPreassttayyria Janeiattsi,, 1110 ste, nes oF REED SSiioreumas Bate rEioatetlinalmpitwe,cf,ff,siee,asesn ieairns, ste, ase, wile hee ftemlienesrenwrte,GTnrot,o beTrwaictihei,n sEgrei,tS:iva lat, Pers, cPoiwse Naatber: ROR 001864 Sussarized STAR Page: 168 3 79 SInudsiaviidaunald SNianrgolsecoTpaivclaatneddKiIcnriasacopRiecprOtbse(rcvoanttiionnuesd) PIT: Too teRraBralLaTbooriactoirtiyes-,DgIencn,city Study in Rats Tale: 2 fFaated: vsirs: 791)18Sa0c0rificeSdeixn WeaxlteresisGrog (31 PIR 0 pn [rLivyer -- KiNdenseaytery WerssTteosptiic Giodsrivoatmisons: Hurt Liivtenrey ng FaNcerssensesry PPlaraaitthiyrryaid Sprioesmtte Tetis/Eididnis aallee, pitt 1nd large. TJeostteuslbialrastnertarlilcy avesslse.ls. J witifoal, ip le ---- DSehsoantciytreegvraecsosliavteiosn,trloact,areisr,keldd Shaesaarlrahrigs,inelorcaallisatrieosn,, wailld celiyirrterstirtoigsh,y, mwriiled pFeerllyratseiisti,s,ofaelrdate JJiodtnoannsions wissing J"ebscuilderaotrsoipsh,y,wslsdpersstogeess, scerate Folyitertis, soterte SThoe nfoslohniinng etisBsuuebsewreeMifroennda,toTboetwsit,hinrischoersa, ELsinpthsg:es, Salivary lan. fFeasd tNere:1081) 0Te5rinal SSuerifWiaclee Brot (3 PAIR 0 an Wacroscpic servations: WicroMsicrpeinca servations: eurt LKiivdneery ny oo visible lasios. tyasrcatritailtidsg,eucrraatiiocn,rofnoucsalp,rswtiilvde, "TCoicvaicarpersa,reislseive eghopathy, wild FPoartraall shimlaendculctewprcoellilferiantfiiolnt,riwti,lesininl HNeepltascotnesvi,colaaltdion, wile Yielpetaote atteation, basophilic, alifacl, "Bsecrailasatralsanrwrtaolvisotciloenr, winiflidltrate, wild SPpreocpieest: Ntabter: OBICROLZ 001865 suiesmarnge tw 380 SInudsinvairdiuzaeld KSaicnrgalsecoTpaibculaantdedKmicirnoaslcoRpecpoOrbtse(rcvoanttiionnasnd) PRT2AE Teo YeaTriteGralLaTboornaitcoirtiye-sD,coTqoecn,ici0ty Study i Rats Tae: 2 fFaoei:l raiboert106R) ITeSrinal SSeanc:riMfailcee Grow: (3) F920 0 pon WicroFsaacpriecssObservations (cantina): Pituitary ""Ihsnloetnscell aden TShteeefno,lTleowsitnigsEtipsisedeisuwier,e Pfroousntdatteo,bSetowiwtchhi,n nUorrimnaalryLBiliatdse:r, Thyroid, Prathra, Trach, Eph, Salivary Gnd. oFatie:leNsoteers106()0T6e0r5ainal SSuecifKiaclee Groups (1 PASH 30 pn [Sniny -- WicrHosicraepnc Disrvations: LXiivdeerey TM - siSatluiivtaarryySlan tin "ifsoetgdatcsi.rcular inflamed Lesions, both hind SRimeuaslolityl ceelclthsyp,erpcloarstiea,, dfioctails,e,ailwdild "COheronoifcpapirrogprreessseinvte nephropathy, ald oNretaallacstoovsosm,claeianicoelll infiltrate, aild Haelpdatacye alteration, basil focal, "piearsicvaalsacrulsairnesraolinzaotimona, ianiflidltrate, wild "~lHatroeoansine, aissing Fosniwraatiti, ulcerative bilateral, marked TShpeleefno,loHweianrgt,tiTssstuiess/Eeprdeidfyoauinsd,toPrboestiatteh,inStmoonrcshe,l Uirniintar:y Bladder, Thyroid, Parathyroid, Traches, Esophagus, Fancreas. JFaotei:n sakbesr:1080 ) Terinal SSec:riiWaclee Gra (3 FRI 0 pon Macroisctoepirc Ohservations: Nicrosacratpic Observations: iter "Ucerated are, 0.7c dia, right Kidney. pwolctairfoictails,, wcihlrdonic nnssppratioe, ~Daronic pragressive nephropathy, ald sPpreocjieecst:uashter: O2BCROL2 0018 Suanrized STR Page: 190 - 381 PISruisEsvasriiTzaseldYSRoiornegrlrsealmTCTaoiburalsactteoedWnAr,noiasparklie,cReeipot8rWytnS(acaotnyitioniunnedR)ats Tales 2 Faiite eotes100 ) Tawa Sacriafiece Ge (9 PATE WerasCapric Oration (cmtinedl Heatacte acilation, mitifcal, wild boHepatocyte alteration, vacuolated, multifocal, ny Megalocytosis, is sild whe hSieonfl,lvTienngsiEdsismewe,e fFurnodsattosbeStwointkhhiyn nliorraaryTBiatde:r, real, Troi, Pathroi, Troon, sama, uv Elan, Pasar, Pris, eFikt eNokw:101) 6T0orso SSeisflcee ro 9) EL on [Jes-- in -- orratn Microscopic Observations: Kfitees iSulsiisd as,Tx0Thay ia,wt ae, HGicoiwrirttci,sv,cewlcladrtoionn sdnifsfpe,tiseeyat mFroarelt bveieeanuttteenrtciohe}rptniitolnri,stieWdEwild es ACVoyesnptroeiaidreadlessgaienneeawrimiaztmlaieetonil,oenfs,ocawflii,ldtwrialdte, id Tonietasry LTprloaisae,ensal el foal, fre Tpeenf,elTleiEng seae,wre Ffroantdattoe boe mittihs rroanralyiBnliatde:r, Prthyrld, Traces, Espa Si nk, Pres. Pfrojeoct Naber: CAIRNS 001867 [---- 382 ISnudainvirdiuzale RSaicnrgolsecoTpaibclaatneddicmriansaclopRiecpDtsercvoanttiinounesd) iar Laboratories, Tc, 3% FN-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats Tale: 2 Fiatoe:l tNhaebseer:700) S9ucificedSeixn Weanlterenisougt (3 F394 30 pon RacrSaksicnpic Oosrvations: "has, 5.5 ca i., containing greyyellon te Hcrosbcrpoinc servations: Ee iver ng Ppaarnactrheyarsoid SSailnivary Slane inary Blatter "ircgeahdsteodeuyas texaeutdraostpreho,iweddrigewhiytt.h lcaotrenreaall hueladc.eration, o"atratxiatnisi,nesdeties,siwvngilateral, waked orLtiasel,sporafnocrlaetae ccealrlnaflilvterrat,e, wild HNeeaatlascyytteosvsa,csosliantiinoanl, autifoca, wild VPaesrciuvlaasrclsairnesaolninzaactlieoanr, ianlfdiltrate, wild iNentuastataitcragnheys,lawsoederate J"Sohtrospchyainad, not in plane of section Soural dcifaflarceatricaitveodn,, ublecsesrated vith oetxternasiivneeadxcrsoississiinginfiltrative, TShoelemfno,loKwiidnngey,tisHseuaerst,TaersetifsuEnpdidtiodbyeisw,ithPirnostratse,aSitonsicth:, Thro, Trachea, Esohas, tata. FnataedltNhoetseen:59I)ESIuc0ificadSeixn Mmatlreenisroups {1 PHA 30 pon HcroPsictpuiitcarOyoarvaions: WicrSasiconpic Bosrvations: Grietnael Liver Loy ""icsaerdteddarkriwghats,hin|dcafoduitap.d. S"ivmasnseidplroagcretsssiiav,e acogrhtreo,padtihf,fusaei,1dail Foprattaalcstoevonviiccloelwarticoenll, winlftiilftroactse,, wwiilldd vNaesgcluslcatroswiinse,nlsiiznaitmialon iPrviveasscalaacrrospaogens,iamitiffiolctarla,tei,ldwild PSrpoejceicets:hfaabter: OBICROIZ 001868 Somrized STAG Page: 192 . 383 STandriviiteadl SBinoglsecTaaalntdedrMaaalspBerte.r(actaimoinno) Riker Laboratories, Inc. 3 FN-3924: Tuo Year Oral Toricity-Oncogenicity Study in Rats Tae: 2 Foanel tohkes 90 ) SacrificeSd s1 aeslterenseas (3) IH 3 WicrFoicaitcarsyervations continent enon fn Sopteottrntitis, siceratioe, iatera, The olloing tissues wre foun to be within mrmal ints: rae, pnt, Salary Sat, Fares, Spleen, Heart, Testis/Epididyais, Prostate, Stomach, Urinary Bladder, Thyroid, Parathyreid, Fritue NNeasre,885Found tedSn fle Sram {5 FO Sn WroHtiet owrations: ren Kor tLoyw oPtruytary SGiomrm rriagic ws, 110.8 a. J ular Mp aeplabe cores--i-- oConrtiica wergorneesaitvieno, amty, aininl HPeepltviocerstiewraaslailnttiiosn,wwilrtdiecl, aitd SEiivna,tesiveiralimtion wid "TiTrorn Wrslasia, sates, aig svar ne--s --wesc Toevro,tiPoanrikngastiEsassuye,s wSrweiftonUri1nabrey wBitthien,rTmedisnitP:atho, Trachea, Esp, JA FFaitense taiteer108A) SEacrificedSeisn aFtereenssSeg | 5) FTCA 8 on [tat-- a -- Kany Sant Le Seuvisrd awas,, 0s.a5raatiegis.ss, 31 2, in ve Speutttien iglley fac. Flte Spleen Possibly enlarged Aooimionns MACRDSCopic. COSERVATION | RicwrEyE Areopry - NoTISSUE To BE THKEA Hoy orezcrot SPpaegcieets:dRabt s omiomz 001569 S.anwizee sti pe 155" . 584 ISnudniaviidaueald NSianrgolsecToaivculaantdedKchraasacopRiecprOtbse(rcvnattiioonnsd) PSR Tos YuHrieOrralLaTbooriactiotriye-sO,coIpnec,ici0ty Study i Rate Tale: 2 oFael: eYakneers1010ASEac2rificeSdaicn PmexarleesisSeow (1 FAIA 30 gpm Wroscorpeinc Dhservations {cotinued: "SCoirtsicaallvasctualsatiiso,n,Coaritle, adnate itr ppeelrvpiicassiinae,ralpielzvaitcione,ithalelldivn, papillary, Liver cHwreniatsropienyiesTiso,lexartersa,newtndierra,tewild Lag FYeersbrvransacgael,arloscoanlanacrleesa,r wiinlfdiltrate, ale Fir tuitil ry Sen ""ThMhdaenmnstocenapsrociisnsoinss,,nptirpalsleaarlylary, increased, ess Nwoitreednsine, aising TThoeutfsolDowrianyg tSitsosuueehs,weUrreinfaoruyndBltaodebre,wiTthhyirnaido,raPlraLthirvsei:, Trach, Esopus, Salve Bland, Pancras, Ere Foaie:e anseers1091) 2TeSrinal SSeuxriifFiocuels Grog |) FIR 30 pin WarPoistcupiitcarWyharvations: Haney Eland hosbse,r0.4wicsa,fi7a.5151 2.5 cn, throat are. Worosrcpeinc arvtions: Gin T"pSeeinlovuuitscsseistailenevaraiclcaieszlaiat,tiiooncn,o,rstmiein,litaiwlfaekceadl, sini ner wg "Wsetntaortesnaelrtaelriaztaitoino,n,vi6r1s4late, wild Meeworluagem,acrloopchaalgessr,sf,ocawli,daininal FHiarutrhyyraliand Pituitary DFoitbroesntanionnes, not in plan of section "hmscurcinons STahlyirvoairdy Shing J"omtscearrnciineo,n,aifslilnigcslar The fallainrg tiWsasrueess,wDrreyf,onSdtomtaochb,e wUirtirnianrywSoardmrl,nitTrsa:chea, Esohaqs, Pacress. FSrpoigeecstsouaatber: OALCROLZ 001870 Sunarized STAR Pages 194 385 rport Susaarized A reBkac nemy y MaStkoi ts Single Tabulated Mnisal Report (continued) a2 a Yo ae a 9 J EH $S01Sd1a.3icnin, iy es ws, 8 Newsne ratios or SAetnR,t-- e --wr KFtrtrse Hp3ioeeti,ns wssy boBSiieers FeTpormrtpee,is, ssn ratte, rant, Pil nae a i aot, ossin Ie eeit,syssrwr oSdot iinin,rodiLn Cv aSo ie os 9 Pn rs(Fsiytions: eTptorarna w1acptsn te tbHoneas Se Ftar ewayraeptret, 4 ory tt ens HAliieseAptriaamssi wit, 4 FlHoae e EBeSat, ssn Pir Species: Rat cn 001873 Savio 18 gs 386 STneairle aSlpe TistoddsisltfeBt ocianota Riker Laboratories, Inc. SN FN-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats note 2 oFeiteets1BSErticeSe1 orleevsro {3 FE 5 rssicon ctinad: TShheeeeltovtBistt,s wDreey,atnotbeVtihniany mBaohrr,inDtsr:e, rth, The STeoe eaer,15B) TEest aSeiFeete Sot 13 FE heresricrBSadrto: aaenk 3i2aa,stlatsareetsan 3c i, NrrityBeaton: Aiaa wfirlhi. o, 01 cn ts om Sint tai, crt wie Heart Kite f enfailts,,p sdrlen m--S "Myocardial fibrosis, wultifocal, sild t=iv pSvetlyasr sssrarteiio,n,,awlailitaf,,ldssn --r-- Hnpirrrieoon, a tSFuiareytwa TS"ieotowamerpse,stwsld, bibl, ai ort iWveiotosine& aollt, ta, wd hTerFelSoonnsisboasrwrBifert,tPo 0rastth,sTrralce,lts:ph, ei Sly ures eFid trets15BATDaal eSraresle Go 3 FA [OrFTayta-- Ek . rT ea,a15 ct tn, thst aes Wrmist: trical tortion, Lal ses we Fone Species: eRart : acon 001872 .`Sussarized STAR Page: 196. 387 SInodminvriidzuaeld MSaicnrgolsecoTpaibculaantdedNiMcirnoascpRiecporOtbse(rcvoanttiionnused) Riker Liboratories, Tne, 0 FH-3924: Two Year Oral Toricity-Oncogenicity Study in Rats Tale: 2 Ffiotwel GMeaeskhser:109A) RTeTrainal SSeaxc:riFfeimcaele Grow: (5) PII 50 pon Hicrohsecaarptic Boervations (contivued: doy Liver FLanngny Shand tvry tFeiruietsary "Wcarditis, chronic sonspurative, "Cwhlrtoinfioccaplr,ograelsdsive nephropathy, winiml "fPoerltvailc saoinnearnaclliezaartiocne,l siindfiltrate, ild HFeoprtaatlocybtielevadccotlaptriloinf,erwaattiiofno,casli,ldsininal "Hveapscautloacrytesiavletrearlaitziaotni,o,vacsuionlinaatled, wild "HHitehmicnarrceirnmolnVinits ~nhdeeroofnspair present "Cystic glands, arked STphleeefno,llSotuoimnagcht,isUsruiensarwyreladfdouenrd, tTohrbeaiwdi,thPianrantohrymraoidn,itTrsa:ches, Esophagus, Salivary Gland, Fares. mFaien:alhNeaeblesr:59B) ASRucDrificedSeni:n FexetmraelneisGrew: (1 FRI920 0 pon MacrFoisctoupiictrsyervations: Nasary Gland Nicroscpic Mhserations: Hererntal ivdevrey Lng PaNraanthnyyrosildand PTihtyuriotidary theres H"eSsuolrlrhwaigtisc, u2s4s%, 12.x43 0c.h8dciun,diar.ight wile, "WSyicmasrcdiidaall eftibarsoisai,s,comritteirf,ocsaold,raatled "HeCpraotnaecytperogvraecsassilvaetionne,phrcoepnattrhiyl,obufloacra,l, aalldd "Vvaesclualarr ssiamcrroaplhiazgaetsi,ons,ulwtiilfdocal, ald FHiebtroorartheangoe,naLocal areas, a0 o"Htereoxnanind, wissing t"ttytiecxagnliines,t,iswosdienrgate TShpeleefno,lloDwuirnyg,tiSstsouense,werUerifnoaurnydBtloadbeer,witThrianchenao,rmaElseLpihsatgss:, Sulivary Gland, Pancreas. PSrpoejceicets:Mafahter: O2ICHOT2 001873 Sumnrized STAR Pages 197 388 Sdiuvairdiuzale MSicnrgoleesTiabculatneddNiMciraoaslcpRiecposrter(vcaotnitionnused) Pr3t2k: To YekreDralLiTboervaitcoirtiye-sd,ncTocgm.icity Stuy in hats Tale: 2 nFatae:l tNhanbkosrs10I5RATReZrYainal SSaec:rifFiecmeale rougs (1 PRI30gAon HacrSotsicnpic servations: Adrenal Hiroscroepniacl Bernations: hart itrey LiLvger BKeassutreryGland tPuarncyreas Fitsitary air oss n forelegs. Riegihtt aatdrrennaall einnlvaorlgveedd. in a mass, 3x 2 cai "SPhiemoscshirdolccaycttouns,ia,aacloirgenra,ntmawrnkieldateral "hWyooccaarriitails,fibcrhorsoinsi,c lnoocsaulpuarreaatsi,vea,ld "Trocaacarperso,grweislsdive epopaty, oderate pPaeltvaicctaienrvailciwaoltaitoino,n,owfletriaftoecal, sininal "Fnreiscaoani,inienatleirzsattitiioanl,, wcihlrdonic, mltifocl, iPelrebvascalr somnaclaw infiltrate, wild lHcetwrarcheglee, alifecal, wld LiTouwaosnroctodnesscribed rosy. Highly "Naamuptlaathiycp.erplasia, itd o"mtonersanined, missing TShteeefno,llawrinegs,tisSstuoemsachw,ereUrifnouanrdy tBolagbeerw,ithTihnyroniodr,salPariastthysr:oid, Traches, Esephgas, Salivary San, Skin, Foatie:e eNtabeer:101500Te0r0sinal SSaeccrifFiecuele Brug (1 FTA 30 gn NrosFcipuiitcirByerations: Hoary land tess Wirohsicpriecd Oserations: itn ""Ssusl,l d2a.r5k1le1s3ionc,b0.r2ighctb dmai.lla epstic eawrihh,ag$i1c43cpt2i.c5 clte,sironi,ot21ing1u.i3naclb., right horn. "eCosrttiocasl,degteinbelraart,ionw,rifeedcal, wild PSrcoigeecnt:ufbate: OAICROIZ 001874 sucismrge mw 389 STwointe RSNitweatTshoecttiorTiieS,lOtpErtuecanont FI-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats aie 2 t Fae trht 1)1T0rl SSoaiFnue roms (3 [I fr ---- pFeotraal xSe foc rcnlitnt,,aiswt - Fofyanto weaslt, traslWaidel, froarytieSnt STPoaevrrutsn setei csh ioif slci,onsl rtaer TSoi SFIihoemfi,elolrtDss Swroe sftittybe Biatth,rPrreeo, tcs, Gps, Sv it eFoevhry SartSeoFraesrag (3 5 aNsasioecnuBraanttioonn F------ GTreray SSSeiiostsamtcainni,,,croanmn,diwtee, so - tuPontn,s,rwormeslaan,ehwo,irtnw,d wit, rity rnSoeerni, tia, ae SSirey ne SSvoair, str heeertslalr,asP,rtDoosssesarfsofats,bSotnsn, rmnrd iaidtr, Toys, iti, cs, on ae: Species: Rat con 001875 ------ 390 Sduimvmiadriuzaeld MSaicnrgolsecoTpaibculnatdedNiMcirnosacopRiepcorCth.se(rcvoanttiionnased) FA-592: Tao YeRrikeDrraLibTooriactiotryi-esB,ncoIngcm.ici3t8y Sody in hats Table: 2 JFaatteo:n (aebsetsr:10R9 ATeBrminal SSeaacdrifFeimcaele Group ( 3 F-S20 30 pon Nacrostcuorpyic Bhserations: Microsrceopniacl Shservationst Li[veer h wn Fitruartyhyroid FSiatliitvaarryyBland TThryirkoeisd "Soll sutulr wise, 0.8 co dis, Let ovary. SJiomtsceixdaanilnee,cawsiisas,iocgortes, wild JhHeepgaltoaccyytteasvsi,cawlialtdion, waltifacal, wild "FVrasecuutlnaira,aiinnetrearlsitziattiialo,n cihlrdonic, aultifocal, Havledlar ascrophages, multifocal, wild "oTtableaxramiandeedr,onssissing "ohteroxnasnined, aissing lott cexaanniinneed,, asiissssiinngg TShpeerfo,llKowiidnog,tiHsesaurets,vOeraerefso,unMdatmoarbye Ewlitahni,n nStoornmsaclh,LiUirtisn:ary Mader, Pacrens, Ere. fFaotea:l eNsasteer:89I)RASRaEcSrificeSdexi:n FeexmtarleenisGro: (3) P24 30 pa WacroHsacsosprcyDoBsleirndvations: WicrLoiwvaepric Observations: real Fnidgney Nlasesmry Gland "aSnugrefacaeis,e,in1gu5i5nal12axres3.ca, ulcerated tgpears enlarged "CSoirntuiscoailalvacewcotlaastiiao,n,cofrotcea,l, warlkded v"apeslcvuilcarsianiernaelailziaztaitoino,n,siwniitladl wPirleesonta, interstitial, Oran, miltifocal, FHivberoldaerrcansscropages, wltifocal, il fewnwadteorptaeiess, etranedllary, increased, LTSihaelvievf,aorlHyleoawBriltanyngd,UttisePsiatusue,istaGwrueyra,ey,fPoaSuctnrodewsatscoh,,beLUyrwsiihntahriNynoeBnloar(dmedaselre,nLtiTrmhiiytcsr):o.id, Farathraid, Traces, Esophages, PSrpeocjieets:Mafahter: 08ICRIOL2 001876 Somwrived it ge: 20" 391 SInucsiavirdiuzale SMaicnrgolsecoTpaibclaatneddNiicnraolscoRiecpstercvoanttiionnuesd) FRITH Tog YeirteGralLbToorvactiotiye-sG,cogIencn.ici3t0y Sad in Rats Tale: 2 fFiotae:l (Measbtse:109I)ATRerIainal SSeaxc:rifFiecmeale Geo: (3) FIS920 0 pp NcrosHcapwiarcysEelravnadtions: Wiros[cp2ic servations: Euiopehrags Liver TM NPaonacnrreyss Eland TPhirtauiitdary "Lonbgueliatneld aarsess,, 65x51 3 ca, right "CSoirntuiscoaildalacesclaastiiao,n,Corftoecasl,, wwiildld Zoetlviecansiineer,izsaitsisoinng, siviml TWoerattaacsoeanacltleerwartiocne,llvaicnsfillattreatt,e,miaitlifcal, Plorgtal bile dct proliferation, wild vPaasecauolnaira,siinnetaelrisztaittiioaln,, cahirlodnic, sltifoal, Aillvaeolar sacropages, sltifocal, ald lFitbroeaxtnerionnes, issing "keceilalgncearscsi,nonisnadeguate section TSphleeefno,llHoewairntg, tRiessraaess, wDeureryf,ouSndtontochb,e UwriitnhairnynoBrlmaadlderL,inPtasr:athyroid, Traces, Salivary Glad. nFaitne:a eortiheers10(51T-e5ranal SSecxr:ifFiecmeale Grau (3) FAS 0 pon Nacroscopic servations: icrosHcaorpeinc Observations: Liver Lag rSaalcirveasrsy Gland Thyroid o visible lesions. ""Shienpuastooicdyatle evcatcuusoilaa,tiocno,rtuei,tiwfodoecrla,teaild Haelpeatocyte alteration, vacwlate, sltifocal, "Hieasrcoarlraarges,inmeualltiizfaotcialo,n,awlidld Jott saxrsiinaend,, sniisstsiinngg Shperpasia, cal, mitifocal, ania TShpeleefno,lloFwiidnngey,tisHseaurets,weUreerufso,undDutroy,beNwaiathwiyn nBolramnael, TSitnotmsc:h, Urinary Bladder, Parathyroid, Traches, Esphagas, Pituitary, Lyng Nate (senteric). SPpreocjieecst: NRuastber: O2BROL2 001877 Sunaried STAR Page: 200 - 392 `TSnudsisvairidzueld MSaicnrgolsecoTpaibculaatndedKiAcnriossalcopRiecpoOrtne(rcaotnitionnused) Br3t28 Too YeRrikGeralLaTbooreactioyri-eGsc,ogIennc.ici1ty Std in Rats Tale: 2 SFaota:] habeeer:105I)RATRe3rSnnal SSeaac:riFfiectee Seow (1 FRA 0 ppm Wacratsceopic Ooerations: Haury Sand Wicrotsceopic Orarations: Liver Lng Soaunrayry Sand SiPitnsitiry Urinary Blatter p"asceirtiya,lrisgehutlee,n.| ca din, perineal are wlaist,era11w5e3s.115 2.5 ca, Tit "Rteatrat,atwrnoiplhya,terdailffuse, unilateral, wares PForrttaall sbiolneedculcteaprcoellilferfaitlitorn,atwei,ldwile Wseiaetacte alteration, vicslate, focal, "vsecaalle ascinreorpaalgienst,ion1,1dild "emwaarrrchaigneo,nmsltifocl, 116 Toatbuleaxruibynpee,rpliassias,nbilateral, aarked "oLtipeaxaioe, aissing TShpeleefna,llKiidnngey,isHseuaers,aUrkeeufsu,ndSttooabcehwidtrheinnln,orsTahlyroliidn,itsP:arathyroid, Trache, Escphages, Salivary Glan, Parcreas. FIantoea:leNtoteer:8I)RAFGoSunTd beadSe: Fale Sroupt (3 FRT24 30 gon [ey ---- WicrXoisdcrpeirc harvaions: liver uFintsgitary USrailniavrayryBGaltatnedr lo visible lesions. "Ppelevricsisiane,ralpiezlavtiiconi,thweilldiun, mila pPoorrttaall bsinlmeadcclteaprcoellilferiantfiiolnt,ratael,dalg cHepaatolcyteinvearcauloilzaattiiono,n,seslitlifocal, ile oott eexxssiinnee,, aaiissiinngg Jot exsine, wissing STphleeefno,lobwairntg, tWiassrueess, eDraeyf,ounadsmtorybeElwaintdh,inSntoonrcah, lAidarietnsa:l, Thyroid, Parathyroid, Trachea, Spcies: at Project Nusber: 0281CRO01Z 0018'%8 ; Suswarized STAR Page: 202 393 SInudmiavriidzuaeld MSaicnrgolsecoTpaibculaantdedWiocirsoaslcopRiecporOtb.se(rcvoanttiionnuesd) FS924: Tuo YeaRrikreralLaTboosriatcoirtiye-sD,ncoIgnecn.ici3t%y Study in Rats Table: 2 foimal Naber: (R-4GT Sex: Feaale Groups | 3) F-39240 pp Fate! Gets 87) Found Dead The fNoilclroowsicnogpitcisOsbuseesrvwaetrieonfsoun(dconttoinbueedw)i:thin normal Jinits (continued: Esophagus, Pancreas, Small Intestine. Fiantiea:alGMeoeskhser:98()R-S4aEc3r8ificedSexi:n eFxetmrleesisGrow: (3) FIFA 30 pon WacrPoistcuopiitcarOybservations: LiSvpleeren Ransary Gland Hicrohsicraepniacl Observations: Xidney LLuinvger Fanwary Gland Pancreas PPiatruaitthayrroyid Spleen Thyroid ""EEnnllaarrggeedd h"Haalses, 3.5 x 1.5 ca, miltilobular, perineal a6r1ea5u1lc4er,atedriwghitltillaotbeurlaalr aaresas,, ""SPienluvsiocidsailneercatlaisziaat,ionc,ortseisn,isasloderate "NHeesshartaospiosi,esitsa,baleaxrt,ranweilddullary, siniml ""VAadsecnaolcaarrciinnoenraa,liztuabtuiloanr, sild "ANdotenoecxaarnciinneodm,a,ipsasiinglary ""Nhotenoemxaanined, issing "Hesatopoiesis, extranedullary, increased, "Nwortkeedxanined, wissing THheeartf,ollUotweirnugs,tiOsvsaurye,s wSteormeacfho,undUrtionabrey wliatdhdienr,norTmraalchelai,mitEss:ophagus, Salivary lan, Eye. fninal Naber: (R-1839 Sex: Female Group: {3) FFIS24 30 pon Fate: (eke 105) Terminal Sacrifice Macrosskcionpic Ooservations: Microascroepiacl Oiservations: Kidney Liver "Hair loss on forelisbs. "~SCihnruasnoiicdaplroegrcetsassiav,e cnoerptherso,patshoyd,eraatienisal "PHeelpvaitcocsyitneervaalciuzoaltaitoino,n,#imludltifocal, wild Psrpoejceiecst:ahbaetr: Q28ICRIZ 001879 Sunnarized STAR Page: 205- 394 neadroi aSiageme TamwuaatreWii,raaslrceaieep1era(tniotno PHT: To Yeu da Torrone Std in Rts aie 2 E Fs ae 105 ToraR n Sui Fee Py, [L4e]------ Ten e--s -- VrinaaerryoyiHdater eeeint npn sissing Tr ig tiepi Srpeemeafsdhn,beSaoHa,wTnotrdinTsetchs, Esphies, Slivay San, Fern, Sis Pree eaemee aSnuitScesaesees ro {PH 7m WeraTshipoircanaeerraatiton: A ey rh, e an 252 4 fn ner iV.m Tpiaee,dwd vsmteseated sete, 315 ch pravterd to cri, oR 10 Weprsisroaptinc Omron: Nrecriossa, iatei,elaltetralw,aasviiedd Vows wr b FTeOc wseam ninah ertti rete, inl eTpoperiaicbsintea,fstwirnrt,eercat,yion,roaoiutned rwwenrmyNoe Wthorcic oeesesntesisaiy, id DHyirnas THoinn m weeston, itoeeorf ,chaeind Siew rtaepiests, rally nse, vrs TA jon it , --ie--s --rs cso 001880 Soriced srg 0". 39 Sussarized Single Tabulated Mnisal Report (continued) AI-I3n9d2i4vidTuoaolYeMaabrcirtoOersracloLpiiTbcoorraacntidrtiyMe-isDc,nrocsoIcngocnp.iicci3tD%ybseSrtvudaytioinnsRats Tale: 2 Ffaotei:l GMeaeeksr:99U)48Sa0c0rificedSexisn FeexmtarleeisSeow: (3) FII920 0 pon Microscopic Observations (continued): TSthonfaohl,lowUirnignartyissBuleasddewrr,eThfyournodid,toTbreacwhiets,hinEsncoprhmaagles,linSiatlsi:vary Glan, Pancres, Lywh ode (esoteric). JFaotei:nhMeoseher:101R) AScBrificedSeni:n FeetmraelneisGrow: (1 F390 0 pn WacroNwaswpaircy OEblsaenrdvations: Maren LPiavnecrreas LtoidgohneNnodtein(taeersaeln)teric) ters Hicroiscrpeict Ghserations: LKiivdenrey LFiannhnyNotlean(daesenteric) FaPcitrueitsasry Stomach trhienrrsy Blatter "Sowbicltlasn,esas was, 45x33 2 cn right l"Leeft atrenal marge, "o3l.t5ilcaab,ulianteardeaesoafrrpahngcirceasaasism,ol4v.i5n1g3 x "Fitlhelecdauadiathteblliovoedry lfolbuei,d. ""EHnlltairgleodblar oystic mas, $35.51 25 en, near cervis, "sWianluisgoniadnatlIeyscpthsoinaa,, chiosrttieo,cytrikced ""Cohrrtoanlicbpilreesdsetivperamleihferroaptaitohny,, sainlidnal ""HLaolbilgaurnthypIeyrspplhaosni,a histioetic a"llaitgneaanvtinIey,mhiosnss,inghistiseytic "Ycaelirgnant Iyshons, histiseytic "HatliigcuangtlaInysm,howmisl,d histiscrtic Walignnt spon, histiocytic STphleefno,llHoweianrg, tLiasnsge,esOwreye,foTuhynrdoitdo, bPearwaitthhyirnoindo,rTaraclhienai,ts:Escphags, Salivary Glan. SPpreocpieest:NRaasth: O2ICKL2 001881. Susnriaed STR Page: 205 396 SInudsimvairdiuzaeld SMaicnrgolsecoTpaibculaatndedBiAnriamsaclopRiecpoOrbtse(rcvoanttiionnuesd) FA-3924: Tao YeaRrikOerralLaTboorriatcoirtiye-sD,ncoIgnec.nici3t1y Study in Rats Table: 2 mFaitnea:l GNaebter:1051)R-T4eBr2ainal SSaecxriFfeiscaele roup: (31 FI-IRZA 30 ope FacrosSckoipnic Observations: PiRtauniteayryShand Wicrohsicroepniacl Oservations: Litvneer Ung Rasuary Bland OPaunrcyreas Pistkiunitary Thyroid "afiosnetdpadi.nflamatory Lesion on right hind H"aLosbsu,la0r.7mscsa,di2a..5 1 2 ca, Jeft inguinal area; Tianbguulianralmaasrse,s3l1ob2ulaar,marsisg,ht6x 5% 3.5 cu, right asilla, "PSeilnvuisocidaailnerecatlaisziaat,ionc,ortaeixn,itamlarked "FPoorrttaall sboinloenudccltearprcaellilferiantfiiolnt,ratsei,nimwailniml "HVeassocruelhaargea,indeirfafluiszea,tiowna,rkewdild FFiibbrrooaaddeenroonan "TFuibburloaardehnyopenrplasia, bilateral, soderate "hIcsilentarcealtlropahgye,ncwearked ""Phodeondoermaatitis, ulcerative, unilateral, "wHpaekresdlasia, C cell, focal, aild TShpeleefno,lloHweiarntg,tiUstseureuss,veSrteoafscohu,ndUtroinaberywiBtlhaidnern,ormPaalratlhiyirtosi:d, Trachea, Esophagus, Salivary Gland. Ffaitsea:lthKeoeskhesr:85()R-F4oBuAn DadSex: Female rows ( 3) F-35210 poe NacrFoistcuopiitcarOybservations: NicrasNcaoapwiacryOhSshearnvdations: hirenal Liver LPuanncgreas Parathyroid i"Srucaalllaarilrkaicsyetd sins,ing0u.i8nalcoadrieaa., ""Sfionrutsaolidsaolnoencstcalseiaar, cceolrlteixn,fimlatrrkaetde, sild "Pvoarstcaullarbilseindeurcatlipzraotliiofne,rawtiilodn, aild ""Nhoott eexxaasniinneedd,, waiissssiinngg sPpreocjieecst:afbaetr: O2BICRMIZ 001882 Sunnarized STOR Page: 206 - 397 P8`n2Sui:ssvareTizoledYScuiNrnegenalre TLnaoTbbuwlnaatdteordWiAten,risnoaeslceoRoenposrterS(vctaotdnitioninnusedR)ts Tae 2 aFaitea eosres 5TFAondStedS Fee Gr (9 PAE pm WerashaiictsBarations (ction) re. SSaevy hand meeniotrwtsspngt veaadn fot errniee Wneng Khiedof,oioHeirnsg, iWsesruee, wGroeryf,ouandvtoybeSiantsiesryl Biliaste:r, Exghges. rFeerl tYerhs105T) ATSorso SSuoifFeose Gro 3) 3 5 on Nrss[ceichtartiss iKpineer ovary Rise rk ws, 0.1 cn dae o e"viavnsecptoa_ menmiavecso heeipas,t,ald31d "Cyst, unilateral HFiotrd eJtvnnies Wes Troi enon, wissen TShheefnoloLninveg,tiHsesruse,s wWearesf,onMdantenybeGwaitnhsinSwtoorinh,nWiitnsr:y las, Traces, Espa, Slivay Sd. eFare tNhaebee8TASBatieSe1t weraelnsron (EH pn -- tity fies HShuienttyass,e0.7 cdi [irrw -- rte degeratin, Ta ares, tte toe Seetrralltbsyoereattaienrtai,flerafotiileotnr,,atmewi,erauitlteee un eva svraistion, ile SgrecesssWaet, OBER 003833 B Susmarized STAR Page: 207 398 SInudninvairdiuzaeld MSaicnrgolsecoTpaibclaatneddWiMcirsaaslcapRiecpoDrbtse(rcvoanttiionunesd) FI-3924 Too YeaRrikOerralLaTboonriatcoirtiye-sD,neoIpce.nici3t0y Study in Rats Table: 2 nFaitnear) (Kloebekesr:90I)RASBaIcSrificedSexi:n FeexatarleensGroups (3) F394 3 gon MicrosPcaonpcirceaOsbservations (continued): Pituitary "tHaitenoenxaained, aissing TShpeleefno,lloKxiidonagy,tisHseuarets,weUrteerufso,undOuatroy,beKwaimtnhairny nGolraanadl, lStionnatc:h, Urinary Blader, Thyroid, Parathyroid, Traches, Esophagus, Salivry Gland, Lyuph Rede (seseteric). fFaitneasl (Nhaebsesr? 80R)4F4ou6nd DadSext Female Group: (3) FASTA 30 pon NacraFsictoupiitcarDyiserations: NicrasMcaeapsiicryGhEslearnvdations: hirenal Liivdenrey KLauanngary Shand PiPtanucirteaasry TShlyeroid ""Lwaarlgteilohbeusolrarrhasgaisc,as2s.,571.12c1o,1pecar.ineal ares. Snineusoofidpailrepcraessiean,t cortes, winieal FPoerltvailc sioenroanlcilzeaatriocne,llaiilndfiltrate, wild "PVoarstcaollarbilaeneuracltizpartoiloinf,erawtiilodn, aild FJiabtroeaxdaeinnoenda, sissing "hheiseonsoinadersis, aild Utiscbranchial cyst HTehaertf,olUltoewriunsg, tOivsasruye,s Swteorneacfho,unUdritnoarbye wBliatdhdienr,noPramraalthLyirnoiitds,: Trachea, Esophagus, Salivary Gland. fFoaitnea:l eNkosees1091)84S0a4c7rificeSdexi:n Feesmtarleenisrow: (3) F924 0 pp Nacrohsacaorptic Observations: harem Nicroisdconpecy Observations: Kirenal ""pLoesfstibalderenpaelriceanrldairtgiesd due to wass, 1.5 ca odpies.r pitted "CCoarrtciicnaoln,atcroorpthiyc,alw,iluantielraatle,ralmarked Aeophy in non-neoplastic gland. SPpreocjieecst: Mhuastber: 028I0R012 001881 . Sumnrized STAR Page: 208 399 ISnudmiavriidzuaeld MSaicnrgolsecoTpaibculaantdedWihcoriousaclopRiecpoOrbtse(rcvoantitoinnsu) 3924: Tuo YeaRrikeOrralLaTbooxriactoirtiye-sO,ncoIgnecn,ici3ty Study in Rats Table: 2 Aoiaal Mander: (4807 Sex: Fenale Group: (3) FA-392430 pon Fate: (bests 105) Sacrificed in extreis Nicroscopic Observations (continued): Heart Kidney Lung Nasaary Sland Pancreas. Pituitary ""Cpherroinciacrdiptriosg,recshsriavneicn,epdhirfofpuasteh,y,sasdoedreartaete "VParsecluolnaerphrsiitniesr,aliazcauttieo,n,unislialtderal, sarked Netastatic neoplase "HPolteureixtainsi,nedc,hroaniiscs,ingdiffuse, soderate h"Noott eexxaamniinneedd,, wwiissssiinngg TShpeleefno,lloLwiivnegr,tiUstseuruess,weOrvearyf,ouSntostaochb,e wUirtihnianrynoBrlmaadlderl,isiTthsy:roid, Parathyreid, Trachea, Esophagus, Salivary Gland. : fninal Mosher: (R48 Fate: (beets 65) Found DeadSex: Fenale Brow: (3) FA-IO0N 30 pon Macroscopic Observations: Liver KSikdinney Microhsicroepniacl Observations: LEiscvpehragus. Lung Hasaary Gland Bary Pancreas. Parathyroid Pituitary Salivary Slang Skin Thyroid Trachea Urinary Bader Pale ""NSautbtcluetdaneous ass, 21 1.5 ca. "Hot examined, wissing P"Noorttaelxabiinleed,ducmtispsrionlgiferation, winisal "Vascular mineralization, sild ~benocarcinons H"Hoott eexxaanniinneedd,, wwiissssiinngg -"bNdotenoenxsamined, wissing Not exanined, issing "Susbiccurtoasnceoopuisc nmaassinnaottioanvailable for "Hot exasined, aissing "hot exanined, wissing "Not exanined, essing TShpeleefno,lloKwiidnogwy,tisHseaurets,weUrteerufso,undStotnoacbhe,wirtahiinn.moral Linits: PSrpoejceicets:asRatter: S281CR0012 001885 Summarized STAR Page: 209. 400 Suswarized Single Tabulated Anisal Report (continued) Individual Macroscopic and Microscopic Observations -- -- 001886 sure 401 Stnriinnd SRvigete TLnaaelwaoertiNoone,rloTcepTeeo1Brwcetiioonn HT To er al Tor copii tty i ats Tie 2 oFria a SusieSe Feiusry {9 Fn J0ooh[onmAistt--ayw--o o--v--itn srs Nits oni oFer eenr0TFRond ek Fi og {9 Tn [Soieop n -- paem Yo rk tas, 210.7 ca fn ight stro brn HSiotus itote wfoith odf kstowme:, 02 ia Massary Gland "Maessv, 2i5x 5w1.5e7cu,crletfat saxorinliylgah;61 2x 4c multilobular [ rel -- prio Gta wea, eal aes, ade iter STeeesenosssversssiiwtihioetnisal,rdseimds nr eTnraei teeea a,rwss tabrvtteits ws trWeeitnteowns,aaraeettreirnsr,eitmiete,s id fo---- F[sicortresaam hSrtt T[troinnn meri id islantien pe Stour fSeoprreirss, atraliey, irene, fYroires attr TfEueimeiihist ses ite, i htieatiaeeLesr tos twk l res Species: oRart s cron 001887 SindST ae 21 - 402 Srnirinzn aitecretlaetnetdnHbeiroacpB,orBtavCnattiovnet FN-3924: Two Year Oral Toricity-Oncogenicity Study in Rats aie: 2 aPoe enn 0TFon be rie So 3 Fm Wrsanic tation (cntined: rFt E Bry: Fase, eve, pa, Sy--h-s, Pures rrea eems0BFonto si en Sg 9 PY Weroroniec dprntions Lapgleywile us, 17x 48 erin KroinaietaByorie: pr J Site eta, ert, brite wn J Spsrvietneass a1 un sWWertnienstct,anosoenend,iwnwgiid,sw,ie a4 eP"etyre Sit nFoteoainntw,saiisiongns Wid iTJt erd TTeoveesmniins, tae of trully, scion ices pi he olin ines we fnetoabe aattheesrTlreientT:hs, Esha, Slvr Sa rFiee taee 8aSaorisn i FvoriesSo 9 TH [ Neirina-- mrntions ied rnc ae, 1105 cn rt-oo CimeSeeaatevwaeitistionnc,,toes,ptwisld, ie oeateaestohnaddate, ald et Species: aRart : cco? 001888 suis" . 403 Sussarized Single Tabulated Animal Report (continued) FN-3924: Two Year Oral Toxicity-Oncogenicity Stuy in Rats Tol woz 001889 " Sduimvairdiuzaeld MSaicnrgolsecoTpaibcalnatdedMiMcrrionsaclopRiecporst.er(vcaotnitionnused) PIA: Tao YairteOrralLaTbooruaitcoirtiye-sO,ncIongce.nci3t%y Study in ats Tale: 2 fFaota:l hNeaseer105I)AETeSrSaimal SSeusesifFiecmaele Grow: (1 PII 0 pn WacrPoistcoupiitcarOybsarvations: Wassry Blind Wicrohsecrapoincl Observations: Kidney Liver TM Wasnry Gland tPaanrcryeas Pituitary iassse,d5a1ass3,c0,.5rciaghdtisa,xillas firs mss, 11 x G'S co, right inguinal area, "SCiorntsiociadlaldeegcentesriaat,ionc,orstoed,ramtaerked "CPherlovincicspinreeraslsiizavteionn,iphwriolpdathy, alg "Fraorrttaall bsiolneanducclteaprrocleilferiantfiiolnt,rawtieldald "Vlevesoaloaproiseascsr,oshaatgreisa,edaulltliarfyu,alw,inaiinladl FBibrraaanner,onsfocal, sinissl hhiieeonccaarrcciinnoonn peas to arise fron 4 "TaFbiublraordehnyopnesr.plasia, bilateral, ld iJcienye atrophy, sild TShpeleefno,lloHneianrtg,tiUsesresess,wSrteonfcohu,ndUtroinaberywiBtlhaidndern,orTayrlan,itsP:arathyroid, Trachea, Esophags, Salivary Glan, Lyoph ode aeseneric). Ffaotea:l eNsatseer:901)RASGaScErificedSenisn FexetmraelaeisGrow: ( 1 FI 30 opm MacroPsictoupiitcarOybservations: Wierosrceapniacl Oservations: LXiivdeorey Piutnugitary sStaolinvcahry Stand werss "Large ewseenagic mass, 1x 15 cn S"iEnhursnoiicdaplracgtraessiin,t cnoergtreorp,atwhiyi,naslinimal SHoerptaatlocwytneomvcalseoalraticoenl, pinefriilptorrattae,l nalideal ""haeeroorrnhsage, miltifocal, aild TJeottonc,ansiunebss,oialis,sisnogderate Gran, ini oly PSroocjieocst:Wafaster: O2ICRIOT2 001830 Sunri sm rg 405 i Bee Uterus ~Prolapsed through cervix. E-- 001891 106 Susuarized STAR Page: 215 Sumarized Single Tabulated Mrinal Report (continued) Individual Nacroscopic and Wicroscopic Observations PR-3924: Too YeaRrikeOrralLabToorvaitcoirtiye-sO,ncoIpnec.nici3t%y Study in Rats. Table: 2 MFaitaea:l (Noeskbeer:105()R-4TEeSr8minal Sex: Female Sacrifice row | 3) F-39240 pp Nicroscopic Observations (continued): Lung PPiatnuciretaasry ""Avcaisncaurlaratrsoipnheyr,alaiizladtion, aild "Menon TSphleeefno,lloHveairntg,tiUstseureuss,weOrvearyf,ounNdamstaorbyeGwliantdh,inStnoonramaclh,lUirsiitnsa:ry Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary land. Arial Fate: (MWuesebkesr:1051)6-4T8e5r9winal Sex: Fesale Sacrifice Sroupt (3) FA-3920 30 pou Nacroscopic Observations: Wicroscopic Observations: hirenal Heart Kidney Liver Lung Salivary Gland Uterus Ho visitle lesions. "Sinusoidal "Ayocartial ectasia, fibrosis, corer, marked wltifocal, sild Wyocartitis, chronic nonsuppurative, witifocal, ail "Chronic progressive nephropathy, marked "PPoorrttaall bsiolneonduuccltearprocleillferiantfiiolnt,rataei,ldsild Hepatocyte vacuolation, sultifocal, sild Vascular Alveolar ascirneorpahlaigzeast,ionm,ultaiiflodcal, aild ""ESyisatliacgengiltainsd,s, cshordoenriac,te aild STphleeefno,llOovrairnyg, tKiasnswuaersyvGelraendf,ouSntdostaochb,e UwriitnhairnynBorlmaadlerl,iniTthsy:rcid, Parathyroid, Traches, Escphages, Pituitary, Pancreas. Ffantien:al (Neuakbeer:72I)R-SAaRc0rificedSexi:n xFetmraelaeisGroup: (3) F-39230 gpa . MacroSstcionpic Observations: Nicroscopic Oservtions: Kidney Liver "CiLrecfatnsicnrdibefdootu;lcelraartgeedsmuabscsu,ta0ne4oucsa dia., ass, 31103 1 ca, right inguinal area. ""CHhersoantiocpopiresoigsr,esseixvteranseepdhurlolpaartyh,y,anwiimnailsal SPrpoejceicets:NuRsabter: 0281CR012 001892 Summarized STHR Page: 216 407 SInudsisvairdiuzaeld RSaicnrgolsecoTpaibclaatneddMiMcirnoaslcopRiecporOtbse(rcvoanttiionnused) F-3924: Tao YeaRrikOerralLaTboorractiotryi-eDsn,coIgnecn.ici3t%y Study in Rats Table: 2 iFantae:l ONlosebker:721)R-S48a8c0rificeSdexi:n FeexmtarleenisGrow: ( 3) F-35240 pou WicroLsucnogpic Observations (continued): ONarssyary Gland Psakrianthyroid Silom Thyroid "Wascular aineralization, sinisal Hyperplasia, septal cell, focal, ld "hCoytst,exuanniiloaetde,raalissing faottodeexraasaitnietdi,s,aiuslscienrgative, unilateral, aFirbkreodas Large lesion fron inguinal area, Extensive "Hneescartoospiosi.sis, extramedullary, increased, "hsoetnaextaenined, aissing THheeartf,ollUotreirnugs,tiSstsouteacsh,werUerifnoaurnydBtloaddbeer,witAhdirnenanlo,rmaTlracJhienist,s:Esophagus, Salivary lan, Pituitary, Pancreas. Ffaitnea:lGNeaebker:105()R-T1e6r8m1inal SSaexc:rifFiecmeale Group: ( 3) FR-IF24 30 pon RacroLsycaopphicNoOdbeser(vaaetsieosntse:ric) Picrohsicroepniacl Observations: KiLdivneery LLyunnsgh Mode neseateric) Uterus "Enlarged "CSoirntuiscoaildalvaceucotlaastiiao,n,corltuceaxl, asruefaesr,atmeoderate ""CFhorrotnalic spornoognruecslseiavrecneellphrionpfaitlhtyr,ates,iniwnialld "HVeapsactuolcaryteaivnaecruaolliaztaitoino,n,au#litlidfocal, aild ""SCiysmtsiocidgallandesc,tassioad,erastoeferate The following tissues Spleen, Heart, Ovary, NwearsewafroyunGdlantdo,beStwoimatchhi,n nUorrimnaalryiBilatdd:er, Thyroid, Parathyroid, Traches, Esophagus, Salivary Elan, Pituitary, Pancreas. SPpreocjieecst: hRaabter: micro 001893 Sunnarized STAR Page: 217 - 408 SInudaisvairdiuzaeld SMaicnrgolsecoTpaiuclaatneddHidcnriassaclapRiecporOtb.se(rcvoanttiionnused FIR Too YaHrikOerralLaTbaorvaitcoirtiye-sD,ncIangce.nci3t%y Study in Rats Table: 2 rFaitne:a bbeeatrs:93R) ASaGcrificeSdeixn FeexmtarleenisGroup: (5) FAITH 30 pp MacroPsictoupiictarObyservations: LSitvoneirch Wicrhaasrceanpacl Observations: heart titney Liver Lung PPaintcurietaasry SSuplneen Stonich Urinary Bladder a"Esnsla,rge1d1g0as8traic, rugae. "ale and ottled. ""Saiynaucsrociidtails,ectchsrioan,icconrotnesrp,puarnadteirvaet,e "wCiotnidioccaplr,ogsrensissiavle nepbrapathy, ald opreltvailc wsnoevroanlcilzeaatriocne,llsiinnifsialltrate, alld FHoerptaatlucbyitlee vdauccwtolpartoiloinf,erdaitfifouns,e,wisladrked vNaesccruolsairs,wfeorcaall,izasitniiosni,l sild Perivascular sonnaclear infiltrate, alld "doteneoxnained, sissing "LHiegsoosniderosis, aild "Eudternsi,tissu,baacocnea,l, sooddeerraattee "Epithelial hyperplasia, simple, diffuse, ald TUhteerufso,loOwvianrgy,tiRsassuaersyweGrleandf,ounTdhyrtoaidb,e wPiatrhaitnhyrnoeirsda,l TLraicnhtess:, Esophagus, Salivary Bland. JFaoties:al (Neakbeer:10(5RTAeGrSainal SSaecn:rifFiecmeale row: (31 F924 30 pn NacrPoistcoupiitcarOybservations: Kanwar Shand Hicrboasrceonpsilc Observations: tLiidvoeery LKuangsnry Gland bury Hhaassse,,10..53 cxa 1daca., perineal ares cystic ass, 25% 1.5% 1 chy left axilla, ""SCihnrunsiocidaplroegrcetsassiav,e cnoerptherro,pawtihnyi,naalild ""HMeipnaetroalciyztaetivoanc,uolfaotciaoln,,pawrietnicfhoycaaall,, wwiilldd "hLdabeunlsacrarhcyipneornplasia "Cyst, wilateral SFrpoejceicets:huhsabter: OZICANIZ 001894 Susmarized STAR Page: 218" 409 SInudsimvairdiuzaeld MSaicnrgolsecoTpaibculaatndedWiMcirnoaslcopRiecpoOrbtse(rcvoanttiionnused) Riker Lasoratories, Inc. 30 FI-3924: Tuo Year Dal Toricity-Oncogenicity Study in Rats Table: 2 AFratiea:l (NHoesstkeer:1051)48Te6r3ainal SSeaxc:riFfeimcaele Group (3) FA-S92430 poe Microscopic Observations (continued): Pituitary "herons TShpeleefno,lloHweianrgt,tiUstesruuess,weSrteomafcohu,ndUtroinbaerywiBtlhaidndern,ormTahlyroliids,tsP:arathyroid, Trachea, Esophagus, Salivary Gland, Pancreas. Ffantien:al (MMeaedkesr:1051)R-T4eBr6n0inal SSaexc:rifFiecseale Group: ( 31 PA-I920 30 poe Wacrescapic Oservations: Wicroscopic Observations: hrenal Kidney Liver Lung "Ho visible lesions. ""SCihnruosnciicdaplrocgtreasssiiav,e cnoerptherso,patshoyd,eramtienimal "PPoorrttaall sbiolneonudculcetarprcoellilferiantfiiolnt,rataei,ldwild Hepatocyte alteration, vacuolated, focal, ail "vascular sineralization, sild TShpeleefno,lloHseianrtg,tiUstesruuess,weOrvearyf,ounadmntorybeGwliatnhdi,nSntoorsmaaclh,liUsriitnsa:ry Bladder, Thyraid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pituitary, Pancreas. fFaitnea:l WMeueakbesr:105()R-4TBeErSsiml SSeaxc:riFfeiscaele Groups 3) PR-I924 30 pp Wacroscapic Diservations: PNiatsuniatrayryShand MicroAscroepniacl Observations: Arenal Esophiges Heart Kidney Lung "aRsasis,ed3l3es2io0n, 20.c5u,cupedriian.eal area. "Left enlarged, miss 1x 0.6 cr. "SNionduusloairdahlypeecrtpalsaisai,a,cocrotretxe,s,maordkeerdate Cortical degeneration, local areas, aoderate ""MNyootcaerxdaimtiinse,d,chirsoinincgnonsuppurative, ~Dwhirtoinfioccaplr,ograelsdsive nephropathy, ail "VPaelsvciuclasrinaeirsaelrazlaitziaotni,on,alsdild APlevreiovlaasrculsaarcrospohnacgneusc,leafrocailn,fialitlrdate, sil Species: Rat Project Nusber: 0261080012 001895 Susnarized STAR Page: 219- 410 SInudmimvairdiuzaeld NSaicnrgolseesTpaibcalaantdediMcirsaaslcoRiecporOth.secrovnattiinounesd) Hiker Liboratoies, Ic. H-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats Te: 2 fFaitneasl (bheesrst105I)RATeBrSsioal SSeaxc:riFfeimcaele row: (31 FI-SV24 30 pp icrosYcaonpacryDbGslearnvdations (eantinued): [2 FPiatriatthayrryoid Tshpyireomid Trachea FSiablrcataotceerloens "Ttaybstu,larwihlyapteerrpsllasia, unilateral, saderate "ehaat enanine, nissing "oHtewaesxiadienresdi,s,siasisling "lot eusine sissing TLhieverf,olleorwainsg, iSstsounecsh,verienaforuynd Btloadbeer,witShailnivnaorrymaGllalni,nitPsa:ncras. nFait:n baesbtesr:91()1S-u8r6ificedSexi:n eFxetmraelneisGroup (3 FIA 30 pon WacrFosiciatpiacrOybservations: XiTdonyesy hNaarneamy Gland Hicrosrceapailc Bhsrvations: Hert idney LLnivger PaHraantnhayyreSihdand PSiatluiivtarayryGland ""Epnlearrgsedednuleartgoedbeworrhgic ass, 1 ca dia, ""FLoestibaldyreenanllaregneldarged, "Ulicnerraitgehdt saxuilltlial.obular ass, $1251 2 chy "Cwoiretriacatle vacwlation, local areas, wilateral, Swienrusaotiedal ectasia, corte, unilateral, Gwairltaitcearlald,egesnoedreartaitoen, local areas, "wMiytaicfiotcails,, chronic wild nonsuppurative, "CPherlovniiccaipnreorgarleiszsaitvieonn,ephsrionpiamtahly, moderate F"oarstcallaraowmiosneurcalleiazatcieloln,inafiilldtrate, wild "Htedtmoorrchaargcei,todniffuse, wrked l"aiteeravine, not in plane of section lt eavine, wissing SPpreocjieets:uRsahter: OBICKOL2 001896 Sonnriaed STI Page: 20 - an SToawirnizte)d aSriosgcoTpaieclsntdedMiMciroaslcopRicpter(actnitoounel PIA Tao eairteGralLoTrosstcoirtiye-sr,coTgce,ici3ty Stay is Rats Tae:2 Fouiel tahbtrs: 1() RSuArifcadSeirn FterwleenGeoups (3) AST 50 po FicroTspmic Oserations cntinnt: fr-- TCShpelueeent,hloeGneirenss,etinsDtsyueer,scw.Sreafnoucnhtoabre widthiin,morTaolyriosidisT:rice, Exabges, Pacres, FfaotienlhYosbts:0R) ASuTriiceSeixn eFsemrleessGroup: (3) 0 50 pn a ituitary Rawry lint HHevKrrhoapgtisc iwn se,re13s11rec.a, rent LeTisiesni,re0.n2 acarfga,s ith du raised Wicrosrceminc! Graton: Sinossitl ctsin corte, aired ine "eDwiantic,prsoegrteeaivweilsaetgehrrosp,athsyi,niinslinal wy Svaelsaar ssiicerraaptaiagtei,on4,16at situtary HFiereirvansclar drole infiltrate, ail SSlaenecs [trerrip-- teres "Tysic shade, erste LTiheveo,lleorvien Gtoisrseuyesbwareyfonunddto UbreinwairtyhiLn aoer,l Tiontrsd:, Parathyroid, Teche, Espa, Salivary las, Press, FSaetiewahNtaebe36A) SBucriicedSeiun sFetmraelessGro (3) ALT 50 pn KcroPstpiitcarOyserations: Ficrersepinct Gaanations: Kildenrey ng Raised bsrrigic as, 0.9 a di. S"iwnoosnitplrgtrseisi,v craerptreosp,atahey,raitseinal SSeapvtaalcarrtesivecrealliantaitoino,n,wsiltifos, asin AFnesrlhaartaposhneci,eamrltsiffaicllr,ata,ldald easrhae, oc wes, were Srpaejceicest: sRart : CZELROLZ 001897 usr . 412 SInudsinvairdiuzaeld MSaicnrgolsecoTpaibculaantdedMiicnroaslcopRiecporOtbse(rcvoanttiionnused) FA-I924 Too YeaRrikeOrralLaTboornaitcoirtiye-sD,ncIonpce,nci3t1y Study in Rats Te: 2 nFiitne:a eKsobtesr:98I) RSaAcrificeSdexi:n FeexmtarleeisGroup: (1 FI-IEZA 30 pn NicrosOcvoapriyc Doservations (contirued): FiSptlueietnary ""THaboulnasr hyperplasia, wilatera, ald ensiderais, soterate HTehatf,olUlLoewriansg, iMsassuaersyvSeraendf,ounSdtontiochb,e wUirtihnianrynDoaugaerL,inTihtysr:cid, Parathyroid, Trachen, Esophges, Salivary Glan, Pancreas. Ffintien:al(Neastbser109R)ATBrYain SSaecc:rifFiecmeale roup: (3 FIG24 30 pn WicroYsaampaircyObEslienrgvations: Wicrosraepaicl Observations: Kidney liver Lng FNaacwrweraysGland PPairtautityarrsyid Sle eres "pass, 81 6x4 ca, period ares, "SWienduusloliadraylceelcltapiear,plcoarstiear,, wfiolcdal, aild Hsypiedrplasia, pelvic eithelive, wilateral, "hHeeppaattooccyyttee vaalctesrlaattiioonn,, baalsotpihfialciacl,,fomcianli,sal "saisncianllar siveralization, wild hvmoalcaarrcianxcornopages, mtifocal, ald o"ltat xcaanniinneed,, sniostsiinngplane of section ""Heemoantospoiesis, etraneiolary, increased, "aHlodly THheeartf,ollQoawriyn,g tSitsossucehs,veUrreinfaoruyndBltaoddebre,wiTtrhiandn,orTraachLeisi,tsE:sophagus, Salivary land. Ffiotei:l(Meassthser:105I)RATGeTr0minal SSaexc:rifFiecmeale Grows (3) FII920 0 pon MacroPsictoupiitcarOybservations: NicrHoisrcpeinc erations: "Saal dark raised Lesion, 0.3 cb dia. "Sinusoidal ectsia, corte, mberate sPpreocjieecst:uRsaetr: OZICHOL2 001898 Suanriaed STH Page: 22 - 413 SInotnvriidzaeld RiFooaslrcpTLiaicbrealattnerdiienr,iEasTloc,pecr3rtat(ciaotinnsud) FIR: To ter Bal Toicity-ncogenicity Stay in Rats Tate 2 vFaeen tNhoseetrs1651) T)orwioal SSewtifFiecmeale Grogs (9 FRY 10 on Werasaorptic Bserations (continued: Kony LLivger jAi titary Sraatonaretitpriosg,rersainneie,shfooplat,hya,ldanimal uehpeslivtticoapaeewnraelrctwaioztliaittciio,on,,spneornilpaoerltal, asdrate JSeittneoanvined, oti plane of section SThleeefo,loGneirngs,tiDssauyes, wTeroenefoyntSatnosbeSwoitwhcinh sroararyLiHmidts:d, Parathyroid, riches, Esshges, Suivary Blane, Press. SPrpoejceicets:NRaaatr: OZ81ERO12 001899 Suneiaed STH Page: 25 414 PnLiiSTunosaaoroiorzewdasSliLngiTlet0Tro4abeuBle-sartesdocGemAniismoalBaReaSpttoridtonfosats aie 2 eFade eres08B) ToErsSSalce ro 0 FT [---- [---- 5 isle Lis. nt ite DsWriioikttieoe,,encioeeribnrnemartshiyvew,ld tie Frtoailldbwtieepdeectnopneh,tlidtaiihonnt,wleda,idia - Si aon wie rTShiaeeoete,lToanteuti,senSw,irevaraes,atoePSiwoirthhi,,n otFarersyN,Bate, Kewl, Tors, rath Foire Boewte7TSErcSenc Wtroens r (0 F410 on [I ar-- y Lure bargin, 1.251 co di, - Nerireiewst Barto SDiicnpierssiaan cvorete,nd,soH,iewild tr FFeeotcael msihlaiiaatetieelnc,flritwitionh,ta,idile os sity coHaenlrssTaolirnen,, wtiee rport TSreenaairtes,,stwe,irsat THehrte, lTeisiEtiisatsew,reSnatmtoe0rwyithion es,r TLoiltd:, Prthoi, rcs, Eutae, Slvr Sh, ren, fas Species: Rat 001900 . Sussarized STAR Page: 224 415 SInudairviidzueald MSaicnrgolsecoTpaibculaatndedMiMcirsoaslcopRiecpoOrbtse(rcvoanttiionnused) F-39242 Tuo YeaRrikOerralLiTboorriatcoirtiye-sO,ncoIgnecn.icity Stody in Rats Table: 2 final Fate: (Mhuesedkesr:108() T3erminal Sex: ale Sacrifice Broupt (4) FI-3S20 10 pp Nacroscapic Observations: Wicroscapic Observations: hEasroepmhagus Heart Kidoey Liver Lung PPaanrcartehaysr.oid PSailtiuviatrayryShand Thyroid Trachea "Ho visible lesions. ""GNoorttiecxaalninveadc,uolwaitsisoinn,g focal, ild "Hwyiotciafredciatlis,, chronic ald nonsuppurative, ""OPovrotnailc sopnroongurcelsesairvecenlelphrionpfaitlhtyr,atew,ildail MNeegcarloosciyst,osmiisl,tisfioncails,al ald "AVlavsecoullaarr swaicnreorpahlaigzeast,ions,ultsiidlfdocal, wild "hot "Not eexxaanviinneedd,, aissing issing ""Hbodtenoenxsaeined, ising "Not exanined, ising "Hot exasined, wissing TSphleeefno,llToewsitnigs/tEipsisduiedsyaviesr,e Pfroousntdatteo,beStowmiatchhi,n nUorrimnaalrylBilsaidtdse:r. mFiatnea:l GNeueskbesr:108()R-TeBr0minal Sex: Male Sacrifice Groups (4) PACIA2N 10 gpa Nacroscopic Observations: sn Ricrohsciorpeic Observations: hHaeraerntal Kidney Liver Lung sPkairnathyreid "Cihricnudlafrontrpaaids.ed inflamatory lesion, left "Right adrenal slightly enlarged. ~"PMhyeooccahrrdointcicsy,tocnhsr,onibceningonn,suupnpiulraatteirvael, "wCihrtoindioccaplr,ogwrielsdsive neghropathy, wild "pPoorrttaall sbainloenudculcetarprcoellilferiantfiiolnt,ratsei,ldwil Nesalocytsis, aild "PVearsicvualsacrulwairnesroanloinzuactlieoanr, siniflidltrate, wild -"PNoodtodeexraamaitniedt,is,notulcienraptliavnee, owfilseactteiroanl, narked SPrpoegceicets:WuRsabter: 076100012 001901 Suamarized STAR Page: 225 - 416 SInudminvirdiueald MSaicnrgolsecoTpaibclaatneddNiicnroaslcopRiecpOtsarcvoanttiinouness) P3124 Too YeiraGralLaTvooercaittayie-sO,ncoTgce,ici3t%y Sod in Rats Tae: 2 rFaiea:l eMkoeers10(8 RTeHrinal SSucerifWiaclee Soups (0 FIA 10 pon WerosTrcapciecs Ghservations (continued: "Trachitis, aironic, wile STphleeefno,laTveistngsitEipstsduieesarsesr,e Pfroousntdatteo, bSetowmiatchhi,n tnrranrly lBilmiatdse:r, Theis, Exphges, Salivary San, Pituitary, Pancras. rFaiteasl eMsoteers103110S8a1c5rificedSein mMaalteressrout (41 FAIRE 10 gon WarosTcoguictseinrtveartniaoln)s: EsSalheages Cir ""FlilalredgewitwhitrhethFiclkiecn.ed wills. aTphdeiaarnsanadllIt Lateral Lobes appear shrunken aTatthersvley14roucgahuastuerfiLcoebsesepiatle with wltiloblr sis, 1.51 231 25 ca. TPSerttooisntscalhtpeidiepis Microsictonpeirc Baerations: iver ng Pirtausiattaery TestsrEidiepis eimary Blaster o""Ahtpaphteiaptrlesestsewfsaolclaslmalalr.es of ulceration. "Sovratnae spornongcrelseswirve cnelslbripnaftilhtyr,atew,ildssterate etrpotpahyc,llwarliatcarcivons "Fisbrcosirs, wpnoeratlali,saatrikoend, ald ANveaessttaaticmacnreolphaaagnes, 116 r"otsattatigtariss,inaetrtaee,tiasrked "wTtuelraeteatrophy, aspermatogmess, bilateral, "Epithelial hyperplasia, siwle, diffuse, wild TSphleefno,loHnairgttsSsoaness,werierfeu]n,d tTohybreoidw,ithPianrastehrraai,LiTnrtac:hes, Esohaqus, Salivary Gland, SPorcoijoest:Maatbe: ZBL 001902 Sunrise THE Page: 26 oar SInusimvairdiuzaeld aScirngolsecoTpaibculaantdedWiMcnriomsaclophiecpoOrbtse(rcvoanttiionnused) FI-3924 Too YeaRrikeOrralLabToorraitcoirtiye-sO,ncoIgnec.nici3ty Study in Rats Table: 2 Binal Fate: (Naasbkesr106R)0T1er6ninal Sex: Male Sacrifice Group: (4) FAS924 10 pou Racroscopic Observations: Ricroscopic Observations: Arenal Heart Kidney Liver Lung Testis/Epididyais No visible lesions. "Nodular hyperplasia, "Ayocartitis, chronic corte, focal, wild nonsuppurative, "wCihtroinfioccaplr,ogarelsdsive neghrogathy, ild "PMoergtaallacyataonsoinsu,cleaairnincealll infiltrate, wild "Avlavsecoullaarr smaicnreorpahlaigzeast,ions,ltaidiolcal, aild HPeesroirvrahsacgael,arloscoanlonaircelaesa,r infiltrate, soderate sild "HWeeslolthedliifofnesr,entbieantiegdn, pupillary neoplase arising fron capsules of both testes. STphleefeonl,LoPsriosntgattei,ssSuteosnawcehr,e UfroiunnadrytoBlbaeddweirt,hiTnhynrooriada,l Plairsaitthsy:roid, Trachea, Esophagus, Salivary Gland, Pituitary, Pancreas. Ffaitnea:l(NMaesekbser:1081)8-T3e6r0a7inal SSaexc:rifMiaclee Group: (4) FA-IS2N 10 poe Wacroscapic Observations: Ranaary Slant Wicroscopic Observations: LiLuvnegr PPiatruaitthyarroyid skin "Lairngel,efftirisn,guisnuablcutaarneesous mass, 9x 35 cay ""Haesgcaalloacyrtoasiinse,ralsiinziantailon, sild Preusonia, interstitial, chronic, multifocal, Aalivleolar sacrophages, wultifocal, ile Hot exanined, tot in plane of section -"AFiebnroonmss TShpeleefno,lloKwiidnngey,tisHseaurets,weTreestfiosu/nEdpitdoiybneisw,ithPirnostnaotrem,alStloisiatcsh:, Urinary Bladder, Adrenal, Thyroid, Traches, Esophagus, Salivary Bland, Pancreas. SPrpoejceicets:WuRsabter: 0281680012 001903 Summarized STAR Page: 227 - 418 SInudmiavriidzuaeld MScinrgolsecaTpaibculaantdedWiMcnrioasaclopfiacpoOrbtse(rcvoanttiionnused) F924 Tuo YeaRrikeGralLabToorxactiotryi-eDsn,coIgnecn.ici3ty Study in Rats Table: 2 AFoaitoea:l (Nbaeebtesr: 76I)R-SFOo1u8nd Sex: Dead Male Group ( 4) FA-324 10 poe Macroscopic Ooservations: NicrPoisctoupiitcarOybservations: Adrenal Kidney PLiutnugitary "Large hesorrhagic wuss, 1.3 0.4 ca. winte hionf npoarimralprelsiennitts ""Cvharsocnuilcarprsoignreersasliivzeatinoenp,hroapialtdhy, wild ~bdenona STphleeefno,llLoiwvienrg, tHiesasrute,sTevesrteisfoEupnidditdoyabies,wiPtrhoisntantoer,malStolsianciht,s:Urinary Bladder, Thyroid, Parathyraid, Trachea, Esophagus, Salivary Bland, Pancreas. Ffantien:al eMsustbeer:1081)8-T3e8r1a9inal SSaecx:rifMiaclee Grow: (4 FR-IS2L 10 pon Macroscopic Observations: skin Microscopic Observations: adrenal Heart Kidney Liver Lung Pituitary Salivary Bland Skin Trachea "Rahiisneddfcolnctapraadt.ed, inflamed region on right ""CMoyrotciacradlialvacfuioblraotsiiosn,, wmlitlitidfooccla,l, wsiilldd ""CHaevgoanlioccytporsoigsr,essmiivenniephropathy, ld "vAalsvceuollaarr wsiancerroaplhiatgaetsi,ons,altaiilfdocal, aild perivascular sonanuclear infiltrate, aild "~Nhoitnoenxasmined, ising "Fododernatitis, ulcerative, wilateral, "nTarrakcehdeitis, chronic, ald TShpeleefno,lloTseisntgist/iEspsiudeisdyawiesr,e fParuonstatteo,beStweiatahcihn, nUorrimnaalryliBnliatdsd:er, Thyroid, Parathyroid, Esophagus, Puncres. PSrpoejceicets:NaRsabter: 02BICRIOIZ 001904 Suanurized STAR Page: 228 S49 SIaabnvriitzuld RSiTkooegslrceoTLpaiuvcletrnsadatrNiiiec,aralnseo.epcr3etra(tcainotnisna) PITH: To Yer BalToniDcopeicity Std in Rats Tae: 2 fFaotaesl tNhaebetr:108E) 2To0rin! SSeccifMiaclee ep: 0 PAST 10 an [rHtmuitar-- y ier "lharsste,inp,le0.n05d 0pi2esa, Wcrsetrontt Dsavaions: itoey icavredriaprefribersoisnise, elporcaalatarheya,s, srarikedte liver FFaorrtt sblreondulcatwrlcieflraitniioltnr,atiet,d16 wn VNPaeegpraavllaaosrostalwsnase,rwaoisozinaneticimlolenn, afilldtrate, sild JfFaaaeitrteos n JFaetbrvteariintliys,awk rin elan of section "aeron STeosntsinside JFaetlpvrtianitei,s,iessroagte TShteefeonllFoirnogstti,sstersinwaerryeMfaodnetr,toAbreenwailt,hinTysroomtadl, JTiraicthse:a, Esphges, Salivary Gland. Fiuat:n eNeakbeer15) SacrificeSaisn slteressrons {2 10 pon [Htu-- itiy -- Wcrecrmeiact ssrations: wtryey FPuiattuhityarroyid SSioeuth Large as, 1.35 1 che ATiotehionf arene npioruareLisstts progressive neghopathy, odeate JCovteusaarvweidnersaoitsaitniopn,lesof section "Servsoindrosis, erate ee, marie TLhieverfsolHaenairntgs tTietsosnu sweiepfson,d tPoosbtetwei,thiUnrisnaaryaBlLaidsetrs,: Thro, Trace, Escapes, Salivary Blane, Pancres. SPrpoejceicets:MRuaatr: OZBICRO0RZ 001905 En -- 420 SInudsimvairdiuzaeld MSaicnrgolsecoTpaibclaatneddWiMnriassaclopRiepcorst.erv(caotnitoinnused FI-3924 Too YeaRrikOerralLaTboosriatcoirtiye-sD,ncaIgnecn.ici1ty Study in Rats Table: 2 mFiatnea:l (NWaebekesr:1061)8-T3e8r2a2imal SSeaxc:riMfailcee Grow: ( 4) FIIR2N 10 pon Nacroscopic Observations: Ficroscopic Diservations: Liver LPiutnugitary Ko visible lesions. "PPoorrttaall aboilneondculcetarprcoellilferiantfiiolnt,ratsei,ldwild "Mveagsacluolcayrtossiinse,raalniziamtailon, wild "herona STphleeefno,llToweisntgist/iEspsiudeisdywaesr,e Sftoounnacht,o bUerinwairtyhiBnlandodremra,l ALdirietnsa:l, Thyroid, Parathyroid, Traches, Eaophagus, Salivary Eland, Pancreas, Kidney, heart, Prostate. fFaitnea:l GNeaebkesr: 851)8-3S8a2c3rificeSdexitn MeaxlteresisGroup: ( 4) FR-S24 10 ppm WacrFaasccorpiecasservations: HicrKosicdonpeiyc Observations: Khiidrneenayl Liver Lp Thyraid "Suall nodule, 0.5 x 0.7 ca, in area of "Ropuagnchresausr.face ""SCihrmosnoiicdaplroegcrteasssiiav,e Cnoerptherso,patmhiyl,tifaoicladl, wild "FPaorrttaall abiolneonudculcetarprocellilferiantfiiolnt,rataei,niswailninal "Hbeawsocrurlhaargea,inlroaclailzaatrieoans,, awilldd "Ultisobranchial cyst TShpeleefno,lloHweianrtg,tTiessstuiessEwpeirdeidfyoauinsd,toPrboestwaitte,hinStnoomramcahl, lUirmiintasr:y Bladder, Parathyroid, Traches, Escphaqs, Salivary Blane, Pituitary, Pancreas. fFiatnea:l (NMaebekesr:1061)0-3T0e2r0niml SSeaxc:riMfailcee Group: ( 4) FRCIT2A 10 pan Wacroscopic Dservations: Nicrohsicorpeic] Observations: LKiivdenrey ha visible lesions. ""CCohrrtoinciacl pvraocguroelsastiivoen,nemplhtroipdaatchayl,, maairlkded "pPoorrttaall obniloenudccletarprcoellilferfaitlitorn,atsei,nismialninl PSrpoejceiecst:uRbaetr: OZBICRUIZ 02! 001.906 Summarized STAR Page: 230 Snuniavriidzueld NSianrgolsecTpiaculatneddiicrsosacaRsecpohrtrv(acotnitoinnused) F928: To YeaSrikeDrraLaTboornaitiotryi-eds,ncoTpcn.ici3tKy Stuy in ats Tale: 2 fFaae:a tbhrets10I6 Tecainal SSecrxifWiaclee rp: (0) PISS 10 pn NirosLciogpic rvations (continued: Praaractheysroid TPeistutiitsaErpydiepis "esocrarhlieges,inleoaclailsaatrieosn,, saoldderste Jlteteanceilnleds,denvootnin sla of section J"oylsyu,rtpearristiisn,tesrianeiinal The faloning tissues sare found to be within orl Lins: Spleen, Heart, Prostate, Stosach, Urinary Bladder, Thyroid, Trachea, Esophagus, Salivary Gland. iFlue hNaebeer:1081)08Te7r5aioal SSeciriMflcee Groups (0) FIA 10 pn [a-- nes ---- Werssdoopeisc Berton: ver "haiigsehd pkailteoeya.us, 0.4 co dia, in corte of "hCeornoincs progressive ssbraathy, ald oErxctapssaltaedn, poilcleallrianftitletrna,te, alg Fortal bile uc proliferation, wild ng FiPtaruaitthyiryoid TSraalcievsary Sng sAMcevgaaleloascrytoassisicesrr,alpiwhsiganeitsmi,aolnm,itiitfdecl, ald Hoattneoxmained, ot. in plane of section JTroatcheixtasiisn,ed,crsainssei,ngwild eThretf,oTlelswtiinsgEtsidsiseuyeasiss,erePrfoosutnadtet,o Sbteomwaicthh,inUrnionramray Bilsasttse:r, Areal, Thro, Escphages, Pancras, Splem. FianteasleWsateers1061)08Te2r5inal SSiercifMiaclee rou (0 PRISE0 10 gon Macroscopic Observations: Weroasorpeiacl ervtionst Ho visible lesions. "Cortical degeneration, facal, mile SPorocjieocst:Nautber: O2B1R0L2 001307 Suanrized STH ge: 231 422 SIundsiavriidzuaeld SRaicnrgolsecoTpaibculaantdedMiicsraoslcopRiepcorOtb.se(rcvoanttiionnuesd) F924: Tao YeaRrikeOrralLaTbaosriatcoirtiye-sD,ncoIgnecn.icity Study in Rats Table: 2 dFaaitwea:] habeesr:101803T0e2r6ainal SSeaxc:riMfailcee Grow: ( 4) FR-IEZA 10 poe NicrHoescaorptic Observations (continued): KLiidvneery PLiutnugitary "Awyistciafrodciatlis,, scihnriomnlic nonuppurative, ""OHherpoantioccyptreogvraecswsoilvaetionne,phrmouplattihfyo,cala,iniwaianlinal HIeopcaatlocayrteeas,altoedreartaiotne, `vacuolated, "Nveassacluolcayrtoisniesr,alaiizlation, wild "Kot exained, missing STphleeefno,llToewsitngist/iEspsiudeisdawiesr,e Pfroousntdatteo, bSetowniatchhi,n Uorrinaalry lBilmaistse:r, Thyroid, Parathyroid, Traches, Esophagss, Salivary Gland, Pancreas. Ffaitnea:l WNeoeskbser:1081)8-T3e8r2m7inal SSaexc:rifMiaclee Group: (4) FRITZ 10 poe RacroSshcionpic Observations: Wicrohsicroepniacl Observations: Heart KLiidvneery Lung sSkailnivary Gland "cifrocoutlpaart,s.raised inflaseed lesions, both hind "CPohretoiccharlonvoaccywtloast,iobne,nilgoncal ares, ald "Eyncdaorcadridailtisf,ibrcohsriosn,ic,locdailffuasree,ss,sosdeordaetaete "~CFhorratnalic opnroongurcelsesairvecneelplbricnpfaitlhtyr,atew,ildsild FRoerstaallocbyitloseisd,uctmipnrimoalliferation, aild "Pdaaesueaoolnaira,ainienrtaerlsitziattiiaoln,, cwhirlodnic, ltifocal, Aallvdestar wacrophages, wiltifocal, wild "FNoodtodeexrammtinietdi,s,isuilcnegrative, Bilateral, mrtes STphleeefno,llToewsitngist/iEspsiudeiscyvaesr,e Pfroousntdatteo, bSetowwiatchhi,n UnroirnmaarlylBilmaidtdse:r, Thyroid, Parathyroid, Trachea, Esophagus, Pituitary, Pancreas. PSrpoejceicets:WaRsabter: O20ICRIOIZ 002903 Sunnarized STH Page 232 - 423 SInutsiuvairdiuzseld RSaicnrgolsecoTpaibculaantdedMiAcnriossaclopRiecpoOrbtse(rcvoanttiionnused) FR-3924: Too YeaRrikeOrralLabToorxactiotryi-eGsn,coIpnecn.ici0ty Sty in Rats Table: 2 fFaotie:l GNeatbesr:1081)H-3TEe2r8minal SSeasc:riMfailcee Grow ( 4) FA-IR2N 10 pon MacrosLcioapgihcNoQdseerv(aetsieontnesr:ic) Microscopic Oservations: Heart KiLidvoeery Lung PLaynscgrheaNsode tnesenteric) Rarathyrold "Soft henorrhagic mass, 1.5 co dia. "SWpyooccaarrddiiatlis,fibcrhorsoinsi,c wsiolntsiufpopcuarla,tiowei,ld "wCihtaifroicaplr,og1re8ssive nephropathy, wile "hortal Portal wboinloenudculcatarprcoellilferiantfiiolnt,ratsei,lvild "AVlavsecoullaarr swaicnreorpahlaigzeast,ionm,ultsiifnoicmall, wild FHeesroirvrahsacguel,arLoscoanlonasrcelaesa,r sionffeirlattreate, sil h"cHiesnaanrgiaotsraorphcyo,n ile "hot exanined, not in plan of section STphleeefno,llToweisnigs/tEipsisdaiedsyaviesr,e Pfroousntdatteo, bSetowniatchhi,n UnroirnmaaryLBilsatdsd:er, Adrenal, Thyroid, Traches, Esophages, Salivary Bland, Pituitary. Ffaitnea:l hbeesr:10R83T2er5inal SSaexc:rifMiaclee Group: (4) FREISZA 10 poe WacrPoistcuopiitcarOybservations: Ricrotsicdonpiecy Observations: Hirenal Kidney Liver ng PiPatnucirteaarsy "HHyeisroornrehahgriocsiass,s,ri0gh.t81Ki0d.ne6y.ca. "SMienduusloliadrayl ceecltlashiyae,rscloarsteisa, multifocal, sil "CCohrrtoinciacl pdreoggerneesrsaitvieonn,epfhorcoapla,thya,ildwild PCeallvciucluss,inepceallviizcation, sild "HPyoirrtaanlepshornocsuicsl,eaurnilcaetlelrailnfiltrate, aild PCoyrsttaolidbidleegednecrtatiporno,lifweirtaitfioocna,l,wilwdild vPaesrciuvlaasrcalwairnesroalnioznaitciloenr, ainlfdiltrate, aild ""hhciennaornaatrophy, #ild SPpreocjieecst:Nfoastter: 0281CRIIZ 001909 Susearized STAR Page: 233 - 424 TSdoniriidzaeld MincgrloecpTiueclantdediicraoslcpRieepoBrtrv(taitiovnasn) F124 To eaFrieGralLoTeoantcoirtyi-eD,roTgce,ici3ty Stay in ats Tate2 iFitee eVokn16H8) TEerwial SSuctiaflie Group (ITI on WcrTsyScirpeiecmeOsentions (continues inary Bate T-- ell srs Faillon THheeirf,ollToweingttrissauess w,rerfeusntadtet,o bSetwwiithh,inPnaorramtahlyroLiids,tsT:rche, Espen, Slivary lad. Fiinteltohvsetr:1680 ) Terai] SSeecifiWaclee roi 0 FR 10 90 WcroscieicdOsarations: Wcrsataric Oserations: Live ne TpreTotosstriadbteitiamis Tater [r-- "SOutvaeln sprooroesnine cseleipnftilt,rates,is#i1nl4 oJerpattocbpileeaultceratpiroonl,ifevrcaitoiolnd,idi,fsuites], Ieshslocposs, wininl uHvaellar aicerrloipnhagtei,onJ,oaaldres, aterste Zpurossattaatritissi,ersaiitzei,tiwono,rsseist TCrealchletisse,nowson, sete HTeearf,olSltooiunt,tUirssuverssweHreatfeorn rtoonbes,witPhirnstnyrrmosld,isxiasb:ags, Selvay San, Pituitary, Pancreas, Spleen. Fiatnesa eatbeer01) Fond DidSec le rons (0) RT 10 on [I Sir -- Ktnwer iosrsdatilocne,raItet Lseisidon,fi1rsco ia with sc Sogtraanrseasl,ce4a3ts43Is2i.5c,co,rirgihgtht Siunelfaalteaf,ac Tile as, 05 0intsneev10 pobesi. region of Tia Hine, sth ple mes, SPapgcet:Nfuatrs ERIROLZ 001910 Sumnrized STAR Pages 74 - 425 FSpTursaoarfTizeiedtoASirnigealelnTCTagbaouleaprteaddAninisayl cRepoSrt S(oconyttinuedB)t on 2 re te 1 Food 1 sa eo 0 sic Bente tion: rprisey]tnian tw PEPpp-- raitrwceel psetsar, ,itiil, ie huore frTreitstoenntee, . Bani ogwros Tletni annSeHoa, iwit, pore HiTiifnmnroosm waih,icssootasisro.itcre wie ietmet,arm, endAsrs. sons et, sie ILehie ltlenseisPsi,snw.reHfodtetbrthsis csl iToto:ts PATE, Tis, xb BiaonnoEaeSeae fon 0 Fn rs Beto: mariasd Duration: F-- rons weenie st wri tw oTTerienraeara espacro si,tiia i tori rLAsnwiahe, aa IeHeisteslomooeboso,asatiaroeef,Bmaeo,tbHtotsihi,Srsd imity: Mtr, nl, Past Fe Species: aRabt.r: concn 001911 Sere S70 ie: 25 426 SInudminvriidzuaeld MSaicnrgolsecoTpaibculaantdedMihcnirnoaslcopRiecpoOrbtse(rcvoanttiionunesd) F924: Too YeaFrierralLabToorsaitcoirtiye-sD,ncoIgnec.nici3t1y Study in Rats Tale: 2 fFnaiteea:l Wbeaeshkesr:100R)6S5a5crificeSdesisn Meaxlteresisrow: (4) FIRE 10 pon Racro[scopic Oservations: PiSptlueietnary Wicrhoasrtepniacl Observations: HEeaert tiLidvneery FLiutnsgitary Spleen hyreid "Fecal Dark mcaosrsn,ea0l.5pcaacidtyiin both eyes. "Slightly enlarges "CSoirntuiscoaildalvaceucotlaastiiao,n,colrotceasl, adriefafsu,se,wiladild he of air present "eratitis, chronic, focal, bilateral, wild "WMyyaoccaarrddiiatlis,fibcrhorsoinsi,c mnlstasiufsopcuarla,tivwei,ld Cwhirtoinfioccaplr,oglredssive nephrapaty, ald gNaittaotciyc taectivvaictwyl,atiinocnr,easweidt,ifiofcauls,e,411adild ""hwaesncoanlaar sineralization, wininal Heenraatotpeoissis, estranetullay, increased, Hyperplasia, follicular cell, diffuse, wild The falloving issurs were found to be within Testis/Epididais, Prostate, Stonsch, Urinary oreal linite: Bladder, Parathyroid, Trachea, Esophagus, Salivary Shan, Pancreas. Fnaites:l(Keaeslbser:70I) RSaScrificedSenitn eWxatlreesisGroup: 1 F-32410 pp WacrLaisvceorpic servations: idney icrHoesacrotic Observations: titoey Liver ""SSliigghhttlyhyparloeneshrosis, left kidney. Hplooccaalrdairteiass,, cwhirlodnic nensuppurative, "CHhyrpoenripclaspirao,grepseslivviec neeppihtrhoeplaitohny,, mwlitniifaoaclal, "Faolrdtal mononuclear cell infiltrate, wild PHoerptaatlocbyitlee vdaccstolpartailoinf,erwautlitoinf,ocaali,l ild CFresstaaliadcydteogsesn,eraatniiomna,lfocal, aild Species: Rat Project husber: 0281CRO012 001912 Summarized STAR Page: 23 - 427 Sumarized Single Tabulated dainal Report (continued) Individual MaRcirkoesrcoLpaibcoraatndoriMeisc,rosIcnocp.ic3O1bservations F-30242 Too Year Oral Toxicity-Oncogenicity Study in Rats Table: 2 final Kusber: (RIN Sex: Male Grows: (4) FR-IS2N 10 pon Fate: Weeks 10) Sacrificed in estreis Microscopic Observations (continued): Lang PiSatluiivtaarryybland "Alveolar sacrophages, multifocal, eild "~Hhodteneoxmaanined, aissing The following tissues were Spleen, Testis/Epididyais, found to Prostate, be within Stonach, normal lisits: Urinary Bladder, Adrenal, Thyroid, Parathyroid, Traches, Esophagus, Pancreas. Fnaites:l (Mbaesekhser:1061)G-T3e6rSm5inal Sex: Male Sacrifice Grows: (4) FR-IS2N 10 pon Macroscopic Dbservations: Wicroscopic Observations: Heart Kidney Liver Lung Pituitary o visisle lesions. "Hyocardial fibrosis, local areas, soderate Wloycoaclarairteisss,, cwihlrdonic nonsuppurative, "Chronic progressive nephropathy, ininal "PHoerptaatlocsytoenoanlutcelreartiocenl,lvaicnufiolltartaetde,, mwiitlidfocal, sil "Vascular mineralization, siniml Perivascalar soronuclear infiltrate, sild "bina The follouing tissues were Spleen, Testis/Epididyais, found Lo be within Prostate, Stonach, normal lisits: Urinary Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas. FAaiten:a (MMaeaekbser:104()RT8e3r6ainal Sex: Male Sacrifice Groupt (4) FAIS 10 pou Wacroscopic Observations: Ere Skin "Right and left eyes appear cloudy. "Raised circlar mass, 1.5 co dia., dorsal Stomach Kidoey Microscopic Observations: hreml "Enlarged gastric rue, "Several raised clear cysts, 0.9 ca dia, in leit tidrey. "Cortical vacuolation, focal, wild SPpreocjieecst: Nfaastber: C2BICRIOIZ ~~ 001913 Suasarized STAR Pager 237 - 428 SIanmnraat RScirlscTniataeMiicrnoslcopRiecseat.racttiioonn PI: Ten euRrikerralLiTroatsotriscoImncm, it3 Sty in Rats Tae: 2 aFikl HNeer08 Terao SSuorifailcee Gri 4) FIT 1 pn [rooerat ------ tor TiLPheyeis oscturrcei,a biHliartoeruasl, "vane ares astkiteia,l, wsikgate SpGoaecryaalcarsnumeraailzatcoenl, iinfliltrate, wig Foaptl,litcueawinpclluiiionn cnstic, wilateral, ret SThheenf,oloTienkg EHpstsiudsparwer,e rfeosntdatteo, bSetowintchhi,n stoirneylBiagdee:r, Parathyroid, Traces, Esp, Sib Elan, Fitba, cree, Foliel eeser10I) TTerai SSewcriailcee Gps (0) 0 10 an [THeT -- Sul carnal Lesion, right ee. Wrorneg serations: Ga[tiAcal valtion, fecal, wild tenit Areaatdtisn,,caAtrea,mcsmiemrta, a,ted iif, ale Kiiwtny FDPaaarrnaalembiplareensdccstievreoctsaslabtoiipnaoltntt,ry,teia,llgwid eepsattauttee shwacrataitoionn,, awclatliteecsl uitliefocal, [wrine---- wn aeFicrbrraess,,saimclistittdis nwlgd [iarteans Heoroanse sien cll sour, erate SEThteeeaefm,aoslT,oesstiaEvirEsulpadwtre,e rfeosntdatteo, bSetiasths, urayLBiatt:e, Thveid, Parsthroid, Techs, PcaigeessNhate: omiaorz 001914 Sunred STA Page: 20 - 429 rriite MSoiegetetacbeaartreidrofnoiaec,BmorBtsmcvnaitovne F528 To Yeu Bl Toe conic Sat in Rts noir 2 oeAninal tenNusber: 5 ace nets IR-3838 Sex: Male Group: (4) FN-3924 10 ppa [ To v-- n wn ewnewipesayn, w2a5xg2fcon0vorl et tErrisonvegnteos.y4 roeysbin to [ prBioaats-- rae, win--g ---- _~ ie oF[ariitnhdei srsoecelinary hoitth,a,sianto tr Troevrsteesetnowna,, wwiid f, sfrte St Tiss rc) FTSrotrodtonre of raepriocirserownhbr. [-- w Sraanay ok esto. STiherlyoenSuga,,taonsteyew,retrfoohen,n0tboe yitdnirrleitiss Purse, Trace, Froae hoeab ea SsuostWteie oy FN 8m [ Tn -- lre owt npt.e, slg wages right [ -- -- -- Srineanetesaccowrmtea, --fo--ca--l,--wferte ite vi teneteeenaasoiverst, wed ve eTtelssbaietni,coktnraaosetaa,tei,tat oIy " evettn, mSoetsmpes iaolns,,hae4 hee eoleiatHoersrw,re oonatto beStohihn ssryiBntth:r, Thre, Prats, Trace, Fail Species: Rat -- 001915 Sanize 5 Pie: 29 o 430 Summarized Single Tabulated Mrinal Report (continued) Individual Macroscopic and Wicroscopic Observations Riker Laboratories, Inc. 3 F392 Tuo Year Deal Tocity-Dncogenicity Study in Rats Table: 2 Aoinal Musber: IB-S39 Sex: Male Groupi (4) FA-S924 10 pon Fate: (besk= 106) Terwinal Sacrifice The Nicroscapic Observations (continued): following tissues ere found to be within normal Lisits (continued): Esophagus, Salivary land, Pancreas. Ffanties:al WMeaenkdser: ST()RSIacOrificedSexi:n Male extrenis Browps 4) FU-IS2N 10 poe Macroscopic Observations: Lung HeLiavretr Hicroscopic Ohservations: HeEsaorphtagus Kidney Lung Soft Tissues (thre) "Latrhgreoayceilclocwaivsihtygraenyd adaisssplaficlelss entire noreal Lung tissue dorsally. Nass seasures 4 x 4.5 x t2h.ocra,aciacdhwearleld; troiglhetftapliactaelrallung lobe "hcuoslcllaepsaepdp.ears flabby. "Pale ""HBopticaerxtaistiinse,d,cahirsosniincg, focal, wild "Nineralization, meltifocal, cortical, sild VBaeslceucltaarsiisn,erdailfifzuaste,ionw,irkaeidld "Liposarcons The following tissues were found to be within normal lisits: Spleen, Liver, Testis/Epididyais, Prostate, Stowach, Urinary Bladder, Adrenal, Thyroid, Parathyraid, Trachea, Salivary land, Pituitary, Parkreas. fninal basher: (RSL Sex: Male Group: (4) FR-ISA 10 poe Fate: (beets 108) Terwinal Sacrifice Nacroscopic Diservations: Skin MicrKoiscdonpeiyc Observations: Liver skin TTreascthiesa/Epididyais "Raised circular lesions on both hind footpacs. "Chronic progressive nephropathy, inisal "Portal sononuclear cell infiltrate, aild Portal bile duct proliferation, sild Negalocytosis, ~Pododeratitis, suilncienraaltive, bilateral, sirked a"Tsrcaachleairtisa,inecrharloniizca,tioanl,daild SPpreocjieecst: MRaastber: 020100012 001916 3 Sumarized STAR Page: 200 4 Erb Susaarized FA hg Single Tabulated Anisal Report (continued) ie 2 Esophagus, Salivary Bland, Pituitary, Pancreas. et Species: vReatr: csc Hepatocyte vacuolation, centrilobular, wild 001917 432 Suaarized Single Tabulated final Report. (continued) Individual aRcirkoesrcoLpiivcoraatndoriMeisc,rosIcnocp.ic3O%bservations FIT: Tuo Year Ural Toxicity-Dncagenicity Study in Rats Table: 2 fninal Nusder: (R-1665 Sex: Male Groups (4) FRCIS2N 10 pp Fate: Ghesk= 108) Teraical Sacrifice Hicroscopic Dservations (continued): LPuunsgcreas Testis/Epididyeis Thyroid ~"hVcaisncaurlaratrmoipnheyr,alaizladtion, aild "nTaurbkuelse atrophy, aspersatogenesis, wilateral, "Ultiasbranchial cyst The following Spleen, Heart, tissues ere faund to be within normal liits: Prostate, Stosach, Urinary ladder, Arenal, Parathyroid, Traches, Esophagas, Salivary Sland, Pituitary. Faantiem:al eMsustbser:108()R-TJe6rnMinal Ses: Male Sacrifice Brows: (4) PRISZN 10 poe Wacroscapic Oservations: MicrKoisdconpeiyc Observations: EHseoaprhtagus KLiidvneery PLaunncgreas Parathyroid Prostate Thyroid "Fluid filled cyst on left kidney. ""HMoytocaerxadviitniesd,, cwhirsosniincgsonsuppurative, witidoaal, ald "Chronic progressive nephropathy, soderate "portal ononuclear cell infiltrate, aid HPeoprtaatlocybtielevadcuucotlaptrioolni,fermualttiiofno,casli,laild Wegalocytosis, ainisal "Vascular aingralization, siniml "Phoelyiarrteartirtopihsy,, ssooddeerraattee "Hot exanined, "Hyperplasia, nat in plane of focal, aoderate section "Hyperplasia, C cell, soterate The follosing tissues vere Spleen, Testis/Epididyais, found to Stonach, UbreinwairtyhiBnlandodremra,l Aldirmeintasl:, Trachea, Salivary Bland, Pituitary. nFaitae:l (Mhuesebte=r:106()RTSeSrai Sex: Male Sacrifice Groups (4) FR-ISN 10 poe Macroscopic Diservations: Ere Hicroscopic Observations: Ere "RIGht tye atrophied, no tissues to be taken "Retinal atrophy, local aress, wild Species: Project Rat Nusber: 0231CRO0I2 001918 Suanarized STAR Page: 202 - 433 SInugmiavriidzuaeld aScirngolsecoTpaibculaantdedWiMcnriossaclopRiecpoDrbtse(rcvoanttiionnused) Riker Laboratories, Inc. 38 F392: Tuo Year Oral Toricity-Oncogenicity Study in Rats Table: 2 AFoaitnea:l (Nhoesebkesr:1061)-3Te0r5ninal SSeaxc:rifMiaclee Group: (4) FAI 10 goa Wicroscopic Observations (continued): Heart Kidoey Liver LPuargathyroid "Mwoictairftoictails,, aclhdronic nonsuppurative, ""Cphorrotnailc spornoognruelsesairve cnelelphrionpfaitlhtyr,atew,ildsild Portal bile duct proliferation, wild Negalscytosis, wild ""hPoetriveaxasmciunleadr, sonontonuicnlepalraneinoffiltsreacttei,onaild STphleeefno,llToewsitnigs/tEipsisduiedsyawiesr,e Pfroousntdatteo,bSetowniatchhi,n nUorrimnaalrylBilsaidtdse:r, hirenal, Thyroid, Trachea, Esophagus, Salivary Slane, Pituitary, Pancreas. Ffantien:al bNeusstbeer:1081)8-T1e4ra6inal SSaecx:rifMiaclee Grow: (4) PRIF2A 10 gpa Macroscopic Osservations: Microscopic Observations: adrenal Kidney Liver Lang Pituitary Trachea Ho visible lesions. ""CCohrrtoinciacl prdeoggerneesrsaitvieonn,esfhorcoagla,thyw,ildild "pHoerptaatlocsyatneonaulctleeraartiocenl,l vaicnufoillattreadt,e, ssuitlidfocal, sRielgdalocytasis, ainisal Necrosis, "Frewsona, fioncatle,rstwiitniiamla,l chronic, focal, wild Perivascular sononuclear infiltrate, aild ""IEryastc,heiptairss,dichsrtoanliics, sodirate STphleeefno,llHoewairntg, tTiessstueiss/eEirdeidfyoauinsd, tPorobsetawtiet,hinStonnoarcmha,l liits: Urinary Bladder, Thyroid, Parathyroid, Esophagus, Salivary Gland, Pancreas. PSrpoejceiecst:MuRsatter: 028100012 001919 Suarized STAR Page: 200 434 SInudsiavairdiuzaeld MSaiRcinrkgoelsrecoLTpaaibbcourlaaanttoerdiKeiAscn,riossaTclocpRiecpo5hr%tser(vcoanttiivnnused! P3924 Too Yor Gal Toicity-Oncogenicity Study in Rats Tale: 2 : AFnaitsea:l tNuhsebter:100I)R-JSBa4c7rificeSdexi:n MeaslterousGroup: ( 4) FN-3924 10 ppa WacroSscootnicTirsvsuaeti(oleng)s: HcroLsicvaepric Baerations: ointeney Llinvge PFiatruaitthayrryoid iThnyarroiyd Bladder "FSocsllseinlrisglhitghtnly sLoetttiehdi,nd fret. CHertahniteisp,rogsryevsistiviesinajhoriontpst,hyB,ilaitledral, ail "oortt,alcosrtoicnalal cell infiltrate, ail "Psrciavlaascralsairvrsaolsioantaicolno,a iinlfdiltrate, wild o"dteneoxnaioed, sissing iJolteauwsained, sissing STpheeefno,llaosro,g tTisstsie/sEpweirteiofmoinsd, tPorobsetawtiet,hiSntosnocrha, ALrietmel:, Traches, Esha, Siliviry Blan, Parcress., Fianteasl eNeabeer:1081)03T0e0r8inal SSecnrtifaclee Grp 4) FHI 10 pn [F--itu--itir-- y Nirbosrcapilc servations: berms Liioneey lng PiLtyiothahrtye Frsosttatie pes "Tailsuerdgeduss, 0.5 cn dia. dOaoloaf phaiprepplreassmit, corte, aired ""Oovratnailc spornaongarcelseianre ceelpl oisnafitlytr,atei,lewild PNoeratlasybtiolessd,ataipnriomlliferation, wild sPceaulsnaira,inaertaelsittiattiaoln,, Oilrdne, altioca, Aivleesta axraphges, witifeal, ald fSiinuvsoeidal ectsis, soderate TSohlpyeirrptlearsiitah,s,focaailt, soderate STpheeefno,llHoasrnkg, tSisosuess,wrWeinfaornydBltaoddbeer,wiTthhiniss,orFaaraLtihmyirtoss:d, Traces, Essbags, SPpreocjieecst: NRaabter: OAICRO1Z 001920 Sumnrizet STAR Page: 200 435 SInudsimvairdiuzaeld SMaicnrgolsecoTpaibculaantdedMiicmroaslcopRiecpoOrbtse(rcvoanttiionnused) FR-3928 Too YeaHrikOerralLaTboosriatcoirtiye-sS,acoIgnec,nici3t0y Study in Rats Tae: 2 nFiatnea:] (Mbaesehtesr:1061)R-TTeHrEsinal SSeaac:riMfailcee Groups ( 4) FRI 10 gn The fNoilclrooesicnogpitcisOsbesservearteionfsoun(dconttoinbueedw)i:thin sorml lisits (continued): Salivary Gland, Pancreas. Ffaitnea:leNkeerd1081)0T9e0r9ainal SSeacctrifMiaclee Group: 4) FRITH 10 Nacrescopc Oisrvations: Hicroasrceopnct Observations: Liivdoeery ung PPairtautihtyarroyid "to visible lesions. "CNoarttuilcaarl hvypaecrapltaisoian,,colorctaels,arfeoacsa,l,wialidld ""Cfhorrotnailc spornoogurcelsesairve cnesllhroipnfaitlhtyr,atew,ildaild PHoerptaatlacybtielevadccwtolaptrioolni,fercaetnitorni,lobwuilladr, #ild "VReassaclucleayrtoasiinse,ralaiizladtion, sinisal "Hheastorerxhaangien,ed,sulntoitfoicnalp,laineldof section -hterona STphleeefno,llHoevairntg,TteissstuiessEspeirdeidfyoauinsd, tPorobsetawtiet,hiSntonmoarcmha,l Ulriimniatrsy: Bladder, Thyroid, Traches, Escphags, Salivary Bland, Pancras. Ffaitnea:l eKoeakbert108I) RTe)rainal SSeacctrifMiaclee Group: 4) FRITZ 10 pp NacrFaisteoupiitcarOybservations: HicrLaiscvaepric Observations: ng FiPtariattahyrryoid pSrploesetnate "aised circular ass, 0.5 co dia. oProtratla aboilneondccletarprcoellilferiantfiiolnt,ratwei,ldwild Hepatacyte alteration, vacuolated, witifocal, vaalscdular ineralization, aild oAltveoelxaarinseadc,ropnhoatgeisn, pmllatneifoofcasle,ctwiiolnd "Prdoesntoantitis, acute, aild "Hesosiderosis, aild SPpreocjieecst:Naatber: O2CROLZ 001921 Suanarizes STAR Page: 25 436 Sdiuvviudruiaeld MSaicnrgolsecoTpaibclaantedHMicirnoasapRiecpoOrtsecroanttiionnuesd) PIN: To YeirteGralLabTooriactoyr-iDens,coTgce.ici3tKy Stay in Rats Tale: 2 nFaitae:l tNhabeotrs106()13T6e5r0ral SSaecrifMiaclee rougs (4) FAA 10 pon Wiroscopic serations (cotinued: TKihdnefyo,tleonairngl tiTsessutes/Ewpairieyfuoinsd, tSotboewiwhi,thUirninsaorryaBlaidndietrs,:Adrenal, Thyroid, Traches, Estas, Selivary 8nd, Pacres. FraitaeltNhaiaer1001)36T5e1rai SScerciKfaclee rout {0 PRISEH 10 pon Wcroscroepailc Ooservtions: HicrosTcsopticipBierivdaatiiosns: forrental Ltiidvneery Fiutnugitiry TestisEyidiepis LLeefftt etnelstairsges,ll .ca din, dark. ""hyessccahrdrioaulccyftibormo,sism,ligwniitnitf,acbai,latweirladl Tvoarntai)csporaognrcelsseiaveceslglhrionpfialtthr,atew,odesriantienl HHeepmattaoccyttee avlatcesroaltaitoin,e,viacuwtoilaftoecda,,miatilidfocal, "aslcdalar siveraliation, sinisal J"oTyuebrupllaastirao,pym,ltiafsopcraels,togpernsesdsi,stuanill,ateeirlael, siried STpheeefno,llrowoisntgatti,ssSuetsoneer,e UfruinndarytoBbaedewrit,hiTnhynroorimda, Pianrtstsh:yrad, Trche, Esabas, Suivary Sand, Pent, Faiear aNstkrs1091)0T5er2inal SSierifMiaclee Grog: | 0 PAI 10 pon Hcroscpic Ormrvtions: Wicrooscrotpic Ooervations: Ltiivteerr lo visible lesions. "Tpeolcvaiccitaiiasr,alcihzraotniiocn,mnasuulptufrosctsilv,e,wiwlidld Sortal aoanaclesr cell infiltrate, ail HHaeelpadattaoccyttee avlatceuroaltaitoino,n,vwauulltitfeocda,l,mstiinfisaacll, Neglacposis, aild Species fat Project husber: C2HCROOI2 001922 Sonnrized STH age: 26 437 Snutmiavriidzuead MSaicnrgolsecoTpaibculnatdedMiMcarionsacopRiecpoDrthse(rcoanttiionnused) FA-IR24 Too YeaRrikeOrralLaTboorriactoirtiye-sD,ncaIgce.nicity Study in Rats Tae: 2 fFaotie:l (Naeakbeert10I8 TSerainal SSeanc:riMfailcee Group (4) FRCIT0 10 pn Hicrascopc Obsermtions leontinued): Lung sPcearilvascralsairnesraolnioznaatciloena, iwniflidltrate, ald STphleeefno,llToweisntgist/iEspsiucsisdywiesr,e Pfroousntdatteo, bSetowmiatchhi,n UnroinramryJBiliatdsde:r, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland, Pituitary, Pancreas. Ffaotien:alWNeaebkesr:108R) ETeSrainal SSaecx:rifMiaclee row: (41 FIIT2A 10 pps Wacrosapic Oburvations: Wicroscapic Ohsrvations: Heart Kidney Liver Lug TeTrsatcihs Epididnis ke visible lesions. "Myocarditis, chronic nonsuppurative, wild ~PCehlrvoincicsipnreorgarleiszsaitvieonn,epwhirlodpathy, wild FWypeelriptliass,isa,cutpee,lviwcildepithelion, aild FPoorrtta]l sboinlaensdculcetarprcoleilferiantfiiolnt,ratwei,ldaild Hepatocyte alteration, vacaslabe, mitifocal, Nsegillocytass, aininal "vpaoslaalarr ssiicnreoaplaigzeast,ionm,ltiwifnoicsaall, ald aPsecrailvascrulsairnesaolnioznastciloena,r isinnfiinlatlrate, aild "Tracheitis, chronic, wild The folloring issues were Spleen, Prostte, Stonich, UfroiunndarytoBlbaeddweirt,hiAndrreenaall, TLhiymriotisd:, Parathyreid, Esophages, Salivary Glan, Pituitary, Pancreas, Ee. FTiotieltaesbtesr:108I) TSeraina SScer:ifMiaclee Grow (4 FIN 10 pon WacroPsictoupiitcarOybservations: Hicrtoiscdonpeiyc Observations: Heart --lhaeised dark mass, 0.5 ca dia. -Mwydsecraaitetis, chronic nonsppurative diffuse, SPrpoejceicets:MaRsahter: O8ICRO12 001923 Somnrized STR Page: 207 438 SIundmiivriidzuaeld MSaicnrgolsecoTpaibculnatdedMincirsoaslcopRiepcorOtb.se(rcvoanttiionnused) FAS924: Tao YeaRrikOerralLaTboosriatcoirtiye-sO,ncoIgnecn.icity Stuy in Rats Table: 2 fFnaitoea:l WNeoeubkesr:10(6R-JTBeSrHaimal SSeaxc:riMfailcee Group: ( 4) FIS2A 10 poe Microscopic Diservations (continued): LKiivdenrey Lung PiPatnucirteaarsy TSeaslitviasr/yEpsildainddais "oCrhtroanlic spornoognrcelsesairve cneellphrionpfaitlhtyr,atem,arkweidld PHoerptaatlocbyitlee adlutcetraptrioolni,fevraactuioolna,tedw,ildwsltifocal, "aValsdcular aineralization, #ild "Hhecsionrarrhaagter,ophayl,tiafolcdal, #ild ""HNoitereoxnanined, issing "Polyarteritis, #ild STphleeefno,llPorwoisntgattei,ssSuteosmavcehr,e UfroiunnadrytoBlbaeddweirt,hiAndrneonramla,l Tlhiymriotisd:, Parathyroid, Trachea, Esophagus. nFaitnea:] GNeoenkbesr:1061)8-3T8e5r5ainal SSeaxc:riMfailcee Group: ( 4) PR-SR20 10 3pm Macroscopic Observations: Wicrohsicroepniacl Oiservations: Kidney Liver Lung PiPatruaitthayrryoid TTheysrtoiisd/Epididmis Ho visible lesions. "CNoorbtuilcaarlhvyapceuropllaatsiioan,, cloorctaels,araeialsd, ail "CFherlovniiccspirnoegrraelsiszaitvieonn,ephariolpathy, 4114 Calculus, pelvic "Fortal ononuclear cell infiltrate, wild PCoyrsttaalidbidleegednuecrtatiporno,liffeorcaatli,onm,inaimiall Hepatacyte alteration, vacslated, aultifocal, "Vwaislcdular sineralization, aild aAltveoelxaarninmeidc,ropahiasgseisn,g wild ""Vaatsceuxlaanrinweidn,eraailsisziantigon, aoderate "hot examined, aissing STphleeefno,llHoewairntg,tPirsossuteastev,erSetofsoiucnhd, tUoribnearwyithBlianddneorr,malTralcihmeiat,s:Esophages, Salivary Gland, Pancreas. SPpreocjieecst:aRbaetr: O281CRMIZ 001924 439 Sumarized STAR Page: 248 ISnudsinvairdiuzaeld MSaicnrgolsecoTpaibculaantdedMiicnroaslcopRiecpoDrtser(vcoanttiionnusedTTM FRI Too YaRrikOerralLaTboornaitcoirtiye-sG,ncIsngce.ncity Study in Rats Tle: 2 mFaitnea:l MNeoeabkesr:10180-3T8e5r5simal SSeaxc:riMfailcee Group: ( 4) FIITZ4 10 pon NacraPsictoupiitcarsyervations: NicrLosicvoepric Oservations: Hart tidney Liver PUintugitary SpSlaleievnary Bland StToensatcihs/Epidiis Thyroid ""LPaalregeahnedsomrorthtalgeidc. mass, 1.21 1 a. "WWpyoaccaarrddiiatlis,fibcrhorsoinsi,c nmaolntsiufpopcaarla,tivwei,ld Dwhiotinfioaplr,oglredssive nephropathy, sodeate "PProerltiatliss,onaocuuctlee,arwincienllilinfiltrate, aild PHoerptaatlocbyitleevdauccwtlaptrioolni,ferpaetriiopno,rtawli,ldsirked ""hadsecnaclnaar ineralization, sild HHeootsiedxearionseids,, awiislsding l"veaescrular sineralization, wild "Hyperplasia, C cell, focal, wild PTrhoestfaotlel,owUirnignatriyssBuleasddweerr,e hfdoruenndalt,o Pbaerawtihtyhrionidn,oraTarlachLeism,itsE:sophagus, Pancreas. fFaitnea:l eKoebker:10I8 TRerninal SSeaxc:riMfailcee Group: (4) FRITZ 10 pa Wacrascopic Bservations: Hicraascroepiacl Oiserations: Heart KLiidvneery Lng Testis Epidionis "ho visible lesions. ""GHoyrotciacradlialdegfeinberroastiiso,n,diffofcuasle,, wwiillde Myocarditis, witifocal, iclheronic nensuppurative, "~CFhorrotnailc spormongurcelsesairvecneellphrionpfaitlhtyr,atew,iniwaialld PHoerptaatlocbyitleevdauccstolaptrioolni,fersaatlitoinf,ocasli,l wild "NVeagscaulleacrtossiinse,raliinziastailon, wild AFlevreiovlaasrcumlaacrrospohnaognecs,leamriltiinffoiclatlr,atew,ildaild "vascular sineralization, wild PSrpoejceicets:KuRsabter: O2BICRIGIZ 001925 Somnaized STAR Page: 249 - 440 SInutsisvairiuzaeld MSicRinrkgoelsrecTLoabibocurlaaatntoderdiWeiAscn,irsoasIlcnocp.Riecpo3Dr1tbse(ncoanttiionnused) F924 Too Year Oral Tonicity-Dncapenicity Study in Rats Tile: 2 MFeiitned:l (Neasbtesr:1081)83T85r7ain SSeaxc:riMfailcee Grow: (4) FNSE24 10 pon Nicrosapic Ooservations (contioued: TShpelefno,llPorwoisntgattei,ssSuetsorwcehr,e UfroiunnadrytoBlbaeddweirt,hiTnhynroorimda,l PLairmaittsh:yroid, Trache, Esophagus, Sulivary Glan, Pituitary, Pancreas. fFiotei:e (NHeasbheer:100 8 Teraiml SSaec:rifMiaclee Brows (4 FIT 10 pon Macroscopic Ohserations: Nicrosrceopniacl Bhserations: LXiivderrey lng "ho visible lesions. F"Chhersoenhircospcryoglroensss,ivbeensieghnr,opuantihlya,teraal0 FFoarrttaall bsiolneondcuclteaprocellilfeirnaftiilotnr,atwei,ldaild vMAaeslgcvauleloaacrrytoassiaincser,roaplhwiaigzneiasst,ailonm,ulatiilfdocal, ald Perivascular soonaciear infiltrate, aild STphleeefno,llHoewianrg, tTiesssateiss/wEepriedifdoyuunid, tPorobsetawtiet,hinStonnosrcmha,l Ulriinniatrsy: Blader, Thyroid, Parathyroid, Traches, Esophagus, Salivary Shand, Pituitary, Pancreas. Ffartie:edGMeaeskhser:10I8RTTEeSrSaiml SSaexc:rifMiaclee Group 4) FSE2A 10 pa NacroTsecsotpiiscEOphisdeirdaytiaosns: Nicrohxiarpeic Observations: heart LKiivdenrey PLintugitary Testis/Epidigpis "hth testes enlarged de to extensive edens. "HCyocrtaircialtivsa,csldartainoinc, rloowcaulpraarteisv,e,woderate "wCihrtoinfioccaplr,ogwrielsdsive nephropathy, aild aProtrata]l sboilneondculcetarprcoellilferiantfiiolnt,rataei,ldwild --Cvrasctaoliadrdeagneenrearlaitziaotn,ionf,ocasli,niasialld ""HTiarleenatrophy, spermatogenesis, bilateral, wrted SPpreocjieecst:NRoasth: O2ICROL2 0013926 Suamarized STH Page: 250 441 STroiniindasd BSiogseoabnlantdedcmirsaalsRsptera(tcoinotinnsued Hier Lowatrie, To, 3 FN-3924: Two Year Oral Toricity-Oncogenicity Study in Rats Tate 2 iFatee Wweoele1080 ) Teint SSauctriafilcee ron (0) ITE 10 go Kerscpic Osentions (continues TShteenfo,llrowoimnat,issuSeos nwrse lfroiuanrytoAbdeeweit,hinTonorrdma,l Pianrtatsh:yroid, Trches, Espa, Sbvry sans Parres. Fiatee: eweokve108) Terinal Searctrifailcee Group |) TA 10 WcroSsocatpcTisBssurensatainacn)st WeroHctpuitcarsytration: rt itor Liver [ Hrruretss Soft Thos tact) FRiariseedwawsa,s,280.56 2c.b2fcios,, Left side of sec, yWsictridfisatls,, uclreane ssnspprative DHeenine mreorpaessiavteions,earifpy, wild fgarstoalcrsesot,laninctel filtrate, ald aetlaa rwoawrpahtieat,ions,tafldu, ile SAicearrostrony ad Fin TShteeefno,llTosensg ttiessEueisnwer,e fForausnatteo,beStwointchhi,n sriomualryLiMiatsst:er, Kresl, Troi, Parathyroid Tachs, Esphages, Slvr Shan, FianeltNtaebe70A) FTond DadSn emis rons (0) RITZ 10 po Wcroscpic stration: [rreEnt -- Fnayas Sing vary Htuitary Ac.visible lesions "Soartgiecarl vwancelnaaltiizotni,onl,ocaKlilaeres, sere JNaittisnovaierta, atiisnstnsg Aodeeofnpair rest TShleeoe,ltLviivnestiesdsunes,woreurfsoWnartes,beSwointshcihn,noUrmralasiBlta:der, Tord, Praiyoi, Traces Species: mat Project Nusber O281CR0012 001927 Sonrized ST Page: 251 442 Srniribzd RSviogexeiTLueoat4wedrNaeireslscenBsoerstwcttioonn) 38 To Te a Tor Scepcity Std in ats Tae 2 eFtr oe AFouEnd test Foie om | TT 100 he[fAlog bo--se w--e fa-- nt to--o sitio srl nts enon Esophagus, Salivary Bland, Pancreas. Feti eoeee05I) TEoso SurFii gy {0 A on [ SHoennn-- as t0o.7wxdion 0 trl crforown Omri Swainctisleaitaenc,ortse,ittoideersateanil PHJroeris eSBesvepesassiteops toei SY Hien etiersis, ald ETrhieremf,alinenebg,itUssreeS,wtrryey.Ffaoreders,ybeShnwoieythinSshrwle,irita:y Mater, Tred, Traces FevintNoert10TATSew SSuriFieoe fr (0 P10 on Merson Omri: rsp Oration: -- ptrewrr) SSa riemwteniel peGireeset,eceJrvto,awepreataaeiate ou oes lation wif, id oy tHr pepiataoncytpewale laitetraitioonn,,vacwueioltleatoetd, he follwing tases wre fd te be sitio srl iiss Spleen, Uterus, Ovary, Maseary Gland, Stomach, Urinary Bladder, Thyroid, Parathyroid, Trachea, H-- ae her: R012 001928 Swiss ST Pages 52 - a3 SInutairviidzueald MSaicnrgolsecoTpaibculaantdedWiMcniraoaslcopRiecpoOrbtse(rcvoanttiionnuesd) F-39024: Teo YeaRrikebrralLabToorraitcoirtiye-sD,ncoIgnec.nici3t%y Study in Rats Tale: 2 Arnal Naber: (B04 Sex: Fesale roupi (4) FA-S924 10 goa Fate: (Hest 90) Found Dead Macroscopic Observations: MicrPoistcuopiitcarOyservations: Kidney Liver Pituitary Spleen Hass, 1x0 ca ""CPhorrotnalic spornoognruecslseiavrecneelslhrionpfaitlhtyr,atel,dwild PHoerptaatlacbyitleevaduccutolratailoinf,erpaetriiopno,rtaslo,dersaotdeerate ""HMeesonsoinderasis, ald THehaertf,alLluonvgi,ngUtteirsussu,esOvvaerrye, fNoauwnadartyo Gbleanwdi,thSitnomnaocrhm,alUrliinsatrsy:Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas. Animal Naber: IR-4075 Sex: Fesale roupi (4) F-39210 poo Fate: (eek 100) Found Dead Macroscopic Observations: Stin PLiitvueirtary Microscopic Observations: Adrenal Esophagus Ee Kidoey Liver Lung Nasary Gland DPuarncyreas PaPriattuihtyarroyid Salivary Bland Spleen TThryarcohieda Urinary Bladder "Large mass, 11 x 13 ca, right side. ""DPaarlke raendd awsost.tle. "CSoirntuiscoaildalvaceucotlaastiiao,n,colrotcea,l aress, aild oderate ""hHootdieaxgannoisniesd,, siinsasdienqguate section "Pelvic sineralization, soderate tne of "Portal pair bile pdruecstenptroliferation, wild Wecrosis, "Alveolar mcaecnrtorpihlaogseasl,arm,ulatiilfdocal, wild Throabus, wsltifocal, soderite ""NFoitbreoxaadneinneodm, issing "Not "Not examined, exanined, wissing aissing "Not "hat eexxaanniinneedd,, wissing aissing . ""hHaetaosexiadmeirnoesdi,s,wissosdienrgate ""NNoott eexxaammiinneedd,, awiissssiinngg Species: fat Project Nusber: 0281CR0012 001929 Summarized STAR Page: 253 444 SInudairviidzueadl NSaicnrgolsecaTpaibculaantdedWiMcnriossaclopRiecpoOrbtse(rcvoanttiionnused) F024 Too YeaRrikeOrralLabToorraitcoirtiye-sO,ncoIgnec.nici3t8y Stody in fats Tae: 2 AFnaitnea:l (MBuesbeekr:100()BAFoTuSnd Sex: Dead Fenale Group: ( 4) F-39410 pou Nicroscapic Observations (continued): The following tissues vere found to be within noraal liits: Heart, Uterus, Stonsch. Ffaitnea:l(Mhaesekh=er:105()R-TAeTra6inal SSeaxc:rifFiecseale Group: (4) FR-IS2A 10 ppa Wacroscopic Observations: NicroNsacsoapaircy DGilsaenrdvations: renal Liver Lung Nasaary Shand Thyroid Uterus "Lobular mass, 5.515 x 2 ca, right axilla. ""SHienpuastooicdyatle eaclttaesriaat,ionc,orveasc,uolsaotfeidr,atefocal, sil ""FViabsrcoualtaernosnisneralization, wild "Ulticbranchial cpst "Poly The following tissues Spleen, Kidney, Heart, vere foune to be Ovary, Stosach, UwriitnhairnysoBrlaaadlderl,isiPtasr:athyroid, Traces, Esophiges, Salivary Gland, Pituitary, Pancreas. Ffantien:al WNeueskbser: 801)R-SAaGcTr7ificedSexi:n Female Group: extrenis (4) PA-IS2N 10 pon MacrPoistcuopiitcarOybservations: Microscopic Observations: KAiddrenneayl Liver Lung Pituitary Salivary land Splemn Thyroid "Raised mass, 1 ca dia. ""SCihnruosnoiicdaplroegcrteasssiiav,e cnoerptherxo,paatihlyd, ild "PHeelpvaitcocayitneervaalciuzoaltaitoino,n,sipneirtiaplortal, anderate "VPaesrciuvlaasrculwairnersaolniazmautciloena,r aiinlfdiltrate, wild Hesorrhage, sultifocal, ails ""Nhoetroenxasnined, wissing ""UHiewtoissibdrearnocshiisa,l aiclysdt The following Heart, Uterus, tissues Ovary, were found to Naswary Gland, be within Stoach, Unroirnmaarly LBilsaidtdse:r, Parathyroid, Trachea, Esophagus, Species: Project NRuastber: 0Z81CR012 001930 Susnarized STAR Page: 254 445 Snduimvairtiuaeld BSirnogslceopTaibclaatneddMiicnroaslcopRiecpOtercvoanttionnused) P3124 Tan YekreGralLiTboocriattyr-ieGsn,cogTecn,ici3t%y Std io Rats Tae2: nFaitae:l tRhaetetrs 6A0GSTa]crificeSeicn Feexmtarleenisrows ( 0 FAS24 10 on Th fI alloing tissues ar-- e found to be within rsa ints (continued): Facress. rFaiten:d eMtaseers10R5ATTeaEinal SSuec:rifFiecmeale roup: (4) FIA 10 pon . [rHaymar-- Slant -- NirosPciotpuiictarByaervations: rena) idney iver Lng tuNranyay Slant Fitaitary Fuirietmsas,a,bx0.453cn2dcisn, right axilla, Switemrste] actsia corte, anilateral, Ppelevlitcss,insrcaalti,zawtiiloa,tearsatle,rataeild eHseaatteaccyttee avlatcewrlaattiioon,n,vapecriilgaarttea,l,fowiclid, "lscdalar ainealintion, ild vPeeulnanirs,acirnothearsgteist,ialm,itcirfaoiccl,, wuilltdifocal, Failberosdeons T"hudebnaonls bpeslasia, bilateral, ld Uterus. Cystic glands, noderate STphleefno,llhowairng, tSitsosnuiecsh,arUerinfaoruyndBltaoddbeer,witThyirnido,raParaltihnyirtosi:d, Traces Esophges, Silivary Slant, Pures. Foiiteseeerks810 7Fou0nd DadSei Fels frogs (1 PAIN 10 pon NrosScofpticTisBseurevsat(ilogn)s: Lier [cPityuitar-- y rons) "hsIss,. 7x x 2c arty teste, Let hind "H0i.g1hly0.h3acragdeidn,witohn mallltiIsolbes,pale Iesions, Hesarrhagic mss, 0.31 0.5 ch Sinussidl acts, corte, berate SPprocjieecst: Naatbe: CZEICROIZ 001931 Sumaried STH Page: 55 446 Sumarized Individual NSaicnrgalsecaTpaibculaantdedMiMcrrionsaclopRiecpoOrbtse(rcvoanttiionnused) Riker Laboratories, Inc. 31 P3924: Too Year Oral Toricity-Oncogenicity Study in Rats Table: 2 Aninal Naber: 1R4G79 Sex: Female Group: ( 4) FA-3924 10 ppo Fate: (heek= 84)FoundDead Microscopic Observations (continu): KiHedanrety Liver Lung PaPraanctrheyars.oid Pituitary tin Spleen Thyroid Malignant Iyaghona, histiocytic Protein resorption droplets, ail "MNaelcirgonsainst, Iysphons, histiocytic local areas, soderate "dascular sineralization, sid Kalignant Iysphoma, histiocytic Heaarrhage, local areas, wild "HHoott eexxaasniinneedd,, wwiissssiinngg -enom "MarloisgsnanLtesiIoysnphforwoan, lheiitstihoicnydtliecg. "Hevosiderosis, aild Not exanined, wissing The following tissues were found to be Uterus, Ovary, Nassary Gland, Stowich, within normal lisits: Urinary Bladder, Trachea, Esophagus, Salivary Gland. Anil Nosber: 1-480 Sex: Fenale Broup: ( 4) FA-3924 10 ppu Fate: (Meeks 78) Found Dead MacroUstecroupsic Diservations: Pituitary NicrKoiscdanpeiyc Observations: Liver Lung PMaanscwraerays Gland PSiatluiivtaarryyGland Spleen Bath har filled with dark fluid. ~Hesorrhagic eas, 0.4 ca ia. "pelvic sineralization, wild "Hepatocyte vacuolation, periportal, ail "Vascular sineralization, wild -bdenocarcinon Hot exanined, issing ""HAotrneoxnained, wissing "Hesosiderosis, soterate The following tissues Heart, Uterus, Ovary, were fount to be Stoaach, Urinary within normal Linits: Bladder, Adrenal, Thyroid, Parathyroid, Trachea, Esophagus. SPrpoejceicets:WaRaabter: 0Z610R0012 001932 Susnarized STAR Page: 25 447 ISurnirinzad RSaiicrlrcaTpviacolra4tntaddriWaec,rlnsec,Bper3to.arCaotntiionnused) PA To Yu a Toit cect Std in Rts Tie: 2 Foitae eVtrs109A) TLerai SSaecsriFfiecee Ge (FAI 100 Warssic Barrios: WeroNsaacswiraesryBBelarndtie: real l"oSbtuilacr emeasns,,52x130x82 ccha, Lreifgththor.axilla, Simsoitl casa crt, wild ut ity oHWncicii,p,rogurcedsrsioven psrrsogppraa,tivaieninl Une Spseacctse wicteilaoino,n, vsoildtee,, fwocladl, Rngar Slt "uaLlsoeacr wipnresraalsiization, id [ttyi ters a"ot,anwoiant,eaadt i pane of section Fay hSehefn,lSotwgichi,sruayareBafdedr,oThbeorwi,thirncvh,rEixighta:e, Slay Gln, Pitta, Frtl: tNhaer109R) TEenn SSwer:ifeicmeis Se: (A) STA 10 0 arssopviarcy aGlaanrd ti: Suwilt aSn1s5, 2 cnefn,i,eiriighnnlil Large Werourcoennicd taartion: Ti a 0x1 cy ight nly sinoital wt, crtr, wed Hout lve "Fwosriatlriiw,s,rldderoscenlmsnaitprrattiev,e anil FHeawrtasobilseisd,ctsrtotsrerati,on, sannila un aeahn,ssiwnlairsstiitoian,, dwriodne, mite, --r-- HBalieirctocrtleo Lioalra bheyrppaassisa cis mt 001933 Project Ne: o2IRO1Z swims 448 `Susaarized Single Tabulated Aninal Report (continued) P7I2nd:ividTueal YMuaicraoscoepiTac arndonMi,croosocoeptic3O1bseSrtvadtioinnsRts aie 2 rFle aer18BTeiarrSirFeonie So | TRH 16 [Fh-------- to eosse e eral, sabre heSenyfllYonenldse,rtaSBstoeiscthawyr,erfFaondresBt.erbeee,witThirn ev,rPrLstiosad, Tres, Espns J Fs he 5 Toren Seiten pp. NersTspiinc gtrations: ovary nt Ftcrot.a wn, $1551 2c righ iotioTarta wosi,e41s4e1335cn5.51 23 ps , al ml, -- ow we FBYoereoestwms,eiaveuaintsioaanlriafslidltrate, id J---- FTSoaarratsbeiatse,cterrt eerti,on, swiis SRFiertsotiaoonns frPbuoiryreesd e oelneratsaiisoan, wild SSitewy iad eprtaiynielater, nro ar6tHe aJg,hSneShoahonWeiSmaer teoenr reatd,SPletri, Triton, Shas, Peek Species:NRaabter: oaicss2 001334 SaridST Page 28 - 449 SInudairviidzueald MSaicnrgolsecoTpaibculaantdedMinciroaslcopRiecpoOrbtse(rcvoanttiionnused) Riker Liboratories, Inc. 38 F-3928 Too Year Oral Toxicity-Oncogenicity Study in Rats Table: 2 fail Nusber: (RABE Sex: Female Group: (4) PA-3924 10 pa Fate: (eke 105) Terninal Sacrifice Macroscopic Observations: Waaary Bland Kidoey Uterus Nicroscopic Observations: Arenal Heart Kidoey Liver NLaunmgary Gland Dury Pancreas PiSatluiivtaarryyBlane Spleen Uterus "Large lobular ass, 10x 81 5 ca, perineal "Coknigdeaneiytaelnlaabrsgeedncewiotfh eit sal kidney; cysts. right "CoFniggehntitsaildeabaspepnecaersofnolreaiatl.uterus and oviry} "Simsoidal "Myocardial ectasia, cortex, fibrosis, local marked areas, aild "CHhyrdornoincephprroosgirse,ssibvielatneerpahlropathy, saderate ""HHeyspaetropplaaiseisai,s,seepxtatlrasceeldlu,llfroyc,al,siniilsadl "Fibroadencas "ost ""NNoott eexxaammiinneedd,, wiissssiinngg ""NHoetnaetxoapmaiineesdi,s,wiesxstirnagredullary, increased, sild "Oystic glands, soderate TShteosafcohl,losUirnignartyissBuleasddewre,reTfhoyurnodid,toPbaerawthiytrhoiind,norTmraalchelsis,itEss:ophagus. Ffartien:al (Nbuesebtesr:1051)8-T4e6r8a5inal SSaecx:rifFiecseale Growpt (4 PA-ISZA 10 pon Macrascopic Observations: PiNtausiaatrayryGland Microscopic Oiservations: Arena) Clitoral Gland Kidney Liver Lung ""HFaisrse, m0a.s6s,ca2.d5i3a. 2x 1 coy left anilla, "Sinusoidal ectasia, cortex, aild "ICnyfstl,ammaaotdieorna,techronic, soderate "PCehlrvoincicaipnreorgarleiszsaitvieonn,esihrlogathy, aid "HHeeppaattooccyyttee avlatceuroaltaitoino,n,vauclutoilfaotcead,l, mild "Lsoccaallaarreawsi,newrialldization, sild SPrpoejceicets:huRsabter: 028100012 001935 - 450 Suwnarized STAR Page: 259 SIunadsivairdiuzaeld MSaicnrgolsecoTpaibculaantdedKiicsraoslcopRiecporOtbse(rcvoanttiionnused) k FI-I924 Too YeaRrikeOrralLiTboonriactoirtiye-sD,neaIgnecn.ici3t1y Study in Rats Tae: 2 Fmaitnea:l hKeoebtesr:105I)R-ATBeErSinal SSeaxc:riFfeimcaele op: (4) FI-SV24 10 pp icrosTcasoniacryDSslearnvgations (continued): PTihtyuriotiadry F"idbernaoandaenons "Uitiasbranchial rst TShoelefmo,llHoeianrgt,tiUstesruuess,weDriearyf,ounSdtontaochb,e wUirtihnianrynoBrlmaadlderl,inPtar:athyole, Trachea, Esophages, Salivary Gland, Pancreas. inital Nosber: IR Sess Female Grow (4) FISV24 10 pp Fate: theeks 99) Found Dead RacraTscaonpwiacr DGslearnvdations: Lhiivreernal PUirtiuniatrayryBladder Hicrhoisrceoniacl Observations: heart idney Leivner RSaaalniavrayrySlSalnagng Spleen inary Blatter ters "Large lobular Fira mass, 1.5 x 11 x 45 ca, ailneinguinal area. ""Etnhliacrkgeendedwiwtahllmsltiple pale foci. "Slightly mlarged "ySoicnausrogiidaall efcibarsoisai,s,cowritteisf,ocaaalr,kedald "PHeylpveircplassiinae,ralpiezlavtiicone,pistihledlium, aild hHcersoastioosi,esciosn,territlroabunleadru,l lsaardye,rawtield "vAalsvceusllaarr ssiancrroaplhiazgaetsi,onw,ltwiiflodcal, wild F"hiobtroeuxdatsnionnesd, aissing Hwenhaetroaptoeissis, xtranetullay, increase, "wiatkheedlial hyperplasia, papillary, diffuse, reas of squasous setaplasia of hyperplastic Oyesstiitthiesl,iuec.hronic, diffuse, aarked "Cystic glands, marke TOhvearyf,ollSotxoisnicgh,tisTshuyersoidw,ereParfaotuhndyrotiod,beTwriatchhiens,poErswoaplhagluisn,itsP:ituitary, Pancreas. PSrpoejceicets:Yufastbr: O2ICADIZ 001936 451 Summarized STAR Page 260 `ISnuisvsairdiuzeld NSieincegrlroescTLaaiibocurlaaatntaerdiMeiAscn,rionsaIlcroep.RieepoOrbtse(rcvoanttiionnused) PRIN: Ta Year Bal Toicity-Bogenicity Study in Rats Tale: 2 Fnaatea:] hWaeteers1001)04S6a6e7rificeSdxi:n FenetarleenisGroups 4) FISH 10 gn NcraPsictpuiictareyrations: HcrLoisvaeprc Bernations: hiierers! liver ng SPiitumitary ters aHoipseersaasl,e a0.d8cmottdliae.d. ""Tavrtoicnal prvoegsroelsastiivoen,shloecaal tahe,s,alwdild FFoelrvitc asivnraoliwaticoanlliilndfiltrate, wild FHoearttacbyielevdiuoclatprioolni,ferpaetriiopno,rtawli,leederate HTeoaaltacaryees,altseordaetriiotne, basepilic, sSceaslha awiicnreaaplhigzeast,ionm,itailddecl, ald SSertuosnlo, focal, ainssl SHeaseysyiderosis, ild THheertf,olOowyin,g Ntisasuyes aElraend,fuSndtntso,beWwiintheiyn oBlradsder,inTthsyr:oid, Paratha, Teaches, Esephages, Salivary Blan, Picross. Fraiea:ltNhaebreer:71RAFBoBunSd beadSe: Fonte Sous: {4 PRIA 10 pon NcrSesicnopc Bsevtions: Wic[rorscoapic Ohervations: Xiidvoeery Lng FiFraactrehsysri SlSaeliwvary land TTrheoies aie Wiming dorsal are in hed. eestbietaissin,eds,etaei,ssifnogcal, ild e"sscaaltaesivneircaallianattoino,n,elrdortl, ald EPionrst,ialu,cabrroancsh,eponbeaeornaat,e diffuse, acts, wetiaretaerned ising Joott eexxaaiinnee,, awiissssiinngg eostceoarstess, iis1ing Jot exsine, aissing SPproejceicet:Nhoate: OAICROIZ 001937 Sumarited STAR Page: 261 452 Susaarized Individual MSaicnrgolsecoTpaibculaantdedWiMcnrionsaclopRiecpoOrbtse(rcvoanttiionnused) Riker Laboratories, Inc. 3 R324 To Year Oral Tovicity-Oncogenicity Study in Rats Table: 2 fail Wunder: 1R-4B88 Sex: Fesale Groupt (4) FA-3S24 10 poe Fate: (beet 77) Found Dead Nicroscapic Observations (continued): Bterss "Not exanined, wissing THheeartf,ollOovwairyn,g tKiasssuuaersy wlearned,fouSntdonatcoh,beUwriitnhairny nBolramdadler,lisAidtrse:nal, Pituitary, Skin. Ffantiea:al (Rbuessbteer:105()R-TAeGrBaYinal Sex: Female Sacrifice Grow: ( 4) FR-JS24 10 pon Macroscopic Observations: MicrPoistcuopiitcarOybservations: Arenal Kidney Liver Lung Rasnary Shand Pituitary "Hesorrhagic ass, 0.7 ca dia. ""SCihnruosnoiicdaplroegcrteasssiiav,e cnoesrherro,pamthayr,kedaild "PHeelpvaitcocayitneervaalciwzoaltaitoino,n,imludltifocal, sild "aFsrcueloanr ,ainienrtaelrisztaittiioanl,, acihlrdonic, multifocal, sPielrdivascular sonsnuclear infiltrate, ail "Galactocele -Aenons STphleeefno,llHoesairntg, tUitsesruuess, wOevraeryf,ouSntdostaochb,e UwriitnhairnynoBrlmaadlderl,imTihtysr:oid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas. Ffaitnea:l MNeueakbser? 941)G-SAaBcSr0ificedSexi:n Fesale Group: extrenis (4) FA-IS2N 10 pon Macroscopic Observations: Pituitary KicrosLciovpeirc Observations: harem Kidney Liver Lung Pituitary Spleen "-RHepdpteianresdpwaalses, 1 ca dia. ""SCihnruosnoiicdaplrocgraesssiiv,e corte, ail nephrpathy, animal "PHeelpvaitcaeatineervaalciuzoaltaitoino,n,sidniifsfaulse, marked "VAalsvceuollaarr msiancerroaplhiazgaetsi,onl,ocaalilareas, aild ""Hbeiseonsoindaerosis, aild Species: Project NRuastber: 201CRO0I2 001938 Suanarized STAR Page: 262 453 STaadnivriiduzael BSiHcniTgelsrecTLpiabiualrantteeodriMeiiscm,roasIlcco,pBipcrBter(vcaatnitoinnsa) 328 Tao Yer Gal Tver ncogeicty Stay in Rats Tate 2 iFaaen tasieers01)4S0a%rifcedSein PxeaelenGroups (01 FRI 10 pn WcrsicnpaircyOsBeardnetrions (continue: | "Tosvistiiveonstiecpeiltheciraclinoonosr. High atatic ititvirty.ittse idlaomtoy cel ehersfolUlorwien,g tOisvsu,es wHroewrfyeuldatnd,bSetowiwtshhi,n Tsraroai,LiPnarsa:thyroid, Traces, Esphages, Sivan Sisk, res, Large testine, Fraeel hYote 81SacrificedSeirn sFtermeessBrot (4 LT 10 po [I Sn -- lFiivietary Hewroritc stration: rel tveorr Hragss Hhtwry uSerwrTmogsiconsbayt, 01.11,% r0i.g6htthwir. Saeteyareea torTefsiion,s0o.f1e0d.2nca, on the HiTgoh.ateesa. possibly slightly enlarged. iSte hof mpeirrarelissitts "onic raresiv shrpaty, aild HTeopttaaarrtees,voHildaion, cotrilablar, Jsaatlvairnneesralaisaetiinon, ald Siero hteeeo,lloavrintg,titsasrueos,wDreryf,oTuaktorbye1w1it0h,inSnaorvmaalhiUnrtisna:ry Bde, Tooid, Parathyroid, Tacos, phan, Sti Sn, Frain, i. rFietel hRaoke,165A 1 Tewimal eSactiFfoiwlers (0) IT 10 on WcrosFcupiitcarDysvaions: Wanary Bland hTsinsr,aer0e1,wcia6sh5ti3a1..55.55131423 ccbn rinight millas arleltaawresa, f2i1a s1a5ss1y 14323c5n3, co, in Lit SPpreocjieets:NRaahtr: CBIOL2 001939 Sanrized STR Pg: 263 454 PSS Aari1dte itnbot Ta o nwaii nipce3BtaScttotnbs oe iPBe n Seoes C0 Perc tion tion nooatpnarienytentc -- ibts sta, carpn ietaan i a a, Hepatocyte vacuolation, multifocal, sild - imnt,w,aa, ,oake, rie Hepatocyte alteration, basophilic, focal, tory 08 -- aeTaiieiStnoo,n wre te heh BIalisgiireernsefotc niesycidn, st, eos Ton, A Coca wasds twesa (8 rHeSpirrdsrtaotinonss tes no rt L007 aio tain, cre, tet tr im ePpentaer maaniyewwinnw, 14 iironr eeTomss, wesen in SIe loyn otesaSvoortsSte: intse rt trst, iw on, por n ibe: on 001940 Seer 5 2 455 SInucmimvairgiuzaeld MSaicnrgolsecoTpaibcalaantdedNiMcrriansaclopRiecposrter(vcaotnitionnused) PRIn8: Too YuirteGralLbToorxaitcoirtiye-sO,coIgnecn,ici3t0y Stay fo Rats Tle: 2 JFaotie:e Woeashtesrs109() RTeBrainal SSeaxc:rifFiecmeale Groups ( 4 F-S920 10 pon MacrosTcaopwincyBShsienrdations: NicrLoisvoepric Ohserations: FLancgress FiPatriaitthayrryoid tTheyrrosid Cirrucputluarrednosdpuole,incLiSsiocno.dia. silk cyst which ""evpaastcalcayrteaivniecaslliaztaitoino,n,saalitlidfecal, wild iJctinsrxaantirnoep,hy,notsotienraptleane of section ""iUdtiearcotmranchial cyst "tytic glands, aild TShpeanfsollKowiidnag,tiHsesaarets, wOevraeryf,ouRnadwntaorybeElwiatnh,inStnoosarcmh, LUiriitnsa:ry Blader, hirensl, Trachea, Euaphaes, Salivary Bian. JFaoti:n haebsesr:80A) SSaScrificedSeni:n eFxemraelneisBram | 4) FRI 10 pn Wacroscapic Ohservationst WicrHoewaarptic Observations: Liver PLintugitary ko visible lesions. "Hwpilctairfdaictails,, aclhdronic sonsppurative, "hNeepcartosoicsy,tefvaalcw,lastiinoins,alwiltifocal, wild "epaoerornhsige, local ares, aaderte STphleefno,llKoiwdinnegy,HiUstsesreuss,wrDeurfyo,undNatmowrbye Gwliatnhdi,n Sotormasch,liUsriitns:ary Blader, hireml, Thy, Farithyroid, Trach, Esophagus, Selivary Glin, Pancreas Ffaotei:l(Naasbkesr:109R)ATBerEminal SSaencsrifFiecmeale Grou (1 FRI 10 pon , NacroNscaonpnircyBGhlsaenrdations: Wicroisdcatpeiy Observations: herent --FLaolbelaarndwapgist,ied4.3x 2 ca, left milla, "CSoirntuiscoaildalvascwclaastiioan,Colrotceasl, awrilees, sild Species: Rat Project Musber: 0281CR0012 001941 Suenriaed STAY Page: 265 456 Susmarized Single Tabulated Mnimal Report (continued) Individual Macroscopic and Kicroscopic Observations P3924: Too YeaRrikeOrralLaTbooxriactoirtiye-sO,ncoIgnecn.ici3t1y Study in Rats Table: 2 nFaitae:l (Mbaeaebtesr:1051)6-4T0e8r6ainal Sea: Fesale Sacrifice Groups (4) FA-IS2N 10 pp Wicroscopic Observations (continued): Kidney Liver Lung Nasr Bland Ovary Pancreas Pituitary Uterus. ""CPhorrotnalic spornoognruecslseiavrecneellphrionpfaitlhtyr,atem,arkaeidninal Portal bile duct proliferation, sinisal Hepatocyte alteration, basophilic, focal, aild "Alveolar macrophages, focal, ainisal Fibroadenous "TCuybstu,larwihlyapteerrpallasia, bilateral, soerate "Polyarteritis, sarked ~hdenona "Palyarteritis, soderate The following tissues were found to be within normal lisits: Spleen, Heart, Stosach, Urinary Bladder, Parathyroid, Trachea, Esophagus, Salivary Gland, Thyroid. fninal Nasber: 1R-ABS7 Sex: Fenale Brows: (4 FR-ISZA 10 pha Fate: (beets 105) Terainal Sacrifice MacrPoistcuopiitcarOybservations: Microscopic Observations: Adrenal Kidney Liver Lung tary Pituitary "Soft hesorrhagic aass, 0.6 ca fia. ""SCihnruosnoiicdaplroegcrteasssiiav,e cnoerptherro,patahayr,kedanimal Pelvic sineralization, inital "portal agnonuclear cell infiltrate, ail Hepatocyte sininal alteration, basophilic, focal, Hepatocyte vacuslation, periportal, soderate "Alveolar macrophages, focal, minieal oLsatrge cystic bronchus with squancus setaplasia of epitheliun; filled with keratin. Vascular sineralization, ald "Ost, unilateral Tabular hyperplasia, bilateral, wild "Mons The follosing tissues vere found to be within soraal sits: Spleen, Heart, Uterus, Namsary Bland, Stonach, Urinary Bladder, Thyroid, Parathyroid, Traches, Species: Rat Project Nusber: 0281CR0012 001942 Summarized STAR Page: 266 457 STaenreiend rSNigeolee TLcaeulsntdtedeeM,raaelnec.Bto0rpat(cionotnivsnt) P28 To Yeu BalTenerScqeicty tay in ats Tate: 2 iFanel Noweer,10A) TTeal SSousiFteewer 4) FI 10 90 Ehreafs[ ei,oS-- viso-- Sower,e -- efornadsa,--bre ii.H srl Lit (tines eetiean"v7TFoE be srt Fee ri PR 10 on [A -- WerLmHuennemgiritcsuBysertios Ahepapieraeere,dd twooabTre tfio,lnlehdcndwithireeddflwudid.frkoe, rent STaitincalsdseetriastiiaonc,ortsea,ltrreast,e strate rt ir cdwieatntittee,ssmtSaertmiiiosns , sitifm ecal, wild i bury Stiowei,sseTtoscs]m,ersmvisni,tiroaner,tnseiclieon frBietear SIneteenlads, mrad Hydronetra, irked GhTiermefenorlsoo,innayg,rtiTsysvueesnrhwr,Eencf,ornedStatosewebe, wtitihinnysoBualtel,isT:roi, Paratha, Traces, FSietrea eeer,0 Found bakSe ems Gri (0) FH 10 30 [RSirr -- Kites NeroieotnriitscryBserations: rvee isd SrujbncurtaneouOs Tsassh, 2m31w3tcto,r10of8 0ional. Apearevd mlergdswriint1F5a1l3ltaa tae dr, oSottecvvaaesnaset,esaveaitginn, id PFeesiacsh sroemoemerleintieilrate, ile f-- Project Nusber: OZ8IR0012 001943 Sunred ST Page: 267 458 SIoranireield MSicgrlnecoTnaial4tedMIcrnsacniBcirBtua(rcaonttoinvset) PSEA To Yeau eBalLTaoatcrin,corgee.icity Stay in ats Tae: 2 eFiitet eYeekr,80A) FouSnd oSd Fie Gr 4) FSH 10 pn icrsWsaepenOSselntations (tines LSeacltmrss JnSwiabetyrsie rSJeeyvveanrose,, iwsiileng TTroroenn Jeatt aniinett, awssssiooyn Win Hatter 30k rained, wang LTihveerf:alKoendinegy tHisosures Bwearset,fartyt,o beStwwisthhi,n SsourerHintds:, Paces, oFtl NNeaser1a5 S0urificdSeicn FmeiwieenGe (4) AEN 10 30 [i--er UBroew teste WcroLSsutolscbIonadteeerstasittneitoenr:ic) . raet ian [p-- hLoer LTaorotEendsteric) ry "SRtiuuiriei1sy5p4l23si1th15ratha,sortcr,dig fren Jaconnlat Caaseinrgla vrievseiswteisn, in valve rea oTetsietineg nin gross seargeut aShiishtlWyieetds.er coc. SAWraiicannitktio,Isptatanosenims,iccbmoirsattei,rsotitrceit,e fc, Siralaistgenntres1uspbtoionn, lbeisttsi,cpiwcrked Aoiutnnsmshceeraaktpioonns,of NiLamtnltvsaeecfnaeof:cel wall ullisigngcitnsnaIwykagltozosnnt,ioBMnii,tisactrriiscd olnaitlgivnghaaisntaepr,oinoesnt,,ryhNiasttiiotpiicc SPrpoejceicets:Vofsabter? 0281CROIZ 001944 Sanrized ST Pg 28 459 Susmarized Individual MSaicnrgolsecoTpaibculaantdedNiMcniraoaslcopRiecporOtbse(rcvoanttiionnused) 3924 Tuo YeaRrikeOrralLaTboouriatcoirtiye-sO,ncoIgnecn,ici3ty Study in Rats Table: 2 nial Fate: lRiusseblesr: 951)6-4S3a0c0rificedSexi:n Fesale Groupt extremis (4) FA-I924 10 pon Hicroscaic Observations (continued): PaSnaclreaIsntestine STphlyereonid Urinary Blaster Malignant "Malignant Lysphona, lyeghors, histiocytic histiocytic M"aUllitginbarnatncLhyimaplhomcap,sthistiocytic "Haliguant Iysphons, histicertic TUtheerufso,llSotwoinnigcht,isPsaureasthwyerroeidf,ounTdracthoeab,e Ewsiotphhiangunso,rmaPlituliitsatrsy,: Salivary Gland. AFantie:a (Nbufaebkeer: 361)8-4S9a0c1rificeSdexi:n FeexmtarleesisGroupi (4) FA-3924 10 pon Macroscapic Observations: Stir Wicroscopic Observations: [ LKiivdenrey Lung Naseary Shand Pancreas. Spleen Uterus. "Large sternal subcutaneous sass, seasaring 10 REE ""tpeerlavtiictiasi,necrharloinziact,ionw,ilaitneirtaall, aild ""Hveassactuolpaariessiinse,raleixztartaimoend,ullsairlyd Pressonia, interstitial, chronic, multifocal, Pweordievraastceular aonsnuclear infiltrate, soderate Hesorrhage, altifocal, aild "Fsitberronaatlenownasss. H"Hoetmteoxpaasiienseids,, weixstsriansgedullary, increased, wterate "Hot exavined, aissing The following Heart, Ovary, tSitsossuacehs,veUrreinfioruyndBlatdodeber,wiAtdhriennaln,oraTahlyroliidn,itsP:arathyroid, Trachea, Esophagus, Salivary Gland, Pituitary, Large Intestine. PSrpoejceicets:aRbaetr: C21CR00I2 001945 sunrises stat Page: 269 460 STuennriead RSiunsglceoTnaiulaatedMfeinraslopnrtM.seCrcattionnsnt PRS To YouhreralLTiesbcrharOycnoeee0 tay in ats Tae: 2 iFotl NNerse,10R1AFoEnd tedSw Fue Seo NNrearsscmpiiitcacrytBaoretritoinsssst ra fioeer HSiimyetwt 0 FR 10 om Herre us, 0b codi SEirtseaalegsmteaattaiocnotleo,chwiwlees, ald eTSecinatsrsiwnwwaraissaiitanittoeinno,nimdniitiefeal, wig iSevneders, wld THFheresmflalW,oavriSegsiinDusrsyu,SkwFe,roeufPradhrdeo.,beStwuitshhiyn storraayiBiatde:r, Thyroid, Prather, Tracks, FSietien Neesre,108 5 Terai SSawreitwe Ei |) PLS 10 0 [HIeat -- Merposn Baertions: ot britsor Hltyituy Set serge, 0.7 ca. awhiiten, ssiolt -- a---- FFreetaaitl tbielemturtrtasinroan,v,arasaitedoan,msalg Hrulaapration wid Sen pSThhoeemnfe,eslW,aorSnt,HysDsuysSienvdryetcfyuendSnat.nosbeSwtiotmhaicnhtserawryLiMatd:er, Thyra, Paths, riche, oral Yaar,i tot stSe Fee roi (0) FREE 10 pn [aa-- y End-- hen Hptiebllaas,A$x 2y5x 12 cn, i righ Saarena dof right forelisd, 3x 3.4 1 2.5 ca. Sapeceies:YReatr: ORO 001946 Soanrizd STH Pages 70 461 Susaarized Individual MSaicnrgolsecoTpaibculantdedMiMcnrionsalcopRiecpoCrhtse(rcvoanttiionnused) P3924 Tao YeaRrikOerralLaTbooxriatcoirtiye-sO,ncoIgnecn.ici3t8y Study in Rats Table: 2 Aina Musber: (R-AS00 Sex: Fenale Group: (4) FI-3G24 10 pp Fate: Meets 95) Found Dead Macroscopic Observations (continued): NicrosLciovpeirc O(bcsoenrtviantuieodn)s: HKiidrneeny] Liver Lung Faseary Gland Parathyroid SSpalleievnary Shand "hale ""Spienluvsiocidaailnereacltazsaitai,onc,ortielr,d aild "Hepatocyte vacwolation, centrilobular, Nseocdreorsaitse, centrilobular, #il "Vascular sineralization, aild "hhdieennooccaarrcciinnoonnss "Hot "Not exasined, exanined, nnoitssiinngplane of section "Hematopoiesis, extrasedallary, incresed, wrked HTehaertf,olUltoewriunsg,tiDsrsyue,s Swteormeacfho,unUdritnoarbye Bwliatdhdienr,norTmhaylroildi,nitTsr:achea, Esophagus, Pituitiry, Pancreas. final Fate: (WWuesebkesr:1051)6-4T5e0r5aimal SSeaxc:riFfeiscaele Group: 4) FR-I924 10 pon Macroscopic Observations: Microscopic Observations: Adrenal Heart Liver Lung Uterus. ho visible lesions. ""SMiyomcsaoriddiatlis,ectcahsrioan,iccoorntswep,puaroadteirvaet,e witifocal, siniaal "Portal sanonaclear cell infiltrate, ald Portal bile duct proliferation, wild ~Presonia, interstitial, chranic, multifocal, "aylirdonetra, arked Folyp STphleeefno,llKoiwdinnegy,tiOsvsaureys, vNearsenafroyundBlatnod,beStwoivtahcihn, cormal liits: Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Bland, Pituitary, Pancreas. sPpreocjieecst:RRaabter: 028ICRHIZ 001947 462 Sunarized STAR Page: 271 SIunndarriaz)e aSifntgolescTpaiilneddrMiasaspRepoertra(ctntiionunnt) PrST4 Tae YeaWrhBealLTaxbotraS,hcqneei,ci3ty Sad in ats Tae: 2 iFintea Gweoevle 7A 9) SacrificedSeaitn FeserteesisGrows (A) TE 10 oe RcrosFcaptiacrDysarnations: Tawny lant Wcresreepinct Bsarations: Kitdnogry AhauwtrryySlant Sir SSuabeideesdiwts,wa1s.h2523080.c5n.fn, i right aoa rt. "Tirnit pogreein p eprapa-- thy sinint Fhreevinin, erstitial, aor, atifacl, LYaebalratragWp,erlpclasiaaris, wile ZSeewnsointross, trite TLhieverf,olHleoawrisn, tWiesrsuee,s wDraey,fuSndtntso,beiwniathriyn Bnolramdaelr,inTthsyr:oid, Parathrold, Trachea, Esohias, Salivry Slant, Pancras, Sin. Faitea: eNeber:1051)4T1e0r7inal SSucerifFicoewler: (A PRR 10 pn [I Hrutny-- awry lint Worosrceeict ssrations: KiGdrneey ng "TSuorfkt baeev,orrAug1i4c3ma3ss 1copcidnip, riate Tefoturirgmisnsa 5a1r4a2360 in STiomrsaamicdplrosgteasmtiav,e ecaprteeps,stwha,kedald SFoortrat vileoducmt prcteillfraitdiiotnr,atie,iwile aFcrotnat,sieraslitvatinon,, raladnc, stifecl, [ wie ---------- Maswary Gland iteuristary f~hFairbmrroocaeadrencoinrson ee sands, wrk TSeoerf,ollHoai,n HDiusya,r SakoewfsounUritnoarbye Hwiatshtine,rTmordi,itPr:sthyroi, Trche, Esphge, Sivas sa, Patras. SPapgiet:Waatr: OBIGHOLZ 001948 Sanrized STR Pg: 72 463 Sdiovwirdiuzale MScirogscTpaibclantdediironslcpiperQths(rcnotnitoinnused PA Too teirkGealLToorsstoeriesr,coTpce.ici3ty Stay in Rats Tae: 2 oFaitel: taebkrs: 47()R4S0ur0ificedSexin Fsterevwser (FIST 10 po FaPritouietarsyerations: "Large eerhaic mass 1.2 co dia. Rawr Slant "Ciynsteicrsewdayndglraingdhst en, afinlilledlariyth ite fluid FicrocrpeincdOserations: areal Ait rent elage, Sivcitl ctasia, cartes, ried itor TPielrvoicnspireorgrleistsiivoenn,epwhrroiptasthy, isial rg Hpeenrrsrihsgtse, lpieallvicreist,heslodoernatesild Nake land aGclticuteacllee FPitristtiyroyid Siem oHatnornine ot in plane of section ewsiteress, wberate TLievero,lelaori,n Wtiasrae,s Owrrey,fSntowstcoh,berwaitrhiyn olardmd)er,inTthsi:s, Traces, Esha, Silivary lan, Pncress iFantea sNakber103114S0cr7ificedSni eFevwelnesGrougt (A) T2010 pon NerSotcopnicch Osertions: PiKtauirtyarylind Tnagras Gsternal) iver [ itor -- ares! itn iHetsirsrlhaegifcecailssa,re0n.1ofaalicae.ratio, Suwbialtlus,oous sis, 251 2 ch in righ FHielvlrerdaigtch, lailld,lobes. Faald,asesttelepd,tawithsusrcaactet,ered yellowish foci Hale nd pie. "aSritniscoailtliceactaiiao,n,orleocsa,l aarlearsi,tewild Gaolniegnproygroess,ive hoissotipsiyttihcy itd lPelivigc tsieprahloiast,ionM,stMiIzEetic ratein ressption droplets, weed Srpoejcicets:sReatr. : EBLRO1Z 001949 Soanrised STR Page: 275 464 Suanarized Single Tabulated Mninal Report (continued) Individual MaRcirkoesrcoLpaibcoraatndoriMeisc,rosIcnocp.ic3O1bservations FI-3024: Tuo Year Gal Toricity-Oncogenicity Study in Rats Tale: 2 AFaaitnea:l (Nbuesebtesr:1031)6-S49a0c9rificeSdexi:n Fenale Broupi extrenis ( 4) FA-3920 10 pou Nicroscpic Observations (continued): Liver Lung Nanary Gland Pancreas Parathyreid Pituitary Spleen Stonach Urinary Bladder Uterus M"avalsicgunlaanrt siInymeprhaolnisz,atihoins,tiosciyltdic WHaelniogrnhaangte,ysdpihfofnuss,e,hissatrikoecdytic "WFailbirgonaadnetncaIsysphons, histicytic ""NMoatliegxnaamnitneyds,phfoants,inhpilsatnieocyofticsection "NMoalidginaagnntosiLsy,sphionnasd,eqhuiastteiosceycttiicon "Malignant Nalignant Iysphors, Iywphoss, histiocytic histicertic "Dystic glands, marked The following Heart, Ovary, tissues Thyraid, vere found Trachea, Etsoopbheaguwsi,thiSnalinvoraarayl llainsdi.ts: AFantea:l WNeaebkesr:851)-S9a1c0rificedSexi:n Fenale Groups extrenis ( 4) FA-S924 10 pou Macroscopic Observations: Pituitary Nanwary Slant Microscopic Observations: [2 Liver Lung Pituitary Spleen "Henorehagic aass, | 1 "Hilk cyst in perineal 0.5 cr. area. "VPaicguuselta,tiocno,nv.contvu.b, tuebi.theepliituhee,iunb,roawi,ld sil "pPoorrttaall sbiolneanudculctearprcoellilferiantfiilotnr,ataei,ldaild Hegatacyte vacuolation, centrilobular, ld Hepatocyte alteration, basophilic, mtifocal, ld "vascular ineralization, sild Alveolar sacrophages, wild ~bdenoma "Hewosiderosis, soderate The following Heart, Uterus, tissues Ovary, ere found to Namnary Blant, be within Stonach, normal lisits: Urinary Bladder, hremal, Thyroid, Parathyroic, Trachea, Esophagus, Salivary Gland, Pancreas. ----_ Project Muster: 0Z810R0012 001956 Sunarized STAR Page: 274 465 STundniavriidauaeld MSaicsrgolsecoTpiaclaan tNfiraoslcaRpecpOtbsecrovnattiinounesd) PIR: Teo YeaRrikeBralLaTboordactiotryi-esc,ogTec,ici3t%y Stay in ats Tale: 2 aFaae:) tbvries $T1 ASiTcrificeSd ein Fexetlressisro: 0 PRT 10 pn [treynal ---- PiFtaueirtyarySlnd Weroscraepnic Bserations: eClrittual Gland tne Live Lng Haney Shang tFiatruytary ""loaursgley slightly enlrsed. "Si4k5catcua,neoruisedamlitllos nsbcsuatsi,eo8s.s5 x 85 1 wTlittilaxiinlllars csyusctuictiaososs,s 3a1ti4c,5x 2c, in srets ifillled swaistsh,ta8n1c7ol3or3edaF,luiid throat ""Sointusoidal acts, carter, marked J witifocalp , itd ---- FWeplhvriacsssi,ertlaibzlaatri,ons,oaritniemal eislaatcyte alteration, Saaphili, saltifocl, "Fsaceaalcnaira,sinienrtaelrisstaittiioanl,, cahlrenic, sltifacl, iAlveer screphages, miltifocal, il FSeernilaosncsl,arwistiofancla,r#1i4nfiltrate, ail FBilbircotaetceerloens FMeimraacaatrecrionnosns "yTeta,enairlsatoenalin are of ahalae byperlasia. nens STphleeefno,loWnairoegs,tiSssouwess,werUerfiomnrdy Btloabdeerw,ithTiynrosido,raParLaitmhiytrso:id, Teaches, Ecphsus, Salivary Shand, Panes. PSroocjieocst:Wuastber: OICROL2 001951 Sunaizad STAR Page: 275 466 Sinaiitz RSiianvgtleeoLTnaiilbanrtdadMrreyarloseoBngr0atracotnitoinnu) P02 Ton Yee ral TodDcoqicity Std in Rats Tales 2 iPie sr, 8TSAwrivicedSein Ftruuesseo (0 FRI 10 3a NKcersrsopiintc ytsoearrtaitoinosss: Henri ws, cdi. br . "eBDorlointe,esrnsogaarteesa,siroielsptrtgubt]ty, sie iwye eSPvrevatilsiailvrcrimaaeitnnittoiinoo,,n dniiihllestea, tseoderwaitled Reaetcahsgte, toralcatrta,widl tButraytay J Teavnis mesa Sister, udrte fro -- heEreutrfyeeih,orienseg,viRrsosyuveesSywnirgnekfFyoouSrnotsto,hbe UirtaiaysBoaretr,LiKte:en, Tro, Paths, Trioen Foiitel eNsaveer39BESaScrificedSeisn eFenlssGi | 0 SE 10530 [I wiatraryy-- Bland Heenntreidenwys, 1c.a2hcuagi Tgp inal. Werstroentl Bserations Kier S"ivneaniasrsarcetmiunse chorrptee,thwyil,d alg tr Fowoperekrwatopnic cheleiini,lvawtetiwfilcda, pPrta rbileaflctorlnif,eramtiiont, oaieald Lop rMetlea rinoeabieesstiioffiadcl, ile JVainnSlant Shy Sst FSeivvenaon Jet nae, sssing Sfoend STanritr,ovnate Tihoe nf,oloFsonrtgsiWsarue,wDreorfrennd atoybeMwaitehrin,uPaastLeilt,: Traces, Esse, Paces. FSrcaigsowfatne: aaicorz 001952 Sanrized SH Page: 06 267 SInugmimvairdiuzaeld aScinrgolsecoTpaibculaantdedMiAcnriossalcopRiecpoOrbtse(rcvoanttiionnused) F-39242 Tuo YeaRrikeOrralLabToorractiotryi-eDsn,coIgnecn.ici3ty Study in Rats Table: 2 MFaaitnea:l Oolnbeekr:105()R-ATSeIr4minal SSeasc:rifFiecaeale row ( 4) FA-3924 10 poe Macrascopic Ohservations: PRiatauniatrayryGland Microasdcroepniacl Oservations: Heart Kidney Liver Lung Navwary Gland UPtietrusistary ""HLeasrogrerhfaigriec maaassss,, 80x.4 6c3a dia. 4 ca, left asillap sIueaflt] icnygsutiincalmaasrse,a.2 6 dia, in ""SAiynoucsacriddiatlis,ectcahsrioan,iccosratnesxu,ppuarialtdive, focal, "sChirlonic progressive nephropathy, sinisal "PHeelpvaitcocayitneervaalciuzoaltaitoino,n,8islldtifacal, aild Hepatocyte alteration, basophilic, focal, "sviasnciuallar aineralization, winisal APlevreisvlaasrculaacrrospohnaogneusc,leaartiifnofcialtlr,atew,ildwininal Fiebnraocaadrecnicneoans, papillary ""Chyesrtoincsglands, aild STphleeefno,llOovwairnyg, tSitsossaaecsh,veUrreinfaoruyndBltaoddbeer,wiTthhyirnoindo,rmPalaraithiytra:id, Trachea, Esophagus, Salivary Gland, Pancreas. Ffantiee:al (NMoenebkesrs82I)R-F0o9u1n5d DeadSex: Fowale Group: (4) FA-3924 10 pon WacrKoisdconpeiyc Observations: MicrLosicvoepric Observations: herenal LEsiovpehragus Lung tury Pancreas "pHaolteties "Pthneeccohfropnacicrytporness,enbtenign ""HNeotpatnoacnyitneedv,acuioslsaitniogn, diffuse, arked "AWlavsecoallaarr mmaicnreorpahlaigzeast,ions,utiwiflodcal, il "tHniethoifn opariralpreLsiemnitts "Not exained, ising SPpreocjieecst: MRaastber: 0281CR01Z 468 001953 gprives stat rg: 2m rio aoiecR CiorriHeeR roropee, at-- ion F-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats Tae 2 T pre s rie Soy 0 TH 16m [Terr-- r. ---- to e--ty-- so Trael Book ttnst wsvog ha str 2 vies si thenelai Hoesee, wreeafsounobyitSiund Srolnsiries eoer eoms0BTorso o Sireetne og FE NerorcoapcrmSenntions Rieiwe tone, 1a55193 45 a rgd wt Le ri ed 0 a, 17 cn -- Sfhisurtgaieweofan41cohntden, bwnetde sive fioor Saoeienetasi nsiron,, asstot foil, I" EH-ret bs--a--t,--mitts, ---- A ow --- AJiocthiatemt at; he omg Hoses wn ee cnebe tviinrorTalsieiEtsha, Silvey Sa, Flt, fits p-- Species: Rat 001954 Sawwioe 58 Page: 78 469 Susmarized Individual MSaicnrgolsecoTpaibculaantdedMiAcnriomsalcopRiecpoOrbtse(rcvoanttiionnused) 324 Tuo YeaRrikeOrralLiToorsaitcoirtiye-sO,ncoIgnecn.ici3ty Study in Rats Tae: 2 fFiatnea:l (Nbuessbtesr:1051)6-4T9e1r7winal SSeaxc:riFfeiscaele Group: (4) FR-I920 10 pp Macroscopic Observations: NicrPoistcoupiitcarDyiservations: KAirdenneayl Lung PiOtruiytary "Raised mass, 0.9 co dia. ""Spienluvsiocidaailneercatlaisziaat,ionc,oraeisl,d soderate Calculus, pelvic, soderate "Pvraeswcsuolnaira,miinnetrearlsitziattiiaoln,, schirlodnic, sultidocal, Paelrdivascalar sononuclear infiltrate, ail "Tubular hyperplasia, bilateral, ld "Adenona STphleeefno,llLoiwvienrg, tissues Heart, Uwteerreusf,ounNdamstaorybeGlwaintdh,inStnoonramcahl, linits: Urinary Bladder, Thyroid, Parathyroid, Trachea, Esophagus, Salivary Gland, Pancreas, Eye. Fnaites:l(Nbuesstbeer:105()R-T4e9r1a8inal SSeaxc:rifFiecseale Growpt 4) FR-IS2N 10 pa RacrPoistcuopiitcarOybservations: StLoivmearch MicroUstceorpuics Observations: hrenal Eisdonpehyagus Liver Lung Pancreas SPpitlueietnary Stonach Mass, 1.8 ca dia. "pRaaliesed mass, 1.31 Lon "Large tira cervical mass, 3.51 3.5 co. "SCionrutsiociadlaldeegcetnaesriaat,ionc,ortleoxc,alaialrdeas, woderate ""CNhortoneixcanpinreodg,resissisviengnephropathy, wild "PPoorrttaall bsiolneonduuccltearproclelilferiantfiiolnt,rataei,ldail Hepatocyte vacuolation, diffuse, ald "WVeassocrurlhaarges,inelrocaallizaatrieaosn,, saoidledrate ""Nhodtenoenxaamined, aissing "Hesatopoiesis, extrasedullary, increased, "aUlicder, diffuse, aurked Gurlocsesrataipopnearwaintcheeodfesaa moafsssudbumeucotosae.xtensive SPpreocjieecst:NuRaatber: 0281080012 001955 Sumarized STAR Page: 219 470 PSiutssarbiTzeedTSTiiunagvlrpelcrTTaobuelsamrtkerdsaAncirmaal pcReiporsta(Stctouniytioniunneda) s aie 2 oFire tae 8Te6val SSoereenu Gs {0 10m [rs ---- aa etits, ate, id a rnc; atesive sero. ehetsFeGlonn Hsevs BwretornutsoeBdiithri,n osardl,iiats: h, The, airy lan, Ee. Feiitd eonew614e5al SSerreil es 0 10 [ Hortess-- te pTeerrsrwierea,h 0c a WeJrHotreyBsertions: ve wl. F---------- eBNeottwt, dmiptat, will, sist ite itSeo iseneoestiotetadhrtehsi,andiddessin iovyr SaPeeteesiatitnai,n,Wmeaite, wile dpry iitoiasosepmeaptoen bibl, sfrte ores Ziwoaaciamrcinmwl deretits sity SSheeinte,eibHants,iUFses,mworewendStt,eStoiin srrlyitSosb:er, rth, Trace, Espa, Pceissometr, anon 001956 Soret SH es 0 471 SInudninvaiidzuaeld MSaicnrgolsecoTpaibculaantdedNincironsacopRiecpoBrthse(rcoanttiionnused) Filter Laboratories, Inc. 31 FN-3924: Tuo Year Oral Toxicity-Oncogenicity Study in Rats Tale: 2 dFeaitnea:l lMeaeskhesr: 801)1-4F9o2u0nd DeaSden: Female Group (4 F-SR24 10 330 MacrLoiscvoepric Ohserations: shin Nicrosraepailc Diservations: Liivdeery HLanngey Gland Fsihuiintary Sle Thyroid "a0le0,-s1catetnerdeidnshite nodules on all lubes, "SGbciaatabnyeo2uscbatshsickbehwiintdh 3Lefcto sdhiao.ulder, 6 ca acerated ares. ""Hreontsetionaireessiosr,tieoxntrdarnoepulleltasr,y,sarwkineidsal ""NVaalsicgunlianrt sliynmepahloimzaa,tihoins,tiowciyltdic "~dtodtereoxmasind, wissing H"aHelniagtroapnotissLiysg,hoensst,rahneitsutlilnaerpyt,ic incressed, "fUtmiscbranchial erst THheeartf,ollUotweirnusg,tiDsrsuye,s wSetroenicfhu,ndUrtionabrey wBiltahdidner,norPmaarlathLyiriotisd:, Trachea, Esophagus, Salivary Gland, Purcress. Species: at Project Kusber: 02B1CROO1Z 001957 Sunnrized STAR Page: 281 472 Tissue Inventory Table: 3 RikerLaboratories, Inc. 38 FPR-3924: Too Year Oral Toricity-Gncogenicity Study in Ra=tOsne Year Interin Project Nusber: G281CR0012 Species: Rat TissueNase Dose Group Nane: CONTROL 0 pp TICILEI EII IntIttIinE ey RRRARARRRRARRARRRARRRRARR igal Musbers 3==3IsIToImITmIeIsIIIIsTAcMeMLnA4e44s4 5555555555555555555556646 1172022273543465051596870758078828588899001081020 Sex RENNNNNNKNNNNNNFFFFFFEFFE Arenal forta Bone Narrow Frain Esophagus Ere Heart KiLadrngeey Intestine Liver tang LyoghNode (esenteric) HaOviarryyGland PPaanrcartehaysroid Pituitary PrSoaslitvaatreyGland Suall Intestine Spinal Cord Spleen TSetsotniasch/Epididynis Thyroid TUrraicnhaeray Bladder Uterus reeeeeenneeeeeeee The Nesentary Skin following tissue(s) FS erhat eA ab E es r FC erauh be se he ir see s FF erae be b bi ea rs y FF erahe be e be b rb y Cheese carrey FC eraa hbeb sahei be aas r ey CEdociadimbeeere hiba erit chieber rrTy es ee eeeeteabeaaeas CF ocche ceseb rrcce hcccr ercey rice BaCahir Esa e ahab b aba e mey een Lebaree Sheers BC eshbe breair berice ericeb ereiaeeey b Cebbeee Ce ai a re m s nes CC evche coasib bisasre iters itene nies Cieeeiaieitaiiieitiaiiiiateeiaiebaaaieisc wF ere not requiredR By protocol -seR ereeresesecroone ees A+ indicates that Acindicatesonly a diagnosis was anoadiagnostic sade. A - indicatesthat consent as made. Please nroefedr itoatgheSnoirnocgoslmeienTstabulaastedaaAcnei.mal Report. 473 001958 Tissue Inventory Page: 282 Tissae Inventory (continued) Tle: 3 F392: Too Year Oral TfoinkiecritLya-bGocroagteonriicesi,tyISnct.udy91in ats = One Yer Intern Project Species: Nhaabter: 0281CR012 DotseiGronup Nan: CONTROL 0 gpa nies] Naber RE- R<R<R= bfheess 2930313240 Tissue Nase So FEFFF fsoirretnsal oe Marron cCheieens Sera Essaoipnhass Cbeeaeess Eert CGeerraan tLiadrngeeyIntestine C"oeveenn LiLvger Lyush de (asenteric) CCeeran ren tMuarsyer Slang Pancreas VCeerraes Coren FiPtaruaitthayrryoid cehceeer FSraalsivtaartye Shand Sul Intestine Ceoenaen Cees SSpeinn Core TCeeeens StToensaticshfBpitidpis a eee ThTyrircohieds Teavaes UUtreirnuasry Bladder EEeeereec The folloning tisue's) rLoene were nat required By protocal ~--w-wweeeeeee Rsteisnetary i a. eter Ri + iinnddiiccaatteess otnalty a4 Gnhoanginaosginsaswtacs wcaodnev.ent w-asinsdadiec.atesPltehaaste rnoeeargntoostihse oSrincgolneseTnatbuwlaastewdadnei.al Report. 47 001959 Tissue Inventory Pages 283 Tian Tovestry (continued) R928: To Year tral TReivkceirtyL-aGbnocroagteanriecsi,tyTSc,td30in Rats = oe Year Table3: Intern Spbriojeesct:NaRabter: OBICRNLZ Tissue Nore TRoCeRLIRGrTAouRp RNaRse:RAFASRRR10A0 RpRnARRARRARR RIPIRALAL S4317373731E37IL731EI7I7I1I7I71T1A7A7M1M7M7N7N1L7L7 991114152021222732333637474857606163757980828385 Sex ANKRANNRNNRRRRREFFFRFFFFF phe Caan Large Intestine canna LPoahnrydSeinadpsntaic) [sOtRrORrOnRRnOnPInPnRIeSlPnPOiRiRRlRl: FiPatruattihrrsyi Ccehvtercieiciciciarceerice sSuilllivrIynStlesatniene c canan nnin lnl SSptloeneenr TestisiEididnis L caa nn n a rit Trait DO Urinwry Bader Ln Neesntrary es The flloving bissuls) mwreesmot required by rota]I--ToweTeeme=oees A iinndciictateess tohnally &+ dnoivghaaopsesstwiacs mcaodmee.ntAwa-s0ian0ddiec,1ate9Psl6ehsas0te nreofedriagoTostihees SoriIngCmloemeTabrtlaywatsesdsaAt2e8i.4sa Report. 475 Tissue Inventory (continued) Table: 3 F324: Tuo Year Oral ToRviikcerityL-aGbnocraotgoerniiecsi,tyISnct,udy3in Rats = One Year Interin Project Nusber: 0281080012 Species: Fat Tissue Nase Adrenal hort Bone Narrow brain Esophagus Ere HKeiadrntey Large Intestine Liver Lung Lyosh Kode (aesenteric) Nasaary Eland Drary PaParnactrheyarsoid PPirtousittaatrey Salivary Gland Sull Intestine Spinal Cord Spleen STteosntaicsh/Epididis TThryarcohieda UUrtienraursy Bladder reeeeeeeseeeeeceee The SNkeisnentury Urster minal following Dose Group Nase: FI-3924 100 pou Tint RRRRR Nusbers = - - = Kaa 71788 8788930818 Su FFFFF beree bbeeeeeenn freee veces beeen beeen beeen Ieee beeen Ieeee beeen feree paren [oReR vCheecece PvEeces bara fever Ieee viens faereee Irae fare berie tissues) wPerreenot required By protocol ----wre-nssereorenee EI E AA c+ iinnddiiccaatteess othnalty aa dnioangdoloasginsostwiacs wcaodmee.ntA w-asinsaddiec.atesPltehaaste nroefdeiragtnoostihse oSrincgloemeTnatbuwlaastewdidAen.imal feport. 476 001961 Tissue Inventory Page: 285 Tissue Inventory Table: 4 RikerLaboratories, Inc. 0 FR-3924: To Year Oral Toxicity-Sncogenicity Study in Rats Project Wusber: 028100012 Species: Rat Tissue Nase DoseGroupNase: CONTRpOpL TIIIIL IIL T I taIttIy Binal Mabers R= RwRmRRmRmRmRRnAmReRnRAnRnRAnRAReRnAnRaAR 3333333333333333333333333, 51152525252525252535353535353535353554545054545448 Ser HBN9N1N3N4N5N6N8K9N0N1R2N3N4N6N7N8N9N0N1R2N4N5N7N8 Adrenal forts Bone arom Brain BErseophagus Heart Kidoey LargeIntestine Liver Lung LNyasssahaNryotGel(anadesenteric) OPvaanrcryeas. Parathyroid Pituitary Prostate SalivaryGland SullIntestine Spinal Cord Spleen Stonach Testis/Epididynis TTrhaycrhoeiad UrinaryBladder F Fr e e e ss be ees FFeebbabEe s i a ir aes s KFEeE AeE esab bese aeiacbr aarcecr Faby Faery PS era be e brb eae thbr eaas FChAbAecEEhe eesair abarca e sabs er eas Cn erarerae eeeitceae tereaereeys CFaorachbce ces rcea srrt criicce haiae Febeaaerch bericht F Chea er b be ra e Fierce CFAAERe E ba ey e Fhe br beer CK etare terhir tarcie chiacs hies Cereb eeat creereeeeneeeeeeee The following HSsUR(s) were not required by protocal -seeeeereseseeecee CBlointeoral Gland Seen a HaLrydseribaandeGland P SE eP eE s Lyssh ote Cabdoniral) ea NLeyssegnhtaNroyde (thoracic) e e e e e A indicates that a Glagnosis was wade. A - indicatesthat no diagnorocsomienst as sade. 477 Acindicatesonly anondiagnestic consent as sade. Please refer to the Single Tabulated Anieal Report. Tissue Inventory Page: 286 001962 Tissue nvstry (cntined) Tae:4 PRI To teHrieGralLiTeoriactiotryi-eDsn,coTgcen.ici3t0y tay in ats rSpoejceicest:Nhabter: O8ICOOI2 [TM Proptial land SSooffttTTiissssuueess hedaod)ne) SSooffttTTiissssuueess (nleegc)) Soft Tissues (thoran BoCseHSCoup ase: CONTHOL 0 gpa aslMabrs +E=REsRnRReRRsRAnRnAeRnRsReRRnAeRnAiReAsRnAsR 35535353535353535353553538353535333538335353335353835 Sex K1EA19R21K23R24R25R24K26A29R30N51R32R33R34R36N37R38N39R40N41N02R44N45N47N48 eeeeneesenesnaas SCeLsrIasiieaiiieiiioiiios SCeLsIrinetatiiiiieioaias LLL 88+. iinnifccaatteess haalty 34 einadgnaognriosstwiacs cmdoe,mnAt~snwsaiec.atesletahsaet rneofeirag1ostihse SoirngcloemeTnatbulwaitsedaf.aa Report.478 001963 Tissue Ivntary Page, 27 Tissue Inventory (continued) FI3F24 Too YeaFrieDralLaTboornaitcoirtiye-sD,ncIongce.nci3t0y Study in Rats Project Nosber: O28ICRIOIZ Species: hat Tale 4 Tissue Nase fsotrrtosna FBroanien rron EEseophagus Heart KiLadrngeeyIntestine LLiuvnegr LRyaanpheyodGelan(dasenteric) PPaarnactrheyarsoid PFriotsutiattaery SuSallilvIarnytBelsatinnde SSpplieneanlCord StTeosnteisd/Epididais TTrhaycrhoeiad Utreirnsary Bladder --enenneeeeeeessssse The ClHairtdoerriaaln SShlaanndg LLyiyihHootdee Gabdoninal) LNyesentoardye. (thoracic) nital following SoPs LGrCouCpNase: CONTR0pLpL Natbrs R-A-RsARsRsRsAsRRoRnRnRAnRiAeRRsReReRReAeRsR $55353535353535353535353535I5I5T5I3I5I3I3I5I5I3N5 A9S25354555657586061626364656667697172737476777879 Ser NNKNKNKNHNHHNNKN RRN Fb ARE C ra ee e ries CFAebEer eerce beers C CA eC eC s ae PFEhea er eat e er S FCH re ee acs e AFReCHereiceh aees eee CFerrEecbctcrrrcracerccEe eiti ecct cceeic FPEeEee eereriiic e casas CSaiceereeesebbciceiiaaaceses C Feeher esraeaatb rbcre rerbe aeaeacae aaais CS rreee eeeear biaire irreer aian C Crees e baC rc e a Fieeesreeeriiciiiiricies tHSSee's) C MeRot FEQUIFede By protocol ~-ee owrwrwrrrrrrrre e ee e s e eee s S eI eI s A+ indicates tahdiaagnotsis was sade. -indicatesthatno diagonrocosmienst ws ade, 479 Acindicatesonly a nondisgnastic comen0t 0as1s9ade6, 4Please refer toTitsshueSiInngvleentToarbyulPaatgee:d A2n8i8sal hep. Has tvtaey ttre ie Lirtrivs, Tr. 30 note4 P28 To Yu rl TorSac tty i ats Sprojecet her: zc Tis ae rt Sas SSSithtrTTiiiseees bOoed)e SSttTTiimee earha tte Toss TPT oeRBArREoReRCT ORNTERLRORoERRI RRRARnRnR B 3B33h3i i3n33i naaina aaniaiiLaini iiinsgsyss So SKAERIRS ARRRIaINHARsR IRANIARIRR aRRR eee A T S IA a NI A n E M DM I AT , Lin # + cto indicates oythat a has diagnosis was ssadve.tA05- 0int1diec9ate6sP0lthoatt rnoodeiag3nToashimessoyryceomeanr tlwaasemadie. e 30.480 Tissan Inventory (continued) Tle:4 PRIA: Tao Yfeairke(ralLabToorxaitcoirtiyes-,DcoTigce.nci3t0y Study in Rats PSpreocpieest:Mhaasther: O8ICRNE2 Tissue None fasrertesna BfroaeinMarron FEerogs HKeiadrnety LLiivregre ntestine LLyagshNote (aesenteric) taRarwynry Bland FaFruanctrheysrsaid FPirtousttaitrey SSuallilvaIrnyteSsatinnde SSiplieneanlCord StTeesntcihs/Eididnis TTrhiycrhoeisd Utreinrasry Bladder EEreceeeec The CHalridteorriaaln Ellaanndd LLyyie Nootsee (abdominal) Lye ode. (thoracic) DosT eGroupHaeI : COENTI0RL pOpL E HO]NAB R=RR= R= RmRmRmRRm ARARRm AnRnRRnRRm eRAeRnAsR F5A5R5A555555555555555466a6a8a88 7777580818384868791925394959697989500020304050407 Se FRFFFERRFFFFFFFFFFFFFFFFF C Cee riic r rche ee rs ee as LOOAPLOPOPPPOPIRRIIPRRRRY J i iR cccaY reer e L ra es L bi e ee r Soccesrebcrchcciirireeeeee ViALeeeecer tebe "Lebcbcrceect rceeh ecce eeecc cecEa cic c STII anna Cc riirrrrcersse eceeaeirinee r Le ay l S FI RI I r breri ereeerr iia ie eese r L ee e r following tssae(s] wre nat required by protocol ---rw---nomere== SSIIIITIIIIIIL SDIITLIIIIIIIIIIIIIIIIIIIIIIIIILIIL CII B&o iinnddiiccaatteessotnhlayt 44 drioangduaogsinseswtacs mcaodmee.ntAa-isndsiadcea,tesPletahsaet nreofedr i0atghenoSriocngoslmeienTsatbuwlaatsedadAen.imal Report. 481 Tissue ventoryPage: 250 001966 Tissue nvstry (continued) Tae:4 PIR: To TekreGralLiTbeoircaittayi-eDsn,coTgce.nici3t8y Stuy in Rats SPrpoejecciteosaatb:er: GZBICRONI2 Tsun ane pretial lant SoSfittTTiissssuueess Gaabotn)en) SoSfitt TTissaunrs (luecgt)) Soft Tissues three) Unidentified Tissn SoV s Grau Nase: CI ONTROL 0 pp E Tn Bi] Mars R=AR=AnRRRn RARn ARAn RARAeRReARnRRsRR L S5555SS5S5SSe SSSsseabiis 77197081638084678192959495949790999002030403050407 So FEFRFFRFFRRFFRFFFFFFFFFFF a CCe eeiieiiieieiieeiiiiaiioiieiiioenn Ceeeieieeieeiiioiionoes CLIT EE A#. 4 iinndticcaatteess otnhlayt &a odinadggnnosaisstsiacs caodmee,ntAwasianxiec,atesPltehats r10efedriatgoonhies SoringcloemeanbtlawtsedauA.nal Rept.482 001967 Tissue Invstay Page: 201 Tissue Ioventory continued Tae 4 PRIA: Tao YeFarietrralLabTaorsaitcairiteys-,OcoIgnecn.ici3t1y Study in ats SPpreocjieest:NRuast br: 8ICRO012 Tissue Nase wfaarrtesn SownienMarron EEsecphaes KHiedanrety LUurreIntestine LLuygahNote (aesentaric) MvaarsyryBland FPaanrcartehsysroid FPirtousttaatrey SsuullilvryInGtlesitnigne SpSiplneaeln Cord stTeosntcihs/Epidionis TThrycrhoeids Utreirneasry Blatter erences Th Calrietroriaaln SEllaangnd LLoyahhNNooddee (abdominal) PLeyssnphtNaorsye (thoracic) SC oe Group Hae: CT INTROL 0 gon I AlMaths R<=ER R<RRnRAAtReReRRnAeRnAeRRiRiRiRReAoRsR GS EEELAE6Ea AE8EbE88s 8b08868 $O112I3I4I5161718191122232425242728233435343738393 Sec FEFFFRRRFFFEFFFFFFFFFFFFF CCebsbeirciiebereercierierraisiaateirriaaeaeyt eh rriea eirtn airan riita aaay CSeerecesrreercnctaiceiciiarcniiiieiotnctt CH etree reretl iariii ireern iaay Ce overrerii iaittiian tiiitaet Cderabie aeeaein aeenaea aiiaiayay Ccerebieecaecidataeiaiineainiiaaenct Cectcreceerciceieererictiectercecitcaeerncnt Fe e ebl iiceri icaets iiaiie iiice e ern ratn a ra ratri iaet Ca evttrria traitttia ertrian aar nal e r y r Gr er a C eeriee ren re, following 18848(5) ere St eGuired by PONG) --rrereorieieree s Lal nni a: eCrIeLrIeIeIrIrIiIeIrIrIiIiInInIvIiIiIaIeIeTeNsN SB oIIIIIIEIRIOISIR IaoInI0IICIoIIEII)I AH+c iinnddiiccaatteess tohnalty 4 drioanginaosginsaswtacs acaodm.entAw-asinadaiec,atesPletahste nroefedriagtnoostihse oSrincgloemeTnatnlwaatsedmadnei.sl Resort. 433 001968 Tisseae InvInevnentooryrPyaggee::22%92 Tissue Tventory (continent) Tale4: Frat: To YeaFrieOrralLabToorvaitcoirtiye-sD,ncTongem.ici3t8y Stuy in ats rSpoejceicet:Nfaatber: CZ8ICROIZ Tissue ae FsrienutialSlant SSooffttTTiissaseuses G(bhedaodn)e) SSoiftt TTiissssuueess ((lnegc)k Soft Tissars (thoras) unGedneernaltiCioemdeTtisse oV e Group NasI : CONTROL 0I on I ial Naber Ro ARRRARRRn ARRRRRRneAe RnRAnRARnRsR C GbbEsbbseL aboibbibA siiasiidbh O$1I2I3N4I5I6I718191122232425242627288534353637388% So FFRRFFRRFRRFFRFFFFFFFFFFF FEeens Si II eee CC e eeeeiI eeoiiI niaes CLI C I s iinndiicaatteess othnalty 4a dninadginaogsiosstwiacs cwoamdme,entAwe-siandiec,atesPletaaste r3efedriagtonotshiesoSingcloenmaabtulwaitsedadAei,sal Report.484 001969 Tisse Inntory Page: 255 Tissn Invest (continue Tie4 PHS28 To tFeairkGeeaorTaotnocriitey-sB,rcToeg.eic8ty tay in Rats Sroojcctat:abtr: ZEICROLZ Tiss hae osV e rsp NoeEs FL TE 100 gon E foie Manes R<=RRooAoRRoRoAeRoAoRoRRiAoRiAiRiAiRAiRlAlRlElS $3e3737373737373731313731173137313731373137313737 9760001020304050607000910121316171510232425242829 Ser KBNKNRRRARRRNARNARRRAARN Sone arr pr aaannnnannann Cheverertetivisarararrory LFyawsrbyelean(taster) PFarrcsrtshsrons e SenonlIa IIIIIIIn IIIIIIN CChrcerrrerriecrotciercroecrieuroeivoeirreiroennt SsiualrInstelstaigne SSiineam Gord STettnasiitionis Tid raearearnrtlerisiiniiirairanrnarnanrens C Ler nne nne nns nn C Le el ai na n Crerereterirarairiin, inary attr frennnnnnn Cee Th fllonin issn) wre at RTE By BOOK rere irtsaelt sSanieg LLoo Hhed bios LRepseabro Bac SS II oTL CSILIIIIIIIIIIIIIIIIIIIIII SIImn + idnidiacattees tahnayt 33 iadgiaagiasstwiacs acdoem,ent4a-sinaddic,atesPteht 5T0ideig1r0ehsse oSringcloemeTtawtsemeA,nal fort. 485 001970 Tissue Inmatory Paes 2 Tis totry cmtionsd [---- je P32 Teo Ye al Tosco conch St in Rs Jp -- Species:Rat Tis rept sland SoSthtTihreeesss hhestnons) Sohk TTionmse inrnes [RT EERSRRARAR--RR--TET R--RERRRERRRAR BL $H33R33n83I533n35E33n933N33E3u3aY9e% STeEa0n1e2e05a4i3n6e7et8i3i0i2i3ni8i4Ta58n8v8i50n sw RARRARARARRRRARRARRRRAA eeeeneateeeaaeaaans H S Sa annA nn ie n i S n s s Soe Get Samm. Iedni A + indicates that a diagnosis was TN wade. A - gr a Bn indicates that no diagnosis or comment GOA EA Ss mes waassmidT3e. OY 486 Tissue Iavestry (continued) Tale4: FRA: To YeairterralLabToorvaitcoirtiye-sG,ncTocg.nici3t0y Stuy in ats SPrpoejecciteNsaatb:er: 2BICONZ Tissue Nase SsTeUGrToupENan:FI-5924 100pon nial Kibars R= RRRRRARRARRRn RRRRRRnAeRRnRAeR 313137373131373737373137313931T1373131373137313737 Sex NSGN31RTHN3SKI8NIINN0RAINM2KMINAAKNSRNENA9NS0NS1NI2RS3NS4N55NE6KS7Ns8RS9Ne0 fsoerrtesna F S re eer ne e y Bornaentarron F Cherr ie e ee ee , Efsephags CC erebeC bcreae earey iaertr C Chririeaay LiLvegre Intestine SC iccee rriir ariir aiiea einy frLoh Nee aesnteric C Cecerrercr ecttreree etirreet tuNraayr Slan e l e l e PPaanrcartehaysroid CCerrccrcieirrcieiracriceirccierriiiiicriaanney FPirtousittaitrey C Ce rcr e c ai e ay SsaullilvarIyntessltainned CSriCeceeerehieaieiiaeeriaattieiceihieeeineeyy Spspilneaeln Cord S Cra es TSettoinsed/Eididmis C Cri ee e r TTrhaycrhaeia L Creei r er iaea. eaat Ursienaasry Batter SC LIIIIi IIIIIb IIIIIa TIIIN renee The following tissues) wre sot required by rotacl --eeroeereroes HalridteerriaansGllaanndd LLyahNhaksee abdominal NeLsoehntaNroyde (thracic) lll a l ALLLi lIIIl lllli llll EISNHE RI HR api AAvcinidniiccaatteess tnhlaya4 ndoinagdniosspiesstwiacs cmaodmee.ntAw=isinaidcea,tesPltehaastemroefderitao tghenoSroicngoslmeienTsatbawlaastedadie,sa] Apert, 487 001972 Tissue Iovntary Puse: 256 Tissue Toventory (continued) Tale4: FAS: Too YeaRrikeOrralLaTbooircaitteyi-eDsn,coIgnecn.ici3t0y Stdy in ts SpPerocjieecst: MRaasther: OICREEI2 Tiss Nase SFirenptial Gland SSoofftt TTiisssauress (ahbedaode)n) SSoottTiTissssuueess ((nlegck)) TfhtsTissues (horas) seUnniedaenltifCioemmdeTnitssue ToRTseRHGRrIoRuTpRKASanRIe:RRFAERARA10R0 RppRRAi RARRRRR foilNhs 3o337n37o31m31m373m737n31n37n31i31a37n37r31e313e137n31t37I31i37i31e11s37 DTII3A3SIEI0A1A2N3N4A5A6A9A0S1T2I3S4S5I6I7S8SS5E0 Ser KRRNRRARRKNKNNNNNRARRRNNK b CII eeen J Eh es BOJ Losi J CIeI tt BEe Re e hAe+ iInndtiacatteess othlayt a& ndoinadgaogsniosstwiacs csaodmee.ntAva-siandi0ec,at0esP1let9ahsaet7rn3eofedriagtonToistsihsseueSoirInngcvleoenmteTonartbyulPwaaatgseed:madn2e9i.7na Report.488 Tissue Inventory (continued Table: 4 FN3924: To YeaRrikOerraLlabToorraitcoirtiye-sO,ncoTgce.nici3t8y Study in Rats Project Nusber: 0281080012 Species: Rat Tissue Nase adrenal dort Bose Marrow Frain EEseophagus Heart KiLadrngeey Intestine Liver LLyusngghNode(aesenteric) NasaarySlang OPvaanrcyreas Parathyroid Pituitary PrSoalsitvaatrey Bland Swall Intestine Spinal Core Spleen TSetsotniasc/hEpididynis Thyroid Trachea Urinary Bladder Uterus rereeenmeeeeeeeees The Clitoral Bland LyHairdherihaanteGland LLyyssgshhNNootdee((atbhdoornaicniacl)) Nesentary iol following DoseGroupNase: FA-3924100 pps TIUUEILaE IIiI ttiI tiiIey RRRRARRRRARRRARARRARRRARR Rupbers B= = AnAm meen ncn neneeen 17717771177117111777117777 SS56466666777777778888999 892456789012346781469012 Sn FFFFFFFFFFFFFFFFFFFFFFFFF bFaebees aiiersaecaereey F Feeeae aeer aa e eab ha bae e ibar r ty F FCeACC E erbe bhT ba riTa a a c re ae at FSeieeaeeeebbee ehib e irre e FCeCreaarhereae ib ba ay a bC eee erir isbae eaircab iccEhay BCrA brite KCeierse ahbetr aberar cer Coedrcacchberacherbiieete Siberia e Ceeeaer e abe er Mera be sabia Clearer C Chr e ea rae es y eee Cereeaeeeaie array CC ereaae ee ar bb eab s er Ceeaaberaibs riers tissues) were not required By protocol =wemnesoeecneene eee aes Se e ee ae e eae +indicates Acindicates that only a diagnosis was anondiagnostic sade. A -indicates that coment was sade. Please mo diagnosis refer to the SoirngcloemmeTnatbulwaatsedmadfen.isal Report. 489 001974 Tissue loventory Page: 298 Tissue Inventory (continued) Table: 4 Riker Laboratories, Inc. 3 F4: To Year Gal Tovicity-Dncogenicity Study in Rats Project Nusber: 0281CKIOL2 Species: Rat TissueNase Prepstial Gland Soft Tissues (abdonen) Soft Tissues(head) Soft Tissues (leg) SoftTissues (neck) SoftTissues (tharas) Thyass identifiesTissue GeneralComent Bose Group Nase: FA-S924 100 pp TEEULEIIIiIiTdsEtiItnSy RRRRRARARARRRRRRRRARRRRAR Anigal Kupbers = <n nnn mene meee A7A1A17777771711717111711771 S556b666666777777778888599 892456789012346781465012 Su FEFFFFFFFFFFFFFFFFFFFFFFE eee ees eee es ees ee ee eee es BA+c iinnddiiccaatteess tchaalty 3a dnioangdnioasginsosatisc scaodmee.ntAw=asinsdadiec.atesPltehaaste nroefedriagtnoostihse oSrincgloemeTnatbuwlaastedmadden.imal Report.490 001975 Tissue Inventory Pages 29 Tissue Inventory (continued) Table: 4 RikerLaboratories, Inc. 31 FN3928: Tuo Year Oral Tosicity-Oncogenicity Study in Rats Project Nusber: G281CR00I2 Species: Rat Tissue None Dose GroupKase: FI-3924 100pon PIIII L t Li IiEeI Binal Mader =RR= R==AR= R= RmRmAmRRn RARRRn RRnRReRn nEnRReRe NAAR aay 7777770868888860888688888 94959697989900010203040507080910111213141517181920 Sex FFFFFFFFFFFFFFFFFFFFFFFFF Haodrrteanal Bone Harrow Brain Esophagus Ere Heart VLiadrogeeyIntestine Liver LLyusnoghNote (nesenteric) Nasaary land Dry PPaanrcartehaysr.oi Ppirtousittaatrey SuSalllivarIynteBsltainnee SpimlCord Spleen TSetsotniasch/Epididynis Thyroid Teaches UUtreirnusaryBladder wemmeeeeeeesseeneee The BColnietoral Stand HLayrodgehrioatne land Lyigh Node(abtoninal) NLeyssegnhtNaortye (thoracic) following tissue(s) SF ARSerrers Ferre Peebe ibe FKEreA eber reeraa siret eriih braEnyiee KEaerserrb are ra y y Ferree FARE BAER E best FF eeere cecar rrEer gcee ratee chie F Fehrerbear aeee CetrcccerrbcEabtrcEirrcet FAR bebay eee Febabee rces F SAr REeEebarsaey KARE FAR bay ae e Fire ee aee Series F Cebee hcer rhbcr i bear ras t were fot required by protocol -seeeereesseeereres S e e e ee p e ee e n e s Sree PR > AAciinnddiiccaatteessonthlayt aandoinadginaogsniosstwiacs cwoandse.ent4w-aisndsiadcea.tesPletahsaet rneofedriatgonostihse SoirngcloemeTnatbulwaastedmaAdnei.mal Report.491 001976 Tissue Inventory Page: 300 Tiss Inventory (eantinad) FI Too YeairteOrralLabToorvaitcoirtiye-sD,neIscg.enci3t0y Study in Rats Project Species: NRuastber: 0281012 Tale: 4 Tissue Nase sFirenptial Slang SoSoffttTiTissssuueess ((haebaddo)nen) SSoofttTTiissssuueess ((elcgk)) SoTfhtymTuisssues (thorax) sUenniedeatliCfoimnmdeTnitssue DoTseHGCroupT Nae: FRI 100 pn pm Brita] HATS R<R=RRR=RRn RRARARn RRARRRn RRRnRnAnR 7777778886888888888T088T388 94959697969900010203040507080910112131415171815102 Sc FEFFFRFFFFRFFFFFFFFFFFFFF e eeee gen enas en e ee e ns s Ceeeneeneseneseeeecieieeeeaanaaes iii een eis nan A#4inidndiiccaatteess tahlaty a3 dnioangdnaogsniosstwiacs csaodmee.ntAwa-sianddiec,atesPletahsaet rneofeEria{gouotihse SoirngClOeMTMaEbalWaItSedwadnei.na port.492 001977 Tiss lventory Page: 301 Tisae Inventory (continued) Tale4: PAI928: Tua YReairkeDrrLaabTorxaitcoirtiye-sG,cogIencn.ici0ty Study in hts SPpreocjieecst: Mhaabter: GZBICRO0L2 Tissue None oVse BUroupTNasEe: FCS924 30 onEitan HL MBs R=R=RRmRmRmRRRm RARRRe RARRRnRn AeRaKnRsR 1S137373137I737393131I1I7315131I137I731313737I781 G1A2b3L44546s7E8L9T0T1T2I3T4T5I6I7T8T9T0R1E2E3S4E5E Sec RRRRRNRRRRARARRNRRARNA fwoarrtean Se ereriarsl iiareriil aiiianes RBornienarrow em e eei eelil lill iliii lll faEErectce e CCreenreerarscice iieeegceiraeaen cicicieeicacne LKiirgeerIntestine e an e ne a LGnugr C GLi AN e S LiNagwwhrNyatBelin(daesenteric) li iil i i GaFurncyress e rer rrterre rieariaeay PPiatruaitthayrryoid Ca occEeEccechcn orcEroriEret SParloisvtaartyeSlang PCeevetebrrisrtertcoteirrsereiinriyor SsaplinlalCIontreestine a i aiil lllll iilil iill sStloenes CC rtieesetiasen tiaatiiiaes TTersotiissigpicidpis CSoevbiiiecaetsieireiatiittieitaiiaarieitiirieneees Trachea urinary Blader CC eetiiea reiietn iciaetn iiaes oteeeerseeececee Th following issue(s) wmreelnaLtreqLuireld bIy prAnGKaLl --rIreoeIoroLrrerIree CHlairtdoerrailanGBllaanndd LiLyighNNoadee abdominal) LNiegsehtNaartye (thoracic) Pc RO onnie SSILTITIIITILIIIIIIIIIIIIILIIIIIIILE PL E l 44+ iinnddiiccaatteessot nly +hdnioangt inoasgiusaswtacs acaodm.entAw-aisndwiacdea.tesPletahaste nroefedr itoathge ooSricnsoglmieensTtablwaitsedmdne,isl Resort.493 001978 Tissue Inentay Page: 02 Tisse Inventory (continued) Tite4: PRIA: Teo YeirtetrralLaTbooxriactiotryieGsn,coIgnnc.ici3t0y Study in Rts PSrpeocjieets:Nhuastber: 08ICRO12 Tine Nase Preptial Shand SSoofttTTiissssuueess((hdaosnhee) SSoofttTTiissssuueess (lugc)h) STohfutTsissues (thoras) SeUvniedreanltifCioemdTetiss DoTseGUrouTp Mane: F-ST302p4n italNogbers R<RnAAAnReRsAsAReReRRnAnRAsReRnARsRiRAnRsR I1I131I1II1I7I1I1II1I1I7I1II1I1I1LG1I1I11I17G 1626564656667686970717275747576777079808182838485 Sec KRNNRNKRRKNRNRNNKNRNNNRNN Sees a a es es b ee e s eens en Ain+diincdiactateessotnhlayt a3 dtioangdnaogsiuseswtacs acnotmee.nt -xsianddiec,atePsletahsaetnroefedritoatghenoSriocngoslmeieTnsatbulwaatsednadAen,inal Report,494 001979 isu Imory ge: 33 Tisue Inventory (continues) kerLaboratories, Tic. 30 FN-3924: Two Year Oral Toxicity-Oncogenicity Study in Rats SpPerocjieecst: NRaatbe: OAICROLZ Tale4: Tien Hane TTTIGoro Meane: F5E390T2on ny HilRaber = RRRRRAm RRARRRn RRAnRRRnRRRnAeRsR 17373773737371737371737373738303613383383838383838 978885309192539495965796950001020304050607060310 Sex HNKRHNERKR RBENRNR N sarnst Ceres BonaenNaron Esptags LM ILIEMRAM Cetrcccciaricriieiriiie Kihdanrety LiLvgeer Intestine LLagh ede (usenteric) Hani Slane L Ca ei rn a S rI eL aI , SL II ane [RO FaFarreatshrid C Chcer rcere cciae crier ciri, iic FFirtousittiitrey SC evier ir ecoia iay SasluilvarIyntleastnidne L La I iT nT e SSliemeCord touch L CI i Ln I Cerraier aiae TThnytriois/pididnis C a eri, TrUrcitnaersy aster LEC E eR ar R a te ess ee he folloning tissr(s) wJ re 1 regired by protocolt--rarreEorherreoneDee CHlairtdoerrailanslaGlnadnd LyLaahh hoedee aboninal) LNoeshntNaardy thracic) eCeLeIrTensenrinrireaneieoe STIIILIITIIIIITIIIIIIIIIILIIIIILIIIIIIITIIT CSLIILTI Af+cinidniticcaatteess tohnalty a3Ginaognenloasginseswtacs acaodm.entAwa-sinadkiec,atesPltehaaste rnoefedritoatgheonSroicngsolmeienTstablwaatsedwadien.al Aeprt.495 001980 Tissue Inventory Fig: 304 Tissue Inventory (continued) Table: 4 FA-3924: Too Riker Laboratories, Inc. 3 Year Oral Tosicity-Oncogenicity Study in Rats SPpreocjieecst:RNaastber: 028100012 Tissue Nase Prskeipnutial Gland Soft Soft Tissues Tissues (abdomen) (head) Soft Soft Tissues (leg) Tissues (neck) SoftTissues (thorar) TUnyiadesntisiesTissue Beneral Comment Dose Group Nase: 3924 50 pps RP RRAI RRARI RTRAEU RIRRRL RRRI RRRAE RAR MainalNoabers 3-3-3-3-33e3e3s33s3s3o33n3o3o33-3e3e33e3s3s3 7777777717777788888888888 B88999999999900000000001 789012345678901234567890 Sex KNKNNNNRRRRNNNNNNRNNNRNANN e bbb a n be e t eens eee eee Serene eee ees C See mn en n te s A+ Ac indicates ingicates that only a a diagnosis was nondiagnastic csaodmee.nt Aa-s imnaddiec,atePsletahsaet nroefedriatgonotshies SoringcloemeTnatbulwastedwaiden.al Report. 496 001981 Tissue Inventory Page: 305 Tissue Tovntory (continued) Table4s F-59242 Too YeRairkeOrralLabToorvaitcoirtiye-sD,ncsIgnce.nici3t0y Stady in Rats ProjectNaber: OZICRINIZ Species: at Tissue are BoTseGrIoupNUase:UFL9LI230 p4Lo1n1I11E31I81L11 ital WARTS ARRRRARnRnRnRRnAnRnRRRRARARAeRRnAnR r6r66r688880880888888888888 2222222223333334343443434 See F1R2F3F4F5F6F7F8F9R0F1F2R3R4R5F6F7F8F9F0F1F2F3F4F5 Adrenal Ceres Hobnreanarrow eeeee e EErseophagus SSieiIcIerIeIraIrIcIicIiIiNiiIiIiIneNeIy KHiedanrety SCierbereereeeabaiiiirtrrereersay LLiivregre Intestine F ee e s LLuynngsh Node (eseateric) L eee e kbe eaas eas OKvaawrsyarySlang C Le e err c airr ae PPuanrcsrtehaysroie FCieicceeesessicceecrescracrcrirrrccrcriirreeccse pPriotsutiattaery i Leeeeree asaniie chcaere icarey SSaulilvarIynStlesatnigne b Ditcce ereree rcaice icasin rices SpinalCord Spleen een Cees StToesntaicshEpididis S CI eL cI e TTrhaycrhaeiad C Ciieri ercea ercec rrarc crebi eccs UUtreirnuasry Bladder CPeirctecearteareeertiiriibciciiiciairiiiireess --rmmmmemeneeeeeeee= Bone The following tissuels) BEvere not required by protocol ----r-w-rre--m-eeees ClHairtdoerriaaln SGllaanndg E SLI e LyLymuphnNNodee (abdoninal) DES oe SITLL LNyemspehnNtoardye (thoracic) SLIT EE AB+ciinndtiiccaatteessotnhlaty a#dnioadginaogsniosstwiacs scaobmee,nt4-wiasndaiacda,tesPtlehaastenroefderitao gtheuorieclsoemienTsatbuwlaastemddie.wal Report. 497 00198 He ter Pues Tissue Inventory (continued) Table: 4 FA-S924: Tao YeairteOrralLabToorxaitcoirtiye-sD,ncoIgnce.nici3t0y Study in Rats PSpreocjieecst:NRuaatber: O28ICHOIZ TissueNave Preputial land sSkoifntTissues (abdonen) Soft Soft TTiissssuueess (head) (leg) Soft Soft TTiissssuueess((tnhcokr)as) UTnyidnesntifiedTissue General Consent DoCseHGUroIupTNaEmeE: IFII-3I92I4 I30Ipspiitiiintt fninal Mupbers R--RA= R=mRRm RRRo ARKs RmRRmRs sRRRe RRRs RAR AA8A58a 80888a 6660Ea BERRRRh BEREE 21222324252627282930313233343536373839404142434445 Su FEFFFFRFFFFFFFFFFFFFFFFFF e C ss e en ieeee ee ieeeeee e me e r e ie e m me ee ee e A+ Bo iinnddiiccaatteess that only a s ndoinadgiasogsniosstwiacs caodmee.nt = vas isnaddiec,atesPlethaaste rneofedriagtonotshies oSringcloemeTnatbulwaitsedmdfea.imal 001983 Teme tetany ig: 307 Report. 498 Tissue Tnvetory (continued) FA-3924: Tao YFeaireOrrLalaboTroaxtciotryi-eGsn,coIgnecn.ici3t0y Study in Rats Project Master: 0281CK0012 Species:Rat Tale 4 Tissue Nase foarrteana BBornaeinMarron Esophagus HKeiadrnety LLiirvgeer Intestine uLygnghNode nesenteric) BRuanrsyary Gland paPanrcartehaysroid PPirtousittaatrey SuSallilvaIrnytSehsatninde SSpplieneanlCord stTeesntcish/Epididais TTrhaycrhaeiad UrUtienruasry Bladder eeeeeeeeeeeceees The HaCrlditeorriaalnllaanndd LLyyssgghhNNooddee (abdoninal} NLeyssesnhtNaordye (thoracic) Brita] : following DoTseIGrOouIp INasIe:IFHI-3I924i3i0 Ipouiiiiitin Kr RRRRRoARoRoRRnRnnRRARRRARRRRRAnRs A 9BE8EE088A 86688808A 88888886 A$A7A8A9S0S1S2S354S5S857S8S9b0a1b2b3b4b5b6e7s8s9T0 Sex FEFFFFFFFFFFFFFFFFFFFFFFF m Creebere esesrae iiiiire eriaes eee ee ns Ciceberrer irene FC heera eeaeae aiiiir eirriaet S rr re reree e tm ie id e Deeberees iraeee F Certrbecetee rairr crarbecrirbe rtraec reeaeeheasy CSrieccaocaeccceecsebrbebririeircriaiaicicioioccee e LehdEetee seterters iiiiiiiy t Cierere eraccae iiiiiis ciees e Cer beee en eeraeae e Se e r n rs e ee CSeiCceeeceebsiticieri enar caic ircreeareeecy CSiiEeebreeseeeeseanrchairiiiirtesirreiiss tissue(s) wre not required by protocol ---------------===--= eee eee e ee ee e eee ee e AA+ciinnddiiccaatteessotnhlaty aa dnoinadginaogsuiosstwiacs acodmee.ntAa-sinsdaidcea.tesPletahsaetnroefderitao gthenoSroicnsoglmemieTnsatbulwiitsedmadAen.imal Report. 499 001984 Tissue Imestory Page: 308 Tse ventory Ccntions) ite Liseatris, nc, 30 Tae FI To Your BalToc Scgeicty toy in ats Sprescieets:aTrt : oscEOL2 Tost ae retial lag SoSSifitttTTTiisissuaess dGeegso)n) SSoofftt TTaaauenst ((hiocr)s SneiaenntiCsiooad tissn eRVsiEGRoRsRRMoAe:RRRE2R0RA1R0RgARRARRARAR inters H- =ConsnLLnLREs REAn RER C7SOE8UE9EE0SR1ST2SE3SR0ST5SE0SN7ST8SA%SR0hE1iR2sT1iE4iR5iE4iR7iI8iE9tN0)S So FERERRRTFRFFRFRFRRIFIITTF renee eSSeoerIsaIriIIIIIiIIiIIiIIlILlILlIIlIIIIIIIIIIIIIIINIINNII SSIoLeIsIeIsIIIiIiIIIIIIIIiIIIIIiIIIIIIIIN SSeeenriiIIiILIIIIIIIIN 14 innfbccaattess oanly 44 oiadgirosnnirstwca cmdoei,n wa-s0nai0dch1te9sle8tnh5et e0rlag0eTsatihkseuSorTgoctovmeeTnytawPtsge.mdM3ei8nd grt500 Tissue Inventory (continued) Table: 4 H-3924: Too YeaRrikeOrralLaTboonriatcoirtiye-sO,ncoIgnecn.ici3t0y Study in Rats PSpreocjieecst:NRaastber: 02810012 TissueNase adrenal foBrontes arrow Brain EEsroephagus KHiedanrety LiLavregre Intestine Lung LHyaesoaharoyGtlea(nadesenteric) DPuaanrcyreas Parathyroid PPriotsutiattaery SSaullivaIrnytGelsatninde Spinal Core Spleen TSetsotsiasch/Epididynis Thyroid Trachea Urinary Bladder [e=rtenemneeeeeees The HaCrldietorriaalnBlGalnadnd LLyysighNNooddee (abdoninal) NLeysseonhtahratye (thoracic) inal following DoTse GI roupUNameU s FI-L3924I10 I IponIItdItiEitInt ighers R==AR=mRRmRRmRmRAeRAeRAsRRnRAeRRsRAoRnAonRn 3B3838363630383636363838353038383836303B38383E3E3D T1I21314151617181920212223242526272825303132333435 Sex HRNNNRNNNNRNRNNRNNNRNNNNN f Ferae bes r rem ir e eean aay e ee en ns s m Ciceee ererbe e be n rr a y FPerrraeirbeeereihiatbeertiariabreiriiereaarieeyy m Fere ree ttinraa re, m Cerare eeeae beiirnira ate e em mm ma a FLeicccehsbecraerscacieerrcaeirireertreeeraarteesy CP ebee abe r be cte tai aa m becuae erchre ericen catesa aicy Fm eeeee aa is e FSheeeraeat eba reibrab hricaca rhrsee CSecaiecr e aia e a a rbee baer ar raey Prtareeeaabeereieiieereieernaaieesy tissuels) were not required by protocol -=--e--eeremreoeee eee i e e e ee e e ee ee e eee A+ Ac iinnddiiccaatteess that only a a nGolsadginaogsniesstwiacs wcaodnes.entAa=s imnaddiec.atePsletahsaet nroefedriatgonotshies oSringcloemeTnatbulwaatsedwafdnei.nal Report. 501 001986 TisuessueInvIenventtoroyryPage:Page: 310 P28 To Ye[iwteGIraLTtesnatertis--S,conqee,ic307 Stay in ats Tae4 rSeaecs Nhotr; CRO DRH osEGRoRwRENoResRRFI RTRERE1A0RgRRE RRRRRRAR ; Tose are restal tag SSitt TTisiseuess nboyne) SSootTTohes Sot Thus fnet) rac ranted issn TST3Ii3IaITsIis3ieI1nI1sI2aI0iI2sI2sI2sI2aI2eI2iS2eI2tN3aI3iI3tI3aN3Ii3Gn Sor ALR2R5A0N5R6A7H60R0A1R2R5R4A5N8A7A8R00R1A2R3E4R8 sesseersresnessasssacnnss SSILIIIIIIIIIIIIIIT SS S esII IIIS I TIIN IIIE I nIIT IIn LIIIIIIIIIIIIIIIII A+ eindaictatses hthyat a edvaaepaos cwoamee,nt4sudaadte0es1let0shast8r5e07fedr p1TetshmeeSoIvnceeotmaToytoaPagde: ,n11al per 502 Tissue Inventory (continued) Table: 4 F-39242 Tuo YeaRrikOerraLlabToorxaitcoirtiye-sO,ncaIgnec.nici3t0y Study in Rats Project Nusber: 0261CR0012 Species: Rat TissueNave adrenal fBoorntea arrow Brain EEseophagus Heart KLiadrngeey Intestine Liver LuLynegsh Node (nesenteric) HasaarySlang DPuarncyreas PiPatruaitthayrryaid pSraolsitvaatreyGland Sul Intestine SpinalCord SSptloeneanch TTehsytriosid/Epididyais Tracker Urinary Bladder Urteeerueseeeeueeeeeeees The Bone ClHairtdoerrailanBBllaanndd LLyyohghNootdee (abdominal) LNyeisgehntaNroyde (thoracic) Bnioal following DoRT seRGRrI oAupRANaU Rse:RRFU IA-3ER92R4L IR10RipE RouRtRI iAaRRiI RtRaAE eRyR Washers 3==3m3m3m3m33mImIIn IIIeIIsITs IITeIIsLG 38I8T8I8A8A8M846A6A8A94846465858585858505858585869 Sex KN7N8N9N0N1R2K3N4N5R6R7N8N9N0N1N2N3N4N5R6N7N8N9N0 Cire er ee ei eme eee eee e e me e e e e bSemimsecniaipbicreih riliicleelallc rlala blle B Creere abeear et a a ir t e Cre ee e r aay e Fearn hen rbea rt e me en es e FLeeeaeaabciaeb chr ccira cichacy rcbery CCeebrearbaCCae abre iaarCe a ar es Ce eeabcan rtrerin iaiicia chbey C me e r e re a C Ce er re es b CCeebreeaebaccaeb eabic saaec aaba, iat Cm eeaere ce be ra nra y tissueis) wPeAreRot required by protocol --eroeceseseoeonce e ee ee s J iets eee eee AAc+ininddiiccaatteessotnhlatyaandoiaadginaogsniosstwiacs scaodnes.ent a-simnaddiec.atePsletahsaet nreofedr itoatghenoSrioncgsolmeienTstabulwastedwafdnei.nal Report. 503 Tissue Inventory Page: 312 001988 [-- Hite aaa es 4 rts Te ep a roSct St is Rts riotpeetsr: CHO -- J osSns a--r SToa ft rTiisstuiess (tnescke) fet oS e aIaA 3T2TAR1A R0 RRRRRR RRRRE nH aiinni ninnH nanbnnH nnniyh w EETARR R RRRIE haan ee C ASSII in CI CS S II e in mi en i feteesnzaiiiiiiiiinin A + indicates that a eat diagnosis was tineys Bl he Se Tate ial OBES" ot enor pa 35 sade. A - indicates that no diagnosis or comment was wade. Br. 504 Tissue Inventor: Tale4: FAST: Tuo YeaRrikeOrralLaTboorxaitcoirtiye-sO,ncToogcn.icity Study in Rats Project Species: NRuastbr: Z8ICR0L2 Tissue Nase DosVeGOroTupHae: FR-I190g2p0a Binal Mpbers RERnRRnRRRnRRReRRAnRARnRRRaRARRR r EBI0EE0E0EE8r E086080AE880 71727374757677787560818285848586878889909192939493 Sc FEFFFFRFFFFEFFFFFFFFFFFFF wren Sereraesriiareiiaieiiaiy sfeoien arrow me lile i e Esphages Sliceresiraisitaceetaaey HEeert e L gi esn ta d s Liidroeey Intestine CPrEiaSeIerNi0ta0e0ei0a0a90e00e05t0 LiLvyer F Ca a ae s SLaywwahrNyotEela(nadsenteric) Ce ri a ma ia a, ] ouFurscyress F Cerie ceer rcear itce iatcr icas eet FiPatruatthryryaid VCievteicceeeeetrieaceaisiecriiarrceotriraiaceceet SaPlriovsatrayte Bland Frrerrretrreererevceieeceren rc n einaes SSpuilnlalCIontredstine CroCrIrIItIIaIIa IIIiIIiIIiIIiII.II sStioencmh LCr t iriieisiiiie arseieiieaeeaiii aeareaaeats TTheysrtoiisgfEsitionis Cle rlclie rr i cia aeey trTienacahreysBlaster CL eeiiea reriar triiae ttirin reet theres Ler ebieieeiaeaiticirterey erences Th folloving iSSuei) ere 10t eRUired by PrOtGKo ---nerrorerrrnes HaClridtroiraalnGiSalnagng LUyyahNNootdee (abdoninal) Lia Node (thoracic) Nesetary CrrIvTiTiItIiIiItIiIiInInIaItInInInIIeIInNI.E CLOoToIoIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIINIE POrA ereTirinamnenTreaesnemes AB+cinidndiiccaatteessotnhlayaa sdieangdnioasginsoswtacs acaodm.ent4w-aisndsiacdea.tesPletahaste nroefeGr itoathge ooSricnsoglmieensTtanlwaktsedmdAen.imal Report. 505 001990 Tissue ventory Page: 314 Tissue Inter continue Hiker Litratoris, nc, nates 4 . F928 To Yeu GaTec Sceicty Stay in ats reject es aia Species:Rat Tiss Nae Freputia stad SeiittTTiissssueess (deohns) SSitt TTiomeess (nehg)) SotTisserand rite Tisee ese Group NoeIs FT AITE 10g T RRRRTRARRARRRARARERRRRRAR SrEr3r088ERBEERTEREERERTENS 71125707570777787080818285648886078800500132733495 So RERFRFIFIFRFFFRFFRFRFFFFF EE DeIsII IIII IIII IIIT III: IT SS LIIIII IIITIR TIIIII IIII SLIT LIIIIIIIIIIIIIIII 34 dinidcicaattees otnhlty +3 eiangraopseissiwacs Catoee,n wa-s iwnadiec,ateFs ethet o2fGrag1rontihse SoricgomTsatblistsedawsleal ise Iventry aes 315 Fert, 506 001991 vr Tost Ivory continued Tae4 P32 To YeRuikeGraLTabooractories,coInqce.ic3ty Stay in ats J Sees ht oT se rosy an: PEA 1T I0 po intrs RC oRRoRRRnEARtRRRta ARnRRREARRTAERRREAERY $$557989900090051052093004008070007008019130101102133104105104137108100270 J-- Su FRERTERERRFITRRFARFAFFIEE Ly hte (meric) soni Prsovsia HAMEL SSStuimalirCyesrstainsg s nnanRSRiLnteLte LenlY ooavisessassassonzazosany Tes Esdionis Sanne in str PAA eee Te elonng tisas) were et required By MOG] rere SrietnassnSednt UTen ootdee a(tthiani) T eaerainmaaalt lIi0 a Sl h la l 34 nincdaictaetess nhlty 2 saoahppossstwis ucoim.ent w=sinediecatesFetihtt rsoeeirg13utsh aSlceomeatawsdaer.a Fort. 507 001692 Te Imma a 34 [Ip -------- Tae4 PIE: To YeFrieGralLabToorniactoOrinesc,oIgc.en3e0 Stay in Rats SProajetctesaab:tr: 2812 Tiss hae Freutial Sand SSoofttTTiisssuses haeotn) SSiittTTiissssuueess (nleegc)) Sit Tian hor! Undetiied Tisse esC e Srp sI es RITI E 10 gnTA foal aber R=RA+oRRtRaRAiRiARtAiRReRlRRiReRRlRlARaAsR T88R099990010309899799999% $L979893000102030405080708091011213141518171811%20 So FREFRFRFFFFRFRFFFFEFFFFEF rare aaaaaaeas DTIIIIIIITIIIIIIIIIIIIIIIIIIIIIIIIIIIIIN TD LL IDI TITTIES TLL C+ innddiiccaattees tshlty +4 inargaopsaisstiics acodmee.nt4w-iiiniec.atesletghet e10 hragathse Soirngcloe aTtaulwaasedainei.al Reprt. 508 001993 Tissue ventoryTFhp: 317 APPENDIX ITEM E STATISTICAL METHODS 1. For memo dated February 11, 1985; see Tables 12-18 2. For memo dated September 24, 1985; see Tables 19 and 20 001994 509 Internal Correspondence Appendix Item To Chuck F. Chesney - Riker Path and Tox = 270-35-05 From Sally E. McCarville - Riker Res Data Ops - 270-3A-01 swt Statistical Analysis for FM-3924 in Rats aM --ee--------O--ste--Fe--br--uar--y --11,--1--985----------------eeeeeeeeereeeees cTaherbolnabFoMr-a3t9o2r4y vianlureastsanhdavoergbaenenweaingahltyzedda,taafnodrthteheresstuudlytsofarefluoro ptoresaennatleydzeinthethedataattaacrheeddetsacbrliebse.d Tihnethsetatfiosltliocwailngmeptahroagdrsapuhsse.d statistical Methods Tbhoedymewaenisghtandratsitoasn,darodrgadnevwieaitgihotns toforbrapienrcewnetighotrgarnatiwoesi,ghtandto laboratory data were determined separately for each sex and dose group. Tofhesvearidaantcae.werIef atnhaislyzteedstuwsaisngnoBtartsliegtnti'fsicatnetstatfora h=om0.o0g0e1n,eittyhe dthaetacwoentrreo]furgtrhoeurp ausnianlgyzeadtwbyo-tcaoimlpeadrinDgunneeatcht'stretaetstedagtrotuhpe tao= 0i.n0d5icastiegdnifbiycaanscteerilsekvsel.onThteheremseualntstabolfesD.unnIefttB'asrtlteetstt'shavteestbeen wDausnnestitg'nsifitceasnttwaast aper=f0o.r0m0e1d,onthethedatraankwse.reThreasnekedresaundltsa thawvoe-tailed been indicated by the pound sign (#) on the mean tables. References AndeBrasrotnl,ettV.'Ls. Teasntd McLean, R.A. (1974), Design of Experiments: A Realistic Approach, New York: Marcel Dekker, Inc., 16-22. WineDru,nnBe.tJt.'s (T1e9s7t1), Statistical Principles in Experimental Design, New York, McGraw-Hill Book Company, 201-204. 001935 5i0 Appendix ten PStaagteis2tical Analysis for FN-3924 in Rats SEM:enr 02/11/85 Rank Transformations Conover, W.J., and Iman, R.L. (1981), "Rank Transformations as AameBrriicdagne BSteattwiesetnicPiaarna,metVroilc.35a,ndNoN.onp3,ara1m2e4t-r12i9c.Statistics', The kInfowy.ou have any questions regarding the analyses, please let me dSiEmM senr Att. c: Cathy E. Ludemann MLEeEn/RJA.H Sibinski 0019396 511 Internal Correspondence APPENDIX ITEM E 7% L. 37 Stbinski - Riker Path and Tox - 270-35-05" Fom S. E. McCarville - Riker Res Data Ops - 270-3A-01 sweet Statistical Analysis of Microscopic Findings for FM-3924 in Rats owe September 24, 1985 3M The major microscopic findings of the Two Year Oral (Diet) RTaotxsicwietrye-OnsctoagteinsitciictayllyStuadnyalyozfedF.luFoorrocaerabcohnorFgMa-n3/9l2e4siionn classification the sexes were analyzed separately using a two-tailed Fisher's Exact Test comparing each treated group to the controls. An @ = 0.05 significance level with Bwiotnhfienrroenaic'hsoragdajnu/sltmeesniton/fsorexmuclattiepgolrey.comIpfartihseonesxpewacstedused value of each cell was greater than 20, then Yates' corrected Chi-Square test was used. An asterisk on the summary tables indicates a significant difference between the controls and the treated group. References Fisher's Exact Test: Conover, W. J., (1971), Practical Nonparametric Statistics, New York, John Wiley and Sons Inc., 162-164. Yates' Corrected Chi-Square: Fleiss, Joseph L., (1973), Statistical Methods for Rates and Porportions, New York, John Wiley and Sons Inc., 14-15, 19-20. dome Catt S. E. McCarville njm - : MEE/RWH : 001997 512 APPENDIX ITEM F GROUP MEAN BODY WEIGHTS, INDIVIDUAL BODY WEIGHTS AND FEED JAR WEIGHTS OF MALE RATS RECEIVING FLUOROCHEMICAL FM-3924 IN DIET FOR TWO YEARS NOTES: Code 1 indicates a control group rat weight Code 4 indicates a FM-3924 - 100 ppm group rat weight Code 5 indicates a FH-3924 - 30 ppm group rat weight Code 6 indicates a FM-3924 - 10 ppm group rat weight Codes 11, 14, 15, 16 indicates the total feed jar weight for the previous rat AN weights are in grams 001998 513 [------ mo Yenc oraPlao(rbiostta)rmosoinctMty 3= ancionnemneitceity Study Group ean my weights (g) standaca Deviation ies stay conEteRndRI0EoTmWE 0SLOmNasGadIs g Wo BwmeaaalY B oon WwIaiDit 1JBSSGI aaii H3Bo SSBI eAiT 3N3 oGmGeSSaIEl omsaIminim daowroielenen WUDhnUeD Saehdsieem) MSsaaoillsme ooBaSasTiiiesm en100mpmio mE mawmmaisedd mN00o0ElRs ewSmaaabtii eRnnoAllE)e GsieIaDTt vTRioEelDneE waemacote: awaoishslleen) wsmmeowen:ss aaoviensllleen mmSoeenaadlt GdsSiiEeeN m2e0 rpmes M0 Ewmnaoiss N2wn5eG6ee0 mwdeaeist mdBenai6od0 wn5e0rddd seNaei6Ge00 wwseeawesid 4a4z00e0o sawmaiaies sGmsaeGGoo0 esWenUnDsi 0S00I0G0GN0o ke1e0 pEmas ml aosnnesoe: 1hussnGoee esDesasita raBeodI0(EG)e) essenensdss wenadaidteee ssSewaeotdt anaevsss (G(ooeno) ssWhioastit aaansisGee) sWSeena:tt assee dotee T2w Siomtiocfe anatnidmiaflfser rweinscehefsrom Control at. the 51 level (oumnett's Tests 0 0.050 Appendix tiem vo Year OroaflFl(ubloerto)carTbooxniciPt-y30=24OncionarRnaitcslty Study Group mean ody Weights (9) + Standard Deviation SGetny caomnit-rs0oplmW,E J3 SSoIs LA GmEa5sT GWWo eGnasRiI 8SM0 hGiati 55 G@m3e3d S5o eeneesd G eeumaald G Gh 0G3 ast T raGeses S90al(6e0 6e6l6z0n eBde(n60) esruoieetn mJoaa(meh TMedalmm) TTSIAAUB) TTo0e(m7) smarsUnM m1m00mpsrso 002 ISLEF sSeIsMs tsaaasd sseaadt ssemearls w0 ens: 2 es: as esSeLe0sL snaamls a45.4 (G600 o40l5 e(6n) SS0a0l(e6n) 5S0U8S ((66)) sSuse2(W6n) $60907 ((41D) 6608046()n 6695..48 4(466)) e7n5a20(8a)) m5e0pnmmsso 002. SSeEeAdL 4705G0O Sa0e:o SS1142(050)) 6H0e8s:s 5s2.e0 l(5s0) 669000%3 Ss4a8e G(500 eemeasi sSeez (G00) aE6s:: 6S0e.00(5(00)) 6@07301% 6529296500 GMae7T: 6706079 ((5500) 6e0Sz: 772259(5)0 me1e0 mpmmsso ondn s5e8x. ss.rr:: 6#0539: 6e5a23E e60w0:% t6e5s2s%a 6@1924it eaee.0s: 6600.s6:5 a42s.0 G(5o0) 4479.s9 (5500)) 5s2o.r7 ((5s0o)) S506.12(5(500)) eS1s7 (6500)) 6629..09 9(5)0) 6640W6o9)) 6650.59 ((4499)) 6790..53 (L4o9)) 02 uSimabneirfiocfantanaiimtaflasrewnecieghefdrom Control at the Sv level (Dunnett's Tent; as 0.05) > mo Yat Ocpal r(Blei) umndeed- copmiesnt sey Group ean Body Netohes (a) Standard Geiation sBorYcRomeNol-Eoom | NwTBo ooeodmdeGeaDadlI wommianeni main ggnhmoo mGneaaiii RmmIaaNiiDmn BRMNMm GhGmnnsd:i MsmaAaiUnm B NSoee omal slt iNoimnlnai w1Ne eGmaaosdT eWorWiAiOmnn TIUWELE eolpime wt. MmsAeuNaaEt: GRGaoUoiNnn seNmIaaDdl oDdmealillnn MWweaansalis mAGsaaimmn Mmmeeadaiid mBnoholOmeD mWmemMaaTdl oaNooOnhN mGEeRsI aBbRO0Dn ewnme wfLewnmFie ow?. MGGernse:.: amoananm oSGwelastioamonanliemm eGomalasr aeenisiin aGeeersai:r mmmeaaliienm eSGwoeeilr wwGauiiinwn mSeId swiohn sdannnes:s: n7nnime wGeeiweeit: amwriawi eaemmseairi omamiiee eaeanadsd mmmaaeliiom sewenintit mnaeimiiinne eann:imsim r+2 wmuisbtertoefeaniBmiaHleseewnetisgheHdom Control at te 53 devel (unnett ents = 0.09 = THO YEAR ORALCDIET) TOX-ONC STUDY OF FH-392E4x.&wFC0-21e4A3cROIBNIZRATS TTGEOCRHYN'ISCIADNATEI:NSITI4A/L2S1:/SE1MH RSOEXOMOFNURMAETESR::SS WDA-L3E4S WEIGHT GF FULL FOOD JAR:S SOOGRAMS EEK iFROeO3DsJiAsR e1i1s5 e0e0r7i2o0i1i0e0r0. e6a0 111 1FROOOIDSIIATR 6111S5 600677340011106020 0700 411 1FROGOIDJ5A1R6 011155 Geu7rSce0illesoTe 6600 111 1FROOD3D5J1A9R 6111S5 G00O7r570E1L6L0T0E. T0O0 111 1FFOoD3D5I2A0K 6111%5 G0o1O0s0e0i1i6c6s0 G600 111 1FOROED3I5A2R1 6111S% eGii0o1z6e1l1c5e7e 4o0r 111 RFOEODIJASR G11i% eeliee3d6eiiieteze S0u 111 1FROEO3DTJZA3R 611155 e01100%56011108638 1600 111 (FOOeD3J%A2Rq e1i1s5 e0i1c0r8e6i1r6d6s8 e6o0 111 1FROEO3DSIZASR 611153 e01l1e6s61e6s0?8 x60 111 F1OROeD3I3AZRS 011155 10111120611165650 4000 111 1FROOO3D5J2A7R 611155 001111346611105070. 6600 111 F1OROGD3J5A2RE G1A1S5 @e11115s0e11107830. 6000 111 F1OROeUIJ5A2R9 611155 1e1117S0e11105050 200 411 RFO0OD3IA5R 0111F5 G0112i0S6e1i0l6E0e S1u6 111 F1OROECIJZAIR1 6111S5 @@i1z2120el1i0c0e0 SGUu 1a1 1FROaO3D5JIA2R 0111S5 @@1izzzaeeliic6ess 1o0n 111 F1OROeDIJSAIR3 B11155 10122560611167060 6600 111 F1OROGD3J5A3K4 011155 @0i1z276e6l1l0e0z0 S6u 111 F1OROeD3J5AIRS 011155 e011z3s0e6i1i0s0z06s0a 111 F1AROGDIJ5A3R6 6111S5 00113312011010506 S0u0 111 FOO3D5J3A7R e1i1s5 e0a1i3s4e0n1s6r0s0 z0o 111 1FROEO3D5JIAER G111S5 ee1i3i5cee1licsode 3e0o 111 - 1FOROGDIJ5A3RS 611135 0e11337g6e11166e5e 2800 111 1FOROGDII5A4R0 G11155 001134906011165020 000 111 1e67.6 1e62.7 1o57 176.7 1e62 1e57.4 1@72.5 165.1 1a48 1e57.6 1eo59.4 1eo57.6 B7s 155.2 1e510.5 se 3 1 631 178 6B 25 opry 1a56.3 173.2 eo184.3 - 1eo65.1 1e32.5 002002 517 sFkaoosooramne i1u1s5reGgiaaEctemieonens sseeo d131 FiFrooicscieiisn e43i11s35 ccciiiisssseeeiiisoieesnss ov6uo 13111 LIixeFSSoCes M5811%3iGSlieaaceeirineesse b8e i111 FfFrioetciei: 181111%%3 Gsciiissseiscceiaietoeetsso sebvev 13111 TFfReeOeiteCenrs o131i33 ecsiiivssisseceiisisicersse Ssvaao 1I3n FiFniooescgveies 1o111i%%: ceCiiisssscseeeisisiserdsss ee6asa 11h1a LFRoeoiioitn:k s3i1:3 cciiscseeirsiecse 64a0 111 1ROISS1 iFRoosiate: 815 5311%% 6n sC1ii6cc1ss6ee1si1isk 4st5es. 1ve0se 1 21 iRFRoeeossiisvnses:r 66311133% sCsiiiceesdreeeassiesrwassr es3oa 1n1n FiFohOsaOusssTemEes 16111%55 oeGilicetsseeecaiiicesosass 85spe0 1211 GPErooscmseo:a1e1i3s ccaiivzisneeniisaseee e6n3 1i11 iFiGiciodirek G81i11t%3 esciiivrrssseeisictsezesas wseooa 13Ii iFSroReoosoSeooseder 81s11i%%s ccGiiirrrrseeeeriiiissseies scsoao I1i FGHoRiceosnuseceei 1sh1i%IGceiicmNeieoinnsiesEss E0s0n i1Ltn GFGorrceeosovsee:s aiGiifff cGGiiiectsieeasiltsieereersoeuo i3i RFFioLitvoSise hG1i1ft% Gcciiiecesrsoetdseeeesnss ebooov ni1n GFeRoeaosecllis aiditlf ccaiilgsseeeeiinisneess o nwi dn1 FGHuoRooSovoSeeCre iGGiiifff eceiiissdsteeedltisseee:s wnbio iti1t FiiffCeeosibssictnss eGiiissf eeeiiisvsrsceeonriiacssnrs wn ov 1131 TFoooSooouyInoew iGSiiifff eGeasioesssseeerddaeece:os foortn 1i1n1 RErGeo3osu5nig a3Oi1ff%f cGSeoheiseeeadeaonmnse wa7nc0 ias . 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FFiiifodaooioi7emen odaiasisc oGoiiirvrcoeoseeececszsey S47a0u 11444 3f2reaer iroires ba: oizicesss 10 4 61 FiFoRooeosoornenE: doaaa::: cGciricectsoeeonessseerie 83301 14444 LReSTaS oi: creseessr en 4 Hewidde fo FPiroiaolih7aianms d4oacas Gociilscaecrooeooaursiodsrd 24s00t SRaius ou: Giesesce 63 11494 4 fwprriesed p= FiFRoooooibo7ioemnssg od4au5s GcGiiiosvecieeesosestizises eaToo 1444a iPacrar oa eisseesso 8 4 E prs 35 FSFhoooiurooeonee 1o19i4%:3 Ccciirsoosswoeeesssseesssss S@Suo 14444 Geers GF Gifeens 10 4 MiSeees ai FRooeIhitm 145 GE Giscoosss Saeseses So 70 I14)a iral7os ea oroicesce 10 4 3Sno2ee37 Bel - FLFioPooRotTioSnkEk 1aO4eF Cccciceiotcweeovesascoesss sSTouo 14444 LRoi7ot oa Gooesser to 4 efWrsesaed 7 FLouOieEk i4F5 Gcdroovceoewsssser 016 41a f=r: 002069 584 rf WgoosmwetaIa4iscmoenr eees puna uusin 0BE d3k4L es L bwaier,3 EH H h a ehE uanI meaS ate E nl fue up sums 8 3L3LeL 4 ===3:, = HeEfeeomtnma auaarrEubuIammnamanEtnSln pom senens 3L3L L ==3 i1, Mt pEfeoooinmms aaee EdanmIil eSng n3L Bb rac ri &o5=::s 53 Hfsfeeeemeri pe SigieseEmnmmaEimniiEhn8 L34 iiNE i a maie = mt EeeeoedmSiaienmneranmEens fee wen 3kb 4Lo a= =m.ie me phEF poLemuemme eauEes mEersSnkL2 i3u35Et, $=1:2 BESTCOPYpygypg opfiieewimaSaa3n0emeGimvnnssNeeEseemssyna0 d4L15b fms elf foEieef: LE HHfrfeeeneeisnno GEufIaamEnnm TmemEEIElEl LL Lk4b =Eomaeee) ur mm pTfemreTmeEm mEIoaTa mEesNngELsnndblL roEasHd2 EH mpfpTeopommme aiseiamTiameeatn EslnLLbb = 3 wEmg = fL jHeoeouoeigo d lirfg ee mnmee meenenl}lIk1Lh =mBirse:e =e - pg rfEeetEauese nGsufIIgse EeeTEmEesen Hn SkL3LLo = i#= pe:1: Tem EEnn d 2 002070 bFGuiitlrmo a1dtu5sn eooocrrieeasasnesr T0 reo %335% FSLheiuiivrteehn oiivofe: voGzoirrreeeveeesssssettrs o7sd0o 5d5S EPSNuGtIUiNnEEa555 C GGeaccstee auvsisss a dseo fd1S9 SFf ioGiiTnk aocislg Seicacsaovuosiises 75I08 515 FSFoRooGoSoiIo%ne, 11a50%:: ccccoeetssreeusseseiesc:ts 52w0t0 13i5S FiSRRaooiiirreoanc 1oooi5:s gGcioisomevieeseesrssseessr 2r1a0 5i5s FiFoRooeoacsrehew 1e15c5::: sooiiesssiseeccoeesirecesas 7420b8 31185 iFSouoctorraanss eaoc5ok: ccoeccysedrseooeaesssrrrasr 231a30 5355 FSFoooucorirso 1a155o:%: occcoocossseuesesciresare as86o S33S5 Fiiorfoooostooeeonrs: oo1uv5e:s ccGisaoooizacewesessseesrrs 0 asdo S35S FSFiRooioseseee:k 4o15u5:s ccGrroeoessneeusszrsseie 708 15i5s iEinrLooiiSgeecTys 1obo5is%: cccoesercsoeeesniiseezsls 31000 3355 FiFRooosoaonkms 1so5tt0es cooiriiicisevvseoedriesssa efsiun 3i5s iFioRPoooottioonares o1bu5os:: ooorraiissseeoeeessrersls 1avd8o 5i3s FiFoRooooootirsnoeeks i1655o:: oowriiissceevsueisszeeisr gT3om0 33155 iFiroreoososeyeiennes o1bu5es: caGxrafoseiscveuesrreeszee 18100 3iS FiFoPoooooivrnieenssk oacocsrc oooraracesezcvueosnresssss 30a00 i61s6 iFiPiRaoacpsaiennnses e1oocct ccersssresooeoesnsedrsse 3s3u00 6166 Fra oocoohee ac: Geriset wsre go I ds PFiroelOi:lr ooAefEs eGGieseeaoriucss 2a4v00 a&e - FFiRooonstoaainns 1bS6ei::c ooorrriiesdcuoosmaseseoscs staoub 416 rFiieoisuttneiv1ief5 aVoisionseewiscetr I 6fu )66 mas7?7 EESs7 f3wr1ee HEEEert = eesz e36z17 3eF5a0rz1 E7EAos resases e6=s3 W375ls7 z6Er=s: BEST COPY AVAI ABLE eS35ec6s1 SEEeeen Eersa F3Bo%es sa3eei1s Se3es: Ss=zse sseeezls dsWeese iFfoeH 586 002071 F fpSoaisRLsaees rSeeieeske TdS3 pfpnioernneemsreong ieenennL LpIEoREsLm i se au aay n mn SL EppLhrLioawgbIuaMsEeIsRN aa 4& pTffoehoHodeisEe abEcess meamodeIetenRiee 70 8, &8 ee pTroonsgeuse a1asce: t r sseswa nsk 8o8 pfpfooooekoienle beses amt ridaeeelnnekb58 pfjfooooiniseee:iuGsseee:srrpsiaiieccesneneememaenllisnt 3 3 pProEseLs sEr sOeNme f FfE TBOoOeiOuJenRsR 1aaa6e5ss GnE aiTmdeGomeN ionr y6f0 f1&L6 fflmoeggus L i Ss uae iea t XbL2i Lpoaonsieaert ps se aumsmei eeeTe 4 32 rE fpooegieee pses mmetne lEe f8 teRBoEchaeLdssVw Eie dS) mminetan unnneko&5 feorse Ee us Esisasmrmimmeagmeeald 3 - rTfHososteiivae EbrLfE mSe ussaesR seas 2 15 Lfiodels Ber isutisese 8 =wE=r!L Bftwordes iw=mdeee Z2=o,si bw2 oEli 2mwmseee ua=Eee=so ou=en. 3 Ewre! si==oe,c BEST COPY AVA ABLE = == = E4 B=El IEoaZHde. 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PLF0lo0o8oi0s0nn%e s83i11% eSoiccaoesssssseoensrmesis dsiooo LR0E0TS Gi Chacseara wn i1itt 1 ode HERES Rh saferces 3fHeee . oSFssH 5Epie7 E5Eei8 SP3iee ES5eesd ea pid Ee=lg 7 8 57 EEWeise 15 BEST COPY AVAILABLE powrree SrEeeo E$3E6eH3 p5i37 &EEs: 3ia.: 9 oiii e@fded w= sesl . eEEdis : Swelt 002093 608 [rsaooreeOe OTS 32oi%s 01% eSSzeTsesseeesniasss Gvoseses 40a0e0 do 311 4a snneeiei 8 Wi fEI weoSoiEne B3Bi1Ss2 G2 GeGriiistseessesressrcs Coser ds 0o0 t13 ee 1 eos if ieee 1 ppEreede) i HfI ee ee Ui11SS% eCSoliiecrrveeossnrsseo a23e00 i iS Gisseuze 40 4a41 4 $SWeeid =i ree nie su Ee 002094 609 Wb Vhs OHRLACAET TENG STUY GF ecco TIRES FH-35E4e_ FeC-14a3 ItN BTS TE SimSoS nes iPiEt: FEE Fe gs souks weer 10 m STseoeniensw s iATzEEasGieros iinserss 0 stoe L83 ae OTToNorriEe dLSiYif RE MGSGeerrmceeeneniiriatie :tsase ae34ae TLEREESyET iufi BGtHioeseerseiieeien a3a 8d8e be i TOraTne ITE 0NTSi3EfIMGGhUobteeNeeiimEasrR3l a e OS8ae I ESEoTrmE enAEiaCaGuhrmeeeeesseensnsalosb 8L3 L aTTtehel Te aNSiEfobBnilnteaere iE oe je 8a4e de TEfhreerRcet sMMEf Rhee Sif eaGiitetmeneeteontazbn loser se 4La ie BfeoEunlTs nT GiMEadGeiSemene 2 SE been 8w4e ae rBE preeecior tua hreenn n SnU L TIe ieTlisl e MkEf BESTE af Gbaiimddaene tiieeeet Rf3oe fn 8d8e ie roew Fostrte aiSa1fF mdGGriaeamneelhsn 3L de - 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HLE CamoLm A omnaumnmE emenesEg1L I ffn eenldnia usenmamea n ensa 3 4 ELErEEnEinee uamammmammpnanresgTf4o I E EhoimsnSmam p aLa aamaen nty 42 SETHpooarmrrsiEhuaaaumneenmsessngL2 fELREiRE pe ss mgmermeeeRnnessx ns 84i . pfoBorRsrmRsiysfeea esmme nl A WHu=msl wwale iT=wheiee ofuesit5 EaoEse,Hr ew1 E+te ==Ee!Yi = = Ewes: EiiEEH:i) BEST COPY AVAILABLE ===f.H L= =Eoo. =5a Eo, = = o=d: 5F= iH1 E= = weL E = awnes 002096 ell unk i Symi 2% 2 BEST COPY AVANABLE Begone Lo =i foie EL & 612 002097 FOODIRF 155 029400359. 90 1s des. 9 : FOIE BUS AZIEA04ES. 20 5 465.2 fn 5 SEE S27 BESTCOPY AVAABNLE meh lame nO Zi 002098 613 Wsfhauo ht uvn a uenaR e SE d HfSiiRstEe Abes GGoaieegrt w sfs P LesetdiEBE lgMoiereterrorsrA a306 a5e eHHoonhiee 0vDDo a EGitNvE eSseEs SR 30 LL5 oreeilistd 1a6E3 r oEsiEoetiEcs BEb if F[Fihoboilnoam Gieiisft bboiooeesseassseescsrs saaq idee SiFrerelsiilcss odAreEsc cbSooualecsoeaiscess 3ee0oo ae F[MoPioien 1br6e5:IcwEaisrmoicvNeeisErees dn R a fLis LFr feociitsa biee esose csaevorrec:s atnni 5ae HFelsoEit:o GGBefZ GfarEeesEeeeZrsiERamnn 8is SPPkoeosnEiaoms Eb16e3 sEoiisrenocsesiessss moRbn ie LEFiSbiieShte bGfeeet ttciierrastsceaesseerts ao se fiiss FL TileeE aae EcErdmReaEtEena nsEiFs FiCroilioiiekn 1b36esf SbGiiirsreeesswosaoeras3dfas0on a8 ds cFSmioiliahvaosidSleeff r ovcisseme sseerr cme fas PF irioinEiae: EAbef iSnisEiseEsaeRse i1R e0 Lgfe iPibfooicstioeess bGaoiesf eeDiiiitzcseeeeecriasststs af46n6 a [ FLeoliier e 8t2ea cSsieste eeiisr d1n0 i&e FGiifboRiiitAneer b4Ge5fs% voGiiisdsveesoraeessrc g4sb6 n:5is F$Foicrioeoonee b3Se56i%0 eeesiascereeesiireets Szsoee i6ise . FiShroicPiseen b8Geost GaEiicsiseeneeerssiscst 6sao 551s FiFkoioindeitoc o3S6ei3f oGoaaasvpmsoeeesietsss e37e0a adfs aeErsts HEHEes i fPrEi F=EEli EEEEti fpseees E3p&se Gppeaeed i5Es3i aEi:e fimeett B3b2oe3is BEST COPY AVAIL ABLE SSEaeEs i S=ail asEe:ss EE$Ha7 idEerlres pESriieed irei:s iSsaeii EiesHld WE#ii3 002099 614 kFOiUeInR:E v16e5s w4apbEs0eRvIaStey 020 16 a38v5e2 1FROEUIUSI5R4E 015655 G@446EST0E0O3I8S4O 2S0C 16 338%4. 52 1FROEUIDEJSFSE 0166S5 084461900000434542 2300 16 344548.32 1FRoOoI0EISREE O1S6S5 @@4ailz1eGe03dedsE 0200 616 a38a3.2 1FO.O3D5J5A7R 01665S 84411340000433531 8900 16 w35i1e9 1FROEOIDSISAER 0166S5 G0a4a1c500o307473.52600 616 33757.28 1FROOOIDEJSASR G1C6S5 0@4a1i7s0e0e43124s.0400 16 431248.4 1FROOU3DEICA0R 0166S5 0e4a1z5o0e0o435s9e.2s0o 6i 435640..25 ssssssesss es e 002100 615 10 VER ORRLCOIET) TOROS STUDY GF Tecmncin TIALS F-35E 238 Fa L-LZtI RA- TS Tp ESeSmAaneFerE ebeesdat S0-R33E8 ssecnmns weer a1 smpireohsmrseiesicaGafsrassaestanemoeEseiirica gno L3 za bt pTLeoroOeoricEthe r GGlilfeeGeamreoeeoessenss esoaa 1intt Or0a eO0e GU4Uif%lf eaGGirebeimmeeoeninrrc 7s5z0a0e 41I& Lm peO00vaIa F% tBLIil Eg eGaiheat EessoeuRrees se 03l0 ib1it pPfe eeetdid oe 23U1f% mCeheoemseorssnt 30e0 b1 oi feooeeteer GliiffieSabeltseelemnweensseo 1on bt Li eOooeIe GoHGtltiSSGhtioeeteieenazrree en4on fiLTeaotlree BMGstEifeieeteeteamsanz do nbtibh pHr oorwoged51tSdeeimneecer a 2 1 1 ipr oeoiteeir UGff rsolsr temeeeeeniHetsEa2ea ht bt pHNroIrriEaiasUnsIlehe aiaRteeteetnine esSoE 1o1bn GTfToooolusnsee 63GwiS%fs stGeildeemeeaneenrna x20sea0a 411it - EL0m0e0 8s12 aesEseRsl7a o1b su$asiea miFdis 3 EEpegss BS2 wiii ii Ewoes EEp2ryl 5532332 BEST COPY AVAILABLE "7 Eie oEiEs,e e8i E5li awowiiiel piiEde aEpwireirt : EE 002101 616 msmosesmmaaansrtnacaumemSaEnne o42b EpmtmiRwegnmap anaumEi NmEEnEre OlL L EnTheeEmlmLmnoseiIismumemmammEmennsnE 4 L opTTeeriemoroitamt euanmng 4 hb TpTpromeammmeaa asaimmamemnnnn 41hb LnTAEehrammmsapnisipaaueamameeemisteei do4b mpTfeommme aiuInmmnaaeemNemyEnbL)1 ImGEmemmmm saitm aaanTma eumnneEsaEb4o)f msi iMTf mFRLieDetJsemRtmo Re sson1i1:5iarosw1im7rm4s0neat 0ee3r9nnc2ss. ak5b0 b141 T EEBrmemradhiia aiommnem emameenn 4ibh T m HDoawmem gaiea ws neesenb4 m mTDooeowmraa3ptneaemnenmennn0 L bt n Dneeemrmeaoataao ammmmmn eunnne LL L TDmoommomroea3umttamasenemmsinn 1 hs 4 LTHIoebuwmmaapuiaarammamenmmmninenen 1 4 Lo EE Smmem oaama amarn LL =FTwAi:ye =FB HiEe::r. Ema5tet: iFoEssHt EIZ=Eti: =5HusrH f=Eiai: i ipWr:s bd 3==E3o82.eii.9 OEST COPY AVAILABLE muomieii 5oo=:ei: wem5sde: EFBoiEmi: aiEEEHet: MwaBms:t: . E=is3 002102 617 BsCeUsisLreEa trois wBSaiIsSE 91% SCwaoehmTeeonovimsr oxewere ecaou0 m31t at rsEaocas pi Hr Tohnoees G3tiifF SSrhiiifso eoaossis BE Sit chissesti oesoco o41m1 p=ri dFiEs LSCRaotcvEaites hone dGGiiFf Sif CoCrihittroooomsssueszde chigewel eatnu 50 111 1 Sapiy7l dCroisetse i61t5 Cccliseoaosrsss 0r0o 1L ppre 618 002103 THO YEAR ORLCDIET> TON-ONC STUDY TECHICIN INITIALS OSFHHFH-352e6e& FCe-z1e4i3croIvNszRATS FTfoyOuRnSonCcaete < L7orseees . CETGHT OF FULL FOOD JAKE SEOGRANS veer 11 aFSORrGeoOsIisAceRy e1c4aa5ss eeeae0vrvsiocceeeirssizsss s3ea0b 4i4e FGFrOogGosCiIscReeR 1o14i45s5 oeeauorvvaseceveeesszscests g%So0014i4e SFfiRcStiricosnpa1i4s5 eee aoovroosh eesseess 300 4ie FiFiRoseoo7toeeeLrr de14ea5cs leeilcvoeiicoveeeiasczetzr e2so0o i4iee iFirroeeosst7reoesr: a4ei4ifst eoellioosaseccaoedricessss w1an00 4i4e FiFSOSROEU0rIeResF 1a44i55f Geltioeecrseeeeeciserssst emauo0 14 as iPGrRoeGsiIr7ioResE oiGaiatst lloisoiestceeebsratisid sZ3au6 4i4e FGFrOOeGosUCsIoeRArEr 1o14i45s5 eieliiiiszsceeecerisseetde 705a0 14i4e iFiRFoEeiSio77nCeres 04eaSct ioeiiiiiscceoetovasarszers 0z1o0 4d4e FiFOorCusijrgeiarcr 1o14i45s5 ieoiirzeieocveso3esertscs E3Sou i4ias Fiorveisoeaiky e4ics eciizzizseesnsieo dsio 4ie 1FFiORRoSeOoOs3JJ77nRl1wEs2 00114444Ss55 0Gre1iis2zzs3eee0sa0eec4sss2sce9yed. 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REST COPY AVAL ABLE 002154 = 669 EEEGiAEEERE SE. BEST COPYAVAAIBLIE 002155 = 670 tmorsas ous Leer efERwOaOeLdE rie AAHaGEfICGuaOMvTeleEeEtneGEtEE hn 1e h L4 dm P mfhoeiawedoauslfirnuSssbIleaeEeTNHniASlyaLi4 eTHfoesome LAHGEffEmCSiSeNtSeaew00 onbob mfm Foooieeeo MLdEt ESuii IGeMnNSnDa on hb foTooOnnsEe AASAEf Ef e sEe aLnSe SL n1on rTEFoonemeei NAE eS Ma eTeN b i 21 e ooEEmegLgSEGr mEEAOeETe IUmLNIiGEG RFn41 iE E SEotreIeN E e sLSiifc en T a Nivcee san e e si a a0 n a114 Tm ESomoo LaAi fiMi i ANSSa e NnEE 41on EfEfoooceeidee wz aME r se SSiNew n S s n31n EfTooouses iazTMm Ae eIaNRen ErndSL oo1n fone Gf A Se mteieeteano ete Lnn rfpfooesoieee aAEEsur GeiTtrewesNe teEsEcofusL LTfeEeeTt uTf Si sMe neel o1b I . r pmfooonmmsamdrsr ESaNOTiNElR bt 4 we imwEo:ei =gTge:ite - #EBo1ig3 w02we.i =EEeH F=weH.ee owwis =f3=+] He p $Xoue+ie BESTCOPY AVA ABLE Boweil3: i 9=3i wBoesi: f=w=ol =E2). 5S=Eois:e BEuEeAon. 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[| 1tRo0o3o7i2a6e s4uss 0G1i3n9e0e6e4i2s1 6o0b 43e ESee (ESM ANSEL 3 73 002158 GErEesEGiEEGaErameEsssG0 OD 3B7E RES] oopAVNIRE fmmamay a - 1Re2(5: 04s ooleeases. 30 4 482.5 002159 674 Fours 195 cozzooiss ca 14 smc Foie 5a owteoien co| ie fr 1. 2757 ois eoiv00sss 20 4 463.2 FTHoeosotrricmese 5o5n3s sspoeuuermemeeetnross a1a00 33Iss a5ald - [| pP5orooe%ccnoi 153g52%2 esSfeestileeeeaserees 73ra3a 31s3 8 55377 fpoorree 1a5% ptssatens so 1s His Rpotirdo:ieorrn ovits se 1 EEEE onaeesoyrcoPY AVAILABLE jet ret ES tigger ae Fporrees igo eeserostee 20 10 i 8 O00 G3 Sei se 3 as Lo |[EAnfRoaoDnoRIrtAosRnE1S3I553S22R0Ss2eoS9fv1it0cEo0ee3ss6Eoe8rr. 6dN300aG 1i5iss i = = 388.6 STboeiRveec 3OoEfE Ssaeonsseee sneeeurs a10 0:5Io EwH2e 002160 67 5 i. - FCFLOrohOiroLsiJ7rmAeemRs co1oe5sssSs cc0c0lii2ooc3e:i0oe0aoo4ds3ise0ses. 0s1400a9 + as 3b FiFCn3oeos0sreo6re, e1Go5E:5E Ceciiivocsseeeoecaasdmessss c47o00 5iiss CLDRoEOEt7SSiE 3o5i3s CGooreroerknoesczenes 3ak d5s PTHooRilIiioEseSie 5tG3%o5 oCoaihloisssoeosssiaaesssss os0bu iins SFSrReiist7ereas 3obio5:ik cooiialzrsosodeosssecdxee z02o04 i5n 0FiiRoo0osoi0nlec ia5o:r seeiriiiissvoeeoaossssssea tdeaas: i&1s% iLFRROoe5ssi7riooarsn eossoo:ss ccciiisidaceveoevoteasscsss oSasbo &335 FGFoRooainiriieno.es 1o1f5%:% ocoiiizzssieoooeesaiszz 2i00e a5 13 HGTriohitec: 0i0i%i CGbiiimieesenemeait:za evdee asS5 HFDibtere N EiIo Ooa ismeee NosrEa Rwh a1s5 iFDfUoUcNiRoEr GooinE:: O esieseoIertsiEseen L&5L FhFioitciiaiie.ne 3iiiio:swiCbiitsiissoeeseessastsiiiSaao0 a539s FiRFoiEiiaEe: o1aii5;: cbciiisissrseeessssssiasere fveoeb 535s FLForoiioicsiseger: iiooeo:: oociiissscoiososssseserss aS3no6 i51s% LFiSRoeetsicaaiess s1oo5t:%: ccciaistizssoemesesissessr %s36o0 3i5s FfFoRoooooaosioeinrse od1ce5:t3 oooiiistesroeeoassss3seser 33r68o 16i5e FiiORr0oaissoianiikzs o1oc6etk: eeoiiidsscasacesecssarieesc 4s06o i5s FFpooroooociotnnine v11i665reooiiessotseoroesdedoes i4800 16 26 FiInRoeGosSasEieCs o1accc5k seiiisssassceaoedissrctss 344008 &16 TFonil5iiilhnrk 3c256s53 ecciirssseprveeaess3sresasa 33300 8166 iPiReReoost3eoeinsces ciocesss soeiiisccosiooonootssrores.s 7o3ada 616 RFOo03osszn0e oiecst eeiiccsisoeonneess s5o0 6ie 002161 4SSe3ee8aeas Wpef8 . #FFiAe1H $iSise sSYeieds f35r%83 Esseats 3EE2ri2] EST COPY AVAILABLE EsSeeei se Seaeies s5E3iee damisi i5Eoo3s pe=esi E$7ed3 35550337 esSelies ifNreeds] psHieeo dd 3Fs6oa3ld w3F2re FseHs 676 [FPoiosaen 1a6s5sEoSiisstn roeuszise tea cdao| tifee jaj FriteeieTuEdegenrmeieeterr ir6J0 1 TFSuhEsiieNilesGiaEifs Giciplreoneeieeerys 0sS0ao 1&66 HDiEe NGEEeAEeSrHEse a8e Pa Foomopsoem aAscest eScuuerrmsoeiss sasoa 1s56e | 1HFIioRfRc@se0oIias8ai%e2ne08n 0d aas5iae5f:t e0cce1iii8sss0sia0m eo0oes5nsi0rr4osi .sr Se33On00 | 6L61e6 e IFTiEoSenEa ioffe cMmirsseionottleis 3sEao 6ie EFi oEie N810;IUiGsiEReeSiEaErER20 816k ETTeRel SSbEEIN M UEIlRIEERdL FPFoiRlinEa nif 16f ccahimosrimiooann 6 ou a18e ETGRaIeEilt Ebi: AtoliwNemvNeedrErs S0ei6+ FTriveeiL16E:ptavhimee emueen 3S0a i 1 IFTRoStNiierLnw aaBiEffE cSCoaomtsmetenneitsni f4wo0o 6a8e PFIoEotRouIrnEk 2B15E6%E% oceuassveerseeeicctiiyen 24s06o 16i6e FriEloioniseass 6occt eeexiiictesirsiis afno i5e FFIloPiSioOiinmSee SS3ii5ff% ccenoaiitsseseoeeensrearrte s32o00 i8e | HRSIoERoSieSiSnAAw SS06i65f%eoGoianinteseneoensmiaaeiis s30 ofL85es I IRSASO EBiik ceEasMmaeiIiraTSfon de || FHGdRoeeoEoso3asninec:eeSBoeflfsf mosGiiampfseeomseorrmirces m0t lo0o Li&8c | Fomine Set oisronies so 56 LA | 1RO38SZ EEENEE BES 22600423. 50 OL 002162 p22550r.16 Ff5rH2 E5FiH Pasd2 aoElsr 58 2e04.ss9 &8w7ls3 f2=r5]3 =fiHid i5prl3 8 5i$ce 2Bi7i n8 eSTCOPY AVAILABLE t8sieae1lld =&S@eile wfEiri sa meess n1Fi3rd3 Ensi5 ei= wii Set WB 423.9 677 f io1FrRoocOo0i2eEnisSskeI RscaEoecStts 0oce2zas2srs0ize0ce0een4sss5eas8iss. 77es0ane 646 is aStBoosieneee"7 || FiRo2eo0so3tvasi%:e5 beoecks: sLoosiisisssceeeosssssisez am3a ie66 3f8e37d5 | | ETFodSOeiTsNise 3SS65ef GSoisssirceatccsiiears s02o8 i8ae6 Fp$=o3 DFThoeedoimrls G3aof nGSiaaeaessnaiiez dsv n:fiFs HFEeeHi FRFooidioioense ibbeecifi cosoiviievoesncletys eSbea iea&s SE=isNH | SRanAna 23 002163