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THO YEAR ORAL (DIET) TOXICITY / CARCINOGENICITY STUDY OF FLUOROCHEMICAL FC-143 IN RATS (RIKER Experiment No. 0281CRO012) VoLuwe 2 oF 4
ConpucteD DURING AeriL, 1981 - Mav, 1983
RIKER LABORATORIES, Inc. / 3M ConpANY
ST. PauL, MinwesoTa 55144-1000 U.S.A.
00879
SToadniavriidauaeld MSaicrnoescoTpaibcolnatdediicraaslcopRiecsorDtbecranttiionnds) FEAR: To teirteGralLTisonrat-oGriceas,pnIriec, it0y Sad in ats Tae: 2
nFaaen:t Oeettesrs 781) 0Sc6rificedSeixn Fenetsrleesisagi (1 F143 0 ge
Hcrfocrasic servations (contivee: fLrohitKeiked (senteri) Pissiietniry verss
"escearliare,inedrifafluisae,timoanrkewdile oHott eeannaiinnde,, raitssinngplane of section SHheercsaimdeross, saterate "ste glands, ale
Traeinf,ilSipnag Ctairsds,esfoweereRrorouwd, tBoeaBrte,wiStthoianchs,omSaull]LiInetse:tine Luge Intestine, iSaslaivrayryBSaldaedr,, Efroer.ks, Dury, avery Slane, Trachea, Keren, Tyrid, Pacres,
aFante]hsehie:1051) 6Te0rmin SSaecnrtifFiecmeale Sra (1 F143 300 pp
WacrePsacswiacrGBslearsattions:
Later was, 3 a dia, right wiki,
icrosHcropeimcl Gserationst
Sinusoidal tas, corte, aild
KiLeenrey
""ehlevpitcaanieervaalaiszlaattiioo,n,ssinitsail l, wild
-
islaetay aitration, vakolated, cl,
Hsenptlacte alteration, basphisic, fal,
wp
ahsypeelrpalrastiinceanloidzulaetion, ald
Nasir lant
THiterastiwocnrstags, sido, ald
fuincarrnys Bader
oott ewaanriendg,, iissiinngg
Trhaeinf,olSowaiinng tGiosds,osBowneereMarfreonnd, tSoplbeeen,witHheianr,noSrtoamacihn,tsS:al ntestine, Large Intestine fLoyrtn, NWheerease,seDnrtye,rc)P,itSiatlairvya,ryTrSahcahneda,,ETe.hea, Parathyrod, Esphages,
Fsrpoijeest:Maatbe: azCROIZ
suweioe 78 Pa: 8 29. 2 200680
SInctainvairdiuzse)d NSaicnrgalsecoTpaibclaatneddMiMcrrionsaclopRiecpoOrtbse(rcvoanttiionnused) Riker Laboratories, Toc. 30
FEMS: Tuo Year Oral Toricity-Oncogenicity Study in Rats Table: 2
beinal Fate:
GNaesebkers105I)RATGeErSsiml
SSeaxc:riFfeimcaele
Group
(5)
FC-143 300 gp
Macroscopic Dservations: Ranwery Shand
Microksacroepniacl servations: Horta KLiidvneery Lug LFaysaesrtryNoBtelan(dsesenteric) RRurtaatihtyarrsyie
"Laarsgse,ma5ss5,115015 d4 ecaa,, right aillai lobolar Lei inguinal. "lSoitnuseoxiadnailnede,ctawsiisas,ingcortex, waked ""PPoerltvailc saienneornaclliezaatriocne,l?alindiltrate, wile "Pfolrvteasllarbilaeacdrocpthapgerso,limfletraitdeosc,al,wiladile Hesorrhage, local areas, ile ""HFeimboersrahtaegneo,ns marked ~"Htoetenoenxsanined, sot in pase of section
bTrhaeinF,ollSopiwnianlg Ctairsds,eesBonwereNarfroowu, Stpelebeen,wiHtehairnt,norSmtaolsacLhi,nitSsu:ll Intestine, Large Intestine, itary lagder, eras, Dury, Trachea, Thyroid, Esophagus, Pancreas, Salivary Slane, Eve.
Fdintiea:albaebeesr:105I)E-T0e5r0s6imal SSaecxrifFiecmeale Groups ( 51 FEALAS 00 pp
Nacrascopic servations: Watwiry Gland
Ficroscipic Ghsarvations: Haeaarretnl
Kidney LiLvregr Fasaary Bland Puanrcyreas Purathyroi
"Susaeltlclanerdemlaasrs,m4ss1, 21.5caa,dirai,ghtJef wills willa. ""Sbiyneucsaoriddiaall efcitbarsoisai,s,cofrotceasl,, ostienria'te Myocarditis, chronic nonsuppurative focal, ~Dshirnoinniacl progressive nsbvopathy, winieal SFPoerltvailcaniemnruacllzeaatriocne,llairnkfeidltrate, ld ~Hesorrhage, local areas, oderate "Fbietnrcocaadrecnionnasns ""HTeaibneelraratDriosgehryp,lasaiian,imsloterate "lat exaained, net in plane of section
PSrpoejceicets:Nuastber: 028100012
Sunarized 510 page: 18 293
00681
ISnudmimvairdiuzaeld MSaicnrgolsecoTpaibcalaantedMiicmraoslcopRiepcorDti.se(rcvoanttiioonuesc) F143: Tao YeaRrikOerralLaTbooxriactoirtiye-sG,ncoIpnec.nicity Stay in Rats Table: 2
fFartien:albNeaebesr:1091)0-T4e6r0a6inal SSuec:rifFiecmeale Group (5) FC-143 100 gon
WierPoistcuopiitcarGyservations (continued): SUtaelriavsary Slang
. ""Hleitreexnanined, missing "Cystic ghands, wild
GTrhaeinf,olSlpoiwnianlg Ctoirsds,ueBsonweerMearfroouw,n tloebne,wiStthoienacnho,rmSawlalllimIinttse:stine, Large Intestine, Uricary Blagder, Aorta, Traches, Thyrold, Escohages, Lyesh Node Gaesenteric), Bye.
Ffaitnea:l GNeaebkesrt1051)8-T0e6r0a7inal SSaec:rifFiecmeale Groups | 5) FE-14S 300 gon
NacraPsictsupiitcarGyhservations:
"Hass, 0.5 co dia.
KicroAsrceonpailc servations:
"Sinusoidal ectasia, cortes, irked
:
KEisdonoheayges
N"Cohtroneixcasipnreadg,resmsiisvseinngeshropathy, winiaal
Liver
"HFeeplvaitzscystienevraacliuzoaltaitoino,n,awiniituiaflocal, wild
Lung oury
""CVyasstc,ulaurnilaaitneerraallization, soderate
PPiatruaitthayrryoid
""bKadtenmcawnined, wissing
TTrharcheeiae
""NNoott eexzaanniinneedd,, wwiissssiinngg
inary Bagger
"Net examined, wissing
The following Brain, Spiral
tCiosrds,uesBorweereFarfroouwn,t
tSoplbeemn,witHheiarnt,norSntaoluscLhi,nitSsw:all
Intestine,
Large
Intestine,
Aorta, Uteras, Kanary Gland, Lyn Node (aeserteric), Pancreas, Salivary Bland, Eve.
Animal Naber: 16-0608 Sex Fesale Braupt ( 5) FE-145 300 gpa Fate: (eels 8) Fosse Dead
WacroNsacsopaiacrysBelravnadtions: Microscopic Oiserations:
KiEdrneey Large Intestine
"Large Fira subcutanecas ass, 121 915 ca, on leit side. ""hpeetlviecxaniinneerda,limziastsiionng, aild "hat exanined, aissiog
SPpreocjieecst: Naabter: 0281080012
Suamrized 518 Pe 110 294
00682
ISnudsimviirdiuzaelg RSaicnrgolsecoTpasbculaantedNiMcarmoslcopRiecpoDrtise(rcvoanttiionnused) FL-IA3: Tos YeaRrikDeeralLiToorxaitcoirtiye-sD,aceTgoecn.icity Study in fats Table: 2
AFraitaes:] (Mhaenedlesr:881)8-F0o6u8nd DeadSex: Female Group ( 5) FC-143 300 gp
Wicrascopic Observations (continued): Lrg NLayssssahryModEleanCduesesteric) Farathyraie sSkaianl! Intestine
"AHlavsecoallaarr swaicnerroaglhiazeast,iona,utiwidlodcal, wild lPaetriveaxsacnianleadr,saoinsascirlgear infiltrate, wild K"loatt eenxaanniinreedd,, mmiostsiinngplane of section "SlFaitbreoxnaniond, aissing
TBhreainf,etlSopwiinnagl tGiasrds,aesBoesereMarfroouwn,d tSoplbeeen,witLhiivner,norHmeaalrt,linSittosw:sch, Urinary Bladder, Aorta, eras, Dury, Fitsitary, Trachea, Adrenal, Thyroid, Essphages, Pancreas, Salivary Blanc.
rina] Naber: 1046S Se: Female roupt ( 5) FE-14S 300 pp Fate: (ek 105) Terminal Sacrifice
MacrFoistcoepiitcarDyservations: Naraary Blase
Microwsacroepniact Ghsarvatiars: Ltiivgeaery Lrg Rasniry Bland Patraartyhyroid PSiatbuiivtaaryryBlunt
"iSsuaelldaasuss,s, 0.c8a cduiad,ia.possidly inflamed wilt cyst, perineal area. ""GCoarrtainciacl partorgoraehsys,ivebilnaetberroagla,ttayc,dermaitlee "PPoorrttaall bwinloencdculcetarprcoellilfeniantfiiolrtr,atiel,eald "perivascular soonclear infiltrate, wininal "FGiatlircatsadceesloen ""NToutbaelxaarnihnyepde,rpnloatsiai,n pblialnaeteroafl,secotdieornate "-hhadterecxmaanined, aissing
bTrhaeinf,ollSpoiwnianlg Gtoirsds,eesBonweerNearfroouwn,d Stpolebeen,wiHtehairnt,norSmtaolwscLhi,niStws:all Intestine, Large Intestine, EUrrei.nary Blader, Rota, Uterus, Traches, Thyroid, Esophagus, Lys Node (aesenteric), Pancreas,
PSrpoejceicets:NuRaabter: 02810012
Suonrized sti page: 131 295 COO0ES3
ISnutainviirdiuzae)d NSaicnrgolsecoTpaibclaatnedMiAcnirsoaslcopRiecpoOrbtse(rcvoanttiinounesd) FE-143: Tao YeaRrikOerralLaTbooxriactoirtiye-sO,ncsIgnecn.ici3t%y Staty in Rats Table: 2
SFaotie:l ONeasbteer:1001)6-4S6a5c0rificeSd ein eFexmtarleenisGroupt ( 5) FL-14T 30 por
RazrosPciotpuiictarByservations: sun
MieroNsacaanpsircy BBilsaenrdsations: hareral
Kidney Liver Lang KBaasrcyary Bland Prathyroig Pituitary Skin
""RHaeirsrehdacgiirccumlasrs,in0f.1lacmae6ale.siss on Left reac "Rofuonudtgaads., 1 cn dia, dn inguinal ares. "SRiendsuloliadrayl ceelcltahsyap,erpcloarstieas,, wwinlldateral, wPhteesrcahtreoaccytons, malignant, wilateral
Infiltration of segplastic tissue into "pseulrvircounsdiisnegralciozmaetcitoin,vewtiilssce. "PPoorrttaall sbinloenudculcetarprcoellilferiantfiiolntr,ataei,lewile Hepatocyte vacuolation, mili, aild ~Phearsicvualsacralwairnesraolniozsactlieoanr, winiflieltrate, wininal ""Taulbaucltaorcehlyeperplasia, bilateral, oderate "Not exanined, not in plane of section -hiesons "wpioldoatteerruaalt,itimsar,keudlcerative, hireles,
Tbrhaeinf,olSlpoiwrianlg Ctoirsds,zesBonweerMearfroouwn,t Stpolebeen,wiHtehairct,neSrtsoamlaclhi,nitSswa:ll Intestise, Lurge Intestine, Urivary Slaceer, Serta, Stars, Triches, Thyraie, Esophagas, Lyset ce (sesenteric), Paccreas, Salivary Slart, Bre.
frinal Mosse: 10-0651 Sex Fenale Groups ( 5) FE-143 00 gpa Fate: este 98) Sacrificed in extrenis
MacrPoistcuopiitcarOyservations: KicroAscroepailc Oiservations:
Esophagus fLaerge Intestine Liver
"Raised wuss, 1.1 ce gia. "Sinusoidal ectasia, cortes, mild oat examined, aissitg h"Naott eexaasniioneesd,, wwiissssiiongg "Haelpdatocyte alteration, vacwolated, focal,
SPrpoejceicets:MaRsaster: 028160012
Suanrizes sit pge: 12. 296
C0684
ISnudaimviirdiuzaeld RSaicnrgolsecoTpaibcslaatneddMiMcarionsacopRiscerOt.bse(rcvoanttiionnusrd) FEAT: Too YeaRrikOerralLaTboonriactoirtiye-sD,acoIgnce.nici3ty Stuty in Rats
Table: 2
Ffnaitnea:l GMeoenrdosr: 9I8)R-0S6aScLiicedSexi: FeexmtarleenisGroups ( 5) FL-1004goTo
Ficroscapic hservations (continued): OPraarraythyraid FiStaaliivtaarryyBland Tweiytraerity adder
- diagnesis, imdeqate section "hot exauined, aissing ""hboeterecxaanines, aissing N"heott eexxaanmiinneedd,, saisssiing
The following Brain, Sim]
Ctoirsds,aesfowreereMafroruen,d
tSoplbeees,witKhiidnneyn,ormHaelartL,imiLtusn:g,
Stomach,
Seal
Intestine,
horts,
Uterus, Taseary Bland, Lyst ode (aesenteric), Pascreas, Trachea.
fninal Mader: IR-USS Sex: Female Group (5) FE-1004g3p Fate: Gels 9) Sacrificed in extrenis
PacrasPciotpuiictarsyervations: LiNvasesrary Bland
Fierohsicrsesriacl Observations: KEisdcnpheiyges Liver Lung
""HAeIsKorrehsatgicinarsisg,htcibngudiiaal. ares, "Ale ""Shiontuseoxiadnailnede,ctaasiisas,incgortes, wile "Cironic progressive nevcgathy, ainisal "WHoerpcantsocclyetaer vcaeclulalaitnifcinl,tradt:ifofnu,se,sulntairieoscal, -Ppraerueanccnhiyaa,al,intneirlsetitial, chronic, mitifacal,
Nastary last Pancreas Pituitary Spleen
"bMitLhEincyssotrsnaolt Liinnciltusded wth section exavines. hina atrophy, nile "bdenons "Heucsiderosis, ail
Tbhreainf,allSopniinanlg tCiosrsd,uesBowneereMafroruonwd tHoearbte,wiStthoirnchn,ormSaelalLinIinttse:stine, Large Intestine, Urinary Bladder, forta, Uterus, Dury, Trachea, Thyroid, Parathyroid, Lyash Kade (nesesteric), Salivary Bland, Ere.
sPrpoejceicets:Maasther: 028100012
Smrizes st ges 138 297 00685
TSaentriroan RSRelosercoLTpocrlsaanereirefs,uiaTse.egr5st0ea(ttioinasl R15 To Yer (a Toasty apni Say 1 ats Tales 2
iFtl teeer 57S) FHou DeaSder Foal up (9) FEE 50 00
osecy BEseintions:
Siallts,anasswesw,s 6s3i5l1 l2 sca i Int
Keroscraeict serio:
pry Simic tsa, cores, siete
Giitgs
SSepasianne,,asromiessvpritive fel,
FuGnaeske Git
FSraeirtaionbi,nlesdteetrnpirtea,iaav,e,wlfdoci, itd
Press
Fucratiton, orc, diffs, sere
ETSnrivscnlSEienadtCnsftoerbteerheFaasfreo,dn,r9Syp,oben,FwiitKhtiigtnesrr,,aSTtwasnccht,hs:Souls,teriant,heurr,e Intestin,
Gt aie samt), eivry i, Ee.
FiantelNwaateer05BETTris SSerrifFceee Gro 51 C14 5p0 an
Raroassrsyc OSeattions:
abal.a wn 26 53 1 ca in pein)
HerBaeoress Gseratins:
SJoitnsiacnaa,ctmssicores, wg
Key Gre
FiPraorenacihcasprmevreesanivercse)ewie1fs4lt,rate5,4ile
pForta tblevaatssprilei,ferwatiicnf, ,4144
Snialrtyy SSluts Ser
SSFieamenintdias,,oicd, wtrate
in ste
at ernie, sissing
riToatnensf,,aSluylnyoaw,GtoFarids,tetsToovnwee,eFTaarrasocndes,WtoiTboteeiiLta,ig,sPtraormcshe,L,iSenEisdabIanetses,tiLn,rLarRgoedentaessinte,errt [
rSpeaciees:aRart : CBG
Samians sh pg101 0682968
Pancreas
~hcinar atrophy, eild
sais ss 500339
Summarized Single Tabulated Animal Report (continued) Individual acRirkoesrcoLpaibcoraantoriMeisc,rosIcnoc,pic3O0bservations FLA1A3: Too Yar Oral Toxicity-Gncsqencity Study in Rats Table: 2
fFnaittea:l GMeaeakbesrs105I)R-4TEeSr9aimal SSeaxc:riFfeimcaele rowps (5) FC-143300 pp
NieresSctaorpeisc Oservations (continued): "Fol
TBhreainf,ollSopwiinanlg tCiorsds,uesonveereWafroruonnd, tSoplebeen,witHheianrt,norSmtaoluscLhi,nitSse:ll Intestine, Large Intestine, Urinary Bladder, Ovary, Pituitary, Trachea, Thircid, Parathyroid, Lysgh Node (nesenterss), Salivary Bland, ve.
AFantiea:alhSeosmibeer:1051)6-T0e6r6a0inal SSeinrtifFiecmeale Groups | 51 FC-145 00 pon
NacroPsictoupiitcarOyservations:
"Hass, 0.6 ca dia.
Raaniry Eling
Ha2ss4,2205,x21leit3 cinn,gilmeflt.axilla; mass, 44
MicroAscroepiacl Bservations:
"Sinusoidal ectasia, cortes, marked
KEisodpnheaygus
"lCohtraneixcaniporeosg,resasiisvseinngeshropathy, siniaal
Pelvic sineralization, sinimal
LiLavregre Intestine
""FNoerttoaldisaosniasn,uclceoalrecell infiltrate, ald
Portal bile dict proliferation, ile
-
HCeypsattaoicdytdeegevnaecruastliaotni,on,focsatlt,ifnoicnailm,lairinal
tung
"Alvesiar acrophages, focal, wile
LPyasasnharNyotBelan(dmesenteric)
"Fpiibgreeanatt,enbornow, aild
Fancreas
"FIistlretaadceenllonscarcino
PPiutruaitthayrroyi
"-Nbodtenecxuaanined, not 18 plane of section
Spleen
"Heacsigerosis, wininal
BTrhaeinf,ailSpoinrianlg Gtoirsds,ueBsonweerMearfroouwn,d Hteoarbte,wSittehnianckr,orSmaaallllinIinttse:stine, Urinary Blaser, Berta, Uterus, Dury, Trachea, Thyroid, Salivary Sland, Eye.
Species: at Project Masher: 0281030012
Sumnrizet st page: 135 30c 0
G00688
SIundmiavriidzuaeld RSaicnrgolsecoTpaibculantdedMifcarioasa]copRiecpoDrtbse(rcvoanttiionnused) FLeIA3: Too YeaRrikedrraLaTbooxraitcoirtiye-sG,ncoIpnecn.ici3ty Study in Rats
Table: 2
Fraitnea:] GMaedler:1051)8-0T6e6r1minal SSaec:riFfeimcaele Groups | 5) FE-143 S00 gon
Mcrsscapic Observations: MicroEssctosphiacgesOservations:
LKiigvneery Lrg Parathyroid
-Xo visible Lesions. ""NDoitronxiacnipnreodg,rewsissisviengshrogathy, siniaal "FHoeeptaatlocyatoe cvalcweolraticoenl,l imnuiltlitfroactael,, wwiillde "Shlavsecoallaarr amsicnreorpahlaigzeast,ionm,itaiflodcal, nile "hot exsained, not in plane of section
BTrhaeinf,allSoguiinnagl Ctoirsds,uesorweereNarfruonwd, tSoplbeeen,withheianrt,norSmtaolsaclhi,nitSsm:all Intestine, Large Intestine, ULryisnsahryNoBdead(eers,tntfeorritcs),,UtPearnucsr,easD,uarSya,liNvaasrsyarGylanGdl,andE,ye.Pituitary, Traches, birenal, Throid,
minal Mester: 18-4662 Se Fesale Groups ( 5) FL-14Z 00 pp Fate: Geeks 109) Terminal Sicrifice
FacroNsacaoapaircy hGslearnvdations: Miereascraapniacl Oservations:
tEisdcspehaygis LiLvregr LKyaonshnaNoGdlean(daeseteric) Pituitary Spleen
"Uicerated secrotic ass, 4x 3 ca, in right inguinal area.
"Sisusaidal ectasia, corter, marked ""Cahtroneixcaspirneodg,resasiisvseingneAroathy, ald ""vhaosrctuallaransoinmaecalleiazratcieolnl, isniflidltrate, ald Heorrhage, multifocal, ald F"Fiitgreeasdte,robrnows, soderate denon "Hiersksetodpuiesis, extranedallary, increased,
BTrhaeinf,olSlpoiwnianlg Ctoirsds,uesBonwearMearfroounn,d Hteoarbte, wSittohmianchn,ormSaelal]LinIinttse:stine, Large Intestine, Urinary Bladder, Aorta, Werus, Ovary, Traches, Thyroid, Parathyroid, Pascreas, Salivary Slant, Be.
SPrpoejceicets:MaRsahter: 02010012
Sunnrined 54 ge: 17 501 000689
ISnutainvairdiuzaeld NSaicnrgolsecoTpaibcelaatnedMiMcrrionsalcopRiecporOtb.se(rcvoanttiionnused) FE-143: Tao YeaRrikerralLaTboorraitcoartiye-sO,ncaTgoecn,icity Study in Rats Table: 2
AFnaitaea:l GNeaebkesr:1051)04T6e8r3sinal SSeaxc:riFfeimcaele Groups ( 51 FL-143 30 poe
NacresFcoapsicsBsEleirnveations: NicrohsecroepsiaclOservaticns:
sdrecal Kidney Liver
Lg Rosaes nBland
: Hiss, 3
23 a, in the throat area.
"Right adrenal appears sill.
"Swiintursaoitdeal ectasia, sorter, unilateral, "DPherlavniiccspirnoegrraeliszsaitvieonn,ephirlopathy, wile "FHeerptaatlocwytoeonvcalseaalraticoenl,l sinuftiildtorcaatte,, maillee Hegatocyte alteration, vacuolated, focal, "Awlivleeolar acraghages, local areas, ald FHiebscrrarahatgeen,saild "Kot exanined, not in plane of section
.
The fellonizg Brain, Spiral
tissues were fond Gord, Boe Narrca,
to be thin norma Lints: Spleen, Heart, Stousch, Swill
Intestine,
Large
Intestine,
LUryiangahryNodBeatatgesre,ntfeorritcs),, UPtaenrcurse,asD,uaSray,livPairtyuiSthaarnyd,, TEryaec.hea, Thyroid, Esophagus,
nina] Mondor? 10-065 Sec Female Groups (5) FEAIAS S00 pon Fate: (hashes 94) Sacridiced in extrenis
MacrPoistcoupiitcarhyservations: MicrosPcaoapwiecryObSshearnvdations:
seEsrcepnhaalgus Litoey Liver Larg FLyaanshnyNoSdlean(taesenteri) Ory PiStlueiteary
""RSaaiaslledwrieldh emrssst,pr1e.s2es0t.ia. ""Shiantuseoxiadnailnede,ctaasiisas,ingcortex, nile "DPierlevniiccapirmoegrraleiszsaitvieonn,eraoignaitahly, minieal "PPoorrttaall inolneacdlucetarprcoellilferiantfiiolntr,atwei,ldald "Hveassocrurlhaargew,ineloecaallizaatrieaosn,, wwiilldd ""Lhaottuleaxrampineerdp,lassisisai,ngaaderate "Tabular hrperplasia, aoderate "--bbdeesnoosnisderosis, aild
PSrpoejceicets:Noastber: 0281CR012
sonrizes spe: 118 302
00690
SInudmimvairdiuzaeld SMaicnrgolsecoTpaibculaantdedMifcarinoaslcopRiepcorOtb.se(rcvoanttiionnused) Riker Liboratories, Inc. 3
FEIT: Too Year Oral Toxicity-Dicogenicity Study in Rats Table: 2
fFaitnea:l (Mhaensdiesrs98I)R-4S6a8cSridicedSexi:n Feexmtarleenisromps ( 5) FE-143 300 poe
Kicrastcrsepriscs Observations (continued): hytronetra, moked
The Fellowing Brae, Spiral
tGiasrds,uesBoevereMarfroounn,d
tHoeabrte,wiStthoinnicnho,rmSaalalLisIinttee:stine,
Large
Intestine,
Urinary Slagder, birta, Trackes, Thyroid, Parathyreid, Pancreas, Sabivary Bland, Eve.
fFraitsea:l WNaasssteer:105R) 0Te7reizat SSeaxc:riFfiaclee osgt (5) FC-LAD 300 pp
RacrosPcietpuiictarsyervations: PicrasUcroipniacryBsBelravddaetrions:
hEsecrpehaaglus Kidney Liver Lung
Nanwaey Bland DPaurraythyroid Pituitary Salivary Gland inary Blaster
""RHaaillsedapmpesasr,s t1.h2ickaeneddia..
""CNoorttiecxaalnioaetdr,ophayi,ssbiinlgateral, sodete
"Pelvic "hortal
asinnoenruaclliezaatriocne,llaiilndfiltrate,
ald
Portal Bile duct proliferation, wild
"vFaesgcaulloacrytwoisnse,ralaiizladtion, wild
Pwrielueacnia, interstitial, chronic, aultifocal,
AHlevwecsrtrahragem,acrloopchaalgeasr,easl,ocaslodaeraeatse, soderte
"GNroatncelxoannsi,nedm,itaiipslseing
""TNuobtuleaxranihnyepde,rplnaostiai,n ipllane of section
"bimons
""ENpoittheexlaisailnedh,ypewrisslsaisniga, single, eiffuse, aild
Hpertroghy, miscalaris, sil
STrhaeinf,olSlpoiwnianlg Ctoirsds,ueBsonweerKeafroounn,d Stpolebeen,wiHtehairnt,noSrtmoanlscLhi,mitSse:all Intestine, Large Intestine, forts, Uteras, Trachea, Thyroic, Lah Node (vesenteric), Pancreas, Eye.
PSrpoejceicets:Naabter: 0201086012
Suansrized 518 Page: 139 303 00691
ISnutaimvairdiezaeld MSaicnrgolsecoTpaibcalaantdedMiociraoaslcopRiecpoOrtise(rcvoanttiionnused) FU-LA3: Too YeaRrikeOrralLaTboorractiotryi-eDs,acoTgoce,ncity Study in fats Table: 2
AFoaitaea:l hNeoealbesrt B1116-0S6a3c8ridiceSdeidn eFexstarleenisGrout ( 5) FL-143 300 gon
PacroPsictsupiitcarsyervations: Mersscopic Oservations:
LSiavreenral Lung PPaarnaetehryroBildand PSiltueietary Thyreie rivary Bladder
"Enlarged
due
to
red
mas,
1x
0.8
ca.
""SHiepmastooicdyatle evcacteasslaa,tiocno,rtpee,riwpiolrdtal, sederate "VHaesscourlrahragea,imrlaoclailzaatrieoans,, ##iilld N"hoatt xexaanniinneedd,, waiissssiinngg "-Hbedaeonsa:mdaerosis, wild ""hhaatt eexxaanniioneedd,, wwiissssiiorgg
The folloning brain, Spinal
tissaes were found Core, Bone Narrow,
Ktiocabeey,wiHtehairnt,soSrtmoamlacLhi,mitSsw:all
Intestine,
Large
Intestine,
Rorta, Uterss, Dury, Traches, Escpragss, Lymph Mase (sesesteric), Pancreas, Salivary land, Eye.
fFaitnea:l (Neoesitesr: 2I)R-4S6a1c0ridicedSexi:n eFexmtarleenisrust [ 5) FL-U4T 00 gon
macroscspic Beervations: MicroPsictoupiitcarDyiserations:
herenal vitney LiLuvrger PiRtauainatrayryBland Speer
"Raised henorrhasic ass, 1 ce Cla.
"SMienduusloliadraylceelc!tashiyap,erpcloartseisa,, wmiilltitoecdil,, swiizled
"EPxerlovniiccapirnoegrraelsisziavteionn,esharoodpeartahtye, ald
""AFlivgeaselratr,
aKcuprtoeprhacgeelsl,,
fborcoawl,,
wild ald
Perivascalae sononclear iniltrate, winisal
-badtencenxssnined, aissing
"Hesositerasis, wild
TBhreainf,ellSopniirnagl tGiosrsd,uesBoweereMarFroonwg, tHoearbte,wiStthoimcachn,ormSaelalLivIinttse:stine, Large Intestine, ULryisngahryNoBdlead(dseers,ntAeorritca,),ePraunscr,easD,urSya,liTvraarcyheGal,andT,hyrEoyiee., Parathyroid, Escghagss,
PSrpoejceicets:MaRsahter: 0201080012
Saanarines 518 ge: 100 304
C00692
ISnuainvairdiuzaeld NSaicnrgolsecoTpaibcalaantdedMiAcnriomsacopRiecgrDt.bse{rcvoanttiionnasne) FO-1A3: Too YeaRrikOerralLaTboorxactiotryi-esD,icoIngce,nci3t%y Study in Rats
Taste: 2
AFoaitaea:l (NMaebekesrt1051)0-0T6e7r2ainal SSeaxc:rifFiecmeale Geouss (5) FE-143 300 pou
WacrasPcistpuiictarByaervations: Wicrohscroepeiacl Ohsernatioes:
LEasrssyhagus oLyresyh Mote aesesteric) PiPtasriatthayrryoit Salivary lant TrThaycrhoeisd
"Hasorrhagic mss, 0.5 8 tia. "Sinusoical sctasia, corter, animal ""Hleatscreexhaangien,ed,locaailssairnegas, aodeate ""TFuibguelenatr,hybpreorwpsl,assiia,niw]ailateral, ssserate -lbaeteraensaanine, wissing "Sialatesitis, chronic, aoderate ""lNaott eexaanviinneedd,, waiissssiinngg
BThreainf,ollSopwirianlg tCiorsds,uesBonweereMarfroouwn,d Stpolebeen,witLhiivner,moKriadloeyl,iniHtesa:rt, Stoaach, Small Intestine, Large Tntestine, inary Blacer, forts, Uterus, Nasnary Eland, Pancreas, Eve.
AFnaitoea:l WNeaeskbesrt 79I)R-SHaTcSrificeSdexi:n
Female Graupt extrenis
(5)
FOALAS
S00
pon
PacrPaistcoupiitcarByhservations: Suin
Micr[osrcopeic Dservations: Liver FLarngaary Slane
PiPtauraitthayrryoid Thyreid
""LSaorbgceuthaenseonrsrshaagaiscseas,ss1,.511.511.511ca1 cdai,a. right anilla; 3.5131 2 cn let ail, ""PSoirntuasloidsaolnneacctlaesiaar,cceolrlteisn,fiwlitlrdate, ald "Pioarstcaallarbilseindeuacltizpartoiloind,erawtiilaer, aild "Adenccarcinon LBoatlaalcatrocheylpeerplasia, wederate aOrnees ooff tghaelagcrtoascsoleylsdeasncdribleodbulaaarssheyspewripslaas1ia. "hHeetroenxsanined, wissing "Hot examines, ising
The folloning Brain, Spinal
tissaes were found Cord, Bone Farrow,
to be thin nora Limits: Splees, Kidney, Heart, Stouach,
Small
Intestine,
LLayragseh bInotdeest(iensee,atUerriinca)r,y BPlaandcreera,s,huSratlsi,vaUrtyerSslsa,ne,OvaEryye,. Trachea, Esophagus,
PSrpoejceicets:Maastter: 0281012
sonnrizet 518 page: 11 305
C00693
ISnudainvairdiuzaeld MSaicnrgolsecoTpaibculaanteedMiAcnraoasdcopRiecpoOrbtse(rcvoanttiinounesd) Riker Laboratories, Inc. 31
FL-143: Tuo Year Oral Toicity-Gncopenicity Stay in Rats Tate: 2
Animal Fate:
OKloaebker:1051)04T6e7r5minal
SSeaccriFfeimcaele
Grup
(
51
FL-145 300 pe
Macroscopic Bssrvations: Kistgney
Nicros2cop)ic Observations: Sscahagas Heart Liivdenrey Lung
Parathyroid Fitsitary
-pparent areas of conselidation. "Soatat pale and pittec. "SCionrutsiociadlalvaeccutoalsaitai,on,corate1r, aoderite ""NMoytscaerxdaintiinse,d,chirsosniincgnonsgauTative, ~OLhorcaanlicarsearse,grewsilsdive mshrapathy, acherate "portal sononclear cell infiltrate, wild "NVeagsaclualcayrtossiimse,alaiiznaitniaoln, ail Branslon, diffuse, naried cLealrlgse. arFeeauoffraggruaennctlsonofwfiotrheiagannmagtiearnital "Norteseexcatn.ined, not in plane of section -hdencns
The following brair, Spiral
tissues were found Gort, fone Marrow,
tSoplbeem,witShtionnaacohr,saSleall]iniItnst:estine
Large
Intestine,
UPursicnraarays,BlaSdadleirv,arAyorltae,,UeErvues., Ovary, Famsary Slane, Trachea, Thyroid, Lysgh Kode tnesateric),
dFaotien:al (oetshhe=rs105()RTTerTsina SSaecctrifFiacseale Graugt (51 FC-143 0gp
MacroNsacnowpaircy DSilsaenrgvations:
HicroHsacroepniacl Oservations: KiEdsonpehyagas Liver
Lung
aswse,lti2l5ebl1a5r cwaa,s,in6l.e5i1t a5n.i5l5las2 cu, in perineal area. "CSoirotuiscoaildalvacecwtlaastiiao,n,coirtlees, ile ""PNiogtueenxta,ninceodw,.atiasbs.ingepithelia, brows, "Psoirntianlalwononclear cell infiltrate, wsderate PRoergtaallocByitloessc,tainpiraoalliferation, suderate "Vascslar wineralization, wild
PSrpoejceicets:aRbaetr: C21080012
Suanrized ST page: 12 306
00694
ISnutsimvairdiezseld MSaicnrgolsecoTpaibculaantdedMiMcarimoaslcopRiecporDto.se(rcvoanttiionnused) : FE-IA3: Tuo YeaRrikeOrralLaTbooriactiotryi-eDs,acoIngce.nci3ty Study in fats Table: 2
final Fate:
Gaebtesr:105R)ATTe)rmin!
SSeac:riFfeimcaele
Beouss
(5)
FLALAS 00
gon
MicrosLcyoep.icNDosdeerv(aatsieonntseri(ccrontinued: Ronse Shand DPuiaturiytary
-"Sinusoidal ectasia, anderate "FFiibtrrooautdeennooun ""hTduebruclmasr agenom, wnilateral
The follaving Brain, Spinal
Ctoirsds,ueBsonveerMearfroouwn,d
Stpolebeen,wiHtehairnt,sorSstaolmaclhi,aitSsw:all
Intestine,
Large
Intestine,
Urinary Blatder, Rota, Uterus, Trachea, Toyraid, Parathyroid, Pancreas, Salivary last, Ere.
FAaetiea:alMKesebkesrs49()B-S4a6c7r8ificedSeixn eFxetnraelneisGroups ( 51 FC-145 00 pp
Macroscopic Observations: NicrFoistcaupiitcarsyervations:
Harenal LKiivdenrey tang
Parathyroid SPpilteuietnary triniry Bader
"Enlarged tue to mass, 130.7 ca ""Spienluvsiocidaailneercatlaisziaat,ionc,ortmeirl,d 14 fHoerptaatlocyatonesnvuaccluesalraticoenl,l lioncfailltraartees,,wsiille "Pvearsicvualsacratsairmrsaolrioznactlieoanr, iwniflieltrate, sil lHoettoerxrahmaignee,d,Loncoatl ianrepasl,aneaootfeastecetion H"ebwciseidnerosis, #118 "Not exanined, missing
The faliouing Brain, Spinal
Ctoirsds,uesfowreereFarfroouwn,d
LHoeabrte,wiStthoisnacha,erSaeallaIintte:stine,
Large
Intestine,
forts,
eras, Ovary, Nasaary Glard, Trachea, Thyroid, Escphagus, Lysph Made (nesenteric), Paes,
Salivary Blane, re.
FAantien:al(bbeeetrst105I1R-TAe6rTa9inal SSaecxrifFiecmeale Sraust (5) FE-LES 0 gps
MacrPoistcuopiitcarOyservations: Fasnary Bland
"Raised "hatular
bemsaosrs,rha1gicca
agsisa,,
0i.n5
lceaft
diadx.illas
Large wass, 1 5 ca, in right
inguinal area,
SPpreocjieecst:Naastber: 0281080012
Sunarizes STAR Eois9s 07
TSduinvriidsule MSicsrgolsecoTnaiaclaatnedKiErnaaslcnBiecrOtor(vcanttiionanesd) FE: Tae YeaHrieOrralLoTroaitcoirtiye-sD,esIgcn.ici3t0y Std in ats Tate: 2
fFaota:l eWakseer10I) TTeraina SSueecriFfeimcaele Groups (5) FIAT 300 pn
WicrosrcerniaclOharations (antined: iffoyus LLnegr
oNuarnny Blast jFirsitary
tte
"Saritniscoaildalvaeccatatsiioa,n,cosrdteer,atseorte oMtaleexpahynpde,rplwaissiian,gcorter focal, adnate roratnale Bpirloegrfeascstivperolsiefterraatpiaotny,, amilries naurtioanlia, tersitial, dons, foal, PEevreisvlaasrclmacrroapnheangsc,iofnecailn,fwlialtde, ile FHietnrrraviavee,nlocal ares, moderate "aeaetnis perplasia, Bilateral, 4118 A"Ctyisstiecragrlaesisa,l aeirnsitnal
ETreinf,oiSon0i0n)g otirstsesEnwereMarfroonnd, tSoplbeeen,thHeiart,norSmtaolmacLhi,neSse:al] Ttestine, Large Intestine, Eineet Batter, Kets, Trach, Paathyor, Lap ode (ssenteri), Puree, Salivary Sand,
Fnaitea:lawsatsers1041) 4Fou0nd esdSex Female Groups 1 F145 30 pn
RacroNseapaics slearnadtions:
LiPvietrary Weroscroepniacl Busrations:
htonrt tiLitrngeeyIntestine Gwivser Loss ode (asenteric)
"arresae.msMsa,ks9a1d9s3ecr5o.8ticca,, in Left inginal uhrenrLheasisoinc, 0su.r4faccoe.di. Tle Sotimamsi]nede,ctawsiisas,incgarts, aid WoJoccaalriatriiss,, rwialene ronsgprative, oeltviscisniemr,aliaizsastiinng, sinissl Scnrsocsalsr,sciontrarlizlaotuiloanr,, wwilide ot exaine, sissing
FSrpoejceicets:Nfaahtr: 02812
Sumrized Pg 0 308
00696
ISnudairviidzueadl RSaicnrgolsecoTpaabculaantedMiAcnriomsalcopRiecporOtbse(rcvoanttiionnuse) Riker Laboratories, Inc. 30
FE: Tuo Year ral Tosicity-Oncogenicity Study in fats Table: 2
RFaetae:l (Khaenette=r:100I)R-AFSoEu0nd DatSect Female Group: (5) FU-143 300 ppm
Hicroscapic Oiservations (continued): Waany Eland PaOrratyhyrsic PiSteuliltaIrnytestine tera
"LLyamrhgaengweilolsadricfofnerentiated tuscr with sunerces soterate to large size spices continirs fx "TIubuipltaorcyhtyepse.rplasia, werate "Net examined, not ia plane of section ""Kaoetereoxnasnined, wissing "Kot examined, missing
TBhreainf,allSopniinnagl
tissues were found Cord, Bone Marrow,
to be within nora! Linits: Spleen, Stasach, Urinary Bladder,
Aorta,
Trachea,
Thyroid,
Escahigss, Facreas, Salivary Slant.
Beinn Naber? SG-MSL Sens Female roupt | 1 FC-143 300 ppm Fate: Gieeks 97 Sacrificed in estreais
MacroPsictoupiitcarOyhservationst Nicroscopis Observations:
EsAorpehnaagles Kite LLiuvnegr
Ovary FPaarnactrheyarssit Pituitary Slee
"Heacrrhagic ass, 1.2 ca dia. "Sinussidal ctasia, corer, soderate ""pKeoltviecxanaiinneedr,aliwziastsiionng, sininsl "HPeeplaittoicsy,te avcuatce,atuinoinla,termaull,tifwoocdaelr,atseite "HViavsecoullaarr swaicsreorpahlaigzeast,ionf,ocaali,ldsinimal Ferivascular sononaclear infiltrate, sivisa! "HTeaabsurlrahraghey,pefropclaals,ia,wilsdoderate "Acimr atrsphy, aild "Ket exasined, fot in plane of section -Aenons ~Hesssiderosis, ald
The fetloning tissuts were fount to be within normal Linits:
Brain, Spinal Gord, Bune Marrow, Heart, Urinary Bladder, Rorta, Werus, Nasr
6Sltaonsda,ch,TraScehaelsl,
ITnhtyersotiidn,e,LLyairhgeaIdnetes(tsiensee,nteric),
Salivary Bland, Eye.
PSrpoejceicets:Nahsabter: 028100012
Sunarized STAR Page; 15 30 0086: 7
SIunadmiavridiuzaeld MSaicnrgolsecoTpaibcalaantdedMifcirnoaslcopRiecpoBrtuar(vcoanttiionnused) FE-443: Tao YeaRrikOerralLaTboorxactaotryi-eDsn,csIgnecr,ici3ty Study in Rats Table: 2
rival Fate:
MMeaeatbesrt
91)0-F0o8u2nd
DeaSdex:
Female
Browpt
(
5)
FE-143 300 pou
WacrosNcaospniscrysGelravnadtions: Microhsicroepniacl Observations:
EEseophagis Lirge Intestine Lurg PLaysaasahryNoBdleanatesesteric) Bary FiParractrehaysrsie PSiatluiivtaarryy Glare Sul Intestine Styornsiicch Urinary Batder Uterus
-"Large wttilobalar ass, 11x 9x 6 ch in leit axilla,
"hSaitnuseoxiadnailnede,ctaasiisas,ingcortes, marked N"hoott ecxaanniinneedd,, wwiissssiinngg "vBavsecsutlaarr aaiamcreoaplhiazgaetsi,oni,ltwiidlodcal, ile F"hiobtroeaxagneinnoend, wissing hat exanined, aissing ""Nhoott eexxaanniinneedd,, awiissssiinngg ""bliatenoemxaamined, aissing "hNaott eexxaanniinneedd,, waiissssiinngg N"Noott eexxaamniinneedd,, awiissssiinngg "lot essnived, aissing
The felionirg Brain, Spinal
tissues wre foun Cort, Bore Marrow,
tSoplbeeen,witLhiivner,norKmiadlneyL,imiHtesa:rt,
forts,
Traches.
Seal Kaaber: 10-0ET Sent Fesale Groups { 51 FE-145 00 gpa Fate: (asks 105) Tersiml Sicrifice
MacroPsictoupiitcarOybservations: NicroHsicroepniacl Gservations:
LiEsvoeprhages Lang
P[arathyroid Pituitary
"rass, 0.5 ca dia. "SAidneunsooniad,alcoercttiacsaila,, wciolratteesr,alsoderate ""hNaorttaelxasimooendu,cliesarincgell infiltrate, wild "BFroarnedilgonns,aatmeirtiiaflocianl,sorweilgdranslonss. "THaebauolrarrhaygep,erplolcaasliaa,reabsi,lataelrdal, soderate "tat exsained, rot in plane of section Hence
PSpreocjieecst:NRoaatber: 0281080012
Suanarized STH Page: 16 31)
. C00898
ISnuniuvairiuzaeld RSaicnrgalsecoTpaibculaantdedMiAcnrimoaslcopRiecporOtbse(rcvoanttiionnused) FE-143: Tao YeaRrikreralLaTboorraitcoirtiye-sG,ncalpiecn.ici1ty Study in Rats
Table: 2
foil Naber: (RES Sex Female Groups ( 5) FLAAAS S00 pp Fate: Gets 105) Teraiml Sacrifice
Nierescepic servations (continued): :
BTrhaeinf,ollSopiwnianlg Gtoirsds,uesBenweerMearfroouwn,d Stpolebeen,wiKtihicneyn,ormHaelartl,inSittosu:ach, Sul] Intestine,
Lirge Lyssh
Intasting, Urinary Node eserteric),
PBlaactdeesr,,
ASoartlai,varUyteSrhuasr,d,NaEsraea.ry
Gland,
Trach,
Thyrcic,
rina] Naber: 1E-4684 Se: Fenale roups ( 5) FLA14S 300 gpa Fate: Geek 102) Found Beat
PacrFsistcoupiitcarOyserations:
"Raised, hessrrhagic, 0.1 ca tia.
Microsrceopniacl Gsarvations:
"hat exanined, wissing
Essooprhtaagus
lHaott eexxaaniinseedd,, wiissssiinngg
Lung Lyaph Node (uesesteric)
"laostceelxaasrinweidn,eamliissziantgio, aild
Kasaary Slane
et enanine, wissing
FBaarrayttyroid
""NTeutbaleaxranihoyepde,rplwaissisai,ngwoderate
.
PSiatluiivtaarryy Bland
""hNoitmoenxsanined, wissing
Tyrsie
"Not eanined, wissin
hTiradcehnetaidied Tissue
""LNoitgoenxanined aissizs
Lsapregceifneicerdo.tic tor of atipase tissue, Site
BTrhaeinf,olSlpoiwnianlg Ctoirsds,uesfonweerNearfroouwn,d Stpolebeen,wiLtihvienr,noHrimdalneyl,inHietasr:t, Stomch, Small Intestine, Lirge Intestive, Urinary Blader, Uters, Pancreas, Ere.
FGartiev:el WNeaenkbsert751)8-S0a6c8r5ificedSexi:n eFxetmraelmeisGroups ( 5) FE-1AT 00pp
MacroRsacsowpaircy OGblsaenrdvations: Microhsecroepniacl Oservations:
rel
"Lawrigteilmoabsesl,ar1,55 9x 4c sommetat fire ant "Both prared enlarged with dark foci. "Sinssial ectasia, corte, soderate
SPpreocjieecst: NRoastter: 028108012
Summarized STAR Page: 147 31 1
00699
SInudmimvairdiuzaeld SMaicnrgolsecoTpaibculaantdedMiMcarinoaslcopRiepcorOtb.se(rcvoanttiionnuesd) FLAT: Too YeaRrikeBrealLaTbooxriactoirtiye-sD,acoIgnec,nici3t1y Study in Rats Table: 2
nFiatnea:! (Neaabtesr?751)R-4S6a8c5rificeSdexi:n FeexmtarleensGroups ( 5) FL-143 300 pou
WicrasEcsuopphiacguOsbservations (continued): LKiivtneery Lang
Nanary land SpSlaelievsary Blang
-"lat exanined, aissing "hpeeclrvaisciss,nearialltiizfaotniaoln,, amlaerked "Hveausactaclsaroiessiinse,raelxitzartaimoend,ullwairlyd, ssderate AHlevxeoorlrahragea,croLopchaalgeasr,esf,ocaslo,fewriantieaal h"Faitbreoxaatneinnoends, aissing "lHeenstopsiesis, extrasedullary, increased,
bTrhaeinf,olSlpoisnianlg Ctoirsts,aeBsorweerNearfroouwn,d Hteoarbte, wSittohmianchn,ormSaelallimIinttse:stine, Large Intestine, ULriitnharKyotBeadndeesre,ntReortiac),,UPtaenrcusr,easB,arEyy,e. Pituitary, Trachea, Thyroid, Parathyroid,
Fiantea:l boebetesr:1051)R-T4e6r8a5inal
Sess Female Sacrifice
Sraupi
(
51
FC-145 00gpa
PacroPsictoupiitcarsyervations: Panwary Blase Liver
NicroHsacroepriacl Oservations: ELsitvpehragas tang
FiNtauaniatrisrsFart
"Saall "Large
hletsiolrrohbaugliacraassss,,0.130
cxa7dxia.4
ca,
in
asrsig,htSaxnil3lac.a, in right lateral Ize,
N"Seitnasecaindianlete,ctawsiisas,incgonten, ie "F[ artal bile 2a c: pride, w "PHaraitvitsazatearrtwieessc,leaeailn,fil6tr1ate, wininsl Heserriage, local areas, wid "Fiiebrrcaantaeroas
"ca ietioning Brice, Spinal
tse were found Gord, Boce Mareow,
S15lebee ,wiKtihcioeeyn,orhmaelartn,itScso:uach,
Suall
Intestine,
LLiyrgse KIondteest(ianees,ntUerriinca)r,y PBalnaccrteears,,fSoarltia,varUyterEulsa,nd,OuBryr, Traches, Thyroid, Farattyroie,
SPpreocjieecst:Nuaattar: 028180012
Sumrized sti ogee 312
C00700
ISnudainvairdiuzael? MSiicnrgolsecoTpaibculrateedincriensacoRiecpsOeStse(rcaoanttiionnaset] FLAT: Tus YeaRrikeOrralLaTpornactiotryi-eDsa,ceIgnecn.ici3ty Study in Rats Table: 2
Reid Fate:
GNeealtsert199S) UTeRraial
SSaeccriFfeimcaele
Bray
(5)
FC-143 09 par
PacrFoistcaapiitcarByasrvations: Picroascroepiacl hservations: rent
vitrey LPiarngcearyInGtleastnidne tary PiSitlueietnary
ss, 0.9 cd ""Shiyneucsacridciatlis,ectcahsrioan,icconrotnesru,gpwuirladtive, "wChirtoinficoaplr,ogrsels6sive nphrogathy, wile "hNaetwateaxcainaisniesd,, acoilsosning "~Tbadbeunlcamra hyperplasia, doderate "Hescsiderosis, wile
Tbrhaeinf,olSlpoiwrianlg Gtoirsts,uesBonveerNearfroouwc,t Ltiovebre,wLituhni,n Sntoorwmaaclh,LiSnwiatlsl: Intestine, Urinary Blaster, hurts, Sstaelrisvsa,ryTGrlaancdh,,yeT.hose, Parathyroi, Esophagus, Legh Node (aeseteric), Pancreas,
doinal ater: (F450 Sout Female Grospt (5) FO-143 0 pa Fate: asia 165) Terinal Sacrifice
Macrescopic Dservations: Wizrashceorepniacl Bhservations:
does LiLvregr
FLayrsasthhyNroodie Garseteric) Thyroid
"Ho visible Lesions. "Sinusoidal ectasia, cortes, unilateral, "Drakroendic pr ogressive phrogathy, ail ""Vhaespcautloacrytienevarcaslailzaattiioons,,waelltdidocal, ail Preanonia, interstitial, chronic, maltifecal, Rwlivleeslar wacrophages, local aress, wile ""hPaitgaeenxta,ninberdo,n,notwiilnd plane of section "Wtiastranchial cyst
bThreainf,allSopniinanlg tCiosrsd,aesJowneereMarfroounn,t LSoplbeer,witHheianrt,norSmtaolasclhi,teSm:all Intestine, Large Intestine, Urinary Bladder, Aorta, Urs, Duary, Rasaary Eland, Pituitary, Trache, Esophagus, Salivary Gland, Ere, Pancreas.
PSrpoejceicets:WaRsahter: 0281R0012
Sanarizee STM Page: 169 313 00701
ISnudairviidzueals MSaicnrgolsecoTpaibcalaanteedMifcnrieoaslcopRiecporOtbse(rcvoanttiionnused) FO-443: Too YeaRrikreralLaTbooxriactoirtiye-sO,nceTqoecn,ici3t0y Staty in Rats
Table: 2
Ffaitnea:l (Maeshker:100B)ASS9ac1rificeSdeai:n FeexmtarleecisGrog: (5) FC-143 300 pp
Pacroscopic Bsarvations: Liver
MicrospceorpeircalDservatioes: sarenal
[= tigney LiLavrser
fascress Sleer Stomach TUhryirnoairdy Fladder
"Hpaeareeesn,targed With weltiple pale fact in "Left atrenal appears eslarged.
"LSeirntuiscoaildalacaecettaastiiao,n,corltoecaxl,
ress, aild nilateral,
"wWayrskceasrditis, chrasic nerscgpurative,
"wChirtoinfiecalpr,ogarelsesive neproathy, sisinal
Frotein resaation droplets, tubular, marked
""VmaaslciuglraarntwiInyesrhaolniaza,tiAoins,tiwoiclydtic
Faliguant Iysphona, histiocytic
"HEedseonsr,rhaignet,erslioctailtiaalr,easa,csaeirlate
"Hteamttopeoiesis, extramedullary, increased,
"~HEytpoenrss,lassuibaa,scouacle,ll,woftoecraalt,e wild
"Maliguant Iysghows, histiocytic
The falioncsg tissaes were found to be thin normal Hits: NBraasiana,rySpBilnaanld, GoPridt,estBaornye, MaTrrraocnh,ea,SuPla]ratIhnytresotiidn,e,EsuLsahraggessI,nteLsyteicnhe,Nodfoertase,seUnhteerrsisc,),Dury, Seliviry Eland, Eye.
final Nasbert IR-0633 Sect Female Groans ( 51 FL-LA3 00 gia Fate: Geeks 105) Terminal Sacrifice
Macroscapic Otserations:
+
MicrPoistcuopiitcarsyervations:
"bark raised lesion, 0.5 a ia.
hiidrheneayl
""Spienluvsiocidsailrercatlaisziaat,ionc,ortweixl,d marked
LLiinvger
""HPerpeautsoscayitae, viancteorlsattiitoina,l,slctiriednoicca,l,locmailtsareas,
wld Alveolar
aacrophages,
local
areas,
wild
Fitaitary
bPeareinvasscalar soaclear infiltrate, aild
PSrpoejceicets:Mafsahter: C2815R0912
Suarized STH Page: 190 314
00702
ISnduiviadunal NScirngolsecoTpaibculaantdedKiicnroaslcepFiecgaDrtBse(rcvoanttiionnesed FC: Tee YeaFrieGralLiTsoorsaitcetryi-est,hesfogce.ici3t0y Std in ats
Tate: 2
RFeaitnea:] (Rhaeaeb:195I) RTeSrminal SSeac:riFfeiacaele Sous (5) F-10300 pn
Fieroscoic servations (continued):
BThreasf,etSopniinnalg Cboirsds,iesBonwterMearfroounn,d SLpolbeee,wiHtehairnt,rSatolnsclhi,niStse:al Intestine, Lire Intestine, LriytiaryReBelad(eaeers,tatheerritca),, UPtearnucsr,asD,rySa,bbvRaeroywalryanad,sdE,ve.Trachea, Thyroid, Parathyroid, Esophges,
fFoavteea:l (Khoeeblesr:10I5)BATEeSrKainal SSeaxc:riFfeimcaele Group (5) FC-143 S00 pm
MacrosFciotpuiictarOybservations: Nanny Slant
Fizrowsicroeiacl Oseruaticns: Kidney Fuansgnry Shine tPuarraythyroid Fistislieteary
i"Ssueldnmodsusl,ar1.l2esicoon,ia0.8 ca dia, in right ila posible wilk cyst. ""SCihnruasnoiicdaplroegcrteasssiiav,e nceoprrteep,atmhryk,esile "PAelvviecrainmearcarloipzhaatgieoss,,awtiinfitoaclal, sild "FCiybsrt,zataeirloanteal "eNontoenarings, net in plane of section "Hexssierasis, waderate
TBhreainf,ollSoowian!g Gtoirses,cesBovweereMafroxn,d Ltcivebre,wiHtehairtn,nSotrommachL,iniStusa:ll Intestine, Lurge Intestine, Srailnivaa'ryBSadletr,, Eybei.rt, Weros, Traches, Thyroid, Estphagus, Lysh Node (eesenteric), Pascreas,
Ffaiten:dWMeaesktser:10I5 ATeSrainal SSaec:rifFiecweale Groups (1 FECHA 00 pn
RacrPoistcuaiptcarOysarations: Nawnary Eland
FicrLoisvceoirc Dservations: hirenal idney
HLeonbuotrahragciycstmicsss,s0,.84a5xdia3.x 20a, in left Maasls,la3..51312 ca, in nen lobe, "Swiinruesdoidal ecasia, corte, unilateral, "PDerlovincempirnoegrraeliszsaitvieonn,ghsrialpdathy, wild
Psrpoejceicets:Naubter: C2BICRGR12
Sunarized STH Pages 151 315
C0703
.
eSadngizeeds RSianlre eTbsuliatndReiriasdopeicrtQuessttiionnts) ker Lvrataries, Inc. 3%
F103: To Yur Oral Tascity-rcgenicity Sty i fats Tate2:
Foiitee tseekr1694) 5T5rea SSueritFiocuels Gras (9) F-10100 po
Hifriaeo Bsrations cntinat): "psuarttaalcysteomaecoaanltcil,l iwnlftiiltfroactael, wwiillee
Fwsos Elid sitwrtasty
HyLcpogeererplialtseitsiioconnnowadttuhlhesxraemslieo,e cst Tribbarsouetdoanrs saci Imilirate, ainsi sGricmsccrucrciinnoonns arises i fibration. Ttayrereonstant, ait
rTaheinf,eSlpoaln Liorsd,eovweeeMarfruonn,d Stpoebeen,wiHeirt,seStaelncLh,itS:eal Intestine Lure Intestine, LiiogeNeSetieesr,atforrite,DPrry,esT,achSau,barTyo1i,,PrEay.bror, Esha,
oFaatets tNerre:1091) T6erai Saacsiedwee Egy (1 F103 00 on
Hurospapirc Baration:
ahiullalrsmwssi,lt5i1lna45u1ss,25 ca, it S301 2 cn in erin nd 0 igual
WarLeeshDaeertaimoentse:r) irteel Liver
rg a atic, S"Dionoiapraersetssaisv,e caoprotpsi,thwiyl,e ile HTepeastocryates,altweirladtion, viialaes, Reales, siniual
rg
Loh Kee tester Nor Sli
riHiepvastocclytaeraltseraotiona, basionpfhiilliirci,te,focaail,inl YGrearthoang,, lTocoaull raeraess,, iwlld SBirnisotioana,l wascettues',ymrhet FHiibnroaatecrinoonns
sPrpoieecst:Naabter: EBICHOLE
Souarioed SH Pe: 12 316 00704
SInudainvairdiizaeld SBaicnrgolsecoTpaibculaantdedMifcarinoaslcopRiepcorOtb.se(rcvoanttiionnused) FAS: Too YeaRrikeeralLaTeorxaitcoirtiye-sG,nceIgneen,ici3t0y Staty ie Rats
Table: 2
nina] Masher: 18-46% Sex: Female Group (5) FC-14Z 00 pou Fate: Gest 105) Terainl Sacrifice
Hic[rosacapic Dservations (continued: PSiataulitaIrnytestine Thyreid
-"Ost, wnitateral ""Shraenwulnons, esentery hyperplasia, cell, foal, wile
The Following Brain, Spinal
tissies ere fount Cord, Bone Marron,
to be within normal Lisits: Spleen, Heart, Stousch, Large
Intestine,
Urinary
Bladder,
forta, ers, Trachea, Parathyroid, Esophagus, Parcreas, Salivary Blane, Eye.
Grins! Masnert R497 Sea: Female Group (5) FC-143 300 poo Fate: ueete 109) Terainal Sacrifice
Wacrascapic Gservations: PicreAscroepniacl Ohservaticns:
HLiugngnwy FTihtyarieitdary ttarus
"ko visible lesions. "Sinusoidal ectasia, Cortes, aoterate "fHaysdcroolnaursharianseirsa,liwzialtaitone,ralwild -bFteerisovniascalar soonsclear infiltrate, s13 "Hyperplasia, cell, focal, wile "Cystic glands, acderate
The feiloning tissses were found to be within normal Limits: LBarragine,InStpeisntailneG,ardU,rinBaornye MBalrardoewr,, Sdpolretean,, DLiiavreyr,, Meaassra,rySStoawsisc,h,TrSawcehlels,InPtaersattihnyer,oid, Essphagas, Lytih Mote aesestericl, Paceas, Salivary lat, Eve.
foiaal tert 16-0692 Sex: Female Graupt | 5) FLALAS 00 poe Fate: (hess 165) Terninal Sacrifice
PasrFoistcuopiitcarsyervations: Nassary Blase
Nicrosiconpeyic Dservations: Liver
Lung
""hhsass,, 04.x5 c3a.5d1ia,3 ca, Jest inguinal, "Chrasic progressive nephropathy, wile "pPoerltvailc ssionneornaclliezaatriocn,ellaiilndfiltrate, sininal NHeegpaaltooccyyttoesivsa,cusoliantiinoln, multifocal, aild "Phearsicvualsacralmairwrsaoloinzaactlieoanr, ainlflidltrate, aild
SPpreocjieecst: NRuastber: 0281880012
Sunrises 510 pages 155 317
00705
Souinreed MSioessTiedaatendRfATaEaREBIGterttiinees) F105: Ta YeirbGeaLaTrenacrhiyeSsc,apTnci,ci3t0y Std in ats nae 2
CFiiteel hXehe10T) Tsrina SSunrifFicoee ro {1 E18 0 0
WeshiancsOBgrnadtions cotinagt; oy itty
-- ZTiuttsorwimieaasts, ere Hives
Bhreinf,eSlooinn CtrsteEwsrerfeaed tSoylbees,witWheianrtroSrtsicih,ntSsal Ttetin, Large Itetis, ietnWeSeateesr tKiertrUerrae,e,TatSaasv,arMyrBah,,Tbotees, Prahrad, sos,
FiiteNee58) Sidicet i vFeeei ro 9) FEAR 0
[ any -- Sd
us, 3x2 cn in it with,
Srrta
Soiagrserpaoliswowsriatsie.
Wreistte!r Oration:
CRN
rn
Srimaoditl has, cartes, wiltera,
ECotrtaictal drpemper,atisoinltweialla,treat,rmaerked
weortts
JrotoecianeswoitsisngTscal wes, ide
rine
TvwreisenapeWeess:tirn vyaneriiehde
BJ aers Sn--
bfpi-- en
PJarsd Sl sting
"Saiatoina,aiTopeaa,iramrasis,tss
mried en,
id
STtonrse
S3eenvosris,tewnthiwere
hFaeif,eSlionne tGosrsdyesoreeRaetodn tSoebenwitLhiinne,reclrelsitteosn, Uinry lsr, teres,
Pitty Tuten, phe Fas, Sty Sid, rt
sFpagoent: eart : zbcaotz
Sanvstiszgee1s8 318 - 00706
SInudmimvairdiuzaeld MSaicnrgolsecoTpaibculaantdedMidcnrioasaclopRiecporsta.rv(caotnitionnuses) Riker Laboratories, Inc.
FE-143: Tuo Year Oral Teicity-Dncogenicity Stay in Rats Table: 2
nFaitees:] (Neassbtesr:10B5-7T0e1rai SSeaxc:riFfeimcaele row: (5) FCAT T0C pe
Macroscopic Observations: MicroPsictoupiitcarOybservations:
Lihevreernal Lrg Prathyroid Pituitary
"Henorehagic ass, 0.5 ca dia. ""Shienpuastcaicdyatle vecatcaasoilaa,tiocno,rtaes,itiwfielcdal, winieal Megalacytosis, sinial "APlrveeusstcanira,macirnotpehrasgteist,ialf,ale,reai,ld fecal, wild "Net xanined, not in plane of section -hrons
The following tissses ere found to be within normal Linits: Srais, Spiral Cord, fore Marron, Spleen, Kitner, Heart, Stoaach, Seall Intestine, ELsicrpgheagIenst,estyiaoeh, NUortienar(yesBoltaedreirc,),arPtaas,creUatse,rusS,atiDvuarryy,ElNaansds,arEyyeS.lane, Trachea, Thyroid,
fFnastuea:l WNeaekbeesr?811)8-0S0a0c2rificeSdexi:n Feexmtarleesisromps { 5) FO-143 300 pon
MacrPoistcoepiitcarByservations: Waanary Eland
NisrLosicveepric Ghsarvations: Epsecagrhtagas itney
LiLvregr Nwarsnyary Slas PiPtaunicrteaarsy
hedtish nass, 1.21 0.9 ce. "Laobnellaaterd raesgsi,on.3x 2x Lan, in leit "rattled n slightly ale. ""NMectcaeratsiitniesd,, Saoinssiicngnonsuppurative, ~wEihrtainfiozcaplr,ogwrielsdsive nphrogathy, winieal PPerlevliictisa,inearcaultiez,atwiiolna,tesrianli,salsild ""HVeapsactoolcayrtewivniecrawlliaztaitoino,n,pewriilpdortal, saderate hHoeesncrcrehaargcei,nomnultidocal, wild "Tabular hyperplasia, soderate ""Hhotenoenxaanined, assing
TBrhaeinf,olSlpoiwrianlg
Ctoirsds,ueBsonweerNearfroouwn,t
to be within normal lisits: Spleen, Stosach, Saal) Intestine,
Lurge
Intestine,
SUarliinvaarryyBSllaadndte,r,rAeo.rta, Uterus, Traches, Kirenal, Thyroid, Parathyroid, Lys Node (vesenteric),
SPrpoejceicets:MaRsahter: 0281CR012
suanarizes se pages 155 319)
C00707
SInudainvairdiuzaelg RSaicnrgolsecoTpaibculaantdedMifcariuoaslcopRiepcorOtb.se(rcvoantiioounesd) Riker Laboratories, Inc.
F143: Tao Year Oral Toicity-Dnesgenicity Stady in Rats Table: 2
fFnaittea:l GNeaesskesr:10[9-4T1e6r5min! SSeaxc:riFfeincaele Grow: (3) FC-143 300 ppm
Racrascapic Oservaticas: MicrosTcaoewpiircy OShisaezrdmaticns:
Ehsicorbea]gis Heart Litvheery
Leng
Kanwar Gland PPaistcurietaasry
"Latelar mss, 33 2c, in perineal ares, "hSaitnuseosiadnailnede,ctamsiisas,ingcortes, warted "Hwyistciafrodciattis,, wDilreone novsapative, "Chronic progressive neghregathy, wild "HHeegsaattooccyyttee avlatcesrlaattiioonr,,vamcuwlotliaftoecta,l,wlwtiniifteaclal, wile "Parleduacnia, interstitial, chronic, focal aress, "lRolbvuesllaarrhwyapcerropglhaasgieas, local areas, wile ""Hkypeenrcpnlsasia, islet cell, ail
The falloning tissues were found Le be within moral limits: Urraiinna,rySBpliandaelerC,ordf,atoar,eUtFearrcrso,w,OvSaprlye,en,TraScthoewsa,ch,ThySrwoaildl, IPnatreastthiynreo,idL,argLeyiIhntMeosdteine(,sesetericl, Salivary Bland, Bre.
final Kanter: IR005 Sex Fenale Becupt (5) FE-IAS 00 gan Fate: thesis 6) Found ead
Pacrascosic Bservations: Pitsitary
MicrEossccpophiacquOssarvations: HeEanrt Liver LSualgivary Slant inary Bladder
"Tolocsuaalltiae.ssrrhagic lesions approxinately hlaott eexxasnainiende, aaiissssiinngg "Myocarditis, chronic nonsugpurative, "hweiptatiofcoytae,vaacludclation, waitidecal, ail "iRaesgcaulloasrytroisnsr,alaiiznaitmiaoln, ail dot eanines, missing "Not amine, aissisg
SThpeinaflollCoowrdi,ngBtoivsesuMrasrrowwe,reSftooumnadch,toSbeeallwitIhnitnesntoirnaea,lLalrignietsI:ntestine, forta, Uterus, Dury, Wansary Gland, Pituitary, Trachea, Adrenal, Thyroid, Parathyroid, Lysh Note (aesenteric),
FSPpreocjieecst:MRaasther: 0281R012
Sunn stat page: 186 320
00708
Sori StfilotiTsbiotalHibonareBotrSoctonttion) FA: Te Ye Bak rico St it ts ie: 2 a i eTooe Gy 3 FE 0 Pheeo[ nnbyahieew-- Kifme 1 abi ae Hats cto'
f--_rrip--
Sanipcgo157 321
G00709
InfiviSeuulaiRaTntoRSiIsCleiTniaRletreasdcoipinclBiswausrtions F103: Teo TekweGralLitToenaiyta-rGivcs,apImnci,ity Stat in Fats Tate: 2
iFintea taebher1085)3T0r6an SSuertifailcee runs 6) EAI 30 pn
MarLieers Bsration: Woroocitic Gsaratios:
npoeews
Pwrscras TSrlady Elise
".ossivly ale, satin, Whesccawrittails,ivrosoinss, nmintesratine, wld rSFonrtail ssraocrsleievecoolnismielrnateH,l:wile Ffoerat tbislevdaccotlapteiaolni,ertatiifono,ali,lsnim ipiece alteration, acetates, cl, J"ost lnaaiosein,eraaitsisnitnigon, ile hSpiaelsattaistai,s, ccreoln,focrail,edwile
lThaersf,ollTeoswtsisisasihudensaiwsa,e rfaosutsatteo,bSetwointchhi,n aIrrnaary LBiliatsi:n, Kress, Faatoyrai, Trane, Capa, Pitty.
Fiatnesa tNeaesser107 ) SidesSe1x eMarleesGroat (6) F530 gn
WavosstsactrByaation: sar
HicrSotsocpnceBaeratisns: ort itwy jtrw
ittissitary ston
faaiisseed hulcoerratead cLeesio,ns 0o.n8bcaothdhii.ng "oastsbtlse.aes of lceratis is aria. "wbitciodcl,, aclrdaic somgpurtine, "Preitectpmrrogariesssaitvoens,epsritiethy, write o"rstc,aaeinnoenrcalieanticoenl,iailltdrate, wild cHealrraiger,iisiusf,,a1i4f, ald Sforteotmrntits, ulcerative, bilateral, aed er, ried
Testis/Epidiynis
~TVaabuclle ratrsoipnheyr,liansspteirosna,toge1n6esis, ail
SPrpaigecst:Naakte: QIERUIZ
Sawrizet 50 ge 158 322 00710
SInctainvairdiuzaeld RSaicnrgolsecoTpaibcalaantdedMiAcnrimoaslcopRiecpoOrtbse(rcvoanttiionnesnd) Fiber Lisorateries, Inc, 0
FE-IA3: Tuo Year ral Toicity-Dncsgenicity Study in Rats Tate: 2
fFaitnea:l MNeassbher:1011)53S6a0c7rificedSeicn MxatlreenisGrow (8) FCAT 30 pon
Microscopic Dservations (continue): Urinary Hager
"Eritheliat hyperslasia, siwle, diffuse, ale lEopciatlhealrieaals,pewriplldasia, papillary, Calculus
Ihe following tissues were fac to be within sere Hts: Spleen, Prostate, Arent, Thyroid, Parathyoie, Traches, Escphases, Salivary Sad, Pancreas.
SFeaitnea:d Oaenldeer?8I)RSIac8rificedSei:n MeaxlternisGrow ( 8) FC-IAT 30 pon
Macroscopic Rservations: Ths SLpilveeern Crash Note abgaaioal)
MicrKoistconpeiyc servations:
Liver Lary PLaysacprheasNote abscninal} siPitteuitary Toyess
"Lotbhuluasteta,real,ight-green wiss, 2.5 1 1 ca, in ""EProlsasrigbel!y slightly pale. enenala,rgeidntaenrdnalLigihltiacgreIeyngihshniontecsolsalri.ghtly "Leukenia, ayeloid PErxotteenisnivreesionrfpitlitornatdiroonpleofts,proillieferating cells "Loefsteenairal,y aapyeellooiitd series ie hilus. "Lestenis, yeloid "HLeeasokrernhiaag,e,apemluolitidfocal, wile hat esanined, aissing N"Loetskeenxiaan,inescy,eloiisdting "Leskenia, yeloid
The following tissues wre found to be within rarmal Linits: THreaacrhte,a,TeEsstoisphEapgiudsi,dySaailsi,varPyrolstaantee., Stoaach, Urivary Elater, birenal, Thircid, Parathyroic,
PSrpoegceicets:Nuastber: 0281080012
Suanized STA page: 159 323 00711
ISnutnimvairdiuzael SWiCsPgOlSeCTObBuclaatndedWiicmraoslcepRiecporOtbse(rcvoanttiionnused) FEAT: Ten YeabrikBeralLaTboorriactoirtiye-sD,acoTgoecn.ici3t0y Study in Rats
Table: 2
FAantiem:al(Neoakteer:108R) 3Te9raimal SSaec:rifailcee row: (8) FC-IAT 30 pom
Wacrascepic Observations: Ficrsscopic Dservations:
hiidrneeryal Paannycreas Pituitary TShaylrioviadry Bland
) 4b visible lesions. "~NCehcruatnliacryprcoeglrlesWspiveergnleagsnirao,patwhyl,ia1o1, wild "~ibaescnaelaratwreiznheyr,aliwzialtdion, il H"ySpiaelrapdleansiitai,s,aecthriofnoicca,l,otpearrastedistalis, wile "UHpletrisalsarsairas,halceclyls,t mltifocal, saderate
The fatlonizg tissues were found to be within moreal Hits: STirlaecehne,a,LiEvsesre,hasHiesa,rt, Testis/Epididyeis, Prostate, Stonach, Urinary Blaster, Parathyroid,
fecal Fate:
ONeaiactser:108I)E-TTeEr0ainl
SSaecctrifMiaclee
Groups (6) FE-1A3 30 pp
Fazrascopic Observations: Nicreasacroepniacl Qservations:
Kidney Liver Luss parcress Sativary Slang
Ko visible Lesions.
"CPohretcicchaelonsdceygteonnesr,atimoanl,ignfaenctal,, aaioldaetreartsel
.
"ChMreasnpilcastpircogrceeislssivehignhslbyvopplaetohcyor,phsioct.erate
"FNoerctraolsiss,orofnoaccalle,araicneilnlalinfiltrate, si2
"Hhlavsecsullaarr wwaicnreorpahlaigzeast,ionw,itwiifloecal, wild
"bSciiarlaadrenaittriosp,hy,chrsoondiecr,atmearked
he folloning tissses were fount to be within nerral linits: STpriaecetse,a,HeEasrotp,hagTuess,tisPiEtpuiidtiardya.is, Prostate, Stove, Urinary Blatter, Thyrcid, Parathyra:d,
PSrpoejceicets:MaFsaster: O281CR012
Suirizes STAR Page: 160 324
00712
ISnudinvirdeuadl RSiatre eTcslaitnescirnalsBsersteacamttiioonnst) F-403: To Yekre0raLeTresscainteys-D,rcngte,ncity Std i Rat Tate: 2
Ffitue tNhaesner108E) TEras SSuerfHaaclee rugs C6) FE 30 po
[rioyw: --
"Kilis cst is ane arn of right bien.
rel fweortbs Hers lier
Ptages Fsitry
"tSoirntuiarltlvcsoleattsio,n,Corltoecsa, iarEes, ild hoteradnsne,,cirsaiincgrowsgrative, sini "PDeolvniiccaesraeisrateions, paantale, Motte aOpt,accoertivcaal,cawtlitiosnlewitifcal, wile apiate alteration, ecalates foc aMeslscytowinse,raliinnitnilcs, ald Hpeerptliasna,sfsoic,siprs dstalis
Th flionng sss wre dn ts be ith mre Linda:
Siwy Sard, Spleen, Testis/Eziciconis, Prostate, Stomach, Urinary Bladder, Thyroid, Parathyroid, Traches,
FBiined tNhaiete9035Sc2ificedSu1t ralee nSeon (1 FOE 0500
WariteisarByaration: Sant
Hcroesrcemriacl Gswrations: tidiorny
TM FPiatsuittaery STstriuaeinht inuy Baer
LSiastiagnpdeoarstotwheisc,ken1s.2 acammctino.nss paste lee in area.
""Coorltuitnaiovnssloamti.ont,it.wiwtiitfheeaolk,s wnldial
SHoeratatsbtieleadoclt artaiolne,rsfiiotrs,,imtiele
"vsetelr nianceraatbiaaetsi,onw,tiadleacal, wile
Frraostantitis, wate, wete
eiHeprvro,ssiitwearikoasdi,
wild cll,
mitifaal,
ile
"arteiial brerlasi, sil, dius, ald
PSroojsec:t aadte: 20108012
Surizet SW ge 16 325
00713
SImncairviizdaeld RSainrgolsecoTpaibcalaantdedMincirnosacopfiecporOtser{cvoanttiiovnaesd) FE-143: Tuo YeaRrikOerralLaTboornactiotryi-eOsn,coIgnecn.ici3t%y Study in Rats
Table: 2
AFratiea:l Oaebleer:90()63S6a5c2rificeSdexi:n MeaxlterenisGrout ( 6) FC-141 30 pon
Hicroscepic Bservations Continued):
3
HTehaertf,olTloweingsatittsfsisietsvsses,rePfaoruanthtoab,e wTriatchhiena,rorSmsaslshalsiessi,ts:Salivary Eland, Parcreas.
fron! Neatart IB3E53 Sex Male Broust {61 FCAIAT 30 poe Fate: (esis 108) Tareina: Sacrifice
Pisrascipic Gseevitions: WicroTsecsetsiis: EDrsiecrivdamtiiosns:
idrey tong Testis Epidityais
"Right testis small. ~Earasic progressive nephropathy, ei2 "Hveassocrurlhaargem,imleorcaallzaatrieoans,, saolteeate "wTurkkselte atrophy, aspernatogerests, snilateral,
STshleeefno,llLoiwvienrg, tHiesasrute,s Pwreorsetaftoeu,ndSttoonbieh,wiUtrhiinnarryorFeallattteirn,tsh:icenal, Thyraid, Parathyroid, Teaches, Essphasus, Salivry Bland, Pitiatary, Pancreas.
frinal Noches RTE Send Male Grog: (8) FC-14S 30 pon Fate: teste 105) Terainal Sacrifice
MacroFsrcaoipnic Bservations:
WicrsAscroepailc hservations: rain Heart Kithey Liver
Lung
"park area, possibly ald heacrrhage, is Daenatiesrpihoerrep.art of right cerebral
"Simsoidal ectasia, corte, scterate
"hPrsetsrcoacryotnocmc,ytobnesn,ignbeniga, bilateral
"MLyuorcgaerdinteissp,lascehroocnciucpynionngswspcurhatoifvec,eresros.
"wDialvteznhioccaplr,ogwrielsdsive nesNrgzathy, eile
"Pheelpvaitcacayitneeraalltiezraattiioorn,, svaecuaoltated, focal,
wile Begalacytosis,
wininal
"Paesacnia, interstitial, chronic, aaitifesal,
aRllveeclar aacreshages, mltifocal, ald
SPpreocjieecst:MRuastter: 0281080012
Saanarized S18 ges 12 326 00714
ISneainvairdiuzaeld aScirngolsecsTsaibculaantdedMihcirmosacopRiacparOtbse(rcvaanttiinocnesd) Fe: Too YeaRrikOerralLbToorvaitcoirtiye-sD,ncoIgnecn.ici3ty Study in Rats Table: 2
fFraittea:l (Mhgebsesrt108()RTEerLainal SSaeccriMfailcee Brows (6) FCT 30 gpa
MicrosFsaonpcirceasCservation (contiesed: Parathyraic
~-Hcinar atroghy, soderate "lot examinee, nat in Slane of section
The fotloning tissues were Sle, TestislEpididyns,
fount to be within Prostate, Stomach,
nUorrimnaalry llinaistdse:r,
Thyroid,
Trachea,
Esopnagus,
Salivary Bland, Pituitary.
frsual Naaber: IR3655 Sex ale Grows ( 6) FE-I4T 30 pon Fate: Oske 108) Terminal Sacrifice
MacroSsocfotpicTisOsbuseesrvaetciokn)s: Testio/Eratidynis
Micrshsearoepniacl Oservations: Kataey Lary TSeasltiivsarEypilgaienntnis
""MRaisgsh,t 4test2is5ela2rgcead,,saplailvearyyelglloannsdhar1e.a5,ca dia. ass.
""CCohrrtoinciacl prvocgarselsastiivoer,nefpehcraclg,athwyi,ld sscerite
aPseclvaiicarsinperaelriazlaitniaotni,on,sitweile
"ASlivdeloaldaeritmiasc,ropwhaatgee,s,
local waked
ares,
acterate
"Tudule atrophy, spermatogenesis, unilateral,
Lwedyetriastecel] adenoma, unilateral
STirelafso,ilLoixviecry, tHiesasrete,s Pwrroestafteo,uSttoonbaet,wiUtrhiinnaraycrmBallattLeirm,itTsh:yrsid, Parathyroid, Trachea, Essphagss, Pituitary, Pancreas.
frinel Mater: B36S6 Sex: Male row ( 8) FEIT 0 gon Fate: tasks 851 Sacrificed in extrenis
MacrPoistcsopiitcarDyservations: Wicrobscroepnict Qesernations:
LKiidvneery Lung
"Large mass, 1107 ca dia. "Cortical viushation, focal, wile ~CShirnaunsiocidaplrogercetsassiivae, nceogrhtreoxp,atahiy1, winieal ""hHaesscaotloacrytaeinvearcasloilzaattiiono,n,iafiiluse, sederate Heworrhage, witifocal, wil
PSpreocjieecst:Mofnadtor: 0R0012
Suewarized ST ges 15 327
.
0715
SInuniavriidzuaeld MSaicnrgolsecoTpaibcolaantdedWiMcrrinoaslcapRiecporOtbse(rcvoanttiionnused) Riker Laboratories, rc.
FE-143: Tao Year Oral Toncity-Gncogenicity Study in Rats Tale: 2
SFaitoea:] GNoaaabtesrt 89I)E3S6a5c8rificeSdeixn Meatlreesisrout ( 6) FC-1AS 30 pon
Wierascopic Bservations (ontinaed: FiPutrsaitthayrryose Salivary Blan
Hbaeteenxamined, not in plan of section "Net exanines, wissing
STphieerfse,tlHoesicr=tg, tTiessstuiess/Ewgeirdeidfyoauinsd, tPorobsetawtiet,hiSntocnriceha, ULriimniatrsy: Bladder, Thyroid, Traches, Escitas, ances.
Ffiitee:dfNheoskmse5)10S3a6c7rificedSeixn eMxalterensSeoupt | 6) FERIA 30 pan
Facroscepic Dhservations: WicrFuistcaopsitcarSyheervations:
Heart LiJveer
FiPtanacirteaasry Salivary Slant
"Enlarged, 0.8 ca dia. "Myacarditis, chronic povsspprative, focal, "Pwotretralatesnonsclear cell infiltrate, wild lHaisvecsdlaarr msaicnreoaplhiangaest,ionm,itsiidlodcal, ile hHeesiornrhaagter,ophlyo,calaianriemals, il ~henona "Not exanines, aissing
TShseleefns,lloKniidnngey,tisTsessetsisw/eErpeidfiocuynads,toPbreostwaitteh,inSstoowrscah,LUiriitnsa:ry Bladder, renal, Thode, Firatiyroid, Trach, Esophags.
Ffartien:al WNeasbieer:108R)3T6er8minal SSacerifailcee row (6) FEIT T0 pon
Macroscopic Oservations: MicroEsrceopic Qservations:
KEirdeney Liver Lung
"Right eye appears clout. ""tDehraatniitisp,rargroessiseiv,e wniplraotpeartahty,,nialled "hepatocyte alteration, vacsslates, sultifecal, Mwaigladlocytosis, sini "Asicvaesllaarr ssaicnreorpahlaignetsi,osm,ultaiidlodcal, wild
SPpreocjieecst: NRsabter: 0281280012
sarin sti ge: 14 328
00716
SInucnimvairdiuzaeld MSaicnrgolsecoTpaibcalaantdedMiAcnrionsaclopRiecpoOrstse(rcvoanttiionnased) Riker Liboratories, Inc. 30
FE-143: Tuo Year Oral Toicity-Dncogenicity Stuty in Rats Table: 2
MFaitel: (aebcoasrt106R! 3Te5rainal SSeaxc:rifKiaclee Grows: ( 6) FOIA 30 pon
Wicras[cepRiceBhservations continued): Thyraie
:"Gist, pars distalis "hyperplasia, cell, focal, moderate
he follenics tissues vere found to be within normal Linits: TSprlaecetre,s,HeEssestg,haTgeess,tisSaElpiivdairdyyaliasn,e,ProPsatnarteei,s.Stomach, Urinary Blader, Adrenal, Parathyroid,
Arinal Mosher: S350 Sex Male Group ( 8) FEIT30ppm Fate: Gesle 91 Sarificed in extremis
MacroPsictsugiitcarOybservations: MicrLosicvoepric Diservations:
hirenat Kidney Liver
LiFnugrathyreid PiStlueietary Testis/Essdidyais
"Large Sesorrhagic mass, LA x 0.8 ca. "Fale and settled, "CSoirntuiscoaildalvaceusotlaastiiao,n,Cordtiefsf,usew,iliele "CPherdaincicmpnreargarleiszsaitvieonn,eshmraorgkaetdhy, wil "PFoorrttaall sbielneondculcetarprcoellilferiantfiiolntr,atwei,ldwile Hepatacyte vacuolation, periportal, sotrate ""hveatsceuxlaamrinweidn,ernaoltizaitniopnl,anewiolfe sctice ""Hbeinssonderusis, 4i3 escular einesalization, wile
THheeartf,allBoreoisntgatet,issSuteosascwhe,reUfroiunnadrytcBlbaeddewri,thiTnhyrsaasrm,l Tlraicihtess:, Sscshages, Salivary Slard, Parcreas.
Ffarties:al Waaetieer:1081)03T6e8r0sial SSierxifailcee Geeust | 6) FO-1A3 30 pp
Macroscopic Dservations: Microscopic Oservations:
Hiheraerntal Kidney Liner
Ho visible Lesions. ""SHiyneucsaoritdiatlis,sctcahsrioan,icconretnessu,gpawrialtdive, "wCihtroindioccaplr,ogwrielsdsive neshropathy, ail "fFaorrttaall obniloevedculcetarprcoellilferiantdiiolntr,atsei,ldald
PSrpoejceicets:Nafsaster: 028108012
Somnrizee S10 Fuge: 165 329
C0717
ISnudainvairdiuzaeld MSaicnrgolsecoTpaibcula11t6edMiMcironstcopRiecpoCrotse(rcvoanttiionnused FEA: To YeaRrikebrralLaTsorxactietryie-sD,cogIenen.ici0ty Stacy in Rats
Tables 2
fFiatnea:l hKeeatrs:1016)34Te8r0aimal SSaecsriMfailcee Group {8 FC-143 30 pe
Ric[rotscypic Baervations (continued): TFhayrraotihdyoid
": weal sineralization, alld PArlevuesaaleaira,waicrnotpehrasgteist,ialw,iicthidaoaciacl,, faoiciadl, wild "hatcelelxanaidneeodn,s,matuniirlatpelraanl of section tistranchal erst
STpileefne,tToensitnigstEipisdeiecsunwiesr,e Pfroonsetatteo, bSetowwiatchhi,n UerrimnaalryiBnliatdse:r, Trachea, Esophazus, Salivary Sad, Pituitary, Pacreas,
Fraiten:atNeoesse108R)4T6er1minal SSaecxrifMiaclee Grau (6) FCS 30 3p
Ficroscpic Osernations: Ficraorscesaics servations:
heart KiLrdgeey Sitivary Sint
e visisle lesions. ""CHocratricdailtivsa,cslchartoinoinc, wfsupla,twiivlde, "wCihtrniidcocrae,grweislsdive neshgathy, 14 "Sitaalsaederitsiise,raethirzaastiico,n,al#d126
The following tissues were fsa? Stem, Liver, TestisErididais,
toPrboestwatiet,hinStnosocrhm,
GLiraiintaer:y
Blader,
Thyroid,
Parathyroid,
Trachea, Esatagas, Fituitary, Pasress.
aFirtiea:al(Neakseh:41)8S3u6c2riticedSeixn eMxatlreemisGraupt (6) FCS 0 gon
BacroBsceopic Qsermations: Lang Lsiineern KTiedsnteiys/Epdicnis
Nicrhaescroepacl Otserations:
""BHilltaitperlael iotuietileessions, 0.2 a dia. in leit
oie, Slightly
arsed
a"Bsosth, K4id.n5ey1s4p1ale2 cahn,d LeneltargLeast.eral Jobe,
oth testes very small.
"Sinusoidal ectasia, corte, ald
SPpreocjieecst:hfuabter: o28ICROOIZ
Suanarized ST ges 166 330
00718
ISnudmimvairdiuzaeld RSAiCnrgolsecoTpaibclaatndedMidcnriaoaslcopRiecpoOrtbse(rcvoanttiinounesd) Riker Lboratortes, Tac. 31
F3: Tuo Year ral Toxicty-Gncogenicity Stay in Rats Tale: 2
GFraitmea:] GMeaenkdesr:90R)3S6ac2rificedSeicn MeaxlterenisGrow: (8) FC-LAT 30 poe
MicrosEceopic Dservations (continued): "-Cataract, Eilateral
heart
awciatridfietcails,,wcihlreonic soasuppurative,
vitres
"CPhrreotniitcis,praocgurtees,sivweileneshropithy, marked
Liver
"FDoiestta,l csoretniocnalc,lasrodecerlalteinfiltrate, wild
Portal ole dict proliferation, ail
Haeislatacyte alteration, vacuolated, focal,
HeLpiragteo,celplouolralry cdaifrfceirreonntiated neoplase.
Trabecalar nd aden patterns.
ws
"Avlavsecoullaarr miancerroaplhiazgaetsi,onm,ltiaflodcal, wild
Hesorrhage, local areas, ald
bPairtuaittsayrryaid
""NEoytstyexapnaircsedd,isntoatlisin plane of section
Testis/Egiiais
"Tsuibtuele atrophy, aspersatogenesis, bilateral,
UThryirnsairdy Hadear
""tEaptitheexlainailnedA,ypenortplaisniap,lanseimopfle,secdtiiffounse, wild
#
Gystitis, chronic, diffuse, nininal
The fatlouing tissues were found Lo be within areal Linits: Splers, Frostate, Stomach, Trachea, Esophagus, Salivary lane, Pancreas.
dFnaitaea:l Wbeeerl:10(6R3T6e0rral SSeaxc:riMfailcee Group: 6) FOI 30 pre
WacrVaisdconpeiyc Bservations: MicrKoistcooepyic Observations:
Liver Lung
"Tyst, 4 cn dia. "Cheon progressive neghropathy, asderate "PPoorrttaall abiolneenduuccltearprocleil]feriantdiiolnt,ratiel,eail "hascular wineralization, wile
The fatloning tissues were fond to be within moraal Limits: PSaprlaetehny,roHiodu,rt,TraTcehsetai,s/EEsgoipchiadgpuasi,s,SaPlriovsatratye,GlaSntdo,sicPhi,tuiUtraircya,ryPaBnlcardedaesr., renal, Thyroid,
SPpreocjieecst:nabter: 0281680012
Summarized STAR Page: 187 331 00719
ISnucnicvairdiezaelg RSaiznrgolsecoTpaiuclaatneedMifcerinoaslcopRiepcarOtb.se(rcvoanttiionnused Riker Laboratories, Tac. 3
FE-143: Too Year Oral Toxicity-Dacogenicity Study in Rats Table: 2
fFartaeu:d HNeaeakbe=rt1016)03T6e6r0aisal SSaeccriMfailcee row (8) FC-14T 30 pon
Racrsseopic Observations: WieroHsecaorptic Diservatiors:
LiLuvnegr
A:g visible lesions. "Mwyiatciafrotciatlis,, arlednic nensative, "sHcupoelrsalrasiwai,neKraalfizeartiocse,ll,eidleibs, aaterate Hencrrhage, local areas, ail
STphleeefno,llKoindianegy,tTiesssuteisswpriedifdouuands,toPrSoestwaitteh,inStnoouramcahl, lUirniitnsa:ry Bladder, Adrenal, Thyraic, Farathyreic, Trictes, Esopus, Salivary Gland, Piteitary, Pacreas,
FGartiea:alGNeossiteer:401)6SSacTrificedSein eKxatlreentsrow (6) FE-IAT 30 poe
McroLsicvzezric Observations:
"slightly pale
RSapalneaerny Slant
"SHlaisgshtwliythmualcgeerasted heaoragic surface, 4.5
Hn 4S aa, in right anilla,
NicreLsievoepriz Diservations:
Necrosis, conteilobalar, 16
Purathyroid
"HHaetateoxpasaiienseids,,noetxt1r6anpelaalnlearoyf,seacitlion
Suir
Fiibgrholsiyrccoenllsular neoplase with Iymptic
Steen
"Heinnsvtaospisoinv.sisS,urefratceeanseldceelrlaatreyt,. creased,
wirket
KTihdenefyo,llHoewairntg,tLisusgu,esTewsetries/fEopuincdictyoaibse, wPirtohsitnatneo,rmaS!tonLaicnhi,ts:Urinary Blaster, Adrenal, Thyroie, Traches, Esophagus, Salivary Blanc, Pituitary, Pancreas.
nivel Noster: 18-3656 Sex: Male Sroups | 6) FEA143 30 pan Fate: ers 108) Teraimal Sacrifice
Macro[scaopic Observations: skin Pituitary
"Opacity, right ove, "Hair less on Links with scat formations "Rpaoisssei?bldearkdermmsast,iti0s..8 cn da.
PSrpoejceicets:NoRsatter: 020130012
Sunrizec STH Page: 168 332 C0720
ISnudainvairdiuzaeld RSaicnrgolsecoTpaibclaatneddNiMcariomsalcepRiecporOtb.se(rcvoanttiionnused) Riker Laboratories, Tac. 30
FEAT: Tuo Year Oral Tosicity-Dacogenicity Study in fats Table: 2
Seial Kater: 103688 Sent Wale Braust 6) FE-145 30 pga Fate: Orie 108) Terminal Sacrifice
Macroscopic Batrvations Gontined):
B
MaresViizgzeirz Q(eeroarttiinocents): BEireeral Heart ViLtivneery
Lg PiFtaracirteaasry sSaebivary Slane Testis Spicsemis
"Fates possibly somewhat enlarged. ""Shientuisnoaildaaltreocpthays,iau,nilcaortteersa,l soderite "CMaytoacraarctti,alunfiilbartoesriasl, focal, wile ""Dbiorratnailc apsrroegnruecslseiavre cnesllhroignfaitlhtyr,atea,cteer1i1te Naolrgonuclear cell infiltration, wattifecsl, "Hveassecruelhaargew,imeLorcaallizaatrieaosn,, aailtdd ""FAoelryaorntaritis, icin ""USlicaelra,denairtkiesd, chronic, oderate Falyarteritis, aild
The detlonizg tissses were fone to be within sora Limits: Spleen Srostate, Stosicn, Urinary ladder, Thwoid, Parathyroid, Traches, Escghages.
feiael Noster: 10-3067 Sex: Male rot (6) FC-IAT 30 pon Fats: Waele 108) Terminal Sriice
Macroscopic Dbservations: Wieroscopic Diserations:
Heart itrey Liver LPuanngcreas Piteitary STahlyirvsairdy Slang Witiey Bladder
Xo visible lesions. "Myscartitis, chronic novsaparative, ~Ewairtainfiecaaplr,ograessive neshromathy, wild "pPorretlailtisa,oneancauctlee,arnlcell infiltrate, wile "Fsocratallarbisleimrduacltinpartoileinf,erawtiiloen, sile h"biienroamsatrashy, aild ""SHiyaplearcpelnaistiias,, Cchcreolnli,c,fomzaarl,kedeile "Not exanined, issing
STphleeefno,lTleowsitnigstEipsisdairdsyawiesr,e Pfroousntdatteo, bSetowsiatchhi,n anroremnaall,LiPnairtast:hyroie, Traches, Escphages.
SPpreocjieecst:Nfaabter: 0281080012
Somariond STH ue: 49 333
00721
ISnutaisvairdiuzaeld RSiicnegolsecoTpaibclaatnedMiicrloscopRiepcorOtb.se(rcvoanttiionnused) FLAIA3: Too YeaRrikeOrralLabToorsaitcoirtiye-sD,aceIgnec.nici3ty Study in Racs
Table: 2
fFaitnea:l (Mhaansdteer:106I)RTTer8sinal SSuecriafilcee row (6) FCAT 30 350
Pacrascopic Ghservations: Microhsicraepniacl Dservations:
seact LiKivdenrey Ln; Pituitary
43 visible lesions. ""WSyiencuasrotiidtails,ecttahsioa,ncorretnexs,rawitlidve, "Dwhirtainifcaaplr,igrweislsdive neroathy, winieal ~Nfeacrrtoaslisa,ongfonceacll,earwilcdell indidteate, a12 "Hveaasccrurlhaargew,inselratliidzoactailo,s, sistiel ~hencas
:
TShpeleefno,iloTweisntgisltEipsiscuiegsyawiesr,e Pfroosttatteo,beStwoimtachhi,n sUarrianaalryliBnliatcst:er, Thyreid, Parathyroid, Traches,
Escphagus, Salivary Sland, Pancreas.
Ffaitnea:lhKeanetrer:701)6-S3a6c8r9ificesSexi:n emxalreesisGroups 61 FL-143 30 gan
PacroSscnopic Bsarvations: Large Intestine
WicrLosicvoepric Gservations: Arenal Esophagus Lung Parathyroid SSailnivary Bland ThTyrraochieda
"Lerfetctsaild-eseorfotaslcroatbusncesusl.cerated with "tadrikleadtatiinopanctoifonreamtaitneirnvgincaolloncolaocn alnesss containing fecal material. "hale "HOintehionf pneariualprLeisneintts ""ANlavteoelxaarsinaeadc,ropwhiasgseisn,g mltifocal, aild "NHoetscerxeahaaignee,d,wlwtiisfsoicnagt, #16 "-Niobtsceesxsan,inseudb,cuwtiasnseionugs N"hoatt exxaatniinneedd,, wmiissssiinnsg
The following Spleen, Liver,
tiKsistuoeeys,eHreeartf,ounTdesttoisb/eEpwiidtihiynnisn,ormParlostLaitmiet,s:Stomach,
Urinary
Bladder,
Pituitary,
Sul Intestine, Large Intestine, Pancreas.
PSrpoejceiecst:NoRsatter: 0281080012
Suarized STAR Page: 179 334
C0072:
ISnavmirhaal NSirieatsrecaLTpbaecrlaataadtriMeiisc,raolsIcnoep.BiecprBtra(ctcinotinnsns) F-13: To Yer Oral Tec Occ Sad is Rats Tele: 2 aFitle hNeohes1801)3T7r0ina SSorcfiaclee Brug (0) F163 30 go
MacrSosiceotptiecerOiservations: HesLsiee Gratis:
ler fwansirs
TeFSsatliisirydBliadneyis
""CiTlehs,ug1,7xpalLeY cap0tea.ra of pres. vFaarsae speerssreslseiavrecnellewsitit,rtwerew:ie uPosrtealdilseiesriltinptailofne,rat1i4on, 14 HeWzilcrdciifnieonetite, dctila paten. Lise cwinaetaorf af,itHsildsirns SPenln y rte SFaillpurdteriittiiss,,aevornact,ewieate
TShleef,aiecritr,irsostnaw,eeStfonne,toUrbienarwyithPiantesre,alMrLeinlt,:Trai, Parathrsi, Trach, Epa, Lu he (sari). Fwitde hweraet1081)3T7r1ea SScurtifRicee Grog 6 F06530 an
[-- HerHoaeresn Dmratios:
iEttr is LiLnyer Paarcsrtiersest TThSerisettiiie,arbBiludeiis Tron
Ao isi sien. SHeitnneiandesctssi,sicrt ile "Feerrali vreoorcelsievre cwllawhpit,nter,iewdld uFscrlairsweralwinnctiloenn, 1i1i6ltrate, wld aSetiunssitnr,is4i1n6g FHoetrerxisiss, awisriintg e Koott nniannes,, iissiinngg
hSpeiefso,lleowritng, tParossetsatee,reStfoenned, tloibsearwyitWhianteerrm,aliianrts.:
SPreocjoecnt:oathter: BEET
Sunrize ST piges 71 335 00723
ISnudaimvairdiuzaeld MSiicnrgolsecoTpaibculaantedMifcarinoaslcopRiecpoOrbtse(rcvoanttiioonused} FE-L43: Too YeaRrilOerralLiTbeoxriacteirtiya-sD,acoIgnecn,ici3t%y Stay in Rats
Taste: 2
fFaitnea:l tNhaesetesr:1061)0-3T6e7r2ninal SSeaxc:riMfailcee Grout (8) FCT 30 gon
NacrFaistcoasiitcarsyervations: Testis/Egicioneie
MicroVsicdonpiecy Bservatioes: Liver
Lrg PPairtautthayrryoid Testis/Epididnais Thyrie
wLeaftt atersntis sual. ""DFiorrotnalicapornoegnrsecslesairvecselhlroignaftilhtyr,ates,ini0s:a1l6 Hepatocyte alteration, bassphilic, focal, "aiiaisdcalar wineratization, 10 ""Nhadteneoxnasnined, not ia plans of section "Tiarbkuelde atrophy, asperaatogeesis, unilateral, "Ost, colloid
TShpelesfsa,lloHmeiasrtg,tiPsrsousetsatew,ereStofonuancdh,LoUrbienarwyithBilnasdmeorr,alAdriesniatls,: Traches, Esophagus, Salivary lun, Pascreis.
minal Nobert R375 Sex ale ours ( 8) FECT 20 pon Fate: (heeks 106) Terainal Sacrifice
Macroscopic Observations: Nicroscopic hservations:
Li[v2er
Ling SPaalnicvraerays Gland
Xe visible Lesions. ""DRieerotnalicoanreorgarcelsesairveceelslsroinsfaitlhtyr,atew,ildald Hepatocyte alteration, vassslated, altifocal, Hweigealocytosis, ainiml "Piearsicvualsacralaairnwsranloinzuactlieoanr, ianlddiltrate, ald ""SHiyapleardpelnaistiias,, acchirnoanricc,elol,desroadtlear, mile
The following tissues were found Splees, Heart, Testis/Epididais,
to be within sorma Prostate, Stosach,
ULriiintasr:y
Bladder,
Arenal,
Thyroie,
Parathyroid, Trachea, Esophagus, Pituitary.
PSrpoejceiecst:asfatter: 0280012
Suanarized ST se: 112 336
00724
BESTCOPY AVAILABLE Sfwainve nsieeaTLnaothre eiiabteetnactoinotnin
E05 Te Tr Gl Tore cpt Sy i is nie 2
rFet osaBTeis n Sreee G {0 Ft
Jr---- [--
5 vie so.
A
y wiiiryeosr sonar
hio n
DCriet rweeptinienaaeonwsttiyi,Eeidie
sre sh, win, wie,
frosee
Semnieee,hwaioef ein
The toning tes ar ed 5b th sl it
Fin Sos Ss Spleen, Testis/Epididyeis, Pn rei, Prostate, Stomach, Urinary Blaster, Adrenal, Thyroid, Trachea,
el ns es pr
Nairda Gratin
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fi itis, dvs espn, ail
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Di raare auwrrioeennwiioecs i6
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a Siero-- , sens
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[Or66723557
BEST COP!
AVAIAHBLBE LE SBas sa Tooew aDshanttmacrioonns
FEAL: Teto Sl ToSiicty Sey i Rts at
a toneohBrsain Snwe Bo 0 06
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SSettser ihhotn t in ot
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soni srg 0 338 00726
ISnudninvairdiuzaeld RSaicnrgolsecoTpaibcalaantdedMiAcrriomsacopRiecgarOtb.se(rcvcanttiionnased)
.
FE-L43: Tuo YeaRrikeDralGbToorsaitcoirtiye-sD,acTongee.nci7ty Stuty in Rats
Table: 2
fFiatnea:l (Nkneebeesrt106R)3T7er7minal SSaecriMfailcee Grow (8) FCT 20 gpa
MicrTeeszsetsiisc/EGpsiceirtaytaiiosns (contisue):
"F3elyirteritis, aild Leydig cell adenoma, anilaterat
STphleesfso,llHoewairntg,
tPirsossuteastea,reStofnoauchn,
to be within normal linits: Urinary Blather, Adrenal, Trcic,
Trachea,
Salivary
Glare,
Pituitary, Pascreas.
fFnaitae:al fbueesir=t 4I9) ISaRcrificedSeixn MeaxlterentsGrows (6) FC-IAT 30 pon
Persscosic Biservations: Pituitary
MicrLoiscvoepric Dservations: trey Liver
Lung PiSptlueietnary Stonch
"Hesorrhagic mass, 13 0.7 ca dia. Fossibly slightly pale. "Chane progressive neshronathy, il "Portal soonclear cell infiltrate, wild PHoerptaatlacybitlee vdauccwtlaptrioolni,ferdaitfifouns,e, wisloeserate "Hveassocrurlhaargea,inweiratliifzoactailo,n,wialidld H"ehsesrsoindserasis, sile "Ulcer, aarked
The fotlonis tissaes were found to be within normal Liits: EHseoaprhta,guTse,stSiasl/iEvpairdyidyBlaainsd,,PrPoasntcaretaes,.Urinary Bladoer, Mresal, Thyesi, Parathyroid, Traches,
Ffartien:al easbiesr:1081)53T6e0ra5inal SScexr:ifWiaclee Grow: ( 6) FC-IAD 36 pon
Macroscopic Diservations: Wieroscopic Oservations:
HeKiadrntey ug Pancreas
"Ho visible lusiozs. ""MCyhsrcoanritciaplragfirbersessiivse,nmelphtriofpoaztahly,, waiil2e "bHaesscoarlrahragev,ineLroaclailzaatrieoans,, asiodleate "hyperplasia, acinar cell, nodular, aoderate
The following tissues ere found to be within sarmal Linits: Spleen, Liver, Testis/Epididynis, Prostate, Stousch, Urinary Bladder, Adreml, Thyric,
SPpreocjieecst:uRaabter: 0281020012
Swiss 8 pigs 0 339)
00727
ISneiavirteadl SSaicrrsalsecoTpaisclaantdePAenaislep:gSesecraoatiionAsc : BEST COPY AVAII ABLE FH: Too YeaSrilreradLTowriiceeE,rsaiet,icity Sad in Rats Tale: 2
Fiiewr fbionsee1T3ena GSetiNnae beg C6) FE 2p
Tr fneiinebrBesatweiesfeuoti6sw:ih sees ints Gertie Fuattait, Tas, Esha, Satiey Sich, Fitter.
Fdrietd tKonte 11GTErae SSeesttiaclee bg (8) RA Tan
rirtsesc Beans Hae tote
""pEahcitay,aylettae,e,Ta To, atte ts get
Rerearic Reta: He
prre PSrlr, itpre)
""Cteagtiac,rewgrietsseinvel eropath, siete FFoulrtts,alatetez,aacal inflate, wld aSisachzaarritsimse,radlrizotsi,on,wewidg Fibrana
SineF,iftorot, eTeesswrte aac,d 1ProBsetawtie,thStraecnhd, ULriimniatrsy: Bader, rsa, Thai, Frito, Tacha, Shae, Pitty, Pare,
FGeueet tNhetss10) Torna SSeeeriflicee Sgt (1 R16 pn
HerSshsionic Seratics: WereFsictssatiacryRserations:
Liievre es
Firtostiattrey san
SuainsdedLeufltcehriantedfaStoptalsa.matry esis, igit "Sul raised esorrhaic Lesion, .2 58 ine o"Brrotnaic mpornecgelsesairve cneelghenoigittrhay,tei,leitd VPasraliar,svienrtaeirisatittiioanl,, iclodnc, stil, Raelrdiiscalar soonclen inflate, wild r"atsraotnistis, wit, ai ohtudtlen,atwiatkie,d siceratine bilateral,
PSpreocisees: Naatbe: azcK012
sanriaes sa gee 340 00728
Saarized Single Tadulated Aninal Report (continaed!
BEST COPY AVAIl ABLE Individual RaRcirkeerscoLpaitcoraatnderiNeisc,rasfcaocp,ic3O0bservations
.
F143: Too Year al Tonicaty-Dacsgencity Study in Rats Table: 2
fFaitnea:l fMeenasdhesr:106I)R-TTe8r1einal SSaecxriMfailcee rowpt (6) FC-IHT 30 pon
FicrasTcheysriecieBhservations (continued):
"=Fellicular hyperplasia, cystic, wnitateral, warkec
The dallouing tissues were found Le be within normal Lint: SGpalceaemna,gesK,eirSta,lTaersytisSlEaanied,isPyaanicsr,easS.tow, Urinary Blaster, Adrenal, Parathyresd, Trachea,
Fdantiea:al(KMaeteesr:1081!8-T3e6r6a2inal SSeanctrifviaclee Broupt 6) FC-103 30 pa
Nacrascosic servations: KiersLsicvaepric Obseriations:
aerenal trey Liver
try Testis Bpididinis Trait
"Hotties "CNoorttailcaarl bvyasceuropllaastiiao,n,colrotcaels,arfeoacsa,l,asloeterate "CChartoenuiicns,prepgerlevsiscive nepropathy, a11 "pPeorrttaall abizlseonsdculcetarprcoellilferiantfiiolnt,ratwei,ldile "Chrasstcooitdardewgienneerraaltiizoant,iorm,it4i:f1o6cal, 1g "ALlevretoilgarcelmlacrhopprhpagleass,ial,ocamlilatirfeosc,al,aatweirlidte "hFyoplelripclaalsaira,dercceelsl, focal, wile
The fallosing tissaes were found te be within roreal Liits: SSpalleievsa,ryHeGilsatr,e,StPoimtauciht,aryU,rinPaarrycreBalsa.dder, Parathyrie, Prostate, Traches, Esophigss,
Ffaitnea:lGNeaebkesr?108I)-T3er5aimal SSaecctrifMiaclee Grout (6) FO-103 30 pra
Macroscopic Diservations: Microiscdonpeiyc Oservations:
Liver Lary
Xo visible lesions. "Dironic srogressive nesdrogatiy, id "THoecpaa!tzaeryetaes,alwtedreartaitoen, vacslated, "AVlavsecoullaarr awsirnoerpahlaigzeast,ionm,ultwiiflodcal, sil
SPpreocgieecst:Maoatter: 0281020012
Sumrized STH page: 11 341 00729
BEST COPY AVAILABLE Sanvwiies oilse TsaliadtcmioncReporGt r(cointisnued) H-14 To YeHreGealLTaobnris-oBriceasg,nIintc.ity Stat in Rats Toe: 2
fFaitnea tweehrt10S0) EaEriel SSectiaflie ug (1 F105 50 pn
fFeatima -- Jot vind, rat ie plate f section
STheewnfo,llrowrin,g sTsesetsa eorreefsun,treobsettwiet,hiSntrouat, rLiittey: Made, Area, Thre, Traces, Tatras, Sati Ehud, Fitba, Press,
Fie ane 100) Tras Sritics
TE
[I -- Pr Sel --
joort Ler ws Stary Shue
a isd Leis. Stinrsciittael ,sctdasoa,c,corfties,heari,dwied "Yreancinsoeaarraeteiosn e1p6a, Hid arrttadl siolsencultearprcoleilferiantiilorn,atae,lewile "daivlear swuinceratluigzeast,ionm,ist16o, ald Silatenitie, rene, sate
TSheeenf,etiToenssstiisseesrawsr,e oPruosdtatteo,beStwointchhi,n sUorraiTBiltast:t, Thyra, Farsthyrei, Traces, Eps, Fit, Pres.
Fiiakeneeeres190I) ESeSricaSeitn nalee nrat (6) F103 30 pon
HurSoicsnic Gssrations: WcreFstaspitcurByuration: [th
ipnye Fitessiattiery SSiinvry Sand
"Aulnltaucltcerrante.d Lesion on aft bid fostiat. GHaeruocnoperoagbreasasitvieoanpr1aa6thy, eines pZeartc] saortmiaeticoon:,ismiitetate, aie Spreevseanitis, te, aie oedtctaariadii,ti,issilnagraine, wriet
-- Mages--her: zc?
Surizes STi Page: 8 342
00730
BESTCOPYAVAL ATESAuRap:mapreiztevd vrSiinvgclaeelTsLaTbuoltwsstdeodrsSAnisimo!cscRaepo3rm0t t(vceorntsininuetd)e ate 2
eFiv lnaer,14T, SEitifoas aoleeises {0 F050
J Tin -- Nja} uoe trpy, sprntsgsts, wilt,
ePThreosftitSniang,taosewsswraeteSru,d AorebentsiTtheroerrionitde, Tite, Exe ies,
Feire eVrhs BTEern wSeiraee Bogs 0 FA
[---- [r--
--
leon
PSaacoitdv-- cpmaramtioni, f-- omale,natel, aie
SHiitm stunt
ASJFaeitpna,ltzcptyrtse,ailttewreatmniosn, vacuolated, focal,
STioetrf,itii,trrHLoiks,esTwEeeiehsftos,arsa,beni,rtohsaa, Siolki,taWin Sut, een, Thre
FFiatsn hNela8 SuriticdSsin lmeooiGran (0 FT
rsscTnorirtcn Btiumteri:
"TSotsisitwhhleorst tips fli
ioLnry
TSTieuetshmiwatdevp,sof scecnehittio,n
Tesairbiions
ieetates errss saentd.ses,
Werrae Buration
"Stiialllaeilitiso,n,crIosnl, wsehsa,rerid
rt
Awirridekiatiilas,elasertea,s moiwse,a0
_Hee--r vers cnc:
Sunnrizes STH ge: 9 543
00731
Sneavniiiaal aSirnaglseeTpicbla1tneddWreraelserbscghtsetatiinont : RAS To Youir walLrTaroites,chee,pt Say in ats nies 2
eFta eWraers 31: 0r0iceSens lteensrot 1 61 FAG 070
Wersbasrc sertion (tines sr ws
JFurassreets TFeirnsions
f vic sp weetie--ie---- aTtotaal abie anprGoteeraitrioant,ea,iile Ceasies tdrpanelsatiionn,flS,ieiheS16 aHtinswrpaain,tionmiiai, we PRrealeutiiatss,Seextirs,imieeei Isa ri, Staebaet, wed SJaat veaanrensesitiisn ste of sitios JPatoervatiueysbaussnes ---- FTortsercael,mawsesea acl, aerate Ect, erste
STehefeelStivsicth sWieveasredifrods tToobre rwiethTinotsoern!Eisnptass, Salivrs Slant, Ee Fitaian.
SFuiet iaeites)aSEerticdSein. wmirinisen 0) F103 0
[ Frit-- Coanit Te[stis iiepis
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Snneaoreldto erreidndstacbolyinanaihse.. aStheowayn ishegpty wwe. Zope sal ivemraecpsecsei, csorute,eayia wits Seespsterst1w6aataarian,s aerotewen 14 auaeeoainseat tia0tsehe41o8f ection SSeevveers, wie
SFpeociees: aRart s CRA
Sonries si re 10 344 00732
BEST COPY AVAILBBLE rv ch
Microscopic Observations (continued):
i.
Testis/Ep:didyais
"Left testis somewhat small.
sowrizes st ge: 1 345
00733
Suanarized Single Tablated Mind fagert. (continued) Inchvidaal MaRcikreorscoLpaibcorantdoriMeisc,rosIcnocp.ic3D0oservations FL-143: Toe Year Oral Toicity-Dacogeicity Study in Rats Table: 2
nina] Mondor: IR3690 Se: Male Grows ( 8) FC-14T 30 ppn Fate: (Hest 106) Terainal Sacrifice
MicroPsictoupiictarOyhservations lcontinued): Testis Epiciyis
""Tjusbtu,lepaatrrsogihnyt,ersspeteiramatogenesis, unilateral, irked
Toe fatleuizs Eissaes ware found to be within normal Links: Spleen, Lars, Prostate, Stomach, Urinary Bladder, Thyroid, Traches, Essphases, Salivary Slare, Purceeis.
Faantiea:al eNruarbsert1081)6TTeSr1ainal SSaeccriffiaclee Grout 61 FOU 30 an
Sacrascipic Baeevations: Masaary Shard
Mi[ergsiczaic Dserations:
Kishor LLiigver Purcreas Pasriaethyroid
"Suscetaneous, mltilobular mass, S51 415 a, leit. "Myecardial fibrosis, local areas, wile wWirlsctairfdoiatli,s,wiclhdronic nonscppurative, "Civoniz progressive neprogathy, wile "PPerlevtiacl wwinnoenruaclliezaatriocne,lliilnfiltrate, a114 ~"aacsicnaalraratarienaehyr,alisziatniio!r, A614 ""NFeitbroesxaamricnoeada,, nsootbeiuntapnltaonues of section
TTheestfioslflEowsiincgidtiiss,seePsroswtraete,fouSntentcah,beUwriitnhairny rBelvaesaelr,Linbidtrse:nal, Thyroid, Traches, Esopages, Salivary Eland, Pituitary, Speer.
Fnaitnea!l HNeoecih=ers10R6 3Te2rminal SSaecx:rifMiaclee Gras (6) FEIT30pom
Nacroscopic Bservations: NicroKsicdonpeiyc servations:
LLuinvger Pituitary
Ko visible lesions. "Dhranic progressive nephrcgathy, eile "Fvearstcaullarapanianreurcalleiszratciaolnl, iinflidltrate, w1 "bierona
The following tissuts were foun to be within normal Spleen, Heart,TestisEpididyeis, Prostate, Stomach,
linits: Urinary
Bladder,
Adrenal,
Thyraid,
PSrpoejceicets:aRnabter: 0281080012
Sumarized STi Page: 12 346 00734
BEST COPY AVAIL BLE cane soe rites bieaserocront
RO: Tn Ye eno Se
2
raw Se BR
BT enrieeaBnurae inntSiiatuns Shosrursean.s mts
TT A ra ----
-- ne
gpaetet net ts vt
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a_i
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aon wimn-- Minsr
ry
i pE it naT M----
ne
A air0
-
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i=e es
E iTkinwgnI
SBBOraeenmHinns ose S--oe -- ot--Rar, Ted, sts, Tris
a
nn Tw
wS pbroeonwsar-- io Fate: (eek 106) Terwinal Sacrifice
-
ath 05 S mip wat
Bsorsatte cn
Sunes sae 3 347
00735
ISnudmimvairdiuzaeld MSaicnrgolsecoTpbisclaatneddMiMcaraoslcopRiepcorOtb.se(rcvoanttiionnused) FE-I43: Too TeaRrikOerralLaTboosriactoirtiye-sD,acolgoecn.ici3t0y Study in Rats
Tale: 2
final Fate:
(NHaesbiesr:106R)3T9er8ninal
SSaecriMfailcee
row ( 6) FC-IAT 30 3pn
FicresLcivaepric Dhservations (continued): LiFunsgcreas Pituitary
"PPoerttaall bwirloenauclcotaeprcoellilderiantfiiolstr,atwei,ldwild ""Hbylpveercpllaarsimaa,croipshlaegtesc,ellm,ilndedular, wild "hderons
.
The following tissues Spleen, Heart,Testis
were Fouad tc be within acraal Epdidyes, Prostate, Stonich,
Limits: Urinary
Batder,
Thyroid,
Paratha,
Teaches, Zssphagis, Salivary Bland,
AFoaitaea:l GNeeeekrs:10(8E3T8e9r5minal SSeacztriWiactee Braust (61 FO-145 30 pon
Macroscopic servations: Wicroscapic servations:
renal HeEasorpthagas Lievyer Pituitary
ko visible Lesions. "Rneetulolfarpyaicelp)resheyspterplasia, focal, ale Not exanined, wissing "Wwyistciafrodciatlis,,adihlrdanic nonsugpurative, ""Pioarstcaallarseinornacliiezaarticeolnl,inaflidltrate, wild Fresaonia, interstitial, cheenc, focal, aild Not exaniaet, wissing
TShpeleefno,lloVwiidnsgsy,tisTseusetsisw/eEraeidifcoyuanids,toPbreostwaitteh,inSntoorwmaaclh,LUiriitnsa:ry Bladder, Thyroid, Parathyroid, Teaches, Salivary lane, Pancreas.
Ffaitnea:l ONkabeer:721)0-S0a1c0r8ificedSei:n eFxetsraelneisrout | 6) FL-145 30 pon
Macroscopic servations: Nanaary Bland
Microscopic Diservations: Khiidrneenyal Liver Lung
"Lalregiet uilncgeerianatledaaresss, 1.5 1 LS ca cia, in ""SCihnruosnoiicdaplrogecrteasssiiav,e cnoersthevso,gatwhiysi,maalinieal ""Hveaassctuolpaorivasiinse,raelxitzraatsieodna,llmairnyi,mal4ild
PSrpoejceicets:MaRsatter: 0281080012
somarive 51 pige: 1 548 00736
ISnudmimvairdiuzaeld MSaicnrgolsecoTpaibculaanteedWifceriuoaslcopRiepcorOtb.se(rcvoanttiionnused) FLAT: Teo YeaRrikOerralLaTboorxaitcoirtiye-sD,ncoTgoecn.ici3ty Study is Rats Table: 2
Ffrastaee:l (Mahsebiers 12()BS0ac0rificeSdeni:n Feexmtarleesisrow: (6) FC-1AT 30 gpm
MicrosNcaospniicryDsElearnvdations (continued): FFarractrheysrseid FiStleeietary
""hbeiimnsarcaartcriorgohyn, winiaal ~"bNeoetroemxsanined, rot in plane of section "Hesatasoiesis, extrasetllary, increases, whet
HTehaertf,olUleowrisnsg, tDisusruye,s Setroemacfh,eeUritnoarbye Bwliatdhdienr,seTrhmyarloiLdi,mitTsr:ache, Esopmags, Salivary Slane.
Aoioal Naabert (B-4707 Sex: Female Graust (6) FO-145 30 pga Fate: eers 90) Found Dead
MacroWsacseasaircy OSblsaenrevations:
WicrPsisctaupiitcarsyervations: vhiidrneesyal Fvaaarwyary Gland harathyreid Pituitary
"Lawrigteh cbylsotoidc, minssp,er8inxeal5xa3 2T.i5ghctn, filled Heienrgruihraaglicarleess.ion, 1S 1 1 ca
""SCihneuasnaiicdaplroegcrteasssiiav,e ncoerstheera,patihtyd, wile to "aHeitshian rroiruoalnLinits
"GNroet oefxapnaiivred,prenseetntin plane of section "Asana
STphaewfne,tlLoiuviezrg, tHiesasrcte,s Lvuenrge, fUotuenrdust,o Sbteonwsicthh,ieUrsicnrasrayl BLliancidtesr:, Thyroid, Trach, Esopags, Salivary Eland, Purcreas.
Ffantsea:al GMeasdheer:105R)0T0er8ainal SSaecx:rifFiecmeale Group (6) FC-1AT30psn
Mascoscopic Diservations: PiPtaunintaaryGland
MicrMorsceonpiacl Gservations:
""RSauiaslledsweadsisl,ar0.m5ssc,a d|iac.a Gia, in left rariiglhlta;ingfaairzgaelaaasrse,s,$153 5 ca, in "Sinusoidal ectasia, cortes, soderate
SPpreocgieecst: MRaasther: OZBR0012
Sanit ST8 Pages 16: 349
00737
[Saoamrrtishd
Sige vw
Tut ia Set Laertrie, Ic. 3%
contin
Ee: To Yur Ba Tosh copy Stay is Rats ie 2
:
rFius tNaaer15BTrSincSeriecae Gow: (8 F050 on
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Fritt tvkaer,39D) S0critceSeicn neoleesSo: (8 F645 300
WarsiaBartion: econ Gera
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SWee is, wtraeslany, roses,
Hheerft lUraag,tOisyts esuechf,ebitsasbe Bitehrsrhloii,isT:he, Esphs, Sliy hse,
Howe Species: vRaet : ec?
sunrine
si
ue
ws
350 00738
ISnucainvairdiuzaeld aScinrgolsecoTpaibculaantdedMiMcariomslcopRiepcerOtb.se(rcvoanttiionnused) FE-1A3: To YeairtearlLaTboornaitcoirtiye-sD,ncIongce,nci0ty Study in Rats Table: 2
AFratiea:l OKieelre:10(9R4Te1r0minal SSeacxriFfeincaele Geaczt (6) FEA1A3 30 gan
MacrFoistcoupiitcirDyservations: Naonary Elant
Wizrescesiz Gssrvations: biresal PLoansgsa Shard Rtaarraythyrait Pituitary ters
""LHaeregrerhwalgtiizloataesls,ir0.a6assc,a d9ixa. 1.55 3 ct, in eft snguizal area. "SCionrutsiociaclaldeegcetnaesriaat,ionc,ortseosd,eraatreked F~ihbasrcsualtaerrownianeralization, sil Extensive necrosis of tuscr, ""hsattexsnined, not in plane of section "atom "Leyiosmyonslsants, warked
SIphleeefno,tlLoinvienrg, tKiisdsaeteys, wfraertf,oSetomtaochb,e wUriitnhairnynBolrasdaderl,imiTtrsa:ches, Esophages, Salivary Slane,
Fascress, Thraic,
-
SFnaitnea:l Hsetcokret105I)-T1e1rmiml SSeaxc:riFfeimcaele Group ( 6) FE-14T 30 pon
NacrasWcaoepaiacryheElaarnvdations: Microhsecroepsiacl Dservations:
Kidney Liver LPuangsay Eland Pitsitary Splens
"Lairnggueinmaalssp,er1in0e3a1l0area4.ca, is right ""CDorrtoinceal pvraocguroelsastiivoen,shlroocamlatahrye,as,a:l#:1 Pelvic sineralization, #1 ""WHaespcaatloacrytaeinvearcawtliaztaitoinon,, mwaitniifnoaclal, aild "Fitraatercms ""Hhesiantoapsiesis, mteanedellary, increases, nderate
The following tissees Heart, eras, Ouary,
were found to be Storch, Urivary
Bwliatdhdienr,soTrhmyarloildi,aiPtsa:rathyroid,
Traches,
Esophages,
Salivary Gland, Pacreas.
PSrpoejceicets:NaRsabter: 0281020012
susie ST ise; 10 351
00739
Snaainle aSiegkeaiTbclaatnedHteearltfaoat asttiint F162 To YuRikaerlLTsoornaaeriyes,caTep,i Say i Fits rates 2
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FreelssEro
{1 FUE 0 30
H- arti ws, 1.35 8 he tTee pwinis trenuendS1wi5th163c in oFandsllahre,otic ssh 211 on in rit Sen esl 0.3 ca di. Seiiririnced,,tasfeire,ecowre--s--, --t--r.e, DHriveeasrmonpltisstioen,agrHeophttly, aininl eerraall abmeedtaetrpreaeilsenaftitornatwei,eald AHrvaalr salaipest,ons,iltfe, wid Seucrailen Toett cel atoms TSieeenss, erate
TShheoeettSntiwgcthistseosmeyredfiorun,toTobreowridthiPnaarrsme,LiiTtreahen, Escuas, Silivy Sa. Faiitea tNeakske1TEFSt beatSe Fie Erg 8) FI 9 on
[ fe -- Vas
Wersrsiaaic Bertin: LTwyianesSect
SLeitghtteaeehrs bis sll cei twist iYrs e0.a5s8y dairntntriendaFtirlieed with dr sey tas. J erase, tifa, ie Suspaere,wmrlasatti,on,sosirttee J nie, Hebe
frp Species: Rat
Sania S18 ge 18 352 00740
i Sri AiWlie nTaitgNfialegr2Bt cona
Tots: 1 Yr olTe ct St i ts ie2
avane Fe Sg 0 on
NeFeaHsnoienetins its Hsens, wtrasiivy, sen,
te
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aSheenenl,eontrSe yseHewSrse tfnab,0ssRtersdoitre, arti, Tn
S i vna BeasSeaTre og 0 Fn
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Aaptsi imig vDr ne 85275
PioattottelGoa
:
to os rts wn I ----
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i Srre,waaaiet swaatsstewld
Gierry sit
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iis
Es
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wos
in
PBIeinFalSninnrieseawoSoat 1Roesitae rtd,Lht:n stun, aly ht
ois vaet: anno
Sunrize 50 igh74353
Sonic a Sriee tawlatmeaairaeprBwtiioe
FEA: Te oS Tee Sects Say i ts ote 2
we Weio n enee ro 0 Fn
[AP
v}ite Ln.
[ To --
Svoert wi, cto, ital,
-t vi
a Aa e wn-- t, wee vein sie
b-nmy
iami,ti,n waitt f, nos
TfSromame
BHieeeteer osplie of ston
ow
bess, wid
O eu Bp i Toro, sce, Estas, Sn Sl
BTnvs oesk Serreoi eg (0 70
[J o4h --
ti Wii on be
pr uy
rp ie ep -- nn
bElri
Tn imtms
1h etn ae Te ra.
crehearmfaodon soo,ibvaPhyeanByt,sSarhPl,ociSevtmes,Sierin
Mate,
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cFeoenvaatne: cnn
Sontag 5 grCoo
ISnuainvairtiuzaeld MSaicnrgolsecoTpaibcalaatndecMidcraoslcopRiecgoO.bse(rcvoanttiionnused) FE-1A3: Tao YeaRrikOerralLiTboornactiotryi-eDsn,csIgnecn.ici3t0y Study in Rats Table: 2
Ffaastnea:l ONeaesdtesrs108[!07Te1r7ninal SSeanctriFfeimcaele Group: (6) FC-143 30 pe
Macroscopic Bservations: mFiatsiuiatreyryBland
MicroMsicroepniac! Bservations: [2 Kitany LLirvger Hannary Bland Pituitary tteras
:Heorrhagic mss, 1c dia. "Leorbsatliacr laoswsl,ar43as3s,x 2.5 cn, in left asidlas 25521 12a in prion aren, "Left atrenal nlarget. "SiEnnulsacrigdeaalestectoafsi1ae,ftCoargtreesn,lmadrokeedto massive "Cshirnounsiocidparlogrecetsassiivae.sepropathy, sinisal "PHeelpvaitcocsyitneervaalciuzoaltaitoino,n,ameurlatitfeocal, wile aHsiavelcatarr amiancreoaplhiazgaetsi,ona,lteiidlodcal, ald "HFeisborrarahdageen,onLocal areas, sodeate Bhaileancstcaacreclienons "Hieron "Dystic glands, wild
The folLoning Ssleen, Heart,
tOivsasraye,s
wSetroenafho,unUdritnoarbye
Bwliatdhdienr,noTrhmyarloiLdi,nFta:rathyraie,
Traches,
Esopragas,
Salivary Blane, Puscress.
Ffartien:al hMaagsiheer:904)7S1ac8rificedSex1:1
Female row: extrenis
(
8)
FCT
30
gpm
MacrFoistcuopiitcarByservations: Pacer Eland Mrenal
NicrKoisdconpeiyc servations: Harenal
KSisdenaehyages Lung
""RCayissteidc wsaassss,, 41.23 3cacad,ia.ft anil alk pst "Hiinghttheadpreernianleaelnlaarregae.d. "Possibly pale "SiEnnulsaorigdeanlenetctoafsirai,ghtcoratderse,nalmardkueedto missive kostinuesxcaimdian)ed,ectaaissisai.ng ""CHiersacnrirchagper,ogrleoscsalivearenaesp,hrowpialtdhy, sininal Precaia, foreign bod, local areas, marked
SPpreocjieecst:MaRsather: 21080012
Swit STH Page: 191 355 00743
ISnucainvaireiuzaeld MSaicnrgolsecoTpaibclaatneddMifcnirnoaslcopRiecpoOrbtse(rcvoanttiionnased) FL-A43: Too YeaRrikOerralLiTboorxaitcoirtiye-sD,ncoIgnec,nicity Stoey in Rats Table: 2
fFiatnea:l hMaacdkesr:94I)RASaTcErificeSdexi:n Feexmtarleenisrow: ( 8) FE-143 30 gpa
FicrasWcaorpuiaceyObSsleirnvgations continued): PPiatruaitthayrryoie ters
F:ireatensns "Bhaaltucetxoacneilneed, not in plane of sectin ""hyersesglarcs, woderate
TShpeleefno,lloLwiivnerg,tiHseasrute,s wDeiraery,foSutnontioch,beUwriitnhairny nBolardmdaer,limTihtysr:oid, Trachea, Salivary ase, Fuscreis.
FFaotrea:alhbeeetrst96()R-S0a0c1r9idicedSecitn eFxetnraelneisGroup 61 FC-145 30 pp
Nasrusceaic servations: Pi[t9uitary Soft Tissues (nck)
LKiivdenery Microscopic Oaervations:
aErneal Niner Liver
Lig Noawary Slant OPaarraythyroid Pituitary SSpalleievnary Bland
""LSeufaltl oyheewdoarrrkh,agipcossliebslieon.besorrhige. "Irregular cystic subcutaneous ease, 6143 2 seannnairnyngelcakndaroera,saploisvsairbylyglare. ""sslliigghhttllyy ppaallee and pittec. ""CAoerrtaitciatlis,vaccaaotlea,tiowni,laltoecraa!l,arenasa,rkedwrite ""DHherpeantioccyptregvraecsussilavteionne,phrdoizdaftahsye,, awiiled Wesatacyte alteratica, basophilic, focal, "hweislcerrhage, local areas, irked "Mbeetnassctaatriccinnoencplase ""NOestt,pxwaisilcaetde,ranlot in lane of secticn -Naedtnoenxsaninet, wissing "Hescsicerosis, woterate
HTehaertf,alUltoenriansg,tSitsosmuaecsh,werUerinfaoruynBltaoddbeer,wiTthhyirnoirdo,rmaTlracLhiensi,ts:Escphages, Pascreas.
SPpreocjieecst: Naantber: 028108012
Summarized STAR Page: 192 356
00744
ISnutsinvairdiuzaeld MSaicorgolsecoTpaibculantdedNifcaroismcopRiecrtD.ise(rcvoanttiicnnused) FE-143: Too YeaRrikeOrralLbToornaitceartiye-sD,acTongee.nci0ty Study in Rats
Table: 2
AFoaitaea:l WNeoeabkesrt1081)R-0T0e2r0sinal SSeaxc:rifFiecmeale Srowpt ( 6) FC-14330pou
MacrosWcaospniacry BEslearnvdations: Mersshceorpeniacl Observations:
KiLdivneery
tax FFaarncrneyssSlant Pituitary
"Kiss in Fight inguinal ares appes to be inflanned wilt erst.
""SFienluvsiocidaailneercatlaisziaat,ionc,ortaeirl, waked "HHeeppaattooccyyttee vaalctesrlaattiioorn,, vealcstcildaetreasl,, fwoicalld, "sHiltveeslar mcreghages, wiltifsaal, ile hpeeerniavcaasrccuilanronssoonclar filtrate, aild hina atrophy, soderate "haanons
The fatloning Spleen, Heirt,
tissces were found to be Uterus, Dury, Stossch,
UwirtihnianrynBolramtaerL,isiTthsy:roid,
Parathyroid,
Trach,
Estsbages, Salivary lan.
fninal Nasbert 18-0021 Sex: Female rout ( 61 FC-143 30 pon Fate: Gasie. 99 Found Dead
MacroNsacaospaircy OEblsaenrdvations:
ters Wicroksicreepnisct servations:
Liver Raseaey Gland tary PPaarnactrheyarsoid PSiatluiivtaaryryBland Spleen
"aisnsg,uin8a1l 7a.re55a w3.l5tialao,tawlaalrtialosbsalirn, right "HLeesfoterihnagsuiicnallesiaorne,s.0.71 1 ca, leit aterine horn, "SHiensuastooipdoailesiesc,taseixat,racnoerdtlel,aryo,decroartteical, "wHaermkaetodpoiesis, extrasedallary, winiaal "AFdiebrrooacdaerncoinnson "THniethiofn pnaoirraprelsiesnitts ""NNoott eexxaanniinneedd,, naoitssiinngplan of section ""NNeott exxaanaiinneedd,, aaiissssiingg "wHaerskaetdopoiesis, extrasedallary, increased,
SPpreocjieecst:Maasther: 281080012
Suamrived STH Pges 193 357
00745
ISunatnvairdiuzaeld MSaicnrgolsecoTpaibculaantdedWifcarinoaslcopRiecsorOtbse(rcvoanttiionnused) FAA: Too YeaRrikOerralLaTboorxactiotryi-eBsn,csIgnecn.ici3ty Study in Rats
Table: 2
fFrateee:] (Mbaeaebtesrt951)0-0F7o2u1nd DeadSex: Female row ( 6) FC-14T 30 ppn
KicrosSctsapnicchQiservations. (continued): eras
"He.eserhage, fecal, mcosal, wild alyp
The fallonins tissaes were fount to be within rorma Limits: Vata, bert, Lung, Urinary Bladder, Thyrcid, Traches, Escphges.
Arias! Nosed IBATI2 Sex Fenale Group: | 6) FIAT 30 pon Fate: thie 33) Found Dead
WecreNsacaospaircy GGhlsaenrsvations: LPiivteuritary
Mierehsecroepniacl servations: Liver ey PiFtasnintayryGland Sativa Gland SpSlhienen [re
"Laariglearraycrorteigcionm.ass, 111 8 x 15 cb, deft "pHielaeorrhagic mss, 0.5 ca Gia. ""SNiencursoosiidsa,l wcilttaisfioac,al,cormtaersk,edsoferate sAclaveloalarr wmiancerroaplhiazgaets,ions,utviidroicaalt, ail -lbadtenceuxsavined, wissing lot exasine, wissing F"Hienbartoossiesis, estranedsllary, increased, "wCytsetriacteglands, marked
TKhietsefya,lloHneiaargt,tiOsvsruye,s wSetroemcfho,undUrtionarbye wBiltahdidner,soTrhyaraiLdi,itPsa:rathyroid, Traches, Esopbags, Pancreas.
final Noabert 18-0123 Sex Fenale Secupt | 6) FL-L04pa5n Fate: Weeks 105) Ternimal Sacrifice
MacroNsacnospaircy DBslearnvdations: Wicrotscroepnicd servations:
Kidney
"pecryisntesallaargsesmasgsg,ear3sxtoSxbeTianfnlaniened alk throat ares, ""SMienpuhsrooisdiasl, etcatbausliaar,, csoordteersa,tesoferte
PSrpoejceicets:Mafsahter: 0281080012
Sanwrized STE Page: 194 358
C0746
nSannrzaat NSirvalsecaTiaaclaatneddcrriomsesretracttiionnese REST COPY AVAILABLE 18 Teo teFrirralLiTareactohrniecs,erIci.c30 Say in Rats Tate2
Fwale tYhais10I5 ETErae SSruiieclee Gra) FE 0 pn
[ os a -- Fairy St
iSesrlcracisrioenr,lipnititoh,yinal
okriyta
Tieotea bpeshate, trate
Jr
Tpreaselasihaart,ewsatrtrsal pill, erie
SShietewia,tronLEiinnltg,,iesPtsaescsisSe,eocfounritsoarbye Hwiatahisn,seTahylroiLd,itP:rthyred, Tash, Esohges,
Faiitem tNeahr105I) TIrea SSuartfiFceens Gro 1 F110 00
fr Sal T-- easing
raCtae.d stosting Filed with insets in
fr Reet --
SCiorntiacailagesneertast,ionc,rftec,al,il44
Gown
alnictspsreoaglrasaetiieons,riapntlh, sninl
ue
pPiotrtaall wileidicet prcaollidfeerabtlitn,ati,lewile
RLwasisyseSint
p"ilcaalsa,parrelaictaitvei,o,simsitnsal ok amined, isin
Pvaarrysbysie Sul Tstine
Tlaetleavpner,sleatiai,n dshiante eof,ecwtiiloen Leiowonrans, jinn
Ldiengnetien.ilriting unr ith onal srface
winwey Hater
Ae avait, wisi
Shieewf,elHoutn,tWisastes,sSeteouftou,nTtooibte,witThricnhrs,eaEcbLuiets:, Selvary lan, Pancreas, Pluie.
FSargcet:oftahtr: CBEEOIZ
.
Swnwize ST gs 12 359
00747
.
ISnutmimvairdiuzaeld MSaicnrgolsecoTpaibcslaantdedMiMcriolscopRiepcorDt.ase(rcovnttiionnused)
Riker Laboratories, Inc. 30
FE-AA3: Too Year Oral Tosicity-Dacsgnicity Stuty in Rats Table: 2
RFiatoes:] (Naesebkert 901)0-0S1a3c5rificeSdeai:n FeexmtarleenisGroups ( 6) FC-14T 30 pon
PacraPsictoupiictarGyservations: Microscopic Bhservations:
HKiadrneenya) Lung Fitsitary
"R|aised red mss, 1 a dia. ""sDidneuosnoiizdaplroegcrteasssiiav,e caaerpteora,thiyl,e i2e "PVealsvciaclarainneerearlailziaztaitoino,n,ainaiisladl Hesorrhage, wiltidocal, ail "benom
The foliceing tissues Spleas, Liver, Haart,
wDeurrey,fouFnadmatroybelawnitt,hinStnoowramcahl,
LUirniintasr:y
Blaster,
Uteras,
Thyroid,
Firathyrsid, Tacha, Escptagus, Salivary Eland, Pancreas.
fFiatnea:l (NMeesetkesr:105()RTAerTminal SSeaccriFfeimcaele Geass 6) FE-143 30 pon
Pacrascopic Dservations: PiRtassuiatrayryGland
Ficrohscroepniacl Oservations:
vidney Liver Lrg Frrathyrsic FtirtianiatrayryRatder
""HSeuuacllrrhsaagsisc, masppse,ar0s.6tocabedami.lk cyst, in trot ares, "SNoitmustoairdaylpecrtsalsaisai,a, Cocrotretse,s, awcacdeerrtiete "DPierlavniiccignreorgarleiszsaitvieonm,priosnaathly, sini ""pVoarstcaullaranoainnaecrlaelairzatcieolln,inmfiinlimtarlate, winieal "HNeontceerxhaaagien,ed,locnaelt airneapsl,anseodoefrasteection ""NAotteexnasined, aissing
TShieleefno,lloHweiunrgt,tiUstseuruess,weOrvearyf,ounMdastaarybeSwliatnhei,nSntoorwmsaclh,liTnhiytrso:id, Traches, Escphages, Salivary Bland, Pascress.
SPpreocjieecst:NRuastber: 0281080012
Summarized STAR Page: 195 360
00748
ISnutahnvairdiuzaeld MSaicnrgolsecoTpaibclaatneddMiMcaroaslcopRiecporDti.se(rcvoanttiianrused) FE-143: Too YouRrikreralLaTboorxaitcoirtiye-sD,ecIongce.ici3ty Study in Rats Table: 2
fFiatnea:l (MHoeasbesrt1051)0-T7e2r7ainal SSeaxc:riFfeimcaele rou ( 8) FC-163 30 psn
Pacrascosic Ghservations: Pisttuiirtary Faawary Blacd
Kicrehsecrsepsiacl Dseations: Kidney Lung rasniry Bland POvaanrcyreas [Piitsitary
""hhaiiisedLosdsarkonmhasesa,d a0n.d5 nceackd.ia. "Maasrse,as;43m3ss,ca, rcioghctiaan,xilLleafrtysaindde,theaat ""Spienluvsiocidaailnercatlaisziaat,icsc,ortseisn,imamlarked "vHaessccurlrahragew,ineiriafluiszea,tiowni,rtweidld "Fibraatences "htiysnt a atrophy, aiviml ""Chyisetriacrglands, warie
The following tissaes Spleen, Liver, Heart,
were found to be Stomach, Urinary
wBiltahsitner,newTehaylroildi,nitPsa:rathyroid,
Traches,
Esophages,
Salivary Bla, Ere
-
final Naber: IR-0128 Sex: Female row 1 6) FC-143 30 gpm Titer heres 60) Sacrificed in mtrmis
MacroBsacgaasaiecn sienrtveartniaoln)s:
WicroMscroepsiact Dservations: Hitney Live LRuesnegntary Pancreas SPpitlueietnary
"aasoninal cavity Filled with blosdy flues ianevsoelnvteadrywiatnhd scoatsatloarr,exgtraennssliavreltyissae, possibly tuner or chronic nflamsation. "SCionrutsicciadlaldeegcetnaesriaat,ionc,ortfeosc,al,aileile "PDehtraasnitcatipcrongeroepslsaisvee nephropathy, wild Pelvic aimeralization, sild "HMeeptaatscteayttiec vnaecoupellaasteion, wultidocal, wininal "Haesvcaatloaproieasiimsr,aleixztartaisoend,ullsairlyd, ainiaal ""HMeestoatshtealtiiocsaa,vpmlaalsingnant -"Mhetsasotmatic neoplase
PSrpoejceicets:MaRsahter: 2810R0012
Suwrized 51 Page: 157 361 00749
ISnudaimvairdiuzaeld aScirngolsecoTpaibculaantdedMihcorioasaclopRiecpoOrtbse(rcvoanttiionnased] F143: Tao YeaRrikOerralLaTboorcaittoyr-iOesn,cagIencn.icity Stay in Rats Table: 2
AFraitsea:] MMeaedkesr:BA1)-1Sa2c8rificedSexi:n Feexstarleenssrou (6) FC-14T 30 pon
WicrSatscoaupsicchservations (continued): UUtreirsuasry Batder
-Nuetctearstatic nesslase ""EHyesttaisctatgilcandnse,spilalsee
HTehaertf,olOlvoawriyn,g Mtaisasaureys Gwlearcee,foTuhnytrctiod,bePairtahtihynrociod,reTraLcihietas,:Esophages, Salivary Shand.
Ffraitnea:l GNeusebker:1051)8-0T7e2r9minal SSeaxc:riFfeimcaele row (8) FEIT 30 gn
Macroscopic Bservations: PiNtaunaiatrayrylast
WierHssacorpeicl Ohservations: LHiivdeerr Lang
Nasnary Eland Parathyroid Pituitary
""MSualatlilroabiosleadr faasrsk,ma3s.s5,x1 3caca,diai.n right wSilxlsb;rlardgene sinslttielnotblaarreanss, "SCionrutsisciadlaldeegcetnaesriaat,ionc,ortleosc,alodareeraast,esoderate ""Fpoerltvai)c aseinnsenruaclliezaatriocne,llaiinnifnialltrate, wisinal "VHaespcautloacryteainvearcaulailzaattioino,n,w1ul6tifocal, inial Presscnia, interstitial, chrnic, local areas, Haelsearrhage, ailticocal, siniual FiSrbarnoualtoennsc,nswultifocal, aild "FNiettroeaxdaennionnead, not in plane of section ~hdences
STphleeefno,llHoewairntg, tUitsesruuess,wDeureryf,ouSntomtaochb,e wUriitvhairnynoBrlsaaddlerl,imTihtysr:oid, Trackes, Esophagus, Salivary Slant, Pancreas.
PSrpoegceicets:MuRsatter: 0281080012
Suanarized ST Page: 198 362
G00750
TSnudnvavriiczuaeld PScinrgolsecoTpiibcuhnatdedKtciroaaslcpBicsSrbecrtvtiisounesd) . FES: To YeFritBealLibTooriacteirtiye-sQ,caIpce,ici3t0y Stay in Rts Tale: 2
fFaete:t aNsahsee10A) FTund DeutSe Femle aus (8) FOU 30m
FasroRscaoniciDlsaenrtwtions:
tTiy 2l5 la, srlicgehrtataendllsaicueptiecs ass, 4 x awhintesFlsuihdi,n,in1.l2eftai6ngu,inalFiled with lly
Hereswcroesset Oserations: rena tity
tir Fwagnwry Slane Spltseitary stes
ht ates lage. SCionrutsiicaclaldetgeamesra,ticnc,artleorc,imaarrkeeasd, moderate "Wharwariaclzpartoigorne,ssiivsetesrspitritaayl,,ar41t4i, Fwotretrailteasmonsclew cel infiltrate, 614 "Ncecirtosairs, iwnaelatliifezatli,onw,ildsirinl eSsisiscrtcceilnson h"eiutseoniesis, extrasolar, increset, owlilye
Treitf,olGluwairn,g LSitosnssecsh,weUreinfareyndBltaoddebre,wiTthhyienide,raPalratLhiynreosi:d, Trache, Escohass, Salvi Bin, Farias,
FPuienli whitse9)EASwTrificetSein eFxetnrleneisSas (8) FCI 0 gan
KurasNzagikcaOBaleirnndations: Stulwl Intestine
Micrroesacl Oasrvations: tLiivtey
ng
"FaCliercmad asilisg,htl3ycoenflairng,es.in right wills Sees of slceation with shesins. "Ceoortsicaflerovsaicss,aladtiifonf,e,thcuorsti,calw,de4r:s1t4e eHraattaecntreesovrisctsioolnatiroanl,etdisf,fusmer,kewseed "WHaalliiggunasntt phoonwss,, hhissttiicoecpyttiicc Melsctsis, local ares, il
FSrpeijcntsWaaster: zBICONE2
Somnrined STH igi: 199 363
00751
eSubnreisnes mSiaiorgrrcLTnsearatMadreieWbsr,ianTdses,RepBtrecroanttiionnenst) Fe5 To You GaToby capita in ats nie2
rFise easees0BTSuLifcetSuin eelreesrot (8 704310 pa
WisfserBearetoen (contin Fan Et
sSii}grnoestopnhen, isticrtic
[JeenAser
ikliningaarppneonnh,,ebmisstiscrrttiicc
Stary sis
fWrpinn Inshon, nstizotic
SfStuholenlrerase
i""tieeeg, hmmeipdconh,amlsetictic
Vinay sate
lt Its mirc
heersf,llTnoig,tiPsaeswtea,funrditseb,iStitnao,emFtliitsa:, bart
Ffotr tNhara35BSTursticedSna oeeesGr {8 F103 3 an
[ ihairyy a fast
wre [rrtEen --
ity te wn
S"uWEatnoc wa,ast,
04.5chafih, sity a epi es
nad
giinreeTiangteidnc em3ea1, 1s+0rc3e3fcaaLpitasatyritghet,
Aiwngiihsti,nr0e1acla dlianrge Lit sre ale
rs wll 1 met,
.
T cCiratnp ,dgaerwasp t,on,i--sseeat-- ds
yi saansb ,feaerbaa rbi,onifeoal, ale
eartoos,eist,ilp, sraian 1, 16
AANbniaatlatisrraeotlisaeetsi,on4, sind
ap Species: Rat
Sie 1 1g 00735624
Srainincaat Siirkcae LTpiiulramiteeatsMI,iireToe.srht acotnitinn) FT Yeu BaToit capt Sa io ats Tae: 2
iFile tiaes 95G) ESu?rifceSein Fstlreeesa (8) F165 0 on
rohseseyBGrnadtions cntired: SFietritiy
sFiirraotteiionns Sseetsetnsoieis, extramealany, incrise, wie
oThier,eWoenr, iDsusruye,s Seroecf,onWitneedye lwiattheirn,meTrhyarsLd,itP:rthyesd, Traces, Esshses, Sis Ew, Pues, Siintd eNaitt119I) TTeTri] SSuetriFeasle Se 1 FL 30 an
fo -- WcrKosirctpeeisac Drutions:
tlo e Pitty
xo visible esa. ZSiensbitailnrcaltsat,ionc,ro#n1,6 sofeate SJvevpeilataetrotsrsamiepclaaigantetisio,orn,m,taiifionafll,,6wile Savon
ThSeatetfnea,,labSraor,biaGssr,ueessS,seeOeeyyf,eSdeanmtseoyPberhweaittsh,i,eSsteroa,LWiitn:ey Bader, Tyr, Pathos,
FFliemtKaatser99BSScrificetSe1xs tFreeentfro: (6) F165 1 an
herFoiets Gratis: Rawr Slant
Wersteropwiec Denti: LRiovaneke last Fiuitiry
Hteinccrigaiacna3t3l3as13eesn,in162856i9gn iwbry stigply ae. SSaitvcarst svaectast,iocn,rtp,eriwgerttearla,testrate SLeovrriaew,pemrliaitse, )ostwiice Herons
SPrcanesaabtr: CBGONR2
Sncize spe 565 C0753
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MicrosSScoiopei:c Dbservations (continued! iH- ics,ierweisnst,oaw,rieadte
iToetfnlSoe,seeehs wGrueryfenrd tyo beBaatihe pTari,LiPtr:thyrsd, Trchs, Esbsin Sivan Si, Frere.
Fointet eoee50T) SSicaSeir rFaees ro FR 3 0
rorsasry GEeis tions:
[wareen -- oFthenotraeid a I
"aWrie freietea,s,ri$g5h 8si5l1ls48 ca, ented FaGlreasteeasw0en125Tocehs.tin 08 sills, SSoarnttaaalsacttiiion,n,cofarln, 1i6tt SrSaeaaesiiaensriuzkesiin,osnhowaeonfdisti Feiermrie Aieenean, inns,
tSTheoafnyesSoee,HSoasaetrsaea,rreyFo,rdSeeet,omSan rietasirsyEsBonmealr,LisTtrs:oi, Traces, Esptues,
Fott tNeatve1631) TSrial SSevrFcoe Gr |)FO 9
Roses Surtions WerosTceapc Gserations
Hjoits Tse
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FSpeaciees:WRaatrs IER
samrized sg 2200735646
EST COP
AVAILABLE
Snuenriizles RSrirnegelrsecLTpgicbrlaat4to3erdsReni,isacIlraes,Rees1eBtar(acotnitoenst) Fett Too eu Dal Tonicty-Gcapeicity Sad in ats Tie 2
fFiaten tRohsses169T) TErina SSeucitFeusla roa (8) FCI 50g [----------
STienef,ollioitnyg,Hibsesrets,eirge,feheese2,dDeeiryt,heRosroyrltiint,s:Stan, Uicry Sater, Kirasl, Tras, Epes, Seley Elune, Pacres.
Fiiaten tNaabher109S) TTrica SSaeritFiecmeie reat |) FAG 30 gn
RarsistcaprcyBaeations: Haar Sint
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siHtuatrtyion, Sfitheu we
Raai,sed2mxss0,80f4n81tpa.ena wes can, ta i pn ve
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rSepjaecst:oatthr: EBERLE
Sanwrizee St Page: 25 367 00'755
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SInndairviidzueald MSaicnrgolsecoTpaivculaantdedMidcnrioasaclopRiecpoOrbtse(rcvoanttiionnused) FE-143: Too YeRairkeOrralLabToorsaitcoirtiye-s,DicIongc.eicity Study in Rats
Taste: 2
Reinal Neaber: 1ATIS Sex: Female roupt ( 6) FC-14T 30 gpa Fate: (ests 105) Teruinal Sacrifice
The fKoitciroonsicnagpitcisBshuseesrvwaetrieonns t(cotnotinbueedw)i:thin noraal Hisits (continued): Salivary Bland, Pituitary, Pancras
Ffarties:al gMeasihser:108I)-T0er0sinalSeSanc:riFfeiscaele routs (6) FC-HAD 30 poe
PasrosRcaenpiecyQSshearnvdations: PicraSsceanpiac: Gservations:
KLiitvenrey Lung PPaarsatahyyroBildand Pituitary Thyraid
mass, 4330 aa, bn pineal area, "SWierduasloliadraylceelcltashiyap,erpcloarstiea,, amoudletriaftoecal, ail ""PHeelpvaitcocyatienearlatleirzaattiioone,, vaiilcdwlate?, wile "WHaesscaatloacrytseimalrtaelriaztaitoinc,a,baesiglkeilic, aild Perivascalar asonuclear infiltrate, wile ""NLaatbuelxaarmihnyepde,rsmloatsiian plane of section ""Ubiietrioenraanchial cst
The follaxing tissses vere found to be within sereal Linits: FSpalrece-se,as.Heart, Uterss, Dury, Stomach, Urinary Bladder, Traches, Esophagss, Salivary Slant,
Ffartiea:aleosnidesr?97IASTuLricedSeixn mFaetnraelneisSeaust (6) FE-1AS 36 poe
PacrPoistcuogiitcarOybsarations: KicrosFcaespniacryDaGslearnvdations:
hiitrhenea,l lisg Pa arathy] roid Pituitary
""RNaoidsuleadrdaLreksiomns,s,1 1c.a3icao,dai.t perineal ares, ""SDihnruasnoiicdaalroegcrteasssiiav,e cnoersthevxo,patshoyd,eraetiele "scalar airalization, sina -HLeosbcurlrahragRey,perfpoclaals,iaail "Not sxanined, not in plane of section ~henons
The fallouing tissaes were found to be within sora limits: Spleen, Liver, Heart, Uterus, Ovary, Stowach, Urinary Bladder, Thyroid, Traches, Esophages,
PSrpoegceicets:Naastber: 0281080012
Suanrizet 518 pages 205 369 00757
sais ms 0038
10\ ANUDE eSuainirisueld MSiiancagrlreesLTaaipbecla1atmtaerdiMeiisc,grsosI)cnoc.ppioer0Btse(acaotniioounesc)
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Microscopic Dsenvatiars (continued):
ol
iEThvenrfiWt,twySvatsreaerEiawreyr,,FfaaSnrteio,,eswairhy Bearer,Liesatl, Tors, Prt, Tras,
FSi rtwaahr15B0T0ern SSeacreeeal Sr (8 F005 an
[ iwrny is
SRaunl, rSi1e0d0rkcnweon, p6r.4ioco)iwe
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SXlicmiiel,iaa,igcarte, rte
ies
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[
arjaelrast,parmtib, va6n, stil,
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SSeidson col tk ins ste
hteef,lLlntFiittss eeretfy aonti iatkissSrel rnihse:i, Patho, Tries,
Sines rd, Pree
Petas tNhearr1BSAacrificedSwin ereessSr {8 F405 an
[rhWeyn-- St
Gtouogerwitha01ecrxess, a, itt
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Eiitaittweotk)
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oetrovtae sltraitioon,ni,e,sitmioist,s,
nan
rSpeaciees:oRsate: E62
:
Sunwin st pg 20 572 0750
aris 3. 076
SSntsd RSilaeerCaelatsreaetsiralmeetBacitor
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CFeT tae Susie rieeisog (170 0
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wr
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eIsttontsWaens,soree,ctenh8 ithiyn srBel,LPt:s.
Fiie RsSBtiec wFoiiesa 6 FA
orFciot BBairtation:
SA vrhicawst1.105 dn
RVtroow Sati:
J reaenersiagoens,-- sowib:a, die
Seecsiesebrt : a2
. `Suswarized STAR Page: 2160 0037762
Snainnia TSiivgcee CTeolraetaierasToe,B.irrt acointninsent
RAE Tes tor BlTesh Sci Stay in es nie1
Fait nhes80B ) Sis te 0 froeesGags 6 E10 3 0
[r(#e4 ---------- "sarlea,sswliosatiwoen,, i41d6
JNaert Gd
KSiuraoenie
TtSheenifsl,LuoSrtHiyttsBaLreee,e,Funearyntc, bSoEemiathSi,ietsirnlyiBiasrs, hei, Parathyrst, Traces
ruteas tNhaere,10Fd odSe en ros (8 F003 10 pn
heoaswiacy BEekrtie:
AStigeallrouns,alt0.o51l2ac,a i right
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ie ray
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are 16
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Sheief,ollrwisn,g Hrayne,s wwrke f,ountitonybe Bwiathiien,rcmhesn,itEs:an, Slvr Bl, Press
FSiane:Raate: 82
Swuriesst pg 20 579 00763
dSuinvniadruizaeld PSiInFgElReOpTaIbEla4tdedRicgraolspifcorOtbse(rcvoanttiionnusnt) Fe43: Too YeaHritGealLaTbooriactiotriye-sD,ceTpcn.ici3t%y Study in hts Tale: 2
dFietien GNeaeskser 21)47F5e1ud eadSex Fewale Grow C1 FCI 30 pn
HarssRcoarsicasBelravnadtions: [Yeidtpey e---- siLes Sl
stonch
"Swoialtlisnous ass, 1 5.51 4.5 chy right P"ealsvciaclrminaeirnaelriaztaitziaotni,on,siwnian}iil hFeinratoompaiess, mtraseullary, incressec, ewrrite
LThievefr,alhoesairntg teirssse,s wDrurey,fouPnadntaoybeBlwiint,hinUreivraaeyl BTlaisttesr:, bieesal, Taroi, Parthysid, Tracts, Eephges, Salivary Ghn, Pituituy, Pancreas.
fFaatel hNaebeors051)0T5e2rinal SSaeccriFfiecmea Groups (8) F143 30 pon
FacrsFsicipticirOynarations: FireKsezrziecs Oserations:
tidney tuanrgy Fiptasictearsy
"ise hworhasc ais, 0.4 a di, SNiemtulsairdahlipercstlaassai,,cocrotret,e,mowdseerraattee "PDerlavniiccspsreorgaleiszsaitvieonr,etsrianpntetdy, 14 T"ysstt,ebrilastieerralaliation, si1 pTeorupdlsarshipse,rsilsalesta,tebli,latweirladl, asterate "enon
STphleesfso,llLoisviern,tHiesasrute,s Uwhreerasf,oMuatnoybeEtlahnidnSmtooircahl, LUiriitnsa:ry Bladder, Thyra, Parathyroid, Trach, Escphages, Salivary Shand.
FTietaeltNhaebteer:10S90T5er5inal SSucerifFiecweale Grog (6) FCAT 30 pon
NarFoisscpiitcarByuervation: hsaiinry Slant
S"ahliarrgTeedswithbsema,ll dork lesions, 0.2 cn a. "Loita ass, 41332 a, in perio ara,
sPpreocjieecst: aabtr: Z8IHOL2
Suanized STH Pug: 212 376
00764
Scamrized Individual
SBaicnrgelsecaTpaibcalaantdedMimcnrinoaslcopRiecpoOrbtse(rcvoanttiionnase.d)
F143; Too YeaRrikOerralLiTboorxactietryi-eGsn,caIgnecn.icity Study in Rats
Table: 2
final Meader: IR-55 Seu: Femle Grow ( 6) FE-143 30 poe Fate: Meeks 105) Terninal Sacrifice
WicrosbcroepinctBservations (continued): LiKvigevrey PLaansgniry Blase OPirtuyitary len
"Si|nusoidal ectasia, cortes, wild ""Fpoerltvailc asoinneenrcaclliezaartiocne,lluniinlfaitletrraatle,, wailreke HPeoprtaatlocybtielevauccatlaptrioolni,fermautlitoinf,ocaall,eaild Hepatocyte alteration, varslate, aild F"isbcraalataerroanisneralization, aild "~hTuebrsclnasr Ryperplasia, bilateral, scterite "Not nasinet, aissing
THheearft,ollUotweirnusg,tiSstsouneasc,werUeicfaoruyndBtleattbeer,witThhiynreiaec,raPlaraLtimhiytrso:id, Trach, Escphags, Saliviry Gland, Farereis.
brine! Noabert 1-8 Sex: Female Groups ( 6) FC-14D 30 pon fate: heres 109) Terwinal Scridice
RsresTcaospuiarcy OSelraungtions: Microastceoapniacl Observations:
Kicney Liver
Lang
Nasuary Slang PDiutruiytary
len
"LabC}lated ass, 83 63 3 ca, in inguinal axe apwesrrienteiacl aanrdeacsystaisc.s is quite
"Sinuscidal ectasia, cartes, aoderate
"wFdigeereantte, conv. tub, epithelium, brow,
"PPoorrttaall bsiolneenduccltewprrocleilfleriantfiiolst,rataei,i14
HHeegpaattaoccyyttee avlatcesrlaattiiono,n,vamcuuletliaftoecda,l,wialldd
vPaosecwuolnaira,wiinnetrearlsitziattiiaoln,,
aild chronic,
saltifecal,
Aallvgeslar macrophages, wltidocal, wild
"Hdenccarcisons
"-Chyismto,mswilateral
"hseondaetrcaptoeiesis, estrasedullury, increased,
HTehaertf,olUltoewriansg,tSitsosmuarcsh,weUrreinfaoruynBltaoddbeer,wiTthhyirnoinda,rmPilaraLtihnyirtosi:d, Trachea, Esophagus,
SPpreocjieecst:Nfuaatber: 0281080012
Suis 518 pug 25 57 7 C00765
ISnuainvairdiuzaeld MSaicnrgolsecoTpaibclaatnecdMifcraolscopRiecpoOrbtse(rcvoanttiinounesd) FE-143: Too YeaRrikOerralLaTdooriactiotryi-eGsn,coIgnecn,icity Stay in Rats Table: 2
FAaetiea:al (KHesehss105R)7T5er4sinal SSaecxrifFiecmeale Groups ( 61 FO-145 30 5p
The
Microssapic Masrvations (continue): following Lissurs were found to be within
aoraal
Hinits
continued':
Salivary Slane, Pancress.
final Maher: 1-55 Fate: (Heske 105! Ternizal
SSaecx:rifFiecmeale
Gros
|
61
FC-1C 30 gon
Nasroscopic Dserations: NicrFoistseapiitcarByservations:
horenal HeEasrcpthigis tigsey Liver tuLunrg y PPiatruaitthayrroyid TThryarcshieta
"Hessrrhagic ass, 0.7 ca da. ""Sliantuseoxisduailnede,ctaasiisas,inycortes, soferate "Mwyiotciafrodziatils,, aOilronic nonswpative, "CPxerlavniiccspirmorgarleiszsaitvieonn,hraoisladthy, mines! "Hepatocyte alteration, basophilic, foal, awlivleeolar sacrophages, focal, ainimal ""hTautbuelxaarnihnyepde,rpwliasssiai,ngbilateral, derate "hhdeetsoenxaanined, wissing Not eran, wissisg
SThpelasfse,llotneiregs,tisFsauwessarwyerSehafn,ouSttoorcbhe,wiLtrhiivnarnyorBmlaalgdeLri,stSsa:livary Slant, Pancreas, Skin.
PSpreocjieecst:Muastber: 0281CR0032
Somnrized 51a Pe: 24 378
C00766
Tissan Invstary
Tie:3
F143 Tas eur Oral TnkiceirtyL-iDenroagteonrciiet,y SItnca,dy 0in Ra=OnteYsou Inter
PSrcojieect:NRaatber: 0ZBCRL2
SoRV eRGRruRpEKRaReI :RACRORNA0RTI pRRpRRRRRI RRRRAR
IL MAB =T553=53m5I5Im5I5mI5T5mI5I5Tm 5I5I5I8T5Am 5M5M3M5M5Nmm 5C4aN8nM4Le8
Tsun hae
So R1R17N20R27A77R35N43N46R50R51K59R66R70R75R80F78E82F85F88R85F00E01F08F10E20
fworreant
F L err e eee ee
boraeinharrow
t Lana na nan s nn
ErEmeages Heart
OCLOaOOLRIPPPOPORIRPIPPIRORN
KiLdiereey Intestine
CL e N
Lwegr J ----
r CS rirtiee tiL etate istiL orr ioicor
Ha[u=ry Bland pucress
S GL EU La In TI nNa G
FFiruaittyirry restite
CS S eccre ceerr L arice iccin L aacee iict
SSnaaliilvarTyteSsatnidne Sint Cord
L L aani nRRn N aRnn un
SSptloenenr Testis icons
LC c er e ar nn ae l
TTrhiycrhoeisd inary Batter
L CLeArtLecoa iraraoi irerirn eiiren
trheres ece Nesntary
The
folloiog
tisuets)
I wDreItIot MreuIirIedTbyIprIotn oTcolI<f-IroeIoeemIemeIeewNeeaNeee
A8iinntiiccaatteessonhlatya4
odinsdgaaognuiassaics
coondmee.ntAwa-eiandniec,atePsletahsaetvroefear g0 teheasSicngoilnensaebdlawitsedwaMdi.nl Tissue Iovestory Page: 215
feport.
379
0787
Tis Tovar (coninont E03: To Yu Gea Trictherr-LOcaerprecsit,y STct.d 3in0 hts rvoasetaaet : anc
Tole: 3 You teria
SroTneainpn am: NO0L
il ars Giains
1f3e3i1t4o
Those ae
Sw PEEET
wpSrroet ren
aLcense
Garoetan
Lwvaaann
rLieer nation
wwvanan
waLyrhyNSeioak ntec)
Lvwansn
bay
wal
PPtetirtesyie
tarenes ta
SSSolilytCerfttlrnse
OLwOaOaH
SiSoenw
svaan
TTTrreiaodnstis
Cwaniaa
Vrrasy Hstr
wainl
BYHnetrman Tht fllnog Hissar] wtberens4iessFerd by ett ommeseremse
nar
ni
4 inniicaatns tshlty 3 earpnicws caonmeetA1 inaditcatesPhets rssogae1ntseoSicreomTntls ieda Rprt, 380 Tone Iveta Pn: 20 00768
Tissue ventory (continued)
Table: 3
FE-143: Too Year Gral ToxRiickeirty-LDanbcoorgaetnoirciietsy, STtouc,dy i3n0 Rats - Doe Year Interia
PSpreocjieecst:Nfaatber: 028130012
TissueMare
aerenal
fBoorntesMarron
Brain
EEseophagus
HKeiadnrety
Large Intestine
LLiunvger
NLayssagahryNoBslean(dasenteric)
tury
PPaarncartehaysroid
Pituitiry
PrSoalsitvaatrye Blan
SSupaitnlalICntoersetine
SSptloenesnch
TTehsytriosidEpididnais
UTrriancahreay Bader
Uterus commen
Th
SNtesienntary
Ureter
Briaa] following
DoTseIGUrouLpTNLasEe:IFCE-1I4E33I0E0 Ipab. IIiIiinny aber =RAmmRmRRRRRmAmRRmRRnRnRnReRnRcRoRsRoReAeRnRn
ISISTSISISIbIbIbIbIbIbIIbIeTbA6M0MbM0M8U8A6N4MLb B89901122223444555464777 Sex NN8N9N2N8N4R3N7N0R2R6N7R8R2R3F2F2F5F6F4F6F5F1F4F8 CFhecrrehrcehrieirceheistibaaetatieacieisieiaiaicsy S Mabeee teetar siisee sianir iiiie C Craer errei rrbbeib reteiaa iiincs FS aere raber sasb eesei ania iiiin iey FLeEeEeerebeartaarteareraiaseaiiriia ich FC AbbA e barr i erce eb sate a aaey SILI n i iiiin iiieeen eecas CSeerecreccecreecraisiaseieertcrrEiacerEtyr E LidiceresC icecesers tariines S Lieire ceesr aeetr eiaae aiirs iins LFeebtbeieribeeerbaeteeiraeairaanieieraieiaianey EC rrbree rereeb raabai aaaaat aaan FAC barreer seaie anas FDearbbceeearierseeisbiiceeitieseasriiiriiiiinya t3508(5) l were Scti FEQuiredl by proti ocol --oe owsoerems meemeree SLTet Sa
A+ indicates tahdiaagnotsis was wade, A - indicatestht 20 diagonrocosnsienst ws ade. 381
Ac indicates only a nondiagnostic coment was sade.
Please
refer
toTitshseueSiInngvleentToarbyulPaagteesd
fnisal 217
Report.
00769
Tissue Iavntory (continued)
Table: 3
FE-143: Tuo Year ral TorRiikceirtyL-aDbnocroagteonrciiest,y Sltnuc.dy 3in8 Rats = One Year teria
Project Nanher: 028100012 Species: Bt
Tissue Nase
Dose Group Nase: FC-143 300 pn RTR11R1R4RAeinal Noabers a == = 8b8e9b9e0r Su 7F9E2FF9F4
afderretnaal
Iceeeen
BBroarienMarrow
ffreenese
EEsroephagus
cfoeeeeenn
HiHdorntey
rfeeees
LLuirvgeer Intestine
Iaeeer
.
Lung Lyssh
Node
tasesteric)
Lbeaicees
Nanaary Gland Ory
cboereeern
PPaanrcartehaysroid
fceorreeer
Ppirtousittaatrey
Cceeneas
SSuaallilvarIyntBelsatnidne
C12 oren
SpSlpierealn Cord
Cbaornees
STteoswtsicshfEpididnis
baeeeeeenn
Thyroid
.
Trachea
vbeerereen
rUtievraursy ladder
bfeanreers
N--eesemnmtmaerymmaeeeeee Th folloving tissue(s) wSeree enost required by protocol wweeeseereeeeeeeeee
tSrtaitnor
lill
A+ indicates that a diagnosis was sade, A- indicates that m0 diagnosis or coment was mide.
382
A indicates only a nondiagnostic coment was safe, Please refer tToistshueeSiInagvleentoTraybuPlaagtee:d 2A0n6imal Report.
00770
Tisostry
oie4
3 To ToirkBelLTtorrysG, Tio. t30 Say in Rats
SPreactne:r: LZ
oP u rap am: OT NO 0 pn T
[ERR
RERRAERRRRERRRRRRARARARAR iii
3TBi1H33131T31e32533E51a31033153T85s3103435733805803008108248443545708488
ioe ae
Sor RRRRRRRRRRRARRRARKRARRAAN
Snharon
enmnnannnann
Homans
eennnannuiin
Lise ntetine Lawoayoe1datric) Purses
saan au aananLn aaniy Crerierrieratreitaeeiene
Sl neste
Lena
TTriedeton
L cee naa nnn inn ana in
rary baste
Lanaanananaun
ccc he follnog tise) we 8 reid prota omen
iLrtther ekeSannet
S TC I I II I
yLWonhtNdoyoh Ganoircail
DI TIIDIIITII IINIINI ININT
RAC+iindniiccattess otnhalty adsiangdnossrisshwacs oat a ad, Flv made. A -indicates that nroeidr i1ia0oghrnoSrooicsovgmimeeTsnratlwiaaese:dsadM2e1.i9 l eet 383 00771
Tis Iter int her dni, 1.
fom
EAE Te Yo a ec Sot ts
eropeears cncEz
J ri ft pSEiIrt Ttnoee nhcyen EShi fToee tae foi te Hos
[OR -- sMB ae at i trrrfrrsrrrnrtatantngant
s HH HninT Nn nnh nT IEa nEGN EMH HEME
ennai n S C ap ll i n es S Radononmeeetm adnonttecal C mas i
he TeanSmerieast icvcor7t,72 A +indicates that a diagnosis was sade. A -indicates thatnodiagnosis or comment was made.
384
Tissue Inventory (continued)
Table:
FE-443:
Tao
Riker Laboratories, Tne. 30 Year Oral Toicaty-Dncagenicity
Study
in
Rats
Project Masher: 02B1CRO012 Species: Rat
Tissue Nase
forrtesl
BBornaeinMarron
Esophagus
EHeeart
LKairogeeyIntestine
LiLuvneg r
LNyassseharNyodBelan(dmsenteric)
OParncyreas
PiPatruaitthayrroyid
SParloisvtaartyeBland
Sul Intestine
SpSpilneaelnCord
TSetsotnisschEpididmis
TTrhaycrhoid
UrinaryBladder
UJ terus LL
Bone Clitoral
lan
LHaersdherNioadneGland
LLyyaspshhNNooddee((tahbodroanciinca)l)
Nesentary
DoPseIGrCoTupENLasIe:IECIOENITIR0pIOIpLiiittiititt ital Waders R=RmRARRARnRnAnRRRARRRRRRRRRAR
355353535353535I5I5I5I5I5I55I5I5I5I5I5I5I5I5L5D5 A9S2S3S455S657S8e0b1e2e3b4s5k6s7a911T2717476777675 Ser KNRKRAKKKNNNNNNNRNRRRNNNE
FFeererrebreerreraericcehsaieaaiiiiaiaieye
SCiibbreserretecerrcearrsaairaieairiiaiehieieys
SALE
rer
aaa
FCeechreseserbeirbiiatirrrareeriaribaeirreeeyy
Fbrhrcehertaebeetreaetaettactesrietrarrrieieieiry
Fareetaeiaiisraery
FFrieeireererbaeerebteetireai riarcricihiairteess
aess
Cierererereceesrieririny
CSeieecrcicirecsricaeirecicceeasrrcccaerErearniecs
LC icee rerer ract eccea sarr iicia riy
CDiCeheeibi arriaaiicceresis e iarcaaanaeeys
CCrirbebeeerrbearieeeitaeesestaesriirciaieirieieys
FEeaerbeebebetiesbiaasbsircreerartriirriacieieess
FPeerbeeerteeesastsaiteiriccaersiarrriiiicthieiyy
eee
A eee ee
e Ce ee n nees a e ne ae e s
B+indicates thadiaagaotsis was wate. A - indicates that mo diaguorocsomienat ws made.
385
Acindicatesonly a ondiagnostic coment wis sade, Please refer toTitshseueSianvgelnetoTarbyulPaatgeed: M22i1sal Report.
Co773
[--
toes4
15 To YeiubeGU0rTaotaSa,caTr.nt30 Stay in ats
.
Sraatees:aabtr: ECRO2
Tissue be praia sas SSoittTiisess (Geee)n SSSiiitttTTTianosns t(ton1r)s) ists Tisee
TRT oeRArsRpAENaAe:RECT RORLRR0RpRRAT RRARRRAR i ars 3353o333n333t333o33351a3a351535383I535E33I3338T35E353A398E3t
SeRAd SN3REAiRsRa eArNaK0Ais RaRaAiRsRn eRrRiRnAeRe RiATNeRy enna CTSIIIIILTIIIIIIIIIIIIIIIIIIIIIIIIIIIN C CL I II T III
4 innlccaatteess shlayt Gpariiaas twadee, o-unmidcetesFatshet rneeagrrtsiohcsekSaeocteomreTnytlewasttedair2e.al Bet. 386 00774
.
Tien tay contin ie Urine, tc, 1
oie
E15 Te Yur Bk Teor epct Sty ts
frsrectmihaeters ac
SPT oe AboAT Roe,ROENRR0T pRn ERRARRn RRRRERRE
TTL SC iiiiiiiiiiisi iiissiii4i4i4i
----
So FRiiEeETiPiHEsIaREaEnHaFnRHnEiRiEEiRnHRicEIoRoIHaIRsIYeTTs
Sos
nnn
re nestioe Lr et atric)
mnnnnnLLann ievenaanaen
Peiwtboyit
LSatsrsisisiseseeescseiiscsiriieseleieeess
ipSotsytosl
S n TI an T nL n n L a
tations
40 saadas ta:
ry tr
Ln
ee Th elmo Svat) wo ot Fee ERS) errs
Ettraatn fstd
S Le o ni n
ooot Grtari)
L La inn nn y
ts Simi Cont i elo Tl 1T0sheSteonaehst05h0l775rt A + indicates that adiagnosis was sade. A -indicates that no diagnorocosmienst was made.
387
a tn cont ets eeiea i rio, Te te i it
po
Jegeot eers a2
re rit ns T0 tSo--n E1 STm frairTo
oS n rgI pe 0T n n CnH HiasnnnH nnH nHhHy wR IRR ees o C C C oo mi n mn i CII gCaItacdiananatonaaiin:
A+ indicatesthatadiagnosis was sade.
a bs nofie rtettontm00i0n 7g7r6 8 A - indicatesthatnodiagnorocsomienst wis made.
38
-
5 Te oither tTioo,cco Tissue Inventory (continued) Stat nts [--,
oJigchcitNemr: 2
tBsehroAoe CIL en Ran REREEERA
aE a
C S Lani n na
----
wo Sn
Sot
nn
i tie
nn
seeye tric
S de auapn agaaed
eit
AIA
fTrereoeynn.s a [rr --
IS e Iiliiibtaaae r iaesinaatei iions: SSOpIeRedAsRaNanansnadss
iy Bate
PIII
ee he elle i re ot en AR]
Breenst imnst
I 00200002I 4an00000I 00000000
Aer ene tGaennt
sI IInI ilsI lsmS ann
1 + ees tat dats wt at, v-efiPocw rttiheosenTnitteea al
389
rt
"Gory
Tissue ventory (continued)
Table:
FC-143: Tao YeaRrikeOrralLaTboornactiotryi-eGsa,coTgoecn.ici3t0y Study in Rats
SPpreocjieecst:NRuastber: 028100012
Tissue Nase prsekpinutial Bland SSoofftt TTiissssaueess hLebaddo]nen) SoSfotft TTiissssuueess ((leecgh)) TSohfytmsTsissars (hora) GUenniedreanltCifoimeednTtissue
DoRVseREGRCroRDupLRIAWaEnAeI:RIRCEROIANITRERR0pIORpLRiRRRiRAtRARRE Boinal aber ===LLmmm neonones
OG9re1Ib2Ib3Ib4Ib5Ib61a71b81e92b12E22s32E42E52s62E72b83E33b43b53b63b73E83D5 Sn FFFFFFFFFFFFFFFFFFFFFFFFE
s se eh ee pn s een eee e ee e ne s een eenen i ee e ee e
390
AAc+iinnddiiccaatteessotnlyahadnioaangdinaotgsuiasstwiacs
scaodmee.ntAw-aisndsiadcea,tesPlehaatsemr0efderitao gthenoSroicnsgolmeieTnsatbulwaatsedmadMer.inal Tissue lnventory Page: 26
Report.
00778
isan ovary (continued ibe Lsoratarios, Tc. 30
jr
FT You BalTotrope Sat in ts
Sreoleeshmstbrs EZ
Tsun bie
SRoT nRRrRoERaRtRRFT -E1R6R39R0ApRoART ARRRRERR tint ers ToIr33e3o333r3e3s3e3n33t3a3a3r3a3i5t3i3l5l3l3
S$E5R33E5E305T513T315059855040e040h0t0s0b0t0i1i1t P12E 3367T 01505H079I 0123T367E 8001
Torben
enn
Le tstioe
rere n errr irr
LTaenshytfel tester)
Ln aapan nazANa IILL
Fuses
Civeviveterreartrtraint
SSiuvlarysttoand Sim Gat
C Ci aer vn arrrra rer rra errren rr ae, Tirnua,
.
TTeriedeidiamis
Vivi rriverrnrern rrvarra rerire
rir str
nnnnnaanas
eee he Fling Heats! we ot reed by rots eee
Citra sunt
SIITIIIIIIIIIIIIIIIINI
Liehhtooid drrariea)
Ds IIIIIIIp IIIIIIn IIIIIII
4 nscates hat iagis sas ane, - inicates ht no digs a coment ws wie 391 iste Testers ae:207 779 Ac indicatesonly a nondiagnostic consent was wade. Please refer to the Single Tabulated Anisal Report.
.
Tissue Invatory (continued)
Table:+
FL-143:
Too
Riker Laboratories, Toc. 31 Year Oral Toicity-Gncogenicity
Study
in
Rats
Project Washer! OZBICRO12 Species: Rat
TissueMane PSrkeipnutial Gland SoSfotit TTiissssuueess ((eaabdto)nen) SSoofftt TTiissssuueess(l(eecgk)) ThSyofmtuTsissues (Whorar) UnidentifiedTissue General Coment
BosTeIGrLoLupENLasTe:IFIC-I14E5I30E0IIIIIiiiittt RARRARARARRARRRRRRRRRRRAR
Arias]Naber 3<3o3s3s3e3s3e3s3s3e3s3s3s3s3n3s3o3o3o1n3n3o3o3n3s B5E5E5B5E5E595959595959595950606080606060606081616
Ser N1R2N3K5K6N7N0N1N3N4N5N6N7N9N0N1R23E5N6E7N8R9R0R1N s Ce a m e en n e ee ee e e ee e ne s b se e ee s n nnnns nnens eee Sees
A+indicates tahdiaagnotsis was sade. A-indicatesthat modiagnasis or comet wis mide.
392
Ac indicates only a nondiagnostic consent was wade, Please refer toTitshseueSivneglnetoTraybulPaatgeed: 2dn2i8sal Report,
00780
. .
.
Tissue Inventory (continand)
Table: 4
Riker Laboratories, Inc. 30
FL-143: To Year Oral Toicity-DncsSgteudvyiicniRtatys
Project Masher: 2810012 Species: Rat
TissueNase
DoseGroup Nase: F-13300 pn RTIRLRIRARRTRTRIRERRIIRRIRRIRAi RRRiRRRtRE nina] Naber =m mmm mmm nnn nnnnnns 3333333333333333333333333 BTIEIbIE1b1b2b2E2b2E2b2E38383E383b38383b304b4b4b4b Ser N2N4K5N6N8N9N1N3N4N5N8N30R12R 345N679A014N5N
forretnsal Bbornaeinarrow EEsroephages HKeiadnrety LargeIntestine LLiuvger Lyagh Node(aesesteric) KBausraayrySlut Pancreas Pi[ tuitary SaPlroisvtaartye Slang Seal] Intestine SlSpeinael Cord STteosutsicsh/Epididmais TThryarcahieda UUtreirnuasryBladder Beoeneeeeeeeeeeeeeees Tht HaCrldietorriaalnSGllaanngd LLyyssoghhNNooddee (abdoninal) Lyash Node(thoracic) Nesentary
flloving
F Sere b b rbae seb srey ee
FF AREarbrrbar etaaeere
LEFER
PPaPa
FC ARE ierr ssa a
FLaebeieebree rrasaashi
FC ARE b ier e rea ae
S ee e ae n
Farrrereraes ices
C FAbeh rerC Cbesbi cc eraae sresE as ca ra
CB erii a bbrsac sasbee aisac isiiae chris tyiy
FFAeErEeer erers r a ee y
Fibber ber aaaae rea
CFeabbieeererbe ree se aaaaes
FS EE b ee rib ete aaeea e r a
Fabeiererasesieieieieiieieiny
tissue(s) wS ere not requirede by protocol ---rg oereeeeeeeeeeeeeeene
e ee ee e
S ee e ee n
Er
Ee
A+indicates tahdiaagnotsis was sabe. A - indicates that mo diagnorocsomienst ws made. 393 Ac indicates aly a nondiagnostic consent was sade. Please refer toTitshseueSiInngvleentToarbyPulaagtee:d n2i9val Report.
00781
Tissue Inventory (continued)
Tate4:
FL-143:
Tuo
RikerLaboratories, Inc. Year Oral Tosicity-Dacogenicity
Study
in
fats
Project Nasber: 02810R0012 Species: Rat
Tissue ase
Preputial land
SSokfitnTissues abdones)
Soft Soft
Tissues ead) Tissues Ueg)
SoSoffttTTiiasssauness ((Wnhecokr)an)
UTnhiydausnstifiedTissoe
General Coment
DoP se GroupE Nase: FL C-L4S 30L 0 gpa ET rita] Mabars Rm RRRRRRRRm ARRARsRAsRnm RnRnAnRoRoRnRnRs
3B3i3bIbIbIbIbIoIbIeIbIbIsI6FsI8IbIbIbIbLbIbIbLbGb 12141504181921232425282930313233343536373940414445 Sex KKRNKNKNNRNNRRRRANNNRNKKN
eens
e ee ee e
eee
nee eee
e Se e ee s
e ee ee e gneen
Crees
394 BA+ciinnddiiccaatteessotnhlayt aadnoindaiaggnnoswotaiscssciaodmsem.entAw-asinsdaidce.atesPltehaastenroefdeiragtuoostihse oSrincgloemeTnatbuwlastedmdfee.isal Report.
Tissue ventory Page: 230
00782
Tissue Inventory (continued) Riker Laboratories, Inc. 3% FL-443: Too Year Oral Tonicity-Dacogenicity Study i fats
SpPercoijeecst:NRaantber: 0281012
Table:+
Tissue ase faerretaal Bone Marron BErsaeiphnages Ere HeKiadrntey Lirge Intestine LiLuvseg r r Naasap ry Glan-- d ] Ptuarrcyreas PPiatruaitthayrryoid PSraolsitvaatrey Bland SwSapilnlal CInotreestine Spleen StTeosntsicshEpididais Thyroid UTrriancahresyBladder Boeecrsecieecs The HClairtdoerrailanGllaanndd LyLygeghhNNooddee Gabdoninal) HLeyseesnhtNaordye(thoracic)
Beinal folloving
DoTseIGLroCupEKIasIe:IFIC-I14I5 I30E0 IpoIn tiiiiiitt Haber -RRR= RmmRmRRmRmRmRRnRoRnoRRRRRRRRRERR
A bibbbbbibbbbbL bbEBEbbEEbEL C1AIL4L5A6N7A8A9S0S1S35457585960616283658788707273 So FFFFFFFFFFFFFFFFFFFFFFFFF
S Farc rrebreersesiiireeietreaeasaearreaairiesn LFierteteeerreeestiaesteesrieiaieiaiaiaieiiiieist SCeesrederrcceerrcceecrrccacrcrErcaarceEiiirieiyt iLeirieeeesrteetraissiiieiirirresarnearrraiiieesn LPeiebeeersceesrtciessiireariareaerrrirrriiireeys FFieterertriertasteatiiareirranciaiaiiiitss CEiRitttrercereesRaRriRrriiRiiYe VCeirceicrgecbcecrcaeieebreaoicaeiricearcacaaicecs CARR een CSeerbrca abcractreeaeaaercaacaaeiest Liiibrieisiireesrseteasririiriiiiirrraeieeanneesn e Cirrerriie aiaiereee reseains PLOiberceercesrcerRreReRsiRcRiTcS:e LC icteiricteistnrceaerscaiirrisrreernrnencnenens tissue(s) were not required by protocol =wwowsoweeromemcres J EEReeE e J eE e t es ee
A+ Ac
iinnddiiccaatteessot nlyaahdoinadgit naogsniosstwiacs
scaobmem.entA-waisndaiudcea,tesPletshsaet
rreofedr itoatgheonSriocnogslmemieTnsatbulwaatsedwadfen.inal
395 Report.
Tissue Iaventory Page: 1
00783
Tissue Inventory (continand)
Riker Laboratories, Tne. 30
Table4:
FE-IA3: Too Year ral Toxicity-Dncogencity Study in Rats
PSpreocjieecst:NRaastber: 028120012
Tissue Nase Prepitial Eland sSokfitnTissues Gbdonen) SSeofitt TTiissssuceess ((ohega)t) Soft Tissues(neck) TSoyftaTsissues (thoran) GeUnniedreanltCifoimedeTnitssue
DoPseGrIoupONasLe:FCU-10I53I0L0IIIILIEI EnIy Anita] Mader =RR= Rm RRRRRe RARRARm RARAoRoAe oRAoRAS
FbbEbEbbEbEbEbELELEEEELELbED AAAEAAISSSSSSSes68888TT Ses FLFIEAF5FEFTR8F9F0F1F3F4F7F8F9F0F1F2F3F5F7F8F0F2F3
aa b e ee e en e ee ee e meee ee a e e ee e ne s
-
396
A+indicates Ac indicates
otnlyahadnioaangdnioatsgniosstwiacs
cwoamdem,entAw-aisndsiadcea.tesPtlhuastemroefedr itoatghenoSriocngoslmeieTnsatbulwaitsedaimdei.nal
Report.
Tissue lavetory Page: 252
00784
-- Riker Lira, Tn. 0
ie
FE Te Tw Dl Torco cpt Sty i ats
rjc huts ec
Species: Rat
Tie hae
SRoT sARroREEtRsRRF1R0R5R0RT RARARERERRRS bint abs C Hoioo IIe IA
Sm TEI ErR012I3a5RI EIERI01I3TEaE5T0IE E T0Ie01I 02I0308
ue
iiiiiienttriiiariereenes
Lhrrset tril
l rrvivirirrii eaarreviess
raed
Siveeinivevenriveveiiies
SSSaitiolrCHyossles
GA s irimI iiia eeS erniL iin eiiE iees
isons
Jilin dttantnans ses
roy tr
ea ye
es Th elon Hes) re Bt Foe A] rr
Stl he
Jaan
LfUoesttteote brian)t
L t L h n n n
rics ol dri Const se Pae el iihesSoewtTo0Pea0ts:7w8l5ert, A + indicates that adiagnosis was sade. A-indicates that no diagnorocosmienst was made.
397
Tissue ventory (continued)
Table4:
FU-L43:
Toe
Riker Laboratories, Inc. 30 Year Oral Toxicity-Dacogencity
Study
in
Rats
Project Naaber: 0281CR012 Species: Rat
TissueNase Preputial Blane SSceiittTTiissssauerss (Ghbadaotn)en) SSoofftt TTiissssuueess((nleecgk) SoftTissues (thorax) UTnhiydwesnstifiedTissue General Consent
DosTeIGrLoIupTINasEe:IFIC-I14I3I30I0IpIpIIiIitaitt Arita]Naber +R+AR+eRRenRnRRnRRnRonRRnAeRnAReReRARRARE
rrr 7G7E7b7b8b6b8b8b8b8b8b8b8b9o9b9s9s3E9s3s9T0T0T0T0T0 5789012345680134567801235 Sex FRRFRFFRRFFRFFFFFFFFFFFFF eee e ee e ne s eee eee eens e eb e ee n reese
AAc+iinnddiiccaatteessotnlyahadnoianadginaotgsniosstwiacs acuodmem.entAxi-sinsaddiec.atesPletahaste 1re0feGr itoatghenoSrioncgsolmeieTnsatbulwastedmifea.isal Repor3t.98 Tissue Inventory Page: 234
CCOT86
B
Tissee Inventory (continued)
Table: 4
FE-143:
Tuo
Riker Laboratories, Tac. 3 Year Oral Toricity-Dacogenicity
Study
in
Rats
Project Masher: OZ81CROL2 Species: Rat
-
Tissue Nase
faatrrtensal
Bone Marron
BErsaopihnagus
En
HKeiadrnety
LiLavregreIntestine
LLuysgshNode (nsenteric)
HOavsasrayryBlane
PPaanrcartehaysroid
Pituitary
PrSaolsitvaatryeSlang
SpSiumaalll CInotredstine
SStpoenecnh
TTheysrtoiisdfEpididais
UTrriancahreya Bladder
Utmemrums
Th
Clitoral Gland HLyaarpdherNioatne land LLyyasgahhNNooddee((atbhdoornaicniacl)) Hesentary
Boiaal folloving
DoTseIGLroIupTNIasIe:IFICE-I31I0i4pi3piiiiitiiis Naber R= A=mRRm RKRm RRRm nRnRnRm nRnRoAm sRsRcRm eRoReRm aRnRnE
3bE3bIb3bIbIbIbbIbIbIbIbIobIbIbIbIsIbIbbIbIbIlGE AA7A8A9S0S1S2S3S4S5S6S7S8S9h0s1s2s3b4a5b6a7i8e5T0 See NANNNNRENNNNNNNNRRRNRNRRN e Cerbe eebn erais aarnis Fe e Faberchee rerteeere iniiiics e Febe ererieireabseaitsieerereieiiainieiness e Gen rbn er a a LEVira ey: e F ss E es Ce rcercherettte ereeiriiriey FCebceeirbearceetreeerteceoteacseiiscrrbriincies FCAeErbereasbteersacchaaeeaseaieriaiaiacsh e ee ee e SBeerrieerere eraserr iirrrra riiiis FFearbbeerriereesririesreresbeiscraasrarsiairiciht FFeebtbtreisbeeararseeeresiisiairiiicihcisy tissuels) we ere fot FAUIrede by protocol wewn eeverecreneeceee IIIs eae i be e e e ee n m SILL emes
399 AA+ciinnddiiccaatteessotnlyahandoianadgiaaotgsniosstwiacs scaodmem.entAw-asinsdaidcea.tesPtlheaaste nroefderitao tgheeoSroincsgolmeienTstabulwastedmidMen.isal Report.
Tissue avntory Page: 235
CO787
Tissue Inventory (continued)
Table: 4
FL-143:
Too
iter Laboratories, Inc. 30 Year Oral Tosicity-Gncoqenicity
Study
in
Rats
Project Nanber: 02810012 Species: Rat
TissueNase PrSehpinutial Slant SoSfutitTTiissssuueess Gesaddo)nen) Seit Tissues eg) SoSfoftt TTiissssuueess(e(hcokr)as) TUhnyimduesntifiedTissue General Comment
DoTseIGIroIupTMIavIe:IFC-145 3T0 poin nian RRRRARRRRARRRRRRARARRRRAR Anita] Mabars 31sTs3sIIe IITsIIseIeIss IsTnsIeoInIs oEnIne InGs BKAELbEESbSbSbSbSLSESbSESsSbebsEsEsbsbsbbbabnbiblE 785012345678901234567890 Sex KKKNKNNKENNNRNRRRRNNNNNNN Se ILI ne e ee ee e eee S ee e an s se etesssrse srsurmeen ressasas eee
A+indicates tahdiaagnotsis was sade. A - indicatesthtnodiagoorcsonisenst wis wade.
400
Acindicatesonly anondiagnostic coment was wade, Please refer toTitshseueSivneglnetoTruybalPaatgeeds A2n3i6wal Report.
CeTss
Tissue ovestory continued)
FC-143:
Too
Riker Laboratories, Toc. 3 Year Oral Toricity-Oncogenicity
Study
in
Rats
Project Naber: 028ER012 Species: Rat
Table:4
TissueNase
afaorretnaal Bone Marron
Esaphages
HEeert
itney
LiLaargre Intestine
LLyuanpghMote (aesenteric)
DHiaasrayarySlant
PPaasrcartehaysroid
PrPiotsutiattaery
SSaullivaIrnyteBsltainnee
Spiral Core
SStloensch
TTehsytriosi/dEpididnais
UrTirniacrkys Bladder
Uteras emma
Th
HCalridtuorrialanBllaanndd LLyysseghhNNooddee(abdominal) NLeysaesnhtbaordye thoracic)
DoseGroup Nase: FC-3104p3a
RTAIRLRLRERTAERIRIRIRERiRIRiRiRiRiRiAtRiRtRiRtEnRt
Hoiaal
Nagbers
== mmmoooooeaseeeees 3333333IIIIIIII3IIIITIIL
b7e1b7b7b7b7b7b7b7b0e8b8b8s8s8s8b8s8b8i9E5b9i9b9s5
Sex K12R34K5K67K8K90N1N23N4N56RN7N8NR9RN0K1NR2NE3N4RE5
e Ce rn es a eee
g Cirberce eresiee siriarn iiiiie FC ebee reeer raser ssiaa niiir iee Ce irberb ee rrs e aares Ceres eee eee eePe RR R RRS CLoileiceeri cerase acasae ccceee rirt FCiabbibriearbeirbeieisaiisatcactearrrianrirnainyy e ee ee e LF eere eseer ratab sisie iiiir iey iCi ib iere etee eisb iiii iaie iiais aiian EDeerrreebterteisbtiasirtiebaiaetaieriaieareeeys folloving issue(s) were sot requbeyiperroeteocdol ----roe-eee-neeeeceeoeee
e ee ee e eee eee ee
es
A+indicates tat a diagnoswias aade, A-indicates that no Glaorgconosenstwiis wasde.
401
Acindicatesonly
nondagnostic comment was sade.
Please
refer
to the Single Tabulated Tissue Tnvestory Page:
niwal 257
Report.
cCo7TEd
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Tae:4
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SPreeecsW:aatrs EICI2
Tee oe je SSiit TTiisss riyoe SoSSfiitttTTiTisisnusesss toeangrt))a) j Soe pfourt--
esT e Gow Me FH -1653300 E RRRRERRRARERRERRRARRARRRD 3i13L13E731i31e37h37i37t38a38i30e383b83i3t03i838i30e38i30t30i30i30t003s% P123P 1507eT n01234H587T80T1254% Cena FETIL m CLI m eee c III IT
8+ atctes that a Gages as ane, - nictes tht no diagnosis 5 comnts ade, 402 A c indicatesonly a nondiagnostic comment was made. Please refer toTothbeeSiIngvloe rTaybuluaetesd 28Animal Report.
00790
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4B+iinricaite ihyt vdacpseonaes,t i- iandti.cateFltute rneeargn1.oistihvse SomictoomrTtrlawieesatM3,1il pt403 0791
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erstetna:ber coz
Tose ae fr SSSohi TiToosnsues (Ghd0ee)hnn StTos (van) rnin Tose
oReEI RroRREtRsRRET R1R5R0ARRRAn RRRRRRES C EE EEn EE E Sw CFTEeeFanTiiEiaEiFiHnsE1iF1TI1aT2Ev2Ia2It2T2sE1aR2Is2FE2En2rTe8mT Fp, C S Co I l h I m Colm cm
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C0072
Tissue Tovey (continued)
F145:
Too
Riker Laboratories, Inc. 38 Year ral Toricaty-Oncsgencity
Study
in
Rats
Project Naber: 028180012 Species: Rat
Table:
Tissue Nase areal fBoornetsNarrow Brain BEseeprases KHiedanrtey Large Intestine Litvunegr Lyosh Node aesenteric) tRaanrwyary Bland PFaarsactrhaysroid Ppirtousittaatery Salivary Gland SSpwianlall CInotredstine SSptloenenach ThTyerstoiisd/Epididais UTrrianchaersy ladder Utreerueseeeeeeees Th HCalridteorrialanSSllaanngg LLyyaspshhNNooddee abdoninal| NLeyseeonhtNaordye (thoracic)
Brita] folloving
DosTeGrIoupTNaseT: FIE-T31I04LgIo5aIIILIIIEEttIy Mader RARmRmAmRRmRmRmRRnRnnRRnRnnRRnRnRnRnRnRaRAeRie
F 1777771771171a 1117177171771 S1I2T3I4I5I6I7I8T9A0M1M2M3M4B5M6A7U8L950T1T2I1S4T5 Sen FFFFFFFRFFRFFFFFFFFFFFFFE Ferbrereraeiereee e eee e n eeean e Fer iiibere rrcracere cearanae e Cereebabeeaerreeeesgaeenaeireeea Fe eeeeeretn eiieisarn ririnieineey FLerbeeeerreereerbaaisiastiirssrirre iiisey e Liberere ccesesn rsarirs riiies CFerbeeeerscetrrsiiceerrsriicahaiaiiiairteyy CLeeerbecreareecbeteireeerscriaastcihrcahiiriiiies e Cerbrerere ataritaee rrrerieieiayn H e en e ne n nes na Ser erceb eeei r a acey e Cee ib n a eeen FFrerreierscrheesreberccerseiraesrccaeicieiaiiiicc C Gibb e ba er sa s aaa tissuels) were net required by protocol ~---eweeeeeeeeenenee enen ee a een ee en eeea en m be e e e ee n
405 AAc+inidndiiccaatteess ot nlya3andoinadgt inaogsaiasstwiacs csoandsee,ntAwa-sianddiec.atePsletahste r7e0feGr ltoathge oSnricnooglmemieTnsatbulwaitsedmdAen.il Report.
Tissue laventory Page: 241
00793
Tissue Lovestory (continued)
Table: 4
FE-143: Tuo YReairkeOrralLabToorsaitcoiritays-,cogTaecn.ici3ty Study in Rats
Project Masher: 081CROL2 Species: Rat
Tissue Nase Freputial Gland sSokfitnTissues Gbdonen) Soft Tissues (heat) SoSofftt TTiissssuueess((neegc)k) Soft Tissues (hora) GUenneirdaalntiCfoinntednTtissue
DosTe GIroupLNasIe: EFCL-31I04pIL3pELIIIiEiInnIy J RARRRRRRRRRARRRRRRRRRRRAE
A 117171771a 171111111a 71177717 333333IIT44MM444444555555 1234567890125456789012345 Sen FEFFFFFFFFFFFFFFFFFFFFFFF FEene eee eee e ee en e eee s e ee em e s
406 AA+ciinndiiccaatteessotnlyahadnoianadginaotgsniosstwiacs csoadmee,ntAv-aisndsiadcea,tesPltehaastemroefderitao tghenoSroicngsolemieTsatbulwaatsedmadfei.nal Report.
Tissue ventory Page: 242 C0794
APPENDIX ITEME STATISTICAL METHODS. 1. For memo dated February 11, 1985; see Tables 12-18 2. Foanrdme20mo dated September 24, 1985; see Tables 19
407
00795
:
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 Swpct Statistical Analysis for FC-143 in Rats
Oo February 11, 1985
3M
cTraerbolnabFoCr-a1t4or3y ivnalruaetss hanadveobregeann waeniaglhytzedd,ataandforthetheressutlutdsy oafrefluorotporesaennatleydzeinthethedataattaacrheeddetsacbrliebse.d Tihnethsetatfiosltliocwailngmeptahroagdrsapuhsse.d
Statistical Methods bThoedymewaenisghtandratsitoasn,darodrgdaenviwaeitgihotns toforbrapienrcweenitghotrgarnatiwoesi,ghtandto laboratory data were determined separately for each sex and dose group. Tofhesvearidaantcae.werIef athniaslyzteedstuwsaisngnoBtartsliegtnti'fsicatnetstatfora =hom0o.g00e1n,eittyhe dtahteacownetrreolfurgtrhoeurp uasnianlgyzeadtwbyo-tcaoimlpeadrinDgunneeatcth'strteeasttedagtrotuhpe ato= 0i.n0d5icastiegdnifbyicaanscteerilsekvsel.onThtehermeesaunltstabolfesD.unnIefttB'asrtlteetstt'shatveestbeen Dwausnnestitg'nsifitceastntwaast oper=fo0r.0m0e1d,'onthethedatraankwse.reThreasnekedresaundltsa htawvoe-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(T1e97s1t), Statistical Principles in Experimental Design, New York, McGraw-Hill Book Company, 201-204.
408 COTI6
Appendix Trem 2 Psatgaetis2tical Analysis for FC-143 in Rats SeM:enr 02/11/85
CaonBorRviaerdrkg,eTWrB.aednt.ws,efeonramndaPtairIoannnanse,iriRc.L.ind(19N8o1n)p,ara"mReatnrkicTrSatnastfiosrtmiactsi:o,nsThase Anerican Statistician, Vol.35, No. 3, 124-129. kInfowy.ou have any questions regarding the analyses, please let me
JSeimm sem
Att.
.
c: Ler CathJy E.1bLiundsekmtann HEE/RNH
409
00797
-
Internal Correspondence
APPENDIX ITEM E
% Le Jd. Sbinski - Riker Path aridTox = 270-35-05 fom Se E. McCarville - Riker Res Data Ops - 270-3A-01 weer Statistical Analysis of Microscopic Findings for FC-143
ove September 24, 1985
TThoeximceijtoyr-Omniccorgoesnciocpiitcy fStiunddyingosf oFfluotrheocaTwrobonYeFaCr-1Or4a3l in(DRiaetts) wteirone t`hsetatsiesxteiscawlelryeaannaalylzyezde.d Fsoerpaeraacthelyorguasnin/glesaiotnwo-ctlaaislseidficaFcoinsthreorl'ss. ExAancta=Tes0t.05comspiagrniinfgicaenacceh tlreveealtedwitghrouBponfteorrtohnei's oardgjauns/tmleenstionf/osrexmulctaitepgloeryc.ompIafritshoensexpwaescteudsedvalwuiethionf eeaacchh cteelslt wweess ugsreeda.terAnthaasnter20i,skthoennthYeatessu'macroyrretcatbeldesChiin-dSiqcuaatrees agrosuipg.nificant difference between the controls and the treated
References Fisher's Exact Test: CNeownovYeorr,k,W.JoJh.n,'Wi(l1e9y71)a,ndPSroancsticIanlc.,Non1p6a2-r1a6m4e.tric Statistics, Yates' Corrected Chi-Square: FalnedisPso,rpoJrotsieopnhs,L.,fiew(19Y7o3r)k,, JSothantisWtiilceayl aMnedthSoodnss fIonrc.,Rat1e4s-15, 13-20.
47 att 5. EL MeCarville sgn
cx MEE/RWH
410
00798
-
APPENDIX ITEMF
GROUP MEAN BODY WEIGHTS, INDIVIDUAL `BODY WEIGHTS AND FEED JAR WEIGHTS OF MALE
RATS RECEIVING FLUOROCHEMICAL FC-143 IN DIET FOR THO YEARS
NOTES: Code 1 indicates a control group rat weight
Code 2 indicates a FC-143 - 300 ppm group rat weight
Code 3 indicates a FC-143 - 30 ppm group rat weight
-
Codes 11, 12, 13 indicates the total feed jar weight for
the previous rat
AI weights are in grams
_--
411 00799
AppENDIX 1700
Two Year OroaflFu(oDireotc)arTbooxniciPtCy_14-3OnicnogReantiscity Study Group Mean Body Weights (3) + Standard Deviation
Males
Veseou.ay
cHooanntroBl 1-W50 p0pm) Mea3n00Bpp2mWSD (0) ee3n0 BppWm sD (0)
2
716055.3%2 1106.45 ((6655)) 213642.3131 2111.70 ((6635) 71617..00%4 154.78 ((5300))
5`
33394/07033 32180110 ((6655)) +27360.8736% 3361..68 ((6633)) 3+2386.95.3%4 3200.98 ((5500))
105
44506122%3 4372073 ((6655)) 4+3330.1233 4394057 ((6633)) w4d4110..53%3 4347.02 ((3500))
11"2
947350.253% 441374 ((6655)) 13928.08X% 4467.47 ((6635)) 44155..143% 4478.65 ((5500))
118s
S5I0521.39%% 4488179 ((6655)) 4a326s..04%: b47i.a5 ((6653)) 443887..59%% 5522..85 ((5300))
222
552261.383% 5492015 ((6655)) 550.4% 53.0 (65)
3e6aT1.43% 4466..97 ((6640)) wase2: 45.4 (64)
551192..41%% 5534.76 ((5300)) 526.3% 56.7 (50)
2 30
556617.503% 5554030 ((6655)) 576133 567 (65)
w7B5e093E S49144 ((6843)) sSime..9z%: e59n.s7 ((5500)) 497.23 51.8 (63) sse.6 4 61.3 (50)
32
850201.9633 65271.54 ((6655)) SS108537 5S22.55 ((6633)) Ss1e16.334 6632..33 ((5300))
338 wo
$59991.0433 5S5947 ((6644)) 684s 6116 (64)
5s2i0i823: 5S33.12 ((6633)) 535.2% 56.0 (63)
558745..04%3 6654.66 ((3500)) 592.3% 69.0 (43)
"2 prs
661192..89%% 6621123 ((6604)) 625% 643 (64)
5*55040..89%% 5578..90 ((6633)) 552003 61.2 (63)
61000..45%% 6699..17 ((4493)) 612.1% 71.0 (49)
s80 52
66296..213% 66730.04 ((6644)) 6863 11 (64)
55656..75% 6644..70 ((6633)) S0.1E 66.2 (63)
662118..19%% 7742..23 ((4499)) 630.6% 76.2 (49)
EE
--
2+ SNuimgbneirfiocfanatndiimaflfserweencieghefdrom Control at the 5% level (Dunnett's t Test; a = 0.05)
412
00800
ApApPPEENNDDIIXX IItteeMmFo Two Year OroaflFl(uDoireto)caTrobxoinciFtCy-14-3OnicnogReantsicity Study
Group Mean Body Weights (g) + Standard Deviation
Males
-_--
sWteuedky
CMeoanntroBlW+-
0 ppm 5D
(N)
Mea3n00BppW+o 5D (N)
30 pm Mean BW4 5D (x)
-_--
5564 s8
665661..364% 7735..33 ((4498)) 668.0% 76.4 (48)
5+7873.156 7619..28 ((4488)) 587.93 73.9 (48)
664461..4+9% 7768..96 ((4499)) 652.7% 78.2 (49)
6620 64
667734..243% 7757..44 ((4488)) 664.5% 77.6 (47)
5+95093..82%3 7754..93 ((4488)) +5963. 80.8 (48)
665565..87%3 7892..15 ((4493)) 656.3% 84.7 (49)
6686 7
665506..836% 8728..19 ((4477)) 661.9% 84.7 (47)
650948..923% 8830..08 ((4488)) 608.23 79.9 (48)
666662..55%% 8842..00 ((4477)) 666.23 86.8 (45)
772 7
665680..38%% 8861..73 ((4467)) - 6*0610.81.%%5 7766..55 ((4466)) 667.7% 84.9 (46) 605.4% 76.6 (46)
665694..243% 8836..93 ((4455)) 663.8% 86.0 (45)
8708 82
667608..68%% 8853..28 ((4466)) 663.13 85.5 (46)
660141..683% 7767..75 ((4466)) 610.0% 77.1 (46)
666691..27%% 8889..03 ((4455)) 666.9% 87.0 (45)
8864 88
667658..61%% 8868..88 ((4452)) 678.9% 86.4 (41)
6v1671.7.5433 7798..18 ((4466)) 614.7% 83.0 (46)
666642..53%% 9925..67 ((4445)) 654.7 3102.3 (44)
9220 5
668960..00%% 9913..69 ((4401)) 678.3% 30.3 (40)
662210..86%% 8857..63 ((4455)) 627.63 80.8 (45)
6656322311..000394.55
(43) (43)
660.0% 86.1 (40)
96 10508
667757..75%% 9958..16 ((3388)) 671.1% sais (37)
662217..023% 8840..68 ((4455)) 625.5% 87.5 (44)
665539..47%% 8878..08 ((3389)) 660.0% 94.8 (38)
110042
66426.035%1.09193..25 ((3356))
661239..34%% 8888..10 ((4444))
665604..80%%
9953..02
(37) (36)
_--
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413
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