Document Neyrrob6MZ6Y3QG7XrVVpBGkp
:
HASKEALLNDLAIBNODRUASTTORRIYALFOMREDITCOIXNIECOLOGY
Trecho Lo apis cc: G. Kennedy
W. Krauss
October 29, 1987
TPoe:on:ChaGrrleges SyRkeeisn,harWdtG,Kw.p
Two-YeaFrluToorxoicchietmyi/caClarcFiCn-o14g3eniicnitRyatsStudy of
tShteuidryIcfohinandvdueincgtrsee.dviebwyedthethe3MpCaotmhpoalnoygyanpdorthaivoenssoefvertahle cchormomneinctsrartegarding
tthhee nionInc-ranmeeasoiepndlaessitsnieccnitdiefanilcnediaongfgrseehmgeepinavtteincwiitn"hmethgtehaelorceiypntotorestri.psre,Stpavetacicioufnoilcoaaftliloyn,,
mp"ehctoyassbpthooalitidasdsmeeg,aenndaesrptaaotrxitioacnti"ety.aamndinTohnetercarenolssefivesartaiwsoaens
ocfleasreruemvidaelnkcaelinoef hepatic and alanine aminotransferase
liensimoanlse. ratTshe (a30bseanndce3o0f0 reflected the relatively
epplme)vatceodrrehleaptaetdic wietnhzymtehsesein htihsetolfoegmiaclaels less severe liver lesions in this sex.
praetghaorldTsohgeirtseottahp(eRp.eairGnsetieltr)opraehntadvaetitohbneeenosftusdosymoemedidroietschategorrreenmo(eLn.n-tneSoibpbeiltnawssekteiin)c twlheietshisotnusd.y
hoTfhyepeardppraletanhsaoillaognyo(3d0urleaparondrth3y0dp0eesrcpprplmiabseifdaemat(lh3ee0s0)splpiasmghm"talslyeecsoi)nndcararnedialsyeodvacroiimnapcnoiudnetdnucbeular
ierennltdaeotrgepednr,oeutsaptrisootbnea,rboliytdhset"h.srtouudWgyhhildteihreeI cFttCoe-rn1'd4s3tocalhatagerrraeecedterwliiitzvhaertitomhneistaofboltihessme of
effects as "equivocal" was not unreasonable.
ncoatrcianpAopLmeLaasrofatontdhebethhdeeopsaietnicciredlenanetcoeepdl.a(smmaslTehseo:bsie3nr,c1vi,ed5de;ncienfeomtfahliesnso:dsutlu0ad,ry0,1hw)ey%rpeerdpidlasia
s(tmaatleiss:tic1a,l0l,y2.; fAesmalien:dic0a,t0e,d3)*inwatsheslriegphorttl,y effect, if real, was a sequela of the liver
tihnicsreahsyepde,rpltahsotuigch not degeneration rather
atlhtaneraatipornes-ne(obpalsaospthiilcicc,hanegoes.inopThhieliicncainddencveacuooflahteepda)tocayltseo did
not suggest a pre-neoplastic effect.
* 0 ppm (Control), 30 ppm and 300 ppm, respectively page 1 of 6
consi(dAelrtehdougtho to adequately
ebtexheplcasaitrnucdiyntohgereenpfioorcltloiwcnionntgchelusdtreaatdt"emteh(napttasge"FfCr3-o51)m.43thietis afpanpoitejnedded
pathology report. (page 123):
= =
i,IInnncifmdeaemlnaecleeraitrnsa,tmsa,mtmhaetrrhyeerewfaisbwarsoa asdaetnasottmiaaststiisctaatilclatylhelysi3g0s0niigfpnipicmfaincltae,nvtelc.oi"mnpcoruenadsed
artelathteed3o00ccpuprrmenlceevelo.f" benign Leydig cell tumors of the tesces
TtoepobretAalwptephrloeiuegdwheatikot. wtahseIsneapoprtrduoemprorrsit,aotetshuepfporlreemhfeiensrtteonrctiehscealpcuibtilenidcsihdieendncteh1eidtaestrtaautdiyre, BIL)a.hbaovrThaeitsoarpyph'eisnsdtemodorsicttahlerecdceaontntatro1il3nclciuhndrceoisndiecn9c54eramtdaaltseatudadniedersiv9e4(7dAppfferenomdmailceHeassokrAell:lCanhd Stperramgiunea-lDlaywlseaycrirfatiscedwhiucnhtilwer2eyeaatrsleoafstag1e.year of age but not
ntuhmebenruI,mnbestrihnecoefCasureantesxoafmaismnaemtdmhaemraydmemntaourmmyiornsag,tloarni,dt
riastmhoerre thraenalitshteictistsoueuse usually indicates
4u(2nu8ds)ei*nvgelco5e0pretdariantolsry aassturgotgphehesitededednogmlaianncadot.mopro)uTnhdein rietnhlceaitdeeFdnCc-e1e4f3foefcsttf.uidbyroIna(d20ei8nt,eomaa3s8r%g,ument
oafgaifnisbtroasudcehnomaansefifnectth,e htihegh-sdtousdey that reported for untreated aging
freepmoarltesst.a.t..e.s wtahsatsi"mtihelarintcoidence rats (Prejean, et al. 1973)."
T1fh8i1ebrofPaerdmeeajnleoeamnarsar!tesf,eIrneannacdney,tchaehsyoew,ewveersrei,ncteerrempthioenratlePldryejaensaancirniscftiiudcdeeyndceiantcoflu1d8oe-ndmloynotn2hl4sy%,
mciatomnmtwraaosrlysantu(mAiopnrpaepndpdaritoxapriCia)s,tecotmhhpiearsreteodrdiocetasol HnoartsekfeealrplepnecaLera.btoorWahbteeonrya'ntsyhechoiFmsCpt-oo1ur4ni3dcal
related effect (42% vs. 37% (p=0.3]).
was aTlshoe siungcgreeassteidveionfcidaenccoempooufndLeyedfifegctc.ellThaedensotmuadsy r(e0%p,ort4%,cit1e4d%)* nrtaowtrosm.arlefTheberaecnkfcigerrssotunidnrefiietnrsceindcceoennctee(nAtonfiveornL,eytdehtiagt alc1.e4)l%l wwaatssumooifnrs lliiintnetlSewpirvtaahgluuete-hDeawley oaclnoddnesritdheerraitdnsugra(tt2ih4oe-n38somfmaolnltthhensumstbofuedryagoef()38rafmtoosrntc(ho9sm6)p,aorfitsahogeen)m.wuiltthiTphleteheusseFaCc-rO1iff4i3tchees, TnshoteudLyesyedcrioagntds tur(me1of3re-sr2e5nwcemeroent(hoHsbaszeolrfevteoadnge)Lianbiostrhaeqtuoe1rs2it-ei2s3o)nambowlnaest,h sotelasdtpeedcriaataslsly(0s/2i8n)c.e
*0 ppm (Control), 30 ppm and 300 ppm, respectively page 2 of 6
dloactutmerentfaitgiuorne pParrants some
soikfsepadtriLacemiyasdmti.i.gcalcleIylnldfiatcfutfm,eorreSniitdncJifodrneoenmsc,eourocfhoiew2fn8.7oe%fx.petrheiTehniHcsaezlaatnedn
d23e._am2Lt8oeh%nyodslitoigrngaytcieeDnledlpiavrittdumumeaolnrt,sitnucsdaiiydesesn.ctehatoofurth1o0e8winr (h13i908s/4t19o8ri)in,ccailwdiedtnhcaetaadar(taAanpgpeesnhdooifwxedB),
hS)iogmhps-ahdrooiwsnsegagtsrhsoitusaapntitsoi(tn3i0ct0cihaedlelnFycCe-1s4oi3fgniL6f.ei1y%cdaing(t5c8e/il9n5lc4r)etauswmeiotrh(ipan0c.ir0da4en)ngceeinof(tAhp1nop1e3r%d.ix
di8f8f/e1r1e52n)t gfirvoemsthaen FiCn-cp1pi4md3)e.nciencCoiofdmebn7i.cn6ei%n,gofwthh1i4e%chHa(spiskae0l.nl0o9t)a.nsdtatHiasstliectanilydata
msatmumdayrIyrnegpclooarnntcdlufsoairiolneL,deydtiiotg aicdseelmqlyuatcoeaplriycniinoaondgdertnehesasstistt.hhee
pFCo-s1s4i3bilcihtryoniocf reaitther The pathology reporc
hdIinisdadnidonittteiriopnnrc,elutdatetheioanauctoofhnocrltuhoesfiobnitohlewohgesirtceuadlythestiexpgtantihfdiiodclaongncioetstoafpcpllheyiasrlaypFpirnsodtpianrtgiesad.te
rhItoidsetsnohtroiuclsadtludbiedeastmaenhtatsioongreeednfeutrteahlatltyherenolitimapbblelieecnathipiousnbtsloirsiohcfeadlthaednadtpaatthhfaootrlogctyhherornHeiapcsokretl.l
Laboratory data was not available to Riker Laboratory.
meavmimdaernBycaesetdutmhoaortn. FouCr-14e3xperreiseunlcteedatinHaasnkeilnlcreLaasbeoraitnorayn,y ttyhpeereofisranto
aipnpcriodpeTrnhiceaeteeoflffyecLtetyedroimfgeda ceeclqhluriovntoiuccmaolro.rsaliCsoemxspptaoirlsleudreutnoctlobeoa3tr0h0 anptdphemmiosgnthutdtyhebe nciosonn-tsnrueoslopsipcliaaosnutdsi,cthepefafrHetacistcksuelllanrolthyeidstiopnrrielcviiagolhutsclooyfn.trtohleAlpdtaohtosaus,gihblaeI 1ps4%etresrioonnicadil-dlreyencleated atbhepelpireeevcveiiadtetenhcaetthetishoepnpoLoterytgdurinegiattcyelelntooutgruhemvoirtesowabrteehedepftrieonsbitatebislvyeo.ncomtphIiosuwnodusltdurdeyl.ated,
J(oHnaessk,ellS L(aHbasz.l)e.tonOctLoabbes.r).20,Tel1e98p7h.one conversation with C. Keenan
MWPiercieesj.beuarCngaenJrcD,erJHP.ReecskSehpaaormncthaJnC,e3o3u:Cs2a7sT6eu8ym-o2Ar7E,s73 Ginr(i1s9Sw7p3or)la.dgueD-P,DawWleeiysbuRartgseranEdK
and Swiss
ALAgenisvniegornsRMRe,sienaCroBchahernri8:eB3rJ-,-2R4eLaart(et1du98a2dM)aa.leCPSapnrdaguFeo-sDtaerwleSJy. RaAtgse.-AsEsxopceiraitmeendtal
page 3 of 6
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