Document 2JjNQwbgb77pBv64g88R1EvGa

@ HAZLETON coomeomes soca FINAL REPORT S Sen si-- iAa rDa,s surat some copies T-a102 FURCHASE ORDER EER: T37359-410 754 Chemica Bckptoat Saencon ison a. CECE, TON JAN281988 ) No, HJ N8o1 0%t serie enreneo: 09.255 FR rrsce ar FICLOSEDS ACUTE ORAL TOXICITY STUDY IN RATS (OECD GUIDELINES) > KoLyyPersonnel 2 fuinsiom semen s16nED: SSSiydnoenSo imhcanoseWN sL ai ES CO0529 HR Ai ZLETOea NSuTsm seman T AChEemical & BoMeA dicalR Sciences Divison FA ---- SerpLE: T4102 rece 2 pr---- pute Toricoton SFoRone--r CSCaeltEvein2 sLa. aHtoreteonn sohaaovnetn BL.roHroiunesrtyor Buality Assurance Doeirka Curley Arndt snatonizal Fasnssege Tahermesen. PoBalnlero, pPheO RSoebnetrltr SBaeloeven supervisor nRneazoa-- lr ------ GPrionuip oLnesadeBrate abaratory anise) Usterinacian CH indyt3. Cary, oUt 06530 @HHTARAZOZLNLSEEBTLTT.OON7N0.v5cowoomnecrBssAmsoOanmcWaeEnncN Se PHcOhCNehEmoimciacS la &siiooMotdie aalSSicoanncceessiDBisovpiosinon SerPLE NUMBER: 20905761 severe: T-a102 BESTCOPY AVAILABLE ~~ ~-c - A DhiSTroraraotteireDvrpieaai:taansfitazTioaotariidomnnitnatirfommoriirnnSreEpeosrtnhaenynactuotnBaaooormtalaeatroroanxciacEiityyppprroaoddutucec0deedrwahs)tehenenaaaetctoeerssdtitng PasAU t ArgtaS riotsATT0 ogiEot averit goveA r icits A Storage and Retentions a TeSon'ueSeatmdaanetteroeniaalSuIin)SbLyTeidT Aisn ooaSo rrsatTaara. Story Procoutions: oNerranalh Smeernftiiinngg grreormemeatds, eIrSesIinNd ring TxArp trebaonhnimaolI s mnYeoauenatgT graarndeulat alais dlriRanSanraftisnI Teodf idtnhdesA erSopnurtpeigcneaueog-ueDssesueiiT cenyetensmstpreatE reinatFwuuerrrieee: Tnuataoyinanw.TnaanremSnnianenalaufrrhTioaaoiseaaanrtpnceyspooamnoeeereooHnePcoseeumeaeimnngaesastpnaMaTtarAiT2co]SomganloryRPdwOiiTetfiorhnRsydoosxnFtiiaannntadtalelraoddn: Ttolnhieeo untHaareoRaiomn eLosis boaapaldeer SeadTItSoindihaovehonveobeeffeecnt pornestehnet'isntutdyh. e mTrfcdnoclniom mogarteredeasatnnhaoiimnna`dwlg3suaeasw,naretTnoodctihpasseonnrao'data ainnerganwndaotdme,rFfotrrdeerTntetihRfeaivcsidtlubadyyiyb:.laTneioTmseaeds]ttLiaannnnuimimbmaealrs or Er a malate foranowarnight periosustbeter ReaTsEonmfaortSpeecaisseSeylecteioTn:abThTeeyrataiia tThaengaanimmiamlalclasslsoiucsaillcyaluelseyedddduuse tn HaA Ytohad:a InFai"ve melfeerann,drfivoe faemalde rabte weeighding BfRromS2A00 Rto 2a 84 o were Fra5phareaSbtieionnmmarniaddnATdeemirinaeigsetnarastniion,eoftTeToeanstts MMaatteerriiaallss Sdnninidnidviivdiudaluadnons TheRdSeasestvolSuomlenoaf hthee tteepstt mmiatteerniaila varisd per dose evel besed upon C0G531 HARZSLSET.OPN BoRmeRnAioenRcn rEc ET F Chemical 8p BlaediatSSlaoenrceetst DDiiviosinon SarPLE NUMRER: eer 70905761 oleae BESTCOPY AVAILABLE -oce erin rptanuitdaBlAy SS TEES C00532 @HHiAAZZtLLEEsTeT.OO7NN. tBOsoRoEcnRowoomRsAsDasOweNnnccWIeeSCrnOesNSIN SET FCOGhheNemmiEicosa4ll&&7BBiiooMM+eoTudXiiocoaallASSeciaMenAnccReesAsDDiWivviSissUiioonn SAMPLE NIMRER: 0905761 sapLE: Ted102 BESTCOPY AVAILABLE J p-- (coNTINED) sunmary Tost oon Animal: ima haAAnlabaiienenrtRatLasBboo-r0aSetporra1g0i0uo3ne,2-,Danueenldee")y1Ps0ot0rr2ta6ai0gn8e7 MI Method of Administration: Oral Gavags Date Tost Started: 10/26/87 Date Tost Completed: 11/20/87 Eatinatod Oral LOSD: PHaleae Brtruseen 0.5t0sandana5.05.8g/ksgaofofbobdyaaweiughdtm DospeiLnovet me a0.t50 Pamala a0.n50 Iarvnerage BBodey siTgahtrsai(T3e)1 DMearntdarluimtbyer(HDuomsbeesr) 2572 [osCadwe 25 i21t0 m wa o2m uwvs 06533 HHAAZZLLEETTOONNtesoonmeeoonnees scoennT ccavee e Chohmeimeie&8BBioe otMeadce sioonnecesss iivoiinon save wan: 0905561 BEST COPFRAMBLE ... . ei oe one cones cca sions THES rs eT BOE LLY 1.58 gi wed night ates afppTeearIeed normal 5 0 55 nn sss e003 3 3 3 3 sea mii0o0e a 8ea meTteeinny 3 05 03 oUoEonOT1 IIOz LE o 0Lo0ga o0n oe 0ne0 0rla ih ll tt LrrrEs ln aopesras norma 5 5 5 sss 000333 4 4 4 4 a wT--ES--S 4bo8 30 BpOeTnIsIfIeInIoOnIZOG0LIO0LO0LO0GL aeaWlide 5esb 80 sesros0r2Isiii11ro0ar0 o0 g0 o0 a Mees 0 0 8 baweriixixa1aa 00534 @ HAZLETON ssowonessencenc Chemical & BioMedical Sciences Division 507 KINSAN BLVD. +P.0. BOX 7545 + MADISON, WISCO53N707S+PIRONNE(08)241.471 + TLX 703958RAZRAL MDS UD SAMPLE NUMBER: 70905761 SAMPLE: T-4102 BEST COPY AVAILABLE PAGE 7 OECD ORAL SCREEN (CONTINUED) C(NLoI.NICofALASnIiGmaNlSs (ACfofnetcitneude)d) Hours Days TH 2.5 40 12 3 45 6 7 8 9 10 11 12 13 14 PASE LEVEL: 5.0 g/kg of body weight rales MHiyopsoiasctivity 45&4 05 Ataxia 21 RedF-acsetained 0 0 YLaaclrliomua-tsitoanined o o Paignenirteafllexregio0n 0 Diaarbrsehnets 00 Tonio Excceosnsviuvlesions 0 0 Deastahlivation fo eo0 o5 o 5o2o0o0 o- I- -I-I- I- I_ I_ I_ C_ 0 00 10 - ---- I I I 7 I 8oo 231000005--2- 1= 2- 2= -2 -2 ooI I_ C_ 0 0100----- - - - _ _ 00 o 00o 18o0 -- -- -= 2- 12= I- 2- 2- I- C. 0 0010----- - - _ _ _ 00 10 420 1110 -- -- o- C- - 2- I- I- 2oo =. Females AHpyppeossrsetdivintorymal 50 50 50 21.00 01 00 00 00 -- -- -- =- o- o_ _- _- HAitoasxiisa 5120 01 o1 oo 0 00 8 00 -1 - -- 0 -- --0 -- 0 -- 0 C-o == Veglelnoiut-asltairneegdio8n 0 0 2 1 2 2 2 0 - a - - e - . oo RGaasdpoisntgained 0 0 190--0 --.- 0 -2-0 s-:0 = CZ Rafsapcieratary 0 0 111000 S - IC1s:I I IrIzC Dcisarnrgheasnt san o0 00 101000000000 -- o- o- I- I- II CI Toncioanwulsions 0 0 0 0 0 1 9 2 0 --e.--- - sco: -___ Death o 0 0 a1 0 1a11 - - - - I I IZ A = Found dead at p.m. mortality check. GOGS3S HAZLETON rome mena Chamica BoMedia Sciences Dison i sore eR: F19t7e1 BESTCOPY AVALADLE SW vec ome. sree retort (cont nue O0SE LEVELS 0.50 ks of body weight WanAiveLt see bikTesBteeDttyions tncropay Comments om me Ho visible lesions. cm wa - vVenntramlacneriviacal orraetgeion20aan.d omer no ae Ho winible tonions wwe wo ae Ko visible tesions. coses moe Wo vinible tasions. sree Fo Wo visible tensors. wef - Wo visible lesions. nF. a Wo winibie Lasions. oe Fo ae Wo visible lesions. crs rae No visible tesians. CO0S36 &@)SoHrAKZRSLHEBLTYO. $N2 SoOrTeRmAsOarWcnRneC ST FCOheNmicEa & Biorole a Seaynces Dtiviesion SAMPLE NUMBER: 70905761 rar [SE p-- DOSE LEVELS 5.0 g/kg of body wages J Tait ony BESTCOPY AVAILABLE === ccontineos css m2 Sr crs eo cme ea Hosa amt moth armen = weaioms FSmtioAmnaTchT glandublaar sporstiionnhen A I C0C537 @ HAZLETON toomrones suena nc a TT CT Tr Chemica & BioMedical Sciences DWiRvision sarPLe mer: Fn9nS761 mgs Ten BESTCOPY AVAILABLE... ,, oFED ORAL SCREEN (cont inuED? Refarencest 1. aOBrgmoanpieseatndieono3ff8o,rE1n5Ec0eo1mnoamisc CSooo2pReTroaattiioRnD anSdadDousalroapmenntt's, G0u!ide! inns 2. OTECoD'msaPrinciples of Gand Laboratory Practice, Ammer 2, C(B1)30 3. NIN Publication Na. 86-23 (revised 1985). 00538 HPLAATHOLLAOBGYNO.REP7O0R9T05761 Acute Oral Toxicity PAGE 11 T5e.n0 gr/aktgs) (wfeirvee mnaelcerso,psifeidv.e feTmhaeleasn)imaflrsontenaacthdioefdtwoon dteosste wleerveelsref(0r.i5geraandted walenerdveeln,eeucdtrahoyapnsiaofetdizdeewadittnha,nidna2nn4dechgrorouoprssssi,eodbussaeutravltalntyeiottnhesermirsnaeamcetoiroddnaeyd.offoArtlnleeacsshutrudvayin.ivmianlgTheaarnediomsoanles pages'8 and 9 of tnis report. Ttenset.mostThferemquucoesnatlyofretcheordsetdomaocbnser(vgaltainodnuslawrerpeortiinont)hosofe asneivmeraalls tannaitmaldsiedhadon doatrhkerbroobwsnervaarteiasonsofwevraeriacbolnesidseirzeedwhrieclhatewderetopopsossitbmloyrttermeacthmaenngte orrelaitnecdi.dentAalll findings which were not related to treatment. PathaoSlogiE. st Palmer, (1734ncs) ate (~25= FF COG539 HLA No. 1090 S70) Perso`nAnceutle STiogxniactoulroegySheet Mame Job Title Signature Becky Beckwith Steve Beloungy Sr. Lab. Animal Asst. Lab. Antmal Asst. id Ken Bridges Pat Crary Sr. Lab. Antmal Asst. Sr. Lab. Animal Asst. (222 Los Shane E1tn Lab Antmal Asst. Hane 37 Shawn Frazter Lab Animal Asst. Saw Lari Steven M. 61aza Group Leader Den MW, Wolly Hahn Kevin Hamilton Adan. Clerk Lab. Antmal Asst. Thabo [TAT Jeff Hicks Sr. Lab. Animal Asst. Zee Calvin Horton Group Leader bdo Mon SGrheagroernyL.JoHhonsvoenry ALdabm.inAimsttmraa1tiTveechA.sst. gnaped,Ochdaenn Paul Krebs Lab. Animal Asst. RAD Mayne Madison Section Supervisor UsesO11 Scott McConnell Lab. Animal Tech. Sd ZC) _. Shelley McConnell Lab. Animal Tech. halla,Melo Dawn Conant ton Mavis sr. Lab. Antmal Asst. (ows Lab. Antmal Asst. Dole Conek Robin Olson Lab. Antmal Asst. Cl a Patricia Padghan Team Leader LoiiaThey dir Joseph J. Daun Lab. Animal Asst. Queaeels 4 Wichael Patzka Lab. Animal Asst. do GR John Pautson Sr. Lab. Animal Asst. b> Doslop, Jane Polnow Dennts 8. Steiner Lab. Antmal Tech. Lab. Antmal Tech. Gone ne Y ain 2 Ai Michael Thesing Lab. Animal Asst. Wickal\ Thoin PNabuelrat6.OlVsaonngen MAadnmpionwiesrtrative Asst. CatHs I4EX,, L Jin dirschele Ben Haley LTE Sr. Lab Animal Asst. Lo, Lecdil FS Wally Initials aA 8 x2 az se I SG EorA PK pr Hom Ame = 7 - A Im 7 WT % COG530 naD90T5e L EE gE ISt ms e fe pte ve il eR nShe ree Nw Tr--smetenle ) iT M mmieailmms|a eE mim =NrNesona ) sme ee ee Re stedstyvr ta)| aC -- N r a =8 DELCEE Ne 8 me: T iratN e =z op Melght S552 Z 7, H SU sl so ~ 8 [El El ular] lr Bl " Eave 2part Nertewt b1Q_ edwae 13.1a67 nr1odoeSl OBSERVATIONS (1ndividu) = tose tower: 0.5 3./kg. Test mterar:_T=4102 a frmoet Garonne frsscasaogn| Sfopg e rarersmeareeae = = looE [TBCae Td I r ECdEr iE23ENr Sttrer r==o pe ee ==r = r e rrrr | esr ==s I mr Rem ere El[EoTlIH 8 EETo 3e 1 doors ototeomTo B & [3087[i e HaetacsT=es(=I ====Se e ITA TSEE EEITSTT= T s[urvi4ving amas Z3 TT T enT 77dFo 3AeeEeET T e ieie]|| mNeawe Se I (7 -- Eeos JUNI 290 re PMee---- EE rrr == r A e A r ei =r It r TE --iir 1e -- 7 Fo i e -- eA 2 3 ve dne e=am [RTEVIAPTIY TR 0 099 [ihErRreenermeb--av er[EIoIE TPT EIe SIS=P= S= =I1 1EE Es0TIPPEi E J OSRlE OY e t=etn =r=A rrree= | we NA co foP aprerceTembeR l--a---- lE = 7E I PIEA=E P R]O[= PT reeoE PEoTI fToT] = testes condition Eg rrr IESFoe=e S SEErH ePeEEa E aee =] a Shan fEoip nitectegty AgtTrTL IRTI ITL ATlAeT at DTPE TTEolE ee |troT S e TtTot] LoE--] APF] ncFoonuodnidAtidnoeanda,nsotPeevidc0e.ntk,S10 nevi by bie 7 IU FARPAA Abl Us FAATSTl Zee] ove ascaaTions (divin) naodosTel soe vets __-S g/kg. Testmtorr: _T-4102 GE i bastion Jag| ire rereSTsrrr o[Beenin cronaaran 2 = s [c3oq 2[eE= rasers deim abrea --mem--eT=SESAeSPSAeESeESsBE eeDA P STPHh E EDEe= ==== leo TPoIistaa re em e A amtrtam--eeeTIAZ P ==I P 2 AP A T a eo eAEP ont To s= - ore BuinEBediiae a==[E=T=ERETEASEEEE EEEeE= e E rS[iCnrEgi smis n $ D |g, lopl, [laf grceesstirveem baoehaovidort e===aHS==S]H E=E=SE=[E--SLEtTdr=[e_S[-E=e] eSeEee = T=] wate __t(20fg) 8 cPoe PB Vr esre esEsmbtbeabert|==Te =3ZA AE AZPtE3EEe EoAA tA o2to]]oA SiFrntatheesien e F eAdt Sh =Er E S Ee EREE EOE E EE n E EE Ee] ] ie AVY va cooo B Pm m REeRe EfRem rRuaSr] ==m EEPEAEAEEEZhiA EEEEf e EEEEEEEEEO=] tices consition (532 [aie gptecaiiiecbodoucP he TP = T=P = T=I==[=n == =I SEASaEtEEReEs] 7S C [G11a l11m 13 FnOiN Bbaete mTP Tr RooLp dRAdBl LeaRlAa LmlTs|] bSreenda F-- x Jas EERE] SSLa Ihseyns ma ro mi WghEr Ba tua e. soaSE z re lo rs m en s Geleznlnbel NJ = le , s =z g mamma fh ZAR - E E a tan P 7`0 oR . a ttt saei stk) 5 aE Han pe ---- tam EE foie Lo Fg (88|iofa|s au SERN RR lla =lglS = aT{)oSs R A sEas ELE si TE tet Gin oei61 aE, gmaain: = hf vwaul ORSCRUATIONS (Individunt) a: Joos = Dose level: SO/Kg. Test material: _T-4109 3 bo osA s falar emsB ap | te3rrat e Pe i errr | =2 = ot99 [DcPoo epupntein-- asChoma = oo {=A=A=S ESi i 1] La a ee Eete t oe n == = == ofa eE = Roon sied War me E =E E = o ee IS 1 | = o<: [osoplI eefShE aelioacreTaeE ===FE5E=7 E=IUE TTSn] = 40 -- -- = I7 [sSuorwSviitvioiendg afnortmuttessmiont g RobetraTome) J VY 3Geo [farleman IT EEAEPES IST] ae NA osoPo[7r se l(edErSVT:omP= r--e II EE EE r E= Ea 5e H = a r EEI=]| siintghaThnence HripR-- S egesertmeaten [ EE= i E =I =orf -- Z P F PSIn NE = a E| aeaaen N oe NA [atin fore[I= =f T= 7EH me| LefPo Hahnrsse aien E=t7e 4E AH EPEETP S I e T s S ] ] f[nidt1eates consition E Lor mp m p r 5 E p ee n eee e Eoliectei51bg 1% ipprea TTT 11 [1 aeuremss or Vo Bote ToPT,Pehl TTTTT] tater Wr:2030576 GRSERVATION (indtviduat) sos tevet:_5.0g/Kg Testmateria: T4102 Re PRE fuscia [iseb rarer Pe --e--r--r--r----| =4m g2 er A e m --nrP7a2E2E= Ee == =tt | EeEe | =] == ElE7e Sa a Ertr 5 rEer rr ee ee =E lo FPPfeiarpieSrc-- hedeadmaze= [--7=TET2TE==eE o =5oT S 1Eo E E ES S E]| surviving ants 2 &iEl l Ea l 7 ebtten For-- m -- ==T 32 53 5 7orr =~ 1 AO [ SR0K V7.8 Fd osaDppigmeriiI a P ee A E I r EEEEEEE E EEEEEEENT E ae NA TimEyr Pde P s-- er ao EE 3EEEE 7I+ E fISFS TaS a (A1s3urv4iving aAntSes O te Se Ronly C RB Paho fien smn E = e -- PTE ] EO FT RamaVWSA RPOSR 2TT re ec--EEaee=2 = ar 2 ee ai | Iwfo[a7 leisasromrE ametsI[ =PT IPCEA EEEE EI t ETE PI E E] ] I 7EaT] aSngthicates condition {YO T Berthr s rnEe Af 1 8I13ST73E3 ol t et Bs EE R aOii Svirge Bate ry aPR ATTT] er