Document E7L9Ya4Q9J0R3g3qd7b4NERR
AR226-3162
DuPont-2932 TRADE SECRET
Study Title H10-2-D40o4se3:OBrailoGpearvsaisgteenScteudSycrieneRniantgs Laboratory Project ID: DuPont-2932
Author: Carol Finlay, B.A. Study Completed on: August 29,2000 Performing Laboratory: E.I. du Pont de Nemours and Company
HElakstkoenllRLoaabdo,rPa.tOor.yBfooxr T5o0xicology and Industrial Medicine Newark, Delaware 19714-0050 Work Request Number: Service Code Number:
,,ol contain TSCACB! Comp"y Sanitized.DoeS
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H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
CERTIFICATION We, the undersigned, declare that this report provides an accurate evaluation of data obtained from this study.
Reviewed bv:
^ ( SGe2nairoy--rWR^e.sJeeaprsco-hn-S-,cP-iLenDti.st
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Date
Reviewed by: Vl3/fjfA CJutd(ith^G. Sftta\dDJleiZrre.c-cKtboiridXL, DL.AaJ>3 T.
2Z'Att6-2c>*>Z>
Date
Issued bv Study Director:
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-A<C<] 1t>0
Date
Conti'Petty
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H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
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TABLE OF CONTENTS
Page
CERTIFICATION........................................................ LIST OF TABLES........................................................ LIST OF FIGURES......................................................
LIST OF APPENDICES.............................................. STUDY INFORMATION............................................. STUDY PERSONNEL.................................................. SUMMARY.....................................................................
INTRODUCTION......................................................... MATERIALS AND METHODS.................................
BA.. TTeesstt SSupbecstiaens.c.e...a..n..d...P...o..s.i.t.i..v..e...C..o..n...t.r.o..l...................................... C. Animal Husbandry..............................................
321... IFHdeoeeundstiianfnigcdaEWtniovanitre..or...n....m......e....n....t...........................................................................................................................................................
ED.. Q4S.tuuadAryanniDmtieanlseHigaennal.dt.h..P.M.r..oe.n.t.ei.t.os..rt.i..n....g....P....r...o...g....r..a...m................................................................................ F. Assignment to Groups and Study Start............... G. Dosing Material Preparation and Administration
21.. PToessittiSvuebCstoanntcreo..l.s.........................................................................................................................
H. B3.odNyeWgateivieghCtosn..t.r.o..l.s........................................................................................................... I. Mortality and Clinical Observations.................... KJ.. TCroelaletmcteionnt oanf dFlAuonrailnyesiDs aotfaB..l..o..o..d...a..n.d...L...i.v..e..r..s.............
RESAU. LInT-SLiAfeNTDoxDiIcSoCloUgyS.S..I..O...N............................................................................ B. Fluorine Data.............................................. :..........
321... TPFoaecssitttoSirvsuebICnstfoalunnectrneoc..li.sn...g......I....n....t..e....r..p....r...e....t..a....t..i...o....n......o....f....A......n.....a....l...y....s....i..s............................................
CONCLUSIONS......................................
RECORDS AND SAMPLE STORAGE TABLES....................................................
CBIcontain t sc a
...4
...4
...4
...5
...7
...8 ...9 ......999
10
..10
.10
.10
.111110 1111
..1112
.1122 12 1132 1144 14
14 1155
15 16 17
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H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
FIGURES....... APPENDICES
DuPont-2932
LIST OF TABLES
Page
1. MEAN BODY WEIGHTS................................................................................................................................... j g
2. MEAN BODY WEIGHT GAINS...........................................................................................................
20
3. MEAN BLOOD FLUORINE LEVELS............................................................................................................... 21
4. MEAN BLOOD FLUORINE CONCENTRATION NORMALIZED TO DOSE............................................ 22
LIST OF FIGURES
Page
1. MEAN BODY WEIGHTS.........................................................................................................................................24 2. MICROMOLAR EQUIVALENTS IN RAT BLOOD..............................................................................................25 3. MICROMOLAR EQUIVALENTS IN TEST COMPOUND AND POSITIVE CONTROLS.............................27
LIST OF APPENDICES
Page
A. INDIVIDUAL BODY WEIGHTS........................................................................................................................... 29 B. INDIVIDUAL CLINICAL OBSERVATIONS........................................................................................................ 71 C. INDIVIDUAL FLUORINE LEVELS................................................................
Companysanlfbed. De*nof coniato TSCACB/
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H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
STUDY INFORMATION TEST SUBSTANCE:
Substance Tested: ( Svnonvms/Codes: H-24043 Haskell Number: 24043
Composition:
Known Impurities: Not supplied by the sponsor POSITIVE CONTROL:
Substance Tested: Synonvms/Codes: H-24019
Haskell Number: 24019
DuPont-2932
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H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
STUDY INFORMATION (Continued)
DuPont-2932
POSITIVE CONTROL:
Haskell Number: 24020 Composition:
Known Impurities: Unknown Sponsor: E. I. du Pont de Nemours and Company UW.Sil.mAi.ngton, Delaware 19898
Study Irutiated/Completed: April 30, 1999 / (see report cover page) In-LifeInitiated/Completed: July 11, 1999/October 12, 1999
c topany Sanitize
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H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
STUDY PERSONNEL Study Director: Carol Finlay, B.A. PrimarMy Tanecahgnemicieannt:: RJuidchitahrdC.P.SMtadaltehre,nPah.D., D.A.B.T.
Blood Fluorine Data Analysis: Gary W. Jepson, Ph.D. Management: Matthew S. Bogdanfiy, Ph.D., D.A.B.T.
Toxicology Report Preparation: Wanda F. Dinbokowitz
>
Laboratory Veterinarian: Wanda L. West, D.V.M., A.C.L.A.M.
DuPont-2932
Convoli; omiiIimiui llul OOiiMlill Cttl
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
SUMMARY gTahveaogbej.eJcotibveeaobfstohribsesdtuadnydwtoasactocuemvaulluaateteinthaempoatmenmtiaalliafnorsHys-t2e4m0.43S,ixwghreonuapdsmoifn5ismteareled by aCdrml:CinDiste(SreDd)ItoGSonBeRgrroautspeoafc5h rwatesrefogriv5ecnon10se0cmutgiv/kegd/adyasy aonfdHt-o2450g4r3o.upTshfeotre1st0sduabysst.ance was Afropmprothxeim5a-dteolsye2ghroouupr.s aOftnersethleectfeirdstddaoysse(,5b,lo1o0d,1w3a,2s4c,o5ll1e/c5t2ed, 9f4ro)m5 rthatesoprebritgarlosuipnuwseoref each rat reeuctohradneizdeodnaenadcthhdeabylooofddoansidnglivaenrds twheenreacpoplrleocxtiemd.ateBlyodeyvewreyigohthtserawndeecklindiucrailngsigthnesrweceorevery dpaneesdrico2rdibp.eodAsidftiodvrietHioc-on2na4lt0lryo4,l3s3., Hne-g2a4t0iv1e9c(o1n0trmogls/,kdge/dioanyi)zaenddwHa-te2r4,0c2o0m(2o0ilm, agn/dkgc/odmay)o,ilw/aecreetotensete(d80a:s20),'
No deaths occurred during the study. No compound-related clinical signs of toxicity were ddouibarsriernrhgveeathd, esiandloitvhsaeintirgoantps,edraioloosdpe.edcRwiaai,ttshbldtahocesketdoescwtulsiatuhrbdHstia-s2cn4hc0ea,r2gH0e-,e2xa4nh0di4bs3itt.eadiRnwiantegst dopoefsrveiandreiwuomuitshapHnadr-t2sd4io0arf1rt9hheeeaxbdhouidbryiitnegd odthielei/oadncoeizstioendngewpnaeetrgeioradtai.vnedActlhooenpteprcooislairtwaivtasesecoxobhnsitberroitvlesed,dHndo-u2rc4iln0ing1i9cthaaelnsrdiegcHnos-v2de4ru0yr2ipn0eg.ritTohdheeisntcuordamyts. odiol saenddwcoitmh pcToohmseitpmivaereaacbnolebnottrodoyltshw.eeCdigeoihmotnspiaazrneiddsomwnaeotaefnrbbaoondddyycwwoemeigigohhitlst ngbeaegitnwasteioveenf tcthhoeenrtraraottslssddaoonssededdhwiwgihitthehrHHth--2a24n400t4h43e3Hwa-ne2rde4t0h2e0 tdchoifamftetrhoeienlr/ceaecweatatossntaueddnyieffgsetaarteritvnaecnecdoinnthtaregoeelxaopnnedcteHtes-td2dr4aa0yte119obpfeobtsowidteiyevnwe ctehoigenhtrrtaotgsla.rianAt,sciwtcoaapuspncetoianmrgspftlhoicartathttehedeabmgyeetahnebfoacdty owiel/iagchettsoannednmegeaatnivbeocdoyntwroelisghatngdaeinqsuaolfttohoerragtrseadtoesretdhawnitthheHH-2-420440319ispcoosmitipvaeracobnletrtoolst.he com adAnodsstinenaogdrwmy-iastlhtiazt1ee0df0ofmor rfglfu/lkuogorirHnine-2el4ecv0oe4nl3ste.innAt wfnohraortelheaebutlenosdotedsruwtbhasestacnnuocrteveaacn(hediseetviamecdhatdpeudorsitinotigivne1f0icnocitnoytn)rsowel.causTtichvaeelcdualyasteodf vAaUluCeIsNoFf/5D66fo,4r7t9h.e1falunodri7n0e,7c8o9m.6pofonrenHt-o24f H01-924a0n4d3Hw-2as402230,2,9re8s.6peacsticvoemlyp. ared to AUCINF/D wDU10eonrscdeeoe-anrapstdhepjceurouscxttoeiivdnmedaaidrtteaeioyalynsss2ure5onsxfdutelahtrneitsddhse3itnuxcdumtyhrov,edeaAed(rUAmatCUienICiaNsIbtNFrsa/oFDtri/poDftnoi)oorfnotfhratehnpedtoestrseiettstitsevusnebutcisbootsanntnatocnroefc.lefsl,,uHHor--i22n44e00i41n39t,hateondbmlHoaol-e2d.4ra0t2s0f,'or
Company Sanitized. not contain TSCACBi
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H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
INTRODUCTION The objective of this study was to define the potential ofH-24043 to be absorbed and to pmbrieobvalcioocouudsmlayunlsdahtloeiwviennr.atomTbhaiemoatmecscatulsimaunbuslsatyatsentceinemwm, aaassmicmnodamilcspa.atereddbtyoa2npaloystiitciavledceotnertrmolinsathtiaotnwoefrteomtalatfelurioarlisne Tafhteeri5nidtiaaylsd.oTsahgeemcheoansebnofdoyr wtheeigsthutdoyfwthaesr5a0ts0amftger/k5g/ddaayys. oHf odwoseivnegrw, daossdinegcrweaassedtebrmyi7n%ated compared to the mean body weight on the first day of dosing. The dosage of 500 mg/kg/day was ddcohososeesddenwwbiiatthhseHtdh-eo2nt4e0st4ht 3esurebexssputaelntrsiceeonfcforeardn5agnecfooinnvsdeeircnauglltismvtueedadinaeysb.soaIdntyatwhdeeaiifgliyhrstdtgoraasinanggeoeffoi2nf9d3i0gn0rgammstugs.d/kyTg, .h5eTrachtoesnrwtaroetsrle r5garrtosauthspawdalesaronehodavodesreaadnllwomviteeharanHll-b2mo4de0ya4nw3befoiogdrhy5twlcooesinsgshoetcfug1ta9iivngeroadfma2ys9s. agtraamdsa.ilyIndtohseagseecoofn7d5r0anmgge/fkingd.inTghsetsuedy,' sTthuedideos.saTgheeodfo1s0a0gemog/fk3g0/0damygw/kags/cdhaoyswenasbraespeedaotendt.heFirveesurlattssodfo2seaddwdiittihonHa-l2r4an04ge3fifnord-ing 65 gcoranmsesc.uFtiivveedraaytsswatearedaolssaogdeoosfed30w0itmhgH/k-2g4/d0a4y3hfaodr a5ncoovnesreaclultmiveeadnabyosdayt awdeoigshatgegaoinf of g1r0o0ump gh/akdg/adnaoy.veTrahlelsmeeraantsbeoxdpyerwieenicgehdt gaaninovoefr2al5l bgroadmysw. eight gain of 16 grams. The control stAhuloplspbelleoamnoadelnystsaaemlsr.pelpReoserwst.uelrtse farnoamlyaznedalyfosrestootaflsefllueoctreindelicvoenrtesanmt. pTlehsiswriellpobertpcroensteanitnesdthine aresults of
MATERIALS AND METHODS
A. Test Substance and Positive Control The test substance, H-24043, was supplied by the sponsor as a light amber brown liquid. The epsuvobisdsitetianvnceceecooafnnitdnrospltsao,bsHiitlii-tv2ye4, 0cso1un9chtraoanlsdsaHapc-hp2ae4na0rg2ee0d,intwoceboreelossrtuaopbrplpeliheuydnsdbiceyarltthhseteastcepo,onwndsaiotsirooanbsssweorhfvitehtdee.ssotuliddys.. NThoe test
B. Test Species Male Crl:CD(SD)IGS BR rats were received from Charles River Laboratories, Inc Raleigh North Carolina. The Crl:CD(SD)IGS BR rat was selected on the basis of extensive experience
Company Sanitized. Does not contain TSCA CBI
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H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
winictihdethnicsesotrfasinpoanntdanitesosuusitdaibseilaitsyesw. ith respect to longevity, hardiness, sensitivity, and low
C. Animal Husbandry 1. Housing Environment
ARantismwalerreoohmousswederseinmgalyinitnaisntaeidnolenssansteaeplp, rwoxiriem-matees1h2c-ahgoeusr sluigshpte/dnadrekd caybcolve e(fclaugoerebsocaerndtsl.ight) oanudtsiadteattheemapcecreaptuterde roafn2g3esw1erCe manidnoarraenladtidviedhnuomt iadfifteyctotfh5e0stud1y0.%. Occasional exclusions
2. Feed and Water nRTuaotpdriewtnioatntLeaarlbwrDeaqiseutpirreo5mv0ie0dn2etdschaanoddwli.tboiTtbuhemef.freeAeedlolifrsasgtpsuewacriefairneetdefeecddonbPtyaMmthIieNnamuntatrsin.tuiofnacItnutreerrntaotimoneaelt, sIpnce.ciCfieerdtified
3. Identification aePasasrsscioiihggrnnrtaemotd.eatnsTosthietgeoancigmnhrfeoronaurttpm.tsoa, tagionroniunopdnsiv,thiedeauccahalgriaedtelwanbtaiefsliscteaimtnicoplnourdnaeurdmilytbheiedreuwnntaiiqsfuimeeda6rb-kydeicdgaiotgreHtiaadstetkoneotlielfdiacnoaitnmiotanhl.entAuamifltbeorefr
4. Animal Health Monitoring Program tAfhosollssoepwethicnaigftiewpdrooiucnledtdhbueereHesaxasprkeeecpltleeLdrfaotboromirmaetdpoaprcyetratihnoeidmiscacalilelhnyetatioflitchasiasnnutderegertnihtvyaitroocfnotmnhteeanmsttuainldaymn:tonleivtoerlisnagreprboeglroawm, the aWndatoerthsearmcpolnetsamarienaanntasl.yzed for total bacterial counts, and the presence of coliforms, lead, Feed samples are analyzed for total bacterial, spore and fungal counts. bSyamthpelecsagfreowmasfhreerssh.ly washed cages and cage racks are analyzed to ensure adequate sanitation rsCepeqeructiiiffriieeemddehannetiasmvayanldmfneeetoadtlstio,s auefsxleacdteo,exdgiunsa,tarcathenldtoemreidnaaxbtiyemdtuhhmeymdcraoonncuacrefbancotrtnuastr,ieoarnntsodomofregkeaetnysocppoehncotiafsipmehdianntaeunstt.rsi,tTiiohnnecalul ding pwroeuseldncneotobfetheexsepeccotnedtamtoiinmanptascbt ethloewinttheegrmityaxoimf tuhme sctuodnyc.entration stated by the manufacturer Tlahbeoraantiomryalanhiemalathl vaentdereinnavriiraonn.mental monitoring program is administered by the attending
Company Sanitized. Does not contain TSCA CBI
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H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
Quarantine and Pretest
DuPont-2932
scfUiolgiprnno6iscnadoalaflmyyislvla.npaeTplsahaster,eHirnnaatjtussskriwyge,nlelsorLeroaawfbbdeoniirsogaerhtamoesrdaeyl,3obtrtheiihemnajrevuasirtosydr.wu. rTeinrhegertrehametsopwvreeetdreesftroopbmeserirsovhdeipdapndidnagielyxcaafmrotroinnmesodarndtadaliilqtyyuafaornardnatninyed
On the bases of acceptable body weight gains and freedom from clinically apparent signs of disease or injury, the rats were released from quarantine by the laboratory animal veterinarian
E. Study Design
Substance NegDCatoeimvioenoCiizloendtrWolaster
Com oil:acetone PosiHHti--v22e440C021o09ntrols Test Substance
Vehicle Not applicable ComCooiml: aocieltone
Dosage (mg/kg) 0 00 2100
Number of Animals 30 3300 30 30
H-24043
None 100
30
Assignment to Groups and Study Start
After the quarantine period, the rats were selected on the bases of adequate body weight gain, freedom from any clinical signs of disease or injury, and a body weight within 20% of the m5 reaatns., sTohtehastetlhecetreedwraetrse wnoersetadtiivstiidceadllbyysicgonmifpicuatnetridziefdfe, rsetnracteifsieadmroanngdogmroiuzpatbioondyinwtoei6ghgtromuepasnos.f
naAgufemteabrteatrhssweigatinsmmmeeaonrtfktdeodosgoirnrogtua.pttsDo,ooeesadicnhognrbatethgweaantasoihlnootufesesetadcdhianyrdai1tv..idTuhaellrya.tsTwheerleasbte3twdeigenits7oafntdhe9awneimekasl of
sRaactrsiftihcaetdwbeyrecanrobtoansdsiigonxeiddetoastphheysxtiuadtiyown earnedrdeliesacsaerddefdorwoitthhoerutlapbaothraotloorgyicpaulrpevoaselusa,toiornw. ere
G. Dosing Material Preparation and Administration 1. Test Substance
H-24043 was mixed with deionized water so an accurate volume could be delivered. The daomsoinugntaondf ttehset sduobssintagnmceixetaucrhercaotnrceecnetirvaetdiown.asTbhaeseradtsonwethree bdoodseydwaetiaghvtocluomlleecotefd1omnLe/a1c0h0dgayoof f
______________________________ ____________________________________ Company San d ed . Doe*
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H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
pbroodcyedwuerieghtot.mTahinetadionsihnogmmoigxetnuereityw.as stirred on a magnetic stir plate throughout the dosing
2. Positive Controls
The solid positive control compounds were suspended as emulsions in their respective vehicles. rbCeeocfemoirveoeisdluwwspaaessnubdsaiensdegdaitsointnhtechoevmebhooidcilyl.ewfToehrigeHhr-ta2tci4oo0l1loe9fc.atecIdettowonnaeseatnocehcceodsmasyaoroyifltdwooadssiins2sg0o:al8vn0ed.HthT-e2h4esu0as2mp0eoinunsniatocneeatochnerat hscuoosmnpcoeegnnestrinoaetniitsoynw..erTehsetidrroesde ovnolaummeasgndeidticnosttierxpclaeteedth1rmouLg/h1o0u0tgthoefdboosdiyngwperiogchet.duTrheetodomsainingtain
3. Negative Controls
Deionized water was chosen as a negative control because it was the vehicle for the test swcsuuoebbmrssettoaathnnikeccaeevc.oeehtrCoipconolmees.sitoTifviolhereatcnshoedenrctparotoosmslswit.oievirkeeacdcoeontsoternodelisn(.8a0E:sa2ec0ph)anrwaetegeraertoicvohemocsoefrnnotamrosltnhreaegtrarateitvcseedivocoesedndtr1owmlsitLhbeotchfaecuotsemesttohielyor
H. Body Weights Adullrirnagtsthweerreecwoveeigryhepderoionde.ach day of dosing. The rats were weighed weekly or every other week
I. Mortality and Clinical Observations waCmaasgoeni-ngsdirtiavetisedxuwaaemlrlyeinhcaoatinnoddnlusecdttoeaddneadtteelcxetaamsmtoionrniebcduefndodarioalyrbndthoerraomduarglahtbsoeuahtnatdvhieaobrsntauondrdmy.aaplApbteeaehrvaaevnricyoerw. aenigdhainpgp,eaeraacnhcerat
J. Collection and Analysis of Blood and Livers tAhpeporrobxitimalastienluys2ohfoeuarcsharfatterfrtohme fGirrsot udposIe., A1-t2amll Lothoefrbsloeloedctwedasticmoellepcotiendtsi,n5toraEtDs/gTrAoutpubweesrferom ceoultlheacnteizdedacbcyorcdairnbgotnodtihoexfidoelloawneinstghescsihaedanudlees:xs^nguination, and the blood and livers were
Company Sanitized. Does not contain TSCA CBI
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H-24043: Biopersistence Screening
10-Dose Oral Gavage Study in Rats
DuPont-2932
Group I I n m IV V VI
r
Dosing Days 1-5 1-5 1-10 1-10 1-10 1-10 1-10
BTliososdue Collected Blood and Liver Blood and Liver Blood and Liver Blood and Liver Blood and Liver Blood and Liver
|
Test day 1 (2 hSouamrspploinsgt dToismineg) Tleesstt ddaayy 510at(2sahcoruifriscepo(2sthdoousrisngp)ost TTeesstt ddaayy 2143 TTeesstt ddaayy 9541/52
dosing)
Five to 10 mL of blood was collected into EDTA tubes at sacrifice. The livers were weighed. paTnahacelkybazgleoedoddfaofnrrdotomsthaailplflplureaodtrsrinewfera.isgererafrtiegdetroatJeadcaknsdonthLealbiovreartsowrye,rDe efreopzwena.terT,hNeebwloJoedrsweyaswahpeprreoiptrwiaatesly The total fluorine content of the blood samples was determined using a Wickbold torch bcolomobduwstaisondemceotmhopdo,sefodlloorwveodlabtiyliaznedalyinsitshwe pitrhesaefnlcueoroidfewieotnosxeylgeecntivaendelsewcteropdt eth. roTuhgehliaqnuiodxyaqyuderooguesnabflsaomrbeining asoclluotsieodn qaunadrtaznaalpypzaerdatuussi.ngThaeflcuoomribduesitoionnspelreocdtuivcetsewleecrterocdoel.leTctheed ainnaalyntical dflautoar(inpepmbioFpienrseiastcehncsaem. ple) was supplied to Haskell Laboratory personnel for evaluation of
K. Treatment of Fluorine Data HN-o2n4c0o4m3pbayrtmuseinngtalWainnaNlyosnisliwn aVsecrosinodnu3ct.e0dsoofntwbaloroed(PfhluaorrsiingehtdCatoarpd,erMivoeudnftraoinmVraietswd,oCsAed).with tAdWimaUtianeCNfoIiNolfendFsloii(snnciconslongufcdetewixnntatgrrraaeaptripooerlanaotvuxeinddtdietmeodreiat)nhmfreienecpiaurtyenr.svseeoTn(fthAsceoUthmmCeapIaxNuritemFian)u,gumCnddmeoerbairvsxteehardevnpebdhdltoaecorromdmnacicncoeoannlkctrhieanantelitftori-ancltiifpwoeanar(saTcmCui/rm2ev)t.eearxfTsrhofremomthe (concentration). The points included in determination of the terminal half-life were selected manually and given in units of time. Since the dosages and fluorine content for each positive control and the test material varied, all doses were normalized to 0.1 mmole/kg for comparative pwuerrpeocsaelsc.ulTahteedaacncdumreuploartitoedn binudtenxo(tAfuI,rtlh/e(rl-ues-ekdt).) and bioaccumulation index (BI, Cmax x Ai) cHo-n2t4ro0l1s9, bauntdbHec-2a4us0e20ofwvearreiaubsielidtyasanpdosliitmivietecdosnetnrosiltsi.viDtyoosifntghedialnuaelnyttsicwalermeeutsheodd,asthneegative bdeatcekcgtiroonu,nadnwyavsalsueetsatli0st.e2dpapsmlefslsuothrianne.0.2Sipnpcme 0w.2eprepmexcwluasdethdefrfolumorfiudrethceorntcreenattmraetinotn. limit of uTsheedpaesrcperonvt iodfefdluboyritnheeasnpdonmsoorl.ecTuhlaermweeaigsuhtreomfethnetsteresstuslutibnsgtafnrcoemanandaplyossiistivoef tcootanltrbollosowdere uorine were used as received (ppm F) from Jackson Laboratory. Fluoride ion was converted to
Company Sanitized. Does not contain TSCA CBf
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H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
dmeisccrroimptoiolanrs (o/xfMda)teaqmuiavnailpeunltastioofnaacntidveprceosmenptoantieonnt aforer pfurortvhiedrecdoimnpAapripseonndsi.xTCh.e data and
RESULTS AND DISCUSSION A. (ITna-Lbliefes T1-o2x, iFciogluorgey1, Appendices A-B) No deaths occurred during the study. No compound-related clinical signs of toxicity were oddtddohieuuibleai/rrsoariidenrnncrhogegivezstetoaiethnhd,dnegeseiwanrdpnelaeoitecvhtrsgoeiaeioravntdritegaoia.rvnntpysed,Oepdcratneihooloreoensidpoertp.readdooct.RslwidaiarAtoi,aittsvshtlbesoelddtpaehoccexweoskcheniitidoatetbhrcsowiwtutHleaslisdat-us,h2rbHno4dHsob0-ti2a-ss4c2cen43l4hrci0vn0aee1eir,2x9cgdHh0aeaidl-,ebn2usxaid4irtnhgei0Hndind4bgs-s3ia2tttd.lea4houdi0epRnr2wieiran0necteg.gcistaotdopThvaoefhenesrverdiesyantdcaurepoindwuoemoymurit.itshohoaedpinHrladiare-nt2nxdsr4dhiaoa0itcbrfs1roit9htdhmeeoeedasxbeadhoduisdborwyiirtnieetghd The mean body weights and mean body weight gains of the rats dosed with H-24043 were tcpchoooammstittpiohvaeirelra/eacbcowleentatotsronoaletshd.neiefCdfgeeaoritmeoivnnpeciazecreioidsnnowtanrgoaoetlefaorbnnaodntdedHys-ctw2ode4mai0yg1oh19itlsbpneboeteswgtiwateiteveivneeentchcotehonenrtratrortasolt.lsrsaTdtasohnswidesadhdsiiwgfcfhioetemhrreHpnthlc-iae2cna4rt0etehs4due3lbHtaey-nd2tdh4inet0h2fea0ct wdieffigerhetntcheasnitnhemceoamn booidl/yacweteoignhetnseognattievset dcaoynt1ro. lTahnedHH--2244004139rpaotssiwtiveerecyoonutrnoglerratasn.dYlioguhntegreirn wcwaaonneendiiimtggrthhhoattellssgaetaaexinxapndpessecleorotqiewfeudtnaehcrlreaetrtoraaeatoteposretfdhrgbioarooensddaeyytdoeowfrwurteniahtigphageinhdHrtta-bhg2noea4idimH0ny4,a-w23list4e.ia0sipgA1cph9ocetcmpagoroapsusiannitrtht.iaiavnbtOegltelchdfoteoeonrrmtttrahheoneealisnmca.ogbameolsddoayiifrlwfe/eaeerceixegnpthcoetencsteaeatdnnsedttgoumadgtyeiavaisenntabrot dy
B. Fluorine Data (Tables 3-4, Figures 2-3, Appendix C) 1. Factors Influencing Interpretation of Analysis
The data used in the kinetic analysis were derived from a limited screen, and therefore several tacoraevbe(lo1ao)tsdaa, sn(i3dn)gcsloetnedasoiddsyee-rswattaaitosenumssaaeyrdenaionmtdphkoairvntaeentbitce.seAnmaaccyohuoiperlvemedoa,yf acnnoodnts(bi4de)eltrihaneteioasran,ms(2op)lfepthsaeirztkiecinuiselatliorcwismaappnopdrltymanoacnyely AimpppaecntdcixalcCu.lation of the terminal half-life. A more complete list of considerations is shown in
Company Sanitized. Does not contain TSCA CBI
14
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
2. Positive Controls
DuPont-2932
rTahteblpooosditicvoenctionnuterdoltsowriesreetHhr-o2u4g0h1o9uatnthdeHd-o2s4i0n2g0p.erTihoed Han-d24m01ay9 nnootrmhaavliezreedacjlhMedeqstueiavdayle-snttastein h(Failgf-ulirfee2oAf)4.0T.5hdeaCysm. aTxhfeorHH-2-244001199AwIawsa9s8599.8.05and11th6e.9B0Ipwpmas(5M83ea8n2..2.STDh)ewHit-h24a0te2r0minal normalized /M equivalents in rat blood peaked after 5 days of dosing and then decreased throughout the dosing period (Figure 2B). The Cmax for H-24020 was 518.12 44.89 ppm (Mean SD) with a terminal half-life of 8.3 days. The H-24020 AI was 12.5 and the BI was s6t4u9d7y.,5w. iFthoronealychfooufrtohef tphoesmitiovceccuornritnroglps,obstl-odoodsew. aTs hsaemsmplaeldl saatmsepvleensitzime eanpdoianntaslythtircoaulghout the pvuarrpiaobsielist.y Tshhoeutlodtableintatekrennailnetxopaocscuoruenrtewsuhlteinngusfirnogmthaendoermrivaelidzetedrmdoinsealwhaaslfd-leisfcerfiboerdcobmyparative HTAh-U2eC4A0IN2U0FC./IDNFan/Dd wfoarsththeefbluaosrisinfeocrocmompopnaerinstown abset5w6e6e,4n7p9o.1sitfiovreHc-o2n4tr0o1l9s aanndd t7h0e'7te8s9t'6mfaoterrial.
3. Test Substance
pT1e5hr.e3io1Hdp-a2pn4md04m(3ManyeonarnomtahlSaizvDeed)rweraiMtchheeaqdtuesirvtmeaalidenyna-tlsshtiaantlefr-a(lFtifibegluoorofed226cC.o3)n.dtianTyuhse.edCBtomloraoixsdefwotharrsHosu-a2gm4h0op4ule3tdtwhaeatssdeo1vs0ei1nn.g07 lstiuifzneeefaopnrodcinoatmnsaptlhyarrtoiacutaigvlhevoapuruitratpbhoielsiestystu.sdhTyo,huweldiHthb-2eo4nt0al4ky3efnoAuinIrtwoofaastch3ceo8mu.4notacnwcduhrterhnineugBspiInowgstat-shdeo3s8de7e.9ri.Tv1e.hdeTtshemrematloilntsaaallmhpallfe bcinoatsmeirspnofaonlreencxotpmoofspuHarr-ei2sr4oe0ns4ub3letitwnwgaesefr2no3mH,2-9a284n.0o64ram3saaclniodzmepdpoadsrioetsidveetwocaAosnUdtrCeosIlcNsr.FibT/eDhdevbAayluUAeCUsIoCNfIFN5/6DF6/D,f4o7ra9nt.hd1ewafnlaudsotrhinee s7h0o,7w8n9.i6n fAoprpHe-n2d4i0x1C9.and H-24020, respectively. The data, calculations and equations are
CONCLUSIONS Rats dosed for 10 consecutive days with the test substance, H-24043, exhibited no mortality or bwtelesotiogsdhutwbgsatasainnncsoett-haraectlhawiteeevdreecdclifonomircpaHal-rs2ai4bg0lne4s3toodftuthoreixnnigceigtthyaetaivnlOedrchdoaandytrmdoolesarianntgsb.opdAeryisowtdee.aidgyhtsstaatnedfomrefalunobroindeyin the dUanydserretshueltceodnidnitmioondseorafttehaisbsstourdpyti,oandamnidnirsettreantitoionnooffHfl-u2o4r0i4n3e itno tmhealbeloraotds.foDro1s0e-caodnjsuescteudtivaereas 2u5nxdearntdhe3xcutrhveeA(AUUCCININF/FD/Df)orfothrepotessittisvuebcsotanntcroel.s, H-24019 and H-24020, were approximately
Company Sanitized. Do* notcontain TSCA CB1
- 15-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
RECORDS AND SAMPLE STORAGE
Specimens (if applicable), raw data, and the final report will be retained at Haskell Laboratory, Newark, Delaware, or at Iron Mountain Records Management, Wilmington, Delaware. *
Company Sanitized. D ou not contain TSCA CBI
-16-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
TABLES
CompanySanded. Ooe, contain Ts c a CB(
- 17-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
m TABLE 1
MEAN BODY WEIGHTS (g)
DTaeysst 1 23 645 987
222111540830 332327 433194 4476 5512 666555120543 766487
D'3232222e22W2225919678i54432o28307839a0926n........t6.36.1.2.631ie3088zredNegaCt23222222i222o2v9887655342m-15e511690419.......1...C92.928314O48oinl trolsCA33333333322o5c5433221099m_e01594614997t........o7.7.2.2905O3466niel:
419- .4 378.7
350.5 378.3
_
430619..08
-_
400.7 _
- __
449- .5
407.8
-
411.4 _
463- .5
434.5
_
_
- 454.9 _
-_
469.7 511.0
464.7
527.6
-_
528- .0
487.0
-
- 505.1
-
547.7
. _
558- .0
515.4 _
_
.
_
_
Positive Controls
H-24019 229911..55 333321100972488.....51763 333321119878....1934
H-24020 222432272...054 225428..49 222222887665938939......195838
338579..97 334101..93
393.9 -
416- .9
_
402.9
- 425.0
-438.1
438.2 465- .6
--
-
45-2.3
52-3.4
465.8
-
- 470.9
Test Substance H-24043 222225543318652.....39330 222876437...094 232299172...370 337595..12 388.6 423.2
-
455.8 448769..57
-
515.2
-
536.7
_
-
9
Company Sanitand. Oon, not contain TSCA CBI
- 18-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
. TABLE 1 (Continued)
MEAN BODY WEIGHTS (g)
DTaeysst DeWioantiezredNegaCtiovme COoinl trolsCAocmetoOniel:
8706 --
-. 53.9.0
8812 57-3.0
-.
.
88 589.5
-
.
9940 58-4.6 556566..29 556672..82
Indicates the animal was not weighed.
Positive Controls
H5-26430.419 570.7
-
585- .3 597.9
H-24020
-
499.2
-
55328-7..78
Test Substance
H-24043 575.8
-
650808..20
-
606.7
Company Saniti zed. Doe* not contain TSCACB/
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
TABLE 2
MEAN BODY WEIGHT GAINS (g)
DTaeysst 1-5 11100---121034 101-05-19/452
D211eW82i7731o611125an......t314353iezredNegaCt2i1ov728662re1a85269..C....O081425oinl troOlsi2l1:1C4A725-695431oc......1me39109tone
Positive Controls
H-24019 2177..14 1611990...202 279.0
H-2244.0920 21558541765.....87024
Test Substance H-24043 6256..46 2128713..764 309.0
Company Sanitized. Dees not contain TSCA CBI
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
TABLE 3 MEAN BLOOD FLUORINE LEVELS
Negative Controls
Positive Controls
Test Substance
DTaeysts 115130
DeW(ipopanmtiez)red <<<<0000....2222
C(opmpmO)il <<<0000.2...222a (0.1)
CAo(cpmeptmoOn)iel: <<0000....3226aC((00..16))b
H-24019 H-24020 ___466_4812....(1587PPm(1)(((_0277_....8669_))))__ ___2675_6214(....P6672Pm(((1()763_1..._.8224_))))__
H(-p2p4m04)3 151..94((10..68)) 155..74 ((02..73))
512/452 <00..22e <00.3.2a (0.1) <00..22d
4226..29 ((22..86)) 100..59 ((03..20)) 42..32 ((00..27))
94 0.9C 0.3a (0.1) <0.2
13.2
0.2C (0.1) 0.8 (0.2)
a Mean of4 of the 5 values. One of the values was below the level of detection (LOD). bcd MOStenaaenndvaoarlfdu3ed.oefvFtiohauteiro5onvfiatshluienevsp.aalruTeewnstohweoesfreesth.beelvoawluethsewLeOreDb.elow the LOD. e Mean of 2 of the 5 values. Three of the values were below the LOD.
Company Sanft/*.
nof contain TSCa CBI
-21 -
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
TABLE 4 MEAN BLONOODRMFLAULOIZREINDETCOODNOCSEENTRATION
DTaeysts
M
Positive FHE-2q4u0i1v9alents
ControlHs -24020 M F Equivalents
1 25911524340
74278..9692 ((21731.3.5)a) 994859..8855 ((4131.65.)9) 641149155...353848 (((443022...695)))
58198..2182 ((2434..49)) 31979141...034155 (((258262...187)))
40..6244 ((10..14))
a Standard deviation is in parentheses.
Test Substance M FHE-2q4u0i4v3alents 137307461....75403370 ((11((5405....1563))))
21743...022770 (((411...532)))
ComPanys,
-22-
CBi'" ' la in t s Ca
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
FIGURES
Company Sanftlzed. D*not ^nfarn TSCA CBf
-23-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats_________
400 -,
%
FIGURE 1 MEAN BODY WEIGHTS (g)
#
DuPont-2932
-0-- Negative Control (Deionized Water) G --Negative Control (Corn Oil) A--Negative Control (Corn Oil:Acetone) X-- Positive Control H-24019 9K--Positive Control H-24020 Q-- T est S ubstance H-24043
12
-24-
TSCA CBI
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
FIGURE 2 MICROMOLAR EQUIVALENTS IN RAT BLOOD
A . N o r m a l i z e d R a t Blood H- 240O19r aftlMG aEvqaugiev a l e n t s Res ul t i ng f rom a 10-Day
eMxipcorsoumreo.laVr (ajliuMes) aerqeuimveaalennstsanodf Her-r2o4r0b1a9rs(paroesisttiavnedcaorndtrdoelv)iaintiorant.blood resulting from a 10-day oral gavage
B. N o r m a l i z e d R a t Blood H- 240O20r a/ilMG aEvqaugiev a l e n t s Res ul t i ng f rom a 10-Day
Mexipcorsoumreo.laVr (a/lxuMes) aerqeuimvaealennstsanodf Her-r2o4r0b2a0rs(paroesisttiavnedcaorndtrdoelv)iaintiorant.blood resulting from a 10-day oral gavage Company Sanitized. O o not contain
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
C. N o r m a l i z e d R a t Blood H- 240O43r a lft MG aEv aqguei v a l e n t s Re s ul t i ng f rom a 10-Day
Mexipcorsoumreo.laVr (a/lruMes) aerqeuimvaealennstsanodf Her-r2o4r0b4a3rs(taersetsstuabnsdtaarndced)eviniartaiotnb.lood resulting from a 10-day oral gavage
0
Com ply Sam/uud. Does
"o* contain TSCACBI
-26-
%
H10--2D40o4se3:OBrailoGpearvsaisgteenScteudSycrieneRniantsg
%
FIGURE 3 MICROMOLAR EQUIVALENTS IN TEST COMPOUND AND POSITIVE CONTROLS
DuPont-2932
Company Sanitized. Oom not
5s3oor'
to
o>o
CO
-27-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
^ APPENDICES
0
Company m u m . 0099 not contain TSCA CBI
-28-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
APPENDIX A Individual Body Weights
Co'"W "i' Sm W M 40(iet
" '" "nTSCACB,
-29-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
INDIVIDUAL BODY WEIGHTS
ABBREVIATIONS: SD - sacrificed by design
EXPLANATORY NOTES
DuPont-2932
C '" P a n ,s .,, ,, ilK tD M s not contain tsca CBI
-30-
H10-2-D40o4se3:OBrailoGpearvsaisgteenScteudSycrieneRniantsg
ANIMAL NUMBER
632649 632650 632651 632652 632653
DAY 1
208.8 223.3 238.6 243.4 210.5
DAY 2
208.2 231.1 243.1 240.0 210.5
DEIONIZED WATER (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP I
TEST DAYS
DAY 3
DAY 4
DAY 5
219.8 239.3 253.6 253.0 217.6
225.1 243.7 260.8 257.3 223.0
240.4 261.7 276.7 272.4 236.0
SD test day 5 SD test day 5 SD test day 5 SD test day 5 SD test day 5
Oo3
a
1vt
o%tO3o flftt (>o0
roa
-31-
#
DuPont-2932
ji
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
.DAY 1
632654 632655 632656 632657 632658
210.1 234.4 236.4 251.5 220.8
DAY 2
217.0 238.1 243.5 255.0 227.5
%
DEIONIZED WATER (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP II
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
227.9 248.1 250.2 265.0 235.1
236.0 258.7 258.0 277.0 240.8
248.5 265.7 261.9 292.0 249.3
259.9 278.0 272.2 297.3 256.7
270.6 289.3 280.3 308.0 264.1
ANIMAL NUMBER
632654 632655 632656 632657 632658
DAY 8
DAY 9
282.8 295.4 286.5 317.0 274.3
286.6 307.1 286.1 324.3 278.2
TEST DAYS DAY 10
303.1 315.8 294.5 329.6 286.0
SD test day 10 SD test day 10 SD test day 10 SD test day 10 SD test day 10
10
3Oo303-U)t> o o -32OB
#
DuPont-2932
H10-2-D40o4se3:OBrailoGpearvsaisgteenScteudSycrieneRniantsg
ANIMAL NUMBER
. Day 1
632659 632660 632661 632662 632663
199.9 232.6 238.1 248.1 219.4
Day 2
208.0 238.9 243.1 255.5 227.9
DEIONIZED WATER (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP III
TEST DAYS
Day 3
Day 4
Day 5
Day 6
Day 7
211.0 240.7 247.4 261.5 229.9
220.9 251.8 258.1 269.7 241.7
231.0 260.8 265.7 279.8 249.9
238.9 268.0 273.5 286.2 257.7
247.8 275.7 285.0 292.8 265.2
ANIMAL NUMBER
632659 632660 632661 632662 632663
Oo33<o
Day 8
Day 9
254.1 279.4 291.8 297.0 272.0
- 261.5 286.1 302.4 302.4 276.4
TEST DAYS Day 10 Day 13
270.0 296.3 304.5 309.2 285.1
293.1 309.1 334.9 331.1 299.9
SD test day 13 SD test day 13 SD test day 13 SD test day 13 SD test day 13
Sanitized. Does
3OO
o
t3--o>ao4- -3 3 OB
0
DuPont-2932
%
H10-2-D40o4se3:OBrailoGpearvsaisgteenScteudSycrieneRniantsg__________________________________________
DEIONIZED WATER (NEGATIVE CONTROL) INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP IV
ANIMAL NUMBER
Day 1
Day 2
TEST DAYS
Day 3
Day 4
Day 5
Day 6
Day 7
632664 632665 632666 632667 632668
208.2 228.3 245.8 254.3 218.7
213.9 236.6 251.0 262.3 226.8
219.9 244.9 263.4 272.0 238.5
226.1 252.4 273.8 285.6 249.3
236.6 264.0 282.8 293.6 260.3
242.9 274.3 297.4 300.6 270.1
252.6 282.1 310.0 315.2 282.0
ANIMAL NUMBER
632664 632665 632666 632667 632668
Day 8
256.0 288.0 314.6 319.9 291.6
Day 9
262.8 297.9 326.9 330.0 301.7
TEST DAYS Day 10 Day 13
273.2 306.5 334.0 342.1 314.7
_a _a __a _a
Day 18
318.2 367.1 398.1 414.4 385.7
Day 24
349.0 408.5 441.8 460.4 437.5
SD test day 24 SD test day 24 SD test day 24 SD test day 24 SD test day 24
#
DuPont-2932
\
i
1 a Rats not weighed.
-34-
Ooeso*cont
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
Day 1
Day 2
%
-
DEIONIZED WATER (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
TEST DAYS
Day 3
Day 4
GROUP V
Day 5
Day 6
Day 7
632669 632670 632671 632672 632673
194.4 224.5 226.8 256.3 217.3
197.8 228.6 230.9 267.1 224.8
202.5 237.4 237.2 272.4 230.8
209.5 246.7 243.5 281.3 241.3
215.1 251.9 249.0 295.1 248.2
221.4 259.9 256.9 304.6 258.6
228.1 268.8 262.0 315.4 265.7
ANIMAL NUMBER
632669 632670 632671 632672 632673
Day 8
234.3 271.0 268.0 319.4 268.9
Day 9
232.6 271.0 273.6 328.4 276.4
TEST DAYS Day 10 Day 13
239.6 280.9 276.0 334.8 285.2
_a --a _a _a _a
Day 18
278.1 328.3 308.4 389.8 . 335.6
Day 24
_a _a _a _a _a
Day 25
301.2 361.5 346.2 441.1 370.8
ANIMAL NUMBER
632669 632670 632671 632672 632673
Day 32
Day 39
TEST DAYS Day 46 Day 52
322.8 389.9 378.5 377.5 400.9
355.5 415.7 421.9 517.0 433.8
366.6 434.9 434.6 542.7 457.3
392.4 449.1 456.4 566.6 484.2
SD test day 52 SD test day 52 SD test day 52 SD test day 52 SD test day 52
a Rats not weighed.
P(o0T
-35-
#
DuPont-2932
H10--2D40o4se3:OBrailoGpearvsaisgteenScteudSycrieneRniantsg_____________________________________
DEIONIZED WATER (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
ANIMAL NUMBER
Day 1
Day 2
TEST DAYS
Day 3
Day 4
GROUP VI
Day 5
Day 6
Day 7
632674 632675 632676 632677 632678
197.0 228.8 238.3 238.1 211.3
205.1 239.3 243.2 240.7 227.6
214.1 243.1 252.0 248.2 233.9
221.7 255.3 259.8 255.9 244.4
232.7 264.9 270.3 261.7 253.6
242.0 271.8 280.9 276.0 262.6
250.9 278.0 289.4 282.0 266.0
ANIMAL NUMBER
632674 632675 632676 632677 632678
Day 8
261.7 285.7 294.1 289.0 278.3
Day 9
TEST DAYS Day 10 Day 13
- 266.0 291.6 300.3 298.0 286.3
.
276.7 296.7 309.8 302.7 291.4
_a _a _a _a _a
Day 18
336.2 352.9 368.3 356.9 351.4
Day 24 _a _a _a _a _a
Day 25
380.4 389.6 411.3 397.5 387.6
Company Sanit*, os
ANIMAL NUMBER
632674 632675 632676 632677 632678
Day 32
Day 39
TEST DAYS Day 46 Day 52
Day 53
Day 60
Day 67
419.5 433.4 441.0 423.9 419.3
465.7 482.3 484.3 458.8 460.1
471.8 485.0 502.4 472.8 467.2
508.2 536.0 530.2 492.8 487.8
529.6 540.7 552.8 514.7 502.0
545.8 584.8 565.0 525.1 518.0
566.2 592.2 571.8 536.4 523.5
5S3onoa' a Rats not weighed. oV)
-36-
DuPont-2932
B
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
632674 632675 632676 632677 632678
Day 74
581.9 612.8 587.0 544.2 539.3
Day 81 _a _a _a _a _a
#
DEIONIZED WATER (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP VI TEST DAYS Day 88 Day 94
583.5 645.4 605.1 562.0 551.6
548.9 652.9 603.2 569.4 548.5
SD test day 94 SD test day 94 SD test day 94 SD test day 94 SD test day 94
#
DuPont-2932
ty oe* not contain TSCACBI
a Rats not weighed.
-37-
H10--2D40o4se3:OBrailoGpearvsaisgteenScteudSycrieneRniantsg_______________________________________________________________________________________________ DuPont-2932
CORN OIL (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP I
ANIMAL NUMBER
DAY 1
DAY 2
TEST DAYS
DAY 3
DAY 4
DAY 5
627789 627801 627805 627810 627818
222.6 215.9 249.4 230.5 229.7
220.7
209.1 250.1 231.6 228.6
223.5 223.5 263.3 241.9 239.1
236.9 233.5 273.6 254.4 252.4
247.7 240.1 283.7 265.0 260.2
SD test day 5 SD test day 5 SD test day 5 SD test day 5 SD test day 5
<
?
I
!
I
I
HI
eo00 - 3 8 -
# ##
H10-2-D40o4se3:OBrailoGpearvsaisgteenScteudSycrineeRniantsg________________________________________________________________________________________________ DuPont-2932
CORN OIL (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP II
ANIMAL NUMBER
DAY 1
DAY 2
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
627793 627797 627799 627800 627808
214.8 239.9 228.9 246.9 235.6
224.4 245.9 231.4 252.8 241.6
232.1 257.3 242.3 265.2 250.1
243.1 267.5 246.2 279.3 262.1
249.9 280.7 258.9 283.6 270.4
257.0 288.0 261.5 295.5 284.1
262.0 290.9 266.4 300.1 287.4
ANIMAL NUMBER
DAY 8
DAY 9
TEST DAYS DAY 10
627793 627797 627799 627800 627808
270.6 303.9 280.2 312.0 303.6
274.9 305.1 284.3 315.4 305.7
283.5 324.2 294.7 331.3 321.8
SD test day 10 SD test day 10 SD test day 10 SD test day 10 SD test day 10
Company Sanitized,
sB5voo>1>>' -39 -
a
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats_______ ___________
ANIMAL NUMBER
DAY 1
DAY 2
CORN OIL (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP III
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
627796 627806 627807 627809 627816
239.8 227.3 221.5 234.2 235.0
249.7 234.2 225.9 240.4 238.6
253.6 239.4 237.1 252.5 250.0
252.5 242.9 244.1 260.3 258.9
267.7 258.5 254.9 272.8 265.1
277.2 270.4 257.7 277.9 274.5
289.8 275.2 260.3 282.6 278.6
ANIMAL NUMBER
DAY 8
DAY 9
TEST DAYS DAY 10 DAY 13
627796 627806 627807 627809 627816
O To3f3iJ)
285.9 282.8 270.7 297.9 291.8
290.1 285.8 274.7 300.2 296.4
300.0 302.8 280.7 311.9 305.7
322.7 320.3 305.2 336.2 330.2
SD test day 13 SD test day 13 SD test day 13 SD test day 13 SD test day 13
Sanitised. Does
3OO o3f3-tiO>o)BotJ - 4 0 -
#
DuPont-2932
H10--2D40o4se3:OrBailoGpearvsaisgteenScteudSycrieneRniantsg
ANIMAL NUMBER
DAY 1
DAY 2
CORN OIL (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP IV
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
627791 627794 627804 627812 627817
231.1 224.4 224.7 221.9 233.5
235.4 233.0 228.8 231.5 231.3
241.2 238.1 230.6 236.3 229.0
246.8 247.8 243.0 245.7 244.8
255.9 260.0 251.7 255.5 255.4
262.6 267.4 252.9 264.9 266.4
268.4 270.1 259.5 269.5 270.0
ANIMAL NUMBER
627791 627794 627804 627812 627817
DAY 8
274.0 286.1 267.2 278.2 277.8
DAY 9
279.1 289.5 270.6 282.7 280.4
TEST DAYS DAY 10 DAY 13
285.0 295.4 278.1 294.3 294.6
_a _a _a _a _a
DAY 20
334.4 377.4 345.8 356.5 368.7
DAY 24
365.6 416.7 378.1 388.4 407.3
SD test day 24 SD test day 24 SD test day 24 SD test day 24 SD test day 24
DuPont-2932
Company SanRtaed
!m3
_3a------------------
af^ats not weighed.
*VoC)O
-41 -
S a n it iz e d . Does not contain TSC
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
CORN OIL (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP V
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
627792 627798 627813 627814 627815
235.8 241.1 214.8 217.5 230.1
240.8 253.4 219.2 220.5 242.2
244.3 257.6 220.5 223.7 243.8
247..9 266..1 233 .2 225..2 255..7
252.5 272.9 239.8 233.8 265.0
264.4 281.9 243.2. 236.7 270.0
268.1 286.2 246.8 240.6 274.1
ANIMAL NUMBER
627792 627798 627813 627814 627815
o o 3 ANIMAL NUMBER *<
627792 627798 627813 627814 627815
DAY 8
282.4 294.3 258.7 248.0 289.2
DAY 9
286.4 296.3 259.2 250.7 293.4
TEST DAYS DAY 10 DAY p.3
295.2 315.7 267.9 257.3 303.3
_a _a _a _a __a
DAY 20
360.0 380.2 323.6 299.3 368.3
DAY 24
389.2 403.5 342.3 319.4 396.5
DAY 34
426.1 443.1 367.9 343.7 434.9
DAY 41
DAY 47
TEST DAYS DAY 52
456.5 470.7 395.0 358.7 462.6
482.3 496.9 407.2 372.7 487.3
496.8 517.3 416.8 386.9 505.9
SD test day 52 SD test day 52 SD test day 52 SD test day 52 SD test day 52
a Rats not weighed.
DuPont-2932
H10-2-D40o4se3:OrBailoGpearvsaisgteenScteudSycrieneRniantsg
ANIMAL NUMBER
DAY 1
DAY 2
CORN OIL (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP VI
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
627795 627811 627819 627820 627821
218.0 228.6 248.8 225.5 227.5
219.5 226.3 255.3 228.9 233.2
225.3 236.7 264.9 239.2 240.7
234.3 246.1 274.4 247.9 246.1
239.4 251.5 280.4 255.6 251.2
246.2 259.6 288.0 261.3 259.8
250.1 263.6 290.3 265.3 263.9
ANIMAL NUMBER
DAY 8
DAY 9
TEST DAYS DAY 10 DAY 13
DAY 20
DAY 24
DAY 34
627795 627811 627819
627820 627821
O
261.4 273 .0 304.5 281.3 272.6
JIMAL gMBER 3
to
27795 7811 S27819 (>27820 S27821
DAY 41
384.2 422.0 505.9 478.0 411.8
o3o
asr sgrjRats not weighed.
2
265.0 276.7 308.0 282.9 275.3
DAY 47
398.0 439.3 534.9 504.1 426.1
270.7 285.6 324.3 292.4 281.8
-a -a
308.0 337.8 399.7 367.2 330.1
TEST DAYS DAY 52 DAY 55
_a _a _a _a _a
411.1 455.4 551.7 529.7 439.1
DAY 61
435.7 463.0 574.4 547.1 459.0
-43-
329.8 360.6 431.2 393.0 352.9
DAY 68
440.7 473.6 588.6 558.6 463.3
362.0 396.4 472.5 445.5 385.6
DuPont-2932
m
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 90 DAY 94
CORN OIL (NEGATIVE CONTROL) INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP VI TEST DAYS
627795 627811 627819 627820 627821
474.6 503.6 638.1 608.6 509.0
485.0 511.6 653.1 618.0 521.5
SD test day 94 SD test day 94 SD test day 94 SD test day 94 SD test day 94
#
DuPont-2932
Dom noicontain
-44-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats_________ _________________________________________________
ANIMAL NUMBER
DAY 1
DAY 2
CORN OIL:ACETONE (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP I
TEST DAYS
DAY 3
DAY 4
DAY 5
625361 625363 625364 625380 625383
322.6 273.7 291.1 289.4 304.7
325.0 271.4 290.9 286.2 299.7
337.6 278.4 299.9 291.5 302.7
340.3 281.7 306.0 300.1 310.7
349.7 286.7 312.0 305.5 313.1
SD test day 5 SD test day 5 SD test day 5 SD test day 5 SD test day 5
O T(30a<3o3at OoQN.
o1o3SaT
T>otoT
w
-45-
DuPont-2932
H10-2-D40o4se3:OBrailoGpearvsaisgteenScteudSycrieneRniantsg
ANIMAL NUMBER
DAY 1
DAY 2
CORN OIL:ACETONE (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP II
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
625355 625362 625367 625368 625378
280.0 290.3 301.5 312.3 309.6
282.0 294.1 307.8 318.0 306.4
293.0 303.5 315.6 326.0 327.3
297.9 308.9 320.1 336.4 328.4
306.1 313.8 327.7 343.7 333.7
311.2 315.8 333.7 347.5 336.6
315.7 323.8 345.6 360.8 346.9
ANIMAL NUMBER
DAY 8
DAY 9
TEST DAYS DAY 10
625355 625362 625367 625368 625378
321.7 323.9 349.1 364.2 350.1
320.9 332.3 352.4 380.8 354.2
333.6 332.9 363.8 386.7 365.4
SD test day 10 SD test day 10 SD test day 10 SD test day 10 SD test day 10
DuPont-2932
Company Sanitized. Does
oo3a5HCCO'trO'i- - 4 6 -
DO
%
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats_____________________________
%
CORN OIL:ACETONE (NEGATIVE Control)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
ANIMAL NUMBER
DAY 1
DAY 2
GROUP III
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
625357 625358 625370 625384 625385
311.9 285.7 307.9 294.2 297.6
308.8 286.3 316.7 300.0 304.6
320.3 295.5 329.5 312.0 313.0
328.4 296.4 337.9 309.3 320.4
340.5 306.0 346.9 316.3 331.9
343.3 302.7 349.8. 314.1 334.0
361.1 309.2 364.1 321.4 345.4
ANIMAL NUMBER
DAY 8
DAY 9
TEST DAYS DAY 10 DAY 13
625357 625358 625370 625384 625385
364.2 319 .-8 373.4 325.6 347.0
370.3 321.6 374.7 331.0 349.5
376.9 320.3 385.6 340.6 358.9
405.6 340.7 407.0 357.1 377.6
SD test day 13 SD test day 13 SD test day 13 SD test day 13 SD test day 13
\
-47-
#
DuPont-2932
%
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
%
CORN OIL:ACETONE (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP IV
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
625354 625365 625371 625376 625381
303.0 327.7 294.5 289.7 297.8
304.1 328.7 299.0 289.9 297.5
310.5 337.9 313.4 302.2 301.7
312.2 343.6 318.3 304.9 305.6
319.3 357.7 321.8 313.2 314.4
324.7 357.2 329.6 317.0 314.4
331.2 364.3 338.5 322.8 321.0
ANIMAL NUMBER
DAY 8
DAY 9
TEST DAYS DAY 10 DAY 13
DAY 20
DAY 24
625354 625365 625371 625376 625381
336.2 370.5 340.3 331.5 321.6
337.0 379.3 345.9 339.0 329.1
348.8 381.2 351.2 345.2 331.6
355.8 407.1 372.6 363.2 341.2
377.7 438.2 413.0 399.7 358.2
396.1 459.6 447.3 432.9 381.8
SD test day 24 SD test day 24 SD test day 24 SD test day 24 SD test day 24
0
DuPont-2932
KudttioO
1
I
l%2.
a9.
>
S
-48-
*
H10-2-D40o4se3:OBrailoGpearvsaisgteenScteudSycrieneRniantsg______ __________
%
ANIMAL NUMBER
DAY 1
DAY 2
CORN OIL:ACETONE (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP V
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
625356 625359 625360 625372 625374
291.7 297.9 296.8 294.8 295.9
291.2 303.3 300.7 298.8 302.2
304.5 314.0 308.5 310.6 312.1
307.0 315.0 312.7 317.4 321.7
316.9 323.5 319.1 324.0 323.4
319.8 323.5 332.2 329.0 328.3
323.9 333.9 339.5 335.6 337.2
ANIMAL NUMBER
625356
625359
625360
625372
625374
Oo3o3>o
ANIMAL NUMBER
625356 625359 625360 625372 625374
DAY 8
328.8 339.1 347.9 344.7 338.0
DAY 9
334.7 346.2 354.3 348.8 344.6
TEST DAYS DAY 10 DAY 13
341.3 353.6 363.4 355.1 350.8
361.9 372.9 381.7 373.1 371.5
DAY 20
396.7 410.0 419.8 395.1 401.3
DAY 24 _a __a _a _a _a
DAY 27
431.3 440.9 465.9 432.1 447.2
DAY 34
466.2 467.7 484.1 454.7 466.8
DAY 52
TEST DAYS
533.7 530.3 555.4 506.2 512.3
SD test day 52 SD test day 52 SD test day 52 SD test day 52 SD test day 52
Sanitized. Dees not contain TSCA BI
a Rats not weighed.
-49-
#
DuPont-2932
Company Sanitized. Does
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
CORN OIL:ACETONE (NEGATIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP VI
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
625353 625369 625373 625375 625377
305.9 281.7 294.6 289.1 293.9
307.3 279.9 301.3 291.0 294.8
316.8 289.7 312.7 298.0 302.9
325.0 286.9 317.0 307.0 312.0
331.7 292.8 325.4 309.6 318.0
330.1 295.3 329.0 314.2 317.4
342.5 303.8 334.6 323.5 325.0
ANIMAL NUMBER
625353 625369 625373 625375 625377
DAY 8
344.7 307 .3 340.6 324.7 325.0
DAY 9
352.7 311.9 348.2 336.0 333.7
TEST DAYS DAY 10 DAY 13
358.1 317.2 352.6 336.9 340.7
371.7 331.1 371.5 350.1 353.5
DAY 20
399.1 347.6 402.3 387.9 376.3
DAY 24 _a _a _a _a _a
DAY 27
427.7 374.9 444.6 432.3 405.2
ANIMAL NUMBER
625353 625369 625373 625375 625377
DAY 34
453.3 388.2 477.1 455.6 419.1
DAY 52 _a _a _a _a _a
TEST DAYS DAY 76 DAY 90
DAY 94
544.9 483.8 628.8 567.3 470.3
562.8 505.3 661.3 589.8 492.0
565.3 514.8 673.7 588.8 496.6
SD test day 94 SD test day 94 SD test day 94 SD test day 94 SD test day 94
3Oo3 a Rats not weighed.
DuPont-2932
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
w
H-24019 (POSITIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP I
TEST DAYS
DAY 3
DAY 4
DAY 5
625322 625323 625336 625343 625349
290.3 285.0 316.5 288.2 303.6
283.7 285.5 313.5 281.9 295.9
291.5 290.2 320.1 286.8 308.2
298.9 290.9 327.1 291.0 310.1
298.0 294.0 329.0 293.7 318.1
SD test day 5 SD test day 5 SD test day 5 SD test day 5 SD test day 5
(
DuPont-2932
,0M"Q T*UIWgXuBdiuo
-51 -
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats____________________
H-24019 (POSITIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
ANIMAL NUMBER
DAY 1
DAY 2
GROUP II
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
625320 625330 625332 625341 625350
279.3 286.7 300.0 304.9 257.1
283.0 286.1 295.9 309.0 268.5
287.7 291.1 304.1 317.5 267.3
288.4 296.5 308.8 320.0 272.2
295.9 304.0 315.0 325.1 272.6
299.4 302.3 322.4 327.5 276.3
300.6 306.7 320.7 327.4 283.6
ANIMAL NUMBER
DAY 8
DAY 9
TEST DAYS DAY 10
625320 625330 625332 625341 625350
308.5 314.0 324.1 332.4 279.8
306.3 312.6 321.8 320.3 282.5
312.1 310.1 318.3 325.6 284.3
SD test day 10 SD test day 10 SD test day 10 SD test day 10 SD test day 10
DuPont-2932
nf confab TSCA C B f
-52-
contain TSCACBl
m
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
H-24019 (POSITIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP III
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
625321 625327 625342 625345 625348
307.0 311.4 273.7 291.2 265.5
307.8 306.6 275.5 291.7 258.6
311.4 312.5 282.3 297.3 268.0
319.6 317.8 285.8 303.3 275.2
322.3 318.3 290.8 306.4 280.1
328.4 319.3 294.2 310.4 285.2
335.2 327.6 326.6 316.1 290.6
ANIMAL NUMBER
DAY 8
DAY 9
TEST DAYS DAY 10 DAY 13
625321 625327 625342 625345 625348
337.8 334.3 304.3 317.3 302.7
339.6 337.0 305.9 312.9 306.5
346.1 336.3 307.8 315.0 309.7
371.2 355.3 324.4 336.9 336.4
SD test day 13 SD test day 13 SD test day 13 SD test day 13 SD test day 13
a.0N O9s
-53-
DuPont-2932
m
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
H-24019 (POSITIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP IV
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
625325 625328 625338 625340 625352
282.8 315.6 264.6 304.0 285.5
285.9 315.2 261.9 309.2 283.9
291.7 323.9 268.5 316.9 289.1
295.5 327.7 272.6 326.0 299.6
303.2 335.0 275.7 329.8 307.9
309.2 340.4 281.9 334.1 308.2
308.3 340.1 284.4 338.4 312.4
ANIMAL NUMBER
DAY 8
DAY 9
TEST DAYS DAY 10 DAY 13
DAY 20
DAY 24
625325 625328 625338 625340 625352
318.6 352.0 287.4 347.0 316.9
321.9 351.7 291.3 352.2 322.3
327.4 357.5 290.2 359.2 321.0
331.6 367.4 291.1 368.1 329.6
355.8 400.2 320.4 389.3 355.7
381.3 423.9 339.9 419.0 375.3
SD test day 24 SD test day 24 SD test day 24 SD test day 24 SD test day 24
m
DuPont-2932
Company Sanitized. Dee* not contain TSCA CBI
-54-
Company San iti*** Does
t>
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
H-24019 (POSITIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP V
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
625324 625329 625333 625334 625344
303.0 318.9 292.4 274.6 262.9
298.5 316.3 291.2 277.0 262.2
305.8 326.5 297.8 286.4 269.0
312.1 335.4 304.1 290.6 273.5
320.1 338.3 307.7 292.0 274.5
322.8 346.7 312.0 300.1 284.1
326.8 351.6 313.5 304.2
-
ANIMAL NUMBER
625324 625329 625333 625334 625344
DAY 8
332.5 352.5 315.8 292.6 280.7
DAY 9
337.9 360.1 316.7 302.2 285.2
TEST DAYS DAY 10 DAY 13
336.1 357.0
319.3 305.8 289.3
299.6 364.3 325.8 312.0 295.8
DAY 20
336.0 396.4 349.2 338.6 309.7
DAY 24 _a _a _a _a ___a
DAY 27
380.3 423.3 375.2 368.8 330.4
ANIMAL NUMBER .
DAY 34 DAY 52
TEST DAYS
625324
397.3
625329
442.7
625333
384.6
625334
384.2
3OOo3K5. 625344
348.3
(o>/> a Rats not weighed.
oBJ
447.4 498.1 427.4 426.5 391.0
SD test day 52 SD test day 52 SD test day 52 SD test day 52 SD test day 52
-55-
DuPont-2932
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
H-24019 (POSITIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP VI
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
#
DuPont-2932
625326 625335 625346 625347 625351
313.2 301.0 290.2 266.0 310.6
317.1 303.6 293.4 275.6 310.9
325.5 302.3 300.2 287.7 321.1
330.9 310.4 309.5 300.0 329.6
336.2 315.1 313.5 308.5 338.2
336.0 299.6 318.6 316.6 341.6
293.6 326.0 326.9 340.7
ANIMAL NUMBER
625326 625335 625346 625347 625351
DAY 8
311.5 294.-2 292.9 330.5 351.1
DAY 9
308.9 285.3 290.8 330.1 357.8
TEST DAYS DAY 10 DAY 13
297.5 274.0 288.4 333.0 350.5
274.2 266.3 296.9 355.7 380.0
DAY 20
335.4 340.1 352.5 402.1 413.7
DAY 24
_a _a _a _a
DAY 27
390.7 393.8 388.2 436.2 452.4
Company D oSanitized.
ANIMAL NUMBER
DAY 34
625326 625335 625346 625347 625351
427.5 427.0 407.4 466.4 483.3
3O
33a5H(O>oo>A'o a Rats not weighed.
DAY 52 _a _a _a __a _a
TEST DAYS DAY 62 DAY 76
DAY 80
497.5 506.0 485.8 568.6 559.0
540.0 538.6 523.7 617.8 596.8
547.9 547.7 532.8 618.1 607.2
-56-
DAY 90
565.2 562.1 542.4 632.6 624.0
DAY 94
577.5 579.5 556.9 638.9 636.8
SD test day 94 SD test day 94 SD test day 94 SD test day 94 SD test day 94
H-24043: Biopersistence Screening IQ-Dose Oral Gavage Study in Rats______________
m
ANIMAL NUMBER
DAY 1
DAY 2
H-24020 (POSITIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP I
TEST DAYS
DAY 3
DAY 4
DAY 5
627756 627767 627771 627773 627777
227.2 227.0 219.5 246.8 225.4
226.4 231.8 214.7 244.4 221.4
233.4 237.9 226.1 252.7 232.9
238.6 245.8 233.5 263.8 239.4
237.5 248.6 239.6 262.3 236.0
SD test day 5 SD test day 5 SD test day 5 SD test day 5 SD test day 5
O To303(S<33N)nfpOl>l.
o
not contato TSCA CB!
-57-
DuPont-2932
%
H10-2-D40o4se3:OBrailoGpearvsaisgteenScteudSycrineeRnaintsg______ _____________
%
ANIMAL NUMBER
DAY 1
DAY 2
H-24020 (POSITIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP II
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
627768 627774 627776 627782 627785
236.9 258.6 212.0 221.6 220.3
244.1 261.6 216.3 228.3 221.7
245.2 275.8 223.7 237.3 234.7
256.5 283.4 226.6 239.0 238.4
256.2 289.3 229.6 238.8 241.8
265.5 301.5 233.7 244.7 250.5
271.4 303.2 236.9 246.7 255.6
ANIMAL NUMBER
DAY 8
DAY 9
TEST DAYS DAY 10
627768 627774 627776 627782 627785
O
I
tn
%oo-%
272.3 319.-8 246.1 251.0 260.7
291.9 326.3 252.3 264.0 268.5
293.5 338.2 254.4 268.2 267.9
SD test day 10 SD test day 10 SD test day 10 SD test day 10 SD test day 10
\
-0A
-58-
#
DuPont-2932
*udu0
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
m
H-24020 (POSITIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP III
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
627758 627763 627764 627787 627788
235.1 212.1 230.0 235.1 219.4
240.3 218.3 235.0 241.0 222.3
248.6 226.5 246.1 250.1 232.2
255.8 234.3 251.3 257.2 239.6
261.2 230.8 254.8 258.6 247.6
272.0 235.5 261.7. 237.6 256.7
276.1 238.0 264.7 240.3 257.9
ANIMAL NUMBER
DAY 8
DAY 9
TEST DAYS DAY 10 DAY 13
627758 627763 627764 627787 627788
280.6 255.-2 275.8 221.7 274.1
283.6 261.2 281.9 235.7 276.9
295.8 272.5 288.0 234.7 284.8
308.7 285.8 306.7 234.9 309.4
SD test day 13 SD test day 13 SD test day 13 SD test day 13 SD test day 13
(5ft.
%ao%.3Ooo3 3T.ofto
-59-
m
DuPont-2932
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
H-24020 (POSITIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP IV
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
627759 627761 627770 627779 627786
226.6 240.7 235.6 231.5 211.6
232.9 247.4 244.3 237.9 218.2
241.4 257.1 253.6 252.6 222.5
250.9 262.5 260.1 261.4 230.4
254.2 266.7 267.7 262.3 230.6
262.1 259.2 277.3 273.8 240.6
265.4 262.6 279.8 277.5 244.1
ANIMAL NUMBER
627759 627761 627770 627779 627786
DAY 8
277.8 240.1 291.4 289.0 251.3
DAY 9
284.9 257.4 301.3 293.4 255.8
TEST DAYS DAY 10 DAY 13
288.0 266.9 306.4 301.0 257.0
_a _a _a __a _a
DAY 20
348.0 335.7 355.8 374.4 304.4
DAY 24
380.1 359.4 379.8 406.2 326.1
SD test day 24 SD test day 24 SD test day 24 SD test day 24 SD test day 24
DuPont-2932
du0
I 1 %
(I)
a Ratsmot weighed,
----------o2-9.(.o-P--------------
-60-
ueduioO
>
H-24043: Biopersistence Screening 1Q-Dose Oral Gavage Study in Rats_______
ANIMAL NUMBER
DAY 1
DAY 2
#
H-24020 (POSITIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP V
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
627757
627760 627765 627772 627781
221.2 226.2 228.3 245.2 219.0
225.4 232.0 235.3 256.4 226.3
236.3 244.4 247.1 266.2 236.5
241.1 251.7 251.6 277.0 242.9
247.9 260.2 256.4 276.9 247.2
252.2 254.5 261.1 285.0 251.6
254.4 258.3 264.7 291.0 256.1
ANIMAL NUMBER
DAY 8
DAY 9
TEST DAYS DAY 10 DAY 13
DAY 20
DAY 24
DAY 34
627757 627760 627765 627772 627781
269.1 262.6 271.5 300.9 258.1
276.7 280.3 282.4 307.5 266.8
279.7 287.3 288.1 317.0 271.2
-a -a
324.3 348.6
349.8 375.5 315.1
343.0 379.9 382.7 404.0 338.8
372.3 419.4 400.9 446.9 372.0
ANIMAL
NUMBER
DAY 41
U3>Noo.
627757 627760 627765
ao9*3aooa3.
627772 627781
(O>pO0>
a Rats not weighed.
______________
402.8 437.7 422.9 478.4 389.9
DAY 47
419.7 448.9 444.8 494.3 408.2
TEST DAYS DAY 52
436.7 456.5 455.6 513.5 421.0
SD test day 52 SD test day 52 SD test day 52 SD test day 52 SD test day 52
-61 -
#
DuPont-2932
Company Sanitized. Does not contain TSCA CBI
6
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
%
H-24020 (POSITIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP VI
TEST DAYS
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
627762 627769 627775 627778 627783
227.2 231.1 224.7 213.1 216.4
235.0 241.1 235.7 217.4 218.2
248.7 255.9 246.8 221.3 226.6
257.3 264.2 254.7 225.5 232.0
263.0 272.3 265.7 230.1 238.0
275.1 286.3 276.7 236.9 243.9
279.7 289.9 280.2 240.4 247.6
ANIMAL NUMBER
DAY 8
DAY 9
TEST DAYS DAY 10 DAY 13
DAY 20
DAY 24
DAY 34
627762 627769 627775 627778 627783
ANIMAL NUMBER
627762 627769 627775 627778 627783
285.9 302. 286.6 244.8 256.6
DAY 41
438.7 479.7 433.2 356.8 409.6
299.1 309.6 296.0 250.8 259.2
DAY 47
439.9 474.6 451.1 373.5 426.9
301.5 312.5 304.5 255.1 264.3
-a
-a -a -a
TEST DAYS DAY 52 DAY 55
_a __a _a __a _a
453.5 512.2 460.8 386.0 449.0
356.5 386.6 353.3 294.0 311.3
DAY 61
473.0 511.4 477.4 393.3 473.8
381.5 414.4 377.4 320.0 340.9
DAY 68
471.6 531.4 478.6 398.3 474.8
419.6 456.5 413.9 347.1 380.0
a Rats not weighed.
-62-
#
DuPont-2932
H10-2-D40o4se3:OBrailoGpearvsaisgteenScteudSycrieneRniantsg______________
ANIMAL NUMBER
DAY 81
DAY 90
H-24020 (POSITIVE CONTROL)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP VI TEST DAYS DAY 94
627762 627769 627775 627778 627783
500.3 566.2 510.4 410.1 508.8
523.3 603.2 537.5 436.5 538.5
528.6 609.6 552.8 445.3 557.2
SD test day 94 SD test day 94 SD test day 94 SD test day 94 SD test day 94
Oe
*S<
CO
S--
1o 8V3Ooo30)> 3H<O>O/>
09
-63-
DuPont-2932
%
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
H-24043 (TEST SUBSTANCE)
INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP I
TEST DAYS
DAY 3
DAY 4
DAY 5
628254 628266 628267 628270 628279
216.9 219.0 229.4 251.6 221.1
219.1 213.9 230.7 254.8 221.4
227.0
223.0 244.4 264.5 231.1
233.6 233.0 248.8 271.0 238.0
244.7 240.2 260.3 281.0 242.9
SD test day 5 SD test day 5 SD test day 5 SD test day 5 SD test day 5
*03<>o C3D oo(U0) 3oOoan5HC>Oot>o"D.
-64-
#
DuPont-2932
Aiieduiod
m
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
H-24043 (TEST SUBSTANCE) INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP II
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
628253 628256 628258 628276 628278
ANIMAL NUMBER
229.2 219.1 246.0 222.9 256.7
DAY 8
232.9 224.4 251.3 227.0 268.2
241.3 229.4 263.9 239.1 276.8
DAY 9 DAY 10
244.8 236.7 268.2 241.8 285.7
253.2 240.5 275.0 249.7 292.4
255.4 248.6 282.9 255.6 300.8
264.4 252.3 290.5 265.8 307.9
628253 628256 628258 628276 628278
271.8 260.2 299.9 275.7 321.3
284.4 267.7 312.5 286.1 328.2
279.8 274.0 319.9 286.7 329.7
SD test day 10 SD test day 10 SD test day 10 SD test day 10 SD test day 10
&
l
l
\
ta. 3 -t
V)
O
>
o s
-65-
DuPont-2932
li
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
^
H-24043 (TEST SUBSTANCE) INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP III
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
628261 628271 628275 628280 628284
ANIMAL NUMBER
254.4 222.5 241.2 207.2 236.7
DAY 8
264.7 229.3 245.6 206.2 245.1
272.2 238.4 258.7
214.0 251.5
277.7 241.1 266.9 216.3 261.4
DAY 9 DAY 10 DAY 13
288.4 248.0 275.9 223.6 267.7
294.6 259.6 283.4 229.2 278.2
306.1 265.1 285.9 236.3 283.4
628261 628271 628275 628280 628284
309.3 278.4 300.'2 243.5 307.2
326.5 279.2 307.9 244.4 308.5
321.7 290.1 321.9 252.2 324.0
335.5 303.2 345.6 271.4 351.0
SD test day 13 SD test day 13 SD test day 13 SD test day 13 SD test day 13
^
DuPont-2932
S90Q 'P
3O n
o3,
3 -4
UO>o>
00
-66-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
H-24043 (TEST SUBSTANCE) INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP IV
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
628255 628259 628265 628274 628282
ANIMAL NUMBER
628255 628259 628265 628274 628282
231.7 239.7 243.6 212.6 242.7
DAY 8
287.8 289.4 293.8 259.3 277.5
234.5 246.0 251.6 215.3 235.4
244.7 253.2 257.7 228.1 245.1
253.6 260.8 264.1 230.4 248.7
260.3 268.0 273.1 239.7 253.7
268.9 277.1 274.8. 245.6 260.1
274.5 282.0 284.3 249.6 265.2
DAY 9
291.5 295.5 302.1 263.9 285.3
DAY 10
301.0 304.5 312.1 267.7 284.1
DAY 13 _a _a __a __a _a
DAY 20 DAY 24
360.4 361.2 383.3 315.3 337.4
391.8 387.1 414.4 342.3 359.8
SD test day 24 SD test day 24 SD test day 24 SD test day 24 SD test day 24
DuPont-2932
.uieyjooyu
t-^4Rats not weighed.
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
%
H-24043 (TEST SUBSTANCE) INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP V
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
628260 628262 628263 628272 628281
ANIMAL NUMBER
628260 628262 628263 628272 628281
O ANIMAL NUMBER
o3> 628260 628262 628263 628272 628281
243.1 222.9 249.1 230.2 229.5
246.6 222.1 253.2 236.9 238.7
256.4 233.5 265.6 243.4 240.2
265.4 238.9 268.3 249.1 250.9
268.6 248.2 275.8 253.6 254.4
266.3 255.8 284.1 264.2 267.0
287.7 264.6 289.8 272.5 270.6
DAY 8
290.9 266.7 294.0 279.9 282.5
DAY 9
306.1 279.0 303.3 281.7 293.2
DAY 10
311.6 283.3 307.3 293.4 296.5
DAY 13
a _a _a _a
DAY 20
372.2 346.3 355.5 350.6 348.4
DAY 24
_a --a _a _a _a
DAY 27
405.3 383.4 383.9 387.3 387.9
DAY 33 DAY 41 DAY 47 DAY 51
429.3 409.5 405.2 413.4 414.4
456.5 449.4 432.6 449.8 447.1
474.7 468.9 457.5 481.8 467.4
490.9 487.6 469.9 505.9 478.4
SD test day 51 SD test day 51 SD test day 51 SD test day 51 SD test day 51
S a n itiz e d . Does not contain
tn a Rats not weighed. >
O
09
------------------------------------
-68.
0
DuPont-2932
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 1
DAY 2
#
______________________________________________________________ DuPont-2932
H-24043 (TEST SUBSTANCE) INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP VI
DAY 3
DAY 4
DAY 5
DAY 6
DAY 7
628257 628264 628268 628269 628285
ANIMAL NUMBER
628257 628264 628268 628269 628285
ANIMAL NUMBER
628257 628264 628268 628269 628285
230.9 247.4 220.0 214.8 235.5
240.5 255.9 225.2 215.8 236.2
249.5 259.0 233.4 222.9 242.3
259.2 267.5 241.0 230.4 245.0
265.1 278.5 249.9 237.4 256.6
278.5 286.6 260.2 243.7 264.6
281.6 290.4 263.7 245.8 267.1
DAY 8
297.5 306.0 273.0 254.0 280.8
DAY 9
306.7 315.6 282.9 263.7 284.7
DAY 10
310.2 324.8 285.5 267.7 293.8
DAY 13 _a __a _a _a _a
DAY 20
385.7 398.4 343.0 312.6 358.4
DAY 24 _a _a _a _a _a
DAY 27
426_ .a 3 380.1 345.9 397.0
DAY 33
459.9 488.1 412.5 362.8 436.4
DAY 41
491.9 514.7 443.6 386.7 485.4
DAY 47
516.8 548.3 459.8 401.0 520.8
DAY 51 _a _a _a _a _a
DAY 54
540.0 575.6 483.1 422.0 555.5
DAY 60
563.9 595.0 504.3 431.7 588.4
Company Sanitized. Does not contain TSCA CBI
a Rats not weighed.
-69-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
ANIMAL NUMBER
DAY 76 DAY 82
%
H-24043 (TEST SUBSTANCE) INDIVIDUAL BODY WEIGHTS (g) OF MALE RATS
GROUP VI DAY 88 DAY 94
628257 628264 628268 628269 628285
604.3 638.7 544.6 463.5 627.7
620.8 655.5 545.4 471.2 647.1
634.2 670.5 558.5 476.0 661.9
647.6 678.2 560.3 478.1 669.2
SD test day 94 SD test day 94 SD test day 94 SD test day 94 SD test day 94
DuPont-2932
sw3tnnU'a TSCACBI
-70-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
APPENDIX B Individual Clinical Observations
-71 -
Conpany Sanitized. Does "contain TSCACBf
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
DEIONIZED WATER (NEGATIVE CONTROL) INDIVIDUAL CLINICAL OBSERVATIONS IN MALE RATS
GROUP I Animal Number____________________ Observation________________________Test Day
632649 632650 632651 632652 632653
No abnormalities detected No abnormalities detected No abnormalities detected NO abnormalities detected No abnormalities detected
1-5 1-5 1-5 1-5 1-5
Animal Number
632654 632655 632656 632657 632658
GROUP II
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected NO abnormalities detected
Test Day
1-10 1-10 1-10 1-10 1-10
Animal Number
632659 632660 632661 632662 632663
GROUP III
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-13 1-13 1-13 1-13 1-13
Company Sanitized. Does not contain TSCA CBI
-72-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
DEIONIZED WATER (NEGATIVE CONTROL)
INDIVIDUAL CLINICAL OBSERVATIONS IN MALE RATS
Animal Number
632664 632665 632666 632667 632668
GROUP IV
Observation
No abnormalities detected No abnormalities detected No abnormalities detected NO abnormalities detected No abnormalities detected
Test Day
1-24 1-24 1-24 1-24 1-24
Animal Number
632669 632670 632671 632672 632673
GROUP V
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-52 1-52 1-52 1-52 1-52
Animal Number
632674
632675
632676 632677
632678
GROUP VI
Observation
No abnormalities detected Hair Loss, Forelimb, Bilateral
No abnormalities detected Hair Loss, Forepaw, Bilateral
No abnormalities detected No abnormalities detected Hair Loss, Forepaw, Bilateral No abnormalities detected
Test Day
1-88 94
1-81 88-94 1-94 1-53 60-94 1-94
Sani,fretf. Dees nof contain TSCACBf
-73 -
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
CORN OIL (NEGATIVE CONTROL)
INDIVIDUAL CLINICAL OBSERVATIONS IN MALE RATS
Animal Number
GROUP I Observation
Test Day
627789 627801 627805 627810 627818
No abnormalities detected No abnormalities detected No abnormalities detected NO abnormalities detected No abnormalities detected
1-5 1-5 1-5 1-5 1-5
Animal Number
627793 627797 627799 627800 627808
GROUP II
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-10 1-10 1-10 1-10 1-10
Animal Number
627796 627806 627807 627809 627816
GROUP III
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-13 1-13 1-13 1-13 1-13
Con*Pany Sanitized. O* not contain T SC A C B/
-74-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
CORN OIL (NEGATIVE CONTROL)
INDIVIDUAL CLINICAL OBSERVATIONS IN MALE RATS
GROUP IV Animal Number____________________ Observation________________________Test Day
627791 627794 627804 627812 627817
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
1-24 1-24 1-24 1-24 1-24
Animal Number
627792 627798 627813 627814 627815
GROUP V
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-52 1-52 1-52 1-52 1-52
Animal Number
627795 627811 627819 627820 627821
GROUP VI
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-94 1-94 1-94 1-94 1-94
S m fS n A Offas n o i contain TSCA CBI -75 -
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
CORN OIL:ACETONE (NEGATIVE CONTROL)
INDIVIDUAL CLINICAL OBSERVATIONS IN MALE RATS
Animal Number
GROUP I Observation
Test Day
625361 625363 625364 625380 625383
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
1-5 1-5 1-5 1-5 1-5
Animal Number
625355 625362 625367 625368 625378
GROUP II
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-10 1-10 1-10 1-10 1-10
Animal Number
625357 625358 625370 625384 625385
GROUP III
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-13 1-13 1-13 1-13 1-13
Qes not contain TSCA C B l -76-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
CORN OIL:ACETONE (NEGATIVE CONTROL)
INDIVIDUAL CLINICAL OBSERVATIONS IN MALE RATS
GROUP IV Animal
Number____________________ Observation_______________________ Test Day
625354 625365 625371 625376 625381
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
1-24 1-24 1-24 1-24 1-24
Animal Number
625356 625359 625360 625372 625374
GROUP V
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-52 1-52 1-52 1-52 1-52
Animal Number
625353 625369 625373 625375 625377
GROUP VI
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-94 1-94 1-94 1-94 1-94
Con^pjoji Sanitized. Does not contain TSCA CBl
-77-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
H-24019 (POSITIVE CONTROL)
INDIVIDUAL CLINICAL OBSERVATIONS IN MALE RATS
Animal Number
625322 625323 625336 625343 625349
GROUP I
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-5 1-5 1-5 1-5 1-5
Animal Number
625320 625330 625332 625341
625350
GROUP II
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Diarrhea No abnormalities detected
Test Day
1-10 1-10 1-10 1-4, 6-10
5 1-10
Animal Number
625321
625327 625342 625345 625348
GROUP III
Observation
No abnormalities detected . Diarrhea
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-4, 6-13 5
1-13 1-13 1-13 1-13
Company Sanitized. Does not contain TSCA CBI
-78-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
H-24019 (POSITIVE CONTROL)
INDIVIDUAL CLINICAL OBSERVATIONS IN MALE RATS
Animal Number
GROUP IV Observation
Test Day
625325 625328 625338
625340 625352
No abnormalities detected No abnormalities detected No abnormalities detected
Salivation No abnormalities detected No abnormalities detected
1-24 1-24 1-6, 8-24
7 1-24 1-24
Animal Number
625324 625329
625333
625334 625344
GROUP V
Observation
No abnormalities detected No abnormalities detected
Salivation No abnormalities detected
Salivation No abnormalities detected No abnormalities detected
Test Day
1-52 1-6, 8-52
7 1-6, 8-52
7 1-52 1-52
Animal Number 625326
625335 625346
625347 625351
GROUP VI
Observation
No abnormalities detected Salivation
Alopecia both front legs Alopecia abdomen
No abnormalities detected Salivation
Black ocular discharge Yellow-stained perineum
Red-stained chin Brown-stained chin No abnormalities detected No abnormalities detected
Salivation
Test Day
1-6, 9-76, 77-94 7-8 76
7, 8, 9, 10, 13, 20, 27
1-6, 11-94 7-8 8 8 8 9-10 1-94
1-6, 8-94 7
ComPany Santized. *s not conta in TSCA CBI
-79-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
H-24020 (POSITIVE CONTROL) INDIVIDUAL CLINICAL OBSERVATIONS IN MALE RATS
DuPont-2932
Animal Number
627756 627767 627771 627773 627777
GROUP I
Observation______________ ;_________ Test Day
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
1-5 1-5 1-5 1-5 1-5
Animal Number
627768 627774 627776 627782 627785
GROUP II
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-10 1-10 1-10 1-10 1-10
Animal Number
627758 627763 627764 627787
627788
GROUP III
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Wet perineum No abnormalities detected
Diarrhea
Test Day
1-13 1-13 1-13 1-5, 7-13
6 1-8, 10-13
9
Company Sanitized. Does not contain TSCA CBI
-80-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
H-24020 (POSITIVE CONTROL) INDIVIDUAL CLINICAL OBSERVATIONS IN MALE RATS
DuPont-2932
Animal Number
627759 627761 627770 627779 627786
GROUP IV
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-24 1-24 1-24 1-24 1-24
Animal Number
627757 627760 627765
627772
627781
GROUP V
Observation
No abnormalities detected No abnormalities detected No abnormalities detected
Wet perineum No abnormalities detected
Wet perineum No abnormalities detected
Test Day
1-52 1-52 1, 3-52
2 1, 3-52
2 1-52
Animal Number
627762
627769 627775 627778 627783
GROUP VI
Observation
No abnormalities detected Diarrhea
No abnormalities detected No abnormalities detected
Alopecia perineum No abnormalities detected Alopecia both front paws
Alopecia right front leg
Test Day
1-8, 10-94 9
1-94 1-94 81, 90, 94 1-23, 94 24, 34, 41, 47, 55, 61, 74, 81, 90
Company Sanitized Does not contain TSCA CBI
-81 -
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
H-24043 (TEST SUBSTANCE)
INDIVIDUAL CLINICAL OBSERVATIONS IN MALE RATS
GROUP I Animal Number____________________ Observation_______________________ Test Day
628254 628266 628267 628270 628279
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
1-5 1-5 1-5 1-5 1-5
Animal Number
628253 628256 628258 628276 628278
GROUP II
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-10 1-10 1-10 1-10 1-10
Animal Number
628261 628271 628275 628280 628284
GROUP III
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Test Day
1-13 1-13 1-13 1-13 1-13
n> c V a i,, TSCA CBi
-82-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
H-24043 (TEST SUBSTANCE)
Animal Number
628255 628259 628265 628274 628282
INDIVIDUAL CLINICAL OBSERVATIONS IN MALE RATS
GROUP IV
Observation
Test Day
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
1-24 1-24 1-24 1-24 1-24
Animal Number
628260 628262 628263 628272 628281
GROUP V
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Sore on neck or chin
Test Day
1-51 1-51 1-51 1-51 1-4,7,27-51 5,6,8,9,10,20
Animal Number
628257 628264 628268 628269 628285
GROUP VI
Observation
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected
Alopecia paw
Test Day
1-94 1-94 1-94 1-94 1-7, 10-60,82,88 8,9,76,94
Does notcwtain TSCACB1
-83-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
APPENDIX C Individual Fluorine Levels
Company Sanitized. Does not contain TSCA CBI
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
Terms: Active % Active
Mol Wt Active Formulation Dose % F in Active
Mol Wt F
TERMS AND CALCULATIONS
Fluorine containing compound Tcohme p%onoefnftosrmulation that is made up of fluorine containing The molecular weight of the fluorine containing components (g/mole) The mg of formulation given per kg of animal body weight Tfohrem%ulaftliuoonri(nweeiinghthtebaflsuiso)rine containing components of the The molecular weight of fluorine g/mol
Compound Calculations:
Dose Active (mg/kg) The mg of fluorine containing compound administered per kg of anim=a(l%boadcytivwee/i1g0h0t.) x Formulation Dose
Dose Active (mmole/kg) Tanhiemmalmbooldeyowf efliugohrtine containing compound administered per kg of = dose [mg/kg] / Mol Wt Active [mg/mmol]
Dose F (mg/kg)
The mg Fluorine administered per kg of animal body weight = (% F in active/100) x Dose Active [mg/kg]
Dose F (mmol/kg)
The=mDmoosleeFof[mflug/okrgin]e/ aMdmolinWistteFre[dmpge/mr kmgool]f animal body weight
Molar Ratio (Active/F) The =mDoloesseoAf cfltuivoerin[me mcoonlt/akign]in/gDcoosme pFo[umnmd ople/rkgm]ole of fluorine
NFoorrmmuallaiztiaotnioDn oFsaector
oTfhaectfiovremnueleadtieodntdooascehtiheavtewthoeulndobrme areliqzueidreddotsoe administer the amount = (Normalized dose of Active [mmol/kg] / Dose Active [mmol/kg]) x Formulation Dose
Company Sanitized. Does not contain TSCA CBI
-85 -
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
TERMS AND CALCULATIONS
Individual Animal Measurement:
ppm F in blood
The ppm fluoride measured in blood
Individual Animal Calculations:
pBpkmg 0F.2inpBpmlood minus Tmheeaspuprmedfilnuocroindetromleaansiumreadl binlopolda.smInatmhiisncuasstehethbeavcaklgureowunads fluoride established at 0.2 ppm.
ppm F in Blood n0.o1rmmamliozle/dkgtoDose
The ppm fluoride minus background that would be expected if the aalsetscuvstdiuev=ylmse.,(med0bsoiu.n1lstiuenis[sewmbanaramesicteoyk0dl.gb/e1krdeogmtuwb]nme/edceAoa)nluc/ksatiegdvmdeiniidfsnfoteiessraeteednr[temoddfmotdhsooeels/sekaocgatf]nu)adaxclbtia(lvpcoeptoimvwdeefFdrlueoionsuresib.neleodToihdnisthe
imolar equivalents of active in blood
Ti0dn.eh1rpeimlv/aesmdmmoofalrl/oabkrmag[s/aetihcdmetioovflnle/uLtdoh]oreicsnpeoe.pn-mccTeohnnfitltsruaaoiatnrsiioisnnunegmoicnefosfmpltulhpaoasortmninaealenlntcpooilnranmsttmahaielnaiziffnoelgrudmoctrouoilnmaetpioiosnu.nd Note=: ([Nm1pogpr/mmmam-liozl1e]d)mxpgp/mLmol[amr gra/Lti]ofaluctoirvien/eFi[nmbmlooolda/ctMivoel/mWmt oFl F] x
1000 /imol/mmol
C mpany S* nHllw t * not contain TSCA CBI
-86-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
DuPont-2932
FACTORS INFLUENCING INTERPRETATION OF KINETIC ANALYSIS Considerations: - cTahuetidoautsalyu.sed for kinetic analysis was from a limited screen and extrapolation should be done -- ASanmalpylteicsailzedaistalouwsed without validation -- TSteeramdiyn-asltaptheansoetmreaaychneodt be reached -- DSoifmfeerecnotmapcotiuvnedasnadrefomrmixutluarteiosnodf oflsueosrwinearteeducseodmpounds --- EDTahifcefhekrcienonemttivpceoshuaincpdlpelmsywaoynerlhyeavutoesepvdleatrsoymddaei,flfinevoreterntfotopsrpmoetuecnliafctiyicoftniossrspureosdourctihnegwtohxoilceitbyody
Assumptions: (May or may not bejustified in all cases) -- PAlnaaslmytaicfalulomrientehocdonisceanptprarotiporniastaerfeolrinaellatrywpeitshorfescpoemcpt otounddosse - iEnldimiviindautaiol ncokminpeotincesnctsan be determined based on total fluorine rather than on concentrations of --- M%BaoFclkedgcarutolaaurinswdthepeilga%hsmt FiasluFtholeurionmreionoleefcitsuhle0a.ra2cwptiepvimgeh(tFolufotrhieneacctoivnetacinoimngpocnoemnpt oinnethnet(sf)orimn uthlaetifoonrmulation
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
Data for H- 24019
DuPont-2932
GivMeno:l Wt. Active (g/mole):
497
F%orAmcutilvaetio(Fn CDoonsteai(nmingg/k)gi)n: Formulation: 11000
M%oFl iWn tA. cFti(vge/:mol): 6159
CalcDDuoolssaeeteAAdccVttiivvaeelu((emms:gm/kogle)/:kg): Formulation Dose Normalization Factor:
01.0020 49.7
MDooslearFR(amtimo o(Al/kcgti)v:e/F): 00..035492
Dose F (mg/kg):
6.5
NuRmabt er G62ro5u32p2I 662255332336 662255334439 G66662222ro555533u334223p3326I 625349 Group II 666222555333323200 662255334510
SaTDmeaspytle pBpliomnodF
111 211...630 11 22..69
5555
51.7 733888...570
5 37.1
111000 1100
6615..16 665380...115
Mp0ip.Bn2mulopsoFpBdmikng 01..18 222...474 51.5 733887...358 36.9 65.4 66650207....3999
pNpomrmFailnizBedlotood 0.1 mDmooseles/kg
35..4987 111113...994332 255.96 119817..3857 318893..1359 325.04 233910292...666179 287.76
Eq/umivoallaernts of ABclotiovde in
33116626....39991222 41.54 755998221...335114 1526074.6.692 1903066.9.125 998269770...667997
Company Sanitized. Does not contain TSCA CBi
-88-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats________
Rat Number
TDeasyt Sample
ppimn F Blood
ppBmlooFdin M0i.n2upspBmkg
Group III 662255332217 666222555333444852
13 111333 13
6717..52 656472...604
67654167....3840 62.2
G6r2o5u3p25IV 662255333288 662255335420
222444 2244
40.3 4463..32 3491..19
4406..11 443138...790
G66r22o55u33p2294V 666222555333334344
55552222 52
222794...387 2293..18
22227984....1569 23.6
G6r2o5u3p26VI 662255333456 662255335417
999444 9944
12.4 111361...140 11.6
1111110262.....89422
ppm F in Blood N0.1ormmmaloizleesd/ktog
Dose 333280240...066796 230892..1330 199.30 221239..7112 210973..2353 114271..1717 111134734...626399 60.63 658430...156118 56.66
DuPont-2932
/molar EofqAuicvtaivleenitns
Blood 1991948034..07.6872 985763..9852 616.92 667564091918....25543464 444315476546....93692822 363.08 214897..2639 111679658...134586
Comply S,, ,,, 2(1(( notcontain rscAC|
-89-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
Data for H- 24020
Given:
F%MoorAmlcWutilvta.etiAo(FcntiCDvoeons(tega/i(mnmionglg/ek))g:i)n: Formulation:
42206 100
CalcDDuoolssaeeteAAdccVttiivvaeelu((emms:gm/kogle)/:kg): Formulation Dose Normalization Factor:
24002.0.647
DuPont-2932
M%oFl iWn tA. Fcti(vge/m: ol): 6199
DMooslearFR(amtimo o(Al/kcgti)v:e/F): 00..076256
Dose F (mg/kg):
13.8
NuRmabt er G6622ro7777u77p13I 662277776576 627777 G6622ro7777u77p13I 666222777777765776 Group II 666222777777677864 662277778852
SaTDmeaspytle 1 111 1 55 555 111000 1100
pBpliomnodF 183.1.2 111460...157 66876405....8830 71.6 56.3 46555341....1680
ppBmlooFdin M0i.n2upspBmkg
1117633..9..390 10.5 6756..16 677941...846 555640...168 4643..94
pNpomrmFailnizBedlotood 0.1 mDmooseles/kg
2176..6839 223924...637172 111435179...869606 115629..0987 119.49 11910268.4..32400 138.24
pmolar EofqAuBiclvotaiovldeenitns
1951748..22.1502 17060.0.792 458424..6210 456788..1226 517.39 430668..5122 433719054...624599
C mj*any S a n a ta *. Does noi contain TSCA CB|
-90-
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats_____________________________________________ -_______________ DuPont-2932
Test ppm F NuRmabt er SaDmapyle Blionod
ppBmlooFdin M0i.n2upspBmkg
ppm F in Blood N0.1ormmmaloizleesd/ktog
Dose
Equimvaollaernts of ABclotiovde in
Group III 662277775684 662277776837 627788
1133 1133 13
4230..57 3103..82 24.9
4230..35 231403...760
429372...266379 6525..6118
313.77 21924418..2.75054 178.99
G666r222o777u777p577990IV 662277776816
24 2244 2244
11914.2..69 96..97
11941.0..74 96..57
19.17 65.22
2314..3218 2103..6856
147807206...612.51092
G66r22o77u77p8517V 666222777777676520
5522 555222
00..96 001...890
00..74 000...876
01..8459 111...274809
2555....09807700 4.35
G6r2o7u7p78VI 662277778632 662277777659
94 9944 9944
0.3 <00.2.2 <00.2.2
0*.1 0.0 0*.0
0.*21 00..*0000
0.*72 00..0000
* = Below LOD (Level of Detection)
-91 -
0'Besrt^cniaio * s c a C B/
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats
Data for H-24043
Given:
MFoorml Wulta.tiAocntiDveos(eg/(mmogl/ek)g:): % Active (F Containing) in Formulation:
494 100 25
CalcDuolsaeteAdcVtivaelu(ems:g/kg): FDoorsmeuAlacttiiovneD(mosmeoNleo/krmg)a:lization Factor:
205.051 197.6
DuPont-2932
% F in Active:
60
Mol Wt. F (g/mol): 19
DMooslearFR(amtimo o(Al/kcgti)v:e/F): 00..076894
Dose F (mg/kg):
15
NuRmabt er
Test SaDmapyle
pBpliomnodF
ppBmlooFdin M0i.n2upspBmkg
G666222ro88822u2567p460I 662288227697
11 111
4665....9224 6.6
45..70 66..20 6.4
G62ro82u7p0I 628254 666222888222667769
55 555
12.7 ' 1993...691 11.6
192.4.5 11912.7..49
G6r2o8u2p58II 662288227586 662288225736
111000 1100
1165..50 1176..80 11.5
111646...388 1116..36 '
pN0p.1omrmmFmailnoizlBeesdl/oktoogd Dose 99..8289 111212...628556 2148..7507 221259...541397 29.24 3323..2210 2322..3830
/molar EofqAuBiclvotaiovldeenitns
3331..3333 444210...630370 668423...636377 7866..0000 19088.6.677 111102..6070 75.33
oesC o m p ly Sanftixed.
not
W a in TSCACBI
H-24043: Biopersistence Screening 10-Dose Oral Gavage Study in Rats_____________________________________________________________ DuPont-2932
NuRmabt er
SaTDmeaspytle
ppimn F Blood
ppm F in M0i.Bn2ulopsopBdmkg
pNpomrmFailnizBedlotood ' 0.1 mDmooseles/kg
Hmolar EofquAicvtaivleenitns
Blood
G6r2o8u2p8I4II 666622228888222267781150
1111133333
5.1 6555....1579
4.9 4655....5397
119921..66..828846
3322..6677 4338..3030
10.47 35.33
G66r22o88u22p5559IV 666222888222687524
2244 222444
43..72 444...590
43..50 443...378
95878.....5295813909
20.00 3310..3030 2258..3637
G66r22o88u22p6722V 662288228610 628263
5522 5522 52
2.1 221...249 2.3
11..97 22..02 2.1
33..7356 1112..3637
43..3955 4.15
111434...360370
G66r22o88u22p6689VI 666222888222856574
9944 999444
00..86 001...189
00..64 000...976
01..7199 111...731889
42644.....6600077000
C-XP" S M U 0MS no(
-93 -
tsca CB|