Document rpQOvbgr3Nj3GnVZemmKb3Kwq
ARR26 - 3233
415
M236 - 3235
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Doms
TRADESECRET
StudyTitle
'H-24890:BacterialReverseMutation Test withan Independent RepeatAssay
`TestSubstance:
H-24890
Authors
ValentinOe. WagnIIeI,r M., S. MichellLe.Klug, B.S.
StudyCompletDiaotne
19March 2002
PerforBmiionRgeLlaabnocreatory ~ for 9630MedicalCenterDrive
RockviMDl2l0e85,0
E. LduPontde Nemao ndu Comrpas ny DuPontHaskellLaboratory P.O. Box 50, 1090ElktonRoad NewDEa19r 714k -00, 50
`PerformingLaboratory StudyNumber
/AAS53CH.5020B0T1.L
WorkRequest Number
ServiceCode
TTT Tae Company Saitized. Does not conTtSaCAiGBnI
'H-24890: Bacterial Reverse Mutation Test with anIndependentRepeat Assay
DuPont-8968
STATOE F CM OME PLIN ANT CE
StudyNo. AAS3CH.502001.BTL wasconductedincompliancewiththe US. FDAGLP
Regulationsaspublishedin21CFR 58,the U.S.EPA GLPStandards40CFR160, and40 CFR
7P9ri2n,ctiphleesUofKGGooLdPLaCboomrpaltioraynPcreacPtriocgeirnaamlmlem,attehreialJaasppaencetssewGitLhPthSetfaonldlaorwidn,ag enxdcetphteioOnsE: CD
The identity, strength, purity and composition or other
`cbhaereanctdeeritsetircmstiondbeeydfintehettheesttiensgtafancdilciotnyt.rTolhseubcsonttarnoclesshubasvteanncoets
havebeencharacterizedasper theCertificatesofAnalysis on file `withthe testing facility.
"dTheesttabileibtyyortfhtemtheesititnengstfaecainldidtyc.ontrol substances has not been
Analyses to determine the uniformity (as applicable), or
concentrationofthetestandcontrolmixtureswerenotperformed
bythetestingfacility. The Sponsorhasindicatedthattheyhave
-
`not performedtheseanalysesonthetestsubstancemixtures.
Thestabilityofthe testand control substancesinthe testand
tceosnttinrgoflamciixltiutrye.sT,hreesSpepcotnisveolryh,haasisnndoictabteeednthdeattetrhmeiynhedabvyentohte `performedstabilityanalysisonthetestsubstancemixtures.
Nt ic 0.Weer
ValeO.aWt agniern,IeI, MS. `StudyDirector
ret x
BoSadyo Mamgel ment e
9Mar2003
Date
19 Max 2002
Dw
StBiuodRyelNioa.ncAe AS3CH.502001BTL
2 Company Sanitized. DoesnocontTSaOAiGnBI
-
wFi-t2h4a8n90I:ndBeacpteenrdieanltReRveepresaetMAustsaatyion Test
'DuPont-8968
QualityAssurance Statement
StudyTile: IHN.2D4E8P9E0:NBDAECNTTERREIPAELARTEAVESRSSAEYMUTATIONASSAYWITHAN
`Study Number:AASSCHLS02001BTL
.
StudyDiesctor: Valeatine 0.Wagner I, MS.
SThisie setyU.hSasFbDoAno(eGdoiovbedidLoadCcibnooartposoyetrPirteeaocipfclooearRpergwourcaetsrsispoenbscos(2.b1 CUeosFfiRin.g r,$8)a, toprbdesoUrmrmSsaemB,dpPliAcdnGgrLapPspserop4ae0chC,,PR
T4010) heOKOLF punsbspmsOLTSab,mdeO5CD
Protocaa tevaSanda OpertingProcedures.
*
x loving pionds, has posi, ondofQA lees
--~
++ PlhoasspeectOn P1r8o:tDoosco-l0Re-vi1e6w-Dec.01 ToStudyDi 13-Dec-01 ToMgt 16D!
4% PlihspaectOn 13D-nFfeRb0e2o.t13-Feb-02 ToSnadyDir13Feb02ToMgmtO7-Mar02
oo PlhaaspoctOn Dr1a9f-Mtatro-F12il1R9e-pMoarrt02 ToSudyDi 19-Mar-02 ToMint19-Mar02
[ InpetOn 1Te4s.tDec0o)rc-o1n4t-rDoemca0t1erTioeSlatuddmyiDsiesi14oDnec-0lToMgmt 17-Dec01 Plahpaeec| tOn E1n8t:rDioncgpli-e18c-ouDnetcs0)inTooASmteudsypDroigrr1a8mDec-01ToMgmnt 18-Dec01
PlahopaoctOn 0P8-r0p02a-coO4f-u9Jaimni0x2otTurnoeStudyDie04-102ToMgmt04-Jan-02
PlahspeoctOn 0S8o-Jmainn-c0h2a-n0c8-eJiann-t0o2nToStudyDic08-Jan-02 ToMgmtOJ
SBtiuodRyelNioa.nceAASICH.5020B0T1L
3
CompanySanitized. Does not contain TSCA CBI
-
F-24890:BacterialReverse MutationTest
`with anIndependentRepeatAssay
DuPont-8968
* PhIanspeectOn * PIhnapectOn PIihspeectOn IispoctOn
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06-FebT-oSt0ud2yDi.r0-6Fe0b-062 T-oMFgmet0b6-0Fe2b-2
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PlaospeectOn ZS8i-mFienbc0ha2mc-i2e8i-zFaetbi0o2n ToStdyDir2-Feb02 ToMgmt28-Feb02
-
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Tehfiescretpoorrtdwesdcrtibeosfthteemneyd.sodrocedorsused nthesutyyand herepreosulrtsstureeldy
"
:
ASSURANCE
19 Mon2002 ATE
BSitouRdeylNiow.cAeAS3CH.502001.BTL
4 `CompanySaniized. DoesnotcontTSaCAiCnBI
'H-24890: Bacterial Reverse Mutation Test with an Independent Repeat Assay
DuPont-8968
CERTIFICATION
`We,theundersigned,declarethatthisreportprovidesanaccurateevaluation ofdataobtained
from this study.
sodbyStudyDincor__
NaluaEiia ogo,
Valentine O. Wagner IIL, M.S.
19 Mar 2652
Date.
sApproy ved by
Mo Dene
SeoReve Sees Maria Donner, Ph.D.
boson
Date
_
StBiuodRyelNioa.nceAAS3CH.502001.BTL
5
GomppmySantas, DoesnotTIEAGS!
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'H-24890: Bacterial Reverse Mutation Test
with an Independent Repeat Assay
`TABLE OF CONTENTS
DuPont-8968 Page
BAPnmmmmsmmmmmmmmmm--------------.ly J TC LI
RAE sssmmmmmmmmmmm------------------ 1
BRATS ccsnssrmssmmmmmmmmmmmm----------
`TTaabbllee 21:: PPrreelliimmiinnaarryyTTooxxiicciittyyTTeesstt iibn SSaallmmoonneellllaa ttyypphhiimmuurriiuumm TTAAIS0B0...." ......2 ...ov.0 ver19
~
`Table 3: PreliminaryToxicityTest in Salmonella typhimurium TAIS3S ..._._.__2.1
`Table 4: Preliminary Toxicity Test in Salmonella typhimurium TAIS3T ..........o.o2o2n
`Table 5: Preliminary Toxicity Test in Escherichia coli WP2 uVTA.........ooowoon 23
TTaabbllee 76:: MMuuttaaggeenniicciittyy TTeesstt iinn SSaallmmoonneellllaa ttyypphhiimmuurriiuumm TTAA9988 WWiitthhoSu9t S.9...............................2245
`Table 8: Table 9:
MMuuttaaggeenniicciittyy TTeesstt iinn SSaallmmoonneellllaa ttyypphhiimmuurriiuumm TTAALIO0Q0 WWiitthhoSu9t..S.9..........................22]6
`Table Table
10: 11:
Mutagenicity Mutagenicity
Test Test
in in
Salmonella Salmonella
typhimurium typhimurium
TALS35 TAIS3S
Without S9 ...........28 With S9...............29
`Table Table
12: 13:
Mutagenicity Mutagenicity
Testin Test in
Salmonellatyphimurium Salmonella typhimurium
TA1S37 TAIS3
without S9 ............30 With S9.............31
TTaabbllee 1154::MMuuttaaggeenaiicciittyy TTeesstt iinn EEsscchheerriicchhiiaa ccoollii WWPP2 i4orrA WWiitthhoSu9t.S.9.................................3332
TTaabbllee 1167::MMuuttaaggeenniicciittyy TTeesstt iinn SSaallmmoonneellllaa ttyypphhiimmuurriiuumm TTAAIB8 WWiitthho$u9t S.9...........................3354
TTaabbllee 1198::MMuuttaaggeenniicciittyy TTeesstt iinn SSaallmmoonneellllaa ttyypphhiimmuurriiuumm TTAA1L0000 WWiitthho9ut .S9............o.o.o.....o.....3376
TTaabbllee2201::MMuuttagaegneicniitcyTiTeetssytt iinn SSaallmmoonneellllaa ttyypphhiimmuurriiuumm TTAA1I5S3355 WWiitthho$u9t S..9........o.c.o.r.........3398
`TTaabbllee 2223:: MMuuttaaggeenniicciittyy TTeesstt iinn SSaallmmoonneellllaa ttyypphhiimmuurriiuumm TTAALLSS337 Wwiitthho9ut S.9.............4410
BioReliance
Study No. AAS3CH.502001.BTL
6
Company Sanitized. Does not contain TSCA CBI
-
'wHi-t2h4a8n90I:nBdaecpteenrdiealntRReevpeeraste MAustsaatyion Test
DuPont8968
Table 24: Mutageaicity Test in Escherichia coli WP2 wr Without S9..........ov.r2 Table 25; Mutageaicity Test in Escherichia coli WP2 wr With S9.............4o3 Table 26: Salmonella/E. coli Mutagenicity Test ~ Summary of Results BI...............44 Table 27: Salmonella/E. coli Mutagenicity Test- Summary of RESults B2...............45 AppendiAx: BIStORCAlCOMED! Dlr:46 ADPEDBX:SUAY PIOOCOL..rarnn menses 48 `Appendix C: Information for Japanese REGUIBOrY AEDCIES........vvvvvvnorersns 60
BSitouRdeylNioa.nceAAS3CH.502001.BTL
7 Company Sanitized. Does not contain TSCA CBI
-
'H-24890: Bacterial Reverse Mutation Test
with an Independent Repeat Assay
DuPont-8968
STUDY INFORMATION
--
HaskellNumber: 24890
Soon: WindiunPgoosntdDeetNvewmoaunr5s6C5o0mpany
USA.
`IStnuidtyisted/Completed: December 17, 2001 / (seereportcoverpage)
IIn-nLiitfieated/Completed: December 19, 2001 / January 24, 2002
BioRelianee
Study No. AAS3CH.502001. BTL
8
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wHi-t2h48a9n0I:ndBaecpteenrdiealntReRveepresaet MAustsaatyion Test
DuPont-8968
SUMMARY
IndeTphenedteenstt RseubpsetaatnAcses,aHy-u2s4i8n9g0S,alwmaosnteelsleadbipnhtihmeurBiacutmertieaslteRsservseirasse TMuAtSaSt,iToAnIT0eDs,twTiAtLhSa3n5 AraoncdlTorA-LiSn3d7ucaenddrEastclhievreirch$i9a.cTohliet"etseesrtswtarasipneWrFfo2rimoerdAiinnttwhoepphraesseensc,euasinndgabtsheen.cpelaotfe idnocsoer-proarnagteifoonmretthheomdu.tTahgeenfiicristtpyhtaesset,.tThheeprseelciomnidn.aprhytaosxei,ctithyetmeustta,gweaniscuisteydtteosets(tinaibtliiaslhathned independentrepea tests), wasused tevaluatethemutagenicpotentialofthetes substance.
`Water wasselected as hesolyeatofchoicebasedonsolubilityofth testsubstance
wasIancthhieepvreedluismiinnagryatcooxnicceinttyrtaetsti,onthoefm5a0xmigm/ummLdoasnedteast1e0d0wuaLsp5la0t0i0ngug apelrpliatqeD;oustehoilsdetvoes.les
te3s3t1e0d5w0ermeg/6m7l, 10, 33 67,100,333, 667, 1000, 3333ancd5o00n0 cppelenfr.otCmor0n.cea6n7ttroati1i0oomnsfnfros.m
_
`Basedonthefindingsofthetoxicitytest, thepmreacxiipimautemdnoosreapplparteecdiianbtlehteoxmiuctiatgyewniacsityobtsesetrwveads.
50ugp0er p0li.
testIendtwheemu1ta0rg0en,i3ce3i3ty,te1st0,0,no3p3o3s3itainvedmu5t0a0g0epngihcprleastpe.onNsoepwraecsiopbistaetrev.ewda.Tshoebsdeorsveedl.evNelos rweedruectoibosnesrivnetdhaetb5a0c0k0gruogpunedrlpalwanteswwietrheeosbtseersrtvreadi.nHsoTwAe1v5e3r5,raendducTtiAoLnSsi?niththreevaebrsteanntcceooufntSs9 activationinthe indepernepdeaettnestt.
indi"caTtheertehsaut,ltusnodefrtthheeBcaoctnerdiailtRieovfoetrnhsise sMtuutdayt,ioHn-T2e4s8t90wdiitdhnaontcIanudseepeanpdoesnittRievpemeuattaAgsesnaiyc responsein itherthepresenceor absenceofAroclor-inducedratliver S9.
SBtiuodReylNioa.nceAASICH.5020B0T1L
9 Company Sanitized. Does not contain TSCA CBI
~~
H:24890: Bacterial Reverse Mutation Test
withanIndependent RepeatAssay
DuPout-8968
PURPOSE
`mea`sTuhreipnugriptsoasbeiolifttythoiissntduudcyerwevaesr0seemvuatlautaitoentshaetsmeulteacgteendilcopcotoefnsteiavleroafltshtreatiensstosfuSbasltmaonnceebllya aynpdhaibmsucrniouemoafnAdraoctltohre-tirnydputcoepdhraatnlliovceur$s9o.fAEsccohpeyroicfhtihaecporloitsoicroaliinsWinPc2luudredaiinnAptpheenprdeisxeBn.ce BactTehrieaslRteuvdeyrwsaeMsuctoantdiuocntTeedstt)o,caodompptleyd wJiutlyh1O9E97C(DpuGbuliidsehleidnFeeb4r7u1ary(G1e9n9e8ti)caTnoxdiwciotlhotghye: IPnhtaermmaatceiuotniaclaClosnffoerrHeunmcaeonnUHsaer(m1o9n9i6saantdio1n997o)f. TechnicalRequirementsof Registr.ationof
CHARACTERIZATION OFTE ANDCS ONTT ROL SUBSTANCES
Tigned hettehstescuobsdteance,H-24890,wasTrheectievsetdbyBioReliwaansceon 13Dizedecebmybterh2e0Sp0o1nasnodrwaass
i
should bk 16 April2003wasprovi
recelp,te test
-~
light. Theaisdentity,strength,pwuraistys,ocroemdpoastirtoioomnotermpoetrhaetrucrhearwaicttehrdiesstiiccsoatnot,dperfoitneecttehdeftreosmt
snuobtsrteacnecievheavceobpeyeonfdtehtiesrrmeiponretd.bTyhtehsetaSbpiolnitsyoor.fTthheeteSsptosnusbosrtianndicceahtaesdtbheaetnBdieotReerlmiiannecdebwyotuhled
Sponsor. TheSponsorindicatedthat BioReliancewouldnotreceive acopyofthestability
report.
713"2T-h1e8v5e)h,iclobetuasiendedtofderloimveIrnvHi-t2r4og8e9n0tCootrhpoertaetsitosny,stfeomrwmearslsyteLriifleediTsetcihllneodlowgaitees,r (ICncA.STNeos.t rsouobmsttanecedmilputieonusrnwdeearreypterleluopwarrleigdehitm.mediatelybeforeuseanddeliveredtothetestsystem at
conPtorsolistwiveerceodnitlruotlesdpwliattehddciomnectuhrye]sautllfyowxiitdhet(hDeMmSutOa)geenxicceiptyttseosdtiaurmealzisitdeed,bewlhoiwc.hAwlalspdoisliuttievde with water. All subdividedsolutionsofpositivecontrolwerestoredat-5to ~30C.
`BioReliance Study No. AAS3CH.502001.BTL
10 Company Sanitized. Doesnot conTtSaCAiCBnI
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wFi-t2h4a89n0I:nBdaecpteenridaelnRteRveepresaetAMustsaatyion Test
DuPon-8968
[ome Lon] room |opm| 9
i
Concentration
Asien
-_ J ion Tatas --
fd WrzionriA
rm
(AuriLcohtCNhoe.mi0c9a1l06CoPsS, Inc)
ExpC.ADSatNeo.146-1S3e-p1-328005
Purity 595%
(Aldric2hiCthreomfitucoarleCnoe. Inc)
ExLp.otDaNtoe. 0O88-7M0ar7-H2S006
`CASPuriNtyo. 650978-%578
(SigSmoadCihoemmiazciadleCo)
ExLpo.tDNaot.e 0095-8JHaOn1-629004
CASPuNrioty. 26569298%-2248
Paw--
(LSoitgmNao.Ch1e0m6iFc0a6l6C8o1)
ExpC.ADSatsNo1.39-N0o4v5-29004
Purity 598%
(A`lMdertihcyhl CmheetmhianccasluClfoo,nsTince)
ExpL.oDtaNtoe.218S-N5o2v6-A20003
CAS No. 66.273
muta"gTeonciocniftiyrmtestth wsaesiplltatyeodfotnhesetleetctsiuvbesatagnacrewitthehhainghaelsitqtueosttvsoulbsutmaenecqeudaolseoletvhealtuusseeddiintthhee test.Theseplateswereincubatedunderthesameconditions athetest.
BStiuodRyelNaon.ceAAS3CH.S02001BTL u
Company Sanitized. Doss not contain TSCA C81
-
H-24890:BacterialReverse Mutation Test
with an IndependentRepeatAssay
DuPont-8968
MATEARNDIMAETLHOSDS
Forsubmissionto Japaneserogulatoryagencies,additionalinformationisincludedin AppendiCx.
Test System
Thetester rainsusedweretheSalmonellatyphimuriumhistidine auxotrophs TASS, TAI00, TAIS35 and TAIS37 as described by Ames ef al. (1975) and Escherichia coli WP2 vr asdescribedbyGreenandMuriel (1976).Salmonellatesterstrainswerereceived directlyfromDr.BruceAmes,UniversityofCalifornia, BerkeleyandE.colitesterstrainswere: receivedfromthe NationalCollectionofIndustrialandMarine Bacteria,Aberdeen, Scotland.
Testerstrains TASand TALS37arerevertedfromhistidinedependence (auxotrophy)to histidine independence(prototrophy)byframeshiftmutagens. Testerstrain TALS3 isreverted bymutagensthatcausebasepairsubstitations.Testerstrain TAI00isrevertedbymutageasthat cmaeuchsaenbiostmhifnraEm.ecsohliifitsasnednsbiatsievepatoirbsausbes-tpiatiurtsiuobnsmtiuttuattiiononmsut.aStpieocnisf,icriattyhoerftthhanefrreavmeersshiiofnt `mu(Gtreean atndMiurioel,n197s6).
_
Overnightcultureswerepreparedbyinoculatingfromthe appropriatemasterplate or from
the appropriatefrozenpermancatstockinto avesselcontaining ~50mLofculturemedium.To
assurethatcultureswereharvestedin latelogphase,thelengthofincubation wascontrolled and
`monitored.Followinginoculation, cachflaskwasplacedin a estingshakezAincubatoratroom
temperature.Theshaker/incubatorwasprogrammedtobeginshakingatapproximately 125 rpm
a`tmo3ni7t4o2redCsappepcrtorxoipmhaotteolmyet1r2ichaoluyrfsoberftourrebtidhiteyaanntidciwpaatsehdatrivmeestoefdahtarvaepsetr.cEeanctthrcaunlstmuirtetwanacse
`vyiiaeblldeincgouanttitteesrtofoanpnpurtorxiiemntaatgealry1pl0atecse,lalnsdptehremidlaltilaiitseor.nThfielebacuttunalottiptreerssewaetredeidnettheirsrmeipnoerdt.by
Metabolic ActivationSystem
Aroclor 1254-inducedraliver S9wasusedasthemetabolicactivation system.The S9was preparedfrommaleSprague-Dawleyrats inducedwithasingleintraperitoneal injectionof Ar27o0clCoorrc1o25l4d,e5ru0n0timleuske,d.EiavcehdabuylskpprrieopratroastaicorniofficSe9.Twhaes $e9swteadsfboarticshapbirleiptayrteodmaentdabsotloirzeeda2taminoanthracene and 7,12-dimethylbenz(a)anthracene to forms mutagenic to. Salmonella Dyphimurium TAL00.
The $9mix waspreparedimmediatelybeforeitsuseandcontained 10% S9, SmM g3lu3cmoMseK.Cplhiosnphaate1,040mmMMphBo-snipchoattineabmuifdfee-raadetnpinHedi7n.u4c.lTehoetidSehpahmospSh9atmei,xt8umreM(SMhgaCmlm;iaxn)d,
`BSitouRdeylNiow.ncAeAS3CH.502001BTL
12
`Company Sanitized. Does not contain TSCA CBI
-
HW:it2h4a8n90I:ndBeapcetenrdieanltRReevpeerasetAMsustaatyion Test
DuPont8968
ccoonnftiarimnitnhge 1s0te0rmilMitypohfotshephSa9taenbudffSehraamtmpiHxe7s.,42,0w.a5mspLrealpiaqrueodtiomfmeadcihawtealsypbleaftoerdeonitssuelseec.tiTvoe agar.
SolubilityTest
dimetAhsyollusbuillfiotxytiedset(wDaMsScOo)nd,uecttheadntools(eElteOctHt),heavceehtiocnlee.anTdhetteetsrathwyadrscofounrdaunc(tTeHdEu)s.inTghweatteers,t spruebpsatraantcieonwoafsttheeshtiegdhteosdtestoelrubmlienoetrhweorvkeahbilclees,tsoeclkeccotnecdeinntroartdieorno,ufpptreof5e0remngc/e,mtLhaftorpearqmuietoteuds Solvents and500mg/mLfororganicsolveals.
PreliminaryToxicity Test
subsTthaenpcreewloiumlidnbareytteosxtiecidityntteshte mwuastausgeedntioceitstetsyatb.liVsehhtihceledaosned-treanngdeoosveelrewvehlisochftthheetteesstt substance were plated, one plate per dose, with ovemight culturesof TAS, TAL00, TALS3S, TAIS37 and WP2uvrAonselective minimalagarinthepresenceand absenceof Aroclor-inrdauciveedr $9. Dose levelstestedwere 67, 10, 33, 67, 100, 333, 67, 1000, 3333 and 5000pgplate.
=
Mutagenicity Test
`mut`aTgheen.imcuptoatgeeantiiaclitoyfttehstte(sitnsiuiablstaanncdei.nAdmeipennidmeuntmorefpfeiavtetdeossse)lwevaelssoufsteedsttsoubesvtaalnucaete(t10h0e, 333,1000, 3333and5000 ug/plate)alongwithappropriatevehicleandpositivecontrolswere platedwith TASS, TAIOD, TALS35, TAaIndSWP32u7rinthepresandeabnsencceoef Aroclor-inducedratliver $9. Alldoselevelsoftestsubstance, vehicle conatnrdpoosiltisve `controlswere plated in triplicate.
PlatingandScoringProcedures
origi`nTahleltyedsetsscyrsitbeemdbwaysAemxepsoeseadlt.o(t1h9e7t5e)astnsduubpstdaantceedvbiyaMthaerpolnaatnedinAcmorepsora(1t9i8o3n)m.ethodology
(WIVO)n,twhaesdmaeyltoefdiatsndussuep,pmlienmiemnatletdwoiptahgaLrh,icsotnitdaiinne,iDn-gb0i.o8t%naangdaLr-t(rWy/pVt)opahnadns0ol5ut%ionNtaoCla finalconcentrationofS0iM each.Topagarnotusedwith S9or Sham mixwassupplemented rweiatghe2nt5s,maLllroeffwearetnecrefsor0ewaactheri1m0p0lmyLtoefrem,indiemioanlitzoepdagwaatre.rFporrotdhuecpedbryethpeaMilorlfia-mQetRdeiiaagoaennndt `cWoanttearinSingy15sB%ottt(oWm/eVa)gmaargawr.a. sNuVtrieo ntbog ttomemaignailmrawla-mseVdoBiguelm-EoBo(nVn noegrelmniannide mBaolnnrmere,d1i9u5E6m)
BioReliance
Study No. AAS3CH.502001.BTL
13
Company Saniized. Does not containTSCA CB
wHi:t2h4a89n0I:ndBeapcteenrdiealntRReevpeersaetAMsustaatyion Test
DuPont-8968
(cdornytapionwidneg1r)..5N%ut(rWi/enVt)BargoatrhawnadssuVpopgleemle-nBteodnwnsiaetlrht2s.o5lu%ti(onW/sVup)pOlxemoeindteNdutwriitehnt2B.r5o%thN(Wo/.V2) `Oxoid Nutrient Broth No.2 (drypowder).
leveEla,ctehsptlearstteawina,slaanbdealcetdiwviattihoanc,aodsedseyssctreimbedtihantiddeetnatiilfiiendtBhiotReesltisaunbcset'asnSctea,ntdeasrtdpOhpaesre,adtionsge Procedures.
testOsnueb-shtaalnfc(e0d.i5l)umtiilolinlwiteerroefadSd9eodrtSoh2a.m0mmiLx,of10m0oklLteonftseeslteecrtsitveaitnoapnadg1ar0a0tp4L5o2f2veCh.icAlfetoerr vpolratteixnigtngh,etphoesimtiixvteucroenwtarsoolv,etrhleatiedsotnstuobtshteasnucrefaalcieqoufo2tw5amsLroepflmaicnedibmaylbaotStoOmLaaglairq.uWohteonf appropriatepositivecontrol.Aftertheoverlayhadsolidified,theplateswereinverted and iimnmceudbiataetdelfyorfolalpopwrionxgitmhaetienlcyu4ba8titoon p7e2rbioodurwseraetsto3r7e4d2atC2.-P8laCtuensttihlactolwoenry econuontticnogcunoiueldd becond(esustchant10edayds).
toxi"cTihteycboynduistiinognoafdtihsesbeaccttienrgiamlibcarcoksgcroopuen.dPlreacwinpiwtaasteevwaalsueavtaeldfuoarteevdibdyenvciesoufalteesxtasmuibnsattainocne
--
wcointthrooultpmaatgenuisfiicnagttihoenc.Toodxeiscisthyoawnndbdeelgorwe.eofprecipitationwerescoredrelative tothevehicle
Ce Se [| NSioimghatyl ||DDiusstignugiuisshheeddbbyyaahneoatlitcheyambilcertohcionlnoinnygolafwtnhe._mi_cr_oc_ol_on_yT_a_wa|| 2 Reduced |acnomdpapreod ssibtloytahesvleihgihctlienccornetarsoelipnatteh.esizeofthemicrocolonies Distinguishbeyd amarkedthinning ofthemicrocoloawnny Reduced" |recsomupalretdingitnoatpherovneohuicnlceecdoinnctroelaseinlatet. hesizeofthemicrocolonies| Extremely [rDeissutlitnignugiisnhaednibnycraeanseeixtnrtehmeestizheionnfitnhgoefmitchreocomliocnrioecsocloomnypalrawend] Reduced [1v0tihestveothiihcelbuencaloindteerdoelypelaastiessoulcathetdchoaltotnhieesm.icrocolonylawnis greater thanorequalto 90 oft% he plate. | 6 | ShPrreecuirpeidtabtye|_|Ttho emibcarcokscgorpoicuntdesatscuebsitlanlcoevprecciapimtastbe.ssecurely alate do
StBiuodRyelNioa.nceAAS3CH.502001.BTL
14 CompanySanitized. Does not containTSCA CBI
H`w-i2t4h8a9n0:InBdaecpteenrdiealatReRveepresaet MAustsaatyion Test
DuPont8968
Non-nterfering|[nDaiskteidncguyiesbheudtbaynypprreecciippiittaattee opanrttihcelepsldaetteetctheadtbiystvhiesiabulteotmo attheed| Precipitate |coel.o,nlyecsostunhtear3tnotalparlticles essotnhanapla1t0e%woiftthh3e0rreevveerrttaannttsc)o.lonycount ing [[nDaiskteidngeuyiesahenddbanyypprreecciippiittaatteeopanrttihcelpesldaetteetctheadtibsytvhiseiabulteo1moattehde] PurcerctiepriitnSeg ||cnoolroentyhcaonun3tpearniecxlceseeodn10ap%laotfetwhietrhe3ve0rrteavnetrctoanltosn).yTchoeusnetp(li.e.)s arecounted manuly.
conRtreovles,rtwaenrteccooluonntieedsefiotrheargenitviernetleybstyerasuttroamiantaenddcaocltoivnaytcioounnctoenrdoirtienotni,reexloyebpytfhoarndpousnilteisvse theplateexhibitedtoxicity.
EvaluoaftReisuoltns
plaFteowrecraecchraeplliccateaupnldalatirnaegr,ettphoeretmeedda.nandstandard deviationofthe mumberofrevertantsper
-
meaFnorretvheertteasntissupbesrtpalnacteetoobfeaetvlaelausatteodnpeotseitsitveer,isttrmaiunsotvcearusaemaidonsiem-uremloatfeditnwcorienacsreeianstihneg
p`coosnicteinvteriafttihoenisoncfrteeasstesiunbmsteaanncer.eDvaerttaasnettssafttohrteepsetaekrstorftahinesdToAse1Sre3s5paonnsdeTiAseLqSu3a7lwtoeorrejguredagteerd
WtPha2nu3v,r0-Aiwmeesrtehjeumdegaendpvoeshiitcilveeciofntthreolivnaclrueea.sDeiatnamseeatsnfroervetretsatnetrssiartaitnhseTpAe9a8k,oTfAtIh0e0daonsde
responsei equaltoorgreaterthan2.0-timesthemeanvehiclecontrolvale.
Crifotr aeVarlidiTeast
`Sal`mTohneeflollaltoewseitnsgtcrraiitnecruilatmuursestmbuesmtedetmofnosrttrhaetemtuhtaegperensiecnictey oefstttheodbeeepcronosuigdhemruetdavtailoind.(A2l)l
atnhedptrheesdeenlceetoiofnitnhethpeKuMvIrOBIgepnlea.sCmuiltduRr-efsacotfort.esAtelrltWraPi2nsuvTrAAcualntdurTeAsm1u0s0mtudesmtodnesmtoruastreatthee:
dseploenttiaonneionusthreevuervtraAntgseinnet.hAelvlechuilctlureecsonmturosltsdaesmfonosltlroawtse(tinhcelcuhsairvaec)t:erTiAs9t8ic,m1e0a-n 5n0u;mTbAe1r0o0f,
`8n0u-m2be4r0s;oTfAbLaSct3eSr,ia5a-r4e5p;laTteAdL,St3e7s,ter3s-t2r1a;incWuPl2tuurvertAi,ter1s0m-u6s0t.bTeogreenastuerrethtahantoafpepqruoaprliattoe
t0h3exn1u0m"bceelrlosf/mreLv.eTrhtaenmiesoavneorfthceamceh paonsitviavleuecoofnttrhoelrmeuspsetcetxihviebviethaitclleeacsotntar3o.l0.-fAolmdiinnciremausmeoifn
tohnreeoernobno-tthooxifctdhoesfeollelvoewlinigscrreiqtueirrieadatroeemveatl:ua(t1e)teAs>td5at0a.% Areddouscteiloenvienltishceomnseiadnerneudtmobxeircoiff
BioReliance
Study No. AAS3CH502001. BTL
1s
CompanySaniized. DoesnotcontTSaCAiCnBI
-
H-24890: Bacterial Reverse Mutation Test
withanIndependentRepeat Assay
DuPont-8968
r`eavcecstoamnptasnipeedrbpylaatneaabsrcupotmdpoasree-ddetpoetnhdeenmtedarnopvienhtichleerceovnetrrtoalntvcaoluunet..T(h2i)sArtedluecatsitoanmmoudsetrabtee rNeedguacttiivoenianndtPhoesbiatcivkegrCoonutnrdollaVawlnu(ebsaicskignrcoluunddedlaiwnnApcpoedned3i,xA4.or 5).A copyof theHistorical
Archives
OpeAraltlirngaPwrodcaetdau,rtehOePpQroPt3o0c4ol0bayntdhaelBlioreRpeolritasnwcielRlAbQeAmuaniintthaeiandeqduaarctceorreddiantg: tBoioSRtealinadnacred, 1le4a9s2tt0hBrreoesycehaarrstaRfotaedr,wRhoicckhvtililmee,tMhDe 2S0p8o5n0s.oPrweirlthlbiseScOoPn,tapcatpeedrfroecrora ddsewciilslibonearsettaoitnehdeffoirnaatl dciosppioseidtainondotfhtehceompaytewriilallbs.eArleltsatiundeydimanttehreiaBlisorReetlurinaendcetoatrhcehiSvpeosnfsoorroarmdiensitrmouymedowfi1ll0iysetarbse.: rUensuidsueadltdeosstisnugbssotlauntcieownislwlebreedidsipsopsoesdeodfoffoflollolwoiwnignfgianadlmiiznaitisotnroatfitohnetroetpohrett.estsystem andall
Deviations
ofthiNsostkundoyw.ndeviationsfrom theprotocolorassay-methodSOPsoccuredduringtheconduct
BioReliance
-
Study No. AASICH.5020B0T1L
16
Company Saniized. DoesnotcontainTSCA CBI
-
wHi-t2h4a8n90I:ndBeapcetnedrieanltRReevpeersaetAMsustaaytion Test
DuPont-8968
RESANUDDILSCUTSSISON Solubility Test i `WaterwasselectedastJ hesolveatofchoicebasedon solubilty ofthetest
Preliminary Toxicity Test
werTehgeenreersualttesdionftEhxepperreilmiemnitnAalry.ItnotxihceitpyrteelitmairneaprryetosxeinctietyditenstT,atbhleemsa1xtihmrouumgdho5s.eTtheessteeddwaatsa
pl5a0t0i0npgaglpiequroptl.aDteo;stehliesvdeolssteewstaesdwacehrieev6e.7d,us10i,n3g3,a6c7o,nc1e0n0t,r3a3t3i,o6no67f,51000m0g,/3m3L3a3anndad5100000ppiLg
pceonrcpelnattrea.tiCoonnsfcernotmra0t.i6o7ntsofr1o0mmg/33mtLo 50, were
ad precipitantoer
a`ppplrateecdiianbtlheteomxicuitytwaasobtgseesretvweadns.5Bi0a0se0cpdoginpetrthpelfyaci. nodftihetnoxgicisty st,themaximumdose.
Mutagenicity Test
`TabTlhese2r6esaulntds2o7f.tThheemusteadgaentiacwiteyrteegsetnareeraptreedseinntEexdipenrTiambelnetss6Bt1hraonudghB225,aDnodsesluemvmealrsitzeesdtiend `owbesreer1v0e0d,.H3o3w3e,ve10r0,0r,e3d3uc3t3iaonnds 5a0t0h0eruegvpeerrtpanltactoe.unNtosrweedrucetoibosnesrivnetdhaetbSa0ck0g0ruogupnedlcapwlntsewweitrhe teNsotperrtreaicnsiTwpAa1i5so3tb5saaenrtdveTedA.LS37intheabsenceof $9activationintheindependentrepeattest.
obseIrnveEdxwpietrhiamnenyotfBthIet(eIsntietirasltrMauitnsaigneeniitchietrythTeepstr)e,sennoceoporsitaibvse.encmeuotfagSe9naicctivraetsipoonn.ses were
`obIsenrvEexdpweirtihmaennyotfBt2h(eItnesdteeprsetnrdaiennstiRneiptehearttTheesptr)e,sennocpeoosriatbisveenmcuetoafgeSn9iacctirveastpioonn.ses were
CONCLUSION BactAelrlialcrRiteevreirafsoerMuatavtailiodnsTteusdtywwietrheamneItndaespdeensdcernitbReedpienatthAespsraotyoicnodli.caTtheetrhate, sunudoelfrttthhsee pcroensdeinticoenosroafbtsheincsseotdfyA,rHo-c24l8o90rd-idirnnaotdtlciuavecurse$e9d.a positive mutagenic responseineitherthe
BioReliance
Study No. AAS3CH.502001.BTL
7
`Company Sanitzed. Does not contain TSCA CBI
-
wHi-t2h48an90I:ndBeapcteenrdieanltRReevpeerasetAMsustaatyion Test
DuPont8968
REFERENCES
AmesMu,taBgNe,nsJ.wMitchCatnhen aSnadlEno.nYelalmdaMsaamkmial(i1a9n75)MMiectrhosoodmsefoMruDteatgeecntiicnigtyCaTrecsitn,ogMeuntsatainodn Research,31:347-364.
GMreaent, MoHnLR.easnedaWr.cJh.3M8u:3r.i3e2l. 1976) Mutagentestingusingtrp reversioninEscherichiacol,
InoterfnaPtihoanamlacCeountfiecraesnfoconerHaHrumomnainsatUiseo.n(GIuCiEdDaonfcTeecohnnicSapleRceifqiuciArsempeencttssfoorfRReeggiusltraattoiroyn oGfetnhoeoIrCiHcipyTresotcsofeonrsJPuhlsayrm1a9c,eu1t99i5c.aFlesd.eSra2l4Rdeogcisutmeern6tr1e:c1om8m1e9nd8e-df1oA8rpar2di0ol2p2t4,ion1a99t6.sip 4
IntemoaftPihoanmalacCeonufteiraelnscfeoorn HHoarmmaonnisUaset.ioGne(noItCoHxDiociftyT:ecAhnSictaalnRdeaqrudiBraetmeernytsffoorrGReengoitsotxriactiiotny TpesrtiongcooenfPJshualsryma1c6e,u1t9i9c7alFsedSe2raBldRoecguimsetenrt6re2c:om1m6en0d2ed6fo-Nroa1dvo6epmt0bio3enr021t,s,t1e9p974.ofthe ICH
MarMount,atDioMn.RsesnedarBcNh,.A1m13e1s73(2119853.)Revised MethodsfotheSalmonella Mutagenicity Test,
`OE1C0DtGhueidOeElCinDeG4u7i1del(GienneestfiocrTtoxhicToelsotgiyn:goBafcCthereimanliRcaelvse,rpsuebMluitsahteidboynTOesE)C,DN,iPnatrhisA,dFdeebnrudaurmy 1998.
VogePlr,opHeLrt.iaesn,d1DBMio.l.BConhneemr.(211985:697)-A1c0e6t.ylomithinaseofE. col: arialPurificaandtSioomne
BSitouRdeyliNoa.nceAASICH.S02001BTL
18
--
CompanySantized. Dossnot containTSCA CBI
H-24890:Bacterial ReverseMutation Test
withan
Assay
DuPout-8968
PBraecltiemriinaalryMTuotxaitciiotnyTeTsetst
Table 1
TeSsttudysuNbusmtbaenrce 14: AHN-S2I4C8H5.0502001.87L
stExrpaeirniment No. :i AmLss
VeDahtieclPelated i: w1a5teDrec 2001
Plating Aliquot : 100 bi
TCeosntceSnutbrsattainocne RevWeircthan5t9s ActBiavcaktgiroounnd
ug per plate per plate Lown
Venicle
18
1
RWeivtehrotuatnts59 AcBtaicvkagrtoiuonnd
per plate Lown
2
1
160.1
I1s
11
128
11
3&3
215
11
136
11
130303 867
218
11
1
i
13s
11
5
1
-~
10330303
23
11
1103
11
5000
16
Background Lawn Code
3
1
i
4i==BNoxrtmraelm;el2y-rSeldiugchetdl;y rS=eAdbusceendt;; JGs=MOobdsercautreeldybyrepdruecceidpitate
Np-lon-Interfering precipitate; Ip=Interfering precipitate
BioReliance StudyNo. AASICH502001 BTL
19 `CompanySanitized. Doesnot contain TSCA CBI
H-24890: Bacterial Reverse Mutation Test with an Independent Repeat Assay
DuPont-8968
PBraecltiemriinaalryMuTtoaxtiicointyTeTsestt
Table 2
ToSsttudySuNbusmtbaenrce 1d:i HA-A2S4I8C9H0.502001.BTL
stErxpaeirninent No. :+ AmL 0
VeDahtieclPelated:t w1a9teDerc 2001
Plating Aliquot : 100 uo
CTeosntcensturbasttainocne RevWeirtthan5t9s ActBiavcaktgiroonund
ug per plate per plate Lawn
Vehicle
159
1
RWeivtehrotuatnt5s9 AcBtaicvkagtrioounnd
per plate Lawn
157
1
16.07
116667
11
117667
11
33
116786
11
116586
11
130303
117m3
11
118588
11
-
1056010
116788
11
1m728
11
50330303
115421
11
210708
11
BackgroLeuNnodrmLaalw;n C2o=dSelightly reduced; J=Moderately reduced
N4e=sEoxtnr-eImnetleyrfreerdiuncegd;preSc=iApbisteantte;; 6=IOpb=sIcnutreerdfebryinpgrperceicpiiptiattaete
BioReliance Study No. AASICH.502001.BTL
20 CompanySanitzed. DoesnotcontTSaCAiCnBI
-
Hw-i2t4h8a9n0: Bacterial ReversAesMsuataytion Test
DuPont. 8968
PBraecltiemriinaalryMuTtoaxticiiotnyTeTsetst
Table 3
TeSBsteturdiySnuNbeusnmttbaneNcroe. 1:||: KAAL-A2S4I8G5H0.502001.8TL
SDeaetaeinPlated i m15asbese 2001
vePhlaiccilneg aliquot i| w1a0t0er
TCugeosntpcoernsturpbalsattciaeonnce
RevWeirtthan$t3s per plate
ActBiavcaktgiroonund Lave
RWeivtehrotuatnt5s9 per place
AcBtaicvkagtrioounnd Low
Vehicle
1
T
Fo)
1
16%7 33
110uw
11 i
11 1
1i i
10&0 333
22s
i1
1s
1
2i
ii
1
1
-
61000 3333
Fies i
i11
270 is
ii 1
5000 Background Lawn Code
1
1
1s
3
NTdea-sNBtoxortnnr-aelIn;netley2r-fr5eelrdiuigcnhegtdl;pyrerSceeiAdpbuiscteenadtt;;e;JsT=oPOd-beIsrncatuterereldfyebrryienpdgrupecrceeidcpiiptiattaete
-- BioReliance Study No. AASICH.5020B0T1L 2
`Company Sanitized. Does not contain TSCA CBI
-
'wHi-t2h4a8n90I:nBdaecpteenrdieanltRReevpeeraste MAustsaatyion Test
DuPont-$968
PBraecltiemriinaalryMuTtoaxtiicointyTTeesstt
Table 4
STtesutdySNubusmtbanecre 1d:i Boerinent No. |
AAHLN-S2I4C8H9.0502001.8TL
StvDerantaieicniPelated
i i
m19asbeyc 2001 water
Plating Aliquoe Test Substance
100 4 With 53 Activation
Concentration Revertanta Background
RWeivtehrotuatnts59 AcBtaicvkagtrioounnd
ug pVeebricpllaete'
per plate' s
Lawn T
per plate
Lave :
b5t.)7 3
5: 5
i3i
255
111
1&00 333
:5 5
11 I
5.
ii 1
-
10S6070
3333
83
Ii
`
i
57
13
s
i
e BacSk0gr0o0und Lawn Code e 5 a1 0 7 ai
NPLdnzNNEooxnrt-nraTalmn;etley3r-frSeelrdiiugnchegtdl;pyre5rc-eiAdpbuiscteenadtt;;e;J=T-oPOd-beIarncatutereerldfyebryirnepgdrupecrceeidcpiiptiattaete
BBoioRkeliance Study No. AAS3CH.502001.BTL
2 CompanySaniized. Doss notconTtSaCAiCnBI
'H-24890: Bacterial Reverse Mutation Test
with an
t Assay
DuPont. 8968
PBraecltiemriinaalryMuTtoaxtiicointyTeTsetst
Table 5
TeSsttudSyuNbustmabnecre Id:i HA-A2S4I8C9H0.502001.BTL
stExrpaeirniment No. : WAeL2 wma
VDeahtieclPelated : w1a9teDrec 2001
BTesR t suUbstC anceELIWiEthY59 m Activam tion sWithout 59 gAectm ivatio-- n
Concenxtrapltaitoen ~~ RevertTaanttes BaLckagwrnound Rexverptlaanttes BackLagwrnound
Vehicle
5
1
15
1
160.7
1122
11
1186
11
&3
i1s2
11
113
11
130303
1165
11
F1g3
11
-
1056070
117
11
1155
11
53030303
1105
11
1155
11
Backgro1u-NnodrmLaalw;n C2o=dSelightly reduced; J=Moderately reduced
N4p=-Etxotnr-eInnetleyrfreerduicnegd;preSc=iApbistenatt;e; GeIOpb=aInctuerrefdebriyngprperceicpiiptiattaete
BioReliance StudyNo. AAS3CH.502B0T0L1
2~ `Company Sanitized. Does not contain TSCA CBI
H:24890: Bacterial Reverse Mutation Test `withanIndependentRepeatAssay
DuPont-8968
Bacterial Mutation Test
Table 6
TSetsutdySNuubmsbtearnce Id:: HA-A2S4I8C5H0.S02001.BTL Experiment No i 51
SeLizvaeirnMicrosomes : Naosnse
DCealtlesPlSaeetdeedd :: 33.0Jaxn 120002
vePhlaitcilneg Aliquot: w1a0t0erun
Concenxtrapltaitoen NPulmabteer Revertlaanttes BacCkogdreound RAevveerratgaents SDteavnidaatridon
Vehicle oonz 1155 11
03
w1
1"
2
100
002 i1s 1i
03
15 1
18
1
333
002 118 11
03
01
18
1
~
1000
o0r2
1u0 11
03
iz 1
un
1
3333
0021
1220 11
03 16 1
16
`
5000 0002 11305 111
3
3
Positive Control o2-rnitrofluor1e3n6s 1.0 ug1 per plate
002 1a5n6 11
108
28
BackgroIuenNdormLaalw;n C2o-dSelightly reduced; IsModerately reduced
NdP-exltorne-nIenltyerfreedruicnegd;preSc-iApbisteantt;e; GIOPbssIcnutreerdferbiyngprperceicpiiptiattaete
BioReliance Study No. AASICH.5020B0TL1
2% Company Sanitized. Does not contain TSCA CBI
H-24890: Bacterial Reverse Mutation Test
with an
t Assay
DuPont-8968
Bacterial Mutation Test
Table 7
STetsutdySNuubmsbtearnce 1d:: AHA-S2I4C8H9.0502001.BTL Bxperiment No : BL
StLirvaeirnMicrosomes : Rmaotsliver 9
CDealtlesPlSaeetdeedd :: 33.0JaXn 210002
VPelahtiincgle Aliquot : w1a00tekrL
C1gonpceerntprlaattieon NPulmabteer Rpeevrerptlaanttes BacCkogdreound _RAevveerratgaents SDteavnidaatridon
Venicle 0o21
2381 11
0
32 1
30
2
100
o012
a3n6 11
0
18 1
28
5
333
o021
328 11
03
22 1
2
5
=
1000
o02
221 11
03
21
2
2
3333
0021
118
11
03
21
20
3
5000
0012
1280 11
03
15 1
18
3
Positive Control 2-o1anincanthr5a8c9ens 1.01ug per plate
002
1667
1 1
591
125
Backgro1uenNdormLaalw;n C2o-dSelightly dnBxtremely reduced;
rSe-dAubcseedn;t;
I=eMOobdsecruarteedlybyrepdruecceidpitate
NPation-Interfering precipitate; Ip=Interfering precipitate
BioReliance StudyNo. AAS3CH.5020B0T1L
2 Company Sanitzed. Doos notcontain TSCA Cal
w'Hi-t2h4a89n0I:nBdaecpteenrdiealnRteRveepresaet
Mutation Assay
Test
DuPont-8968
Bacterial Mutation Test
Table 8
STetsutdysNuubmsbtearnce strain
1d:+:
THAA-A22S04I08C9H0.502001.BTL
ECexlplesrimSeenetdeNdo :: 23.19 X 10
VLeihviecrleMicrosones : Nwoanteer
Date Plated : 3 Jan 2002
Plating Aliquot : 100 ur
uCgonpceerntprlaattieon NPulmabteer pReerveprtlaanttes BackCgodreound RAevveerratgaents DSetvainadtairodn
Vehicle 0012
116778 11
0 155 1
160
16
100
0021
116612
11
03
73 1
165
7
333
002 182193 11
0
199 1
200
12
-
1000
0o2 161497 11
03
21
163
1
3333
o012 151647 11
0
rt} 1
155
12
5000
0012
110510 11
03
121 1
125
2
Positive Control soo1dium azide5211.0 ug pe1r plate
o0a2 Background Lawn Code
65705 11
sao
0
Nedi==stEoixrotmnra-elIm;netley2r-frSeelrdiuigcnhegtdl;pyreSrc=eiAdpbuiscteeandtt;;e;J=6IN=PoO=dbIeancrtuaertreedfleybrryienpdgrupecrecedicpiiptiattaete
BioReliance Study No. AAS3CH.502001.BTL
26 CompanySanitized. Doesnot conTtSaCAiCBnI
-
Hw-i2t4h8a9n0: Bacterial ReversAesMsutaaytion Test
DuPont8968
Bacterial Mutation Test
Table 9
TSetsutd.ySNuubmsbtearnce strain
1d:|: +
A5A-2S4I8C9H0.SO00L.BTL moo
ECexlplesrimSeenetdeNdo :: B2L.9 x 10
LVeihviecrlMeicrosones aRatterliver 59
Dace Plated 3 Jen 2002
Placing Aliquot: 100 uu
Cogncpeerntprlaattieon NPulmabteer pReerveprltaemttes BackCgordeowsd ReAvveerrtaagnets DSetvainadtaridon
Venscle o2r 1br0e5d 11
o 21
101
.
100
a2 m154 1i
o 203 1
wm
2s
ms
0a 161951 11
0 208 1
107
2
--~
1000
00 1m10 11
0 150 1
ww
393
0o 151559 1i
0 168 i
160
7
5000
0a 101509 1I
a 162 i
0
5s
Positive Control 2-aaminoanthraa6cens 1.0fyug per plate
003 s7i8e0 i1
sso
n
BackgroI4ruxNnBodxrtnLraaelvm;aly2caoSdreeldiugchetdl;y rSe-dAubcseedn;t;Ju-MOobdsecruarteedlybyrepdruecceidpitate
NPon-Interfering precipitate; IP-Interfering precipitate
BSitouRdeylNioa.nceAAS3CH.502001BTL
2 CompanySanitized. DocsnotcontainTSCA Cal
wFi-t2h4a8n90: Bacterial ReverseAMsustaaytion Test
DuPont-8968
Bacterial Mutation Test
Table 10
TSetsutdySNuubmsbtearnce 1d:|: HA-A2S4I8C5H0.SO2001.BTL Experiment No : BL
stLirvaeirnMicrosomes :+ NToAnLeS3S
DCealtlesPSleactdeedd :: 30.5JaXn 210002
VPelantiingcle Aliquot +: w1a0t0er
Cugonpceerntprlaattieon NPulmabteer Rpeerveprtlaanttee BackCgodreound RAevveerratgaents DSetvainadtairodn
Venicle 0012
1i7d 11
03 15 1
16
1
100
002
1I3g 11
0 18 1
16
3
a3
002
1i2s 11
03 16 1
15
3
-
1000
0012
21 11
03
21
15
7
3333
0012 116 11
0
12 1
1
2
5000
0012
a1u 11
0 16 1
15
`
Positive Control so01dium azide281.0 ug pe1r plate
0032 1e0s 1i
ses
a
Backgro1u=nNdormLaalw;n C2oedSelightly reduced; 3mdoderately reduced
NdP-=BNxotnr-eImnetleyrfreedruicnegd;preSc=iApbistenatt;e; 6=IOPbssIcnutreerdferbiynpgrperciepciitpaitteate
BioReliance StudyNo. AAS3CH.5020B0T1L
2 `Company Sanitzed.Doesnotcontain TSCA CBI
=
'H-24890:BacterialReverseMutation Test
`with an Independent Repeat Assay
DuPont-8968
Bacterial Mutation Test
able 11
TSetsutdysNuubssbtearnce 1d:: HA-N2S4I8C9H0.502001.BTL
strain
+ Tass
cEexlplesrimSeenetdeNdo :: B0L.5 x 10
VLeihviecrlMeicrosones : Rwaatterliver 89
Date Plated : 3 Jan 2002
Plating Aliquot: 100
Concenrtrapltaitoen MPlmabteer pRoervertplaanttes BacCkogdreound RAevveerratgaents DSteavnidaatridon
Venicle 0oz
117 11
03
51
15
s
100
0o2
1by6 11
03
11
15
3
33
oozn 1z0n 11
0 13 1
15
s
-
1000
o0r2
10 11
03
13 1
12
6
3333
0o2 16s 11
03
s1
10
5
5000
o02
15 11
03
10 1
12
`
Positive Control 2-oramincanthr10a8cane 1.02ug per plate
o0
11106 11
108
1
Backgro1u=nNdormLaalw;n 2Co-dSelightly SnExtramely reduced;
Sre-dAubcaeedn;t;
IGsMOobdsecruarteedlybyrepdruecceidpitate
Ne-Non-Interfering precipitate; IPsInterfering precipitate
-- BiooRReli-- ance ----------------------
Study No. AAS3CH.50200BT1L.
2
`CompanySanitized.Does not contTSaCAiCBnI
'H-24890: Bacterial Reverse Mutation Test `with an Independent Repeat Assay
DuPont-8968
Bacterial Mutation Test
Table 12
STetsutdysNuubmsbtearnce Id:: AHA-S2I4C89H0.502001.BTL Experiment No : BI
stLirvaeirnMicrosomes :+ NToAn1Se37
DCealtlesPSleaetdeedd :: 31.J1aXn 2l0o02
VPelhaitcilneg Aliquot +: w1a0t0er
uCgonpceerntrpalattieon NPulmabteer Rpeerveprtlaanttes BackCgodreound _RAevveerratgaents DSteavnidaatridon
Vehicle o021
55 11
0
10 1
7
3
100
0012
7` 11
03
1
5
2
333
o0n2
7711
03
51
7
1
~
1000
002
106 11
0
i1
2
2
3333
a02
nn 11
03
1
5000 000312 873 111
5
3
Positive Control o9-ranincacrid8i0n1e 75 ug1per plate
0023
957399 11
306
9
Backgro1u=NnodrmLaalw;n C2oudSelightly reduced; 3=Moderately reduced
N4P=aExotnr-eImnetleyrfreerdiuncged;preSc=iApbisteantte;; 6=IOPb=sIcnutreerdfebryinpgrperceicpiiptiattaete
BioReliance StudyNo. AAS3ICH.502B00T1L
30 CompanySanitized. DoesnotcontainTSCACBI
'H-24890: Bacterial Reverse Mutation Test withan dentRe
DuPont$968
Bacterial Mutation Test
Table 13
TSetsutdySNuubmsbtearnce Id:: HA-A2S6I8C9H0.502001.BTL Experiment No : BL
sLtirvaeirnMicrosomes : Rsatyliver 59
CDoaltleePSleaetedded :: 31.J1aXn 210002
VPleahtiincgle Aliquot +: a10t0eri
peConcentralattieon NPulmabteer Repverertplaanttes BacCkogdreound RAevveerratgaents DSetvainadtairodn
Vehicle o012
5 11
03
61
5
2
100
o012
58 11
03
81
8
1
333
0021
107 11
0
10 1
s
2
-
1000
0o21 107 11
0
un 1
5
2
3333
0012
45 11
03
61
5
1
5000
0012
5` 11
0
71
5
2
Positive Control 2-01aminoanthr5a8cene 1.01ug per plate
0023
7726 11
&
5
Backgro1u-NnodrmLaalw;n 2CoedSelightly reduced; 3=Moderately reduced
Ned==Etxotnr-eImnetleyrfreerdiuncged;preSceiApbisteantte;; =IOPb=sIcnutreerdferbiyngprperceicpiiptiattaete
--- Study No. AAS3CH.5020B0T1L
3 Company Sanitized. Dossnot conTtSaCAiCBnI
'H-24890: Bacterial Reverse Mutation Test withan Independent Assay
DuPont8968
Bacterial Mutation Test
Table 14
TSotsutd.ySNuubmsbtearnce Id:: HA-A2S0I8C9H0.502001.BTL Experiment No : Bl
stLirvaeirnMicrosomes +: WNeo2newin
CDaetlelsPSleaetdeedd :: 30.J9anX 210002
VPelahtiincgle Aliquot +: w1a0t0eryt
Cugoncepnertrapltaitoen NPulmabteer Revperertplaanttes BacCkogdreound _RAevveerratgaents DSteavnidaatridon
Vehicle o0o2
125 11
03
21
2
2
100
002
123 11
03
10 1
15
6
a3
002
2105 11
03
11
1
3
=
1000
002
219 11
0 10 1
FY
6
EEE
002
110 11
0
nw 1
5
`
5000
0021
155 11
0
51
10
Positive Control me01thyl methan90esulfonat1e 1000 ug per plate
02
91
Bace kgrour nd Lawe n CodDeYon imams
iti
14e=NEoxrtmraelm;el2yuSrleidugchetdl;y rSeedAubcseedn;t; J6s=MOobdsercautreeldybryepdruecceidpitate
Npetion-Interfering precipitate; IP=Interfering precipitate
2 meme:
BioReliance `Study No. AAS3CH.5020B0T1L
32 `Company Sanitized. Does not contain TSCA CBI
'H-24890: Bacterial Reverse Mutation Test with an
DuPont. 8968
Bacterial Mutation Test
Table 15
TSetsutdySNuubmsbtearnce Id:: HA-A2S4I8C3H0.S02001.BTL Experiment No : B1
stLirvaeirnMicrosomes : Rrat y liver 59
DCaotlelsPlSaeteedded :: 30.J9aXn 2100*02
VPelhaitcilneg Aliquot:: w1a00teryu
Cbgoncpeerntprlaattieon NPulmabteer pReevrerptlaanttes BackCgodreound RAevveerratgaents DSetvainadtairodn
Vehicle 002
1288 11
03
hg 1
zn
6
100
002
120 11
03
an 1
2
7
333
o0a2
3105 11
0
1s 1
2
s
-
1000
a02
118 11
0
20 1
nw
3
3333
o012
1zn 11
03
36 1
25
8
5000
o012
220 11
03
11
20
1
Positive Control 2-o1aminoanthrsazcene 10 u1g per plate
002
57881 11
612
169
Backgro1u-nNdormLaalw;n C2o-dSelightly reduced; 3=Moderately reduced
Ne4s-Btxotnr-eImnetleyrfreerdiucnegd;preSc=iApbisteantte;; 6=IOpb-sIcnutreerdfebryingprperceicpiiptiattaete
BioReliance StudyNo. AAS3CH.502B0T0L1
3 Company Sanitized. Doesnot contain TSCA CBI
H-24890: Bacterial Mutation Test
with an
Assi
DuPont8968
| Bacterial Mutation Test
}
Table 16
TSetsut.dysNuubnsbtearnce 1d:+ fi-A2S48I3C0H.S02001.BTL Experiment No : BZ
stLirvaeirnMicrosomes :: faosnee
CDealtlesPSleaetedded :: 116.7JaXn102002
vPelahciincgle Aliquot +: 10p0atehrb
Concenxtrapltaitoen Plath Revertlaanttes BacCkogdreound RAevveerratgaents DSetvainadtairodn
Vehicle oorz
15s 1i
0
51
10
5
100
0021
86 1i
03
71
7
1
33
oonz 1i0n 11
0
s1
u
3
-
1000
0012
u1n 1i
03
1
i)
2
3333 000312 s 111
s
2
5000
0o1z
7` 11
03
51
7
3
Positive Control o2-rnitroflucr1e5n1e 1.0 ug1 per plate
o0z3 123031 13
162
3s
Backgro1u-NnodrmLaalw;n C2o.d5elightly reduced; JsModerately reduced
N4P-eENxotnr-eImnetleyrfreedruicnegd;preSc-iApbisteantte;; G=IOpb-sIcnutzeerfdebriyngprperceicpiiptiattaete
BioReliance Study No. AASICH.5020B0TL1
i
3 Company Sanitized.Doesnotcontain TSCA Cal
'H-24890: Bacterial Reverse Mutation Test
withan
t Assay
DuPont-8968
Bacterial Mutation Test
Table 17
TSetsutdysNuubmsbtearnce 1d:: HA-A2S0I8C9H0.502001.BTL Experiment No : 52
stLirvaeirnMicrosomes :+ mRastsliver 59
CDealtlesPlSaeteedded :: 11.67Jaxn102002
VPleathinigcle Aliquot :+ w1a0t0erub
Cugonpceerntprlaattieon NPulmabteer pReerverptlaanttes BacCkogdreound_ RAevveerratgaents DSetvainadtairodn
Vehicle o012 1157 11
03
21
20
8
100
o012
220 11
03
19 1
2
3
33
0012
115 11
03
11
Ft
2
--~
1000
002
221 11
03
1s 1
20
`
3333
0012 113 11
0
11
5000
o012 2184 11
03
v1
18
1
20
kl
Positive Control 2-01amincanthr8a9cens 1.01ug per plate
0032
s65e6 11
15
9
BackgroLueNnodrnLaalw;n C2oudSelightly reduced; d=Moderately reduced --
NP4=sENxotnr-eImnetleyrfreerduicnegd;preSc=iApbisteantt;e; 6IOpb=sIcnutreerdferbiyngprperceicpiiptiattaete
BioReliance Study No. AAS3CH.502001.BTL
3s `Company Sanitized. Does not contain TSCA CBI
'H-24890: Bacterial Reverse Mutation Test `with an Independent Repeat Assay
DuPont-8968
Bacterial Mutation Test
Table 18
TSetsutdySNubusbtearnce Id:: HA-A2S0I8C9H0.502001.BTL Experiment No : B2
stLirvaeirnMicrosomes :+ NToAnL0e0
DCaetllesPlSaeteedded :: 21.63JaXn102002
VPelhaitcilneg Aliquot :* w1a0t0erui
Concenxtrapltaitoen NPulmabteer pReervertplaanttes BacCkogdraound RAevveerratgaents SDetvainadtairodn
Vehicle 0012
114523 11
03 163 1
153
un
100
001 191269 11
0
152 1
159
3
333
o02
116622 11
03
152 1
13
wv
-
1000
o021 118960 11
03
162 1
186
4
3333
o012
116572 11
03
40 1
153
1
5000
o0a2 112635 11
03 130 1
146
3
Positive Control so01dium azide991.0 ug pe1r plate
0032
as53s
1 1
a
2
Backgro1u-NnodrmLaalw;n C2oedSelightly reduced; l=Moderately reduced
--
N4e=eEtxotnr-eImnetleyrfreerdiuncegd;preSc=iApbistenatt;e; GI=pO=bIsnctuererdferbiynpgrperceicpiiptiattaete
oR StudyNo. AAS3CH.5020B0T1L
36 Company Sanitized.DossnotcontTSaCAiCBnI
'H-24890: Bacterial Reverse Mutation Test
withan
t Assay
DuPont-8968
Bacterial Mutation Test
Table 19
TSetsutdysNuubmsbtearnce Id:: HA-A2S4I8C9H0.502001.BTL Experiment No : B2
SLitvrearinMicrosomes :+ RTAaLt00liver s3
Colls Seeded : 2.3 X 10 Date Plated : 16 Jan 2002
VPelahtiingcle Aliquot :+ w1a00ter
Concentralattieon NPulmabteer Revperertplaanttes BackCgordeound RAevveerrtaagnets SDteavnidaatridon
Vehicle 0021
127151 11
03
175 1
167
2
100
0012
118937 11
03
m2
1
184
3
333
o0r2 172162 11
03
198
1
195
i)
-
1000
[022 117885 11
03 126 1
163
32
3333
0012 131861 11
03
16
1
160
23
5000
o012 116509 11
03
132 1
150
16
Positive Control 2o-1amincanthr51a5cens 1.0 1yg per plate
0032
774975
13
819
@
Backgro1-uNnodrmLaalw;n C2o=dSelightly reduced; 3=Moderately reduced
N4P==BNxotnr-eImnetleyrfreedruicnegd;preSc=iApbisteantte;; G=IOpb=sInctuerrefdebriyngprperceicpiiptiattaete
BioRefance Study No. AAS3CH.50200B1T.L
37 CompanySanitized. Does not contTSaCAiCBnI
'H-24890: Bacterial Reverse Mutation Test
withan
Assay
DuPont-8968
Bacterial Mutation Test
Table 20
TSetsutdySNuubmsbteanrce Id:: AHA-S2I4C8H9.0502001.BTL Experiment No : B2
stLirvaeirnMicrosomes :+ NToAnLeS35
DCaotlelsPSleaetedded :: 21.66JaXn102002
VPelhaitcilneg Aliquot
vater : 100 un
C1goncpeerntprlaattieon NPulmabteer Rpeevreprtlaanttes BacCkogdreound RAevveerratgaents DSteavnidaatridon
Vehicle o0r2
223 11
03 26 1
2
3
100
0o2r; 125 11
03
hg 1
1
2
333
0012
135 11
03
13
1
12
2
-
1000
0012
u[i 11
03
`1
27
.
3333
[052
11 11
0
11
1
2
5000
0012
15 11
03
pry 1
10
1
Positive Control s0o1dium azide3361.0 ug pe1r plate
0032 336596 11
354
uw
Backgro1Cu-BNncoderrmLaaamlw;enlyC2o=dzSeeldiigohetdl)y rSe-daubcmeedn;t:3sM-oodmemcreartaedlybyrepdruecceidpitate
NP=Non-Tnterfering precipitate; IP=Interfering precipitate
BioRefonce Study No. AAS3CH.5020B0T1L.
!
38 Company Sanitized. Does not contain TSCA CBI
wHi-t2h48a9n0: Bacterial ReversAesMsutaaytion Test
DuPont:8968
Bacterial Mutation Test
Table 21
TSotsutdysNubustmanbcee rTd::
seratn
+
HAM-S2I4C8H0.S02001.BFL mass
CBerlplesriSmeenetdeNod:: 28.26 x 10
VLeihviecrleMicrosomes wRaatterliver 59
Date Plated: 16 dan 2002
CoPnlcaetnitnrgaAtliioqnuotPla:te100Ruesvertants Backsrowd Average Standard
1g per plate tusber per plate
vehicle 0
7
TCode
Revertants Deviation
[03
22 1i
s
100
aa
15 3:
a
53
un
'
333
aa
11 1i
03
3i
1s
s
-
1000
0on 1i0s ii
0
7i
un
s
3333
0a 185 13
a
si
un
`
s000
2o 1s5 i1
03
1i
12
`
Positive
Control
2-001aminoant1hr3iatcsens
1.0 v ug 1
per
plate
0 Backoround Lawn Code
a3
i
128
5
dN1se-E-Nxlortomrnae-lmI;enltye2r-fSseeldriuigcnhegtdl;pyrerSceeidApubicsteeadnt;te;;I6e=IoOPdb-esIrcnauttreaerldfyerbiyrnepgdruepccreiedpciitpaittaete
BStiuodRyelNioa.nceAAS3ICH.502B0T0L1
3 Company Saniized. Doss notcontain TSCA Call
H-24890: Bacterial Reverse Mutation Test
withan
t Assay
DuPont.8968
Bacterial Mutation Test
Table 22
TSotsutdysNuubrsbtearnce Id:: HA-A2S4I8C9H0.S02001.BTL Experiment No : 82
stLirvaeirnMicrosomes :+ NTo1n5e37
DCealtlesPlSaeteedded :: 11.60JXan102002
VPelhaitcilneg Aliquot :+ w1a0t0ernL
CLogncpeenrtrpaltaitoen NPulmabteer Rpeerveprtlaanttes BacCkogdreound _RAevveerratgaents SDetvainadtairodn
Vehicle o0012
55 11 71
7
2
100
o012
+7 11
0
21
.
3
3
002
74 11
03
21
`
3
-
1000
o021
55 11
0
31
5
2
3333
0012
7i 11
03
61
6
1
5000
002
s3 11
0
21
3
1
Positive Control 3-o1aminoacri7d9i9ne 75 ug1per plate
0032
754755 11
708
118
Backgro1u-NnodrmLaalw;n C2oSdleightly reduced; I=Moderately reduced --
N4e=eEtxotnr-eImnstleyrfreerdiuncegd;preSc-iApbisteantt;e; 6I=pO=bIsnctuerrefdebriyngprperciepciitpaitteate
BioReliance StudyNo. AAS3CH502001 BTL
40 Company Sanitzed. Doesnot contain TSCACBI
H-24890; Bacterial Reverse Mutation Test
withan
Assay
DuPont-968
Bacterial Mutation Test
Table 23
TSetsutdySNuubmsbtearnce Id:: AHA-S2I0C8H9.0S02001.BTL Experiment No : 82
StLirvaeirnMicrosomes : mRTMaat1sl37iver 59
CDealtlesPlSaeetdeedd :: 116.0JaXn102002
VPelhaitcilneg Aliquot +: w1a0t0erur
nCeoncentraltaiteon NPulmabteer Revperertplaanttes BacCkogdreound RAevveerratgaents SDteavnidaatridon
Vehicle o012
15 11
03
81
5
.
100
0012
74 11
03
71
s
2
ET
0012
5, 11
03
10 1
5
2
-
1000
0012
s2 11
03
71
s
1
3333
o012
42 11
0
u1
6
5
5000
0012
85 11
03
51
6
2
Positive Control 2-o1anincanthra8cens 1.01yg per plate
0032
78 11
80
5
Backgroiu-NnodrmLaalw;n C2od5elightly reduced; 3=Moderately reduced
N4P-eBxotnr-eImnetleyrfreerdiuncegd;preSceiApbisteantt;e; GI=POsbIsnctuerredferbiynpgrperceicpiiptiattaete
BioRelance Study No. AAS3CH.502001.BTL
4 `CompanySanitized. Does not conTtSaCAiCBnI
F-24890:BacterialReverseMutation Test
withan
Ass
DuPont-8968
Bacterial Mutation Test
Table 2
TSetsutdySNuubmsbtearnce 14: AH-S2I4C8H3.050001.BTL Experiment No : 82
sLeirvaeirn Microsomes : Nweoaneuvin
CDealtlesPSleaetdeedd :: 3186.2JXaxn102002
vPelantiincgie Aliquot: w1a0t0er
Concenrtrapltaitoen NPulmabteerpeRrevertplaanttes BacCkogdreound RAevveerratganets DSetvainadtairodn
Venicle o0r
1s 11
0
ai
12
s
100
o0r2
5s 11
0
51
5
1
a
0021
77 11
03
1
"
3
-
1000
0o
s2 11
03
`1
2
am
002 137 11
03 10 1
10
3
s000
o0r2
110 11
03
u1
1n
1
Positive Control me0t1hyl metha1n12esulfonat1e 1000 pg per plate
0023
98 1i
Fl
1s
Backgroiu-NnodrmLaalw;n C2o-dSelightly reduced; 3eModerately reduced
N4p=eBlxotnr-eImnetleyrfreerdiucnegd;preSc-iApbistenatt;e; 6I-POsbIsnctuerredfebryinpgrperceicpiiptiattaete
_
StBiuodRyelNioa.nceAAS3CH.502001.BTL
2
Company Sanitized. Does not contain TSCA CBI
H-24890:BacterialReverse Mutation Test with an Independent Repeat Assay
DuPont-8968
Bacterial Mutation Test
Table 25
TSetsutdysNuubmsbtearnce 1d:: AHA-S2I4C89H0.502001.8TL Experiment No : 2
stLirvaeirnMicrosones :+ WRPa2t wliuvner S9
Vehicle
+ water
CDaotlelaPlSaeteedded :: 81.62JaXn102002
Plating Aliquot : 100 kL
Cugoncepenrtrapltaitoen NPulmabteer pReervertplaanttes BacCkogdreound ReAvveerrtaagnets SDteavnidaatridon
Vehicle o02
2u0 11
0
12 1
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100
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03
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87 11
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Positive Control 2-01aninoanthr6a3cene 10 1ug per plate
0023 875408 11
51
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Backgro1u-NnodrmLaalw;n C2oSd1eightly reduced; J=Moderately reduced
NP4=eElxotnr-eImnetleyrfreerduicnegd;preSc=iApbistenatt;e; G=IOpb=sIcnutreerfdebryingprperceicpiiptiattaete
BioReliance StudyNo. AAS3CH.50200B1T.L
4 Company Sanitized. Does not contain TSCA CBI
'H-24890: Bacterial Reverse Mutation Test `withanIndependentRepeat Assay
DuPont 8968
BacStuermiaarly MouftaRteisounltTsest
Table 26
TStuedyst SMuubnsbtearnce Id +: AHA-S2I0C8H5.0502001.BTL
iment No : B1
Liver MicrosomAevse:rageNonReevertants Per Plate + Standard Deviation
Dose (ug/plate) TASS ma100
V1e00hicle
18:: 21116650+s 167
1033030
1WBi: 1112630+01s128
53303030
1136:: 0315152524 2172
Positive
148+ 20 580: 60
Liver Microsomes: Rat liver S9
TAISIS 1166+: 31 1155:+ 73 1105s+ 24 ess 1
TAISI) 57:: 23 77:: 21 692+ 34 06+ 93
We2 wun 125:: 2 1178:: 63 1L0z: 24 92: 3
Dose (ug/plate) TASS TAIOO TAISIS TAIS37 _ We2 uven
1V0e0hicle
2380:: 52 11871:+ 258 1155+: 35 88B:: 31 223:: 76
-
1303030
2282:: 62 1W7r:: 32B0 1152:: 66 95:: 22 2L:x 38
53030303
2108:: 33 116400:: 357 1102:: 45 65:: 12 2250:: 81
Positive
5914125 80+ 71 108: 7 63: 9 6121109
VPeohsiictlieve==VePhoiscitlievCeonCtornotlrol
Plating aliquot: 100 ul.
BioReliance Study No. AAS3CH.50200B1TL.
" Company Sanitized. Doesnot conTtSaCAiCBnI
'H-24890: Bacterial Reverse Mutation Test `with an Independent Repeat Assay
DuPont-8968
Bac`tSeurmimaarly MouftaRteisounltTsest
Table 27
STteudsyt SNuubmsbtearnce Id : AHA-S230C8H9.0502001.BTL
nent No : B2
Liver MicrosomAevse:rageNoRneevertants Per Plate : Standard Deviation
Dose (pg/plate) TASS TMI00 TAISIS
1V0e0hicle
07:: 5111590: :1318 2139s: 32
3130300
L0es 32 11862: 1& 172:s 24
50330303
87:: 23 165: 313: 110++ 12
Positive
162: 35 413: 26 350: 17
Liver Microsomes: Rat liver 59
mAISIT 74:: 32 252 33 63:+ 11 708s
we2 uvra 152:: $15 74:: 12 10:: 31 573 3s
Doss (ug/plate) TASS TAI00 TAISIS TAISI7 _we2 uve
-
1V0e0hicle 333
2210:: 38 11087::121 117:+ 87 7+ 2 195: 18 16+ 5
66:: &2 1m4x: 25 8: 2 102 2
10330303 5000
210+: 1116032:3223 111:s 56 20: 7 1501:6 12: 4
s6e2 15 192:: 41 6: 2 7: 1
Positive
619+ 93 819: 87 128: 9 80s 6 7573 8
VPeohsiictlieve==VePhoiscitlievCeonCtornotlrol
Plating aliguot: 100 ul
B-i--oReliance StudyNo. AAS3CH.5020B0T1L
45 Company Sanitized. Does not contain TSCA Cal
-
Hwi-t2h48a9n0I:nBdaecpteenrdieanltReRveepresaet MAustsaatyion Test
DuPon-8968
APPENDIX A Historical Control Data
BSitouRdeylNioa.nceAAS3CH.5020B0TL1
" Company Sanitizad. Dossnotcontain TSOA GB
-
'H-24890:BacterialReverse Mutation Test
withan Independent Repeat Assay
DuPont-8968
Historical NegativeandPositive Control Values
1998 - 2000
overs peeps
Con[ew |5D[i|Wis|We {5D | vin|ie|
TA
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1
322
sa rl as
736| 301| 198] 2871
7
29
38
317
SD=standard deviation; Min=minimum value; Max=maximum value; Neg=negative control (including but not limited to deionized water, dimethyl sulfoxide, ethanol andacetone); Pos=positive control
BioReliance `Study No. AAS3CH.502001.BTL
47
Pre oe
-
wHi-t2h48a9n0I:nBdaecpteenrdiealntRReveepresaet AMustsaatyion Test
DuPont-8968
APPENDIX B Study Protocol
BSitouRdeylNioa.nceAAS3CH.5020B0TL1
" Gampany Sanitized. Doss not contain TSCA GBI
--_
'H-24890: Bacterial Reverse Mutation Test
with anIndependentRepeat Assay
DuPont-8968
Rec bye RAIi OA_v 1-Reed "
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BioReliance
Study No. AAS3CH.502001.BTL
49
@ BIORELIANCE
-
Company Sanitized. Doss not contain TSCA OBI
-
'H-24890:BacterialReverseMutation Test
withan IndependentRepeatAssay
DuPont-8968
Bi`oSkpoenascorePSroajeyctNNuuombbeerr::___A_SDIuCPoHatS$090681BTL
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Email: swagnen@biorelisnce.com
50 PROPOSEDSTUDYDATES
51 ExpaSiurnDlu 21002001
52 Expuinon TamiosionDue: 06555202
53 DutRepeDue:
ran
54 FilReportDu:
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60 TESTSYSTEM
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w'iHt-2h4a8n9I0n:dBeapcetenrdieanltRReevpeerasteAMsustaaytion Test
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70 EXPERDESIIGNMANEDMENTHTODOALOLGY
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-
'H-24890: Bacterial Reverse Mutation Test
withan
Assay
DuPont-8968
SponsorPctNur: _ Duponk$968 BloRelsceSeyNumber:_AASICHS02001 BTL 74 SobiltyDeion dUcnewlmerisksnbatilhoeenSwpiplebane ncoownspducitend ac0sdaintnhoift:tSOmmRbooncfeso sqvhloces,closmrobmlly 5oT0r0IkmLgo/Lfn,p.rfdeofoierrm,ainsovndeiehd.iebu.t(VseClAeiSc1ke6s7c6o0m5p,nsdstno wdditbhn(zCAesSdt6w1ye1a75(sCaAnSd Ssooccrokknocoefo(piCnrAfcSeer6nc7e:,,6v1wp)h.icT0hhp0eovmriancslep.oefefopcahriooocnnwosillhebeglthseest24twee0k,0scbgofcreod.nbflo1re
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BIORELIANCE
Study No. AAS3CH.502001.BTL
52
`Company Sanitized. Doesnotcontain TSCA CBI
-
H-24890: Bacterial Reverse Mutation Test
with an
it
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DuPont-8968
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@ BIORELIANCE
BioReliance
Study No. AAS3CH.5020B0T1L
53
Company Sanitized. Doss not contain TSCA CBI
-
'H-24890: Bacterial Reverse Mutation Test
withan IndependentRepeatAssay
DuPont-8968
SpoorProjectNumber.__ DuPont4968
BioReSltuidysNuombcere: _AASICHLS02B0T0L1
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@ BIORELIANCE
BioReliance
Study No. AAS3CH.502001.BTL
54
`Company Sanitized. Doesnotcontain TSCA CBI
'H-24890:BacterialReverse MutationTest with anIndependentRepeatAssay
DuPont-8968
SponsorProjectNumber,_ Duo 968
BioRStedytNucmbeer: _AASICIHLS02B0T0L1.
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ProcolSPOTSTONN 1a2001 ageTof11
BIORELIANCE
-- BioReliance
Study No. AAS3CH.502001.BTL
55
`CompanySanitized. DoesnotcontTSaCAiCnBI
-
'H-24890:BacterialReverseMutation Test
withan IndependentRepeat Assay
_DuPont-8968
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StBiuodRyelNioa.nceAAS3ICH.502B0T0L1
36
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-
'H-24890: Bacterial Reverse MutationTest
withan
Assay
DuPont-8968
Spor ProjectNumber: _ Dun 968 BiRalnceSty Nuber:_AASOCHLSO2B0T0L + Tnotecrooifnlsat:esmpofusrnctoonttbo;empodsecphertpoldve s;yiphemmodcc oimdpoeosofetlmeiceiobonoslnoc
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Pron SPOTSO01 Lan2001 Page9of11
@ BioReuANCE
BioReliance
Study No. AAS3CH.502001.BTL
51
CompanySanitized. Doesnot containTSCA CBI
-
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DuPont8968
SponsorProjectNumbe:___ DaPont4968 BioRelioceStdy Number:_AASICH SOROOLSTL.
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130 REFERENCES
RAmenedcsm,aiBhnN3g1.s3M4wc7i3C6ha4n,S ,J.sd Yl amaki, o (157b5o),sMoem nthsodTsAfoNrda etainockn aMrioings
rc m,Mh LLo.i.sMi modtMiaornlc R,sWeoc,ho 3(8139.7363).Mage esi wingty'reversion ia
RRIeetggrluiirioyonnGoefCnoPtnhoeariecrcymeaTeecnsosHloaerorhmaHicasaaomcnetUis(cCeiHs:).OSoufAkedTnecsohoiancaSlpRaeccqeoieAmmpmeneossdofoofr
adGoipTtaiio5n81a6t2s0e,pAi4t. o2f6t,1h5e5I.CH procesonJay 19, 1955. Fede Regier
R`IeGgteimbsaoriunioioncnlyoTfCsPoifnaegrroocfcsPehloanassHfcaoorrwmiuisrs.noSan2U.s3ed(.oIcCGuHmo)eocnftnTsecyco:tmieAaSnatnReiqfauoirrsBeomaepntys ffoxc
-
Rsevpe4mtoefr 2h1e19I9C7H proces on hy 16, 1997. FederRepoer621602616030,
UMS ScACTain9J,5.0a 9a5d0Ans,em Bs:Xi.(n19o7f60)o ,0Detcechtiotn a :of dcaarmiaoongen .ePs ro5.Nsailns Agscin$t0e.
mMoSaCiogoonnn1mi,aCshnoeasS , ,roYnaa ma, .l sdtAmee.o s,BeNy.ofn (139079c,eDeme tieecitosn oPn fr cuNraongAscos.s:
MTaeM ra,DMi anRdeAmeo es,B11N3.1n 7(31291835,.Revo MotosfortheSalmon Msg
O`PBAadCsdDaFGeurriyhne1949O87E,1C(DGGeuitdielciTnoesvifocrlhosg:TBowaicnkgeorfsRCehvrerasieeMli,tbailosnhTdebsy),ONEiCDs,h
WSpielrcmeoa,enn7. Npahiidoro,A,TWAeIGdEd,wDiJth.ExscnhderGicehclboolals,WEDG.te(t19s%o)i.nCs.oMmgpoanncsofs
PracaSPOTSUOL 10201 Pageloot11
BioRelance
Study No. AAS3CH.502001.BTL
58
@ BIORELIANCE
CompanySaniized. Does not contain TSCA Cal
'H-24890: BacterialReverseMutation Test withanIndependent RepeatAssay
DuPont-8968
0 APPROVAL
Bi`oSkpeonlssocrePSrotjecytNNuummbbeerr::__A__ADSuIPoCnHt8S906280B0T1L
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StudyNo. AAS3CH.502001.BTL
59
)BIORELIANCE
Company Sanitized. Does not contain TSCA Cal
'H-24890: Bacterial Reverse Mutation Test withanIndependent Repeat Assay
DuPont-8968
APPENDIX C InformationforJapanese Regulatory Agencies
BioReliance Study No. AASICH.5020B0TL1
60 Company Sanitized. Does not contain TSCA CBI
-
Hwi-t2h48a9n0I:nBdaecpteenrdiealntRReevpeeraste MAustsaatyion Test
DuPont-8968
ReportofResultsofReverse-Mutation Testin Bacteria
1. Tester Strains
1) Procurement
Obiained from
Date obtained
10November 1998
tDhaetesiinsnpelcotteidn storage
TALS3S
oe] cua e ares TAIS38
- pSrn ey rt WE2orrh (@kMI01)
Dr. Bruce Ames.
NaotfiInodnuasltCroilallecstnidon Marine Bacteria
11 August 1998
markers for each confirmed on the
We2 (pKMion) | Averdesn Scotland [Top
1993
@) Storag
Composition
Bacterial suspension
LomL
DMSO
009 mL
21.) 5S9ouMricxe, Storage Temperature, tc. of $9
Ee EE BSitouRdeylNios.nceAASICH.5020B0T1L
Name and model of | So-Low, Model 61
Company Sanitzed. Doss not contain TSCA CBI
-
wHi-t2h48a9n0I:ndBaecpteenrdiealntReRveepresaetMAustsaatyion Test
DuPont8968
(2) Preparationof9
Specitee. s,SSetraain| Rattus nornvegiycus, Sprague
[we [ae]oe| `Administration
rane
ge (in weks)
Batch R65) A odmismou | $03 mie
1871g(0Ba2chR76516)| (g/kg weigh
lyweight
3. Preparationof Test SubstanceSolution
mm fon | Manufacturer
aGnrdaldoer
Purity (%)
--~
Water (CAS No. 7732-185)
InvitrLoifgeenTCeocrhpnoorlaotgiieosn,,flonrcm.er_ly_|| 11110131037223; [ poo0
Stabilityoftet substance
w`Mheetnhotdesotfssuubsspteannscieons | Not applicable dificult to dissolve
BSitouRdeylNioa.nceAAS3CH.5020B0T1L
2 Gompany Sanitized. Dos not contain TSCA Call
-
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DuPomu#968
4. ConditionsofPreculture
[ romemoon | Nem [wemfwnrsr[Lovo |
Oxoid Nutrient
|peocd [eo tttprotue|
iStonraogectiumetolabneadgittnenmiipn.ogfonrfom | 20 5 hoursatambienttemperature shaking culture eSntdoroafgce tuimeltanotdstueemfpor.rftereosmt_|<8Bours8:2-8C
Msohdakeelrand manufacturoerf | Ne Brunswick Scientific,modelG-24
a ee (Msehtahkoidngotfyspeh,aksipneged, etc.) Culture vessel (shape,
[[cuoewome
Rotary (125 rev/min. J : cyl
[som
5. Agar Plate Medium
1) Top aga
a
oe |owTs e ]
[oo[ roowsokse
2) Minimum Glucose Ag Tm
www
`Made in-house:
Au
[Mam| foBecrtonDuickinesonr| 1o0013DKSQ
Vomogee min |me]
SBitouRdeylNioa.nceAAS3CH.502001.BTL
6
Company Saniized. Does notcontainTSCA CBI
H.24890: Bacterial Reverse Mutation Test with an Independent Repeat Assay
DuPont-$968
6. TestResults - Judgoeftmheerensultts
[opm [rege
Reason forjudgement and refereatial maters: prNeospeonscietoivreambusteangceenoifcrAesrpooncselowars-obisrenartdvieuvdwecireSt9hd.any ofth testerstrainsincitherthe Referential matters c"oTnhneevcethicalnedanwderpoesciatpiavbelceoontfrodletveacltuiensgianmdiuctaatgetehna.tal testerstrainswerefunctioning
BSitouRdeylNiaon.ceAAS3CH.502001.BTL
o" -- Company Sanitized. Does not contain TSCA CBI