Document daNNDG0ML4JOrG405moa8GqRq
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AR 246 - 3229
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a1
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ARARG _ 3427
DuPont-8867
TRADE SECRET
Study Title 'H-25170: Bacterial Reverse Mutation Test with an Independent Repeat Assay
Authors
Valentine O. Wagner, III, M.S. Michelle L. Klug, B.S.
`StudyCompletion Date
11 February 2002
Performing Laboratory
BioReliance
or 9630 Medical Center Drive Rockville, MD 20850
E. 1 du Pont de Nemours and Company
.
DuPont Haskell Laboratory
P.O. Box 50, 1090 Elkton Road
Newark, DE 19714-0050
Performing Laboratory Study Number
'AAS2XK.5020B0T1.L
`WorkRequestNumber
[em
{aService Code
~~
Page 1 of63
H25170; Bacteria Reverse Mutation Test with
anIndependent RepeatAssay
DuPont-8867
STATOE F CM OME PLIN ANT CE
Study No. AAS2XK502001 BTL
Regulationsaspublishedin 21 CFR
w58a,stchoenUd.uSc.teEdPiAnGcLoPmSptlainadnacredws4it0hCtFhRe
U.S. FDAGLP
160,and40CFR
P7r9i2n,citphlees oUfKGoGoLdPLCaboomrpaltoiraynPcreacPtriocgeirnaamlmlem,attehreialJaasppaencetssewiGtLhtPhSetfaonldlaorwidn,gaenxdcetphtieoOnsE:CD
The identity, strength, purity and composition or other
characteristicsto define thetestand control articles havenotbeen: determinedbythe testingfacility. Thecontrolarticleshavebeen characterizedaspertheCertificatesof Analysis onfile withthe
The stability ofthetestandcontrol articles hasmotbeen
detebyrthemtesitinngfaecilidty.
A`ncoanlcyenstersattioonodfettheertmeistneantdhceonutnrioflomrixmtiutrye(swaesraepnploitcpaebrlfe)o,rmoerd
-_
b`nyottpheertfeosrtimnegdftahceislietayn.aTlhyseesSopnotnshoertheastssiunbdsitcaantceedmtihxatturtehse.yhave
``mTihxetsutraebsi,lriteysopefctthievetleys,tahnadsncoonttrboelearntdieclteesrimnitnheedtbesyttahnedtceosnttirnogl facility.TheSponsorhasindicatedthatthey have notperformed
`stability analysisonthetestsubstancemixtures.
Notastize 0. Wogar, T=
VSatluednyDtiinreecOt.oWragner, III, M.S.
biel Af >
BioSRtyeMlanagnemesnt
Ul Feb 200%
Date
1 pak 2002
Dw
BeRdmee
--_
Study No. AAS2XK.502001.BTL
2
Company Saitized. Doss no contain TSCA Gol
'H-25170: Bacterial Reverse MutationTest with an Independent Repeat Assay
Quality Assurance Statement
DuPont-8867
Study Title: RBAECPTEEARTIAASLSRAEYVERSE MUTATION ASSAY WITH AN INDEPENDENT Study Number: AAS2XK 502001 BTL Stady Director: Valentine O. Wagner, Il, M.S.
QTuialsisttyuAdsyhsuarsabneceemndoinviitdoerds netaoch sofetehess ofpihna-spersoocveesrsphsaseeiss.oUfsistnugdies,Parocensdaumrpeld,indgocosupmepnrtmoacthi,on, `hoequUiSpm.cuFlDrAecoGrodos,deLtacb.oarracteorxyamPirnacetdicien Roergduelrattoiosnusr(e21thCaFtRhe$8s)t,utdhye iUsSpSerEfoPrAmeGdLiPnsac(c4o0rCdFanRce75wi2tahnd L4aS0btoaCrnFadRatrodr1yO6p0P)er,ratschttiiencUgeKaPrnGodcLtePodsuRreerse.egthuatlthteahsettJaadipyaonsecsnoensGduL,cPteSdtsancdoarrdd,iannd1tthheeOpEroCtDocPolrainnd rcelieopvfalnGtoeosd "Th followingaethinspectiondite,phasesinspected,andreportdaesof QAispectionsof hissud.
PhIansspeoctOn~~0P6ro-tDoecco-l0R1e-v0i6e-wDec-01To StDiu06d-DeycO1ToMgnt06-Dec-01
PhIanssepoctOn~~ T1e9s-tDeacn-d0o1r-co1n9t-rDolecm-at0eTrioalSatdumdiynDiisrtr1a9ti-oDnec01ToMgnt 20-Dec-01
IospoctOn 30-102 01-Feb-02 To StudyDiO1-Feb-02 To Mgnt 07-Feb-02
Phase
Draft Report.
InspotOn~~ 11-Feb-02- 11-FTeoSbtu-dy0Di2r 11-FeTbo-Mg0n2t 11-Feb-02
Phase
Draft to Final Report
"rTeiflsecrteptohretrdaewdsaitbsoftthheemestnhdo:dsandprocessesused ithe studyand thereportedrsulsaccurately
Blah SdLatpoour 5u3. d QUALITY ASSURANCE
_2 B_ATE\F0 eh na
_
BSitouRdeylNion.ceAAS2XK.502001.BTL
3
CompanySanizad. Donoscontsain TSCA CBI
H-25170: Bacterial Reverse Mutation Test with an Independent Repeat Assay
'DuPont-8867
CERTIFICATION
`We,theundersigned,declarethatthis reportprovidesanaccurateevaluation ofdata obtained from this study.
tometySuyDiccr:._ NolOa.Wisgank,Ti= c 1Febesa
Valentine O. Wagner III, M.S.
Date
StAupdpyrMoovneidtbory:
fa
Dora
`Maria Donner, Ph.D. `Senior Research Scientist
0g-Feb-2002
Date
--
BioReliance
Study No. AAS2XK.502B0T0L1
4
GorparySesed, SoA INTERNS
'H-25170: Bacterial Reverse Mutation Test with an Independent Repeat Assay
DuPout.8867
TABLE OF CONTENTS
Page
SAT commun
PU sssmnmmmmommm------------------. (Characterization ofTest 0d COBOL SUBSIANGES...rvevrrorvrsersesned) MBAl M s s mn
CU snmmmmsmmmmms--------_
BAIL vncmmmmmmmssmmmmmmmmmmmnmmmononn 37
DESTnmmmmmmmmmsmammsmmsmmmmommmmmmmmmmsmnocl
-
TTaabbllee 21:: PPrreelliimmiinnaarryyTTooxxiicciittyyTTeesstt iinn SSaallmmoonneellllaa rtyypphhiimmuurriitunm TTAALSOSO...................c.v.o.e.:.11B9
Table 3: PreliminaryToxicity Test in Salmonella typhimurium TAIS3S ................20
Table 4: PreliminaryToxicity Test in Salmonella typhimurium TAIS3T .............._.21
Table S: Preliminary Toxicity Test in Escherichia coli WP2 u9rA.............2.2
Table 6: Mutagenicity Test in Salmonella typhimurium TA98 Without S9...............23
Table 7: Mutagenicity Test in Salmonella typhimurium TAB With S9...........orou 24
`Table 8: Mutagenicity Test in Salmonella typhimurium TAI00 Without $9 ...........25
``TTaabbllee 91:0:MMuuttaaggeenniicciittyyTTeesstt iinn SSaallmmoonneellllaa ttyypphhiimmuurriiuumm TTAAIISO30SWiWtihthSo9ut..S9........................2276
`Table Table
1112::
MMuuttaaggeenniiccTTiieettssyytt
iinn
SSaallmmoonneellllaa
ttyypphhiimmuurriiuumm
TTAAILSS3357
WwiitthhoSu9t..$.9.......................2289
`Table 13: Mutagenicity Test in Salmonella typhimurium TAIS37 With S9................30
`Table 14: Mutagenicity Test in Escherichia coli WP uyrA Without S9..................31
``TTaabbllee 1165:: MMuuttaaggeenniicciittyy TTeesstt iinn ESsaclhmeornieclhliaabcpohliiWmuPr2iuum ATAWSithwiSt9h.o.u.t.S.9....................o.w.w.3n32r3
``TTaabbllee 1178:: MMuuttaaggeenniicciittyy TTeesstt iinn SSaallmmoonneellllaa ttyypphhiimmuurriiuumm TTAAIS080WiWtihth9out..S.9............o.......o.....3345
``TTaabbllee 2109:: MMuuttaaggeenniicciittyy TTeesstt iinn SSaallmmoonneellllaa ttyypphhiimmuurriiuumm TTAAIISO305WiWtihthSo9ut..S.9......c.................3376
TTaabbllee2221::MMuuttaaggeeaniicciittyy TTeesstt iinn SSaallmmoonneellllaa yypphhiimmuurriiuumm TTAAIISS3357 WwiitthhoSu9t.$...9.......o.rn 3398
`Table 23: Mutagenicity Test in Salmonella typhimurium TA1537 With S9..............40
Bomeme
--
Study No. AAS2XK.502B0T0L1
s
`Company Sanitized. Does not contain TSCA CBI
aHn-2I5n1d7e0pe:nBdaecntterRiealpeRaetveArssseayMutation Test with
DuPont-8867
`Table24:Mutagenicity Test in Escherichia coli WP uvrA Without $9.........vecl `Table25:Mutagenicity Test in Escherichia coll WP2 iyrA With 59... Table26:Salmonella/E. coli Mutagenicity Test ~ SummaryofResults B1...............43 Table27:Salmonella/E. coli Mutagenicity Test ~ SummaryofResults BL..............44
AERISProt smmmmenmammmmm--------l
`Appendix C: Information for Japanese Regulatory AGENCIES...
59
BioReliance
_
Study No. AAS2XK.502001.BTL
6
Company Saritized. Does not contain TSCA Cal
-
'H-25170: Bacterial Reverse Mutation Test with
an Independent Repeat Assay
DuPont-8867
STUDY INFORMATION
pssst)
H-25170
J
`SubmitsNotebookNumbers) QE
)
Haske Number: 25170
`CASRegistryNumber: {SN )
`uric;(SR) KnownInpusiies{ NR)
`Stability: Tchonedietsitosnusbosftatnhceesatpupdye;amroedevoibdeenscteabolfetunadebrthie was
observed.
Sponsor; ELduPost de NemaondCuomrpasny USA `Wilmington, Delaware 19898
`IStnuidtyiated/Completed: December05,2001/(secreportcoverpage)
In-LifeInitiated/Completed: December07, 2001 / January 10, 2002
BStuodylNoe. AsAS2XK502001BTL
7 Company Santized. Does notcontain TSCA CEI
H-25170: Bacterial Reverse Mutation Test with anIndependentRepeatAssay
DuPont8867
SUMMARY
Inde`pTheentdeesnttsRuebpsetaatnAces,saHy-u2s5i1n7g0S,awlamosnteelsltaetdiypnhtihmeurBiacutmetreisatleRrestvrearisnseTMAutSaSt,ioTnAT1e0s0t,wTiAtIhSa3nS AraoncdloTrA-LiSn3d7ucaendrdEastclhievreirch9ia.cTolhietetsetsetr swtarsapienWrPfo2rumverdAiinnttwhoepprheasseensc,euasnindgabtsheenpcleoatfe dinocsoer-proarnagteifonomretthheomdu.tTagheenfiicristtpyhtaesste.,Tthheepsreelciomnidnpahraysteox,itcihteymteustta,gewnaiscuisteydttesot,e(sitnaibtlailsahtnhde independentrepeattests), wasused 0evaluatethemutagenicpotentialofthetestsubstance.
targeTtetcrealhlsydarnodfusrolaunb(ilTiHtFy )owfatshseetleescttseudbassttahneces.oTlvheentteosftcshuobiscteabnacseewdaosn scoolmupabtliebbiultitcylwoiutdhytihne tetrahydrofuran(THF)at amaximumconcentrationofapproximately200mg/mL.
waIs ancthhieepvreedliumsiinnagrytaocxoinccietnyttreastt,itohnoe mfa2x0i0mmugmd/omsLeatnesdtead2wa5sp5L0p0l0atuigngpaelripqluaotte.;tThhisedtoesset
s0u2bs7t1a0n1ce3w3amsg/asmoLlu.bDleobsuetlcelvoeuldstyessotleudtiwoenraet 26.070,m1g0/, m3L3,an67d, a1s0o0l,ub3l3e3a,n6d6c7l,ea1r0s0o0l,ut3i3o3n3fraonmd
-
to5n0i0c0ijtuygwpaesropblsaetr.vPerde.ciBpaisteatdeownatshobesfeirndviendgbseogfintnhientgoxatic6i7toytres1t0,t0 hueg pmearxpilmatuem. Ndoosaeppplreactieadbilne:
themutatgestewans50i00cpgipertplayte.
testIendwtehreemu1t5a,g5e0n,i1c5i0t,y5te0s0t,,1n5o0p0oasnidtiSv0e0m0utuaggpeenriplcratees.pPornesceipiwtaasteowbasesrovbesde.rTvheebdeogsiennlienvgealts 500or 1500ugperplate. Noappreciabletoxicity wasobserved.
indi"cTahteertehsatu,ltusnodefrtthheeBcaocntdeirtiiaolnRseovfetrhsiessMtuutdayt,iHo-n2T5e1s7t0wdiitdhnaontcIanudespeenadpeosnittRievepemauttAasgesnaiyc responseineitherthepresenceorabsenceofAroclor-inducedrat liver 59.
_
BioReliance
---
Study No. AASZXK.5020B0TL1
8
`Company Sanitized. Doos not contain TSCA CBI
-
aHn-I2n5d1e7p0e:nBdaecntteRrieapleRaetvAesrsseayMutation Test with
DuPont-8867
PURPOSE
meas`uTrhiepnugirtpsobsieloitfyttiosisntduudcyerweavsertsoeemvuatlautaitontsahemsuelteacgteendilcocpiootefnsteivaelroaflstthreatinessotsfuSbasltmaonnceelblya aynpdhaimbusreinicoenofanAdraotctlohreitnrdyupctoepdhraantlloicveursSo9.fEAsccohperyiocfhtihaecporlotsotcroalinsWinPc2luwderdiinnAptpheenpdreisxBen.ce 199`7T)haensdtuOdEyCwDas(c1o9n9d8u)c.tedincompliancewiththetesting guidelinesoftheICH (1996 aod
CHARACTERIZATIONOFTESTANDCONTROL SUBSTANCES
"i Thetestsubstannucmeb,eHr-A25A1S7Z0,XwKa.sTrehceitveestdsbubysBtiaonRceelwiaansccheaornact0e3rDiezcedebmybtehre2S0p0o1nasnodrawsasa
{26
wsahsouplrdovibdeed.stUorpeodnraetceiapmtb,iethntfesttesmpuebrsattaurnec.ewAansdeesxcpriirbateidoans of
puritwya,cssotmoproesdiattiornooormottebmeprecrhaatruacrtee,ripstrioctsecttoeddeffrinoemtlhiegthetstasnudbmsotiasntcuerae.ndTthheestabilityiG,
-
BoifotRheleitaenscteswuobusltadnncoethrcaevievbeeceonpideestoefrtmhienseedrebpoyrttsh.e Sponsor. TheSponsorindicatedthat
109`.T9h9-e9v)e,hGicolleduLsaebdetlo,d9el.i9ve%r,Hp-u2r5c1h7a0s1e0dtfhreotmesAtlsdyrsitcehm CwhaesmtietcraalhCyodrmopfaunrayn.(TTeHsFt,sCubAsStaNnoc.e ditluetiomnspweeurnedrperraeypeatlrleuodwlirimgmheetdiatelybeforeuseanddeliveredtothe testsystem atroom
[o [onli] r recom [ge] conPtorsoilstwievreceodnitlruotlesdpwliattheddicmoentcuhryrlenstullyfwoxiitdhet(hDeMmSutOa)geenxicceiptyttseosdtiaurmelaizsitdeed,bwehliocwh.wAalspdoisliuievde
withwater,Allsubdividedsolutionsofpositivecontrolwerestored a-5 0 30C.
$9
"
Concentration
We2urA
(Ald2icahmChoemmiicraalCzoe.eInc.) | 10 |
ExpL.oDtaNtoe.1049-1S0ep6-P2S005 CASPuNitoy . >61035-%138
BSitouRdeylNiaon.cAeAS2XK502001 BTL
9~
--
--
`Company Saniized. Does not contain TSCA CBI
H-25170: Bacterial Reverse MutationTestwith an Independent Repeat Assay
DuPont-8867
7
$9
"
To Concentration
Fr. TAL00, TAIS3S
2nitrofluorene (AldriLcohtCNhoe.m0ica7l07CHoS. Inc.)
`Exp. Date 08-Mar-2006 CASPuriNtyo. 650978-%57-8 `Sodium azide (Sigma Chemical Co)
BLeotDNoos. 0h98Ha016t9
`CAS No. 26628-22:8
Purity 599%
Si9g-maamCinhoeamcirciadinCeo)
TALS?
No. 106F0668] Exp. Date 18-Nov-2004
---
`CAS No. 90-459
Purity 598%
`Methyl methanesulfonate:
(AldrLiochtCNhoe.m1ic5a5l2C6oA,0 Inc.)
WP2uvrA
Exp. Dates 08-Jan-2003 and
28-Nov-2003
CAS No. 66273
Purity 599%
`mutTaogecnoincfitiyrtmetshtewsatesrpilliattyeodfotnhseteelsetctsiuvbesatagnacre,wtihtehhaingahleisqtutoettvsoulbusmtaenecqeudaolsteoltehvaetluusseeddiinntthhee test.Theseplateswereincubatedunderthesameconditionsasthetest.
_
BiSotuRdeylNioa.ncAeAS2XK.502001.BTL
10
Company Sanitized. Does not contain TSCA Cal
aFn-I2n51d7e0p:enBdaecntetrRieapleRaetvAesrsseaMyutation Test with
DuPout.8867
MATEARNDIMAETLHOSDS ApFpoernsduiCbx.missiontoJapaneseregulatoryagencies,additionalinformation isincluded in TestSystem
The TAL00,
tester strains TALS3S and
uTsAeIdSw3e7reats hdeeSsacrlimboendeblylaAhmpehsimuefriaul.m
h(i1s9t7i5d)inaenaduxEostchreorpihcshiTaAScoSl,i
d'iWrPec2tulvyfrrAoamsDdre.scBrriubceedAbmyeGsr,eUenniavenrdsitMyuorfiCeall(i1f9o7r6ni)a.,SBaelrmkoenleelylaantedsEie.rcsotlratiensstweresrterariencsewieverde
recivedfromthe NationalCollectionofIndustrialandMarineBacteria,Aberdeen,Scotland.
histiTdeisnteeirnsdterapiennsdTenAc9e8(aprnodtoTtAroLpShy3)7bayrferraemveesrhteidftfmruotmahgiesntsi.dTiensetdeerpsetrnadiennTcAeL(Sa3uxSoifsrroepvheyr)tteod c`abyusmeubtaogtehnstfhraatmcesahuisfetbaasnedpbaiarsseupbsatiirtsuutibosntsi.tTuetsitoenrmsuttraaitnioTnAsI.0S0piescriefviecirttyeodbfytmhuetargeevnesrtsihoant ``mecmhaniusm(tGirneEae.nactnodliMiiusrisoeeals,ni1t9i7vs6e)t.obase-pair substitutionmutations,ratherthan frameshift
--
the`aOpvpreompirgihttecuflrtouzreenspweerrmeapnreenptasrteodcbkyinitnoocauvleastsienlgcfornotamitnhiengapp5r0opmriLaotefmcausltteurreplmaetdeoiurmf.roTmo
`amsosnuirtetorheadt.cFuolltulroewsiwnegrineohcaurlvaetsitoend,ieancahtfelaosgkpwhaassep,ltahceeldeinngtahroefsitnicnugbsahtaikoenr/iwnacsucboanttorroallerd oaonmd
atetmp3e7r4a2turCea.pTphreoxsihmaakteegl/yncu12bhaotuorrwsabesfporroegtrhaemamnetditciopbaetegditnismhaekoifnghaartvaepsptr.oExaimcahtceullytu1r2e5wrapsm
`monitoredspectrophotometrically forturbidityandwasharvestedat apercenttransmittance
y`viiealbdliencgouantittteesrtosfoanppnurtorxiiemaatatgealrypl10atceesl,lasnpdetrhmildlaitlaitiesr.oTnhfielaecbtuutalntoittperrsewseerneeddeinttehrimsirneepdobryt.
R`eTvheesrtsuedy MwuatasctioonndTuecstte)d,toacdoompptledywJiutlhy1O9E9C7DG(upiudbelliisnheed47F1eb(rGuenaertyi1c 9To9x8i)coalnodgyw:Biatchtetrhiael
InPtheamramtaicoenutailcCaolnsffoerrHeuncmeaonnUsHear(m1o99n6isaantdion19o97f). TechnicalRequirementsof Registrationof
MetabolicActivation System
preApraorceldofrro12m5m4a-linedSupcreadgruate-iDvaewrlSe9ywraatssuisnedduacsetdhweimtehtabaosliincgalcetiinvtartaipoenrsiytsotneeaml.iTnhjeecSti9onwoasf
`<Ar7o0clCoorr1c2o5l4d,e5ru0n0timlgu/skegd,.fEiavcehdbauylskpprrieorpatroastaicorniofifce$.9Twhaest9estweadsfboarictshapbrielptayrteodamentdasbtoolriezdea2t-
aminoanthracene and typhimurium TA100.
7,12-dimethylbenz(a)anthracene
to
forms
mutagenic
to
Salmonella
_
BioReliance
---
Study No. AASZXK 502001 BTL
n
Company Sanitized. Does not contain TSCA CBI
a'nH-I2n5d1e7p0e:nBdaecntetrRieapleRaetvAesrsseayMutation Test with
DuPont-8867
`lucToshee-$6-9phomsipxhawtae,s4pmreMpaBred-imnmeidiacteloybtefioredniintuascluemsoetiiadenddphcooesnpth-aaitneae,d8d1m0eM%MagS9Ci,l,n5 maenMd c3o3ntmaiMnKinCgl1i0n0maM1p0h0osmpMhaptheobsupfhfaetreabtupffHer7a.t4, pwHas7p.r4e.pTahreediSmhmaemdSia9temliyxtbeufroer(eSthsaumsmei.xT),o confirmthe serilityofthe $9and Sham mixes,a0.5mLaliquotof cach wasplatedonselective agar.
Solubility Test
dimeAtshoyllubsiulliftoyxtiedset w(aDMsScoOn)d,ucettehdatnoolse(lEetcOtHt)h,evaecheitcolnee., Tahceettoensittiwlae,sctoentdrauhcytderdofuusrianng w(aTtHEe)r,, pverboipcyllee, nseelgelcytceodliannodrdpeorlyoeftphryelfeenreegnlcye,cotlh.atThpeertmeistitesdubprsetpaanrcaetwioan sotfetshteedhtigohdeesttesromliunbelteoher `swoolrvkeanbtsl.estockconcentration,upto 50mg/mLforaqueoussolveatsand 500mg/mLfororganic
Preliminary Toxicity Test
subs`tTahnecperewloiumlidnabreytteosxtiecdi.tyVteehsictlewaansudtseenddtooseesltaebvleilsshotfhtehedtoesset-sruabnsgteaonvceerwwerheipclhattheed,toenset:
-
sepllaetcetipveermdionsiem,awliatghaorvienrtnihgehptrecusletnucreesaonfdaTbAsSeBn,ceTAoIf0Ar0o,clToArI-Si3n5du,cTeAdrLaSt3l7ivaernd$W9.ED2osuelAeveolns
testedwere 6.7, 10, 33, 67, 100, 333, 667, 1000, 3333andS000 ugperplate.
Mutagenicity Test
`mut`aTgheenmiucptoatgeenntiicailotyfttehsett(eistnsaulbsatanndcei.nSdiexpednodseenlterveeplesoatftteessttss)uwbastsaunscee(d15t,o5e0v,al1u5a0t,e5t0h0,e w1i5t0h0aTnAd9580,0T0AuIgOpOe,rpTlAaIteS)3aSl,onTgAwIiSt3h7apparnodpriWaPte2vuevhricAleainndthpeosiptrievseecnocnetraonlsdwaebrseenpcleateodf Arcoonctlroorl-siwnedruecpeldatreadtilinvterrip$li9c.atAe.lldoselevels oftestsubstance,vehiclecontanrdpoosiltisve
Platingand Scoring Procedures
origi`nTahleltyedsetsscyrsitbeemdbwyaAsemxepsoseetadlt.o1t9h7e5t)eastnsduubpsdtaatnecdevbiyaMtaheroplnaatneidnAcomreposra(1t9i8o3n).methodology
(WIOV)n,twhaesdmaeylotefdaitnsdussuep,pmlienmiemnatletdowpiatghLa-rh,icsotndtianien,iDn-gbi0o.t8i%naangdaLr-t(rWy/pVt)opahnadns0o.l5ut%ionNtaoCla wfiintahl2co5ncmeLn.toraftwioanteorff5o0reuaMcehac1h0.0mTLopoafgmairnniomtaulsteodpwaigtahrS.9Foorr tShheaprmempiarxawtaiosnsoufpmpeldeimaenatnedd
_
SBtiuodRyelNioa.ncAeAS2XK 502001.BTL
2
--
Company Sanitized.Does not contain TSCA CBI
H-25170: Bacterial Reverse Mutation Test with anIndependent RepeatAssay
DuPont-8867
r`eWaagteenrtsS,yasltlerme.fBeoretntceosmtaogawartwearismVpolgyestle-rBioleu,ndeerimoinniizemdalwmaetedripurmodEuc(eVdobgyetlhaenMdiBlolain-eQrR,ea1g9e56n)t
containing containing
11..55%%((WW//VV))aaggaarra.nNdustuipepnltebmeonttteodmwaigtahr2w.a5s%
(VWo/gVe)lBOoxnoniedrNmuitnriiemnatlBmreotdhiNuom.
E 2
O(xdoryipdoNwudterri)e.ntNuBtrroitehntNoB.ro2t(hdwryaspoVwodgere)l.-Bomnersalt solution supplemented with 2.%5 (W/V)
leveEla,tcehsptlerastterawians,laanbdealcetdiwviattihona,coads edseyssctriebmetdihan diedetnatiilfiiend BtihoeRetelsitasnubcset'asnSctea,ndeasrtdphOapseer,adtoinsge Procedures.
testOsnubes-thaanlcfed(0i.l5u)tmiiolnlwlteerreoafd$d9eodrtSoh2a0mmmiLxo,f1m0o0lLteonfsteelsetcetrisvtertaoinpaangda2r5atu4L5o2fveCh.icAlfetoerr pvloarttienxgitnhg,etphoesmiitxitveurcoenwtraoslosv,etrhleatiedsotnstuobtshteasnucrefaalcieqoufot2w5amsLreopflmaicendibmyalbaoSttOomLaaglari.quWohteofn ianpcpurbopartieadtfe oporsiatpipvreocxoinmtarotle.lyA4ft8ertthoe7o2vbeorularyshaatds3o7l2idiCf.iePdl,tatheespltahtaetswweerreeinnovetrctoeudnatnedd ibmemecdioatenlyfd(ollelusostwichnagntt1h0eedianycdsu)b.ationperiod were storedat2-8Cuntilcolonycounting could
-
toxi`cTihteycboynduistiionngofa tdihsesbeaccttienrgiamlibcarcokscgorpoeu.ndPlreacwinpwitaasteevwaalsuactveadlfuosrteevdibdyenvciesoufatleesxtasmuibnsatatnicoen
cwointthrooultpmlaagtenuisfiicnagtitohne.coTdoxeiscsihtoywanndbdeelgor.eeofprecipitation werescoredrelativetothevehicle
[|NSoiimghauyl |[DiDsitsitnagguuiisshheeddbbyyaahneoatlitchyeambilcertohcionlnoinnygolfatwnh,emicrocalony awa|]
Reancey [20dpossiblyaslight increaseinthesizeofthemicrocolonies|
`Moderately |DiSinguished by amarkedthinning ofthemicrocolony Tawa] Reduced"|esating |compared intoatphreovnoeunhceicdoicnntcrlroeeaspleaiten.thesizeofthemicrocolonies Extremely |Driessutlitnignugiisnhaendbinycarenaseexitnrtehmeestihzienonfintghoefmictrhoecmoilcornoiceoslcoonmyplaraewd]| Reduced [1v0thietvsoethiihcelubencaoilndteredoelypelaasteissoulcahtetdchoalotnhieesm.icrocolonylawnis
Ew greater thanorequal to90%ofthe plate. erEE re Precipitate_|to microscopictestsubstanceprecipitate.
_
BioReliance
---
Study No. AASZXK.5020B0T1L
13
Company Sanitized. Doss not cantain TSCA Cal
'H-25170: Bacterial Reverse Mutation Test with
anlndependentRepeatADuPsoms88a67y
[CodeTDescription | _________Coanctenistis
|
Nou-Intecfering
Distinguishedby precipitate ontheplate that is visible tothe|
naked eyebutanyprecipitateparticlesdetectedbythe automated|
Precipitate |colonycountertotallessthan 10%oftherevertantcolonycount|
(le.sstha.n3, particlesona plate with30revertants).
Inerfeing
Distinguishedby precipitate ontheplate that is visible tothe|
| kodeye and anyprecipitateparticlesdetectedbytheautomated]
resin |colonycounter exceed 10% ofthe revertant colony count (e.g.
pi morethan 3particleson aplatewith30revertants). Theseplates)
arecountedmanually.
Revertant coloniesfora giventesterstrainandactivationcondition,exceptforpositive
controls,werecountedeither entirelybyautomatedcolonycounter orentirelybyhandunless
theplateexhibitedtoxicity.
EvaluoaftReisuoltns
Forcach replicateplating,themean and standarddeviation of the numberof revertants per `platewerecalcaundlaraeretpoertedd.
-
Forthetestsubstancetobeevaluatedpositive,itmustcause adose-related increaseinthe
`meanrevertantsperplateof atleastonetesterstrainover aminimumoftwoincreasing
`concentrationsoftestsubstance.Datasetsfortesterstrains TA1535and TA1537werejudged
positiveiftheincrease inmeanrevertantsatthepeakofthedoseresponseisequaltoorgreater
WtPha2nuv3.r0-Atiwmeesrtehjeumdegaend vpeoshiitcilveeciofnttrhoelivnaclrueea.sDeiatnamseetasnfroervteersttaenrtsstartaitnhseTpAe9a8k,ofTAt1h0e0daosned
`response is equaltoorgreaterthan2.0-timesthemeanvehiclecontrolvalue.
Crifotr aeVar lidiTeast
The following criteria must bemetforthemutagenicity test to beconsideredvalid.All
Salmonella testerstrainculturesmustdemonstratethepresenceofthedeeprough mutation (a)
atnhde tphreedseelnecteioonfitnhtehpeKuMvIrBOgIenpel.asCmuiltdurR-efsaocftotre.stAelrlstWraPi2ns wTwAr9A8caunltdurTeAs1m0u0smtudsetmdonesmtornastteratthee
d sponetanl ieonue tshrt eeuvevi rrtaAno gtsenn ine.thAellvceuhlictluerecsomnutrsotlsdeamsonfsotllroawtset(hinecclhusairvaec)t:erTiAs9tEi,cme10a-n50n;umTbAeLr0oOf,
80-240; TAIS35, 5-45; TALS37, 3-21; WP2urA, 10-60. To ensure that appropriate
m0u3mxb1e0rscoelflbsa/cmtLe.rTihaeamreepalnatoefde,atecshtpeorssittriavienccounlttruorlemtuitsetresxmhiubsittabtelgeraesattaer3t.0h-afnoldoirnecqreuaasletion
ttohhnreeenoeunrombnbo-ettrohoxofifcrdtehoveesrfetolalenlvteoslwosivinegrcrtroihgteuemirireaeadantrvoeaemvleautle:uo(aft1et)hteAer>ted5sap0teac.%tirAveeddvuoecshteiicolnleveieclnointsthrceoolmn.seiAadnemriennduimtmobuxeimrcooifff
BioReliznce
p=
Study No. AAS2XK.502001.BTL
14
--
--
Company Sanitzed. Does not contain TSCA CBI
=
aHn-2I5n1d7e0p:enBdaecntterRieapleRaetveArssseayMutation Test with
DuPont.$867
raocvceormtpaannsipeedrbpylaanteaabrsucpotdmopsaer-eddetpoentdheenmtderaopnivnethhieclreecvoenttaonlcvoaulne.,(T2h)iAsrmeodduecrtaitoenemduuscttiboen PionsitthivbeaCcokngtrrooulnVdallaewsn(ibaicnkcglurdoeudnidncAopdpeeonfdi3x,A4.or 5.AcopyoftheHistorical Negativeand Archives
OpAerlatlinrgaPwrdocaead,ure aonytdhaelBliroepRolratsncweiRllAbQeAmuaiinttaeiandeqduaractceorreddiantg:tBiooRSetlanncdaer,d l1e4a5s2t0tBhrreoesycehaarrstRaofatde,wRhoicckhviillmee,tMheDS2p0o8n5s0o.rPewrilthbiseScOoPn,tapcatpeedrfeocrorddesciwsiillobnearsettaoitnhedefofirnaal dciosppoiseidtaionndtohft.hceompaytewriialllsb.eArleltasitnueddyimanttehreiaBlisorReetluirnaendcteoatrhcehiSvpeosnsfooroarmdienstirmouyemdowfil1l0fyiesatrbse, reUsniudsueadldtoestisnugbssotlauntcieownislwlebreddiissppoosseedodofffoflollolwoiwnignfginaaldimziantiisoniraoiftohne 0retphoret.tet systemandall Deviations
ofthiNsosktnuodywndeviationsfrom theprotocolor ssay-methodSOPsoccuredduringtheconduct
BSitouRdyelNaon.ceAAS2XKS02001BTL
1s-- -- Company Saiz. Doss not contain TSCA GBI
aHn-I2n5d1e7p0e:ndBeanctteRrieapleRaetvAesrssaeyMutation Test with
DuPont $867
RESANUDDILSCUTSSISON
Solubility Test.
targ`eTtecterlalbsyacraodfsuorlaunb(iTlHitFy)owfatshseetleescttseudbassttahncees.olTvheentteosftcshuobiscteabnacseewdoasnscoolmupabtliebbiultitcylwoiutdhytihen: tetrahydrofuran(THF)at amaximumconcentrationof approximately200mg/mL.
PreliminaryToxicity Test
wer"eTgheenreersaulttesdionfEtxhpeeprrielmiemnitnAaLry.tIonxtichietpyrteelsitmairnaerpyrteosxeinctietdytiensTtatbhleemsa1xtihmruoumgdho5s.eTthesetseeddwaatsa
p5l0a0t0inugaglpieqrupotl.aTthe;ettehsitssduobssetwanacseawcahsiaesvoelduubslienbgutaccloonucdenytsroaluttiioonnoaft220000mmgg//mmLLaannddasao2l5ubplLe.:
andclearsolution from 0.27 to 133 mg/mL. Dose 667, 1000,3333andS000 ugperplate.Precipitate
lweavseolsbsteesrtveeddwbeergein6n.i7n,g1a0,t6373,o6r7,101000u,g3p3e3r,
`plmaatex.iNmuomadpopsreepcliaatbeldeitnotxhiceimtyutwaagsenoibcsietyrvteesdt.wBaass5e0d0o0nutghpeerfipnladtien.gsofthetoxicity test,the
-
Mutagenicity Test
`Tab`lTehs2er6esaulntds 2o7ft.hTehmeusteagdeantiacwiteyrteegsetnareeraptreedsienatEexdipnerTiambelnetss6Bt1hraonudghB2.5 aDnodsseulmemvaelrsitzeesdtiend o`rwer1e51050,u5g0p,e1r5p0l,a5t0e.0N,o1a5p0p0reacnidablSe0t0o0xiucgiptyewrpalsaoteb.sePrrevceidp.itatewasobservedbeginningat500
In Experiment BI observedwithany ofth
t(eIsntiteirasltraMutaigenniitchietrythTeesptr),sennocepoorsaibtisveencmeuotfagSe9naicctirveastpioonn.ses
were.
`obsIenrvEexd pweirtihamennytofBth2e(tiensdteerpetrnadiennsit nReeptehearttTheesptr)e,sennocepoosriatbisveenmcuetoafgSe9naicctirveastpioonns.es were
CONCLUSION BacAtelrliaclriRteevreiarfsoerMuatvaatliiodnsTteusdty wwietrheamneItndaespdeensdcernitbReedipenatthAespsraotyoicnodli.caTlheethraets,uultnsdoefr tthhee. ``cpornedsietnicoeonsroafbtsheincsseolfyA,rHo-c25l1o70rd-idirnnaotdtlciuavecurseSe9d.apositivemutagenicresponseincither the
---
BioReliance Study No. AASZXK.502001 BTL
16 --
--
`CompanySanitized. Doesnotcontain TSCA CBI
-
H-25170; BacterialReverse Mutation Testwith
an Independent Repeat Assay
DuPont8867
REFERENCES
AmesM,utaBgNe,ns J.wMitchCatnhenaSnadlmEo.nYelalmaaMsaamkmial(i1a9n75)MMiectrohsoodmsefoMruDteatgeecnticiintgyCarTcesitn,ogMeuntsaatinodn Research,31:347-364.
GreeMnu,tMa.tiHo.nLR.easnedarWc.hJ3,8M:u3-r3i2.l(1976)Matagentestingusingtrp+reversion inEscherichiacol,
InteomfatPihoanramlaCcoenufteirceanlcsefoonrHHarummonainsaUtsieo.n(GIuCiHd)aonfceTeocnhnSipcaelcRiefqiuciArsepmeencttssfoofr RReeggiusltraattoiroyn o`fGetnhoetoIriCcHitpyTresotscofnoersJPuhlsayrm1a9c,e1u9t9i5c,aFlesd.eSr2aAldReogciusmteern6t1re:c1o8m1m9e8n-de1d8f2oA0prra2id,lop2t4i,o1n9a9t6s.cp 4
InteomfaPthiaornmaalcCeountfiecreanlcsfeoornHHaurmmaonnUissaet.ioGne(nIoCtoHx)iociftTye:chAniSctaalnRdeaqrduiBraetmteenrtysffoorrGReengoitsotxraitciiotny pTreoscteisnsgoonfPJhualryma1c6,eu1t9i9c7a.lFse.dSe2raBldRoecgiusmteenrt6r2e:1c6o0m2m6e-n1d6e03d0f,oNroadvoepmtbieorna2t1s,t1e9p974.oftheICH
-
Maron, DM. Mutation
and BN, Research,
Ames (1983) 113:173.215.
Revised
Methods
for
the
Salmonella
Mutagenicity
Test,
`OE1C0DtGhueidOeElCinDeGu4i7d1el(GienneestfiocrTtohxeiTceolsotgiyn:g BoafcCtheermiailcRaelvse,prusbelMiusthaetdibonyTOesEsC)D,N,iPnartihsA,dFdeebrnudaurmy 1998.
`Vog`ePlr,opHeJrt.iaesn,dJ.DBMio.l.BCohnenme.r,2(1189:596)7-A1c0e6.tslomithionafsEe. coi: Partial PurificationandSome
_
BioReliance
StudyNo. AAS2XK.5020B0TL1
1"
--
Company Sanitized. Dogs not cantain TSCA CBI
'H-25170: Bacterial Reverse Mutation Test with
a
t Assay
DuPont-8867
PBraecltiemriinaalryMuTtoaxticiiotnyTTeesstt
Table 1
STtesutdysuNbusmtbanecre 14:: AEA-S2I5X1K70.S02001.8TL
StBrpoariinzent No. :: AmLss
VDeahtieclPelated: t7etDercahy2d00r1ofuran
Plating Aliquot : 25 ul.
TCeosntcensturbasttiaonnce RevWeirtthan$t9s ActBiavcaktgiroonund
bg per plate per plate Lawn
Vehicle
1
1
RWeivtehrotuetnc5s9 AcBtaicvkagrtoiuonnd
por plate Lawn
2
1
160.7
95
11
25
11
3&3
1100
1we
1122
1we
--
130303 567
1197
mmpe
12
we
16s
wwee
5
me
10330303
1160
mmpe
110
mwee
5000
10
me
13
ne
BackgroLusnNdormLaalw;n C2o-dSelightly reduced; JsModerately reduced
4NPxeENxotnr-eImnatleyrfreerdiuncegd;preSc-iApbisteantte;; G=IOpb=sIcnutrerefdebriyngprepcriepciitpaitteate
-Bi--oReliance Study No. AAS2XK.502001.BTL
18 `Company Sanitized. Does not conTtSaCAiCBnI
'H-25170: Bacterial Reverse Mutation Test with o
DuPont. 8867
PrBealcitmeriinaalryMTuotxaitciiotnyTTeesstt
Table 2
TeSsttudySuNbusmtbaenrce 1d:: AHA-S2Z5X1K7.0S02001.8TL
StExrpaeirniment No. :: ATlai00
VDeahtieclPelated : 7teDtercany2a0r01oturan
Plating Aliquot : 25 ul
CTeosntcenSturbasttainocne RevWeirtthan5t9s AcBtiavcaktjiroonwnd
1g per plate
x plate Lawn
Vehicle
148
1
RWeivtehrotuatnts59 AcBtaicvkagtrioounnd
x plate Lawn
120
1
160.7
101221
11
11502
11
3@
113a4
1me
115309
1we
130303 s6
116470
mmee
136
we
113328
mwee
123
we
i
13030303
112143
mmep
115217
mwee
5000
105
me
12
we
BackgroLuenNdormLaalw;n C2o=dSelightly reduced; Jekoderately reduced
Ndp=eENxotnr-eImnetleyrrfeedruicnegd;preSceiApbisteantte;; 6=IOPbasIcnutrerefdebryingprperceicpiiptiattaete
BiorRelirance. `Study No. AAS2XK502001BTL
-- 19
`Company Sanilized. Does not contain TSCA CBI
H-25170: Bacterial Reverse Mutation Test with an Independent Repeat Assay
DuPont8867
PBraecltiemriinaalryMuTtoaxtiicointyTTesetst
Table 3
TeSsttudSyubNsutbaenrce 18:i AH-A2S5Z1X7K0.502001.5TL
stBerpaeirninent No. i aALsi
VDeahtieclPelated:5 7teDtercahy20d0r1ofuran
Plating Aliquot : 25 ub
CTeosntcensturbasttiaonnce RevWeirttahnt5s9 ActBiavcaktgiroonund
x plate + plate Lawn
Venicle
17
1
RWeivtehrotuatnt5s9 AcBtaicvkagrtoiuonnd
plate Lawn
12
1
59.)7 33
7s
11
1
i
012
11
10
1
1o00 333
1126
nnee
1
we
153
wwee
1
we
--
1066070
113
wwee
1113
wnee
3333
3
we
1
me
--S Bac0 kgr0 o1uenNodrmLaalw;n
C2o=dSelight1l2y
aw
0 19
reduced; IsModerately reduced
0
awe
N4e==ENxotnr-eImnetleyrfreerduicnegd;pre5c=iApbistenatt;e; GI=POablscnutreerdfebryingprperceicpiiptiattaete
DBiR oReliance miaeme--------
i----------
_
Study No. AAS2XK 502001BTL
2
`Company Sanitized. Does notconTtSaCAiCBnI
a'oH-25170: Bactetrial ReAvserssaeyMutation Test with
DuPont $867
PBraecltienriinaalryMTuotxaitciiotnyTeTsetst
Table
TeSsttudySuNbusmtbaenrce Id:i HA-A2S5Z1X7K0.502001.TL
StBroeariinnent No. 1i AmLis
VDeahtieclPelated i: t7ecDercahy20a0r1ofuran
Plating Aliquot : 25 pL
TCeosntcenSturbasttainocne RevWeircthan5t9s ActBiavcaktgiroonusd RWeivtehrotuatnts55 AcBtaicvkagtrioounnd
ug per plate Vehicle
per plate
Lawn 1
per plate Lawn
s
1
160.7 33
75
11
5
1
55
11
3
1
1&00 333
se
awee
2
we
7s
wwee
3
we
---
1056070
`3
wwee
`5
wwee
50330303
58
wwep
3s
awwee
Backgro1u=nNodrmLaalw;n C2o=dSel.ightly reduced; I-Moderately reduced
N4P=-ENxotnr-eInnetleyrfreerduicnegd;preSceiApbisteantte;; G-IOPbsaIcnutreerfdebriyngprperceicpiiptiattaete
BioR-- elianc-- e
--
Study No. AAS2XK502001.BTL
21
`CompanySanitized. Dosnot contain TSCA Cal
H-25170; Bacterial Reverse Mutation Test with
a
t
DuPont8867
PrBealcitmeriinaalryMuTtoaxticiiotnyTeTsetst
Table 5
STtesutdySNuubsmtbaenrce 14:: HA-A2S521X7K0.502001.BTL
StExrpaeirniment No. :LoAwle wen
VDeahtieclPelated 7teDtercah2y0d0r1ofuran
Plating Aliquot : 25 ul
TCeosntcensturbasttainocne RevWeirtthan5t9s ActBiavcaktgiroonund
_ugperplate Vehicle
porplate 16
L1awn
RWeivtehrotuatnt5s9
Activation Background
perpl1ate L1awn
160.7
11
11
1102
11
3a3
1102
w1 e
18
11
130303
312
wwee
165
wmee
--
1056070
1160
wwee
112
wwee
35030303
105
wmee
110
winee
Backgr-ouNnodrmLaalw;n C2o-d5elightly reduced; 3=Moderately reduced
N4P=E-xotnr-eImnetleyrfreerduicnegd;preSc=iApbisteantte;; 6I-pC=hIsncutreerdfebryinpgrperceicpiiptiattaete
oR StudyNo. AAS2XK 502001 BTL
2 Company Sanitized. Doesnotcontain TSCA CBI
'H-25170: Bacterial Reverse MutationTest with
a
Assay
'DuPont-8867
Bacterial Mutation Test
Table 6
TSotsutdySuNbusmtbaernce 1d:: HA-A2S5I1X7K0.502001.BTL Experiment No : BL
sLtirvaeirnMicrosones +: mNoense
CDealtlesPlSaeteedded :: 21.94DeXc102001
VPelahtiincgle Aliquot +: t25etrahydrofuran
C1gonpceerntprlaattieon NPulmabteer Rpoerverptlaanttes BacCkogdreound RAevveerratgaents DSetvainadtairodn
Venicle 0021
1100 11
03
10 1
0
15
002
112 11
03
12 1
15
1
s0
o012 1100 11
03
10 1
10
o
-
150
002
15 11
0
10 1
10
2
500
o021
1120 wnee
03
5 we
10
2
1500
0o21 1100 wwee
03
16 we
12
3
5000 o00312 n1u28 wwweee
un
2
Positive Control o2-1nitrofluor1e5n7e 1.0 yg1 per plate
02
78 1
--Ba_c--kground Lawn Code
36 3
ws on
41=eENoxrtmraelm;el2y=rSeldiugchetdl;y Sr-eAdbusceendt;; Is6M=oOdbesrcautreeldybyrepdruecceidpitate
NPeNon-Interfering precipitate; IPaInterfering precipitate
BioReliance
StudyNo. AAS2XK.502B00T1L
2
Company Sanitized. Doosnotcontain TSCA CBI
'H-25170; Bacterial Reverse Mutation Test with
=
Assay
DuPont-8867
Bacterial Mutation Test
Table 7
STetsutd.ysuNbusmtbaernce 1d:+ AH-A2S521X7K0.502001.BTL Experiment No : BI
StLirvaeirnMicrosomes +: mRastsliver S9
DCealtlesPSleateedded :: 125.4DXec102001
VPelhaitcilneg Aliquot :+ 2t5eturoahydrofuran
uCeoncentraltaiteon NPulmabteer pRoervertplaanttes BacCkogdreound _RAevveerratgaents SDteavnidaatridon
Vehicle 0012 1160 11
0
21
16
7
15
0012
11 11
0
13 1
15
2
50
0012
112 11
03
18 1
16
3
-
150
o021 110 11
0
11
1
1
500
o012
120 awvee
03
12 we
15
1500
0012
11 wwee
0
15 we
1
1
5000
o02 1n6 mwee
03
1 we
1
2
Positive Control 2o-1amincanth4r6a7cens 1.01ug per plate
0023
6028 11
rr
3
Backgro1u-nNdormLaalw;n C2o-dSelightly reduced; J=oderately reduced
N4p=eBtxotnr-eImnetleyrfreerdiucnegd;preSc=iApbisteantt;e; 6I=PO=bIscnutreerdfebryinpgrepcriepciitpaitteate
BioReliance
_
Study No. AAS2XK502001 BTL
%
Company Sanitized. Does not contain TSCA CBI
H-25170: Bacterial Reverse Mutation Test with
Py
Assay
DuPont-8867
Bacterial Mutation Test
Table 8
Test Substance Id: H-25170
stStruadiynNumber
: TAAALS020XK.502001.BTL
CEexlplesrimSeenetdeNdo
: :
BL 4.1
X
10%
vLeihviecrleMicrosomes : Ntoenterahydrofuran Date Plated : 19 Dec 2001
Plating Aliquot : 25 yl
Concentration ug per plate
Plate Number
Revertants per plate
Background Code
Average Revertants
Standard Deviation
vehicle 01
160
1
o03z 15604
1 1
159
5
15
0
187
1
0023
115401
1 1
159
2
50
0021 161420 11
03
48
1
150
n
-
150
or
146
1
o0z
112484
1 1
139
10
500
002
156 133
we we
0
161
we
143
12
1500
0021
68 151
we we
0
15
we
124
5000
o0z1
119533
mmee
0
153
we
166
2
Positive Control so01dium azid4e911.0 ug pe1r plate
--_--
8 0023 6 550136 3 11
s5s 03 0on13
Backgro1u-nNodrmLaalw;n 2Co=dSelightly reduced; 3eModerately reduced
NEPx-tlNroenm-eInltyerrfeedruicnegd;preSc=iApbisteantte;; 6I=POsbIsnctuerrefderbiyngprperceicpiiptiattaete
BiRoRebliance
_
Study No. AAS2XK502001 BTL
2
Company Sanitized. Does not contain TSCA CBI
H-25170: Bacterial Reverse Mutation Test with
a
Assay
DuPont:8867
Bacterial Mutation Test
Table 5
TSetsutd.ysNuubmsbtearnce 1a:|: AB-M2S5I1X7K0.S0001.TL Biperiment No : BL
Lsitvraetr Microsones + 1Ra0t 0liver 59
Vehicle
tetrahydrofuran
CDoaltelePSleaedceedd:: 419.1Dec102001
Plating Aliquot : 25 ul
Concexntrapltaitoen NPulmabteer Revertlaatnet's BacCkogdreound RAevveerratgaents SDetvainadtairodn
Venicle aa2 113663 11
a 191 1
163
2
15
o0n 118605 11
0 167 1
m
s
50
o02 16 11
0 160 1
151
2
-
150
a02 162305 i1
03 165 1
189
s00
0o 118513 wwee
0 16 we
166
1
1500
0on 181573 wwee
0 me
176
2
s000
o0r
1m9n6 mwee
0 165 we
wr
16
Positive Control 2o-raminoanthr7a63cene 1.0+ug per plate
20 s2s 1i
es
126
Backgro1euNnodrmLaalv;a C2osdSe1ightly eBxtrenely reduced;
SreeAdbuvceendt;;
3G=xNOobdaecruarteedlybyrepdruecceidpitate
Neston:Interfering precipitate; P-Interfering precipitate
_
StBiuodRyelNioa.ncAeASZXK502001 BTL
2
Company Saritized. Doesnot contTSaCAiCBnI
'H-25170; Bacterial Reverse Mutation Test with
o
t
DuPont-8867
Bacterial Mutation Test
Table 10
TSetsutdysNuubmsbtearnce 1d: HA-A2S5Z1X7K0.502001.BTL Experiment No : Bl
LsitvrearinMicrosomes :+ NTAoLnSe3S
DCaotlelsPSleaedteedd:: 125.7DeXc102001
vehicle
: tetrahydrofuran
E eConE e centrm atN iom n m PLlaItm eE m Revere tantm s Br ackge rounr d Ae verae ge gSte andae rd --
or plate Number per plate Code Revertants Deviation
Vehicle
0012
11s2 11
03
31
15
2
15 o00a32 1r108t 111 1
50
0021 1102 11
--
0
12 1
n
1
150
002 115u 11
03
u1
12
2
500
0021
1100 wwee
0
8
ee
s
1
1500
o012
1102 wwee
03
12 we
u
1
5000
0021
112 mmee
03
13 we
Bn
1
Positive Control so01dium azi2de971.0 ug pe1r plate
0032
233102 11
260
a
Backgro1u-nNodrmLaalw;n C2o-dSelightly reduced; I=Moderately reduced
NdPseENxotnr-aImnetleyrrfeedruicnegd;preSciApbisteantte;; =IOpbssIcnutreerdfebryinpgrperceicpiiptiattaete
BioReliance
StudyNo. AAS2XK502001 BTL
27
Company Sanitized. Does not contain TSCA CBI
H-25170; Bacterial Reverse Mutation Test with
a
Assay
DuPont-8867
Bacterial Mutation Test
Table 11
TSetsutdysWuubrsbtearnce Id:: AHA-S2Z5I1K7.0S0J00L.BTL Experiment No : BL
stLrivaeirnMicrosomes :+ RTaatIS3lsiver 59
DCoaltleaPSleateedded :: 129.7Dexc102001
VPleahtiicnlge Aliquot :: 2t5eturlahyarofuran
Cugopnceerntrapltaitoen NPulmabteer Revperertplaanttes BackCogdreound RAevveerratgaents DSetvainadtairodn
Venicle 0021
55 11
0
31
10
2
15
002
125 11
0
10 1
10
2
0
0021
15 11
---
03
12 1
12
3
150
012
125 11
0
51
s
s
00
002
2100 mmee
03
1s
ee
16
3
1500
0021
u5 mmpe
0
5 we
s
3
000
0o2u
1s mwee
03
12 we
10
5
Positive Control o2-1aminoant1hr2a1cene 1.01ug per plate
0032 1285 11
mn
2
Backgro1u-nNodrmLaalw;n C2o-dSelightly d=Extrenely reduced;
rSe=dAubcseedn;t; 3=6MeoOdbescruarteedlybyrepdruecceidpitate
NPeNon-Interfering precipitate; IPsInterfering precipitate
BioReliance
StudyNo. AAS2XK.502B0T0L1
2
`CompanySanitized. Doesnot contain TSCA CBI
H-25170; BacterialReverseMutation Test with
m
Assay
'DuPont-8867
Bacterial Mutation Test
Table 12
TSetsutdySNuubrsbtearnce 14:+ HA-A2S521X7K0.S02001.BTL Experiment No : BL
stLirvaeirnMicrosomes : NTMoinse y
DCealtlesPSleaetdeded :: 119.6DeXc102001
VPelhaitcilneg Aliquot :+ 2t5etwruanyaroturan
uCgoncenpertrapltaitoen NPulmabteer Revperertplaanttes BacCkogdreound RAevveerratgaents DSetvainadtaridon
Vehicle 0021
s2 11
0
s1
`
2
15
0021
25 11
0
`1
`
2
s0
002
38 11
-
03
s1
5
3
150
002
53 11
0
31
.
2
500
0012
`5 wwee
03
6 we
5
1
1500
0012
87 wmee
0
` we
6
2
sa00
002
53 wwee
0
5 we
5
2
Positive Control S-01aminoacrid5i05ne 75 ug1per plate
002
8o7s 21
602
126
Backgro1u-nNodrmLaalw;n C2o-dSelightly reduced; J=Noderately reduced
4NPeeBNxotnr-eImnetleyrfreerduicnegd;preSceiApbisteantte;; 6=IOPb-sIcnutreerfdebryinpgrperceicpiiptiattaete
B-i--oReliance
_
StudyNo. AAS2XK.5020B0TL1
29
`CompanySanitized. Doesnot contain TSCACBI
H-25170; Bacterial Reverse Mutation Test with an at Assay
DuPont-8867
Bacterial Mutation Test
Table 13
TSetsutdySWuubmsbtearnce Id:: KM-S225X1K7.0S02001.BTL Experiment No : BL
stLriavienr Microsomes :+ Rmaatsal?iver 9
DCealtlesPSleaedteedd:: 119.6DeXc102001
VePlhaitcilneg Aliquot : t25eturiahydrofuran
uCgonpceerntrpalattieon NPulmabteer pReerveprltaatntes BacCkogdreound RAevveerratgaents DSetvainadtairodn
Vehicle o012
53 11
03
51
5
3
15
0021
125 11
03
71
a
3
50
0012
`5 11
---
03
51
s
1
150
002
105 11
0
51
7
3
500
002
s$ wwee
03
5 we
5
2
1500
o012
0
55 wwee 2 me
6
1
5000
0012
55 mmee
0
5 we
5
2
Positive Control 2o-1amincant1hr0a0cene 1.01jg per plate
0I2
9866 11
5
8
Backgr1oeuNnodrmLaalw;n C2o-dSelightly reduced; 3=Noderately reduced
Ne4a=Elxotnr-eImnetleyrfreerduicnegd;preSceiApbisteantte;; G=IOpb=sIcnutreerdfobriyngprperceicpiiptiattaete
-B_i--oReliance
Study No. AAS2XK502001 BTL
30
`Company Sanitized. Doesnotcontain TSCA C81
aHn-I2n5d1e7p0e:nBdaecntteRrieapleRaetvAesrssaeyMutaTtesitwoitnh
DuPont-8867
Bacterial Mutation Test
Table 14
TSetsutdySNuubssbtearnce 14:: ABA-S2O5X1K70.S02001.BTL Experiment No : BL
stLirvaeirnMicrosomes :: WNozneuven
DCealtlesPSleaetdeded :: 1191.2DecX 120001
VPelahtiincgle Aliquos :: 2c5ecryainyasoturan
uCgonpceerntprlaattieon NPulmabteer pRoerverptlaanttes BacCkogdreound RAevveerrtaagnets DSetvainadtairodn
Vehicle 0021 105 11
03
31
5
3
15
o02
1100 11
03
10 1
10
o
50
o02
1122 11
03
12 1
12
o
150
002
irnl 11
0 12 1
5
1
500
o0n2
112 wwee
03
12 we
2
o
1500
0o12 1105 wwee
03
15 me
12
2
s000
0o21
11" mmee
03 be] we
1
3
Positive Control me0thyl met1ha1n3esulfonat1e 1000 ug per plate
--
o0o023 0m97% 3 11 sess a 18
Backgro1u=nNdormLaalw;n 2Co=dSelightly reduced; JModerately reduced
N4P=-BNxotnr-eImnetlery freerdiuncged;preSceiApbisteantte;; GI=PO-bIsnctuerrefdebriyngprepcriepciitpaitteate
BioReliance
Study No. AAS2XK.502001.BTL
3
Company Sanitized. Doss not contain TSCA Cal
'H-25170:BacterialReverse MutationTestwith
a
atAssay
`DuPont-8867
Bacterial Mutation Test
Table 15
TSetsutdysNuubmsbtearnce Id:: HA-A2S5I1X7X0.502001.3TL
StLirvaeirnMicrosomes : WRea2t luvievner 59
Venicle
+ tetranyarofuran
ECexlplesriSmeeendtedNo :: B1L1.2 X 10 Date Plated : 19 Dec 2001
Cbgoncenpertrpalattieon Vehicle
NPulmabteer Revperertpalanttes BacCkogdreoun_d ReAvveerrtaagnets DSetvainadtairodn
00012 111006 111
12
3
15
o0a2
12 11
03
10 1
n
1
0
002 1u0n 11
-
03
10 1
10
1
150
0012 1100 11
03
10 1
10
500
0012
u1 mwee
03
1B we
3
2
1500
002
105 wmee
03
Bn me
5
`
5000
o012
n1w wwee
03
1 we
15
2
Positive Control 2-oa1minoanthr7a13cens 10 y1g per plate
0032
a4230 11
sis
mn
BackgroLueNnodrmLaalw;n C2o-dSelightly reduced; J=Moderately reduced
Np4e=Etxotnr-eImnetleyrfreerduicnegd;preSceiApbistenatt;e; 6I=pO=bIsnctuerrefderbiyngprapcriepciitpaitteate
BioReliance
_
Study No. AAS2XK.5020B0T1L
2
CompanySanitized. Doesnotcontain TSCA CBI
F-25170: Bacterial Reverse Mutation Test with
am
Assa
DuPont:8867
Bacterial Mutation Test
Table 16
TSetsutdySNuubrsbtearnce 1d:: AHS-2I5N1K7.0502001.BTL
sLtirvaeirnMicrosomes :+ mNosnse
vehicle
+ tetrahyaroturan
CEexlpleariSmeenetdeNod:: 2B2.7 X 10 Date Plated: 4 Jan 2002
uCgonpcoerntrapltaitoen Vehicle
NPulsahteer Revperertplaanttes bacCkogdreound
o0r2
21 11
03 1s :
RAovveerratgaents DSetvainadtairodn
1
.
1
002
15 11
03
20 1
16
5
---
0
0012
17 1i
03
5:
12
s
150
o02n 105 11
03 10 1
1
1
soo
o0r 1u0 zwpe
0
s axe
12
s
1500
o0n
2s wnpp
0
5 we
s
3
s000
002
n` 1ipe
0
5 fe
5
3
Positive Control o2-1nitrofluor2e67ns 1.0 ug1 per plate
0032 2289 1i
a3
20
BackgrIonuNnodrnLaalw;n C2o-dSe1ightly reduced; IsModerately reduced
NAe=exNtorne-nIenltyerfraerdiuncegd;preSceiApbiateantt;e; GIOPbsaIcnutreerdfobryinpgrperceicpiiptiattaete
_
SBtiuodRyelNioa.nceAASZXK.5020B0T1L
3
`CompanySanitized. Does not contain TSCA Cal
'H-25170: Bacterial Reverse Mutation Test with
an In
Assay
DuPont-8867
Bacterial Mutation Test
Table 17
TSetsutdysNuubmsbtearnce Td:: AA-S2I5X1K70.502001.BTL Experiment No : 52
stLrivaeirn Microsomes +: TRaa%t8liver 9
CDealtlesPSleaetdeedd :: 24.J7anX 120002
VPleahtiincgle Aliquot :+ 2t5eturiahydrofuran
Cbogncpeenrtrpaltaiteon NPulmabteer pReovrerptlaanttes BacCkogdreound _RAevveerracgaents DSteavnidaatridon
Venicle 0012
22 11
03
25 1
2
2
15
o02
218 11
03
18 1
i)
5
50
0o2
2203 11
--
03
26 1
2
3
150
0021
1250 11
03
15 1
n
3
500
0o2 1n6 wwee
0
26 we
20
6
1500
0021
216 1r1e2
0
25 112
2
7
5000
0o21 1n6u wree
03
2 re
1
`
Positive Control 2-01aninoanth10r1a1cens 1.01ug per plate
0032 1096765 11
101
36
Backgr1oeuNnodrmLaalw;n C2o-dSelightly 4=Extremely reduced;
rS=eAdbusceendt:; 3s6M=oOdbesrcuarteedlybyrepdruecceidpitate
NPaNon-Interfering precipitate; IpsInterfering precipitate
BioReliance
Study No. AAS2XK502001 BTL
34
`Company Sanitized. Does not contTaSiCnA CEI
'H-25170: Bacterial Reverse Mutation Test with
a
Assay
DuPont-8867
Bacterial Mutation Test
Table 18
TSetsutdySNuubmsbtearnce Id:: HA-A2S5Z1X7K0.50J001.BTL Experiment No : 82
stLirvaeirnMicrosomes:+ TNTMoAn1e00
CDealtlesPSleaetedded :: 14.1JaXn 120002
VePlhaiticnlge Aliquot : c25eturbanyarofuran
C9oncpeerntprlaattieon
NPulmabteer
pReerveprltaatnets
bacCkogdreound
_RAevveerratgaents
Standard Deviation
Vehicle o012
12971 11
03
17
1
196
2
1s
a02
118828 11
0
15 1
182
7
s0
0021 118866 11
--
03
200 1
150
5
150
0012 116500 11
03
197 1
180
n
500
002 1a63 wwee
0 163 we
180
2
1500
o012
127185 mmee
03
176 we
150
22
5000
0021
118813 wwee
03
195
we
186
5
Positive Control s0o1dium azide7601.0 ug pe1r plate
002
77755 11
am
5
Backgr1ouenodrmLaalw;n C2o-dSelightly reduced; J=Koderately reduced
NdP=eExotnr-eImnetleyrfreerdiuncegd;preSc=iApbisteantte;; 6=IOPbasIcnutrerefdebriyngprperceicpiiptiattaete
BioReliance
_
Study No. AAS2XK.502001.BTL
35
Company Sanitized. Does not contain TSCA CBI
H-25170: Bacterial Reverse Mutation Test with `anIndependent Assa
DuPont-8867
Bacterial Mutation Test
Table 15
TSetsutdysNuubmsbtearnce Id: HA-N2S5I1X7X0.S02001.BTL Experiment No : B2
SLtirvaeirnMicrosomes :+ RAa2t00liver S9
CDaetlelsPSleaedteedd:: 41.J1aXn 210002
VPleahtiicnlge Aliquot :: 2t5etpriahydrofuran
Concentration ug per plate
NPulmabteer Rpeerverptlaanttes BackCgodraound RAevveerratgaents DSetvainadtairodn
Vehicle 0021 126030 11
03 199 1
108
2n
15
002 128050 11
5 183 1
191
12
50
oo1z
116726 11
---
03 208 1
189
wv
150
0021
115612 11
03 165 1
159
7
500
0021
1219 wmee
03 166 1
189
29
1500
0012 11993 wmee
03 166 we
185
n
5000
0o2 181592 mmee
0 200 we
195
5
Positive Control o2-1aminoanthr5a07cene 1.01ug per plate
02 1002 1
--Bac-- kground Lawn C9 ode ee 1
ss ss
i4e=NEoxrtmraelm;ely2-Sreldiugchetdl;y Sre=dAubcseedn;t; IGseMOobdsecrautreeldybyrepdruecceidpitate
NPeNon-Interfering precipitate; IPsInterfering precipitate
_
BioReliance.
StudyNo. AAS2XK.502001.BTL
36
`Company Sanitized. Does not contain TSCA CBI
aHm-25170; BactetRrieapleRaetveArsssaeyMutation Test with
DuPont-8867
Bacterial Mutation Test
Table 20
TSetsutdysNuubmsbtearnce 1d: AHM-2S521K7K0.SO00LBTL Experiment No : B2
sLitvrearinMicrosomes +: TNaoLnse3s
CDealtelsPSleaotedded :: 24.6JaXn 120002
vePlhaciicngle Aliquot : 2t5etraubhydrofuran
Cuogncenpertrapltaitoen NPulmabteer Revporertplaanttee BackCgordoeund RAevveerratgaents DSetvainadtaridon
Vehicle o0n 1188 1i
03
11
1
1
o0 1200 11
11
1
`
s0
a02
22 :i
---
0 1s I
20
`
150
0a2
112 11
03
11
1s
`
500
002 220 wmee
o
23
2
1500
a2 p1e 1wpe
o
1 we
16
3
5000
00 116 11px
0
1 im
16
2
Positive Control so0dium azide"201.0 uy pe1r plate
o032 w08e 11
ar
a
BackgroIunnodrmLaalw;n c2o-tSelightly -Bxtremaly reduced;
reduced-- ; IoModesately reduced SeAbaent; GeObacurad by precipitate
NP-Non-Intarfering precipitate; 1PeInterfering precipitate
_
SBtiuodReylNioa.ncAeAS2XK502001 BTL 3
--
Company Sanitized. Does notcontain TSCA CBI
H-25170; Bacterial Reverse Mutation Test with an Independent Repeat Assay
'DuPont-8867
Bacterial Mutation Test
Table 21
TSetsutdysNuubmsbtearnce Ia:: AHA-S2I5X17K0.502001.BTL Experiment No : B2
StLrivaeirn Microsomes :+ RTAaItS3lSi.ver 59
Vehicle
tetrahydrofuran
DCealtlesPlSaeteedded :: 24.6JanX 120002
Plating Aliquot : 25 wb
Cugonpceenrtprlaattieon NPulmabteer pReerverptlaanttes BacCkogdreound RAevveerratgaents DSetvainadtairodn
Vehicle 0o21
112 11
03
i) 1
15
3
1
0012
119 11
03
n1
1m
3
s0
0o2 1260 11
--
0
n1
16
5
150
002
113 11
03
10 1
12
2
s00
002
205 wwee
03
1 we
1
6
1500
0021 1185 1w1e2
03
15 we
16
2
5000
002
1Bs 11pp
0
un re
10
Positive Control o2-1aminoant1hr6a8cene 1.02pg per plate
-- 9 0032 115m%83 1 11 a1666 88
BackgroLusnNodrmLaalw;n C2o=dSel.ightly d=Extremely reduced;
rSe-dAubcseedn;t; IsGM=oOdbesrcuarteedlybyrepdruecceidpitate
-_-- NPslon-Interfering precipitate; IpaInterfering precipitate
BioReliance
Study No. AAS2XK 502001 BTL
38
Company Sanitized. Dos notcontTSaCAiCBnI
H-25170; Bacterial Reverse Mutation Test with
a
Assay
DuPont-8867
Bacterial Mutation Test
Table 22
TSetsutdySNuubmsbtearnce Id:: HA-A2S5I1X7X0.S02001.BTL Experiment No : B2
StLirvaeirnMicrosones : mNao1nse37
DCoaltlesPSleaetdeded :: 41.3JanX 210002
VPelhatiicnlge Aliquot :+ 2t5etranyarofuran
Concenxtrapltaitoen PNulmabteer peRervertplaanttes BacCkogdreound _RAevveerratgaents DSetvainadtairodn
Vehicle 0021
s5 11
0
51
5
2
15
002
75 11
03
51
5
1
s0
0o21
103 11
--
0
81
7
150
0on
105 11
03
:1
6
3
500
002
57 uizpe
03
3 we
5
2
1500
0o21
Is awree
03
1
6
3
5000
002
33 rwee
03
2 we
3
1
Positive Control o9-1aninoacri6d9i6ne 75 ug1per plate
------
00032 965%2596 1 11 v6e0 a1m73
BackgroIunnNodrmLaalw;n C2o=dSelightly 4=Extremely reduced;
rSe=dAubcseedn;t;
3s6M=oOdbesrcautreeldybyrepdruecceidpitate
Neslon-Interfering precipitate; Ip=Interfering precipitate
-- BioRelianc_ e --------
Study No. AAS2XK502001.BTL
3
Company Sanitized.Doesnot conTtSaCAiCBnI
H-25170; Bacterial ReverseMutation Test with
a
Assa
DuPont-8867
Bacterial Mutation Test
Taste 23
TSetsutdysNuubrsbtearnce 1d:+ HM-S2J5I1K7.0S02001.BFL Experiment No : 52
sLtirvaeirnMicrosomes :+ Raaitsl3iver 59
CDaatlelsPSleateedded :: 41.J3anx 120002
VPelahtiincgle Aliquot : 2t5etrahydrofuran
Concen:trapltaitoen HPluabteer Revertlaanttes BacCkogdroeund RAevveerratgaents DSetvainadtairodn
Vehicle o0n2
s5 11
03
10 1
5
1
1
002
23 11
0 10 1
5
`
0
002
8` 11
-
03
11
`
`
150
0012 10s 11
03
u1
5
3
s00
o02
32 wwee
0
5 we
5
`
1500
oozu
87 wree
03
5 re
5000
0021
55 w1ep
0
3 we
1
5
3
Positive Control 2-oraminoant2hr1a6cene 1.01ug per plate
o032 171138 11
169
52
Backgr1o-uNnodrmLaalw;n C2o-dSelightly reduced; SsModerately reduced
N4Po-BNxotnr-eImnotleyrfreerduicnegd;pre5ceiApbiateantt;e; 6=IaPbsaIcnutreerfdebryingprepcriepciitpaitteate
BioReliance
--
Study No. AASZXK.502001BTL
40
`CompanySanitized. Doasnot containTSCA CBI
'H-25170: Bacterial Reverse Mutation Test with anIndependentRepeatAssay
`DuPont8867
Bacterial Mutation Test
Table 20
TSetsutdySNuubmsbtearnce 1d: M#A2S5Z1X7K0.S02001.BTL Experiment No : 52
LseirvaeirnMicrosomes : WNoeneuvia
DCaetlelsPSleaedteedd:: 24.5daXn 210002
vePhlaitcilneg Aliquot:+ 2t5eturla.nyaroturan
Cuogncpeerntrpaltaitoen NPulmabteer Rpeevrerptlaanttes BackCgordeound RAevveerrtaagnets SDetvainadtairodn
Venicle 002 10s 11
03 12 i
10
2
5
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11 11
0
Bn 1
1
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2
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Table 25
TSetsutdySNuubssbtearnce 1d: ABA-S2I5X1K70.S02001.BTL Experiment Xo : B2
StLriavienr Microsomes : WReaat wliaver 59
DCealtlesPSleaetdeedd :: 42.J5aXn 210002
VPelhaitcilneg Aliquot :+ 2t5etrualnyarofuran
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Venicle o02n
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5000
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5 we
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.
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0032 1464 11
993
161
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Bac`tSeurmimaarly MouftaRteisounltTsest
Table 26
TSetsutdySNuubmsbtearnce 1d : AK-A2S5I1X7K0.502001.TL Experiment No : BL Liver MicrosomAevse:ragNeonReevertants Per Plate + Standard Deviation
Dose (ug/plate) TASS TAI
Ve15hicle
LToss 10 1195:92:65
15050
010:s 2011091s1%0
1550000
1102:s 032 1M23616:2
P5o0s0i0tive
1m75s+ 232 15063:62:133
Liver Microsomes: Rat liver 59
TAISIS 1134+: &2 112:: 21 19:: 11 21030++ 441
TAISYT 66:: 22 45:: 23 56:: 21 6952:21262
Wea uve 1103%: 03 11B2:: 10 1122:: 02 1985:: 183
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-
1V5enicle
T1e5:+ 72 11613:: 298 1100+% 22 682: 33 112:: 31
15500
1168ss 31 11581914::20 182:: &3 75:: 31 1100:: 01
1550000
115s+ 8111766612:+5 196:+ 33 66:2 21 193:: a2
P5o0s0i0tive
41466++ 332 167577+212186 1110++ 235 s6e:s 28 S1155:ean2
VPeohsiictlivee==VePnoiscilteiveConCotnrtorlol
Plating aliquot: 25 ub
BioReliance
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StudyNo. AAS2XK.5020B0TL1
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Table 27
STtuedyst SWuubmsbtearnce 1d :+ AHA-S225X1K7.0502001.57L
nent No : B2
Liver MicrosomAevse:ragNeonReevertants Per Plate + Standard Deviation
Dose (ug/platel TASS TALOD TAISIS
Vehicle
19: 1942s 18: 0
TAISYT We2 uve 6: 2 10: 2
1505 150
1162++ 65 1102:: 73 1260:: 64 10+ 1 182: 15: 4
76:: 1& 1124:: 14 62 3 2: 8
5150000 5000
152:+ 05311908: :3222 2136+: 43 9+ 3 16: 8 16: 2
56S+: 23 1130:: 44 3: 1 10: 2
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-~
Dose (ug/plate) TASS TAI00 mA1sIS_
V1e5hicle
12690e: 25 11898:: 1221 115:: 33
TAISI? we2 wva 995:s 14 170:: 32
s1500 500
27+s 3311598:91:77 1162:: 52 20: 6 19: 25 10: 6
a5s: &3 110:: 20 5+ 4 11: 3
15500000
2129:: 74 119855:: 178 1160::
Posittiivvee ___ l1o0l1i1+ 3366 999938+: 689 116666::
42 86:: 31 1142:: 34 88 11669++5522 99939:+13611
VPeohsiictlieve==VePhoiscilteiveConCtornotlrol
Plating aliquot: 25 ul.
B-i--o_R--eliance StudyNo. AAS2XK.5020B0T1L
7 `CompanySanitized. Doesnot conTtSaCAiCBnI
H-25170: Bacterial Reverse Mutation Test with
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APPENDIX A Historical Control Data
BioReliance Study No. AAS2XK.5020B0T1L
as Company Sanitized. Does not contain TSCA CBI
H-25170:BacterialReverseMutation Test with an Independent Repeat Assay
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HistoricalNegative andPositiveControl Values 1998 --2000
revertants per plate
soi
eT me |
TA%S
7.
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322 56
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LAB
568
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1371
736
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Neg=negati
ethanol and
ve control
acetone);
Pos=positive control
BioReliance
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Study No. AA52XK.502001. BTL
46
H-25170: Bacterial Reverse Mutation Test with an Independent Repeat Assay
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APPENDIX B Study Protocol
_
BSitouRdyelNao.ncAeAS2XK502001 BTL
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[)BIORELIANCE
BioRelance
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Study No. AAS2XK.502001.BTL
55
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BIORELIANCE
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Study No. AAS2XK502001. BTL
56
Company Sanitized. Doesnot conTtSaCAiCBnI
H-25170:BacterialReverse MutationTest with
nlodepend~~entRepeatADus ponstss ss)y
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BioReSllyiNnumcbeer: _AASIXKS001 BTL
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@ BioReuance
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BSitRuedylNaon.cAeAS2XK502001 BTL
57
CompanySaritizad. Doss notcontainTSCA CBI
'H-25170: BacterialReverse MutaTtesitwointh am
DuPont-8867
10 AreROVAL
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StudyNo. AAS2XK.5020B0T1L
58
Company Saniized. Does not contain TSCA CBI
H-25170;BacterialReverse MutationTestwith
a
t Repeat
DuPont8867
APPENDICX InffoorJarpanemse Raegultatoiry Agoencnies
_
StBiuodRyelNioa.ncAeAS2XK502001 BTL
E)
CompanySanitized. Doesnotcontain TSCA C81
2an5170:IBndaepcentdeentrRiepaeatl ReveArssseaMutation Test with
DuPont-8867
ReportofResultsofReverse-MutatTieosnt in Bacteria
1. Tester Strains
1) Procurement. Obtainedfrom Dateobtained
tDhaetsetainisnpelcotteidn storage
TAI
a a ;
11 August 1
tans brs Suiy
- ne We2 uA NaotfioInndaulstCroilalleactnidon| by 00
(@kMIO1)
Marine Bacteria
Wrz kuin) | Aberdeen,Scotland Tgpoor 1993
mansrch confdiramoefdwyoen the
@ Storag
Composit
DMso
oval
21.) 5S9oMuricxe, Storage Temperature, et.of59
[vem | Prepared on
17 October 2001 (Batch R654)
26 November2001 (Batch R656)
Name 1d mol of
_
SBtiuodReylNioa.nceAASZXK.5020B0T1L
Company Santzed. Doss not contin TSCA GBI
He25170; Bacterial Reverse Mataion Tes with
an
Assay
DuPont-8867
CC Tow T | mom]
(2) Preparationof $9
Speci+eo s, Straisuin| Rattus normveegigcuss, Sprague
Inducing substance
EE FE
Age(iinweeks) 98 (BBaattcchhRR665564)) Sminiuihangsai raton wt | 38,05 gig
a
181 (0 19(Ba8ch R64)|(kgweighty
eight
18710271 g(Batch R656)
body weight
a.
Cee e [wn 3, PreparationofTestSubstance Solution
Grade and/or
Tetrahydrofuran (CAS No. 109-999)
`Aldrich Chemical `Company
10035281
Gold Label, 99.9%
`tShteabsiollivtyenotftest substance in Method of suspension when
test substanceisdifficult to dissolve
Notapplicable
_
BoRemee
Study No. AAS2XK.5020BT0L1
61
GompanySanitzed. Dos not conTtSaCAiCBnI
aH0-2I5n1d7e0p:enBdaecntetrRiealpeRaetveArssseayMutation Test with
DuPoni-8867
4. Conditions of Pre-culture
[ oembon [N |we ater[Le oto |
Oxoid Nutient . CH.B232622
I 1241 bows
`iStnoraogectiumetolabneadgittnenmiipn.ogfonrfom | 2t0 5hoursatambieattemperature
shaking culture
EF Are Storage time and temp. from
"
Model and manufacturoefr | Ney, Brunswick Scientific, model G-24
M(Gehtahiondgotfypseh,aksipnegd, ie) _|FO 21255 rmeviin.)
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bCiultudre vessel (shape, shape: cyli:nder, 200 mL.
[voume [reo vonytinosti7m]
5. Agar Plate Medium
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Made in-house: Ase
[Name [ems [Ma | i econr Dickine on |
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DuPont 8867
Reason forjudgement and referential matters: NaobspeonscietoifveArreoscploonrs-einwdauscoebdsreartvleidvewriSt9h.anyofthetesterstrainsin thepresenceand Referential matters "`Tchoerrveechtilyclaenadnwdeproesictaipvaebcloeontfrdoeltevcaltuiensginadmiuctaatgeetnh.atalltester trainswerefunctioning.
_
BioReliance
---
Study No. AAS2XK 502001. BTL
6
Company Sanitized. Doss not contain TSCA CBI