Document GKLDeoZgqKw8n4rVb1pZVgMdx
DuPont EMSE Report No. 92:02
Study Tide
AFUQNUCETOIUOSN SOTFAPBIHLITY OF 8-2 TELOMER B ALCOHOL AS A OCTheEesCntiDGcua(il1ds9e8Ml1ei)tnheHoyddro11l1y,saidsoapstedFu12t-oMany-o1f9i8.1 OECD Guideline for the Testing of AWuitlhioarm R_ Bert, Ph. 2S7tMuadrycChom2p0l0e3tion Date.
CETeLestdnuFaPcRoineltisdteeaseNe&hmoDuervselaonpdmCeonmtpany Corporate Canefo Engineering Resarch GlNEaenwvsiagrrookn,wmeDunEitkad1li9an7ng1d434M01i0c,0r17o.bU0i.oSlABoogixca6l10S1ciences &Engineering. ad EHNaLeswkdaelurlPkoLDnabtEodr1ea9tN7o1er4myofUuoSrrAsHeaanldthCaonmdpaEnnvyironmental Sconces
STTehpleoonRmseaonnrsd RCeosrepaorrcahtiPornogram A1v2l0i0ngSoonu,thVHAaye2s22S02etUSA ETOM0S6E S4t8u4d2y / ProjectNumber
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Teme
Farent 000033
DuPont EMSE Report No. 92-02 PAGE RESERVED FOR SPECIFIC COUNTRY REQUIREMENTS
went
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DuPont EMSE Report No. 92-02
`CERTIFICATION OF AUTHENTICITY
We tho ieigut esr ot ego dsl prt vs gators ane at AQUEOUS STABILITY OF 8-2 TELOMER B ALCOHOL AS A FUNCTION OF PH
Supervision, and that this report provides an accurate recordof the procedures and results.
Report by:
eo approved:
He ceonm! om Se iron Betent Comps
gs aeA7- MARS 023
Tmnoscars prog
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DuPont EMSE Report No. 92-02
TABLE OF CONTENTS
PCeargteifRiecasteirovneOdffoArUHSpEeRcNifCiHcYCOUNTY REQcUrIcTCTINI......r ....-- vovo-- rcvsn-- onsn-- enccnn 2
Tableof Contes......
A m--; A
10 SUMMA crc I -- --
2.0 General SKY INOMIHON vrs --
3.0 Materials and Methods...
sm"
----
3.1 Test Guidelines...
------------
32 TESUSYSEM.c.oro 32.1 Chemical SYStEM
sns---- wanmm--------_
cer
r----
322 Test System
----------------
----
33 Test Conduct.
--
ws--
10
330 Buffer Soluions...........
s--;
son----
10
332 PreliminaryTest..
s--;
nm
nll
333 Aqueous Stability ofan Unstable SUbSIANCE.........ccc.. wmmnesndl
3.4 Parameters ODSErVed
uv
34.1 ADalySis OFTeSt SSIES...
r--------. msl
3.42 Analytical MethodsforTest Substance and Proucts...........coovvvrcecl
3.5. StatisticalATRIYSS vores
13
3.6 Protocol Deviations... 40 Results and Discussion...
smssss------------------}
s----
smmmn--_g
50 Conclusions...
-------- wes--;
--
6.0 REICDOFHRIECOON vrs 15
7.0 Disposal ofTest SUBSACE Le
.......... srrr--------_5
--------------------
s--
15
Tables
Table014CSonDcAeYnSt.rationof8-r2 TrBrA at
pH
1.2 at 37C and ssmism----
at
pH
4,
7,
and 9 at S0C afte0r --
16
`Tab2lpHeofBuffer Solutions Containing 8-2 TBA at Days 0.and S.....ccccccrrerevvcenc1T
`Table 3 Daily 8-2 TBA
TCeomnpdeurcatteudreatRpeaHdi1n.g2.s.o.f...Shaking
Water
Bath
for ----
Aqueous
Stability of mnt
Table8-42DTaiBlAy TCemopenratduruaetcRpeHatd4ie.n.g.ds..of Shakingo Watem r Baty h for AqueouswSetabailmitmy mofsisndd
Table85:2DaTiBlyATCeomnpdeurcatteudreatRpeaHdi7n1g0sdo9f Shaking Water Bath for Aqueous Stability of ssn)
`Table 6 Steriliy Medium
of
Test Solutions sm--
at
Day
$
in
SterirlesTsriypmteicma--se
Soy
Broth
(TSB)
mmnmionll]
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Appendix A
`Table(A-21 A1na-lytAicaulanRgeds5u-l(t22s6o-0AfUtEh0-e2A020q2u))e.o.u.s..S.tca.bcil.ict.yco.f 8-2 TBA, pa H 1.2, 37s C, Daysl 0
Table(A24--2JuAln-a2l0y0t2i)caalndRe5su(l2t9s-oJfult-h2e00A2q)u..e.o.u.s..Stability orfor8-2 TBA, pH 4.0m, a50tsC, Days 0 23
`Table(A2-13-AAunga-l2y0t0ic2a)laRnedsu5l(t2s6o-fAutgh-e20A02q)u.e.o.us Stabilityof8-2 TBA, pHm 7.0, 5m 0C, Ds ays 0
`Table(A2-14-AAunga-l2y0t0ic2a)lanRedsult(s2o6-fAutgh-e2A0q02u)e.o.u..s..St.a.b.ilityof
8-2 TBA, pH 9.0, m------
50C, Days 0 stl
Appendix B
Table`CBo-n1dAuncatleydtiatcaplHRe4saulntdsRofotohmeTAeqmupeeoruatsuSrtea,biDlaityyo0ofn8l-y2 (T1B6A-Jufolr-2Pi0l0o2t)Etx.periment --
Table(3B1--20A1n-a2l0y0t2ic)aalnRdes5u(lt5s-oAfU-t2he00A2q)uteo.u.s..Stability of 8e-2 TrBAi, pmH i1.2,i50pC,--Da"ysr0 l3
Table(B3-13-0A1n-a2l0y0t2ic)aalnRdes5u(lt5s-AoUfEt-h2e00A2q)u1eouso Stabilie ty of 8-2 TBA, pHa 7.0, 50m C, Day0sl
`Table(B-34 A1na-lytJicaaulndRle5su-(l5t-2sAoUf0Et-h02e020A2q)u)eouscSrtacbility of 8-2 TBA, psH e9.n0,--50C, Dayss0 mi
AppendiCx
AppCeCertnificdateoifTxest SubSIance ARIYSi................
wns
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DuPont EMSE Report No. 92-02
AQUEOUS STABILITY OF 8-2 TELOMER B ALCOHOL AS A FUNCTION OF PH Author WilliaRm. Berti, Ph.D. 1.0 Summary
Test System: ``TahqeueaoquusesooulsutsitoanbsilbituyfoffertehdeattepstHsu1b.2s,ta4.n0c,e 78.-02, aTnedlo9m.e0rwBasAldceotheorlmi(niecd.., 8T-e2stTsByAs)teimnssterile csoynsstiesmtewdoasf itnhceutbeasttesdubinsttahnecdearink aatquSe0ouCs abtufpfHer4e,d7s,oalnutdi9o-nasnidnastte3r7iliCzeadtcponHtai1.n2.ersA.nThe test unstable test substance is indicated by a 10% or greater loss of fest substance within 5 days.
Findings:
The test substance,8 and pH 12a 37C.
-2
TBA,is
stable
under
the
conditions
of
the
test
at
pH
4,
7,
an9ad
50C
Conclusions: "yeTahre:tti,me>1inyweahri,ch 50% of the test substance will transform is estimated as greater than one.
20 GENERAL STUDY INFORMATION
Study Objectives
"teTshtisstuebssttagnecnee.ratTehseesasqeunetoiaulsesntvabiirloitnymoefntaaslubfastteainncfeor(mc.agt.i,ohnydrreolleyvtainct ostatbhielipteyr)issisotneenceooffthtehe
`pomtoesnttciaolmdmeogrnadraeatcitoinonpsatchosnotfroslluibnsgtaanbcieotsiicndtehgeraednavtiiroonnmaenndt.is
therefore oneof the main A procedure to determine.
apeqrufeoorumsesdtaobniliatpyarraetnets saulbsostiasnicmepoorrotannttsinaiqnudeiocuatsinstgabwihleittyheprroodtuhcetsr.tesAtqinugeosuhosusltdabbielity
benevhiarvoinomrenneteadlslytorebleeveaxnatmtienmepderaattuprHesva(l1u0e1s0n6o0maC)l.lyI fiosuanldsoinstohmeeetnivmiersodnemseinrtab(lpeHto4 109) at
dteetmpeerrmaitnuereasq,uesuocuhs satsabpiHlit1.2y aonadfte3s7tsCu,bsrtesapneccetiavteplhyy.siologically relevant pH and
`Specific objectives include:
1. To determine fa compound is stable in an aqueous environment,
2.
To providae material applied test substance.
mass
balance
that
accounts
for
greater
then
90%
of
the
initially
3. For unstable compounds:
2.
To determine the atpH 4,7, and 9
aqueous between
s1t0a1b0ili6t0yrCataeondftathepHtes1t.2suabnsdta3n7ceC,in
sterile
buffer
solutions
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DuPont EMSE Report No. 92-02
b. oTfothiedentetsitfysuabnsdtafnocleliofwftohremfeodr,mation and decline of th aqueous stability product(s) &. sTuobsdteatnecremiGnfearatfeircsotn-soradnetr aanqduehoaulslsitfaeboilfitmyaajtoercaoqnusetoanutsastnadbihliatylprfodoufcttshecaensntotbe
bdeetceornmdiuncetde,dtexahacatlqeyuaesontuhse pstaarbeinltitsytsudtyu)d.y withth aqucos stability product(s) will
Test System Justification "The test system i oulined by OECD Guideline 11 andwasrequested by the sponsor.
Study Personnel
EL +du PCoennttrdaelNReemsocaurrcshaannddCDoemvpealonpyment ~Corporate Center for Engincering Research -
+ HEansvkierlolnmLeanbtoarlataonrdyMfiocrrHoebailotlhogaincdalEnSvciireoncnemsen&taElngSicinecnecreisng
Management:
JEoLhndTu. PGoanntndoen,NePmh.oDu.rs and Company
`CCeonrtproarlatReesCeaanrecrh afonrdEDnegvienleeorpimnegntResearch
GElnvaisrgoonwmeBnutialldianngd3M0i0c.roPbOi.olBoogixca6l10S1ciences& Engineering.
aNnedwark, DE 19714-6101 USA
ES.LLMadrukPoKnetnndeedNye,mPohuDr.s and Company
NHeaswkaerlkl,LDabEora1t9o7r1y4fUorSHAealth and Environmental Sciences
Study Director:
EWiLlldiuamPoR.ntBdeertN,ePmhoDu.rs and Company
CCeonrtproarlatReesCeeanrtcehr afonrdEDnegvienleoerpimnegntResearch
GEnlvaisrgoonwmeBnutialldianngd3M0i0c,rPo.bOi.olBoogixca6l10S1ciences & Engineering
Newark, DE 19714-6101 USA
Analytical Chemist: EBoLgddaunPSoznotsdtekN,ePmh.oDu.rs and Company
NHaeswkaerlkl,LDabEora1t9o7r1y4fUorSHAealth and Environmental Sciences
Technical Personnel: MLiasrakMG.. SSutlaerck,iD,uDPuoPnotnCteCnetnrtarlaRleRsecsaeracrhc&h &DeDveevleolpompemnetnt
Keith B.Pricket, DuPont Haskell Laboratory
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Study Execution Dates Study Initiation Date: Experimental Start Dat: Experimental Completion Date: Study Completion Date:
25-Apr-2002 15-July-2002 9-September-2002 27-March2003
3.0
MATERIALS AND METHODS
31 Test Guidelines "PTHh1e.a2q,u4eo0u,s7s.t0a,bailnidtyo9.f0twhaesedsettesrumbisnteadn.ceT8e-s2tTsyBsAteimnsscteornisliesatqeudoefotuhsesotleusttisounbssbtuafnfceereidn at sayqsuteeomuss wbeurffeeirendcusboaltuetdioinnstihnesdtaerriklaitzeSd0coCntaatinpehrs4,ma7,daenodfn9oann-dad3s7orCbiantgpmHat1e.r2.ialsD.ayTh0eaensdt Dthaeyestssaumbpslteasncweerdeegarnaadleyszeind fodratyhse (coinscengrteraatteironthofatnh|eyeesatrastu2b5stCan)c,e.theIftlesetsstuhbasnta1nc0e%iosf considered sable andno additional testing for aqueous stability s performed. Isftadbeilgirtaydawtoiuolndofaltsho beesptesrufbosrtmaendceathtawdoocacdduirtrieodnaatl tpeHmp4e,r7a,taunrde/sosrepaarnadtedS0byC,atalqeuaestou1s5C T(eo:8t,es2t0foCr afinrdst-3o5rdCe)r abtehtahveioprH, veaalcuhesteastt wvehsiscehl twhoeultedsthsauvbestbaenecneawnaaslyszhedowinn ttiombeeiunntsetrvaabllse tahqauteporuosvsitdaebdilaitmyoifntihmeumtoesft ssuxbs-tsapnacce.edTdeasat spooliunttisonnowromualldlyhbaevtewbeeeenn2a0n%alayznedd7f0or%hoef ccoonncceennttrraattiioonnowfoutlhdtbeetpsluobtstetdanacgeaiannsdt ithsetsraamnspfloirnmgatiinotenrvparoldsutcot(ds)e.terTmhieneteitss dseugbrsatdaantcieon rate constant and hal ives at cach pH.
32 Test System 321 Chemical System 3210 Test Substance
Name: Synonym: Active substance(s) Molecular Weigh: CAS Name:
CAS Number(s:
8:2 Telomer B Alcohol (PerfluorooctyDethanol, 8:2 TBA 8:2 Telomer B Alcohol, 9% 464.12 gmole" 313-D4e4c5an5o6l6,7.7,8899.10,10,10heptadecaluoro678397
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Structure:
rF
F
FE f
F
" F
r
F
DuPont EMSE Report No. 92-02 oH
H Number:
H24691
Lot Number:
P0000!
EMSE Sample Number
E93386.63
Concentrationofas., nominal: ~ 99%
Concenotfras.a,atnailyozend: 99.2%
CerioffAinalcysaistDatee: 13-Sept-2001
Date Received:
26-Mar-2002
Supplier:
Clariant Co,
Solubilityat 25C:
~140 gL"
Vapor pressure:
0.023 mm Hg
Stability:
Stable atambientroom temperature
Appearance/Color:
`White solid
Storage Conditions:
Room temperature; keep tightly closed
Safety Precautions:
`Wear lab coat, protective gloves, and safety
glasses
3212 Reference Substance None
3213 Test Vehicle Solutionsbuffered at pi 1.2, 4, 7,and 9 were added to glass est vessels containing 8-2 TBA L" methanol toattainan inital concentrationof 150 ug 8-2 BAL". For test Satotlauitnioancsonwcietnhtaravtoilounmoefo1f540.5ugmL8,23T3.B8AuLL"o. f2Fo0rmtgest8-so2lTutBioAnsLw"itmhetahvaonollumweasofuse3.d0 mtLo, 212.550 uugl8o-f2 2T0BmAgL8"-2 TBA L"' methanol was used to attain concentration of
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DuPont EMSE Report No. 92-02
32.1.4 Application Information cTohnecetnesttrastuibosntaonfce15i0n umget8h-a2noTlBwAasL"mibxuefdfewristohluptiHon.1.2T,h4,e7a,mooruntboufffmeertshoalnutoilonisnotheatfainianla fest solution was less than 1% by volume.
322 Test System 3.221 Test Units
lDoisftfedruerntintytpheestoefsttepsetrivoeds.seTlesswtevreessueslesdufsoedrtedouccoenodruecltitmhiinsastetutdhyewaemroeuncittohfetres10t msuLbstance bboorroossiilliiccaattee ggllaassss vviiaallss wwiitthh aalluummiinnuumm--lliinneedd sccrriemwp ccaappss ((ppHH 41)..2,7A,llatnedt9vseasmspellsesw)eroerg7rmavLity sterilized by autoclaving for 20 minutes a 121C. 3222 Test Conditions cToevsetrsionlguttihoenstebsutfvfeesrseedlsatuspiHng4,ih7e,iadndoft9hweersehahkelidngatwSa0t:e+r b1athC.foTrhedtaesytscionndthietidoanrskwbeyre r3e7pl1icaCtef4dortSimdeasyasticnatchhepdHaraknbdytcimoev.erTiensgtthseoltuetsitovnessbsueflsfeurseidngattpheHl1d.2ofwetrhee shhealkdiantg water bath. This test conditionwasalso replicate4d times
33 Test Conduct sStteerriilliezbedufbfyepracsosnicenngtrtahtriooungshoa f0.0.205mMm fwleer.e used. After preparation, cach solution ws filter
330 BufferSolusions 3301 pH 1.2Buffer
215.0000mLL woifth0w.a2t00erM. pFoitnaaslspiuHmacdhjluosrtimdeent(sKCwIe)raenmda4d7e5wmitLhof1.002N0H0CNI oHrC!NawOerHeadsilnuetceedsstaory. 3312 pHdBufer:
s5o0d0imumLhoydfro0x.i10d0eM(NpoatOaHs)siwuemrheyddirloutgeednfpoht1h.a0l0a0tLe (wKiHt(hCw,aHt,er0.4)N]oanfdin4al.0p0HmaLdjousftme0.n10t0 was necessary. 3313 pH7Bufer: s5o0d0imuLm hoydfro0x.i10d0eMweproetadsisliuutemdd0ihy1d.r00o0geLnwpihtohspwhataetre.(KFiHn;alPOp)H aadnjdu2st9m6emntLs wofer0e.1m0a0dMe with SNHCL 3314 pH Buffer: w5i0t0hmwLate0r..F0i5nM0albpoHricaadcjiusdt(meHnt:sBwOear:ne)dma2d13emwLitohfSN0.H10C0 M NaOHwere diluted 10 1.000 L
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DuPont EMSE Report No. 92-02
332 PASrpCeralenilmidmipinniaariryy1Tte2essttwas perforomntehde et substance at SOCat pH 40, 7.0, and 90and at.
333 ATSuqhbeusettoaenutcsesuSwbtsaatbainnlicoteypseofrafaobnrmeUedn:hsrtaeblloereSutbessttianngc[e0the aqueous ability of an unstable 334 Sample Collection andStorage 3341 SDaamypOlsianmgplInetserwvearlesfrozen immediately fe the addin ofthe test substan uni
PCxHta4c.i7e,d2a0n4d9amfloysredd.aysD,rayt whaimchplteismewehree swhrakeenfoatze3n7nCt(ibeaxeirreItTed1s2nd1anaSlOyzCed.ber 2342 Test Solution Storage
Tes saions were stored at approximately 20C
34
`Parameters Observed
341
Analysis of Test Systems
3.4.01 SSbtrteoertirhlli(ytTySwMBa)esamdseeutdreierummmiennwetadssounsDdayocshuencpklteshotfelacyhofotfchacehstsasmypsltee.ms,AtSstaemlpelitnrgyp,i0c.a5eLseofy h"TeheteTsStBolmteidoinumwawsaasseipntciucbaaltleydadoded4 dciaundtayrktnsbeesscoatntaCi.ninTghe.5 mprLesoefnTceSoBr msheedeinucme of cloudiness a compared to sterile TSE medium convols determined Stn.
3412 pH Measurement "Test solution pHwasmeasured and documented at Day 0 anda he andofthe experiment.
34.13 "TTehmpteermapetruarteurMeeofashueretmesetnstysstem was monitored and recorded daly thoughout the course ofthe suds
342
Analytical Methods for Test Substance and Products
3.4.21 ASnaamlpylseisproefpaTreasttiSounb:stance "sTphiekeGdCiInMoScaacnhalyssaimspolfe8t-o2aTcBeAthseamepxlyeasctiinovnalrevceodveursy.ofTaheiIn-teOrcntaalnaslt,andardand surrogate PSr0o4d.uc5t.s5,6W6e7s.t85C.ou-mdboidse,caSlCl.uoTrool-eT-rr0flausrComset,hyw)a-sCuAseSdHa20th0e1s5u-r4o6g-at,e9. 8T%heakowood 311D2e0c0a.9n8d:l5,32.38.%6,4O5.a5k,w6o.o6.d1P,r7o8d.u4c9t.s,10W,e1s0t.1C0o-lhuemxbaideacSalOi,orroe9f-euriefdl1u0oraomCe1iy1l-1)5(,CwAaSsYused
TET 000047;
DuPont EMSE Report No. 92-02
a(asCAthuSesHetd67ma8l:t3h0est.na7n.dya5r7d.6t%TOhseaakn1wd-aoDreocddaonPfol2r, 3o3Tt4EA..4W.es5St.i5cC,ka6ls6u7ob,ii7nn85sS99oCt,s1sp0er1lo0ne,ic1m0oeespettyde3caTlohro-
fr1o0re0c0ghueigsm.tL"oTfsoofeuisintssemhaal wmstaearntdHa.rrd adndtsousrpropgeaitoenweerceopnrecpaormedrion wih han ot methanol and stored 56
The pi 1.2, 7, and sample (4.5-mL et solution some) incimp-cappd 10m glass
hSh`veeialcvcsliwontesrewde[svipCiilA3kSetsnHdyrrowi1uing6tgg5ehh.4-h1T30e.4o54Vua(clLoomsmfeenpy5tt0sa upogtwfytC9h!-eiicvasiohaylfmriwnLner"ger.meevTtehrchaenn.oscld2b3oyMr5iT-n1mjB5eLcFitpinwngowertihmengsoao2sludtmpieoon isnvtooe
Voincs. Th vilwhs openeandd | mLof be MTDE ayer ws amps ics GC vi
G(1.M7 mSLs),lspyik.ed Twihthc6aliiLbroatfaion50saungdCr1d1s-iwsoemrLp" mrethaenboyl,pspcirkiaimnpgerds,paeondrsdtubsjecvtoedltuomeosf
e50ruegcmomLt"usmettehdanwoilngofpCe9a-kisro,aC1f1i-igsn0,l8e-t2iTnBeAdtofrI-omnL aMT.BE9.5. The calibration curves
SbTheoecrupsaien(hseaBmporpeelsegeslnc(SeomofuLpmtohesntastiol3eutionthveolsuammewp)lerbeislirdwtaerdtfifreerrednatwpirhteptaooratarinonapearsocoefdt ure fst
amh5eas0xlagicnoeuCnb9(d-eiCiiAsvoSoonHermdeL1sb"0:y-m5cTel4the3hae)anniSonPTlghEiwecacwsoiotuahdmmd3ee(mdLns.otooftottfhhsteesavSiipia.lolp1uwas0enir0ontmlg.va{osPnymAerYinntsnged,fJofocronole1nls5odCmwoheindrniobwmnyiagnr1w.ag5gi+mapL2hson)fl
WhSieolxchain1.emcTLxotIwuPAt.stNaewosadcylieuneowfatshewwisaahlleudomownimwttihosf2deampiciaeofthehorexeradnheaSdEhehxsaenoeawnaahems Aweet0as5smsh.uas
liauotof heIPA oust was SamptoleasdsGC vil (7 mb)spiked wih lof
50 pugC11-is0 mL" methanol, crimped, and subjecttedoGC/MS analysis. The calibration
Pn`scAthanawdnaiorsdlspofrfoerpCatrheedp5AbHy14us0bamjspocl,,eiA 5sn-w3heTreBebAplratEenoApka1preHmdL4byoefsH mpraiktit1ntghMraepparcSohPA perEdiaptPreAo.A vcoleTudhmeuesrmoeafts5as0rhuegwemaLyd"a6
The cahoration curves wars consucted singPe re of sgn ind or oma 08
Instrumentation andconditions
GEMSsystem: HSPlc6i89v0elDuetsecGtCor((AgAigleentn,)WMiPS?lMhmiPDuiEpUonSsAe)gS,aHmtPp$lo9e7GnMear,s,s
Coma
DBaBl-ti5mMoSre.,3M0Dm UxS0A2)5 mm, | um film (Agilent, Wilmington, DE USA)
Temprmp Wi: SS0CCiEmri2nmtoi1n207
SFolow
5500mC/miLn tioH3em,0c0oinana:dnholodwfrm3odmein
Iintieetomn volume
SSorrc
SNSIDftoanrmoeniTtonreedm. mSeoc51,95, 131
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DuPont EMSE Report No. 92-02
Retention time;
82TBA: Co-iso: Clliso:
493 min 4.60 min 5.38min
35 Statistical Analysis DPaaiyre0d atnedstDateyst$s bwuefrfeerussoelduttioodnestaerremitnhee siaftmhee (mJeMaPn, t1e9s9t5s)u.bstance concentrationsinpaired
3.6 Protocol Deviations None
4.0 RESULTS AND DISCUSSION
Under the conditionsof the test at pH 1.2 is stable (Table 1). Tables in Appendix
and 37C and A(Tables A-1,
at pH 4, 7, an9adnd 50C, A-2, A-3, and A~4) contain
8-2 the
TBA
analytical Table I.
resultsof
the
aqueous
stability
studyof
the
test
substance
that
are
summarized
in
`Stabilityof the test substance, 8-2 TBA.
* AtpH 1.2, 8-2 TBA concentration after five days at 37C was 195+ 8.00 ug L",
cDoamypaSraendd tDoa1y830con1c0e.n9truagtiLoantsotfhtehsetatretsotftsuhbesttaesntce(Dwaays 0+).6.T7%h,e idnidfifcearteinncge tbheattw8e-e2nTtBheA
is stable at significant
this (p =
pH. The 0.05).
difference
between
Day
5
and
Day
0
was
not
statistically
+
AtpH 4,82 10 156% 4.22
TBA concentration after five days at ug Lat the startof the test (Day 0).
S0C Th
was 143 + 10.0 ug difference between
L", the
compared Day and
Dthaisyp0H.conTcheentdriaftfieornesnocfetbheetwteesetnsDubasytaSncaendwaDsay-80.7w%a,sinndoticsattaitnigsttihcaatll8y-s2igTnBifAicainststable at
(p= 005).
*
AtpH7, 10199
8-2 TBA concentrationafterfive days 9.12 ug L"at the start of the test (Day
at 0).
S0C was 181 4+ 12.6 pgL", compared The difference between the Day 5 and
0`PHc.oncTehnetrdaitfifoenrseoncfethbeettweestensuDbastyanScaenwdaDsa9y.06w%asinndoitcasttiantigsttihcaatll8y-2siTgnBifAiciasntst(apbl=e
at this 0.05).
1A0t1p6H99., 58.-929TjBugAL"caotncetnhetrsattairtoonfatfhterftiesvted(aDyays 0a)t. ST0heCdwifafse1r7en5ce4be10t.w5eepngLt"h,e cDoamypa5 raendd tDhaisy p0H.conTcheentdriaftfieornesnocfetbheetwteesetnsDubasytaSncaendwaDsay+30.8w%a,s innodticstaattiinsgtitchaaltly8-s2igTniBfiAcainststable at (=005)
Experimental conditions - pH:
+ The pH 1.2 test solutions were pH 1.11 and 1.54 at da0yansd 5, respectively, a variation
`of more because
0.1 the
units (Table 2). compound was
stTahbiles.
had
no
significant
effect
on
the
outcome
ofthe
test
The pH 4 test solutions were pH 4.02 and 4.12 at days 0 and 5, respectively; a variation `of more 0.1 units (Table 2). This had no significant effect on the outcomeofthe test `because the compound was stable.
T10674842
Page 13 of 31 000049
DuPont EMSE Report No. 92-02
The test
pH 7test solutions
solutions were pH 7.03 and 7.04 were pH 9.02 and 8.97 at days 0
at day0s and 5, respectively; and S, respectively (Table 2).
and the The pH
pH of
9
the 0.1
test solutions at unit) during the
these test.
2-pH
levels
did
not
change
significantly
(pH
change
less
than
Experimental conditions temperature:
+
The temperatureof the shaking water constant temperature did not fluctuate
bath by a
used to totalof
maintain the pH more than 0.2C
1.2 at
test solution 37C (Table
at 3).
a
`The average temperature was0.1C(n= 6).
of
the
shaking
water
bath
was
37.1C
and
the
standard
deviation
The temperatureof the shaking water bath used to maintain the pH 4 test solution aat
cthoenstteastnt(Ttaebmlpeer4a).tuTrheediadvenroatgefltuectmupaetreabtuyrmeoorfethtehasnha0k.i1ngC waattSe0rbCatdhurwiansg t5h0e.0dCaaynsdotfhe
standard deviation was 0.05C (n = 6).
Tathaectoenmsptearnatttuermeopefratthuersehadikdinngotwaftleucrtubaatteh buysemdotroemtahiannta0i.n1tCheapt H507aCnddur9itnegstthseol5utdiaoynss
otfhtehsetatnedsatr(dTdaebvlieat5)i.onTwhaesa0v.e1raCge(nte=mp6e).ratureofthe shaking water bath was 50.0C and
Experimental conditions ~ steriliy: * sTtheerilseteartiltihteycehnedcokftsholeutteisotn,sasfionrdtihceactoedntbryotlphHe,la1.c2koatf3b7acCt,eraiandgrpoHwt7hainnt9haedtTrSy0ptiCcawseere
`Soy Broth (TSB) medium (Table 6).
* The sterility check solution for the pH 4 at S0C was not sterile as indicatedby a slightly
cloudinessof the TSB medium after the incubation period. (Table 6). This did not affect
the outcome (Table 1).
of
the
study
because
the
test
substance
was
stable
at
this
pH
and
temperature
Trial studies:
Prior to studies
the are
definitive studies, found in Appendix
several trial studics were B (TablesB-1, B-2, B-3,
performed. and B-4).
The resultsof these trial The information below
`summarizes these results
Table B-1 lists the results ofa pilot experiment that was conducted to demonstrate: that the experimental design, implementation,andsubsequent analysisof the test substance was adequate to determine its aqueous stability. This study was conducted at pH 4 and room temperature for Day 0only.
Table B-2 lists the resultsofthe aqueous stability of the test substance at pH 1.2 and S0C. The test substance was shown to be stable at this pH and temperature after Sdays. The study was repeated because it should have been conductedat a pH of 1.2 `and 37C. Both demonstrate that the test substance is stable (Tables |andA-1).
* Table B-3 lists the resultsof the aqueous stabilityofthe test substance at pH 7 and
`50Con Day 0 and Day S. This test was repeated using different test vessels because:
of the large standard deviationof the average test substance concentration at Day
(standard deviationof 39.8 `which appears to be due to
ug the
L" for Day S compared t0 6.25 ug lossofthe test substance in two or
L" for Day moreof the
0), Day
.
replications. The repeated study demonstrated that the test substance is stable at pH 7
(Tables 1 and A-3)
T0106/4842
Page 14 of 31 000050
DuPont EMSE Report No. 92-02
T5a0blCeoBn-4Daliyst0satnhedreDsauylts5.ofTthhiseatqesutewoauss rsetpaebialtietdyoufstihngedtiefsfterseunbtsteasntceveastseplHs 9baecnaduse:
o(fstthanedlaarrdgedsetviaantdiaornodfde4v2i.a9tiuognoLf"thfeoraDvearaySgectoemsptasruebdsttaonc1e1.c5onucgenLi"raftoironDaatyD0a),y 5
which appears to replications. The
rbeepdeauteetdostthuedylodsesomofntshterattesetdstuhbastttahnecetesitn
twoofthe substance
Day 5 is stable
at
pH
9
(Tables 1 and A-3)
5.0 CoNcLusioNs
ThreelevtainmtepiHn wrhaingcehs5a0n%dotfemtpheerattosutressubisstgarnacteewriltlhatnraonnsefoyremarin(1w;a>t1eryaetare)n,vibreocnamuesneta>l9l0y%
ofthe test substance added at Day PH 40,and79.0.an0dSO,C.
0
was
recovered
afer$
days
at
pH
1.2
and
37C
and
6.0 RETENTION OF RECORDS
For the periods documents and
demanded by materials will
bGeLsPtogurieddelinintehseaanrdchisvpeescioffitchceoutnesttryfarcielqiutiy,reimnecnltusd,insgtubduyt
not
limited to:
study protocol;
+ any protocol and/or report amendments or addenda or SOP deviations;
alla dats;
onc original signed copyofthe final report;
laboratory-specific or site-specific raw equipment, refrigerator, andlor freczer
rdaatwasdautac.haspersonnel
files,
instrument,
`Documents and materialsare archived according to Practice in the organizationofthe testing facility.
the
principlesof
Good
Laboratory
7.0 DISPOSAL OF TEST SUBSTANCE AEfMteSrEislsaubaonrcaetoorfythunetifliinsa erxeppoirrta,titohne draetmeaiannidntghteenstdseustbrsotyaendcebywililncbienesrtaotrieodn,atuntlheesDsuoPtohenrt arrangements are made between the submitter and the Test Facility.
80 REFERENCES
8.1
OECD Guidelines FunctionofpH.
for the
Testing of Chemicals,
Section
1,
Method
111,
Hydrolysis as a
8.2
Environmental Part 160, Final
Protection Agency. 1989. Rule. EPA, Washington,
DGCo.od
Laboratory
Practice
Standards,
40
CFR,
8.3
IMP. Cary,
1995. JMP NC USA.
Statistical
and Graphics Guide.
Version
3
of IMP.
SAS
Institute
Inc.
T0106 / 4842
TT
Pagelsof3l 000051
DuPont EMSE Report No. 92-02
TABLE 1
CONCENTRATION OF 8-2 TBA ATPH 1.2 AT 37C AND AT PH 4, 7, AND 9 AT 50C AFTER 0 AND 5 DAYS
on
Time one 3C2onTc8enAtrAartgioens OiDfaoyr5enacnedDeatwyeosrn
uy
we
*
2 12
o 5
apa 2ag00z
1a95s2i80m0
"64
.
2002002 ssa
4
s prey 32100
ar
'
0 nama waren
'
5 wag wine
os
s
0
nig2002 1092598
s
s 250092002 ss 108
as
+ DCiof=fer8e:n2cTeBbeAtcwoenecnenDtaryatSioannadt DDaayy00 ,%= (Cs - Col((Cs + Cob2) x 100, where:
+ CMe=an8-2sTtaBnAdarcdondceevnitartaitoino;nnat=D4.ay 5
T010674842
Page 16.0131
000052
DuPont EMSE Report No. 92-02
TABLE 2
PH OF BUFFER SOLUTIONS CONTAINING 8-2 TBA AT DAYS 0 AND 5
Tine owe Nomoiinal MesPsHured Noninst temperature TemmpeesreautrusrmeeonftoH
oar
sur su.
0 raga 12 11 Roomtenperstoe
2s
5 maga 12 15
a
a1
0 ama 4 42 Room tempers
20
5 mmme 4 an
0
0 ataganz 7 70 Roomtemperio
2s
5 wag 7 ros
Ps
wo
0 apm 9 902 Room tempers
2s
5 mmpme so sor
0
+ SU. = Standard Units
TO106/4842
Page 170131
000053
DuPont EMSE Report No. 92-02 TasLe 3 DAILY TEMPERATURE READINGS OF SHAKING WATER BATH FOR AQUEOUS STABILITY OF 8-2 TBA CONDUCTED AT PH 1.2
Time oor o 0 2 3 ` s age.n8 Stndars Dovion
oe sapm Zana Basa waa sana sana
Tempura amr 30 2 wo an an a7 or
0106/4842
--
Page 180131
000054
DuPont EMSE Report No. 92-02 TABLE 4 DAILY TEMPERATURE READINGS OF SHAKING WATER BATH FOR AQUEOUS STABILITY OF 8-2 TBA CONDUCTED AT PH 4
Tire ay ' 2 3 ` s
Avesge.n=6 Standard Dovaion
one 202002 2502002 2532002 22002 22002 2wz02
Temperature ws 0 ws ws 200 200 0 00s
TOW06/4842
TT
Pagei9ordl 000055
DuPont EMSE Report No. 92-02 TABLE 5 DAILY TEMPERATURE READINGS OF SHAKING WATER BATH FOR AQUEOUS STABILITY OF 8-2 TBA CONDUCTED AT PH 7 AND 9
Time. our o ' 2 5 ` s
Avago. =6 Standarg Devon
ome 21mgz002 2nga00
numa0z nig 202 aug 202 2A 202
Tomporature 9 00 S01 1s 00 00 wo or
T0106/ 4842
--
TT
Page200f31 000056
DuPont EMSE Report No. 92-02
TaBLE 6 STERILITY OF TEST SOLUTIONS AT DAY 5 IN STERILE TRYPTICASE SOY BROTH (TSB) MeDium
Trsiment
Rost conclusion
cone
clone
sito
or zon TC Ons Clr
sorte
Gaon Comey Nonsts
Bute Tom50,0a
se Sno
outers 50, 0m Cex
sno
+ Scoenrtlaeiniinndgic0a.t5emsLthattestnosoblaucttieorniaawfteerre3otbs4erdvaeydsnof4i5ncmubLaotifoTnSiBnthe dark
30C.
Towerasn
Fazio
00005 +
reeeeee 0EM-- ERar:W-- e,9203
TaBLE A-1 ANALYTICAL RESULTS OF THE AQUEOUS STABILITY OF 8-2 TBA, PH 1.2, 37C, DAYS 0 (21-AuG-2002) AND 5 (26-AuG-2002)
No oH Time Rep SusE iance | Resbe eoton evepe An-- ayies--ptem--senst
w = owe 1w mr r ws x "0
20 1 om
sz 0 2 om
wr
a
"oe 2 om
sz 0 2 om
0
"0
2 0 3 om
Toe 0 om
"
2
soz 0 4 om
nase
Santas Devan
10s
sz sw
=o
a
W0 oroszes
1 om 2m
"o
"
wo ouzos 2 om
woz os a am
Po
0
Woz sams
soz 0s 4 om
ne
woz os om
ws
von
10s
Santas Deviation
Py)
+ Cvaalluceu,lattiemdesby10d0ividing the absolut diffrenceof the two analytical replications by their average
I
TPTageazersl
000058
DuPont EMSE Report No. 92-02
TABLE A-2 ANALYTICAL RESULTS OF THE AQUEOUS STABILITY OF 8-2 TBA, PH 4.0, 50C, DAYS 0 (24-JUL-2002) AND 5 (29-JuL-2002)
No
pH
Time
Rep
SubTseustnce
AmiTyoicuaSlubResptlainccaetion Aversge
AnDyiiffcearlenRceopBlectswieoennst
T wr w ww
' 0 we
02
02
2 so we
5 "0 2 ws
5
os
Ph 0 2 om
5 0 3 wm
5
a
.
03
'
0 a ss
5
a
a0 sw
Average
158
Standors Oovision
2
s as
om
wo
26
0 as 1 om
" ss 2 ss
15
1
n as 2 wm
5 as 3 ow
wo
02
" os 3 wm
ws as 4 ws
1s
00
as 4 ws
Average
wa
Stansors Devision
100
+ Cvaalluceu,lattiemdesby10d0i.viding the absolute difference ofthe two analytical replications by their average
T0106/ 4842
Pa23gofe31
000059
r------ OLEME-- ReesHo. LA
TasLe A3 ANALYTICAL RESULTS OF THE AQUEOUS STABILITY OF 8-2 TBA, PH 7.0, 50C, DAYs 0 (21-AuG-2002) AND 5 (26-AUG-2002)
Mo gH aTiyme . Te 2 Too a Too hn Too 5 Too 5 roo 7 To . Too verse Standard Doviaion
Rep SubTsoisatnce wi
1 om ow 2 ws zm som sm sam 4 om
AnsyTiesctaAvlSeuRrbeapaglteinccateion wl
105 0 an 190 ar
AlDiyfrcaencReepSlectswteosnns = 2s 03 n or
0 Tos
ws
3
a
0 Tos
wm
" Tos 2 we
106
3s
2 Ts 2 wm
Ws Tos som
1s
3
" 7s som
ws Ts 4 om
or
k
Ts 4 wm
Average
1
Stancars ovation
2s
+ aCvaelrcualgaevtaeldube,ytdiivmiedsin1g00t.he absolute differenceofthe two analytical replications by their
T0106/4842
Pagezaornn
000060
------eee eDOHEME-- Amor No52:02
TaBLE A-4
ANALYTICAL RESULTS OF THE AQUEOUS STABILITY OF 8-2 TBA, PH 9.0, 50C,
DAYs 0 (21-AuG-2002) AND5 (26-AuG-2002)
T Mo pH Time Rep swbTessmtce T ATniecvasmRoepcealon _ADnifalirasncReeBpttweeaoonnst
ow
wr
wr
%
Tso
ws
Ea
ds 0 hw
ss 0 2 om
wo
26
9 0 oz 0m
ss 0 3 wm
ww
a7
e Ts s
0 0
1 4
ws wm
or
"
ss 0 4 om
Avan
0
Sundar oviaion
so
ss 0s 1 0m
0
n
woos os 1 wm
noes 2 om
i
or
ves 2 ws
woes sw
0
os
PE
woos os 4 wm
0
woes 4m
verge
ws
Standard Dovtion
10s
+ Cvaallcuu,lattiemdebsy1d0i0viding th absolute diffrenceofthe two analytical replications by thei average
owes
Peon 000061
eeDn E EMSSRegerde, 0202
TaBLE B-1
ANALYTICAL RESULTS OF THE AQUEOUS STABILITY OF 8-2 TBA FOR PILOT
EXPERIMENT CONDUCTED AT PH 4 AND ROOM TEMPERATURE, DAY 0 ONLY
(16-JuL-2002)t
EE No
Rep subTsotsatnceAnayAaveRreagpeicaton AnDaiyffieeresncReeBpoltcwaeiaonnst
ET
'
'
3
n
0
2
'
ww
3
2
~
08
2
`
2
wa
5
s 105
wo
2
s
'
`
02
ns
o
.
`
.
s
we
o
"
5
10s
"
.
ws
"
n
6
ws
'
wo
08
os
"
'
wo
is
s
1s
I
s
"
w
5
I
ws
52
o
w
o
0
au
n
ose
+ EpexrpfeorrimmeedntuspienrgfoprHme4dbtuollaesrseastsrtohoemadteeqmpuearcaytoufre,thDeatyest0mseatmhpoldessaonnldy.anaTleystticvaelssperloscewdeurree.7 ImtLw.as
glass scintillation vials with aluminum-Jined screw caps. 22.5 kL of a 20 mg 8-2 TBA L"
methanolsolutionwas addedtoeach test vessel with 3 mLof the pH 4 buffer solution. After
capping, the sawmerpevorliexe-misxcd for 10s. Samples were frozen until analyzed.
+ Cvaalluceu,lattiemdesby10d0i,viding the absolutedifferenceofthe twoanalytical replicabtyitohenisr average
T0106/ 4842
--
Pa26g1e31
000062
e rr e-- CLE-- MEEBeponMe 9202
TABLE B-1
(CONT'D)
TT
No
Rep
subTsetsatnce|AnTdieyicwAawlemRreapmgleimcateion OAniafleyriacsncReopBhoetautsoennst
wr wr
ow
2
"
8
a6
2
"
100
=
"
w
a
FS
x
n ao
2
a
ww
no
a
=
n
=
7
"
on
08
"
we
i
2
108
2
is
10
3
6
me
"
=
1
2
Average
no
Standos Doiaion
08
+
EpexrpfeorrimmeedntuspienrgfoprHme4dbtuoffaesrseastsrtohoemadteeqmupearcaytoufrte,heDatyest0mseatmhpoldess aonnldy.anaTleystticvaelssperloscwedeurree.7
It was mL
glass scintillation vials with aluminum-Jined screw caps. 22.5 iL of a 20 mg 8-2 TBA L"
cmaeptphianngo,ltshoelustaimopnlwesasweardedevdorttoeexa-cmhixteesdtfvoerss1e0'ls.witSham3plmeLsowfertheefprHoze4nbuunftfielrasnoalluytzieond.. After
+ Calculated by dividing the absolute differenceofthe two analytical replications by their average
value, times 100.
T0106 4842
Pa27gofe31
000063
DuPont EMSE Report No. 92-02
TABLE B-2 ANALYTICAL RESULTS OF THE AQUEOUS STABILITY OF 8-2 TBA, PH 1.2, 50C,
DAs 0 (31-JuL-2002) AND 5 (5-AuG-2002)t
No
BM Tmo
TT Tou eAe rabice Offarence Batwasn pup Subsiince RepicaionAvrase Andes Repiestonst
Tr
wr
wT
=
' oo '
5
wr
2
2 12 oe '
EY
3 12 0 2
w
no
20
s woe 2
w
s 12 0 5
15
0
or
siz oo
3
we
roo 3
52
15
siz 0 3
o
12
.
wo
as
12
.
10s
vorage
"
Standart Deion
ne
saz os '
wa
wn
28
12s +
ne
wooa2 os 2
2)
TM
50
212s 2
2
woz os 3
02
"
ag
wooazs ` 105
1
os
waz s `
1
Avago
ns
Standard Doviaion
26
+ TSeOsCt.waTsesptervefsosremlesdwaetrSe07CmLinsgtleaasdsosfcin3t7ilCla.tiEoxnpveirailsmewnitthwaalsupmeirnfuomr-mleidneudsisncgrepwHca1p.2s.bu2f2f.e8r aptL
0bu7f2f.e2r0smolgut8i-on2.TABfAterL"campepitnhga,notlhesoslaumtpiloenswwaesraedvdoerdtetox-cmaicxhedtesftorve1s0s5e.l wSiatmhp3lemsLwoefrethferopzHen1.2.
4 uDnatiyl0a,narleyplziecda,te 3 measured four times; Day replicate 3 measured once.
Cvaalluceu,lattiemdesby10d0i.viding the absolute difference of the twoanalytical replications by thei average
NA = Not applicable; only one analytical measurementofsample.
T0106/ 4842
Pa28gofe31
000064
DuPont EMSE Report No. 92-02
TasLe B-3
ANALYTICAL RESULTS OF THE AQUEOUS STABILITY OF 8-2 TBA, PH 7.0, 50C,
DAYs 0 (31-JuL-2002) AND 5 (5-AUG-2002)t
No oH Time Ren a suI bse vege -- Amiyies-- Rop--hestonsi
ww wr ow
vor
'
0
wo
1
FOE
'
10s
31
2
we
"
sr
1 2
0
so
>
500
sr
a
1
5 as
Te `
0
ww
i
e710 .
0
ose
0
Sansars Dover
ozs
ss . sor
EX
5
woos '
ss
wore 2
us
us
os
w 7s 2
ur
nr s ) woos s
nor
woos .
7
or
"
wos . wr
vere
wos
Stndas Dovaton
8
1 TDeasyt 5w.aEsxrpeepreiamteedntbewcaasuspeoerffotrhmeevdasuisianigonpiHn 7rebpluifcfaetreart Se0sC.oufTlteesttt vseusbssetlasnwceerceon7cmenLtrgaltaisosn at
sscoilnuitliloantwioansvaiadldsewdi0thcaalcahmtienstumv-esisneeldwsitchre3wmcalps.oft2h2e.5puHL1o2fbauf2f0ermgsol8u-t2ionT.BAARLe"rmceatphpainngo,l the
+ Csaalmcpulleastewderbeyvdoirvtiedxin-gmitxhedabfsoorlu1t0s.diSffaemrpelneces woefrtheeftrowzoenanuallyticaanlalryezepdlicabtyitohnisr average
NvDalue=,Ntoitmedset1e00r.mined; samples were lost prior (0 analysis
T0106 74842
--
Page 29 0131 000065
-- ere SOLEMERBeeNo0242
ThsLE B4
ANALYTICAL RESULTS OF THE AQUEOUS STABILITY OF 8-2 TBA, PH 9.0, 50C,
DAYS 0 (31-JuL-2002) AND 5 (5-AuG-2002)t
No
TT BH Tm Rep
SubTeisatco Ane aiyicAawlnm Riegpelicata ion AmOiiyfirceanlcReepBleicssaornst
ww
wr
wr
ow
1 so '
0
0
os
2 oo '
3 so 2
wo
w@
0
` 00 2
1s
s 90 3
5
0
as
o so 3
wr
' 00 `
52
6
52
o 00 `
no
Average
wr
Standard Oviton
ns
0 0s '
50
w
98
woes '
15
woes 2 ns
ws
x
vss 2 03
wes 3 07
0
23
woes 3 53
wo 9s `
51
w
1
wes `
2
Average
0
Standrs Oviton
as
+ TDeasyt Sw.asExrpeepreaitmeedntbewcaasuspeeorffotrhmeevdaruisaitnigonpiHn 9rebpulliecraatreSsOultCs.ofTetsesttvseusbssetlasnwceerceon7cemnLtragtliasosn at
scintillation vials with aluminum-lined screw caps. 22.5 yL ofa 20 mg 8-2 TBA L" methanol
Solution was added to each tet vessel with 3 mLofthe pH 1.2 buffer solution. After capping, the
+ Csaalmcpulleastewderbeyvdoirvtideixn-gmitxhcedabfsorol1u0t5e.diSfafemrpelnecse wofetrheeftrwozoeannuanltyiilcaanlalryezpeldi.cations by thei average
value, times 100.
T0106/ 4842
Page 30 of 31
000066
DuPont EMSE Report No. 92-02
APPENDIX C CERTIFICATE OF TEST SUBSTANCE ANALYSIS
FRE
= Clariant
wes
Fase
0V00VLY