Document wXkOKKmbm8zLpaydzEX7DgwV

AR236 - 3308 490 TRADE SECRET Study Title ARA36 - 3308 Duran 13202 TEST GUIDELINES: OECD Guideline 111 AUTHOR: Bogdan Szostek, Ph.D. STUDY COMPLETED ON: November 24, 2003 PERFORMING LABORATORY: E.L du Pont de Nemours and Company Haskell Laboratory for Health and Environmental Sciences Elkton Road, P.O. Box 50 ~~ Newark, Delaware 19714-0050 LABORATORY PROJECT ID: DuPont-13202 Wonk Request Nuver: (ES service Cove Novae: [Sl] (aTSCACE! --- ----a posse Tew `GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT `This study was conducted in compliance with U.S. EPA TSCA (40 CERpart 792) Good Laboratory Practice Standards, which are consistent with the `OECD Principles of Good "ee Laboratory Practice (as revised in 1997) publishedin ENV/MC/CHEM(98)17 and MAFF Japan Godd Laboratory Practice Standards (59 NohSan Number 3850. The test substance wach: ized by the sponsor prior to the initiation of his study, except wthaespceormcepnltetceodntaefntterofthis study com`pThleetainoanly.siAsoltfhpoeurgchenttheccohnatreanctteofrization was the test substance not performed under certifi Good ed lab Laboratory oratory, and Prac the tice Standards, accuracy ofthe the characterization was donebyan data is considered sufficient for the ISO 9000 purposes o f t hi s study. ee S Baa e ? ~~ StadyDirector: BogeTtESa Ego Sis 24 NV" dee eP e RR `Applican/t Sponsor: ot ee------ ~ Company ---- Sanitizeq, QUALITY ASSURANCE STATEMENT Haskell Sample Number(s): ax DatesofInspections: Protocol: Conduct: Records, Reports: ac July 25, 2003 August 1, 2003 September 30, 2003; October 1-36, 2003 Dates Findings Reported to: -- Study Director: October 15, 2003; November 20, 2003 Management: ~ October 15, 2003; November 20, 2003 Reported by: JAG`Wonda K. ly Stabs. Date a ~ CERTIFICATION `We, the undersigned, declare that this report provides an accurate evaluationofdata obtained from this study. ApertSE NgS,kACrs ai S 2ewBavseze Tet Suty Dior-- m BoeSm eRCSa ro~mr ~ 2% oweov-dony -- -_-- Company Sanlzed. Doss not contain TSCA CFT ens)... --_ "TOA F CB ONL TENE TS Page `GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT..coccoomsssunsmsssrsmsssrnand. QUALITY ASSURANCE STATEMENT wovvrvssmmssssmssssssssssssmsssssmssssssnd ~~ 2: Prepaofrbufafetrsoilutoionns. A 521 A a Pnom r F y SMoe i di B An R i1 &5. ACauvtiiofs33ToA III I RESULTS AND DISCUSSION vocrvcrnserresssnsssssnssssssssessmsssssonled RECORDS AND SAMPLE STORAGE cornell -- Company SenetDos nc crt Tc ogy _---- LI OF TS ABLT ES 1. 0A0Ss(t15Sre2t0e03o,rseernso E BMD R, 12.37,2Dus 109200%) Page ald 2 P AmitEe et l or sens s--a--i ofGENpsEAR 4.4.0, 50, Dos 02.Aug 2005a 03 0252009 er OS SED 4. A2n0al5yt(i0ca0l50rpesu2lts0fo0r a8quesous silly ---me ---- A 9.0, 50C, Days 0 (03-Sep-2003) en? 5. Messedcocenmaions. 6. Measuredconenaionsof foBH1.402,,5307C,,DDaayyss 00 25(-A1ug0200-9)aa5nndd 5-(10522556509-220000099.9... 23 24 7. Messconeneations &. Messed concenaions or H7.0, C, Dass 0 28-Aug2003) and 5 (02-Sep-2003)... or 415.0, 50,Days 0 (15-56-2003 1205 05-50p2009) 25 25 51.0. DPaHmllyetemAperSateoTrersdDEinygsn0f5ht0e0sshin orre bith... ce oe en] rn --_ LI OFFS IGUT RES 1. (LOcclhriomnatsaongdorefarfsmouspay5.2 1.2 leno tesamr ples (n 3),7500mg. (9), Eand1E5000 mg. Page 0 2. (LCacihbormaosntsoangdruosfafsmousorf ay 5p 4.0gisCtrasamples (4), 7500mL (3,and15000mg. 30 5. (LClcahtrioomnssougnrodfarotmuosfBa3.517.0gioci sample (4), 7500mg.32,and 15000mp. 31 4. (LCccuhirmoiomnataongodrfarfmousor ay pi9.0gtae sample(4s ), 7500 mg/L.3, sd 15000mo 31 5. RepresentativeLCchromatograms ofbark apes orDay 5,pH 12, 40,70, 190.52 76.. RiRenepraenslennstaitrieve.ccalriburmatoiognacumrsveofo5C5R1R)ITIi c _-- 0 r ergsGt R 33 8. RnebpSraesnedntasncromatoguns fr Day, 4a0 dole sabihdspi npdo520v5SRR) 5. RepresctaivechromfaoDaty0o,1g40rbanaksmpse - en st 3 P Company Santized. Doss net contain TSOA CBI EE-- ~ STUDY INFORMATION Substance Tested: -- Synonyms/Codes: H-25707 Sumiter's Noto Nontrt: (SRNR) Haskell Number: 25707 Pusity: 100% Fluorinated polymer Physical Characteristics: Off-white solid Stability: The test substance appeared to be stable under the conditionsof the study; no evidenceofinstability was observed. Sponsor: WEi.lLmdiungPtoonnt,dDeelNaewmaoruers19a8n9d8Company USA. StudyInitiated/Completed: June 6, 2003/(see report cover page) Experimental Start/Completion: June 9, 2003 / September 15, 2003 --_ -_-- `Company Sanitized. Doss notcontain TSCA caf STUDY PERSONNEL Study Director: Bogdan Szostek, Ph.D. Primary Technician: Keith B. Prickett, B.S. Management: S. Mark Kennedy, Ph.D. Analytical Associate: Keith B. Prickett, B.S. Analytical Chemist: Bogdan Szostek, Ph.D. Management: S. Mark Kennedy, Ph.D. `Toxicology Report Preparation: Lisa G. Burchfield, A.A. Management: Nancy S. Selzer, M.S. _ `Company Sanitized. Does not contain TSCA CBI -- SUMMARY I Twahse thesytdedrolytibcuferesd tability oaqued-- us sq-- utionsat pH 4.0, 18,9.0 at 50C and pH 12 0 37C for 1th -- dacysu.diTihone The s-- tability waDsadey0moannsdtrDaditeyemdo5nbasymtrtphaleteecsdomatponadbreaihsnyodntrooslftythoifecoaplelrycmsetnatbleeesuonvdenerricthsseosef test frSoehrpaltpiheceaftDoerasyDa0ampyal>ensdsaaDmrapeyl1e50s,1.p=THh14e..2a0%vreaerpnaldigcea1p0t1eers=caemn1pt.l0re%es,coarvreecsrpi1eec0ts0i.vf=eolr0y.t,h5e%TDhaaenyda0v9e7arn=adg2eD.pa1ey9r%c5e,rneptsiprteecc|ti2ivveerliyc.s DT1ah0ey1%a5,v1ep.rHa3g%9e.a0pnedrrecp1el0ni0tca=rtee0cs.ova8em%rp,ileresessfpoaercettih1vee0l0Dy..ay1T0.h0ae%nadavneDdraay1g0eS4,p=eprH2c.e7n8.t%0,rrereceposlvpieceracitteeivsseflaoym.pltTheehseDaradeyif0omaanndce in TwpehoreucleodnbtsienrrdeivcceoadvteeirnitcehrseehfaoysrderDoofalyysOisaonfd aDgayteStssaumbpsltteiaosnncdeiidfaonpropatrnoryxeoiafmcahttteehleyicntrviwetsoitcoailgradlteoervdseltoeofsmtfac1go0nnd%iitttuihdoanyes. aldodwietriotnh,atnhtehmeecaosnucrenetdracotnisogpniroaftiops indicatedag creaseof of pected if 10%ofthe test substance hydrolyzed. In L) re between Day 0 and Day 5. The incazgse of ~ material present in the test substance. ~ Company Senitized. Does not contain TSCA CBI EE --_ INTRODUCTION CTO a-- mes-- uas mesg iPeH b1y2,80. 7.0a,saind 0.o0 S GueouE s baler EsoluNID "The study was conducted ing to the protocol: the concenirationofthe [whichwaspatterned after the - released from the test substance during the test. 'D Guideline as monitored 111. Additic to investigate i ly, STUDY DESIGN A preliminary test was performed on the est substance at 50 0.1C at cachofthe pH 40, 7.0, 9.0and at 37 0.1C for pH 1.2. If less than 10%of the test substance hydrolysis is observed paeftrefror5mdeady.s,Itnheadtdeisttisounbtsotfahnecetewsats counbssitadnecereddetheyrdmrionlyattiicoanlldyursitnagblteheanpdrenloimaidndairtyiotneaslt, testing the was samples were analyzed for test substance, --- The study exception smallerof design that the 0.0) M complies with the OECD Guideline f1o1l1lorweiqnuigrteesstthgautidtehleinaems:ouOntEoCfDthGeuitedsetlsiunbes1ta1n1c%e orhalf the saturation concentration with used the is the cR-- insoluble in water and the in water. analytical method The does tesst ubstance GREER not allow detectionofthe test substance at trace levels. Therefore, the study was conducted with an excess ofundissolved A Materials MATERIALS AND METHODS 1 `Test Substance CCNoAamSmpeNosiaone: Tet Sbstace Chemi b) Haskell mamber zo Ph`TuDhrIeacptteoseltryidsziuasbtpsiteoarnnscipetayrwaaimnsedtecexhr)asr:waicMttihenrti(hzneeudfmotbloeldorweaitvneegrrmarignsee)e,tthMi W (wei Jeaovneternatg,e9,%Mflsuoorinme,eanndspolcyosmer --_ companySantized. Does not contain TSCA! CBI --- ~~ Fluorine (w/w): 38.8% ~~ Pe 2. Preparationof buffer solutions TghuiedeAllilnoew1i1n1g%,`buffer solutions were prepared as described in the Annex to OECD `The 0.2 M potassium chloride (KCI) was prepared by dissolving 3.73 gof KCl (purity 99.0%, Sigma) in 250mLofwater. The 0.2 M hydrochloric acid of hydrochloric acid (36.5-38%, Sigma) in 250 mL water. (HCI) was The PH prepared by diluting 1.838g prepared by placing 125 mL of 0.2 M KCl and 161.3 mL ofa 0.2 1.2 buffer solution was M HCl solution into a 500-mL flaskandbringing the flask to volume with water. `hydrochloric acid. "The pHofthe buffer was adjusted to 1.2 with The 0.1 M solutionofpotassium `hydrogen phthalate was prepared by dissolving 10.21 gof potassium hydrogen phthalate (purity 99+%, Sigma) in 500 mLofwater. solution was prepared by placing 2 mL ofa 0.1 M sodium `hydroxi The pH 4 buffer 0.1 M potassium `hydrogen phthalate solution into a 500-mL de solution and 250 mL ofa flask and bringing the flask to volume with water. The PHofthe buffer was adjusted to 4.0 with hydrochloric acid. The 0.1 M solutionofpotassium phosphate waspreparedbydissolving. 6.81 phosphate, monobasic (KHoPOy, purity 99.5%, Sigma) in 500 mLo g of potassium - solution was prepared by placing 148mL of a 0.1 M sodium hydroxfiwdaetesro.lu`tTihoen pH and 7 buffer 250 mL. of wtiheth0.w1atMer.poTthasespiuHmofpthohsephbautfefesrolwuatsioandjinutsotead5t0o07-.m0wLiftlhasskodainudm`bhriyndgrionxgidtehe.flaskto volume d pH: sig The 0.1 M boric acid (HBO) solution in 0.1 M potassium chloride (KC) was preparedby dissolving 3.73 g of KCI (purity 99.0%, Sigma) and 3.09 8 of H3BO; 500 mLofwater. The, pH 9 buffer solution was prepared by placing (purity 99.5%, Sigma) in asnoldubtiroinngiinn0g.1thMe flKaCslk an to d 106.5 volume mwiLthowa fate0r..1 250 mL ofa0.1 M H;BO; MThesopdHioufm thhyedrbouxfifdeer wsoalsutaidojnusitnetod a0.59.000.-mwiLthflask p`uWraitfeircuastieodnfsoyrsbtuefmf.erTphreepawraatteironrewsiasstiovbittyaiinse>d1f8r.o2mmaeBgaaronhstmeeaedmN.AANlOl pbuufrfeersDoliuatimoonnsdw`ewraeter -- csetelrliulliozseed apcreitoratteo fuisleterbsy. fTehreibnugfftehrrsooulguhtiCoonsmiwnegreSstteoiriezdaatiornooimtetremsypsetreamtsewith 0.22 ym 3. Equipment WpIanitdteoMrdieBoevaer AOWraMitSoenrCMbOotdMseoldLe2la530i043n5 Fore Reciprocating Wate Bats Stake, Motel 4682 tBSoaonlmiaacnttoirc Petes: Contig: BRMreaseneasrrocnAhMPoErdoe1!1000102,1100r0,B5r0an0s;onEpMpoednedlo5t2t00 Sorvall RTT GVlaorsiVnis FM10lumlTLlhabohvrisvlio,rltcfeasoei,s,carWnidmRspoip gwleasss sviustsoc(apveedlo)21witCh 2o0rm3mpTm boseep and smi B. Methods 1 Preliminary test 9f`:oT0hlelaopnwrdeedlatifmo3ir7neaarCcyfhtoerosftptwHhaes1.p2pH.erlTfeohvreemlesdat.mesetesd.ampA-- lpeprporxeipamraatteiloyn p1r0o0vmedgou5rr0eaCngasteeuadcyh--odfet--hseipoHs4.0, 7.0, sawoualtsuotciiloeanivgewhdaesadlaiudnmdteiodn.euamcThhofoeifl.sviiaxElitsgehwetneor1fe0tc-hremiLmvipaaulcstaopwcpeleradevewpdirgtolhcaestsshseveibdaolftsotrnoamdnoafl3ystmihise saofseptphtraDcaooyvep0rsedaLwumilnp.y cTaonhndetasrihenamikaneignnoiannlg1yc03i0gmhptLmsoafminpalptephsreowwpaertireaertewbrbaautpffpfeeordrwfweiirvteehdptaryhespaaalrteutdhmi(nauspmeprrfvoiepli,sasttuehbeemmbelpraegnrekasdu.irneF.toherBwitagththteevba.lte, tuwheeirewtautsreerdsbaastshpthiteoeDdbeaR yth0e blDaanyk5c s and thepls. Aotdhdeirdoofnnoaurllwye,rseixwrvaipaplecdonitnaianliungmin3ummLfgof aaTnphdpeprnoiopaplerssiin owotfehtreherectvhririaemlespvwcieaalrpsepewudesrewediatrhatphthepebeoqdutaitlniotamyolfcutomnihtneoulsme(pfQtoCula)tasncadomvppellraeecsdedrwiolihnithaeutgoacltavebedhaolgeootnhteDrafwyio.t.h eTThharetee mFoeoftauhsreuorfteestmhteesnuDtbsaatnya0dncooerffviarls.fTthheeseDesyer5vevdiaalraoglpeedottefrwQmoiCnbalstaainmocpn.lveiasTlhsl ewoetrherprfouogofcy kbetdhfeor tDoaoy. n0pDhaorys. dDeatyer5mivniaatlsi,ont.wo blank vials, an C vials were processed for oR 2 pH measurement and temperature. vuTbinhlcaeeappnwpHercdew,ahteshtemsepwaHrsueerrleedcdcteorongsdeDrweFaoa0sR fayrnodDapryoduc$R ed-- itnotbhee vviialasls -- s caonntaidningU2 pHTtrheeeadbmiufnTfgheewrraavsndiretcehuessteedst, TThhese ~ Company Sanilized. Doss no contin TSGA GBI - EE ------ ~~ bath was monitored daily. The water bath temperature readings from the automatic temperature control were checked and recorded in the study recordsdaily. 3 Analysisoftest substance tAofteearchthveiaplH, tmheeavsiuarlsemweenrte, mij 3200 pm. 0.3 mL ofdilutec rdedciatpipoendo,ftvohretexpedhosphafortteenflmuionruotseusr,faacntdancteinstniefcuegsesdarfyorfor ras added Hiteen wetting of after -- facilitates centrifugation. After centrifugation the the pelletingofthe material vials were uncapped and at the bottomofthe the supernatant was vial discarded using 2 manual oftetrahydrofuran (THF) pipetter. The remaining solid and sonication for 30 minutes. material was dissolved by adding 10 Approximately, 1 mLofthe THF mL swoelruetisounbjweacstepdlatcoetdheinsaamgleaspsroLcCedvuirael eaxncdepstubtjheecpteHd mtoeaLsCu-reGmPeCntanalysis. The blank samples The stogi --- olutionoro-- 10mL of THF. Thirty minutes of made by dissolving 0.15 oi(g-- sgnication were requirgg to completely dissolve dtpherb otpesrtiasutbestdialnuctei.onCoaflihberFsartteiosochnk.csatlaiTnbhdraeartcdiasolnifsbortraas tnidoanrda Sstawned-- raerdpsrreapnagreedd fforomca3c0h0i01ns0tawn1ce5er0eo0f0amnamdgce/eLsby, cailniebarratrieognrecusrsvieosn. of the peak height vs. standard concentration `was used to establish the --_ Instrumeanndtcoandtitiioonsn: L1CoCcluSSmaylnsv:etne: CRFIoiloDuwetmRencatTeoermpTereamtupreer: a: DInufaectCioanlVcoliuome: TASeigtyearnhgyetdlrHHoPfRu1r41i,0n70(.wTi3tHhm)Axg3e0n0tmRme,acWtaitveresIndex Detector (RID) 41 0mmCin S13o55umCtin Samples designated os the vial septum using a glass syMage. Neither `were processed by injecting 6 Day Qnor Day S samples mL acetonitrile were uncapped through before cwaanepdrpee1dvm,orLatonedfxetsdhuebfjoeerxctt1reSadcmttionwuLatsCe/strMoaSnnsaafnemarluryelsdfittsuof abe vor= tglseLxCr.alS,ubssepqiukeendtwliyt,htihnetevrinaalls were uncapped standard,crimp the analytical standard as used --_ he analytical refrigerated. standard and thweaisntuesrenlalasstathnedairndtewrnearle sptraendpaarrde.d The calibration standards were prepared fresh for iSntmoectkhsaonloultiaonnsd each calibration (w1e0r0e0smpg e] in 30/50% of -YY Gompany Sanitzed. Doss nt sontsin TSCA CB _ asgeceAtocnointsrtialn.t coTnhceenctarlaitbiroatnioofninsttearnndaarldsstwaenrdaermdawdaes iunsetdh:e r5a2n0ge fogs to2520Tnhoe fi califiationpecaukrvaerseaweorreicoonnstrmaocntietdourseidnfgoth ratio iginthedptehaekcaornecaenftorraitoinosnsm/ofzgio of Instrumentation and conditions: HMPSLlCansserarmsent: M20o,deMlic2r79o5m,asWsaters LCMooClbuiPmlarnea:Pmehtaesrs: LAunea 3r4 C18 2),20mm x 2mm BGra"mdTeiitamheran(omlin a ww Flow (mlinin) o1 3300 2 0 770 100 0022ss 035 6s 300 H 10TM0 o 003388 als CInojlecutminonTVeolmupmee:ra: Column Sieh: 0304C 2and6min -- MISoniPzataiorn maodme: Capillary voltage: E2le5ct%rospray, negative ions CSoounrcevoTteamgpee:ratures: o12v0C DDuetsaolAvcaqiuiosnitTieomnpeFraantucrien:: 3020TCBA: SIRof463, 509, 523; 04 min * These ons repose D-82 TBA: deprotonsed SlIecRuolafr4o6n5,-- 514, 528omz; 06 mifnormate si -- oCfosmcpcntoantreenatndilnohrefom-- robmialteipn hheasystem inationgrfmom oer methoSdsOatTrfemron etceosnysrande oee ytse 5. Calculations The follgying calculations were used S vial andSi bbsequent1l-4y).diFssoorlevexdamipnle1,0 to determine(pe miLfo0f.1T00H9 gFof nominal concentrations f-- dMing sample processin, trhaiss woWueligdhedreipnrteosethnet bthyedniovmiidinnagltchoencmeenatsruarteiodncoofnc1e0n0t.r9atmigo/n0b.0y1thLe=n1o0m,i0n9a0lmcgo/nLc.entTrhateiopne,rcteinmtersec1o0v0e%r,y is calculated . fTohle3lgyesx:pTeotcthtaeed4vo5(lnouummLienoaoflf)1e0cx2to0rnamccetnitsr9agmoLn:o3ML.poifkebTupfirfneertsheaennsidpsi64km.e5dLLsoaxfmapcle1et0so2nw0iatnseglc/.aplLcT=ulh4aet5ee9dx0paensctltdl Company Saniized. Doss not contain TSCA CB eT ---- ~ `nominal concentration o the extract is: 4590 ng/9 mL=510 ng/mL. The percent recovery is calculated by times 100%. dvidingthe measured concentration by the nominal concentration, `The ydtgipoectledicgoendcecnatnrabteioenostidmatepd imn .the ftohleloawceitnogniwtaryi.le extract if 10%ofth Ten percentof 10i0g of presents 10 mg. Taking into account that the test fluorine and aSsuming that all fluorine is. present in the formofbounc jtance contailf 38.8% the 40 m64g.o1ftmgh/emmtoesltes)u=bSs5t.a5n6ceowlgyld releaseT:hi1s0 memoguggx o0.38%/(324 hydrolysis of "o/umlmdoble contained in 9 mLs ofextract. Therefore, expected concentration of 618 mg/L. ould be: 5.56 mg/0.009 L= The concentration of `extraction, is: 10 (1780 pg/L). mgof contains residug) ferived from raw ae mt in the Xtract, expected, assuming maximum complete (0016%/100)/0.009 L= 1.78 mg/L --~ Company Sanitize#4 D098notcontain 14 cg RESULTS AND DISCUSSION T`rTehacebolvaeevsreir1e-as4goepbrpieeasriecnneetndtthfreoerrceDosvuaelrtyis0esfaonfrodmrDetaahseyuDr$aerydepc0loiancncatedenDtsraaaymtpi5lo,enpssH< fo1r.p2Hrep1l2-- i,ca4t.e0,Sa1.m0p,l0es a0refuspecpteivrecleyn.t D10a1y15,.p2H%4.a0ndrep1l0ic1a%te1s.a0m%p,lreesspaercetiv1e0l0y.= 0T.h5e%aavnedra9g7e+pe2r.c1e%n,t rreecsopevcetriiveeslyo.rTthheeDaaveyr0agaend p1e0rc0ent0.r8e%c,ovreersipeesctfiovretlhye. DThaey0avaenrdagDeapey5r,cepnHt r7e.c0orveeprliiecsatfeorsatmheplDeasya0rean10d1D=ay1.53,9%pHan9d.0 rtehpelDicaayte$saanmdplDeasyar0ec1o0n0ce+nt1ra.t0i%onasndoft1h0e4%te2st.5s%ub,srteasnpceectwiaveslylags. Ththeanrel1a0ti%vefodrifafneyroenfcethbeetween iinnvveessttiiggaatteedd pHs. pHs. TFihgiusriensdi|ctaote4s cthoamtptahre the LC chromatograitf sofhyfdoruorlyrteipcliaclaltyesstoafblDeaayt 5 sreasmppeclteisvewliyt.h tThheecshhraopmeaotfotghreamcshorfomtawtoogcgaglpihbriactiopneas,taenldutairndgs ffroog r pH7 1t.o2,114.m0i,n7u.t0e,s9,.0is, indicative oL hfathpe oms ofltechulegg Rhwyeimgahtrdeedsuiclsattlriiinbbrucathtiaioonnongresaofnthdeed-- obs- cgye-- d --peak) sha- pe. `CTo. hmephayrdirsolohynseiosDfaotyhfe3pesaakmples indicates that no evident changeofthe peak shapeTor Days samples WS obseryed for anyofthe ~ sitnavbeislittiyg.atFedigpuHrse. $ 7.0, 20d 9.0. Tphriessefnutrsthtehre sLuCppcorhtrsomtahetocgonrcalmussoiofn.the-- Day 5 blank samples 10 pH 1.2, 4.0, `Additional evidence supporting the hycrolyge stabilityo from the measured tration "gal 7: ydrolygs of bederived ould `BAassseudmionngtthheatchtahrectbeurfifzeartieoxntrdaacttas,atlhethteg substance experiment, the expected concentration Of contains iit intghetpherotciemsesoefd hexytdrraocltyt(i3cmstLabbiulfitfyer and co6nmceLntacreattoniiotnrili e) g vould. pe 1t.h7e8 emxgtr/aLct(,siefe10%B.5 Cofalfulations). Similarly, ghe expected vas hydrolyzed, is, d6tah1te8aemxstghr/oawcLtss(asfcoseriBgD.n5aifyiCca0alnactunidtiDoanjgypsre)as5.e, reTpalbilcaetse5s-a8mpprolenescTMsenfiorrtaphteHiomne1.ai2ns,ut4rh.ee0,dD7ca.oy0n,c$9e.sf0ar,marpteliseopsen,cstwii vheelny.y thTeh. e caovnecreangteractoinocnesntrreaatcihononoly some oftohre Dexapyec0t%eidndleDvaelyof$fsualmlpyleexstraarcetecompared. JHowever, the 1780 ug/L) and t1h0e%seofatrehaeptpersotxsiumbasttealnycetwwoouolrddehrysdorfolmyazgen.itTuhdeeilnocwreerastehoafntthhe goncelngations Zxpected when cenigationdbgtveen thgDay Qand Day 5 samples is simply a resultof extraction of1 on a pmeeracseunrtermeecnotveirnyttrheheseuDhlatyysdro 0olayngaic sDtaayo iltsyamepxlpeesr5if-mo8re)nastlluapipnveoelrsettvigtaahtteeeddvatleipmdHpiset.yroaftTuthrhee DayG05C osrafl37eC). The percent system recove during rtyherehsyudlrtoslydteimconsstatbrialtitey that exp enroimseingtn.ifiFciagnutrleos6s sh ow s representratiive from the test calibration ~ CompanySatized.Docsnotcontain TSCA CB) -- -- Dcuaryve0,opbtHai4.n0 etdestt@amRplLe,YandFiDgaurye0s,7p.H9 s4h.0owblcahnrkosmaamtpolger,aemsspoocfivleliy orsion standard, t`T0hae.b1wleaCt9.ersubmamthartiezmepsertahteurweatwearsbamtahintteamipneerdattutrheedastpaecfiofripedHle1v.2e,l 4w.i0t,h7d.0e,viaantdio9n.0n.otInexaclcleansdiensg, v`4T.ea0sb,tl7ei.g01,a0tasenuddmpm9.Ha0s.riwzTaehssearmeetshaulstussropeefdctihpfeiHePdfHonrommDeiaanysa0ulrlaeemnvedelnDtwasiytfho5rtrDheeaplydiecv0aitaaetnisdoanDmspalneoy5ts samples for pH efoxrcealeldoifntghe 0.1 1.2, CONCLUSIONS `The hydrolytic stability of % was testedin buffered aqueous sglutions at PH40, days. The 7, 9.0 at 50C and pH 1.2 at 37C for Te conditions." Thestabilityaf the demonstrated be hydrolytically stable under these test vas demonstrated by the comparison of cthhreopmeartcoegnrtarpehciocvepreieask osf hape for Day 5 samples. ThreDadiyff0raenndceDianype5rcseanmtplreescoavnedriaensaloyrsiDs aofy0 ~ concentrations of ted an frerease or nent between Day 0 athnedtDesatysu5bsstaamnpcleesfodriadnynootfretahcehintvheesctriigtaictaeld lteevstelocofndi1t0i%gnst.hatIwnouglddditiionnd,ictahteemtehaeshuyrderdolysis of and Day5.Theincgease Of th onceniraticaonbe accougtedforby the presence of atphperorexsiimdaut:ely two ordJnertsoheftmesatgsnuibtsutadnecEl.oweTrhethiannctrheeasceoofncentra ire entratignpoies if 10%ofthe test substance hydrolyzed. RECORDS AND SAMPLE STORAGE NSepweacrikm,enDse(liafwaaprpel,icoarbalte,Irroan wModutnat,aainndRtehceofridnsalMraenpaorgtemwielnltb,e Wrieltamiinnegdtoatn,HaDseklealwlarLea.boratory, REFERENCES 1. Noi. GOurigdaenliisnaetsiofnorfoTresEtcionngoomfiCchCeomoipcearlast,iHoyndarnoldysDiesvealsoapmFuennctti(oOnECoDf)p.H, MQaEyC1D2,Gu1i98d1e.linOeECD _ -_-- CompanySaiize. bosetconten 5c car S | O = --~ --] DuPont-13202 TABLES Compazy Santzed. Doss not contain Tsca ca) ee eee e eee Tw ~~ Table I: ADnaaylsyt0ic(a1l0-rSeespu-lt2s00f3o)r aaqnude5ou(s15s-tSabeipl-i2ty00of3) H1.2,37C, [on on]. Cm men] rT Tr rt Co oa] Fe oT ow Feo mT ee ww] aww == Fe ETT ew ww comp Sn. smi son Lee ~~ Table 2: DAnaaylsyt0ic(a2l8-rAeusugl-t2s00fo3r) aaqnudeou(s02s-tSabeipl-i2t0y03of H4.0, 50C, Fe ww | EE Fee ComperSnoes cssn -- Table 3: Analytical results for Days 0 (28-Aug-2003) aqueous stability offZonyl and 5 (02-Sep-2003); 8300-82sotadfpn 7.0,50C, Fr % Ee e Feo Feo T a oe w oa a] ] Fee I CO CN on TS ae] Ny FET == mw] Fe Fe wm oe wa] ae] Fe ow 5 ~ | == -Y Gompany Sanitized. Doss not contain TSCA CBI NN-- ~~ Tabled: Analytical results for aqueous stability of Days 0 (03-Sep-2003) and 5 08-Sep-2003)" ... pH 9.0, 50C, I].[Emam Htr= a i oTT= w Tw I F F Ee om = m e T Te w = m w] ] ~ == " ou Pa Company Sized. oes not conctaeona --~ Table 5: Measured concentrations -- PH 1.2, 37C, Days 0 (10-Sep-2003) and 5 (15-Sep-2003). Le Looy|o|]cSS ml ||crfli[o] o | E -- er er r r r t CC oo T] C I rr ~ E T r -- [ECaTfroeT rw e r a T s t ] ] C [r eT ---- T r T----a&T r --1--a--| CrTm ~ Ce TT |-- -- e C er e t t e C C rrT TrTToemer oTr T C [ Ee] e w T lw ea w o s] C C TT or T r ec gpyy Een ews ry ~~ Company Sanitized. Does not contain TSCA CBI Ite. --~ Table 6: nMeaasu0r3e-dSceopn-c2e0n0tr3a.tions -- PH 4.0, 50C, Days 0 (28-Aug-2003) [Jono]Emme |Emme| Cee [eo Tov Tm --T [oom Tw 1 [oo Tw 17 [eo oT TT rrr rT [TT1 weeTw 17 r [TTTomtom |r [[Ceooo [foofaeeaa]l]w 50w T w& w w T ] 9 || TT 1 TTmeT w To] [| swhwoisw | 2s] ~ e e 1 o w we 1 || e [oTw s T ws T CTT ETTT wee | wo 17] [1TV soso J0]1] rr rr r 1 [ro IsTeal wo "T --w T7 ] [eo lsleal wo Ta 1% [so [sfea] 7s Tw T7w | TT ee se ay rE C ea r T t swsioT ivin| 21] ~~ Company Sanitized. Does not, contain TSCA CBI -_--mk58m-- @m- oy Table 7: Measured concentrations of PH 7.0, 50C, Days 0 (28-Aug-2003) and 5 (02-Sep-2003). Lo [|| EmEme)l|mmy e | rrr [oe Tov1] [re fos [oT 1 | Fe oT 1] rrr 1 Trew m1-- ee[5| rrrT [oo ode 0| 5% Tw | [ro Toleal 0Tw || Se 11[11 TT aw | --~ LT Saimin| 20 [ TTT Tw [oe ssw [ose | rrr rT C ew T toi |20] 1 TT [ooTefen T= Tw | [ro lsTea 0Tw |o [lsfel Tw Tw Tw] rrr TT eww] C1 T seioem |5 E + QC1,0Cn2dy Qe fe Te A y cm ea ch _ com Stott nn ~ Table 8: aMnedas5u(r0e8d-Sceopn-c2e0n0t3r)a.tionso(Mor pi 5.0, 50C, Days 0 (03-Sep-2003) LaLu] |[ e ad| f r eo r f[o2o [ToopTe] Tw[ r F r ee T r tesmi 6 F oT rew fooT rroo J el-- e -- agrE ~ FT Te iow 0 rrr [oo [oo 1% Fe [oo os [oo rr FT ee F Cr e ro r [oo fo l eee 1 wTm % --%--] [r oe ole r JTr w] C YE T Y ewivS omn 5 2 ] tactacome 1oe es cc, rm - Company Sanitized. Doesnot contain TSCA CBI Pe. Table9: Dailytemperature readingsoftheshaking water bath. Dupe Tfon) C C Ce o aTTT v hoaw mwTmmi]]| ase ee] ES AT=S BT T Coo oTm omo To0r]] OS---- ~ C T CT o 0TTT eommm eeTTa oo]] T ET ITT S T rw=w rwTe] I Co --m -- mTw] C C C oom To T wom wm|[Tseee]]] CTTamm Te --~ companySeiuve. ze. p0o%sanetcanainTSG aco ~~ Table 10: pH measurements for Da0y and Day 5. (-- 1 71 TT oT ws Tm] TT Cs TT = T=] Tw] 1 Tan] --10 1 Ta] Tw Cs TwTa] 1 [TT] Tw] Te TT 6 71 Tw] T TT T w T ] wm Te Te TT TT] Ts Tw Tow TT ~ ps-------- T T T T] uw Cs TT 5 Cs1 7 50 908 ") --~ Dupont 13202 FIGURES COMPANY Santizeq, page ot contain Tso ogy TT --_ Figure: LC and chromatograms 15000 mg/L (C) of four Day calibration 5, pH12 sonar te samples (A), 7500 mg/L (B), er If] EEsiEEEEay -]| |1 - -|J = { c Sa BA NA O || 7/ \Nlf } Ji } fi Figure 2: LC and chromatograms 15000 mg/L (C) ocfalfioburraDtiaoyn5s,tapnHda4r.d0srG eplicate s-- amples (A), 750 mg/L (B), | " ]i 1 | | = 1 EE - c Na A ~N A\ B JUAN 1 // V\ o)fl ) WA { | mses Company Sanlzad. Doss not contain Toc ca ~~ Figure 3: aLnCdc1h5r0o0m0amtgo/gLra(mCs)ofcafloiubrratDiaoyn s5t,apnHda7r.d0srej -- ite samples (A), 7500 mg/L (B), | Su \ ! A\ 1 - B \ I/ / \{ -li 7 \"Ah .| AN[a| rp me ~ Figure 4; LC and chromatograms 15000 mg/L. (C) of four Day calibration s5,tapnHda9r.d0sreplicatte saimplens (4--), 7| 500 mg/L (B), FEE eee SEREEEEEE ER E E = =|| wd | 4 -- _--_-- BAL aN Sa i / \i /}/ \\ J | |i `Company Sanitizad. Dos not contain TSCA CBI --_~ Figure 5: TReoprmesaent5a0t.ive LC chromatograms of blank samples for Day 5, pH 1.2, 4.0, - EEEees -| i !| - | | I i"| i IA| Ry ~~ Company Sanitized. Dossnot contain TSCA cB] TM Figure 6: Representative calibration curve or alebrraoatiiononnocrnaero: e1.1r35f=6308i5x856.c7011,l6722=e0.n997t343 supnoenSspee:tLoiene:arn,loimanl SiE(xcRuedfe,2)W.elrgehain"g(.1SaCodncs./1FSaAner:eao)ne DuPont 13202 ~ - 5 5re0 1000 is- o oo ganpot --_ Figure 7: aRenpdre5s2en0tapytivg chromafoignrtaemrsnaolfs2t5a.n5davrd7. A vrson standard [052803573 Smosh) 1. 207 082o503513 Smoot 15) 100 = s4s2s1 [a e7111502 Sold chann4e6l5s.5253 400364003 | 50 - SRot channelsm5i.n 750i3o50.1050235 ob 180 ah SR :ah ah abie -- - CompanySeniizod.Doss no:conten sec ci --~ Figure$: Representative shromagggrams for Day 0, pH 4.0 hydralytic stability sample .i: 5363 152104005 E "4: TS . &E2-"~n 7 emiintimessin| 0 ET E Tr > T min) ~ -- = Srwm Figure 9: Representative chromatograms for Day 0, pH 4.0 blank sample. . TT NR primarryy |* | | 5 7% pry ry ry comp sat DostcoaTSCAGE!