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3M MEDICAL DEPARTMENT, CORPORATE TOXICOLOGY
Protocol for Study No. T-6316.17, T-6295.21, T-7132.3; ST-41
`Derivatives. "SThtiusdsytuObdjiecstdievse:ignedtogeneratespecimensforthe 3MEnvironmentalLaboratory Fluorine Analytical Chemistry Team to usefor development and validation amethod of
Research Client:
3M Specialty Chemicals Division
3M Center, Building 236
Saint Paul, MN 55144
Sponsor:
33MM CSepnetciearl,tByuCihledminigca2l3s6Division
Saint Paul, MN 55144
StudyLocation:
3M Strategic Toxicology Laboratory
3M Center, Building 270-35-06 room SB314 Saint Paul, MN 55144
|
Study Director: Andrew M. Seacat, PhD.
Toxicology Specialist
33MM MCeendtiecra,lBDueipltd.i/nCgo2r2p0o-r2aEt-e02Toxicology
Saint Paul, MN 55144
Ph.: 651-575-3161 FAX: 651-733-1773
Study Taxicologist.
ADdevaannncaeLdueRbekseera,rcMhSToxicologist 3M Medical Dept. / Corporate Toxicology
3M Center, Building 220-2E-02 Saint Paul, MN 55144 Ph: 651-737-1374 FAX: 651-733-1773
ProposedStudy Timeline: ITno--LLiiffee EStnadrtDDaattee::WMeodnndesadyaNyoNvoevmebmebre2r2,241,9199999
TRheigsusltautdoyrywiClolmbpelpiearnfcoer:medinthe 3M StrategicToxicologyLaboratoryunder adefined pTrooxtioccoolloagnydLcablGaLsP sParsioagfr"aCimlaPesrsodBcedSutrued.y"asexplainedin TOXSOP0950, Strategic:
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T3617, T6295.21; T7132; ST41
Test Material: fDuemnisHhaekdesh,igPhr-opduuricttyRNe-spEotnFsiObSiEl,itPy FLiOaSisaonnd3PMFCOhSemAitcoaltsheDiSvtirsaitoeng,ichTasoxpirceovlioougsylLyab.
Identification: Name: Npe-rEflFuOoSroEo:ctNaanresruolwfoRnaanmgideoNe-tEhtahnyoll, FM-3923. * PFOS; Perfluorooctane Sulfonic Acid, Potassium Salt; CAS # * P27F9O5-A3:9-P3erfluorooctanesulfonamide Molecular Formula: * PNF-OESt:FOCSiEF:/C08SF01;7KS"O2N(CH2CH3)CH2CH20H PFOSA: CiFirSO:NH,
Lot
Number:N-EFOSE: one sample.
Lots
30035,
30037,
30039
mixed
and
analyzed
as
PFOS: Lot #217
* PFOSA: L-10009
Parity:
+
aNnEdtDFSOCSEt:ech9n8i%queass(d1e)termined by GC, GC/MS, *F-NMR, "H-NMR. PPFFOOSS:A:>99% as determined by "F-NMR (2). Analysisby GCMS determinedthatthestaringmaterialwasover
Qu9a9li%taptuirvee(a3)n.d quantitativecompositionalresultsthatwerederived tfhraotmtthheecsoimnpgolseittriiaoln'wHa/s'*6F5-.N8M%RCcFr3os(sC-Fin2t)exgr-aStOio2n-aNnHal2ys(iNsorremvaelaled mchoanion)m,e1t8h.y7l%bCrFan3c(hC)F,21)1x.-2C%F((CCFF33))2-C(FC-F(2C)Fy2-)Sx0-2S-0N2H-2N(Hi2nternal b(rIasnopcrho)paylndbr0a.n2ch8)%, (3C.F5:%):CCx{FC2Fx2+)1--SCOF;(-CNFH3)(-tS-B0u2t-yNl Hbr2a(nAclhp)hda). pHpPmLoCf/PMFSOcSh,ar1a,c1te0r0ipzaptmioonfofCt;hFe1sPSFOO:SNAH,sa5m1p0leppremveoafled 9,600 C`CuoaFiFssSOH0S:NOHNs,H6,,610,020p0ppmpofmoCfaCF FOH1;S5NHH;S,O,NH2;4,a0n0d0lpopwemrof `icmopnucreinttireast,itohnesopufrsietvyoerfatlohtehPeFrOamSiAdessa.mBpalseewdoounltdhbeesaupmproofxtimhaetely 96% (5).
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T316.17, T2952); T-71323; ST41
Stability: Documentation will be kept on file. TeCShtsaotrramacagtteeerrCiiosantldiwicitsli:lobness:toredtightlysealedatroom temperature.
tIhnefotremstatmiaotneroinalswyinltlhbeesiksempetthoondsfi,l.composition or other characteristics that define
AnimalsS:pecies: Rat
Strain: Sprague Dawley
Source:
Harlan
A`gWeeiagthtiantitiinaittiioantiooftnroefattrmeeanttm:ent:
NumberGRanOdUsPex1:: cont1r2olm,alne=s3
GGRROOUUPP 32:: NP-FEOtS,O1S=E3, 1=3
IdentifiGcaRtOioUn:Pu4n:iqPuFeOtSaiAl ,manr=k3
a9p-p1r1owxiemeaktsely 200-250g
Husbandry:
HousiAngl:l ratswillbeindividually housedinwire allow for collectionofurine and feces.
bottommetabolism
cages
to
Diet/W`aHTtaeerkrll:aadn,TMealddiasdonL,M-W4I8,5anMdotuaspew/aRtaetrSwtielrlibizeapbrloevDiidete,d tsuopaplllireadtsbaydHlairlbaintum
Environthmreonutg:hout the study.
Etenmvpierroantmuernetoaflc72o.n4t3rolFs,ohrtuheamniiomfad3lr0io-o7tm0%yw,ilalmbienseitmutommoafin1t0aienxcahanges
ofroomairperhourand a 12hourlight/darkcycle.
DoseandDosing Procedures: MethoAdloflardamtsiwniilsltbreadtoisoend/vDioasoerparlegpaavraagteioonn:dayzeroofthestudyusing a vroelceuimvee oasfin5gmlle4d0os0imnggs/uksgpdeonssieonof/Nk-gEbtodFOySwEei,grhatt.siRnagtrsoiunpg3rwioll2ruewcipelilve a1s0i0ngmlge/1k0g0dmg/ookgfdPsoFsOeSeoAf.PFUOniSfaonrdmrsautsspienngsiroonusopf4wNi-lEltreFcOeiSvEe (as8i%n;g8l0e mugs/inmgLa)a15n-dmlPtFisOsSue(gr2i%n;d2er0.mgR/em-sLu)swpielnlsbieopnroefpaPrFeOdSina2nd%NT-wEeteFnO8S0E seoalcihdssawmiplllebiespedrrfaowrnm-eudpwiintthhe5ssytrrionkgeesfoofrthdeostiinsgs.ue grinderpestel before
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T316.17, T6295.21; T-7132.3; ST41
faPcoFertmOoiSnneAg,a(2n2e%%;Tm2w0euemnli8ng 0s.2%Rwi/eTi-lwsoluem bseenppnerL n8es0piaot)rnooeadffibPnyFadOlcSioAnsscolesidinsontwairllcaleotvtbfoein1ipeo%e,nntrfhgoernmed gbA ayvapgs uemtpoi5inrmgalttsn /hikenggemg brnooidulsypl iwoe1noite nghhdrotauygdzhoestrehooesofyfvretihhniegcseliteumwdmiyel.dibTaewtaoedloyfmtbihefneoriraetssdtovwseiiilanroge.radl reTcweeievne820%. Tween 80and 1willreceive amixtureof 1% acetone/2%
ObsCleirnivcoafalAOtnbisimearolvasnt:ions:
Efiancdihnagnsiwmialllwbielrlecbeoorbdseed.rvAeddidtaiolnyaflofrimnodritnaglsiwtiylalnbdermeorcboirddietdyaasndthneoytaabrele
observed.
Body`WEieaicgmhhtamnsi:mealpdwriiilolrbtaeoweteuitgheahneladsiiymam.ediatelyprior totreatmentand
FrequeOnnceycaonndtrNoluamnbdeornoefPAFnOimSaAlrsa:twillbesacrificedonday remaininganimalswilbesacrificedonday 2-postdose.
1 postdose.
Al
SpecimMeentChololdecotfiSopne&ciAmnealnysCiosl:lection: Unrdintewaonpdofsetcdeosswei.lTbheecionlilteicatlevdoflruommeeoafcuhrmienetawbiolllbisemrceacogredeodnd,tahyessoidnees `eoafttehreuarnidntehceolfliencativoonluapmpeaorfatuursiwnielwliblelwbaesrehceodrwdiedt.hD5a-i1l0ymfiecdeesiwoeniisgehdt An`newiiclrmloabpelssyr,wie bllloc boedefo u(ot=rhr 6aemnaiicd z)hewadie nbliylmd balCe.Oco;lalnecdtgerdovsisatnehceraobpdsoympienraflosromretda.aDnudring twrialnlsbfeerarleldotwoebdltooocldoctoflloerctaipoenrtiuobdeosfwi1t5htoout3a0nmtiincuoatgeuslaanttr.oBolmoodsamples at$nemdmipcneeurntatetrsui.rfTeuh,geeadsnadegtrahuiemncwalitolt2lwb0ie0lt0lrbxaensgspfteuorrnredemdotowovnleiaabnneyalcreeednm1ta.ri5infimunglgemriaectrdob1fl1u0og0eoxdtcg euflbloessr,
Eascheserplaasbeaalmepdlrpeowliaylprtohtpenylbeeendeimviicdreodfiungteotu2ableiaqnuodtsf,trranosifnezrdrreeydicne0..2.One alaniaqlyusoitsw. iElalcbehulsiveedrfwoirllmbeteaebxocliisteedaananldyswiesiagnhdetd.hTeohtehleirvfeorwribilobcehfelmaischal rfermoozevneidnalniqdusitdnoirterdoagten~.70AsCmfaolrlsmeecttaiboonli(taepapnraolxyismias.teTlhy e3grreammsa)iwnildwlebirel salbcieqruisiftdinocireetddrooagnted-n7af0yor2Cf-upftooursrtbeidbooicsohecewhmieilcmlaiblceaalenaxlacnyiassliyses.diKs,,iwdeniegyhsedfaronmdfalnaismhaflrsozenin
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T3617, T-29521; T-1132.3, ST41
,
Specimen Handling:
tAelmpluorrianreialnysdtfoerceedsaatnd-t70hCesienrtuhmeaSntdrlaitevgeircfToorxmiectoalboolgiytLeaabnoarlaytsiosrwyi.llFboer:
analysis,thesesampleswillbepackedindryiceandshippedto:
K3riMsEHannsevn, Pih.Dr.TecohnonlogmyanedSnafettySearvilces 935 Bush Avenue
TSte.lePapuhlo,nMe NNo:55615313--737383-16081, Facsimile No.: 651-778-6176. tAhlelSktirdanteeygisepeTcoixmiecnolsoagnydltahb eforrebmaiioncdheermoifcaslearnuamlyasnisd.lTihveersweislplbeceikmeepntisn willbestoart-7e0dC.
`fTohlelomwusm:ber,type,anddateofspecimenstobegeneratedfor analysisareas
TABLE 1 ~SpecimensforEnvironmentLabl
Emvironmental LabSpecimens
|Uiie [Fees
[12 [12
T-- 30 ----5
Tio
[3]
[v[seeme 7TT o o TwT] 11]
SSpetcrimaetnTseaxgLiacb[[o oSeem 12T To] 115]
[Kids 7
Two
T10]
Data Analysis: Allresultswillbeprovidedforinclusioninthe finalreport,
RDeanea scpoolnlseicbtiilniLgtuiiene-sbl:kiefersapnecdiAmnednrse,pweSrefaocramtiwnigltlhbeenreecsrpoopnssiiebslaefnodrcdololseicntigntghaenandismeanldsi,ng tAinsdsureeswSpeaecactwifiolmlrdarenaaltnysaissfi.nalreportandensurethereportreceivesappropriate 3M
reviewbefore afinalreport isissued.
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Signatures: Dr. Andrew Seacat Senior Research Toxicologist Study Director Jracsmiacy iat Deanna J. Luebker, Advanced Toicologist Study Toxicologist
T4316.17; T-29521; T-71323; ST-41
Date
7
1/24/99 Date
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T316.17 T2952); T7123; ST41
(
References:
1. PayfTerw,oR.YeChaarrFaceteedriinzgatSitoundoy.fFSM-M3D92A3na,lyMtiicaxl RteoqufuLerosttes#5320408395., 3A0n0al3y7ti&ca3l0R0e3p9ofrotr# 816, 6/23/97. 3M SMDLab Building 236-2B-11.
2. KestSnpeer,ctTr.osFcuoopryocRheeqmuiesctal# I5s3o0m3e0r. D3isMtriSbpuetciiaolntbyyAd"hFe-siNvMeRs &SpCechtermoisccaolpsy.Analytical Laboratory/ SMMD-236-2B-11, December 1, 1997.
3. Payfer, R. GC/MS analysisofPFOSA (L-10009). SA&C Analytical Request No. 59426. Report 9/24/99. 3M SAXC Lab Building 236-2B-11.
4. SpKeescttnreor,scTo. pCyhReemqiuceasltCh#ar5a9c4t2e6r.iz3aMtiSopneocfiaPlFtOyASdAh,esLi-v1e00s0&9C,hbeymi1cHaalnsdAn1al9yFt-iNcaMlR. Labo/SrMMaD-2t36o-2Br-1y1,September25, 1999.
5. DeRoos F. CharacterizationofPFOSA Samples, T-7132-1 (L-10009) and TN-ACo1r58p4o.rRaetqeuAensatly#tiAc-a1l5T1e2c5h4n.olRoegpyoCretnt10e/r7,/B9u9i,ladinndLge2t0t1e-r1a2d9d,enCdAuTmtCo--report 10/14/99. Chromatography Group.
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