Document zQzX1aqJy8Zq6QdGb161gdMJ0
te
SRPT 71149
MEH 27383)
-
Study No. T-7098.1; DT35
Title:
Pharmacokinetic Study of Perfluorooctanesulfonyl Fluoride (POSF) Following a Single Oral Gavage Dose In Rats
3M Strategic Toxicology Laboratory Corporate Toxicology
3M Medical Department 3M Center, Building 270-SB-314
St. Paul, MN 55144
Final Report
January 31,2004
2 x
53 aR
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5
Study Director: Andrew M. Seacat, Ph.D.,
DABT, Toxicology Specialist
Study Toxicologist: DeannJa. Luebker, M.S.,
Advanced Research Toxicologist
Sponsor: 3M Specialty Chemicals Division
3M Center Bldg 236 St. Paul, MN 55144
TE 1257
2
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o 0F9in8a.l1R;epSoTrt35.
Summary
Rpaetrsforremceedivoend daasyisng1l,e4o,raalnddo2s9epoofstSdmosge/. KPgOSpeFrfwlausormoeotcatbaonleisuzlefdotnoylPFfOluSoriwdhei.cNhewcraospsmiaexsiwmeurme
ipnretsheentliivnerseornadaatyap4pproosxti-mdaotseelyatoanpeprtoenxtihmoafttehley 1l1evpelpmf,ouonrd~in1t0h%e loifvetrh.eTdhousse,. PFOS was
ppeerrfflluuoorrooooccttaanneessuullffoonnyaltef(luPoFrOidSe)(bPyOrSat)s
was absorbed following and
and oral
metabolized dose.
to
Study Objective
`cTlheearoabnjceec,tiavnedofbitohliosgisctauldpyewrsaisstteonacseosefspsetrhfelupootreonotcitaalnefosrulofroalnyalbsfolrupotriiodne,(uPrOiSnaFr)yiannmdafleecal SvaprriaegtuyoefDpaewrflleuyorraotoscatafnre asuslifnognlaeteor(alPFdOosSe). baPsOeSdFmaitsetrhiealsst.arDtiantgamgaattehreiarledfoirn tthheisssytnuthdeyshieslop fa dcheafriancettehreizraattieonooffmePtOaSbFo.lismofPOSF to PFOS by the liver and provide data for proper risk
Method Summary
`(T1h)iassntdudcylaswsaifsiepdearsfoar"mCeldasins tBheSt3uMdyS"traasteegxipclaTionxeidcoinloTgOyXLaSboOrPat0o9r5y0,unSdterrataegdiecfiTnoexdicporlotoogcyol Lab GLP Program Procedure (2).
Briefly, the procedure was as follows. Thirty male Laboratories), 6-8 weeks in age and approximately
Sprague Dawley rats (obtained from Harlan 150-250g, were divided into the following
dose groups:
Group
DosePOSF ~~ N
1 2
0mgkg
5
Omgkg
5
3
Omgkg
5
4
5mgkg
5
5 6
5mgkg
5
5mgkg
5
Euthanasia day I post dose day 4 post dose day 29 post dose day 1 post dose: day 4 post dose day 29 post dose
Rmagt/smrLecPeiOvSeFd esiutsheprenasi5omn inK2%doTsweoeefnve8h0ic(lfienaclondtorsoel =(25%mTgw/eKeg)n 8v0i)a,oorarlag5avmaLg/eKognddoasyezoefroa o|f
the study. cages for
Three specified rats portionsofthe study.
fUrroimnegaronudpfsec3esandwe6rewecroellheocutesdedoninddaiyvsid1u,a2l,ly4,in1m4,etaanbdo2l9i-spmost
dose. Necropsies were performed on days 1, 4, and 29 post dose. At necropsy, liver and sera
were collected from each animal. For metabolite analysis, these specimens were packed in dry
ice and shipped to Kris Hansen, 3M Environmental Technology and Safety Services for FC
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TF-i7n0al98R.e1p;orStT3S
.| aannaallyyssiiss. wLaisvneortapnedrsfeorramweedraenadnwaalyszceadncaenldedt.he raw data was reported (3) . Urine and feces
Results
`Treatment with PFOS at S mg/Kg had no effect on body weight or liver weight (Table 14, B)
Extraction and dosed animals
aatnaalllystiismoefpotihnettsiassnudeswsahsomwaexditmhautnPiOn Sthewlaisvedreotnecdtaedy
in 4
the liversof post-dose at
all
POSF
approximately 11 ppm (Table 2). Trace amountsofperfluorooctanesulfonamidoacetate:
(anPdFO4SpAosAt,-dMo5s5e6()Tawbelree2)a.lsTohreepoorritgeidnofforthlieveMr5s5am6plinesthferloimvePrOsSamFplteresatiesduannkinmoawlns,oannddaaylsl one
`%soafmptlhees wdeorsee nweaasrptrheeseprnatctiinctahlelqiuavnetriatsatPioFnOlSimoitnfdoraP4yFOpoSstAAdoosfe0a.s06calgc/ugl.atAedppfrrooxmimthaetesluym1o0f
the liver PFOS and liver PFOS equivalents from PFOSAA (Table 3).
`liTvheerPsFaOmpSleleevxetlrsaicntsthaendsewreaorfe mthaexiramtaslweornedaapypornoexipmoastteldyosoen(eTtaebnlteho4)f. thNeoleovtehlefromuentdabionltihtees
were day 1
detected in the sera. post-dose (Table 4).
Approximately
0.1
%
of
the
dose
was
present
in
the
sera
as
PFOS
on
Conclusions Tbhyersaetsdfaotlalsouwpipnograt stihnegcloenocrlaulsgiaonvatgheatdpoesref,launordomocettaanbeosluilzfeodnytlo fpleurofrliudoero(oPctOaSnFe)suclafonnbaetea:bsorbed (PFOS).
Page3of 11
TF0im9i.R1e;p5oTn3s
" Listof Tables
1. Table 1: Biologica1lAP:aramCeotnetrrsol Group 1B: POSF Dose Group.
2. Table 2: Liver PFOS and PFOSAA (MS56) 3. Table 3: Liver PROS equivalents and Percent Dose in Liver 4. Table 4: Serum PFOS and Percent Dose in serum
Pagedof 11
rpoosms
[Time
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rFinaal Rsepoart n Signatures: Prepared By:
Aras ssa folpla Deanna Lucker, MS Advanced Research Toxicologist Study Toxicologist
02 /az/200 Date
Ondhav
ATonxdirceowloSgeyacSapte,ciPahl.iDst. Study Director
7. Sarund
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Page 100f 11
- DFTinIal ReTpo0r9t 81 References
1.
3M Medical Department, Study No. T-7098.1. Number: DT35. Title: PHARMACOKINETIC
3M Strategic Toxicology Protocol STUDY OF POSF IN RATS.
2. 3M Medical Department, Corporate Toxicology Strategic Toxicology Laboratory Standard Operating Procedure (TOX SOP) No. 0950 ~ GLP Program Procedure, 1999.
3. HPahanrsmeancoKk.inLeatbiocraSttourdyyRienpRoartts.FLianbaolrRaetpoorrytoRefpDoarttaNof.orFPAOCST-FT(OTX--7109186..1)3M Testing Laboratory 3M Environmental Technology & Safety Services 3M Environmental Laboratory Fluorine Analytical Chemistry Team (FACT) 2-3E-09 935 Bush Avenue, St. Paul, MN 55106.
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