Document K6jkarYb71OyjGVQe2NLB4D3X
Larry R. Zobel, MD. MPH
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3M Medica Department
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3M Cente, Balding 20.26.02
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OfficeOfPollution Prevention And Toxics United States Environmental Protection Agency 401 M Street, S.W. `Washington, DC 20460
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Re: SUPPLEMENT TO TSCA SECTION 8(e) NOTICE ON: N-Ethyl Perfluorooctyl Sulfonamido Ethanol (N-E(FOSE) and Perfluorooctane Sulfonate (PFOS) Docket Numbers: SEHQ-0998, 373, 374, 394
Dear Sir or Madam:
On February 15, 2000, 3M submitted final reports for two-generation rat reproduction studies on the above referenced compounds. 3M had originally submitted a TSCA Section 8(e) notice dated September 14, 1998 based on preliminary data from these studies.
`With this letter, 3M is supplementing these earlier submissions as follows:
= 3Mis submitting an amended final report for the two-generation rat reproduction study on PFOS (Sponsors Study number T-6295.9). This amended final report supercedes our earlier submission. It contains several clarifications, including that there were no toxicologically important effects on pup survival or growth at the 0.4 g/kg/day dose level. The amended report also includes all data tables ~ both individual and summary.
= 3Mis submitting additional studies and documents which relateto the PFOS two-generation at reproduction study (Sponsor's Study number 6295.9) `These additional studies and documents are listed in Attachment A to this letter
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Page2 Section 8(e) Coordinator
April 20, 2000
Please do not hesitate to contact the undersigned at (651) 733-5181 or Dr. John
Butenhoff, 3M Toxicology, at (651) 733-1962 for further information.
Sincerely,
o2 W244 re
Larry R. Zobel, MD MPH StaffVice President & Medical Director
Enclosures
cc:
Dr. Charles Auer, Director Chemical Control Division
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AttachmenAt
Pperroitnoactoall/4p1o8st-n0a0t8alCroempbriodnuecdtioornalto(xgiacviatgyes)tufedrytioliftyF, OdeSveilnoprmatesnt(Saploannsodr's study number: 6295.9), Table E20, 1-3
Hianrdbu,ceRd.Vt.o,xicHiatry,tmmaonr,talHi.tAy.,,aannddcCaorxd,iaRc mHy.o(p1a9t9h4)y,iPnrperveegnntainotnorfaftlsubvyasmteavtailnonic acid supplementation. Teratology, 50, 19-26
Haughom, B. hyperlipemic
and Spydevold, O. (1992), effect of perfluorooctanoic
The acid
mechanism underlying the (PFOA), perfluorooctane sulphonic
acid (PFOS) and clofibric acid. Biochimica et Biophysica Acta, 1128, 65.72.
DLeevvienl,opMm.Se,ntaPlitc,haAnJgAes,inScthhweaerxtpzr,esAsiL.o,noEfdgweanredss,iPn.vAo.lvaenddinGocrhdoloens,teJr.1o.l(1989),
biosynthesis and lipid transport `Biochimica et Biophysica Acta,
in human and rat 1003, 293-300.
fetal
and
neonatal
livers
Final Report Protocol Rats (Sponsor's study
418-013 number:
Oral (Gavage) Pharmacokinetic T-6295.12), June 24, 1999
Study
of
PFOS
in
Protocol FACT-TOX-110 Protocol, June 8, 1999
Oral
(Gavage)
Pharmacokinetic
Studyof PFOS
in
Rats,
Final Report Protocol 418-015 PFOS in Rats (Sponsors study
nOruamlbe(rG:avTa-g6e2)95P.h1a4r)m,acJoukliyn2e3t,ic19R9e9covery
Study
of
Protocol PFOS in
FRaAtCs,T-PrToOtXoc-o1l,11JunOrea8l,
(Gavage) 1999
Pharmacokinetic
Recovery
Study
of
S3uMmTm-a6r2y95P.9F,OSArRgauts T4w1o8--G0e0n8e[riant-ilfoen],ReFpArCoTdu-cTtOiXon-0S1t2ud[ya(naSltyutdiycanlu]mbers:
6R2e9p5o.r9t)ACmoemnbdimneendtOrI,al13(GAparvialge2)00F0e,rtiPlriotty,ocDoelv4e1l8o-p0m0e8nt(aSlpoannsdorP'esrisntautdayl/nPuomsbtenart:al Reproduction Toxicity Study of PFOS in Rats, Final Report
CAnoanlcyetnitcraaltiLoanboofraPtootrayssRiepuomrtPeornfltuhoeroDoecttearnmeisnualtfioonnaotfet(hCeASPrNeusmebnecer:and2759-39-3) LinabtohreaSteorryumReapnodrtLiNvoe.ro<fU2Sp0r0a6g,ueR-eDqauwelsteoyrPRraotjsecEtxNpoo.se<d3tMo PTFOOXS6v2i9a5G.9a5v,age, October 27, 1999
C0C03
IDnitsetrroifbfuitcieonMebym'oFf-rNomMRToSmpeKctersotsecorptyo,
Leo Gehlhoff, December 1,
"Fluorochemical 1997
Isomer
`FainndalPeRreipnaotratl/PProosttoncaotlal41R8e-p0r0o8duCcotimobninToexdicOirtayl S(tGuadvyaogfe)PFFeOrtSiliitny,RaDtesve(lSpoopnmseonrt'asl study number 6295.9, June 10, 1999
Summary 014)
PFOS
Rat
Cross-Fostering
(Study
numbers:
3M
T-6295.13,
Argus
418-
Final Rats
Report Protocol (Sponsors study
4nu1m8b-e0r1:4,TO-r6a2l95(.G1a3v)a,gJeu)lyCr2o3s,s-1F9o9s9tering
Study
of
PFOS
in
CAnoanlcyetnitcraaltiLoanboofrPaetrofrlyuoRreopoocrttaonnestuhlefoDneatteerm(iPnFatOiSo)no(fCtAhSeNPurmebseern:ce2a7n5d9-39-3) in
PtheerfSleuorruomocotfanSepsrualgfounea-tDeavwilaeGyavaRgaets,
Exposed to Potassium Laboratory Report No.
U2779,
Requestor
Project No. 3M Tox 6295.13, June 10, 1999
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