Document wg6Nn4QQV0GX89yjB334aLBpQ

- 5 SM avpeciany Marais Nciamersin AR 226-1057 _ wo 859 Fyz_olo2-1378 ao osvey VRRIIGGINAL O g HR January 30, 2002 = 53 DOfofciucmeoefnPtoPlrloucteisosniPnrgeCveenntteiron(a74n0d7T)oxics i= 4U0.S1.MEnSvtirreoentmSenWtal Protection Agency I Washington, D.C. 20460 FYI-00-001378 Attention: For Your Information Docket - Docket No. AR-226 Re: SIunlffoornmaatteisonanodn RPeelraftleudorCooocmipaonuends Dear Sir or Madam: 2 3= 83 sulfonatTehsisancdonrteilnatueeds c3oMm'psouvnoldusn,taarsypasrutbomfisosuironosngoofdiantgadioanlopgeureflwuiotrhooEcPtaAne regarding fluorochemicals. We are enclosing one compact disc (CD) containinga numberofstudies, as more fully described below. La o38 c=o Contentsof Submission "The enclosed information covers perfluorooctane sulfonates and certain hreolwaetvederc,onmopoaudndidtsioansalnoitnefdorimnaptrieovnihoauss bseubcmoimsesiaovnasi.labFloerssionmceeooufrtDheesceemmabteerria2l0s0,1 submission. In ths submission, we are enclosing primarily new study reports, with accompanying analytical reports. However, for convenience, the enclosed CD also includes copiesofreports related to the perfluorootanoate monkey study that the Associationof Plastics Manufacturers in Europe (APME) recently submitted to both the TSCA S and AR-226 dockets. Ontheenclosed CD, youwill find: ORIGINAL A copy ofthiscover letter. Anindex to the toxicology and environmental studies, and copiesof those studies. 85620000001 | CONTAIN NO CF JPaanguea?ry 30,2002 A bibliographyof published literature. This updates the bibliographic references we have previously provided. Please note that we have not included in this bibliography abstractsofpresentations to the SocietyofEnvironmental Toxicology and Chemistry. As in our past submissions, we have organized the studies by chemical, and within the sections for each chemical, by endpoint or type of study. There are no new epidemiology or medical surveillance studies since our December 2001 submission. CD Submission `We are submitting the enclosed materials in CD form only, without paper copies. We understand that EPA and OECD representatives have found this format `most convenient. The CD is for read-only purposes and is not to be modified. 3M will maintain the original CD copy of the documents. As indicated in the note prefacing the CD, 3M' original CD will control in the event of any discrepancy. We will continue to provide information as it becomes available. We look forward to our continuing dialogue with the agency. Please feel free to contact me `with any questions. Very truly yours, 227%) Michael antoro Director of Environmental, Health Safety and Regulatory Affairs Specialty Materials Markets 3M Center, Building 236-1B-10 St. Paul, MN 55144 651-733-6374 (phone) 651-733-1958 (fax) E-mail: masantoro@mmm.com cc: Dr. Charles Auer Dr. Oscar Hernandez 2X ATTA3CMHMFELNUTORTOOCLHEETMTIECRAOLFSJUABNMIUSASRIYO3N0, 2002 TOXICOLOGY, EPIDEMIOLOGY AND MEDICAL SURVEILLANCE STUDIES PFOS Perfluorooctanesulfonate Repeat Dose Studies 1. PFOS 6 Month Monkey Study a. Final Report, 26-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Cynomolgus Monkeys (Covance Study No. 6329223), 3M Reference No. T-6295.7, January 11, 2002. [Note: the analyticalreportto accompany this study was included in 3M's December 22,2000 submission. It appears on CD #3ofthe fluorochemical submissions, where the December 2000 submission begins on the fifth pageof the index.] 2. Two-Year Bioassay a. Final Report, 104-Week Dietary Chronic Toxicity and Carcinogenicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Rats (Covance Study No. 6329-183), 3M Reference No. T-6295, January 2, 2002. b. PAenrafllyutoircoaolctLaanbeosrualtfoornyatReep(oPrFtO,SD)etienrLmiivneartiaonndoSfetrhuemPSrepseecnicmeenansodfCoCnrcle:nCtrDa(tSiDo)n IoGfS 3BRM REantvsirEoxnpmoesnetdaltoLaPbeorrflautoorroyocRteapnoertSuNlof.onTiOcXA-c0i0d2,PoLtaabsosriautmorSyaltRe(qPuFeOstSNTo-.62U9251)2,1, 3M Reference No. T-62954, February 21, 2001. [ptyFFOOSEEaailcoohooll| N-methyl perfluorooctane sulfonamidoethanol Repeat Dose Studies 1. 2 Year Bioassay a. FNi-nEatlhyRlepPoerrtf,l1uo0r4o-oWceteakneDsiueltfaornyamCiadrociEntohgaennoilciitnyRSattusd(yCwoivtahncNearSrtouwdyR6a3n2g9e-2(1928).,1%3)M Reference No. T-6316.1, December 13, 2001 ATTA3CMHMFELNUTORTOOCLHEETMTIECRAOLFSJUABNMUISASRIYO3N0, 2002 b. APnFaOlSyt,icPaFlOLSaAb,orPatFoOrSyARAep,orEtt,FDOeStEe-rmOiHn,atMi5on56ofatnhde PPrFeOsSenEcAe ainndSeCronucmenatnrdatLiiovnerof Samplesof Crl:CD(SD) IGS Perfluorooctanesulfonamido BR Rats Ethanol, Exposed to N-Ethyl 3M Environmental Laboratory Report No. TOX-001, Laboratory Request No. U2103, 3M Reference No. T-6316.1, June 6, 2001 c. APnFaOlSyt,icPaFlOLSaAb,orPatFoOrSyARAep,orEtt,FDOeStEe-rmOiHn,atMi5o5no6f,tahnedPPrFesOeSnEceAainndSCeornucmenatnrdatLiiovneorf SPearmfpllueosrooofcCtranle:sCuDl(fSoDn)amIiGdoS BEtRhaRnoalt,s3ExMpoEsnevidrtoonNm-eEntthayllLaboratory Report No. TOX-003, Laboratory Request No. U2104, 3M Reference No. T-6316.1, June 6, 2001 Teratology Studies 1. Two Generation Rat Reproduction a. Amended Analytical Laboratory Report, Determinationofthe Presence and CPoFnOcSenAtAr,atiPoFnOoSfAP,FaOnSd,EMt5F5O6S,EP-FOOHSiAn AtheanSderPaFoOfSCArli:nCtDheBRLivVeArFa/nPdluPsFORSat,sM56, ELaxbpoorsaetdortyo ERe(qFuOeSsEt-NOoH.,U320M95E,nv3irMonRmeefnetraelncLeabNoo.raTt-o6r3y1R6e.p1o5r,tMNao.y T31O,X2-000112., [Study and initial analytical report submitted December 22, 2000 on CD #3.] [roa [rerMuoroocuancicacid Repeat Dose Studies I. PFOA 6 Month Monkey Study a. F(iAnPalFOR)epionrtC,yn4o-mWoelegkuCsapMsounlkeeTyosxi(cCiotvyaSntcuedyStwuidtyhNAo.mm6o3n20i-u23m0)P,er3flMuoRreofoecrteannocaetNeo. T-6889.2, December 18, 2001 b. F(iAnPaFlOR)epionrtC,yn2o6m-oWlegeuksCMaposnukleeyTsox(iCcoivtaynScteuSdtyuwdiythNoA.m6m3o29n-i2u31m),Pe3rfMluRoerfoeorcetnacneoaNtoe. T-6889.3, December 18, 2001. c. APnearlfyltuiocraolocLtaabnooraatteoFrlyuRoerpoocrhte,miDceatlerimninLiavteiro,noSfertuhme,PUrreisneencaendanFdecCeosncSeanmtprlaetsi,on3oMf Environmental Laboratory and Centre Analytical Laboratories Report No. TOX-226, Laboratory Request No. U2782, 3M Reference No. T-6889.3, Junc 11,2001 We US ENVIRONMENTAL STUDIES Environmental Fate & Transport 1 Photolysisof PFOS Potassium Salt (direct and indirect) a `Amended robust summary, 3M Environmental Laboratory, January 25, 2002 [Report and initial robust summary submitted June 28, 2001; amendment contains `minor correction] 1. Acute toxicity to Rainbow Trout a Robust summary b. Final report, PFOS: A 96-hour static acute toxicity test with the rainbow trout (Oncorhynchus mykiss), Wildlife International, Ltd., January 7, 2002 2. Acute Toxicity to Sheepshead Minnows b. Final report, PFOS: A 96-hour static-renewal acute toxicity test with the sheepshead minnow (Cyprinodon variegatus), Wildlife International, Ltd., January 7, 2002 [[rorn emoowomicns| Environmental Monitoring 1 3M Lifetime Drinking Water Health Advisory for Perfluorooctanoate a. Report, 3M Corporate Toxicology, January 25, 2002 ATTA3CMHMFELNUTORTOOCLHEETMTIECRAOLFSJUABNMUISASRIYO3N0, 2002 BIBLIOGRAPHY PFOS Perfluorooctanesulfonate Case MT, York RG, and Christian MS (2001). Rat and rabbit oral developmental toxicology studies with two perfluorinated compounds. Int. J. Toxicol. 20:101-109. Giesy JP, and Kannan K (2001). Global distribution of perfluorooctane sulfonate in wildlife. Environ. Sci. Technol. 35:1339-42. Kannan K, Franson JC, Bowerman WW, Hansen KJ, Giesy JP (2001). Perfluorooctane sulfonate in fish-cating water birds including bald eagles and albatrosses. Enviro. Sci. Technol. 35:30650. Kannan K, Koistinen J, Beckman K, Evans T, Gorzelany JF, Hansen KJ, Jones PD, Helle E, Nyman M, Giesy JP (2001). Accumulationofperfluorooctane sulfonate in marine mammals. Environ. Sci. Technol. 35:1593-98. Matsumoto M, McNamee CE, Bossev DP, Nakahara M, Ogawa T (2000). Structureofsaltedout, solubilized micelles and microemulsions on the perfluorinated anionic surfactant tetraethylammonium perfluorooctyl sulfonate studied by cryogenic transmission electron microscopy. Colloid & Polymer Sci. 278:619. Moody CA, and Field, JA (2000). Perfluorinated surfactants and the environmental implications of their use in fire-fighting foams. Environ. Sci. Technol. 34:3864-3870. RenRn(20e00r). LC/MS tool to help military characterize fluorinated surfactants. Environ. Sci Technol. 34:372, SandforGd (2000). Organofluorine chemistry. Phil. Trans. Royal Soc. London A 358:455-471 Villeneuve M, Nomura T, Matsuki H, Kaneshina S, Aratono M (2001). Miscibility of hydrocarbon and fluorocarbon surfactants in adsorbed film and micelle. J. Colloid Interface Sci 234127136 N-EtFOSA Necthyl perfluorooctane sulfonamide | -- 1 Bastos JK, Freitas LAP, Pagliarussi RS, Merino RE (2001). A rapid quantitative method for the analysisofsulfluramid and its isomers in ant bait by capillary column gas chromatography. J. Sep. Sci. 24:406-410. [FEFosE N-ethyl perfluorooctane sulfonamidoethanol Case MT, York RG, and Christian MS (2001). Rat and rabbit oral developmental toxicology studies with two perfluorinated compounds. Int. J. Toxicol. 20:101-109. An YJ, Carraway ER (2002). PAH degradation by UV/H;0; in perfluorinated surfactant solutions. Water Res. 36:309-314. An YJ, Carraway ER, Schlautman MA (2002). Solubilizationofpolycyclic aromatic hydrocarbons by perfluorinated surfactant micelles. Water Res. 36:300-308. Biegel LB, Hurtt ME, Frame SR, O'Connor JC, Cook JC (2001). Mechanisms ofextrahepatic tumor induction by peroxisome proliferators in male CD rats. Toxicol. Sci. 60:44-55. Huang Q, and Hong CS (2000). TiO; photocatalytic degradation of PCB in soil-water systems containing fluoro surfactant. Chemosphere 41:871-879. Kudo N, Bandai N, Suzuki E, Katakura M, Kawashima Y (2000). Induction by perfluorinated fatty acids with different carbon chain length of peroxisomal beta-oxidation in the liver of rats. Chem. Biol. Interact. 124:119-132. Kudo N, Suzuki E, Katakura M, Ohmori K, Noshiro R, Kawashima Y (2001). Comparison of the elimination between perfluorinated fatty acids with different carbon chain in rats. Chem. Biol. Interact. 134:203-216. Moody CA, Kwan WC, M perfluorinated surfactants artin JW, Muir in surfacewater DC, samp Mabury SA les by two (2001). Determination independent analytical of techniques: liquid chromatography/tandem mass spectrometry and 19F NMR. Anal. Chem. 73:2200-2206. Moroi Y, Yano H, Shibata O, Yonemitsu T (2001). Determination of acidity constants of perfluoroalkanoic acids. Bull. Chem. Soc. Jpn. 74:667-672. Panaretakis T, Shabalina IG, Grander D, Shoshan MC, DePierre JW (2001). Reactive oxygen species and mitochondria mediate the induction ofapoptosis in human hepatoma HepG2 cells by the rodent peroxisome proliferator and hepatocarcinogen, perfluorooctanoic acid. Toxicol. Appl. Sandford G (2000). Organofluorine chemistry. Phil. Trans. Royal Soc. London A 358:455-471 Yang Q, Zie Y, DePierre JW (2000). Effectsofperoxisome proliferators on the thymus and spleen ofmice. Clin. Exp. Immunol. 122:219-226. : ATTA3CMHMFELNUTORTOOCLHEETMTIECRAOLFSJUABNMUISASRIYO3N0, 2002 Yang Q, Xie Y, Eriksson AM, Nelson BD, DePierre JW (2001). Further evidence for the involvementofinhibitionof cell proliferation and development in thymic and splenic atrophy induced by the peroxisome proliferator perfluorooctanoic acid in mice. Biochem. Pharmacol 62:1133-1140, 8