Document g2164oqjkr2vwK1a0ROVbbj9L

enerrs Offices S YGenNeir u FT - 0500--1578 FY1-08-001378 - MayY 4, 2000 85000000005 z=Z 3 VIA FEDERAL EXPRESS ME ~ N Sod b Dr. Charles Auer Director Chemical Control Division Office Of Pollution Prevention And Toxics - United States Environmental Protection Agency 401 M Street, Southwest Room 403 East Tower (Mail Code 7405) Washington, D. C. 20460 Re: Dear Charlie: Information On Perfluorooctane Sulfonates information onPupresruflaunotrtooocotuarnerescuelnftoncaotmems.uniTchaetieonncsl,os3eMd iisnfeonrcmlaotsiionngsaudpdpiltieomneanlts information submitted to you previously under cover of our April 21, 2000 letter. Again, dwiescaursesiproonvsiwdiitnhg EthPisAirnefgoarrmdaitniognfoiunoraocvhoelmuinsttarryy.basis as part of our continuing The enclosed information covers perfluorooctane sulfonates, including (CAS numbers 1763-23-1 (acid); 29081-56-9 (ammonium salt); 70225-14-8 (DEA salt); 2795-39-3 (potassium-salt); 29457-72-5 (lithium salt). It consists of thefollowing: => Copies of post-1975 studies and environmental science areas: (i) certain other physical and information relating to the chemical properties; (i) following environmental fate and transport; ii) environmental monitoring; and (iv) ecotoxicity. For each study, 3M has prepared a summary in the HPV "robust summary" format. An executive summary also has been included for each area. = hCeoaplitehsefoffepcotssta-r1ea9s7:5 s(ti)udaiceusteantdoxicceirttya;i(nii)otgheneortionxficoirtmya;ti(oini) relating to the following repeated-dose toxicity; 000001 Charles Auer May 4, 2000 Page 2 _ (W) pharmacokineti(cus) teratology; and (v) medical surveilance and epidemiology. 3M has included a detailed indexofthis information. = Alistof all studies in progress and planned studies, along with study protocols or study plans, where available. With regard to the health effects area, this list supplements the list provided undercoverof our April 21, 2000 letter to you. = Abibliographyofpre-1976 studies in the environmental science and health effects areas on perfluorooctane sulfonates. = Abibliography of acute toxicity studies on perfluorooctane sulfonates, except that we are providing copies of key acute studies (with reference to the HPV guidance). = bibliography of published studies on the perfiuorooctane sulfonates in 3's possession = Anindex of submissions made by 3M to the TSCA Section 8(e) docket. This index has been subdivided by EPA docket number. Rather than attempt to segment the index for perfluorooctane sulfonates only, we have included other fluorochemical submissions on the index, as several of 3M's submissions have dealt with multiple fluorochemicals. 3M is continuing our file review and will supplement the enclosed information as appropriate. As you review this information, we ask that you bear several points in mind: = The enclosed information spans several boxes. We have organized the information in each box with labeled file folders and indices to aid EPA's review. To ensure that you and your staff are able to access the most pertinent information, we also are attaching to this cover letter the executive summaries for the environmental science areas and the indices covering studies and other information. = In some cases, the enclosed information reflects recent developments that may supplement studies and other information previously provided to you. As just one example, 3M's previously submitted document entitled *Fluorochemical Use, Distribution And Release Overview" (5/26/99) contains a qualitative assessment based on the assumption that all other fluorochemicals could breakdown to perfluorooctane sulfonates. Another document submitted by 3M entitled "Sulfonated Perfluorochemicals in the Environment: Sources, Dispersion, Fate and Effects" also provided estimates of potential exposure and waste generation based on such an assumption. Recent information in the environmental fate and transport area suggests, however, that this assumption may reflect an unrealistic 000002 Charles Auer May 4, 2000 Page 3 "worst case" which significantly overstates exposure potential to perfluorooctane sulfonates. In particular, this information (which is enclosed) indicates that perfluorooctane sulfonates may not be a degradation product of many fluorochemicals and that high molecular weight fluorochemical polymers and fluorochemical phosphate esters are relatively stable in the environment. = The enclosed information includes some studies and other information on mixtures containing perfluorooctane sulfonates. As we have discussed, 3M will be providing you with further information onotherfluorochemicals within the next several weeks. Wewill include additional studies and other information on mixtures containing perfluorooctane sulfonates at that time. = 3M has not provided you with all analytical chemistry reports on perfluorooctane sulfonates. Rather, we have enclosed certain analytical chemistry reports which may prove useful to EPA in interpreting certain studies; understanding the details of analytical chemistry methods; or verifying human and biomonitoring data. = 3Mis continuing its work to refine the analytical characterizationof the perfluorooctane sulfonates test material being used for our current study program. We will keep you informed of any pertinent developments, = Finally, please note that some of this information qualifies as confidential business information (CBI); CBI information has been placed in a separate, Iabeled envelope. Also, incorrectly applied legends relating to legal privileges and proprietary protections have been removed from certain documents. 000003 Charles Auer May 4, 2000 Page 4 3M looks forward to discussing the enclosed information with you and other EPA staff. In the meantime, please do not hesitate to contact me with any questions. Very truly yours, Holi Q. Hropyprnan WilliaAm.Weppner, Ph.D Director of Environmental, Health, And Regulatory Affairs Specialty Materials Markets 3M Bldg 236-1B-10 3M Center St. Paul, MN 55144 E-mail: waweppner@mmm.com Safety Enclosures 000004 Attachmentot Letter to C. Auer Dated May 4, 2000: Environmental Studies on Perfluorooctanesulfonates (Post-1975) TPihtyesicalichemical Properties Laborstonyor [pDoonvmte aCond7uctWedakingParing Range of PFO:Boling AVutioir nematonsl Lg. R[otGoreGuramgeinMeathhtoedViaoponr PresosfPiROrSUsing Spinning nemaVtoinea, 14. 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AUER DATED MAY 4, 2000: PRE-1976 ENVIRONMENTAL STUDIES ON PERFLUOROOCTANESULFONATES EDantvairfornommenFtaatlheLaadboMraitnonryo,wASutgu.dy2,o1n9F74C.-9(3Ro(b2u5s%t NsuHm4masralyt,ofMPSFDOSS ainndIcPoApiaensodfwdaatetra),be3inMg, provided to EPA) DEnavtiarfornommenFtaatlheLaadboMraitnonryo,wOScttu.d1y9,on19F7C4.-93(R(o2b5us%tNsHum4msaarlty,ofMPSFDOSS ainndIPcoApiaensdofwadtaetr)a,b3eMing provided to EPA) LBaOboDr/atCoOryD.reCsoumlptsleftorioFnC-da9t3e:(2J5ul%yN1H8,41s9a7l4t.of(PRoFbOuSstinsuImPmAaarnydawnadtecro),py3oMf Erensvuilrtsonbmeeinngt,al provided fo EPA) 000009 ATETNAVCIHRMONEMNETNTTOALLESTTTUEDRIETSOOCN. APUEERRFLDUAOTREODOMCATAYN4E,S20U0L:FOONNAGTOEISNG Physical/Chemical Properties PsoetaerncthiarlegFalrudoirnogcphoetmeinctailalCfoomrbfuosrtmiaotinonBoyf-fPlroordiuncdtast(eidnvdoilovxeisnsreavnidefwourfanrse)s,ul3tMsofEnlvitierroantmuernetal Laboratory. Expected completion: Sept. 2000. Study paper in progress. cFolmupourtoacthieomniaclalchDeemciosmtproysciatlicounlaPtriooncsesosf: bQounadn-tbirfeiackaitniognstarnedngAtshssoefsssumlefnotn(aitnevdolves perfluorochemicals), paper in progress. Battelle Memorial Institute. Expected completion: Aug. 2000. Study Environmental Fate and Transport | + AEbxipoetcitcedDecgormapdlaettiioonn:StJuudinees2(0h0y0dr(ohlyydsrioslyasnids)i;ndAiurge.ct2p0h0ot0ol(yisnidsir)e,c3t MphoEtnovlyisriosn)m.en(tSaulmLmaabroryatsotruyd.y plan and screening results summary being provided to EPA) 2d a St En il MTT M Biodegradation Studies (acrobic acclimated closed bottle biodegradation, acrobic soil/sediment 2% bwaitoedre,grpahdoattoidoeng,rapduarteicounl)t,urSepraiernogbbiocr,naLnadbofrlautoorroicehs,emIincca.l Edxepceocmtpeodsictoimopnleptrioocne:ss,Austga.bi2l0it0y0.in (Summary study plan being provided to EPA) | Ecotoxicity Elments 4 7 3 -- PFOS: A 96-Hour International, Lid. Toxicity Test with the Expected completion: FJruleysh2w0a0t0e.rA(lPgroato(cAonlabbeaiennga pfrloosv-aigduetaeod),EWPiAl)dlife +f -- PFOS: A 96-Hour International, Ltd. Toxicity Test with the Expected completion: Freshwater July 2000. Diatom (Navicula pelliculosa), Wildlife (Protocol being provided to EPA) PInFtOeSma:tiAona9l6,-HLiodu.r ETxoxpieccitteydTceosmtplweittihont:he MJaulryin2e00D0.ia(tPormot(oSckoellbeetionngemparocvoisdteadtutmo),EPWAi)ldie {-- ~ FExFpOeSc:teAd7c-omDpalyetiToon:xiiJtulyTe2s0t00w.ith(PDruotcokcwoelebdei(nLgepmrnoavigdeid)t,o EWPiAld)life Intemational, Ld. M 7\ 2P0h0y0t.otoPxrioctiotcyo--l SineepdrloignregssE.mergence, Wildlife International, Ltd. Expected completion: July ~ Environmental Monitoring # g G20l0o0b.al(ESnuvmirmoanrmyenbteailngSaprmopvliidnegdPtloanE,PMAi)chigan State University. Expected completion: Dec. do chapSsef ~ ail 000010 9= f= Balinot ProsPFO onl Parh in 2p74- Lonftet sail 6ghmrelpapl wT 4 Zroldd7-5 ind osspicdbrslly (e-dleVi pp; gS i= ZY o fllrueliomicil in : . Attachments toLetter to C. Auerdated May 4, 2000 Perfluoroctane Sulfonate Studies Acute Toxicity 1) An Acute Inhalation Toxicity Study of T-2306 CoC in the Rat, Bio/dynamics, Inc., PprootjaescstiuNmo.sal7t8)-7185, December 31, 1979. (FC-95, Perfluorooctane Sulfonate 2) Acute Oral Toxicity (LD50) Study in Rats with Fluorad Fluorochemical Surfactant FC-95, International Research and Development Corporation, Project No. 137-083, May 31, 1978. (Note: 3M files indicate samples taken during the study were not analyzed.) 3) Eye and Skin Irritation Studies Report on Sample T-1166 (FC-98, Potassium Perfluoroethylcyclohexyl Sulfonate, presumed 100 %), Warf Institute Inc., Project No. 5011023, January 28, 1975. a) Combined Eye and Skin Irritation Studies Report b) Eye Irritation Study (with washout procedure) Report 000011 Sh AttachmentstoLettertoC. AuerdatedMay 4,2000 - Perfluoroctane Sulfonate Studies Bibliography of Acute Toxicity Studies Not Submitted 1) Acute Oral Toxicity-Rats on Sample T-1389, Biosearch Inc., March 4, 1976 (FC95, Perfluorooctane Sulfonate potassium salt). 2) Acute Oral Toxicity-Rats on Sample T-1390, Biosearch Inc., March 4, 1976. [FC- 98] 3) Acute Oral Toxicity-Rats on Sample T-2297 CoC (Ammonium Perfluorooctane Sulfonate, FC-93 Solids), Biosearch, Inc. October 13, 1978. 4) Acute Oral Toxicity-Rats on Sample T-2275 CoC (FC-99 Old Formula, L429, NB 48490, which is 50 % of the Diethanolamine Salt of Perfluorooctane Sulfonate in water), Biosearch, Inc., September 25, 1978. 5) Primary Skin Irritation Test with T-2509CoC in Albino Rabbits, Safety Evaluation Laboratory, Riker Laboratories, Inc., Experiment No. 479EB0332, 3M Reference no. T-2509.4 (FC-99 New Formula, L-4509, 25 % Diethanolamine Salt of Perfluorooctane Sulfonate in water), June 28, 1979. 6) ALacbuotreatOocruyl,arRiIkrreirtaLtaiboonrSattuordiyews,itIhncT.-,2E5x0p9eCroimCeinntANlob.in4o79RaEbBb0i3t3s,3,Sa3feMtyREevfaelrueantcieon no. T-2509.1 (FC-99 New Formula, L-4509, 25 % Diethanolamine Salt of Perfluorooctane Sulfonate in water), July 13, 1979. 7) APrcoujteectInNhoa.la7t8io-n71T8o7x,ic3itMy SRteufdeyreonfceT-N2o3.08T-C2o30C8i(nFtCh-e9R8a,t,PoBtiaos/sdiyunmamics, Inc., Perfluoroethylcyclohexyl Sulfonate, presumed 100 %), April 12, 1979. 8) LAacbuotreatOocruyl,arRiIkrreirtaLtaiboonrTaetsotriweist,hITnc-.2,9E6x0pCeorCimienntAlNboi.no0R8a8b0bEitBsO,59Sa8f,et3yMEvRaelfuearteinocne No. T-2960.2 (FC-90, L4649, Diethanolamine Salt of Perfluoroethylcyclohexyl Sulfonate, 25 %inwater), February 18, 1981. 9) LAacbuotreatDoerrym,alRiTkoexricLiatbyorSattourdiyesw,itIhncT.-, 2E9x6p0eCriomCenint ANlob.in0o83Ra0bAbBi0ts5,99S,af3etMy ERveafleuraetnicoen No. T-2960.1 (FC-90, L-4649, Diethanolamine Salt of Perfluoroethylcyclohexyl Sulfonate, 25 % in water), January 15, 1981. 10) Primary Skin Irritation Test with T-2960CoC in Albino Rabbits, Safety Evaluation Laboratory, Riker Laboratories, Inc., Experiment No. 0880EB0597, 3M Reference 000012 sr AttachtoLmetetenrttoCs.AuerdatedMay 4, 2000 - Perfluoroctane Sulfonate Studies No. T-2960.4 (FC-90, L-4649, Diethanolamine Salt of Perfluoroethylcyclohexyl Sulfonate, 25 %inwater), January 15, 1981. 11) ALacbuotreatOorrayl,ToRxiikceirtyLaSbtoruadtyorwiietsh,TI-n2c.9,6E0xCpoeCriimneAnltbiNnoo. R0a9b8bi0tAsR,0S6a0f0e,ty3EMvalRueafteiroennce No. T-2960.3 (FC-90, L-4649, Diethanolamine Salt of Perfluoroethylcyclohexyl Sulfonate, 25 %inwater), February 18, 1981 12) Acute Oral Toxicity - Rats, Biosearch, Inc., 3M Reference No. T-2296 (FC-93, `WaAtmemro),niOucmtoPbeefrlu1o9r,oo1c9t78a.ne Sulfonate, 25 % in 20 % Isopropyl Alcohol and 55 % 000013 Attachments to Letter to C. Auer dated May 4, 2000 Perfluoroctane Sulfonate Studies Bibliography of Acute Toxicity Studies Not Submited 1) Acute Oral Toxicity-Rats on Sample T-1389, Biosearch 95, Perfluorooctane Sulfonate potassium salt). Inc., March 4, 1976 (FC- 2) Acute Oral Toxicity-Rats on Sample T-1390, Biosearch Inc., March 4, 1976. [FC- 98] 3) Acute Oral Toxicity-Rats Sulfonate, FC-93 Solids), on Sample Biosearch, T-2297 CoC Inc. October (Ammonium 13, 1978. Perfluorooctane 4) Acute Oral Toxicity-Rats on Sample T-2275 CoC (FC-99 Old Formula, L-4299, NB 48490, which is 50 % in water), Biosearch, Inc., of the Diethanolamine September 25, 1978. Sal of Perfluorooctane Sulfonate 5) PLarbiomraartyorSyk,inRiIkrreirtaLtaiboonrTaetsotriweist,hITn-c2.5E0x9pCeorCimiennAtlNboi.no4R7a9bEbBit0s3,32Sa,fe3tMy ERveafleuraetnicoen nPoe.rfTl-u2or5o0o9c.t4an(eFCSu-l9f9onNaetewiFnowramtuelra),, JLu-n4e50298,, 21597%9. Diethanolamine Salt of 6) Acute Ocular Irritation Study with T-2509CoC in Albino Rabbits, Safety Evaluation Laboratory, Riker Laboratories, Inc., Experiment No. 479EB0333, 3M Reference no. T-2509.1 (FC-99 New Formula, L-4509, 25 % Diethanolamine Salt of Perfluorooctane Sulfonate in water), July 13, 1979. 7) Acute Inhalation Toxicity Study of T-2308 CoC in the Rat, Bio/dynamics, Inc. Project No. 78-7187, 3M Reference No. T-2308 (FC-98, Potassium Perfluoroethylcyclohexyl Sulfonate, presumed 100 %), April 12, 1979. 8) Acute Ocular Irritation Test with T-2960CoC in Albino Rabbits, Safety Evaluation Laboratory, Riker Laboratories, Inc., Experiment No. 0880EB0598, 3M Reference No. T-2960.2 (FC-90, L4649, Diethanolamine Salt of Perfluoroethylcyclohexyl Sulfonate, 25 %inwater), February 18, 1981. 9) Acute Dermal Toxicity Study with T-2960CoC in Albino Rabbits, Safety Evaluation Laboratory, Riker Laboratories, Inc. Experiment No. 0880AB0599, 3M Reference No. T-2960.1 (FC-90, L4649, Diethanolamine Salt of Perfluoroethylcyclohexyl Sulfonate, 25 % in water), January 15, 1981. 10) Primary Skin Irritation Test with T-2960CoC in Albino Rabbis, Safety Evaluation Laboratory, Riker Laboratories, Inc., Experiment No. 080EB0S97, 3M Reference 000014 Attachments to Letter to C. Auer dated May 4, 2000 - Perfluoroctane Sulfonate Studies No. T-2960.4 (FC-90, L-4649, Diethanolamine Salt of Perfluoroethylcyclohexyl Sulfonate, 25 % in water), January 15, 1981 11) Acute Oral Toxicity Study with T-2960CoC in Albino Rabbits, Safety Evaluation Laboratory, Riker Laboratories, Inc., Experiment No. 0980AR0600, 3M Reference No. T-2960.3 (FC-90, L4649, Diethanolamine Salt of Perfluoroethylcyclohexyl Sulfonate, 25 %in water), February 18, 1981. 12) Acute Oral Toxicity - Rats, Biosearch, Inc., 3M Reference No. T-2296 (FC-93, Ammonium Pefluorooctane Sulfonate, 25 %in 20 % Isopropyl Alcohol and 55 % Water), October 19, 1978. 000015 i Attachments to Letter to C. Auer dated May 4, 2000 : : Perfluoroctane Sulfonate Studies Repeated-Dose Toxicity 1) Ninety-Day Subacute Rhesus Monkey Toxicity Study, with Fluorad Fluorochemical Surfactant FC-95, International Research and Development Corporation, Project No. 137-092, December 18, 1978. a) Study Report b) Aborted Study: Ninety-Day Subacute Rhesus Monkey Toxicity Study, with FDleuvoerlaodpmeFnltuoCroorcphoermaitciaoln,SuPrrfoajcetcatntNoF.C-19357,-0I8n7t,ernJaatniuoanrayl 2R,es1e9a7r9c.h and 2) Ninety-Day Subacute Rat Toxicity Study, with Fluorad Fluorochemical Surfactant NFoC-v9e5m,beIrn,ter1n9a7t8i.onal Rescarch and Development Corporation, Project No. 137-085, 3) 104-week Dietary Chronic Study and Carcinogenicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS: T-6295) in Rats, Covance Laboratories Inc., Study Number 6329-183. In progress. a) Summary Report - Week 53 undated b) "Liver Slide Review," Marvin Case to John Butenhoffand Andrew Seacat dated April 5, 2000 relaying the results of an independent histopathologic review of liver slides from the study. ) Second Draft Cell Proliferation Report, Pathology Associates International, August 24, 1999. [final interim report, to be incorporated in final report] d) SintusdaympRleepsorftroomf D3eMterEmnivniartoinomneonftaClyaLnabiodreatIonrsyens-itCiovveaPnaclemiSttuodyile-sCo6A32o9x-i1d8a3tiaonnd. 6329-212, Centre For Xenobiotic Research, University of Dundee, Biomedical Research Center, Study Number XR0108, February 18, 1999. 4) Rangefinder: 4-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid IPnoct.a,sSstiuudmySaNlutm(bPeFrOS6;32T9--6222925) in Cynomolgus Monkeys, Covance Laboratories 2) PUenrafulduiotreodocDtraanfetSFuilnfaolniRcepAocrit,d 4Po-tWaeseskiuCmapSaslutle(PTFoOxSic;itTy-6S2t9u5d)y iwnitChynomolgus Mcoomnpkleeytes),. Covance Laboratories Inc., Study Number 6329-222 (draft not 000016 Le Attachments to Letter to C. Auer dated May 4, 2000 Perfluoroctane Sulfonate Studies b) Cell Proliferation Report, 4-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Cynomolgus Monkeys, Covance Laboratories Inc., Study Number 6329-222 (draft to be incorporated in final report) ) Protocol - Analytical Study, Quantitative Analysis of Perfluorooctane Sulfonic Acid Potassium Salt (PFOS; T-6295) in Cynomolgus Monkeys Following Administration ofa 4-Week Capsule Toxicity Study, 3M Environmental Laboratory, AMDT-041598.1 4d) Memorandum from Marvin Case, regarding histopathology review of liver tissue in Covance Study 6329-222, July 27, 1998 5) 26-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS: T-6295) in Cynomolgus Monkeys, Covance Laboratories Inc., Study Number 6329-223. In progress. 4) Undated report covering the 26-week dosing phase and one year of recovery. b) John Butenhoff, "Dose-Setting Rationale for Six-Month Chronic Oral Study in Cynomolgus Monkeys," dated July 29, 1998 and followup Aug. 3, 1998. ) Fecal Urobilinogen Analysis, Mayo Clinic, Porphyrins and Nutritional Chemistry Group, Test Code: 8308 i) Summary Report from Dr. Joseph P. McConnell, dated March 16, 1999. if) General information from Mayo Clinic, Porphyrin and Nutritional Chemistry Group on Urobilinogen Analysis, dated January 14, 1999. iii) Individual animal urobilinogen lab reports (raw data) from Mayo Clinic, Porphyrins and Nutritional Chemistry Group. 4) Pathology Report (Ancillary Study), Electron Microscopic Evaluation of Liver in Cynomolgus Monkeys, Pathology Associates International, Study No. EM99.76, July 13, 1999. ) Pathology Review, Marv Case to Andrew Seacat, dated July 22, 1999 relaying the resultsof a histopathology review of slides. 000017 :/ AltachmentstoLettertoC. Auerdated May 4, 2000 = Sx Perfluoroctane Sulfonate Studies // f) TLoaxbiorcaotloorgyy RSetpuodryt,wiItnhtePrFimOSReipnorCtynoofmPorlelgiumsinMaornykeDyatsa, f3orM2E6nWviereoknmCeanptsaulle Laboratory, Report No. FACT-TOX-030, dated March 29, 1999. 6) Two Week Oral Rangefinding Toxicity Study of T-2509CoC in Rats, Safety REevfaelruaetnicoennLo.aboTr-a2t5o0r9y.,3 R(iFkCe-r9L9abNoerawtoFroiresm,ulIan,c.,L-E4x5p0e9r,i2m5en%t Ndoi.et1h7an9oRlRa0m2i3n,e s3alMt of perfluorooctanesulfonate in water), February 25, 1980. a EE 7) (Submited under claim of Confidentiality) -- a Ly FIL po om 2,7 JLIY ar gens Za idol) abaaccopery 000018 Attachments to Letter to C. Auer dated May 4, 2000 Perfluoroctane Sulfonate Studies Teratology Pilot Teratology Study in Rats, T-3551 Final Report, May 13, 1983, 3M Reference T3551.12 000019 .. AttaPcerthfolmLueotreotcentrattnoeCsS.ulAfuoenartdeaStteuddiMesay 4,2000 Pharmacokinetic Studies 1) Skin Absorption Studies on Surfactants (1983) a) Report from W. C. McCormick to D. R. Ricker, dated September 26, 1983 `summarizing data ) 28 Day Percutaneous Absorption Study in Rabbits with FC-95, Safety EFvCa-l9ua5t)ion Laboratory, Riker Laboratories, Inc., Experiment No. 0979AB0632 ) 2Ev8alDuaaytiPoenrcLuatbaornaetooursyA,bRsiokreprtiLoanboSrtautdoyriiens,RaIbnbci.,tsEwxiptehriFmCe-n9t9,NoS.af0e9ty79AB0633, p3eMrflRueofreoroecntcaencNsou.lfoTn-a3t9e8,8a.1ss(uFmCe-d99t,o bdeie2t5ha%nolianmwianteersa)lt of 2) Single-Dose Intravenous Pharmacokinetic Study of T-6053 in Rabbits, 3M Environmental Laboratory (FC-99, diethanolamine salt of perfluorooctanesulfonate iFninwaaltReerpLoortt 130, Unit 177. 0.04 - Analytical Study, % FC which solids in water), includes copy of November 16, 1995. in vivo Study No. AMDT- 010495.1, Hazleton Wisconsin, Inc., Project No. HWI 6329-136, 3M Reference No. T-6053.1 3) Single-Dose Dermal Absorption / Toricity Study of T-6053 in Rabbits, 3M Environmental Laboratory, Study No. AMDT-022195.1 (FC-99, diethanolamine salt of perfluorooctanesulfonate in water Lot water), November 22, 1995. Final Report - 1An3a0l,yUtinciatl 1S7t7u.dy0,.0i4nc%ludFeCs isnolviidvsoin Study Hazleton Wisconsin, Inc., Project No. HWI 6329-137, 3M Reference No. T- 6053.2 4) FSelruvoircoecsh,emSitcuadly (NFoC.)TL-e6v3e1l6s.9i,n NDaTi2v1e,RDartasf,t3RMepMoerdtifcoarlODbejepcatritvmeen3t,,MTaoyxc1i4o,lo1g9y99. 5) Analytical Data submitted to Dr. Jennifer Seed, USEPA, by letter dated May 3, 2000, including serum measurements from two in-life studies: a) A1n1a1l,ytwiictahlrdeastpaecftrtoomOArdavla(nGcaevdagBei)oaPnhaalyrtmiaccaolkiSneervtiiccesReSctouvdeyrNyoS.tuFdAyCoTf-TOX- Perfluorooctane Sulfonate in Rats, Argus Laboratories Protocol No. 418-015, 3M Reference T-6295.14. 000020 : Attachments to Letter to C. Auer dated May 4, 2000 ~ Perfluoroctane Sulfonate Studies b) Analytical data from Advanced Bioanalytical Services Study No. FACT-TOX110., with respect to Oral (Gavage) Pharmacokinetic Study of Perfluorooctane: Sulfonate in Rats, Argus Laboratories Protocol No. 418-013, 3M Reference T6295.12. 6) In Vitro Comparative Metabolism Study in Rat and Human Hepatocytes with Various Fluorochemicals, 3M Reference T-6295.1, study of T-6292 (N-ethyl FOSE), T-6293 (N-ethyl FOSE monophosphate ester), T-6294 (N-ethyl perfluorooctane sulfonamide), and T-6295 (Perfluorooctane Sulfonate) 4) Range-finding Cytotocity Assay, SRI International Toxicology Laboratory, Study No. BO10-95 - protocol and faxed results dated Oct. 26, 1995, Dec. 12, 1995, and Jan. 16, 1996 b) Metabolism of T-6292, T-6293 , T-6294, T-6295 by Rat and Human Hepatocytes, SRI International Toxicology Laboratory, Study No. B011-95 ) Advanced Bioanalytical Services, Inc., Analytical Report, Additional Characterization of Metabolitesof T-6292, T-6293 and T6294 from Rat and Human Hepatocytes by TurbolonSpray LC/MS and LC/MS/MS. SemiQuantitative Analysis of T-6295 in Rat and Human Hepatocytes Incubated with T-6292, T-6293 and T-6294 by LC/MS/MS, January 28, 1998, Report 98AGKPOL3M d) Working Interpretation of Results, chart entitled Perfluorosulfonamide Metabolism in Rat vs. Human Hepatocytes, updated Feb. 5, 1998 based on ABS Jan. 1998 report 000021 Attachments to Letter to C. Auer dated May 4, 2000 Perfluoroctane Sulfonate Studies Mechanistic 1) Reports from University of Minnesota Duluth Research (Kendall Wallace): a) Kendall B. Wallace, Biochemical and Molecular Mechanistic Studies of N-Alkyl Perfluorosulfonamides, Research Proposal, April 8, 1997, and Updated Proposal May 7, 1998 b) Kendall B. Wallace and Anatoli Starkov, The Effect of Perfluorinated Arylalkylsulfonamides on Bioenergetic of Rat Liver Mitochondria, Feb. 4, 1998 ) Report on Covance Studies, assessment of mitochondrial bioenergetics, undated d) Summaryofthe Effects of PC's [Perfluorinated Compounds] on Mitochondrial Bioenergetics In Vitro, undated ) Report, Effects of Selected Perfluoro-compounds on Mitochondrial Beta- Oxidation, Dec. 20, 1999 0) Report, Effect of Acute FC Administration on Catalase and acylCoA Oxidase Expression, January 27, 2000 2) Nabbefeld, et al., Displacement of a Fluorescently Labeled Fatty Acid Analogue fromFatty Acid Carrier Proteins by Wyeth ~ 14,643, Ammonium Perfluorooctanotate, Potassium Perfluorooctane Sulfonate and Other Known Peroxisome Proliferators, Abstract, Society of Toxicology, 1998 Annual Meeting 000022 : Attachments to Letter to C. Auer dated May 4, 2000 E Perfluoroctane Sulfonate Studies Human Sera/Medical Surveillance/Epidemiology Memorandum from D.E. Roach and 8.D. Sorenson, 1983 Decatur Blood Fluoride Review, January 20, 1984 Antwerp Blood Testing Results from June 1995, by Jeffrey H. Mandel, M.D., M.P.H., and Jean Burris, R.N., 0.H.N., M.P.H., November 6, 1995 Analysis of Serum Values in Decatur Workers, prepared by Michel Burlew for Larry Zobel, M.D. and Jeffrey Mandel, M.D., Apri2l, 1998 Laboratory Report, Analysis of FCs in Samples of Children's Sera, Laboratory Report No. FACT-GEN-011, 3M Environmental Laboratory, May 21, 1999 iLnabHourmataonrySeCroam,poLsIiMtSe NRoe.por1t6,23A,na3lyMtiEcnalviRreopnomretnstaolf LDaabtoarafotrorFyl,uoArporcilhe2m8i,ca2l00A0nalysis 000023 . Attachments to Letter to C. Auer dated May 4, 2000 Perfluoroctane Sulfonate Studies Genotoxicity 1) Mutagenicity Evaluation of T-2014 CoC in the Ames Salmonella/Microsome Plate Test Final Report, Litton Bionetics Project No. 20838, Protocol No. DMT-100, February 20, 1978. 2) Memorandum Report from S. R. Rohfing to A. N. Welter, dated March 31 1977, on Results of the Ames Spot Test for Mutagenicity screening of various FCs, including Sample 12-583 which is FC-95, Notebook Reference 45867-24, 25. 3) Mutagenicity Test on T-6295 in an in vivo Mouse Micronucleus Assay, Final Report, Corning Hazleton , Inc. (CHV), CHI Study No. 17403-0455, May 23, 1996, and protocol and amended protocol. 4) Final Report, Chromosomal Aberrations in Human Whole Blood Lymphocytes with PFOS, Covance Laboratories, Inc., Covance Study No. 20784-0-449, 3M Reference No. T-6295.18, October 25, 1999. 5) Final Report, Unscheduled DNA Synthesis in Rat Liver Primary Cell Cultures with PFOS, Covance Laboratories, Inc., Covance Study No. 20784-0447, 3M Reference No. T-6295.19, November 9, 1999, and protocol. 6) Final Report, Salmonella-Escherichia coli/Mammalian-Microsome Reverse Mutation Assay with PFOS, Covance Laboratories, Inc., Covance Study No. 20784-0-409, 3M Reference No. T-6295.17, November 5, 1999, and protocol. 7) Final Report, In Vitro Microbiological Mutagenicity Assays of 3M Company Compounds T-2247 CoC and T-2248 CoC, SRI International, SRI Project No. LSC4442-016, 3M Refernece No. T-2247.1 (FC-99 Old Formula, L-4299 which is 50 %ofthe diethanolamine salt of perfluorooctanesulfonate in water), September 5, 1978. 8) Prof. Nicola Loprieno, "Evaluation of Mutagenicity Studies Developed on (PFOS) Perfluorooctane Sulfonate," prepared at the request of John L. Butenhoff, Ph.D. 3M Corporate Toxicology, January, 2000. 9) Final Report - Bacterial Reverse Mutation Assay of t-1, Hita Research Laboratories, Chemical Biotesting Center, Study Code KO1-1802, 3M Reference No. T-6667.1 (FC-98, Potassium Perfluoroethylcyclohexyl Sulfonate), September, 1996. 000022 AttacthomLetetenrtto sC. Auer dated Ma4, 2y 000 : Perfluoroctane Sulfonate Studies `Ongoing Researchy/Study Protocols 1) 104-week Dietary Chronic Study and Carcinogenicity Study with Perfluorooctane Sulfonic Acid Potassium `Study Number 6329-183. Salt In (PFOS: T-6295) in Rats, Covance progress. Interim data provided. Laboratories Inc. 2) 26-Week Capsule Toxicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS: T-6295) in Cynomolgus Monkeys, Covance Laboratories Inc., Study Number 6329-223. In progress. Interim data provided. 3) Protocol for Study: Low Level PFOS Dose versus Rat Serum and Liver PFOS, 3M Medical Department, Corporate Toxicology, Study No. T-6295.16 DT31, October 29, 1998. (Study in progress.) 4) Protocol for Study: Pharmacokinetic Study of POSF in Rats, 3M Medical Department, 1999. (Study Corporate Toxicology, in Progress). Protocol for Study No. T-7098.1, January 7, 5) Study Plan, ST-43: Standard Procedure 3M Toxicology Laboratory for Liver Subellular Fractionation, undated, 6) Plan for Study Nos. T-6295.23; ST-46, Exploratory In-Vitro Pervutancous Absorption Study of Theophylline, Salicylic Acid, Perfluorooctylsulfonate, and Ammonium Perfluorooctanoate in SkinEthic Reconstituted Epidermis Model, May 4, 2000, 3M Toxicology Laboratory 7) Study Plan, Luebker, Inhibition in Pregnant Perfluorooctane Sulfonic Acid Induced Rats and Rat Pups, January 21, 2000 HMG-CoA Reductase 000025 Attachments to Letter to C. Auer dated May 4, 2000 - Perfluoroctane Sulfonate Studies Planned Studies 1) Preliminary Study Outline, One Generation Reproduction Study of PFOS in Rats, Pharmacokinetic Analysis, May 3, 2000 2) Preliminary Study Outline, One Generation Reproduction Study of PFOS in Rats, Mevalonic Acid/Cholesterol Challenge and NOEL Investigation in Rats, April 27, 2000 000026 ATETNAVCIHROMNEMNETNTTOALLESTTTUEDRIETSOOCN. APUEERRFLDUAOTREODOMCATAYN4E, S20U0L0:FOPNLAATNENSED Environmental Fate and Transport Soil Adsorption/Desorption, 3M Environmental Laboratory. Start date: May 2000. Protocol in progress. Multi-Media Modeling of PFOS 2000. Protocol in progress. Distribution, Mackay, D. (Trent University) Start date: June Bioconcentration Factor, Wildlife International, Ltd. progress. Start date: Sept. 2000. Protocol in Ecotoxicity Elements Acute Toxicity in progress. to Bluegill Sunfish, Wildlife International, Ltd. Start date: July 2000. Protocol Acute Toxicity to Sheepshead Protocol in progress. Minnow, Wildlife International, Ltd., Start date: July 2000. Phytotoxicity -- Vegative Vigor and Plan Uptake, Wildlife International, Ltd. 2000. Protocol in progress. Start date: June Acute Toxicity to Eiseiniafoetida (Earthworms), Wildlife International, Ltd. 2000. Protocol in progress. Start date: June FETAX Protocol (Frog Embryo in progress. Teratogenesis), Wildlife International, Ltd. Start date: June 2000. Mallard Duck Reproduction Protocol in progress. (Dietary), Wildlife International, Ltd. Start date: July 2000. Bobwhite Quail Reproduction (Dietary), Wildlife International, Ltd. Protocol in progress. Start date: July 2000. Environmental Monitoring (Environmental Sampling & Release Estimation) Estimationof PFOS in Protocol in progress. Life-Cycle Waste Streams, Battelle Memorial. Start date: May 2000. EstimationofLife-Cycle Protocol in progress. Releases, Battelle Memorial Institute. Start date: January 2001. 000027 Carpet Release Study, Battelle Memorial Institute. Start date: June 2000. Protocol in progress. Mult-City Study, Centre Analytical Laboratories, Inc.; 3M Environmental Laboratory. Start date: June 2000. (Study plan being provided to EPA) Multi-City Study -- AnalysesofSediments. Start date: June 2000. Multi-City Study -- Analyses of Water Columns. Start Date: Sept. 2000. Multi-City Study ~ Analysesof Surface Water Film. Start date: Sept. 2000. Multi-City Study ~ AnalysesofPOTW Effluents. Start date: Sept. 2000. Multi-City Study ~ AnalysesofPOTW Sludge. Start date: June 2000. Multi-City Study --Analysesof Landfill Leachates. Start date: Sept. 2000. Multi-City Study Analysesof Fish. Start date: June 2000. Multi-City Study - Analyses of "Market Baskets." Start date: June 2000. 000028 ATTACHMENT TO LETTER TO C. AUER DATED MAY 4, 2000: PRE-1976 TOXICOLOGY STUDIES ON PERFLUOROOCTANESULFONATES Eye and Skin Irritation Studies Report on Sample T-1117, Warf Institute Inc., Project No. 4102871, November 7, 1974, and explanatory correspondence indicating material is FC-95 (Perfluorooctane Sulfonate potassium salt) Eye, Skin and Acute Dermal LDS0 Study Report on Sample T-991 (FC-93, L-3356, Ammonium SaltofPerfluorooctane Sulfonate, 25% in 20% Isopropyl Institute Inc., Project No. 4053862, June 25, 1974 Alcohol and 55% Water), Warf oceezs Attachment to Letter to C. Auer Dated May 4, 2000: Environmental Studies on Perfluorooctanesulfonates (Post-1975) TPiheysicalichemical Properties. Laboratoroyr [BerofaFenakeing PorvFartgeSnTPFgOS, Boing Wtihdoer | + [pontitConcton nomatona, 1. (r[mRionraGtuiagoen aonTesVapor Press o FOSUsing hoSpin nomWation i 3 {oF[hROoiSnSehrakietFcassremmooatfhsiaann7Aa-NCioaRn.a-nGPooLrWPeFarceasrsPmaort:Seu4Cd5o4y0ui-nf1i0a8r inWailneLtz. Compoleytion Type Zs Prana mes To rhe TR Foi 1 esting Resume: A aes PartonCoufiaartKun)or PROS S[iGanoostan oeWaterSay of PROSbyth Shak [ TechiReapFeor SaliST MessiaenMessenSoTnFCC narmSatoRnaUld,. U oT neraFtionkae, Ui. TE S108 Faesoresamme wo Prat poe ZA iy [FC TR aFn Sar Ww Er TEintevironmental Fate and Transport SGSTtFtsC: Su3m5maFrCyoTf4t3h00SSooAdsoeriptioB n stTuWo dEynofv Tab Rerhorsocanesutoanidc 72256) S[EinmFvuLlCaatTbedsauSPumnmrtagranSytioynaityUh:eanPosgstauSssmmiumuBmaRoSrSafytunofiPhgciyns , ow Bos StyUsing Porvorsoctnenioacness [EBdieogdroraaddsattoonnSSuetsouoffFFducuriocoaerboesns W-sT1 Zr(771ao67ep8osrenpatnd.~~ [[B0OcOIbCo0thrroetfsssrFuuSsXmm(wsiatahkonrPiFbuSs)ztsuemmadry [BOOICOresusTorFE-38 OERsak PFS) ITrmaondsapiongGnockwuednd snnvtrormfmeormtDloConmMpaacikamyerotnst(huegaetchwyatr Fanonngcofiient cacltons [ras orRorachersea Tn Beg ah La"bniotrhaotroroyr SW Em Lab SW Ew Tb Comopluettion Type 22778 Fa) ferres VAS ie Fra Ew To WeTmsO BfIaEmi TE Eo GEeer omer Ew Ge Noda "a 000030 PHYSICAL - CHEMICAL PROPERTIES A Robust Summary, Final Report, and Protocol on the physical-chemical properties of perfluorooctanesulfonate are included for each of the following parameters: PARAMETER DATE OF REPORT RESULTS Melting Point/Melting Point Range Vn-aOpcotranProels/sWuarteer Partition Coefficient Air-Water Partition Coefficient Solubility in pure water Solubility Measurements on FC-95 2/24/99 52//51119/900 3/19/00 5/3/99 26/81 2400C 3.31 x 10"P@20C Not calculable; three phases 0(<2x10) 570mg! 1080mg `The data presented in the study "Solubility Measurements on FC-95," was determined by indirect measurement, not by actual analysis. Therefore, the data is not reliable. Please note that the March 1, 2000 submittal to EPA entitled "Sulfonated Perfluorochemicals in the Environment Sources, Dispersion, Fate and Effects" included solubility data on water other than pure (i. fresh water; filtered sea water; unfiltered sea water). These data were developed, however, in support of other studies and not produced using GLP Standards. For this reason, Robust Summaries, Final Reports, or protocols for this specific data are not being provided. 000031