Document v15Rezq7JMOy53JJrO01qg3Lq

. . ef 3M RAE iv) AR226_1038 MR Ge rn 2EHR _ Oo] -0373 Cfnra rnr, z Septem5,b2e00r1 Sn, on Document ProcessingCenter (7407) Office of Toxic Substances 401 M Street, SW Washington, DC 20460 Attn: TSCA Section 8(e) Coordinator boo 2 e &o -O~ 37 2 o dt 32 Dear Section 8(e) Docket Coordinator: Re: SCA 8() Supplemental Notice on Sulfonate-based Fluorochemicals `With this letter, 3M is providing final reports and other supplemental information related to previous TSCA Section 8(c) notifications. Manyofthe enclosed items are analytical reports providing blood serum and liver levelsof test materials for which the in-life report referring to administered doses has already been submitted to the 8(c) docket. In other cases `where the 8(e) notification consisted of preliminary data, we are submitting a final study report. All ofthe enclosed itemsarealready in EPA's possession and available in TSCA Docket AR-226. We believe, however, that placing these items in the 8(e) docket may allow for more convenient access to information directly related to previous 8(e) notifications by 3M. "The table below lists the enclosed itemsand references the study or data which already has been the subject ofan 8(e) notification by 3M: TORR Filed Under 8(e) 1. Amended Analytical Study, 2(N-Ethylperfluorooctane `Combined Oral (Gavage) Fertility, sulfonamido)-ethanolin Two Generation Rat Reproduction,| Developmental and Perinatal/Postnatal | CMHletCea ROBeOR,SYaAEe rEiRsER OKSaas AsrMEAmBeIdOCS0BCE EOOeSEsOtHeEMnSt.||Co S|lileFl0 ev r 2i. e Determinationofthe Presence and Concentration of PFOS, | Reproduction Toxicity Study of N- . Contaiain NO cgj R-3A e3x28 === B33=33 - 3 ; 1 TSCA Section 8() Docket Coordinator : Page2 | Attail Suypilsst | Filed Under 8() | "2. Analytical Laboratory Report, Determinationof the Combined Oral (Gavage) Fertiiy, | | Presence and Concentration of Potassium Developmental and Perinatal/Postnatal | PSeerrfulmuoarnoodcLtiavneersuolffoSnaateg(eCADSawNluemyber:Ra2ts75E9x-p3o9-s3e)d i0n. the || RinepRraosd,ucAtrigounsTRoexisceiatrychStLuadbyoorftoPrFiOe,S || PReFqOuSesvtioarGParvoajegcet.NLoa.bo3rMatTorOyXRe6p2o9r5t.9N,o.OcUt2o0b0e6r,27, 1999. || n1c0., S19p9o9n,sfourl'lsreSptourtdysuNbom.it6i2e9d5.9, une | | February 15, 2000 supplementing 3. RDeepvoerltopAmmeenntadlmeanndt P1e,rCinoamtbali/nPeosdtnOartaall(RGeapvraogdeu)ctFierotnility, | earlier filing Toxicity Study of PFOS in Rats, Argus Research L6a2b9o5r.a9t,orAipersi,l I1n3c,,20P0ro0t.ocol 418.008, Sponsor's Study No 4. Analytical Report, Determinationofthe Presence and CPoenrcfelunotrroaotcitoannoefsuPlefrofnlyuloarmoiodcet,anMeSsuSl6f,onaantde,M570 inthe LRiefv.erNoa.ndUS2e6r3a6,SaTmOpXle-s0,283,MFeEbnrvuiarroyn2m3en,t2a0l0L1aboratory 13-Week Dietary StudyofN-Methyl | | (PeNr-fMleuoFrOoSoEct)aninesRualtfso,n3amMidRoefE.thNaon.olT| 6d3a1t4e.d1J,uCneov3a0n,c2e00S0t,udSyecNtoi.on638(2e9)-2f2il5i,ng July 24,2000 5. ACnoanlcyetnitcraaltiLoanboorfaPtoFrOyS,RePpoFrOtS,AD,etPerFmOiSnAatAi,onaonfdtEhteFOSE- | DFienvaellRoeppmoerntt,aOlraTlox(iGciatvyagSet)udyof20N- `OH in the Sera and Liverof Cri.CDBR VAF/Plus Rats ExptooN-sE(eFOSdE, 3M Environmental Laboratory || eEtthhaynloplerifnlRuaotrso,oc3tManeRseuflefroennacmeidNoo.)-T- ReRepfo.rNtoN.oT.-6T3O16X.-70,9F,ebLarbuoarr6aty,or2y00R1e.quest No. U2402, 3M | 6to31S6e.c7t,ioDnec8(eem)bdeorck1e7t, p1e9r98l,etsteurbmoiftted August 21, 2000 6. Analytical Laboratory Report on the Determinationofthe Presence and ConcentrationofPotassium | DFienvaellRoeppmoerntt,aOlrTaolx(iScittoymaScthudTyuobfe)N- P2e(rNf-leutohryolopcetrafnleusourlofoocntaatnee(sPuFlfOoSn)amoirdaon-oetthhearromelt(aNb-olite of | TE-F63O1S6.E8,inJaRanbubairtys,113,M19R9e9f,esruebnmcietNtoe.d EEn{vFiOrSoEn)meinntLailvLearbaonrdatSoerryuRmepSopretciNmoe.nsT,O3X-M097, tAougSeucstti2o1n,82(e0)00docket per letter of FLaebborruaatroyr8y,R2e0q0u1est No. U2452, 3M Ref. No. T-63168, 7. EFimnpalloRyeepodratt,tAhlee3xaMndDeerc,atB.u,rMFoarctiallitiyt,yUSntiuvdeiressiotfy oWforkers | 8P(re)lidmoicnkaertydiantaletstuebromfitDteecdetmobSeecrti1o5n, Minnesota, April 26, 2001. 2000 : 2 TPaSgCeA3 Section 8(e) Docket Coordinator Attached Submission | opm] Filed Under 8(e) + FEisTit Reeapn, AecoeteeOelTToniotovnSSRormEenSwwihhrT3d9m0CroCs. |||cBspeeenOmtlTToennyeyRaSSyemrSeetnyew.i || PHT ol CHA No. T-3290(40 % K'PFOSAA in 3 % EtOH, 17 % IPA 1582 [Bibliography eniry in Docket AR-526, inclreport brveri Ere mi SO Laboratories, Inc., Project No. | 3290 (40 5 KPROSAN mo EXOH, | | was 10 bemoved 10 TSCA 8(e) docket] |o61877o5%, [tLPotA Sa0n1od),40%NonveHmob,er2L-506,7187985,2,F- | eSnrrene August 21, 2000 self-audit letter || GF PyePnrtosTr oemeodFRaenmtade in| r5)tmm adea a To Sor | a Senora-- perils 0, Too 11. Giesy, J.P., and K. Kannan, Perfluorooctanesulfonaantde Related Fluorochemicals in Oyster, Crassostrea Virginica, From the Gu ofMl exif co and Chesapeake Bay, Michigan State University, June 20, 2001. 12. Re Fm Giesy, J.P. and K. Kannan, roonEv Perfluorooctanesulfonate and 13. G=B Niaeisyn,e J.P and K. Km annm an, Accum mulation oa fdai | If you have any questions about this submission, please contact me at (651)737-4795. Sincerely, NY Lhe Manager, A3dMamCosrporate Product Responsibility Enclosures ;Po CE L-E[77F8E, CF-E68S273 Acute Oral Toxicity Screen wien reas {Lo 82 in Albino Rats Lint oo sertonnt vou: canmasoze2 contests rel) ti auss e Slee sy 30, 1383 0 nogac 2, 1982 Conducted By: qe@-30-370 3 EfHeaotheeo.g. sRRieuroreorwionyeeesssmfeifmmanonvtr iofcaf DDe.ECaSn3Sdshoot TR Reviewed By: foreireoysrt co stklsy. Fnoaai.erien Wo C. MoCormick Con: lat | Ji] - ERR a & EPA-OTS 0008118320 > >> g Q ed 1 summary Jn acute oral toxicity screen vith T-3150CEC ves conducted from uly 30, 1992 to August 27, 1982 at Riker Laboratories, Inc., St. Faul, Minnesota using pale and female albino rats ranging in bady weisht from 209-269 grams. The test article vas administered by gastric intubation at a dose level equivalent to 200 a9/k3 and 1250 33/kg body weight with 0/10 portalities noted at the 200 ng/kg dose level and 9/10 mortalities noted at the 1250 mg/ks dose level. Te untoward behavioral reactions which occurred during the 28 day observation period at the 200 g/kg dose level consisted of hypoactivity fram 60-120 sinutes post dose administration. Ime 1250 ng/kg dose level exhibited hyposctivity, ataxia, dlarchea and, in the females, unkempt appearance. Recovery vas generally precluded by death. body weight gains vere noted in all animals which survived the study. mecropsies perfomed at termination of the study revealed no Visible lesions, however, autolysis precluded evaluation of three 1250 29/kg dose level animals which died prior to the end of the study. The spproxtoate oral L080 of T-3290CC 8 Greater than 200 ng/kg and less than 1250 na/kg in fasted male and female albino rats. sntroauction me objective of this study vas to approxinate the acute oral LDSO of 1329000 in fasted albino rate. This study ves conducted for research and development. purposes and is, therefore, not regulated by the Food and Drug Jasinistration's Good Laboratory Practice Regulation of 1976, althouh the standard operating procedures of this laboratory adhere to the general principles of this regulation. The rav data generated by the Study Director and the final report are stored in the conducting laboratory's archives. < 2 Method and results Young albino rats? vere used in this test. ALL aninals vere held under quarantine for several days prior to testing with only animals which appeared 0 be in good health and suitable as test animals at the initiation of the study used. The rats wre housed in suspended, wire-sesh cages in temperature and humidity controlled rooms and peritted a standard laboratory ater? plus water ad libitum except during the 16-20 hour period immediately prior to gastric intubation hen food vas withheld. Ihe rats were administered the test materiail at 200 ng/kg ana 1250 ng/kg body weight. ALL doses were adainistered undiluted directly into the stomachs of the rats using a hypoderaic syringe equipped with a ball-tipped intubating nesdled. after gastric administration of the test article, the rate ere returned to their cages and observed for the following 28 days. Initial, 14 day and final body weights, mortalities (Table 1) and adverse reactions (Table 1) were recorded. A necropsy vas conducted on all animals that died during the study as well as those euthanatized and the end of the 28 day cbssrvation period (ble 1). The protocol, principal personnel involved in the study, composition characteristics and Quality Msurance statement are contained in Aopendices 1 - IV. 2Bxuinog nsabiP,uroirneagoLna,bowrtatory Chow, Malston purina, St. Louis, Ho The test article is 40% solids and was dosed at 200 mg/kg and 1250 mg/kg Of 2LscaoolpiipdesrewahniaecphSoenisse, evqNueeiwyv.aHlyednetPatrok,anNXundiluted dose of 500 mg/kg and 3125 mg/kg 6 a ss 1 ACUTS ORAL TOXICITY SCRESN - ALBINO RATS with 1-3290CC Mortality, Necropsy, Adverse Reactions and Body Weight Data (oogo/skeq) Sex 00 8 00 oF sew se Fo aNnuimmbaelr 23m5s8e87 220033559609 pe 282833660087 2=833661009 260 2m03s59e3 22m32559954 23596 wm3e61n3 2m6e1r4s 616 TrdivTiedsutilDayBodNyumbWeeri:ghts (G1 loos 1253 329036 335:218 226638 332089 43669 2 310 36 2nse 226603 226690 2292 223a6 22572 29 2s 20 226605 ((aayy 67)) 226693 (p3a0y3 5) 367 262 (vay 6) 22272 (vaayy 45)) 22146 G(daayy 55)) 209 ay 3) SNuumzbbeerrTevsetaedd ors ors as 5/5 seccceeandt 0 100 ZJ T TShoelitdess,t oafrtuihcilceh wtahse atdemsitniasrtteircelde ucnodnisliusttesd.ohfow4e0v%ers,olitdhse.dose represents mgs of hNaonetde:afceuatFaeliegourrraealsce.Li0nSOpairsengtrheeastiesr itnhdainca2t0e0 tmigm/ekgofanddealtehs.s than 1250 mg/kg in fasted male NB TeecreoB psy+thepe1r2f50ormmoe/dkgupodnoseterlmeivenlatiporondurceevdeanleodvinsoibvliesiSlleosiolonssiounpsonatnectrhoeps2y0,0 gho/wkegverd,ose autolysis precluded evaluation of three animals. cm os soir sn ia as : Camry of soscios ome J PN rai rei 3 wxiy mn ess _--wSfaimeder | weSsfdaeetyeer nang sp non oon5suass ws on us wa B3oa 1a aa a on wonnBo owB ssmvwen on ws mrcion cna te dn 28, Yn, 2 pian satiated hyn uy 1. | a se bene no sinc cons. & Riker Experiment No; 032308362 APPEIDIXI 5 PROTOCOL TEST Acute Oral Toxicity SPONSOR: oM_ComcreialChemicals Diisin CONDUCTED BY: Safety Evaluation Laboratory, Riker Laboratories, Inc, St. Paul, Minnesota resTARTOLE TmRS0CoC conTROLARTIOWE: Mew: PROPOSED STARTING/COMPLETIONDATE OF TEST: Ta = le Jou TESTSYSTEM: Pigino RAT, 0 STRAK SOURCE: KiNG Logs Crecor, NI SNuomxbe4,rF: 45 Weight Range: 200-700 grass I ----"--OBJECTIVE: The oblective of his test wil be to characlerize he acute --a=il__ loxicy o the test uci article in oaflbriensopoT nse, a historit cal ses , ease L In haa ndint g ans d genweerrael asvealielcatbeidiyasa test system for reproMETHOD: Th animals wil be housed in stainless steel suspended wire mesh cages in temperature and humidly cEEGoonodtreaoglelaenwodihfmira= crohowmwiisllldbcueorrimtrnodgejesebnpogtotinhwedidtl0hbeb(yoqhuecaaoardlnaomirnimtnaciilonsdetnieuanrgmne.bddeaterecassctcoohrpndeiarannigoicdmasa1r,l0d,watihhtfeohxwlfeaeovbotedoodrr?,atlhaefonydot'usiwtsassittddeaoernsodoafafgfrteehdreelocdepaveagerelda.lldiiAobnssigtisunpmgrnolo.-et ereetnlrataetoynsoulcphpTalrheaamcettneetrsaitlsaerdtoihcselaegtweiollebyv6elsao.dfmAtihnneiysttaeedsrdteiadtortnocalt,hdeaoadsndaiigtmeoanllaselvieanlntsihwmeialflosbrewmidrleobcceeuimvaeeddnmitfneridosmtaetnrhdeedfsltpehodenswtoeirsh,t f`acftironwesdfneor.thbeautfoalnloortwiibnge'al3i4smidteadysteo;Innhiteeiaarldta,noldunofginsra,l ibvcoegdry,eswkeiic1hgdehytssswahinlrdbegeedrneeocrroarldnegyads.tLrAogionrtowessstsinnaea lcrtorapch stywwihli=bche Yovoeendmeuecriiwooidd.thoAnsnpayielgcarn.oismsmaaalnbsntwoohrnimcathloiditiheeesdwouhrrgiinacgnh taahrneedcooobrnsdseuircevteodobfsdteuhrreivnetgde.stthAeallscorwnaedwlucGatasloafthgteehenaennrieamctarelodspssbuyyrvwtiihvleinbsgetturhdeey Getior ans the final -opor wil be stored in the Riker Laboratories Archive, St. Paul, Minnesota. 2B puyina a LaEboeratoa re y Chow, RaTwlasohtraonmmmPoueraTihnlae, BS1tO.L9L0o0uAs,aa1Mgfisksso2uar(ise vsioliPdsE)STsOoNlu)bto ion 5~ fs i suioi "Tb LL "Sponsor 2.G2a9te52 SwDudyt Direciorwe im > 70kie Riker Dxperinent No.:_0802aR03625. DeviationsAPPaEnNdDoIrX AIme(ncdomnecnltudsedt)o Protocol 1. _the sess arsicle was supplied as a solution with 40% solids not SON. e re -- ---- ----rer re----erer eee e-------------------------------- DSaadynDiretctaoir ban d 173t0/e8 2 eeeeee------------------ ---------------------------------- A ee ------------ udUDPi-- rIector -- ------e-- eeswee a oee eE------------re---------------------- rEe -------------- me ----------------er eee ere SEuEsyT Director er wee " eee-- ee ---- ---------- -------- ------ -- e------ee-- e -- EEe ------er eeee eetei esee sr rer--------eiee SudyeDir-- EectTo-- r e-- ner-- erT wgee 5 A ---- FE ---- ee e em------ ee-- -- SSeur-- dyaDiCreTn ctor--r --Te ? wee lo 7. APPENDIX 11 Principal participating personnel Involved in the Study Name Ho S. Rhodes b. H. Marke, Jr., BS K. L. Evbens, BS X. D. O'Malley, BS G. C. pecore Function hJre.uteLabToorxaitcoorlyogyTechnician TSotxuidycolDoigriescttor sTuopxeircvoilsoogry Testing AsceuntieorTTooxxiiccoollooggyist saunpiemravlisLoarboratory n 5. AppENDIX 111 Composition Characteristics This study is not regulated by the Good Laboratory Practice Act of 1978 and therefore information pertaining to composition characteristics is not applicable for inclusion in this study. 2 5. appENDIX IV QualityAssuranceStatement This study is not officially regulated by the Good Laboratory Practice Regulation of 1978, and therefore a statement signed and prepared by the Compliance Audit department is not applicable. The standard operating procedures of this laboratory does adhere to the general principles of this regulation. The Compliance Aulit dupartment does inspect different significant phases for studies underway in the Acute Toxicology Laboratory on a recurring cycle, and the facilities are examined on a three month schedule. In addition a select number of Research & Development studies are routinely picked at random from the Archives by the Compliance Audit department for review. 13