Document rB52z2dDZgj9dNEnGQ8b4Gdkv

Attachments to Letter to C. Auer dated May 18, 2000AR 2 PerSftluudoireosoacntdanOetShuelrfoInnaftoer-mRaetliaotnedoCn oCmeprtoauinnds 6. N-EtFOSA | N-ethyl perfluorooctanesulfonamide Acute Toxicity 1) Final Report, Acute Ocular Irritation Test with T-3608 in Albino Rats, Riker Laboratories, Inc., 3M Reference FX-12, Study No. (0984EB0367, September 5, 1984 2) Final Report, Primary Skin Irritation Test with T-3608 in Albino Rats, Riker Laboratories, Inc., 3M Reference FX-12, Study No. 0984EB0368, August 13, 1984 3) Final Report, Acute Oral Toxicity Screen with T-3066CoC in Albino Rats, Riker Laboratories, Inc., 3M Ref. No. FX-12, Study No. 0981AR0146, July 13, 1981 Acute Toxicity Studies Not Submitted (Bibliography nly) 1) Final Report, Acute Oral Toxicity Study of T-6684 in Rats (OECDGuidelines), Corning Hazelton Inc., 3M Ref. No. L-14394 (slurry), Study No. CHW 61101149, January 31, 1997 2) Final Report, Primary Dermal Irritation/Corrosion Studyof T-6684 in Rats (OECD Guidelines), Coming Hazelton Inc., 3M Ref. No. L-14394 (slurry), Study No. CHW 61101150, January 31, 1997 3) Final Report, Primary Eye Irritation/Corrosion Study of T-6684 in Rats (OECD Guidelines), Corning Hazelton Inc., 3M Ref. No. L-14394 (slurry), Study No. CHW 61101151, January 31, 1997 Genotoxicity 1) Final Vivo Report, Protocol Mouse Micronuc and leus two amendments, Mutagenicity Assay, Coming Hazelton, Inc., Test on T-6294 in an In Study No. 1785-0-455, May 10, 1996 Previously submitted with May 4, 2000 letter, Advanced Bioanalytical Services, Inc., Analytical Report, Additional Characterization ofMetabolitesof T-6292, T-6293 and T6294 from Rat and Human Hepatocytes by TurbolonSpray LC/MS and LC/MS/MS. Semi-Quantitative Analysis ofT-6295 in Rat and Human Hepatocytes Incubated with T6292, T-6293 and T-6294 by LC/MS/MS, January 28, 1998, Report 98AGKP01.3M | 0 606337 AttacShtmuednitess atondLeOtttehrertoICn.foArumeartidoanteodn MCearyta1i8n,2000 Perfluorooctane Sulfonate-Related Compounds Mechanistic 1) TN.-JE.thCyrlopsesrfalnudorRo.oGc.taSncehSnuellflamannonm,idMee(cNhEaPnFiOsSm)o,f Toxicity ofa Unique Pesticide and its metabolite perfluorooctane SAbusltfroancatmfirdoem(P1F9O89S)SotcoiIestoyolafteTdoxRaibcboiltoRgeynMaeleCtoirntgical Mitochondria (RCM), PMreetvaibooulsilsymsoufbTm-i6tt2e9d2wi(tnh-eMthayly F4,OS2E0)0,0 Tl-e6tt2e9-r3 Q(una-lcitthaytlivFeOISnEvepsthiogsapthiaotnoefdithaemmInonViiturmo ssuallif(oensatteer)),byT-R6a2t9a4n(dn-Hcuthmyal npeHrefplautoorcoyotcteasnUessiunlgfolnoanmiSdper)ayanLdCT/-M6S29a5nd(pLeCrf/lMuSro/oMcSta,ne Advanced Bioanalytical Services, Inc., 96ADEMO1.3M, November 12, 1996 [Preliminary] Analytical Report, Report Previously Analytical submitted with May 4, 2000 letter Report, Additional Characterization Advanced Bioanalytical Services, of Metabolites of T-6292, T6293 Inc., and T- 6Se2m9i4-QfuraonmtiRtaattiavnedAHnualmyasnisHoefpaTt-o6c2y9t5esinbyRaTtuarnbdolHounmSparnayHeLpCat/oMcSytaensdILncCu/bMaSt/edMSw.ith T- 6292, T6293 and T-6294 by LC/MS/MS, January 28, 1998, Report 98AGKPO1.3M Analytical 1) Analytical 1993 and Research Properties -- 3M Industrial Hygiene Laboratory, January 10- - 6006338 AttacShtmuednitess taondLeOtttehrertoICn.foArumeartidoanteodn MCearyta1i8n, 2000 Perfluorooctane Sulfonate-Related Compounds 6. N-EtFOSA| N-ethyl perfluorooctanesulfonamide Bibliography Showing Studies in 3M's Possession Believed To Be In FIFRA Docket. REDACTED Sn- - 600339 Experinent No.: Conducted at: Dates Conducted: Conducted By: Acute Ocular Irritation Test with 1-3608 in Albino Rabbits 0s84zB0367 RPiaktehrolLoagbyoraantdorTioexsi,coIlnocg:y St. aul, Minnesota July 23, 1984 to July 30, 1984 fareAtk! alasts AcuteLaTboorxaitcoorlyogTyechnician Deor;aTTey el Bat SSetnuidoyrDTiorxeicctoolrogist deyriKbL.. GZorbaetnisen | W. C. WeCoraick 0006340 1. Summary The results of the acute ocular irritation test conducted from July 23, 1984 to July 30, 1984 at Riker Laboratories, Inc., St. Paul, Minnesota indicate that T-3608 is minimally irritating (10.3/110.0) to the eye Of the female albino rabbit. Slight conjunctivitis was noted at the one hour evaluation and subsided by the three day evaluation. Neithr corneal opacity nor iritis were noted during the seven day test period. Introduction The objective of this study was to determine the acute ocular irritation properties of T-3608 when instilled into the eye of female albino rabbits. This study was conducted for research and development purposes and is, therefore, not regulated by the Food and Drug Administrations's Good Laboratory Practice Regulation of 1978, although the standard operating / procedures of this laboratory adhere to the general principles of this regulation. The raw data generated by the Study Director and the final report are stored in the conducting laboratory's archives. G00341 2 Method and esuiss Young albino rabbits of the New Zealand breed" were used to evaluate the ocular Srritating properties of the test article. The test method vas soteled ater that of praise et aif, The test. article vas instilled into the conjunctival sac of the right are of each rabbis according to the treatment procedure presented in Table 1 vith the left eye of each anisal serving an a control. At each scoring interval, the cores, iris and palpebral conjunctim vere sxasined and graded for iceieation and injury according to a standard scoring syatesd. The saxinum possible score at any one examination and scoring period 110 points, which indicates maximal Srrication and damage to all three ocular tissues (cores, iris, conjunctiva) while a score of zero indicates no irritation (Table 2). In his scoring aystes, special cophasia ia placed upon irritation or damage to She corses, while lass eaphasis is placed upon damage to the iris and confunctive. Atte completion of the test, the scores were analysed, and a descriptive eye irritation rating vas assigned to the test article. The criteria used for assignment of the descriptive rating vere he frequency, the extent and the persistance of irrication or damage which occurred to hp three ocular tissues (Tble 3). The individu] results are presented tn mabe 4. BrCamoadmsnmieaertt"iocnsDou(mtmicahoileeaan,of1mhc.e, DSeanfveesr,of7hentcals in Foods, Drum and 00342 3. The rating is arrived at by selecting the maximum mean irritation score at one hour, one, two or three days after instillation. If the rate of dissipation of injury does not meet the requirements defined for the descriptive rating appropriate for a particular numerical score, the descriptive rating is raised by one or more levels. The rating system is presented in Table 3. The protocol, principal personnel involved in the study, composition characteristics and Quality Assurance statement are contained in Appendices I - IV. 600343 - ble1 Eye Teritation Twat - Albino Rabbits Treatment procedure ActTeisctle Hdumabterasof Porn pualuated Mdainistersd mQautnatiittiycloef Ainistersd Cboenrtiaocdt ofelMmash BProasltuabtoisoen Tine (seconds) (tap water) Adsimievsation 22600 . powder orem listed none n 1 he7wbnd ,ay1s,2,3 8 S2 # Table 2 5. Sye Irritation Test - Albino Rabbits Scale of weighted Scores for Grading the Severity of Ocular Lesions . Teer TCiosnsjuuensctiva -- Description RReeddnneessss ((Ar)efers to palpebral conjunctiva only). VMoerseseldsiffduesfei,nidteeelypeirnjcercitmesdonabroevd,e normal. individual vessels not easily discernible. Diffuse beefy red. Cnhyenosswieslli(n8)g above normal (included nictitating membrane). Obvious swelling with partial eversion of the lids. SSwweelllliinngg wwiitthh lliiddss aabboouutt half-closed. half-closed to completely closed. Discharge (C) Aamnoyunatmooubnsterdviefdfeirnenitnnferromcannotrhmuasl o(fDoneosrmnaolt ainnicmlauldse).small Discharge with moistening of the lids and hairs just aDdijsaccheanrtgetowitthhemoliidsst.ening of the lids and hairs and considerable area around eye. BGrraadieze 1 2 3 21 3 a 1 2 3 Score (A+B +C) x2 Total maximun = 20 Cornea ' opacity Opacity (A) - Degree of density (area which is most dense is taken for reading). . Scattered or diffuse area, details of iris clearly visible. 1 iEraissilysldiigshctelryniobblsecurterda.nslucent areas, details of 2 Opalescent areas, no details of iris visible, size of 3 pOuppaiqlue,barierliys diinsvciesrinbilbe.le. a Area of Cornea Involved (8) One quarter (or less) but not zero. 1 Greater than one-quarter, but less than one-half. 2 Greater than one-half, but less than three-quarters. 3 Greater than three-quarters, up to whole area. a Score equals Ax Bx 5 Total maximum = 80 Irie vFaolldusesab(oA)ve normal, congestion, swelling, 1 circuacorneal injection (any or all of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive). Ndoestrreuaccttiioonn t(oanyliogrht,allhemoforrthhaegsee,). gross 2 Score equals Ax Total maxinun = 10 Note: Tchoernemaa,ximiurmistoatnadlcoscnojruenctiisvat.he sun of all scores obtained for the 600345 Rating Non-Irritating PNroanc-tIircrailtlayting Minimally Irritating nIirlrailtyating Moderately Irritating SIervreirtealtying ` Extremely Irritating Table 3 6. Eye Irritation Test - Albino Rabbits BaCsleadssoinfiEcyaetioInrriotfatTieosnt MPartoepreiratlises Range 0.0 - 0.5 50.5 = 2.5 52.5 = 15.0 15.0 = 25.0 525.0 = 50.0 550.0 = 80.0 80.0 = 110.0 Definition Tboy mtahientoaniendtahyisreraadtiinngg,musaltlbescozreeros; otherwise, increase rating one level. Tboy mtahientoaniendtahyisreraadtiinngg,muasltlbescozrereos; otherwise, increase rating one level. Tboy mtahienttahirneethdiasy rraetaidnign,g amlulstscboerezsero; otherwise, increase rating one level. bToy mtahientsaeivnenthdiasy rraetaidnign,g malulstscboerezsero; otherwise, increase rating one level. Tdoaysmaminutsatinbet<his10raftoirng6,0%socorremsorebyosfeven the animals. must be < 20. "AIlfso,seveeanndsaeyvemneandayscosrceoreis <2100, Btuhten< 6n0o8anoifmaalnimaamlosngshtohwosescosrheoswing scores > 10 can exceed a score of 30 irfaisreatirnagtinisg toonebelevmeali.ntained; otherwise, dToaysmaminutsatinbet<his30raftoirng6,0%socorremsorebyosfeven the animals. must be < 40. "AIlfsos,evmeenandasyevemneandayscosrceoreis 40 But < 608 of the animals show sShcoovriensg<sc30o,resthe> n 3n0ocaannimeaxlceeadmonag stchoorsee oofthe6r0viisfe,ratrianigse israttionbge onmeainlteavienle.d; 600346 et - Ie Settaion at = ibn bite JP -- Hew -- EEChe-- on w ---------- m ---------- ET ESEiemrieuon Te ;Ter BJean o7 anp d7ean vaan m7ean 0oo -- Trmearon T ET:Wo :laen :Sune T :Sea 7wee ;eww i0 EEiiedeErs a TET:ao 7Seen 7leew 7Sew : :Son a33 TT E STpeor5e8s :: ;: 7: T 7: :: :: 2= TT Pa fit-- STR :: :v ?3 :: :; :; BuH" -- gg TT -- Bo fCocioee anl gaToedanedise . Lo Riker Experiment No: 229834425800336677 avrmwIX 1 PROTOCOL s. TEST:i__fAcouteeOcuullaritnation Toesstt 000000000 SPONSOR: 3M__Comnercial Chemicals ~~ Division `CONDUCTED BY: Safety Evaluation Laboratory, Riker Laboratories, Inc., St. Paul, Minnesota TESTARTICLE: 070 -3680000000000 covmouarree 0 No00000000000 eroosep sTanrmacowpieToone oF test gdl0d TEST SYSTEM:FemaleNew ZealandWhiteAbino Rabbits SOURCE: _HianmglibomDado eee Door semester reesei eters OBJECTIVE: Theobjectiveofthis testwilbeto detarthemiiitantiosn potentialofthe testarticetotheocular tissues f(ocrotmheeair,siernissiatnidvctoonjimuintcatnitvs,a)hiosfto-- rical& use, eaalbsienoofrhababnidtsi.ngRaabnbditgsenweerarleasveailleacbtieldty.as the test system METHOD: rwTohhoiemchsawnwiiilmtlahclfosroroweidslpoabnenddthwooautasceeardrodifanffesirtexadenaddtadroditbhwieitoruuemt-.smEieadscehohfactanghieemscaaligwneit.leTmbhpeeeartasetssuitrgaernteaidcnldeawnhiuulmlmibbdeeitriyensdctolneetardroItlnlategod se(radvdiiontigroniaalscsaecoc)roisnnatgrcionoltfA etrvhaelisgmhatyayboe 8ad8deddosteooffu--rh0e.rc1h_ahr&ao--cutesrwiL aiztenhtdhteh_e1occo,unlr2aarl,rae3taac8tailnoonsdo),oTthfeeascuhaengsiamwyaisll boaotsaselilxg.anmeAdiftnteeordtcahoenmpdtlegesrttiaaodrnteicodlfeft.ohreEtyieeistea,xtiatomnhieanasntcdioorneisnsjumwriaylyacbcbeoeradcniaanrlrgyiz1eed0d,ouaatsntwdainahdadterhsdecsraciipodtriiovfnegsosoyydesutimotmaftouiofornDosrrcaaeitiiznne.g 1 doomed necessarybythe sudy director, washedeye procedures eriang a 5 and 30 second co3stnoatrnaeicdmtapinlesrtihpoeedRrwiikpterhrocL8eadb--uorr5ea.toLrALiletsrE'aTAwrcdhaitvae,agScetn.heoPraavutele,rdMaib.nyne5 tshoetas.tmuudyted.irepcptooerriaonddwtihebeficnaolncrohpcotrtoswsilol nbge . poate 2DrPauirsinea:RAapbpbriatiCsahloowf,tRhaelSsatoent-yPuorfinCah,eSm.icLaolusisi,nMFiososdosu,riDrugs, and Ghismetics (1965) oe oPfubtlhieshUenditbeyd tSthaeteEsd.itorial Committee of The Association of Food and Drug Officials. 7 Pom mT 2a > Director Yo 000348 5. AppEOIXII Principal Participating Personnel Involved in the Study Name Function G. E. Hart Ascc.uteLaTbaoxriactoolroygTyechnician K. D. O'Malley, BS SSetnutdoyrDTiorxeicctoolrogist X. L. Ebbens, BS TSouxpiecrovliosgoyr Testing G. C. pecore nSuipnear)viLsaobroratory ` 006242 0. APPENDIX ITT 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. ' ---- rr-------- ---------- -- -- 000350 un. appENDIX TV QualityAssuranceStatement This study is not officially regulated by the Good Laboratofy Practice Regulation of 1978, and therefore a statement signed and prepared by the Coapliance Audit department is not applicable. The standard operating procedures of this laboratory does adhers to the general principles of this regulation. The Compliance Ault dspartment doss inspect different significant phases for studes undervay 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. ` 600951