Document ppJKR4r25oreMdMy7oy9QN7mB

3M's TSCA 8(e)FluorochemicalSubmissions I 3M's TSCA 8(e)FLUOROCHEMICAL SUBMISSIONS DOCKET NOS. 8EHQ-****-0373/0374 8EHQ-****-0394 8EHQ-****-6006 8EHQ-****-6012 8EHQ-****-6015 8EHQ-****-6016 8EHQ-****-6018 8EHQ-****-6019 8EHQ-****-6023 8EHQ-****-8624 8EHQ-****-t4596 3M's TSCA 8(e)FLUOROCHEMICAL SUBMISSIONS Docket 8EHQ-****-373/374 SORTED by SUBMITTAL DATE 11/19/80 (11/24/80) 11/19/80 (11/24/80) 2/20/81 (2/26/81) 2/20/81 (2/26/81) 6/15/81 (6/24/81) 3/22/82 (3/24/82) 5/15/84 -- t$tH-Q--1 180-0373 S 8EHQ-1 180-0374S 8EHQ-0281-0374S 8EHQ-0281-0373S TM!MFM sulfonamidoethanol N-ethylperfluoroheptylsulfonamidoethanol FC-95 & FC-99 Potassium saltofperfluoraolkyl sulfonates PerfluoFoalkyMlixtures(FC95) N-ethylperfluoroctylsulfonamidoethanol N-ethylperfluoroheptylsulfonamidoethanol Preliminairnyformatifornoman ongointgeratology study 2.Preliminarmyen Preliminariynformatiofnroman ongoingteratology 1.ProtocolsforOr study 2. Preliminarryepo 3M TechnicalReportregardingpresenceof fluorochemicalisnthebloodofsome of3M's plant em loyees. 3.3M Technicalre DecaturEmployee CarboxylicFluoroc Finalwrittenreportoftheteratologsytudy referencedinsubmissionof11/19/80 1.ReportNo. 1609 FC-95 inRats,"2/1 Finalwrittenreportofthe teratologsytudy referencedinsubmissionof 11/19/80 1.ReportNo. 1610, [subjeccthemical]i 8EHQ-0681-03748 8EHQ-0681-0373S 8EHQ-03820373/374S PerfluoroalkMyilxtures (FC-95) FC-143 ammonium carboxylate FM-3422 FC-95 8EHQ-0684-0374 I - perfluoroalkaylcohol Response to EPA letteorf5/15/81requesting additionailnformatioonn perfluoroalkmyilxtures Submissionofstudieson subjectmat request Informatiornegardingteratologsytudies 1. AnimalToxicity Perfluorooctanoate, 1.AnalysisofFM-3 from I.R.D.C.Study 2.FM-3422, Ninety toxicitsytudy,1/16/7 3.Speciallensoralt 2g9gCoC inRats,1 4. FC-95,Ninetyday toxicitsytudy,12118) 5.Reportremoving placedin'non-confid 6.Oral TeratologyS Rabbits,5/10/81- 6/. 7.An Epidemiologic atthe ChemolitePla 1. Interna3lM mem( Pernuoroalkyallcoho 5/15/84 (5/23/84) 11/29/88 (12/5/88) 5/15/98 (5/21/98) /10/98 9/14/98 (9/18/98) 2/05/99 (3/12/99) 8EHQ-0584-0-373 BE-HQ-1288 -0373 8EHQ-0598-031-3(Follow-upon: 8EHQ-1 180-0373 BEHQ-1 180-0374 8EHQ-0381-0394) 8EHQ-0898-373S 8EHQ-0998-0373 (Follow-upon: 8EHQ-1 180-0373 8EHQ-1 180-0374 8EHQ-0381-0394) perfluorooalksyullfonate FC-95 FM-3422fr-3352 perfluoroalkyalcohol FC-95fr-3351 perfluoroalkyslulfonate FluorochemicalFM-3924 N-ethylperfluorooctanesulfonamido ethanol PerfluorooctaneSuffonate (PFOS) PerfluorooctaneSul (PFOS) N-ethylperfluorooctyl sulfonamido ethanol (N-EtFOSE) PerfluorooctaneSulfonate (PFOS) Informationregardingteratologystudies Submittalof reporte@"tTiWtOi@eYdear Oral (Diet)- Toxicity/CarcinogenicSituydy of Fluorochemical FM-3924 in Rats" sulfonate,05/15/8 2. Interna3lM me PerfluoroalkyAllcc 3. Interna3lM me FC-95, 05116184 4. Letterfrom Je reportof T3351, 1 5. Interna3lM me FC-95, 05/16/84 6. Rat Teratology Report,12/19/83 1. Interna3lM me Perfluoroalkyallco sulfonate,5/16/84 2. Interna3lM me PerfluoroalkyAllco 3. Letterfrom Jeffo reportof T-3352, 0 4. Rat TeratologyS Report,3/21/84 Tw1-.o Year oral( Study of Fluoroche Submission of informationon PFOS relatintgo analysisof blood sera samples Summarizing statusof 3M meeting request Preliminaryresultsof two-generationrat reproductionstudies 8EHQ-0299-373 PeffluorooctaneSulfonate (PFOS) Reportson chemistryand seradata 1. The Scienceof0 02/05/99 2. Perfluorooctane of Human Sera Heal 2 2/25/99 (3/11/99) 2/25/99 (3/11/99) 3/15/99 (3/23/99) 5/26/99 (6/4/99) 5/26/99 (6/7/99) 5/28/99 (06/04/99) 2/15/00 (02/22/00) 8EHO-0399-373 8EHQ-0399-374 8EHQ-0399-374 8EHQ-0699-373 (Follow-upon: 8EHQ-1 180-373; 8EHQ-1 180-374; 8EHQ-0381-0394; 8EHQ-0598-373) 8EHQ-0699-373 (Follow-upon: 8EHQ-1 180-373; BEHQ-1 180-374; 8EHQ-0381-0394; 8EHQ-0598-373) 8EHQ-0699-373 (Follow-upon: 8EHQ-1 180-0373 8EHQ-1 180-0374 8EHQ-0381-0394) 8EHQ-0200-0373 (Follow-upon: 8EHO-0998-373; 8EHQ-0998-374; 8EHO-0998-394) Perfluorooctanesulfonate Summary ofratteratologyresults (FC-95) 2-(N-ethyl peffluoroctanesulfonamido)alcohol(FM-3422) Perfluorooctanesulfonate Summary of ratteratologyresults (FC-95) 2-(N-ethyl perfluoroctanesulfonamido)- alcohol(FM-3422) Potassium Perfluorooctane Informationon ratteratology Sulfonate Sulfonyl-based fluorochemicals Summarry of initiaslcreeningdata regardingthe distributionf PFOS inbiota 01/29/99 1. FC Rat Teratoio 1. FC Rat Teratolo 1. Rat TeratologyE PerfluorooctaneSul 2. Letterof11/12/8 Thomas JeffersonL 3. Letterof12/07/8 Thomas JeffersonL Sulfonate-based fluorochemicals Carboxylic-based fluorochemicals sulfonyl-based fluorochemicals Summary offurtherstudiesregardingthe presence of perfluorinatesdulfonatesand perfluorinated carboxylicacidsinhuman sera 1. Chart: Sulfonat identifieidnHuman 2. Chart: Carboxyli identifieidnHuman Informationregardingthe manufacture,use, distributioand environmentalreleaseof FCs FluorochemicalUse Overview (Prepared N-EthylPerfluorooctyl Sulfonamido Ethanol (N-EtFOSE) PerfluorooctaneSulfonate (PFOS) Finalreportsforthetwo-generationratreproduction I . studies 1 2. FinalReport,P Oral (Gavage) F Perinatal/Postn Study of N-ETFC 6316.5,6/30/99 FinalReport,P 3/17/00 (3/20/00) 3/17/00 (3/20/00) 8EHQ-F3oo-o3-73 (Follow-upon: 8EHQ-1 180-0373; 8EHQ-1 180-0374) BEHQ-0300-00373 (Follow-upon: 8EHQ@l 180-0373; BEHQ-1 180-0374) -gulfonate-base-d Fluorochemicals Perfluoroalkyls Informatioonn environmentalfateand effects Response to EPA letteorf02/25/00 (Gavage)C Rats,Study 3. FinalReport Oral(Gavag Perinatal/Po Study ofPF 6/10/99 1 'Sulfonated Environment Effects,3'M, 3M's TSCA 8(e)FLUOROCHEMICAL SUBMISSIONS Docket 8EHQ-****-394 SORTED by SUBMITTAL DATE 3/20/81 (3/27/81) 05/06/81 6/16/81 (6/25/81) 3/22/82 (3/24/82) 10/16187 10/23/87 10/11/93 (10/20/93) 8EHQ-0381-0394S (Follow-upon 8EHQ-03810394C) 8EHQ-0681-0394S 8EHQ-0382-0394 (Follow-upon BEHQ-03810394S) (Follow-upon 8EHQ-03810394S) 8EHQ-1093-0394S Perfluoroalkanecarboxylic acids Correspondingammonium carboxylates Perfluoroalkanecarboxylic acids Preliminaryinformationfrom 3M reportentitled 'OralRangefinderStudy ofT-2998CoC inPregnant Rats' Response to 04/07/81EPA letterequesting substantiatioonf confidentialictlyaims 1.Addftinal lette 3/20/81 2. Oral Rangefind Pregnant Rats, 3. StatusReport Corresponding ammonium carboxylates FC-143 (Perfluroalkane ammonium carboxylate mixture) FC-143 (Ammonium Perfluorooctanoate) FC-143 (Ammonium Perfluorooctanoate) Response to letteorf 5/15/81from EPA, which includedrequestforadditionailnformationon 3M's TCSA 8(e)submission forperfluoroalkane ammonium carboxylatemixture. Sanitized(non-CBI)copiesof studiesprovidedat meeting withTerryO'Bryan on 3/12/82at EPA Informationon toxicity/carcinogenicity 1. ProtocolforOr (FC-143)inRats, 1. An Assay ofC CytotoxicitiynC3 testchemical T-2 2. OralTeratolog Rabbits,2/23/82 3. OralTeratolog 4/81 4. NinetyDay Su 143, 11/6178 5. NinetyDay Su Study, FC-143, 1 1. *Two Year Or Study of Fluoroch FC-143 (Ammonium Perfluorooctanoate) Mixtureof Ammonium Perfluorooctanoate Ammonium Perfluoroheptanoate Confirms telephoneconversationsregardingprior submissionwithpages erroneouslystamped as confidential Toxicity/CarcinogenicSituydy 1.Table 1 -Turn 2. Table 2 - Sum Lesion Incidence 10/93 Ammonium Perfluorohexanoate 5/15/98 (5/21/98) 9/14/98 (9/18/98) 5/26/99 (6/4/99) 5/26/99 (6/7/99) 5/28/99 (06/04/99) 2/15/00 (02/22/00) BEHQ-0598-0373 (Follow-upon: 8EHQ-1 180-0373 BEHQ-1 180-0374 8EHQ-0381-0394) 8EHQ-0998-0373 (Follow-upon: 8EHQ-1 180-0373 8EHQ-1 180-0374 8EHQ-0381-0394) Ammonium Perfluoropentanoat(eor Ammonium Perfluoroalkyl carboxylates) PerfluorooctaneSulfonate (PFOS) Elm Submission ofinformationrelatintgoanalysis-of blood sera samples "showing PFOS atverylow (i.e.p,artsperbillio(n'ppb")l)evels' N-ethylperfluorooctyi sulfonamido ethanol (N-EtFOSE) PerfluorooctaneSulfonate (PFOS) Preliminaryresultsof two-generationrat reproductionstudieson the subjectchemicals; providessummary of preliminaryfindings. -iEHQ-069'9-373 (Follow-upon: 8EHQ-1 180-373; 8EHQ-1 180-374; 8EHQ-0381-0394; 8EHQ-0598-373) 8EHQ-0699-373 (Follow-upon: 8EHQ-1 180-373; 8EHQ-1 180-374; 8EHQ-0381-0394; 8EHQ-0598-373) 8EHQ-0699-373 (Follow-upon: 8EHQ-1 180-0373 BEHQ-1 180-0374 8EHQ-0381-0394) 8EHQ-0200-0373 (Follow-upon: 8EHQ-0998-373; 8EHQ-0998-374; 8EHQ-0998-394) Sulfonyl-based fluorochemicals Sulfonate-based fluorochemicals Carboxylic-based fluorochemicals Sul nyl-based fluorochemicals N-EthylPerfluorooctyl Suffonamido Ethanol (N-EtFOSE) PerflUorooctaneSulfonate (PFOS) Summary of initiaslc.reeningdata rega distributionf PFOS in biota Summary of furtherstudiesregarding@uman-sera 1. Chart: Sulfona identifieidnHuma 2. Chart:Carbox) identifieidn Huma Informationregardingthe manufacture,use, distributiaond environmentalreleaseofFCs 'FluorochemicalU Overview" (and aft 5/26/99 Finalreportsforthe two-generationratreproduction 1. studies 2. FinalReport, Oral(Gavage) PerinataVPostn Study of N-ETF 6/30/99 FinalReport,P Cross-Fosterin 2 . --. N o. T-6295.13 3. FinalReport,F Oral(Gavage) Perinatal/Post Study of PFOI, 6/10/99 3M's TSCA 8(e)FLUOROCHEMICAL SUBMISSIONS Docket 8EHQ-****-6006 SORTED by SUBMITTAL DATE 7/27/92 (7129/92) 7/27/92 (1/12/94) 8EHQ-0792-6006 8EHQ-0792-6006A Pyrolysisvapor of 25% CaC03 and 75% of the following6:3% N-(2hydroxyethylYN-methylperfluorooctanesuffonamide, 3% CAS 068555-76-0,4% CAS #68555-75-9, 1% CAS 68555-74-8, and,4% CAS #34454-97-2 Inhalatiotnoxicitdyata in rats Summary of'Study Design and Results:Acute InhalatioTnoxicitSytudy inRats (FinalReport)" 1. An Acute Inhal CoC inthe Rat, 3M's TSCA 8(e)FLUOROCHEMICAL SUBMISSIONS Docket 8EHQ-****-6012 SORTED by SUBMITTAL DATE 7/27/92 (7/29/92) BEHQ-0792-6012 99% I-octane Oraltoxicityd,ermal irritatieoyne, irritatidoanta sulfonamide 1,1,2,2,3,3,4,4,5,5,6,6,7, 7,8,8,8-heptadecafluoro N-methyl 1% water 1.Acute Oral Tox Pathology;Prima Summary; Prima Summary; Sampi 3M's TSCA 8(e)FLUOROCHEMICAL SUBMISSIONS Docket 8EHQ-****-6015 SORTED by SUBMITTAL DATE 7/27/92 (7/29/92) 7/27/92 (1/12/94) H"792-6015 8EHQ-0792-6015A R&D sample with0.23% fluoropolymer0,.025% sulfonamides,C4-8-alkane, perfluoroN,-ethyl-n(hydroxyethylr)e,action productswith 1,1'methylenebis[4isocyanatobenzene]a,nd solventmixture R&D sample with0.23% fluoropolymer0,.025% sulfonamides,C4-8-alkane, perfluoroN,-ethyl-n(hydroxyethylr)e,action productswith1,1'methylenebis[4isocyanatobenzene]a,nd solventmixture Acute inhalatiotnoxicitdyata Summary of'StudyDesignand Results:Acute InhalatioTnoxicitSytudy withRats (Final Report)" 1.An Acute Inhali the Rat,7111/86 3M's TSCA 8(e)FLUOROCHEMICAL SUBMISSIONS Docket 8EHQ-****-6016 SORTED by SUBMITTAL DATE 7/27/92 (7/29/92) 7/27/92 (1/12/94) BEHQ-0792-6016 8EHQ-07926016A 68% Poly(oxy-1,2- Submittalof acute studies ethanediyl)a,42-ethyl (heptadecafluorooctyl)su lfonyla]mino] ethyl]-w- hydroxy- 3% poly(oxy-1,2ethanediyl)a,42-ethyl (pentadecafluoroheptyl) sulfonyla]mino] ethyl]w-hydroxy- 0 5% poly(oxy-1,2ethanediyl)a,-[2ethyl(tridecafluorohexyl) sulfonylalmino] ethyl]w-hydroxy- 0 1% poly(oxy-1,2ethanediyl)a,-[2-ethyl (undecafluoropentyl) sulfony]amino] ethyl]w-hydroxy- 0 4% poly(oxy-1,2ethanediyl)a,-[2-ethyl (nonafluorobutyl) sulfony]amino] ethyl]w-hydroxy- 0 12% poloyoxyethylene glycol 0 <0.3% dioxane @ Surfactantor coating component Summary of studydesigns and resultsforacute toxicitryeports <0.3% dioxane 1. Acute Dermal AlbinoRabbits,0 2. Acute Dermal Sample T4370, 1 3.Primary Skin Ir AlbinoRabbits,I 4. Acute Dermal t AlbinoGuinea Pi 5. Acute Dermal (sample T-3639), 6. Acute Dermal (sample T-3649), 7. Memo on FC-1 guinea pigand ra study,08117/83 3M's TSCA 8(e)FLUOROCHEMICAL SUBMISSIONS Docket 8EHQ-****-6018 SORTED by SUBMITTAL DATE 7/27/92 (7/29/92) E -0792-6018 1-octanesulfoniaccid, Acute oraltoxicitdyata 1.1,2,2,3,3,4.4,5,5,6.6,7, 7,8,8,8heptadecafluoro-comp. with 2,2'-iminobis [ethanol(]1:1) 1. cuteOralToxi 9/25178 2.Acute OralToxi 7/12178 3M's TSCA 8(e)FLUOROCHEMICAL SUBMISSIONS Docket 8EHQ-****-6019 SORTED by SUBMITTAL DATE 7/27/92 (7/29/92) 8EHQ-0792-6019 Average CBF17SO3-K, Acute Inhalatiotnoxicitdyata potassium perfluoroalkyl sulfonate 1. An Acute lnhala CoC inthe Rat,1 3M's TSCA 8(e)FLUOROCHEMICAL SUBMISSIONS Docket 8EHQ-****-6023 SORTED by SUBMITRAL DATE 7/27/92 (7/2921 8EHQ-0792-60 Ammonium perfluorooctanoate Acuteoralto)dcitdyata 1.Acute OralTo)d 3974 Lot39C, 215/ 3M's TSCA 8(e)FLUOROCHEMICAL SUBMISSIONS Docket 8EHQ-****-8624 SORTED by SUBMITTAL DATE 11/30/92 (1217/92) 12/29/92 (1/5/93) 8EHQ-1 192-8624 8EHQ-12928624S Lithiumperfluorooctane Acute oraland inhalatiotnoxicitdyata inrats sulfonate Supplemental informationon Lithiumperfluorooctane sulfonate Toxicityand teratologystudiesin ratsand rabbits 1. LithiumPerflu PeroralToxicity 6/23/92 2. ProjectNo. 91 of LithiumPerflu FinalReport,5/2 1.Report Summ Minimum Toxic! 2.Summary left teratologystudy 3.Summary left teratologystudy 4.Summary of study 3M's TSCA 8(e)FLUOROCHEMICAL SUBMISSIONS Docket 8EHQ-****-14596 SORTED by SUBMITTAL DATE 11/19/99 (11123/99) 01/28/00 (02108/00) 8EHQ-1 199-14596 Ammonium Perfluorooetanoate BEHO-0200-14596 Perfluorooctanoate Summary of6-month primatefeedingstudy Response to EPA requestfordescriptionand of 3M medical surveillancperogram results 1. GillilanFdD, employees of a r plant.J Occup h 2. GillilanFdD, perfluorooetanoi lipoproteinsa,nd occupationalley) 1996;29:560-568 3. Olsen GW, G Mandel JS, Man investigatioonf r occupationalexp Occup Env Med 4. Olsen GW, B 3M FinalReport plasma cholecys perfluorooctanoi St.Paul;3M Com