Document gb3RoGYqNYdbQwODBB2vrzrJL

-'Vi cenerai osnees 3M Gemer 6S5t.!P7a3u5J'. M11N1055144-1000 fi g.fi.6 _ iS'tt- $ M 'o go - oo3 August 21,2000 Document Processing Center (7407) Office of Pollution, Prevention and Toxics U.S. Environmental Protection Aoency 401 M Street, S.W. . ~ Washington, DC 20460 Attention: Section 8(e) Coordinator Re: TSCA Section 8(e) Supplemental Submissions: Docket Nos. 8EHQ-1180-373 and 8EHQ-1180-374 Dear Sir/Madam: 3M Company ("3M") requests that EPA redesignate, to the TSCA Section 8(e) docket, thirty studies which 3M previously submitted to SPA and are presently contained in For Your Information'' (FYI) docket number 13/8. These studies and information supplement 3M's previous 8(e) submissions in Docket Numbers 8EHQ- 1180-373 and 8EHQ-1180-374. . Attachment One lists the studies for which 3M requests redesignation. We have endeavored to include sufficient identifying information to facilitateIhe redesignation, including date of study submission; study title; study date; study type; anc chemical. These studies consist of health and environmental effects data", ' environmental fate information, and human, and environmental exposure data on various fluorochemicals, these data are consistent with information already included in the TSCA Section 8(e) docket for these or related compounds, but 3M has concluded these data may not be, strictly speaking, "corroborative" of previously reported or published information as defined in EPA's reporting guidance. 3M appreciates EPA's attention to this matter. Please do not hesitate to contact the undersigned if you have any questions or require further information regarding this submission. Viery truly yoursKK._ Idf.J Dr. Katherine E. Reed, Ph.D Executive Director 3M Environmental Technology And Safety Services S u bm ission D a te Studies To Be Moved to 8(e) Docket <$ 0 S ~ 3 J-3 C h em ical/ Product N am e Study Title Laboratory Study Study No. Date Study Type 0 4 /2 1 /2 0 0 0 KPFOS Oral (Stom ach Tube) Developm ental Toxicity Study of P FO S in Rabbits Argus Research Laboratories, Inc. 04/21/2000 K PFOS; T-624S: FC-95 Single Dose Intravenous P haram acokinetic Study of T 6246 in R abbits. 3M Environm ental Laboratory Study #AM DT-042095.1 3M Technical ~aqi$ 04/21 '2000 PFOS; PFHS; PFOA- NEtFOSAA; F O S A N -M eF O S A A ; PFOSAA; M570; M556 Fluorochem ical Exposure A ssessm ent of D ecatur Chem ical and Film Plant Em ployees M ed ica l Departm ent; 3M Company 05/04/2000 D EA PFOS; FC-99 N ew Form ula; T2509 CoC Two W eek O ral R angefinding T oxicity Study o f T -2 5 0 9 C o C in Rats R iker Laboratories, Inc. 418-012 AMDT042095.1 EPI-0Q06 179RR023 01/11/1999 H ealth Effects: Developm ental T o x ic ity 11/11/1995 H ealth E ffects: -Pharm acokinetic & M etabolism Studies 08/11/1999 Hum an Data & Incidents: M edical S urveys, C linical S tudies, R eports or A llegations o f W orker or C onsum er Effects 02/25/1980 H ealth Effects: Acute T o x ic ity 05/04/2000 KPFOS 05/04/2000 KPFOS 05/04/2000 K PFOS; T-6295 A cute O ral T oxicity (LD 50) Study in R ats PFOS: A D ietary LC50 Study w ith the Northern Bobw hite International Research and Developm ent C o rp o ra tio n W ild life International 737-083 05/31/1978 A t 2.2.3 o 9ss H ealth Effects: Acute T o x ic ity 454-103 04/26/2000 E nvironm ental Fate &T o x ic ity D a ta : A v ia n &O th e r W ild life 104 W eek D ietary C hronic T oxicity and C arcinogenicity Study w ith PFO S Potassium Salt in Rats .C ovance . .. L a b o ra to rie s. Inc. 6329-183 / f X ' 2 2 6 - 6 9S& H ealth Effects: C arcinogenicity 'S tudies 05/04/2000 K PFOS; 7-5295 26 W eek C apsule Toxicitv Covance S tu d y w ith P F O S ; T -6 2 9 5 in L a b o ra to rie s , Inc. Cynom olgus M onkeys (Volum e I and II) '" 3 ,2 7 i- 632S-223 04/12/2000 H ealth Effects: C hem ical-Tissue O bservations '05/04/2000 K P FO S ; T-6295; T eiom er A lcohol; T elom er A crylate; PFBS; PFHS ' ^E xploratory 28-D ay O ral Toxicity S tudy w ith T eiom er A lcohol, T eio m e r A crylate, PFBS, PFHS, and PFOS . (positive co ntrol) By Daily G a v a g e In T h e R a t F ollow ed by a 14/28 D ay R ecovery Period 3M Environm ental Laboratory (FACT) / U 2 2-C-- F A C T -T O X 120.3 06/11/1999 H ealth Effects: S ubchronic Toxicity 05/04/2000 P erfluoroethylcyclo hexyl sulfonate DEA Salt; FC-90; T-2960 CoC Acute O cular irritation Test w ith T -2 9 6 0 C oC in A lb in o R a b b its ' Safety E valuation Laboratories, Riker Laboraties, Inc. ID 8 8 0 E B 0 5 S 8 02/18/1981 H ealth Effects: D erm al/E ye Irritation Page 1 of3 A? EPA Subm ission ChemicalZ D ate Produel N am e Study Title Laboratory Study Study No. D ate Study Type 05/04/2000 PFOS 0S/04/20Q0 PFOS. Fluorochem ical (FC ) Levels in N ave Rats - F u rth e r Investigation o f R at C how 3M , / ftfczzi-jko T -6 3 1 6 .9 ; DT21 05/14/1999 Environm ental Fate & Toxicity Data: O ther Environm ental Inform ation Fluorochem ical (FC ) Levels 3M Medical in Nave Rats, T-6316.9 Departm ent, T oxicology S ervices T -6 3 1 6 .S 05/14/1999 . Health Effects: Pharm acokinetic & M etabolism Studies 05/04/2000 05/04/2000 PFOS; PFHS: PFDS; PFOA PFO SA A: M5ES; MS70; M463; M513 A na lysis o f FC s in S am ples o f C hildren's Sera fl-jl 2 U/ Potassium p e rflu o ro e th y lc y c lo h e xyl sulfonate; FC-98; T-2308 CoC A cute Inhalation T oxicity S tuoy of T -2308 C oC in the Rat 3M Environm ental Technology & S e rv ic e s B io/dynam ics, Inc. F A C T -G E N 011 05/21/1999 Hum an Data & Incidents: M edical Surveys, Clinical Studies, R eports or A llegations o f W orker or C onsum er Effects 78-7187 04/12/1979 Health E ffects: A cute T o x ic ity 05/12/2000 PFOS; FOSA: PFOA: PFHS . Q uantitative A n a lysis o f FCs in E nvironm ental S am ples A A ' p - b - o ' U ' ' 2- 3M Environm ental Laboratory (FAC T) ' FACT Gen021, Gen024, Gen030, Gen033 05/10/2000 . Environm ental Fate 8 Toxicity Data: G eneral 05/18/2000 FO SA; T-3421 05/18/2000 N -E tF O S A 05/18/2000 : N-EtFOSA A cute Oral T oxicity S creen w ith T-3421 in A lb in o Rats R iker Laboratories, . 0883A R 0287 bln c - fjii 22 - -<3 93 01/17/1984 Health Effects: A cute T o x ic ity A D evelopm ental T oxicity S tudy of 313401 in Rats W IL R esearch Laboratories, inc. 157016 05/30/1997 Health Effects: D evelopm ental T o x ic ity ' P rim ary Eye Irritation ' Product Safety Labs 3871 11/03/1995 'H ealth Effects: Derm ai/Eye Irritation 05/18/2000 N-EtFOSA; NEtFOSE Alcohol; N -M eFO SE Alcohol B ic a c c u m u la tio n o f F C in T ennessee R iver Fish 3M Environm ental L a b o ra to ry 78-2740 /l#2 2 (r~ 0 f ? / ' 05/22/1979 Environm ental Fate 8 Toxicity Data: S ioaccum ulaiion/P ers; s te n c e 05/18/2000 N-EtFOSE Alcohol -.A b s o rp tio n and "B iotrahsform ation o f N -ethyl FOSE and Tissue Distribution anti Elim ination o f C arbon 14 after. A dm inistration o f N -ethyl F O S E l4 C in Feed R iker Laboratories, Inc. 4 & 7 -2 O yi s 01/19/1983 Health Effects: Pharm acokinetic & M etabolism Studies 05/18/2000 N*EtFOSE Alcohol O ral (G avage) D evelopm ental T oxicity Study o f N-EtFO S E in Rats 05/16/2000 Page 2 of3 N-EtFOSE Alcohol Ora! (Stom ach Tube) Developm ental T oxicity S tu d y o f N -E tF O S E in Rabbits , 4 ^ 2 2 i-bjU T -6 3 1 6 .7 ; 418-011 Argus R esearch Laboratories, Inc. 418-010; 6316.8 12/17/1998 Health E ffects: . D evelopm ental T o x ic ity ' 01/11/1998 Health Effects: Developm ental T o x ic ity EPA Submission Chem ical/ D ate P roduct N am e Study Title Laboratory Study Study No. D ate Study Type 05/15/2000 N - E tF Q S E Alcohol; FM -3422 05/18/2000 N-EtFOSE A lcohol; T-5874 Evaluation o f the - Bioconcentration P otential o f FM 3422 3M Environm ental Laboratory (FACT) 9970612623 08/16/1978 E nvironm ental Fate & T oxicity Data: B ioaccum ulation/P ersi s te n c e . D eterm ination o f the Partition C oefficient (noctanol/w ater) o f T -5874 by high perform ance liquid chrom atography (HPLC) NOTOX. 121275 04/07/1994 E n viro n m e n ta l Fate & Toxicity Data: B ioaccum ulation/P ersi s te n c e 05/15/2000 N-EtFCSEA 05/15/2000 M -E tF O S E A T6322 D eterm ination o f P hysico Chem ical Properties o f . S am ple D-1 AfL 2 Tw enty-eight-day R epeated Dose O ral T oxicity Study of S am ple D-1 in Rats, T-6322 M itsubishi Chem ical Safety Institute, Ltd. 4 B 2 2 3 -4 B 2 2 7 02/14/1996 Environm ental Fate & T oxicity Data: B ioaccum ulation/P ersi s te n c e Bio-M edical R e s e a rc h L a b o ra to rie s ' ' ' BMR143C A -2 2 -& 02/16/1993 H ealth Effects: S ubchronic Toxicity 05/13/2000 N-MeFOSE Alcohol; FM-3S25 D istribution C oefficient o f FM3 9 2 5 in N -O ctan o l W a te r M 2 -2 Y f ' Z - 3M Environments! Laboratory (FACT) ' 997 QC12600. ' 0 1 /1 0 /1 9 7 9 E nvironm ental Fate & Toxicity Data: B ioaccum ulation/P ersi s te n c e 05/18/2000 N-MeFOSEA; T5SSS Determ ination o f the Pollution C oefficient (noctanol/w ater) o f T -5869.4 by high perform ance liquid chrom atography (HPLC) ' NOTOX T -5 8 6 9 .4 04/07/1994 E nvironm ental Fate & Toxicity Data: B ioaccum ulation/P ersi s te n c e 05/15/2000 PFOSAA: T-3290 CoC Acute O rai T oxicity Screen w ith T -3 2 9 0 C oC in A lb in o R a b b its R iker Laboratories, , 0882A R 0362 Inc. . 1.1/05/1982 H ealth Effects; A cute T oxicity , : . 05/25/2000 NH4 PFOA; T3974; FC-126 05/25/2000 P F O A emulsifier, T-6564; FC-1015 Prim ary Eye Irritation In Rabbits, T-3S74 . ' ' H szelton L a b o ra to rie s Prim ary Eye Irritation/C orrosion Study of T -6564 in R abbits (O E C D . G uidelines) C orning Hazelton Inc. 61005209 . CHW 60504574 01/14/1987 H ealth E ffects: D erm al/E ye Irritation 09/05/1996 H e a lth E ffe c ts : ... D erm al/E ye Irritation Page 3 of3 31