Document jmON1rv6mnJOzDGMeQGXM1m0Q

3M General Offices 3M Center St. Paul, MN 55144-1000 FYZ- osoo` i 5 7 ?__ __ O61l2i 7/3JJ3 1111U0 _ 0^ SECuV zGOKAY 3 H FYI-00-001378 <*. 0 FY1-00-001378 May 25, 2000 VIA EXPRESS MAIL 85000000014 Dr. Charles Auer 85000000014 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: Information On Perfluorooctanoic Acid And Supplemental Information On Perfluorooctane Sulfonates And Related Compounds Dear Charlie: e=:>3 c < c_ aE t O'- <--oa=>mo50 --iP 7 y ED HC!C Ts >r ro cn CO Pursuant to our recent communications, 3M is enclosing information on perfluorooctanoic acid. W e also are enclosing information on perfluorooctane sulfonates and related compounds which supplements information submitted to you previously under cover of our April 21, 2000, May 4, 2000 and May 18, 2000 letters. W e are providing this information on a voluntary basis as part of our continuing discussions with EPA regarding fluorochemistry. The enclosed information on perfluorooctanoic acid includes the following: => Copies of post-1975 studies and certain other information relating to the following environmental science areas: (i) physical and chemical properties; (ii) environmental fate and transport; (iii) environmental monitoring; and (iv) ecotoxicity. For each study, 3M has prepared a summary in the HPV "robust summary" format. => Copies of post-1975 studies and certain other information relating to the following health effects areas: (i) acute toxicity; (ii) genotoxicity; (iii) repeated-dose toxicity; (iv) pharmacokinetics; (v) teratology; and (vi) medical surveillance and epidemiology. 3M has included a detailed index of this information subdivided by COOOOl Charles Auer May 25, 2000 Page 2 each compound. W e also have enclosed summaries for the medical surveillance and epidemiology studies and have included copies of certain published studies in this area in order to provide appropriate context. => Lists of all studies in progress and planned studies, along with study protocols or study plans, where available. => A bibliography of pre-1976 studies subdivided by each compound. => A bibliography of acute toxicity studies subdivided by each compound, except that we are providing copies of key acute studies (with reference to the HPV guidance). => A bibliography of published studies in 3M's possession. 3M is continuing its file review and will supplement the enclosed information on perfluorooctanoic acid as appropriate. As you review this information, we ask that you bear several points in mind: => The enclosed information spans several boxes. W e 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 letter the indices covering studies and other information. => 3M provided the Agency with a list of all fluorochemical-related submissions made by 3M to the TSCA Section 8(e) docket under cover of our May 4, 2000 letter. This list included all submissions on perfluorooctanoic acid. => The enclosed information includes studies on perfluorooctanoic acid as well as on aqueous and/or solvent solutions of this material. Many of the studies refer to the test substance only by a 3M product identification number with a "T", "L", "FM" or "FC" prefix. Although analysis of the test substance has been included, where available, it is often not possible to determine from the study report itself the identity of the test substance. To assist in interpreting the studies, we have used 3M's historical product number records to provide composition information (e.g., composition percentages; solvent content; purity grade, etc.) next to each study name on the index and/or on the study summary. Please note that some formulations contain a small amount of "perfluorochemical inerts" - a term which refers to a completely fluorinated carbon chain with no functionalized components. Finally, it should be recognized that product formulations have evolved over the years, and thus, some of the test substances do not constitute current products. CGCC02 Charles Auer May 25, 2000 Page 3 => 3M understands that the Agency has requested information on perfluorooctanoic acid from duPont. For this reason, we are not providing copies of studies on perfluorooctanoic acid in 3M's files sponsored or conducted by duPont. => Consistent with the information previously provided on periluorooctane sulfonates and related compounds, 3M has not provided all analytical chemistry reports on perfluorooctanoic acid. Rather, we have enclosed 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. => The enclosed information does not include a "Use And Exposure Information Profile" or "UEIP" for perfluorooctanoic acid. Our present intention is to provide you with completed a UEIP form for perfluorooctanoic acid by June 9, 2000. => The information on perfluorooctane sulfonates under cover of our May 4, 2000 letter included documents relating to ongoing mechanistic research by Dr. Ken Wallace of the University of Minnesota. Please note that this research also encompasses perfluorooctanoic acid. The comparative metabolism research by Dr. Marion Anders of the University of Rochester Medical Center also includes perfluorooctanoic acid; there are not documents yet available relating to this research. 0G0C03 Charles Auer May 25, 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 C?. William A. Weppner, Ph.D Director of Environmental, Health, Safety And Regulatory Affairs Specialty Materials Markets 3M Bldg 236-1B-10 3M Center St. Paul, MN 55144 (651)733-6374 (phone) (651)733-1958 (fax) E-mail: waweDDner(.mmm.com Enclosures 0 0 OC04 PFOA Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Acute Toxicity 1) Inhalation Toxicity Study of T-2305 CoC - Rat a) Final Report, An Acute Inhalation Toxicity Study of T-2305 CoC in the Rat, Bio/dynamics, Inc., Study No. 78-7184, May 3, 1979 b) Technical Report Summary, Analysis of rat serum of FC-143, reported in terms of organic and inorganic fluorine, Central Research Laboratories, June 20, 1979 2) Final Report, Acute Oral Toxicity (LD50) Study in Rats, International Research and Development Corporation, Study No. 137-091, 3M Reference No. Fluorad FC-143, Lot 340, May 5, 1978 3) Final Report, Acute Oral Toxicity Study of T-6669 in Rats, Coming Hazelton, Inc., Study No. CHW 61001760, 3M Ref. FC-143, January 10, 1997 4) Final Report, Primary Skin Irritation Study - Rabbits, Biosearch, Inc., 3M Reference No. T-1395, FC-143, March 4, 1976 5) Final Report, Primary Eye Irritation Study - Rabbits (Washout Procedure), Biosearch, Inc., 3M Reference No. T-1395, FC-143, March 4, 1976 6) Final Report, Primary Eye Irritation Study - Rabbits (Not Washed), Biosearch, Inc., 3M Reference No. T-1395, FC-143, March 4, 1976 7) Final Report, Primary Skin Irritation Test with T-3371 in Albino Rabbits, Riker Laboratories, Study No. 0883EB0079, 3M Reference FC-26, Lot 389, July 13, 1983 8) Final Report, Acute Oral Toxicity - Rats, Biosearch, Inc., 3M Reference No. T-1585, FC-26 (perfluorooctanoic acid), September 16, 1976 9) Final Report, Primary Eye Irritation Study - Rabbits, Biosearch, Inc., 3M Reference No. T-1585, FC-26 (perfluorooctanoic acid), September 16, 1976 10) Final Report, Acute Dermal Toxicity Study of T-6342 in Rabbits, Coming Hazelton, Inc., Study No. HWI 50800374, 3M Ref. No. FC-1090, LI 3364, Lot 1, FI 1426, sodium perfluorooctanoate solution, October 24, 1995 00005 1 Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Acute Studies - Bibliography Only 1) Final Report, Acute Oral Toxicity - Rats, Biosearch, Inc., 3M Reference No. T-1395, FC-143, March 4, 1976 2) Final Report, Primary Skin Irritation Study - Rabbits, Biosearch, Inc., 3M Reference No. T-1585, FC-26 (perfluorooctanoic acid), September 16, 1976 3) Final Report, Acute Oral Toxicity Study in Rats, Hazelton Laboratories America, Inc., 3M Reference No. T-3974, Lot 390 (FC-126, approximately 88% solid), February 6, 1987 4) Final Report, Primary Dermal Irritation Study in Rabbits - Method, Summary, Raw Data Appendix, Hazelton Laboratories America, Inc., 3M Reference No. T-3974, Lot 390 (FC-126, approximately 88% solid), December 31, 1986 5) Final Report, Primary Eye Irritation Study in Rabbits - Method, Summary, Raw Data Appendix, Hazelton Laboratories America, Inc., 3M Reference No. T-3974, Lot 390 (FC-126, approximately 88% solid), January 14, 1987 6) Final Report, Primary Eye Irritation/Corrosion Study of T-6564 in Rabbits, Coming Hazelton, Inc., Study No. CHW 60504574, 3M Ref. No. FC-1015, Fluorad fluorochemical emulsifier, L I3167, straight-chain APFO solution, September 5, 1996 7) Final Report, Primary Dermal Irritation/Corrosion Study of T-6564 in Rabbits, Coming Hazelton, Inc., Study No. CHW 60504573, 3M Ref. No. FC-1015, Fluorad fluorochemical emulsifier, L I3167, straight-chain APFO solution, August 15, 1996 8) Final Report, Acute Oral Toxicity Study of T-6564 in Rats, Coming Hazelton, Inc., Study No. CHW 60504572, 3M Ref. No. FC-1015, Fluorad fluorochemical emulsifier, L I3167, straight-chain APFO solution, November 8, 1996 9) Final Report, Acute Oral Toxicity Study of T-6342 in Rats, Hazelton Wisconsin, Inc., Study No. HWI 50800373, 3M Ref. No. FC-1090, L13364, Lot 1, FI 1426, sodium perfluorooctanoate solution, November 16, 1995 10) Final Report, Primary Eye Irritation/Corrosion Study of T-6342 in Rabbits, Hazelton Wisconsin, Inc., Study No. HWI 50800376, 3M Ref. No. FC-1090, L13364, Lot 1, FI 1426, sodium perfluorooctanoate solution, October 12, 1995 11) Final Report, Primary Dermal Irritation/Corrosion Study of T-6342 in Rabbits, Hazelton Wisconsin, Inc., Study No. HWI 50800375, 3M Ref. No. FC-1090, L13364, Lot 1, FI 1426, sodium perfluorooctanoate solution, September 28, 1995 '0 2 Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Genotoxicity 1) An Assay of Cell Transformation and Cytotoxicity in the C3H 10T 1/2 Clonal Cell Line for the Test Chemical T-2942 CoC, Environmental Pathology Laboratory, Stone Research Laboratories, University of Minnesota, 3M Ref. No. FC-143 Lot 340, L138679, March 5, 1981 2) Final Report, Mutagenic Evaluation of T-2015 CoC in the Ames Salmonella/Microsome Plate Test, Litton Bionetics, Inc., Study No. 20838, 3M Ref. No. FC-143, February 1978 3) Final Report, Mutagenicity Test on T-6564 in an In Vivo Mouse Micronucleus Assay, Coming Hazelton, Inc., Study No. 17750-0-455, 3M Ref. No. FC-1015, L13167, straight-chain APFO, November 1, 1996 4) Final Report, Mutagenicity Test on T-6564 Measuring Chromosomal Aberrations in Chinese Hamster Ovary (CHO) Cells: with a Confirmatory Assay with Multiple Harvests, Coming Hazelton Inc., Study No. 17750-0-437CO, 3M Ref. No. FC-1015, L I3167, straight-chain APFO, September 16, 1996 5) Final Report, Mutagenicity Test with T-6564 in the Salmonella - Escherichia Co/z/Mammalian-Microsome Reverse Mutation Assay with a Confirmatory Assay, Coming Hazelton Inc., Study No. 17750-0-409R, 3M Ref. No. FC-1015, L13167, straight-chain APFO, September 13, 1996 6) Final Report, Mutagenicity Test on T-6342 Measuring Chromosome Aberrations in Human Whole Blood Lymphocytes with a Confirmatory Assay with Multiple Harvests, Coming Hazelton, Inc., Study No. 17073-0-449CO, 3M Ref. No. FC-1090, L13364, FI 1426, Lot 1, sodium perfluorooctanoate, November 1, 1996 7) Final Report, Mutagenicity Test on T-6342 Measuring Chromosomal Aberrations in Chinese Hamster Ovary (CHO) Cells: with a Confirmatory Assay with Multiple Harvests, Coming Hazelton, Inc., Study No. 17073-0-437CO, 3M Ref. No. FC-1090, L13364, FI 1426, Lot 1, sodium perfluorooctanoate, September 16, 1996 8) Final Report, Mutagenicity Test on T-6342 in an In Vivo Mouse Micronucleus Assay, Coming Hazelton, Inc., Study No. 17073-0-455, 3M Ref. No. FC-1090, L13364, FI 1426, Lot 1, sodium perfluorooctanoate, December 14, 1995 9) Final Report, Mutagenicity Test with T-6342 in the Salmonella - Escherichia Coli/Mammalian-Microsome Reverse Mutation Assay, Coming Hazelton, Inc., Study No. 1703073-0-409, 3M Ref. No. FC-1090, L13364, FI 1426, Lot 1, sodium perfluorooctanoate, December 14, 1995 0C0C07 3 Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Repeated-Dose Toxicity 1) Final Report, Volumes 1-4, Two Year Oral (Diet) Toxicity / Carcinogenicity Study of Fluorochemical FC-143 in Rats, Riker Laboratories, Inc., Study No. 0281CROO12, conducted during April 1981 - May 1983, August 29, 1987, with Study Report Amendment No. 1, dated November 2, 1987 2) Ninety Day Subacute Rat Toxicity Study on Fluorad Fluorochemical FC-143 a) Final Report, Ninety Day Subacute Rat Toxicity Study on Fluorad Fluorochemical FC-143, International Research and Development Corporation, Study No. 137-089, 3M Reference No. T-3141, November 6, 1978 b) 3M Internal Correspondence re FC-143 analysis of serum samples from rats of 90-day subacute study, from Jon Belisle to JE Long, dated March 20, 1978 c) 3M Internal Correspondence re FC-143 analysis of liver samples from rats of 90day subacute study, from Jon Belisle to JE Long, dated March 31, 1978 3) Final Report, 28-Day Oral Toxicity Study with FC-143 in Albino Mice, Industrial Bio-Test Laboratories, Inc., Study No. 8532-10655, 3M Reference No. T-1742CoC, Lot 269, Undated [1977] 4) Final Report, 28-Day Oral Toxicity Study with FC-143 in Albino Rats, Industrial Bio-Test Laboratories, Inc., Study No. 8532-10654, 3M Reference No. T-1742CoC, Lot 269, September 29, 1977 . 5) Final Report, Repeat Application 28 Day Percutaneous Absorption Study with T2.618CoC in Albino Rabbits, Safety Evaluation Laboratory, Riker Laboratories, Inc., Study No. 09790AB0485, 3M Ref. No. FC-143, March 15, 1981 6) Ninety Day Subacute Rhesus Monkey Toxicity Study a) Final Report, Ninety Day Subacute Rhesus Monkey Toxicity Study, International Research and Development Corporation, Study No. 137-090, November 10, 1978 b) Analytical data, FC-143 Analysis of IRDC 137-090 Samples [monkey serum and liver samples], 3M Central Research Laboratories, May 16, 1978 7) Final Report, Vol. I-II, 13-Week Dietary Toxicity Study with T-5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1) in Male Rats, Hazelton Wisconsin, Inc., Study No. HWI 6329-100, May 17, 1993 8) Final Report, 5 Daily Dose Oral Toxicity Study with T-6669 (FC-143) in Rats, Coming Hazelton, Inc., Study No. CHW 6329-197, April 30, 1997 000008 4 Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Ongoing: 26-Week Capsule Toxicity Study with Ammonium Perfluorooctanoate (APFO) in Cynomolgus Monkeys, Covance Laboratories Inc., No. 6329-231, 3M Ref. No. T-6889.3. In progress. Protocol provided. Note: The study is sponsored by the Association of Plastic Manufacturers of Europe, APFO Toxicology Working Group. 3M has submitted a notice under TSCA Section 8(e) regarding preliminary data from this study. 3M and other Working Group members have received draft reports on the 4-week range-finding study and the full study, but these drafts are now obsolete. Final reports are in preparation and will be provided to the docket when available. In addition, the Working Group is still awaiting the hormonal measurements report covering cholecystokinin data; serum, urine, feces and liver APFO levels; palmitoyl CoA oxidase determinations; cell proliferation evaluations; and bile acid and receptor level determinations. 00009 Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Pharmacokinetic Studies 1) Final Report, Analytical Study, Single-Dose Intravenous Pharmacokinetic Study of T-6067 in Rabbits, 3M Ref. No. LI 3492 (45% perfluorooctanoic acid tetrabutylammonium salt in water and isopropyl alcohol), Study No. AMDT120694.1, November 28, 1995; report includes Final Report, Single-Dose Intravenous Pharmacokinetic Study of T-6067 in Rabbits, Hazelton Wisconsin, Inc., Study No. HWI 6329-151, February 1, 1995 2) Final Report, Analytical Study, Single-Dose Absorption/Toxicity Study of T-6067 T6068, and T-6069 in Rabbits, 3M Environmental Technology & Services, Study No. AMDT-011095.1, November 28, 1995; report includes Final Report, Single-Dose Absorption/Toxicity Study of T-6067, T-6068, and T-6069 in Rabbits, Hazelton Wisconsin, Inc., Study No. HWI 6329-152, May 26, 1995; T-6067 is LI 3492, 45% perfluorooctanoate tetrabutyl ammonium salt in water and isopropyl alcohol; T-6068 is fabric treated with high level of LI 3492, 45% perfluorooctanoate tetrabutyl ammonium salt in water and isopropyl alcohol; T-6069 is fabric treated with low level of L13492, 45% perfluorooctanoate tetrabutyl ammonium salt in water and isopropyl alcohol 3) ADME studies with FC-143-14C a) Final Report, Absorption of FC-143-14C in Rats After a Single Oral Dose, Riker Laboratories, Inc., January 14, 1980 b) Final Report, Synthesis and Characterization of FC-143-14C, Commercial Chemicals Division and Riker Laboratories, Inc., January 23, 1980 c) Final Report, Extent and Route of Excretion and Tissue Distribution of Total Carbon-14 in Male and Female Rats After a Single IV Dose of FC-143-14C, Riker Laboratories, Inc., February 7, 1980 d) Final Report, Extent and Route of Excretion of Total Carbon-14 in Pregnant Rats After a Single Oral Dose of Ammonium 14C-Perfluorooctanoate, Riker Laboratories, Inc., July 1, 1983 e) Final Report, Enhanced Elimination of FC-95-14C and FC-143-I4C in Rats with Cholestyramine Treatment, Riker Laboratories, Inc., March 14, 1980 4) Final Report, Single-Dose Intravenous Pharmacokinetic Study of T-6564 in Rabbits, Coming Hazelton Inc., Study No. CHW 6329-186, April 18, 1997 5) Final Report, 5-Daily Dose Dermal Absorption/Toxicity Study of T-6564 in Rabbits, Coming Hazelton, Inc., Study No. CHW 6329-185, April 28, 1997 6 COOOIO Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Teratology 1) Teratology Study of T-2998CoC in Rats a) Oral Rangefinder Study of T-2998CoC in Pregnant Rats, Riker Laboratories, Inc., Study No. 0680RR0018, February 25, 1981 b) Final Report, Oral Teratology Study of T-2998 CoC in Rats, Riker Laboratories, Inc., Study No. 0681TR0110, December 15, 1981, with Amendment to Final Report, December 22, 1981 and Protocol 2) Teratology Study of T-3141CoC in Rabbits a) Oral Rangefinder Study of T-3141 CoC in Pregnant Rabbits, Riker Laboratories, Inc., Study No. 0681RB0331, November 18, 1981 b) Final Report, Oral Teratology Study of T-3141CoC in Rabbits, Riker Laboratories, Inc., Study No. 0681TB0398, February 23, 1982 c) 3M Internal Correspondence re analytical analyses of T-3141CoC, from LD Winter to DR Ricker, dated February 5, 1982 3) Letter re further testing from E. Marshall Johnson, Jefferson Medical College to Dr. Franklin D. Griffith, dated November 19, 1982 4) 3M Memo re FC 95 and 143 Teratology, from Marv Case to Geoijean Adams, dated May 26, 1998, enclosing an analysis of the eye lens defect G Q O ttU Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Human Sera/Medical Surveillance/Epidemiology 1) F. A. Ubel, et al. Health Status o fPlant Workers Exposed to Fluorochemicals- A Preliminary Report, 41 Am. Ind. Hyg. Assoc. J. 584-589 (August 1980), with Summary. 2) Leonard M. Schuman & Jack S. Mandel, An Epidemiologic Mortality Study o f Employees at the Chemolite Plant (February 1980), with Summary of study. 3) Jack S. Mandel & Leonard M. Schuman, "Mortality Study at the 3M Chemolite Plant" (January 1989), with Summary of study. 4) Frank D. Gilliland & Jack S. Mandel, Mortality Among Employees o f a Perfluorooctanoic Acid Production Plant, 35 JOM 950-954 (September 1993), with Summary of study. 5) Frank Davis Gilliland, Fluorocarbons and Human Health: Studies in an Occupational Cohort (October 1992)(unpublished Ph.D. thesis, University of Minnesota), with Summary. 6) Geary W. Olsen, et al., An Epidemiological Investigation o fReproductive Hormones in Men with Occupational Exposure to Perfluorooctanoic Acid, 40 JOEM 614-619 (July 1, 1998), with Summary of study. 7) Frank D. Gilliland & Jack S. Mandel, Serum Perfluorooctanoic Acid and Hepatic Enzymes, Lipoproteins, and Cholesterol: A Study o f Occupationally Exposed Men, 29 American Journal of Industrial Medicine 560-568 (1996), with Summary of study. 8) Geary W. Olsen, et al., An Epidemiologic Investigation o fPlasma Cholecystokinin and Hepatic Function in Perfluorooctanoic Acid Production Workers, 3M Final Report EPI-0003, (1997), with Summary of study, Protocol, and Manuscript accepted for publication in 2000, Drug & Chemical Toxicology. 9) Physician Plant Summary Reports Regarding Medical Surveillance Program at Cottage Grove (1978-1991) a) Summary of Program Reports b) Blood Levels of RF/F in Selected Employees, dated June 20, 1978 c) 3M Internal Correspondence re 1981 Chemical Division Health Evaluations from DE Roach to PF Riehle, dated February 16, 1982 d) 3M Internal Correspondence re 1981 Chemolite Health Evaluations, from DE Roach to PF Riehle, dated August 12, 1982 000012 8 Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA e) 3M Internal Correspondence re Inorganic Fluoride Determinations, from DE Roach to PF Riehle, dated April 9, 1984 f) 3M Internal Correspondence re Organic Fluorine Levels, from DE Roach to PF Riehle, dated August 31, 1984 g) 3M Internal Correspondence re Medical Examinations, from L Zobel to DW Dworak, dated March 20, 1987 h) 3M Internal Correspondence re Chemolite Evaluations, Fall, 1990, from Larry R Zobel to Clair Murphy, et al., dated May 10, 1991 Previously submitted with April 21, 2000 letter to Charlie Auer, Fluorochemical Exposure (Serum) Assessment of (3M) Decatur Chemical and Film Plant Employees. Ongoing Studies See list of planned studies submitted with letter of April 21, 2000, which will address perfluorooctanoic acid as well as perfluorooctane sulfonate. 000013 9 Attachments to Letter to C. Auer Dated May 25, 2000 Published Literature in 3M's Possession Abdellatif, A.G., V. Prat, H.S. Taper, and M. Roberfroid. The modulation of rat liver carcinogenesis by perfluorooctanoic acid, a peroxisome proliferator. Toxicology & Applied Pharmacology 111 (1991) 530-537. Abdellatif, A.G., V. Prat, J. Vamecq, R. Nilsson, and M. Roberfroid. Peroxisome proliferation and modulation of rat liver carcinogenesis by 2,3dichlorophenoxyacetic acid, 2,4,5-trichlorophenoxyacetic acid, perfluorooctanoic acid and nafenopin. Carcinogenesis 11 (1990) 1899-1902. Belisle, J., and D. Hagen. A method for determination of perfluorooctanoic acid in blood and other biological samples. Analytical Biochemistry 101 (1980) 369376. Biegel, L.B., M.E. Hurtt, and J.C. Cook. Effects of ammonium perfluorooctanoate (C8) on Leydig cell function: In vivo, ex vivo, and in vitro studies. The Toxicologist 13[1] (1993) 399. Biegel, L.B., R.C.M. Liu, M.E. Hurtt, and J.C. Cook. Effects of ammonium perfluorooctanoate on Leydig cell function: In vivo, ex vivo, and in vitro studies. Toxicology & Applied Pharmacology 134 (1995) 18-25. Borjes, H.K. and R.G. Thurman. Peroxisomal proliferators inhibit Acyl CoA synthesis and stimulate protein kinase C in vivo. Toxicology & Applied Pharmacology 126 (1994) 233-239. Clapperton, R.M., B.T. Ingram, R.H. Ottewill, and A.R. Rennie. NMR spectroscopic and neutron scattering studies on ammonium decanoate-ammonium perfluorooctanoate mixtures. In: Mixed Surfactant Systems. ACS Symposium Series 501, Eds.: P.M. Holland and D.N. Rubingh, American Chemical Society: Washington, DC, 1992, 268-277. Clegg, E.D., J.C. Cook, R.E. Chapin, P. Foster, and G.P. Daston. Leydig cell hyperplasia and adenoma formation: Mechanisms and relevance to humans (abstract). Reproductive Toxicology 11(1) (1997) 107-121. Cook, J.C., S.M. Murray, S.R- Frame, and M.E. Hurtt. Induction of Leydig cell adenomas by ammonium perfluorooctanoate: A possible endocrine related mechanism. Toxicology & Applied Pharmacology 113 (1991) 209-217. CC 001.4 Cook, J.C., M.E. Hurtt, S.R. Frame, L.B. Biegel. Effects of Wyeth-14,643 (WY) and ammonium perfluorooctanoate (C8) in Crl:CD BR (CD) rats. The Toxicologist 13[1] (1993) 399. Cook, J.C., M.E. Hurtt, S.R. Frame, L.B. Biegel. Mechanisms of extrahepatic tumor induction by peroxisome proliferators in CrkCD BR (CD) rats. The Toxicologist 14[1] (1994) 301. Feller, D.R. and U. Intrasuksri. Mechanism of peroxisome proliferation by perfluorinated fatty acids in primary cultures of rat hepatocytes (abstract). Toxicologist 13 (1993) 395. Gilliland, F.D. Fluorocarbons and human health: Studies in an occupational cohort. Unpublished Ph.D. Dissertation, University of Minnesota, 1992. Gilliland, F.D. and J.S. Mandel. Mortality among employees of a perfluorooctanoic acid production plant. JOM 35[9] (September 1993) 950-954. Gilliland, F.D. and J.S. Mandel. Serum perfluorooctanoic acid and hepatic enzymes, lipoproteins, and cholesterol: a study of occupationally exposed men. American Journal o f Industrial Medicine 29 (1996) 560-568. Griffith, F.D., and J.E. Long. Animal toxicity studies with ammonium perfluorooctanoate. American Industrial Hygiene Association Journal 41 (1980) 576-583. Handler, J.A., C.B. Seed, B.U. Bradford, and R.G. Thurmond. Induction of peroxisomes by treatment with perfluorooctanoate does not increase rates of H202 production in intact liver. Toxicology Letters 60 (1990) 61-68. Hanhijarvi, H., M. Ylinen, A. Kojo, and V.M. Kosma. Elimination and toxicity of perfluorooctanoic acid during subchronic administration in the Wistar rat. Pharmacology & Toxicology 61 (1987) 66-68. Hanhijarvi, H., R.H. Ophaug, and L. Singer. The sex-related difference in perfluorooctanoate excretion in the rat. Proceedings o f the Society fo r Experimental Biology & Medicine 171 (1982) 50-55. Haughom, B., and O. Spydevold. The Mechanism Underlying the Hypolipemic Effect of Perfluorooctanoic Acid (PFOA), Perfluorooctane Sulphonic Acid (PFOSA) and Clofibric Acid. Biochim. Biophys. Acta. 1128[1] (1992) 65-72. Hosokawa, M., and T. Satoh. Differences in the induction of carboxylesterase isozymes in rat liver microsomes by perfluorinated fatty acids. Xenobiorica 23 (1993)1125-1133. 000015 -2 - Hurtt, M.E., S.M. Murray, S.R. Frame, and J.C. Cook. Investigation of a hormonally-mediated mechanism for ammonium perfluorooctanoate (C8)induced Leydig cell adenomas. Toxicologist 10 (1990) 192. Ikeda, T., K. Aiba, K. Fukuda, and M. Tanaka. The induction of peroxisome proliferation in rat liver by perfluorinated fatty acids, metabolically inert derivatives of fatty acids. J. Biochem. 98 (1985) 475-482. Inoue, T., T. Iwanaga, K. Fukushima, and R. Shimozawa. Effects of sodium octanoate and sodium perfluorooctanoate on the gel-to-liquid-crystalline phase transition of dipalmitoylphosphatidyl choline vesile membrane. Chem. Physics Lipids 46(1988) 25-30. Johnson, J.D., S.J. Gibson, and R.E. Ober. Cholestyramine-enhanced fecal elimination of Carbon-14 in rats after administration of ammonium perfluorooctanoate or potassium perfluorooctanesulfonate. Fundamental & Applied Toxicology 4 (1984) 972-976. Just, W.W., K. Gorgas, F. Flartl, P. Heinemann, M. Salzer, and H. Schimassek. Biochemical effects and zonal heterogeneity of peroxisome proliferation induced by perfluorocarboxylic acids in rat liver. Hepatology 9 (1989) 570-581. Kawashima, Y., T. Matsunaga, N. Uy-Yu, and H. Kozuka. Induction by perfluorooctanoic acid of microsomal I-acylglycerophosphocholine acyltransferase in rat kidney. Sex related difference. Biochemical Pharmacology 42(1991) 1921-1926. Kawashima, Y., S. Suzuki, H. Kozuka, J. Sato, and Y. Suzuki. Effects of prolonged administration of perfluorooctanoic acid on hepatic activities of enzymes which detoxify peroxide and xenobiotic in the rat. Toxicology 93 (1994) 85-87. Kawashima, Y., N. 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Canadian Journal o f Chemistry 67 (1989) 1550-1553. Pastoor, T.P., K.P. Lee, M.A. Perri, and P.J. Gillies. Biochemical and morphological studies of ammonium perfluorooctanoate-induced hepatomegaly and peroxisome proliferation. Experimental and Molecular Pathology 47 (1987) 98-109. Perkins, R. Investigation of ammonium perfluorooctanoate effect on hormone levels and peroxysome proliferation in the rat. Toxicologist 12 (1992) 38. Permadi, H., B. Lundgren, K. Andersson, and J.W. DePierre. Effects of perfluoro fatty acids on xenobiotic-metabolizing enzymes, enzymes which detoxify reactive forms of oxygen and lipid peroxidation in mouse liver. Biochemical Pharmacology 44 (1992) 1183-1191. Permadi, H., B. Lundgren, K. Andersson, C. Sundberg, and J.W. Depierre. Effects of perfluorofatty acids on peroxisome proliferation and mitochondrial size in mouse liver - dose and time factors and effect of chain length. Xenobiotica 23 (1993)761. Peterson, R.E., B.I. Kuslikis, and J.P. Vanden Heuvel. Protein acylation by the peroxisome proliferators perfluorodecanoic acid (PFDA) and perfluorooctanoic acid (PFOA) in rats. Toxicologist 11 (1991) 185. Reich, I.L., H.J. Reich, L.A. Menahan, and R-E. Peterson. Synthesis of "'Clabeled perfluorooctanoic and perfluorodecanoic acids: purification of perfluorodecanoic acid. Journal o f Labeled Compounds & Radiopharmaceuticals 24 (1987) 1235-1244. Rozner, M.A. The effect of perfluorooctanoic acid upon microsomal membrane peroxidation. Pharmacology 41 (1981) 2997-3013. 000013 -6- Simister, E.A., E.M. Lee, J.R. Lu, R.K. Thomas, R.H. Ottewill, A.R. Rennie, and J. Penfold. Adsorption of ammonium perfluorooctanoate and ammonium decanoate at the air/solution interface. Journal o f the Chemical Society 88 (1992) 3033-3041. Sohlenius, A.K., A.M. Eriksson, C. Hogstrom, M. Kimland, J.W. Depierre. Perfluorooctane sulfonic acid is a potent inducer of peroxisomal fatty acid Boxidation and other activities known to be affected by peroxisome proliferators in mouse liver. Pharmacology & Toxicology 72 (1993) 90. Sohlenius, A.K., K. Andersson, and J. DePierre. The effects of perfluoro-octanoic acid on hepatic peroxisome proliferation and related parameters show no sexrelated differences in mice. Biochem. J. 285 (1992) 779-783. Staples, R.E., B.A. Burgess, and W.D. Kerns. The embryo-fetal toxicity and teratogenic potential of ammonium perfluorooctanoate (APFO) in the rat. Fundamental & Applied Toxicology 4 (1984) 429-440. Staples, R.E. Improper interpretation of data concerning teratogenicity: A case report. Prevention o f Physical and Mental Congenital Defects, Part C: Basic and Medical Science, Education and Future Strategies (1985) 161-163. Takagi, A., K. Sai, T. Umemura, R. Hasegawa, and Y. Kurokawa. Short-term exposure to the peroxisome proliferators, perfluorooctanoic acid and perfluorodecanoic acid, causes significant increases of 8-hydroxydeoxyguanosine in liver DNA of rats. Cancer Letters 57 (1991) 55-60. Thottassery, J., L. Wingerg, J. Youssef, M. Cunningham, and M. Badr. Regulation of perfluorooctanoic acid-induced peroxisomal enzyme activities and hepatocellular growth by adrenal hormones. Hepatology 15 (1992) 316-322. Treiner, C., and A.K. Chattopadhyay. The partition coefficient of various alcohols between water and alkaliperfluorooctanoate micelles. Journal o f Colloid & Interface Science 92 (1984) 447-458. Trosko, James E. Oxidative Stress, Signal Transduction, Cell-Cell Communication, U.S. Dept, of Commerce, NTIS # F42960-97-0022 (February 28, 1999). Ubel, F.A., et al. Health Status of Plant Workers Exposed to Fluorochemicals- A Preliminary Report, Am. Ind. Hyg. Assoc. J. 41 (August 1980) 584-589. Uy-yu, N., Y. Kawashima, S. Horii, and H. Kozuka. Effects of Chronic Administration of Perfluorooctanoic Acid on Fatty Acid Metabolism in Rat Liver: Relationship among Stearoyl-Coenzyme A Desaturase, 1- 000020 -7- Acylglycerophosphocholine Acyltransferase, and Acyl Composition of Microsomal Phosphatidylcholine. J. Pharmacobio-Dyn. 13 (1990) 581-5 Vanden Heuvel, J.P., J.W. Davis, R. Sommers, and R.E. Peterson. Renal excretion of perfluorooctanoic acid in male rats: Inhibitory effect of testosterone. Journal o fBiochemical Toxicology 7 (1992) 31-36. Vanden Heuvel, J.P., B.I. Kuslikis, and R.E. Peterson. Covalent binding of perfluorinated fatty acids to proteins in the plasma, liver and testes of rats. Chem.Biol. Interactions 82 (1992) 317-328. Vanden Heuvel, J.P., B.I. Kuslikis, M.J. Van Rafelghem, and R.E. Peterson. Tissue distribution, metabolism and elimination of perfluorooctanoic acid in male and female rats. Journal o f Biochemical Toxicology 6 (1991) 83-92. Vanden Heuvel, J.P., M.J. Van Rafelghem, L.A. Menahan, and R.E. Peterson. Isolation and purification of perfluorodecanoic and perfluorooctanoic acids from rat tissues. Lipids 23 (1989) 526-531. Witzmann, F.A., C. Fultz, and J. Lipscomb. Toxicant-induced Alterations in Two-dinensional Electrophoretic Patterns of Hepatic and Renal Stress Proteins. Electrophoresis 17 (1996) 198-202. Witzmann, F.A., B.M. Jamot, D.N. Parker, J.W. Clack. Modification of Hepatic Immunoglobulin Heavy Chain Binding Protein (BIP/Grp 78) Following Exposure to Structurally Diverse Peroxisome Proliferators. Fundamental & Applied Toxicology 23 (1994) 1-8. Witzmann, F.A., D. Parker, and B. Jamot. Induction of Enoyl-CoA Hydratase by LD50 Exposure to Perfluorocarboxylic Acids Detected by Two-dimensional Electrophoresis. Toxicology Letters 71 (1994)271-277. Ylinen, M., A. Kojo, H. Hanhijdrvi, and P. Peura. Disposition of perfluorooctanoic acid in the rat after single and subchronic administration. Bulletin o fEnvironmental Contamination & Toxicology 44 (1990) 46-53. Ylinen, M., H. Hanhijdrvi, I. Jaakonaho, and P. Peura. Stimulation by oestradiol of the urinary excretion of perfluorooctanoic acid in the male rat. Pharmacology & Toxicology 65 (1989) 274-277. Ylinen, M., H. Hanhijrvi, P. Peura, and O. Ramo. Quantitative gas chromatographic determination of PFOA as the benzyl ester in plasma and urine. Archives o fEnvironmental Contamination & Toxicology 14 (1985) 713-717. 000021 -8- Youssef, J. and M. Badr. Extraperoxisomal Targets of Peroxisome Proliferators: Mitochondrial, Microsomal, and Cytosolic Effects. Implications for Health and Disease. Critical Reviews in Toxicology 28[1] (1998) 1-33. 000022 PFOA and Associated Salts Synonyms: FC-26, FX-1001, PFO, FC-143, 78.03, FC126, N-2803-3, FX-1003, FC-118, FC-1015, FC-1015-X Physical/Chemical Properties Title Laboratory or Author Date Type Completed Water, acetone and toluene solubilitiy estimates - FC-143 3M Env. Lab Robust summary, 11/17/81 copy of data sheet Environmental Fate and Transport Title R eady biodegradation of F C -143 (B O D /C O D /T O C ) Laboratory or Author 3M Env. Lab Technical Report S um m ary - Adsorption of F C 9 5 and F C 143 or Soil, and a critique from Dr. S. Boyd, M ichigan S tate University 3M Env. Lab Technical Report S um m ary - Biodegradation Studies of Fluorocarbons - III (F C -1 4 3 ) Technical Report S um m ary - F C -1 4 3 Photolysis S tudy Using Sim ulated Sunlight T ec h n ic a l R e p o rt S u m m a ry - A n alys is fo r F lu o ro c h e m ic a ls in Bluegill Fish, and a critique by J. W . G illett o f C ornell U niversity 3M Env. Lab 3M Agrichem ical Lab 3M Env. Lab R eady biodegradation of F C -143 (B O D /C O D ) 3M Env. Lab Calculated octanol w ater partition coefficient - F C -1 4 3 3M Env. Lab Ready biodegradation of FX-1001 (BOD/COD) Ready biodegradation of FC-126 (BOD/COD) 3M Env. Lab Pace Analytical, Minneapolis, MN Completion Type Date 7 /1 4 /7 7 Robust summary, copy of laboratory data summary 2 /2 7 /7 8 , Robust summary, 5 /1 9 /9 3 technical report, critique by S. Boyd (MSU) 7 /1 9 /7 8 Robust summary, technical report 2 /2 /7 9 Robust summary, technical report. 5 /1 /1 9 7 9 , Robust summary, 3 /8 /9 3 technical report, , critique by J. Gillett (Cornell) 6 /5 /8 0 Robust summary, ~ copies of data sheets. 12 /7 /8 1 Robust summary, copy of calculations Robust summary, computer generated final report, copies of 2/7/85 raw data sheets. Robust summary, computer- generated final report, copy of 5/20/87 final report t ! 000023 PFOA and Associated Salts Environmental Fate and Transport Title Technical Report Summary - Assessment of the Bioaccumulative Properties of Ammonium Perfluorooctanate: Static (fish test) Laboratory or Author 3M Env. Lab Completion Type Date Robust summary, technical report, critique by J. Giesy 5/31/95 (MSU) Ecotoxicity Elements Title 96-ho u r acute static toxicity to fathead m innow - F C -1 4 3 Laboratory or Author 3M Env. Lab Completion Type Date 6 /2 9 /7 4 Robust summary, copy of data sheet 96-hour acute static toxicity to fathead minnow - FC-26 3M Env. Lab Robust summary, 11/10/74 copy of data sheet. 96-hour acute static toxicity to bluegill sunfish - FC-143 3M Env. Lab Robust summary, 4/8/78 copy of data sheet 96-hour acute static toxicity to bluegill sunfish - FC-143 3M Env. Lab Two reports : "The Effects of Continuous Aqueous Exposure to 78.03 on Hatchability of Eggs and Growth and survival of Frv of Fathead Minnow (PimeDhales DromelasV and "Summary of HistoDatholoaical Examinations of Fathead Minnow (PimeDhales Dromelasl EG&G Bionomics, Exposed to 78.03 for 30 Days". Wareham, MA Technical Report Summary - Aquatic Toxicity Testing: FC- 143 (Lot-37) L.R. 5625 S 3M Env. Lab Toxicity to activated sludge - FC-143 Technical Report Summary - Multi-Phase Exposure/Recovery Algal Assay Test method (FC-143) 48-hour acute static toxicity to Daphnia magna - FC-143 (3 studies on diet) Chronic Toxicitv of Fluorochemicals to DaDhnia maana (Water Flea) - FC-143, and statistical analysis of data provided by AScI Corp., Duluth, MN 3M Env. Lab 3M Env. Lab 3M Env. Lab 3M Env. Lab 5/27/78 June 1978 and Sept. 1978 5/8/80 6/4/80 11/16/81 5/5/82, 5/6/82, 6/2/82 8/31/1984, 8/10/98 Robust summary, copy of data sheet Robust summary, copies of two final reports. Robust summary, technical report Robust summary, copies of data sheets Robust summary, technical report Robust summary, copies of data sheets Robust summary,. summary report, letter report 96-hour acute static toxicity to fathead minnow - FX-1001 3M Env. Lab Robust summary, 2/2/85 copy of data sheet. C00024 PFOA and Associated Salts f Ecotoxicity Elements Title Activated sludge respiration inhibition (OECD 209) - FC126 Microtox test - FC-126 48-hour acute static toxicity to Daphnia magna - FC-126 96-hour acute static toxicity to fathead minnow - FC-126 Activated sludge respiration inhibition (OECD 209) - FX1003 Microtox test - FX-1003 Static Acute Toxicity of FX-1003 to the Fathead Minnow, Pimephales promelas Static Acute Toxicity of FX-1003 to the Daphnid, Daphnia magna Growth and Reproduction Toxicity Test with N2803-3 and the Freshwater Alga, Selenastrum capricomutum Acute Toxicity of N2803-3 to the Fathead Minnow, Pimephales promelas Acute Toxicity of N2803-3 to the Daphnid, Daphnia magna Microtox test - FC-143 Microtox test - FC-118 Microtox test - FC-1015-X Laboratory or Author 3M Env. Lab 3M Env. Lab 3M Env. Lab 3M Env. Lab 3M Env. Lab 3M Env. Lab EnviroSystems, Hampton, New Hampshire EnviroSystems, Hampton, New Hampshire T.R. Wilbury Laboratories, Inc, Marblehead, MA T.R. Wilbury Laboratories, Inc, Marblehead, MA T.R. Wilbury Laboratories, Inc, Marblehead, MA 3M Env. Lab 3M Env. Lab 3M Env. Lab Completion Type Date Robust summary, :) copy of data '] 4/20/87 sheets. Robust summary, I copy of data 4/29/87 sheets. Robust summary, copy of data 4/30/87 sheets. Robust summary, copy of data 5/1/87 sheets. Robust summary, copies of data 2/16/90 sheets Robust summary, copies of data 3/7/90 sheets Robust summary, final report, 3/15/90 protocol " Robust summary, final report, 4/9/90 protocol Robust summary, 1/24/96 final report Robust summary, 1/24/96 final report 3/7/96 4/24/96 4/24/96 4/24/96 Robust summary, final report Robust summary, copies of data sheets Robust summary, copies of data sheets Robust summary, copies of data sheets 000025 t PFOA and Associated Salts Ecotoxicity Elements Title Activated Sludge Respiration inhibition Test - FC-1015-X Acute Toxicity of FC-1015 to the Fathead Minnow, Pimephales promelas Growth and Reproduction Toxicity Test with FC-1015 and the Freshwater Alga, Selenastrum capricornutum Acute Toxicity of FC-1015 to the Daphnd, Daphnia magna Laboratory or Author 3M Env. Lab T.R. Wilbury Laboratories, Inc, Marblehead, MA T.R. Wilbury Laboratories, Inc, Marblehead, MA T.R. Wilbury Laboratories, Inc, Marblehead, MA Completion Type Date Robust summary, ' copies of data 4/25/96 sheets Robust summary, 5/15/96 final report Robust summary, 5/15/96 final report Robust summary, 5/15/96 final report Summary Reports Title Technical Report Summary - Final Comprehensive Report: FC 143 Laboratory or Author 3M Env. Lab Completion Date 3/23/79 Type Robust summary, technical report i I it 000026 i Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Update to Submission of May 18th 13. PFOS Perfluorooctane Sulfonate 1) Letter from E. Marshall Johnson to William C. McCormick, III, re Hazleton teratology studies, dated December 7, 1983. 2) Letter from E. Marshall Johnson to William C. McCormick, III re Riker teratology studies on PFOS and ethyl FOSE, dated November 12, 1982. 8. N-EtFOSE alcohol N-ethyl perfluorooctane sulfonamidoethanol 1) Letter from E. Marshall Johnson to William C. McCormick, III re Riker teratology studies on PFOS and ethyl FOSE, dated November 12, 1982. 2) Final Report, Biological Phase, Metabolism of N-Ethyl Perfluorooctane Sulfanomido Ethanol (Net-Fose; T-6316) In Cynomolgus Monkeys Following Administration of a Single Capsule Dose, Covance, Study No. 6329-226, June 9, 1999 Note: Analytical work associated with this study is ongoing. 000027 10 PFOS didecyldimethylammonium salt Synonyms: P3025, L-14394 Physical/Chemlcal Properties Title None Laboratory or Date Author Completed Type Environmental Fate and Transport Title Determination of the 28-^ay Carbonaceous Biochemical Oxygen Demand (CBOD)r for P3025 Laboratory or Author 3M Env. Lab Completion Date Type Robust summary, 5/20/97 final report Ecotoxlcity Elements Title Acute Toxicity of P3025 Developmental Material to Fathead Minnow (Pim phales prom elas) Acute Toxicity of P3025 Developmental Material to Daphnia magna Growth Inhibition of P3025 Green Alga (Selenastrum cap rico m u tu m ) Growth Inhibition of P3025 to Green Alga (Selenastrum c a p rico m u tu m ) Inhibitory Effects of P3025 on Microtox Inhibitory Effects of P3025 on Activated Sludge Respiration Laboratory or Completion Author Date Type AScI Corporation, Duluth, MN AScI Corporation, Duluth, MN 1/2/97 1/10/97 Robust summary, final report Robust summary, final report AScI Corporation, Robust summary, Duluth, MN 1/29/97 final report AScI Corporation, Duluth, MN 3M Env. Lab 3M Env. Lab 2/21/97 5/12/97 5/12/97 Robust summary, final report Robust summary, final report Robust summary, final report C00028