Document 3N8rQ6jL91aJR9axGKG058EqE

m -OSTOO - /3 7/f Attachments to Letter to C. Auer dated May 18, 2000 Studies and Other Information on Certain Perfluorooctane Sulfonate-Related Compounds ( zromxyoo/o) Corrt<L /K30&crtal 9. N-MeFOSE alcohol N-methylperfluorooctane sulfonamidoethanol Acute Toxicity 1) Acute Oral Toxicity - Rats, Biosearch, Inc., 3M Ref. T-2038CoC (L-4309, FC-5160) (75% in 25% CaC03), Study No. 78-1161 A, Feb. 2, 1978 2) Primary Eye Irritation Study - Rabbits, Biosearch, Inc., 3M Ref. T-2038CoC (L4309, FC-5160) (75% in 25% CaC03) , Study No. 78-1161 A, Feb. 2, 1978 3) Primary Skin Irritation Study - Rabbits, Biosearch, Inc., 3M Ref. T-2038CoC (L4309, FC-5160) (75% in 25% CaC03), Study No. 78-1161 A, Feb. 2, 1978 4) Acute Oral Toxicity Screen with T-2574CoC in Albino Rats, Riker Laboratories, Inc., Experiment 0979AR0037, September 26, 1979 Genotoxicity 1) Genotoxicity Test on T-5711.1 in the In Vivo/In Vitro Unscheduled DNA Synthesis and Cell Proliferation Assays in Rat Liver Cells, Hazelton Washington, HWA Study No. 15515-0-494, September 14, 1993, and attached protocol 2) Mutagenicity Test on T-5711 in an In Vivo Rat Micronucleus Assay, Hazelton Washington, HWA Study No. 15515-0-454, April 30, 1993, and attached Protocol and memorandum containing analytical data 3) Evaluation of the Mutagenic Activity of T-5874 in the Ames Salmonella/Microsome Test (with Independent Repeat), NoTox Project 115932, NoTox Substance 38187, 3M Reference T-5874.1, April 19, 1994 4) Evaluation of the Ability of T-5874 to Induce Chromosome Aberrations in Cultured Peripheral Human Lymphocytes (with Independent Repeat), NoTox Project 115919, NoTox Substance 38187, 3M Reference T-5874.2, May 5,1994 5) Evaluation of the Mutagenic Activity of T-5874 in an In Vitro Mammalian Cell Gene Mutation Test with L5178Y Mouse Lymphoma Cells (with Independent Repeat), NoTox Project 115921, NoTox Substance 38187, 3M Reference T-5874.3, April 19, 1994 004364 - 18- Attachments to Letter to C. Auer dated May 18,2000 Studies and Other Information on Certain Perfluorooctane Sulfonate-Related Compounds Repeated-Dose Toxicity 1) 13-Week Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamide Ethanol (N-MeFOSE, T-6314) in Rats, Covance Study No. 6329-225, 3M Reference No. T6314.1 a) Audited Draft Report, May 25, 1999 b) Letter from Andrew M. Seacat, Ph.D., Study Monitor, to Peter J. Thomford, Ph.D., Study Director at Covance, regarding errors in draft report Mechanistic 1) Analysis of T-5794 in a Cell Proliferation Assay in Rat Liver Cells, Hazelton Washington, Inc., Final Report, HWA Study No. 154-207, January 26, 1994, and protocol and analytical data 2) Analysis of T-5878 in a Cell Proliferation Assay in Rat Liver Cells, Hazelton Washington, Inc., Final Report, HWA Study No. 154-209, November 1, 1994, and protocol and analytical data -19- 004365 to Submitted to: BIOSEARCH, INC. p.o. box 8S98 Philadelphia, Pennsylvania 19101 t e l e p h o n e : (215) 848-4499 Project Number: 78-1161A 3M Company 3M Center S t . Paul , Minnesota 55101 Material: 3M Company - T-2038CoC Sample Received: Date of Report: Test: Object of Test: Procedure: Results: Conci us ion : 1/5/78 Study Initiated: 1/9/78 Study Completed: 1/23/78 2/ 2/78 Acute Oral Toxicity - Rats To study the acute oral toxicity in rats of the subject material. One group of b male and 5 female albino rats of the Sherman-Wistar Strain weighing between 200 and 300 gm were employed in this study. The rats were deprived of food but not water for 2k hours prior to dosing. Each animal was weighed and placed in an isolation cage with sufficient ground experimental material mixed with oatmeal to achieve a 5.0 gm portion of experimental material. The rats were allowed to eat the mixture during the next 2k hours. All of the mixture was consumed in all cases. The cage bottoms were examined to be certain all experimental material had been eaten. Following administration the animals were allowed food and water ad libitum for the 14 day observa tion period during which time the rats were observed for signs of toxicity and mortalities. See Tab Ie 1. The subject material when studied in male and female albino rats has an acute oral LDjjq of greater than 5-0 gm/kg. 004366 Karl L. Gabriel, V.M.D., Ph.D. Di rector TABLE 1 Acute Oral Toxicity Material : 3M Company - T-2038Co C, as directed. Dosage Level gm/kg 5.0 5.0 Number of Animals Dosed 5 males 5 fema1es Mortali ties Days 1 2 3 ^ 5 6 7 8 9 10 11 12 13 1** 000 100000 0 0 0 0 0 000000000 0 0 0 0 0 The LD50 <s greater than 5.0 gm/kg. There were no unusual behavioral signs noted. Gross pathologic examination revealed nothing remarkable. Total Dead 1* Days 1 0 Total Survived 14 Days 4 5 Initial Weight gm 200 210 Final Weight gm 240 245