Document aK3bX7308X2J7Qrowzzd1dna

^ 226- 02/6 Attachments to Letter to C. Auer dated May 18,2000 Studies and Other Information on Certain Perfluorooctane Sulfonate-Related Compounds 3. PFOSAA Perfluorooctane sulfonylamido (ethyl)acetate Acute Toxicity 1) Acute Oral Toxicity - Rats, Biosearch, Inc., Project No. 77-1108A, 3M Reference No. T-1983 (FC-128, potassium salt 100%, solid), January 5, 1978 2) Acute Oral Toxicity - Rats, Biosearch, Inc., Project No. 77-1127A, 3M Reference No. T-2001 (FC-128), January 6, 1978 3) Primary Eye Irritation Study - Rabbits, Biosearch, Inc., Project No. 77-1127A, 3M Reference No. T-2001 (FC-128), January 6, 1978 4) Primary Skin Irritation Study - Rabbits, Biosearch, Inc., Project No. 77-1127A, 3M Reference No. T-2001 (FC-128), January 6, 1978 5) An Acute Inhalation Toxicity Study of T-2307 CoC in the Rat, Bio/dynamics, Inc., Project No. 78-7186, 3M Reference No. T-2307 (FC-128), February 8, 1979 Additional Acute Toxicity Studies Not Submitted (Bibliography only) 1) Acute Oral Toxicity - Rats, Biosearch, Inc., Project No. 78-1191 A, 3M Reference No. T-2081 (FC-129, approximately 40-50% in solution), March 2, 1978 2) Primary Eye Irritation Study - Rabbits, Biosearch, Inc., Project No. 78-1191 A, 3M Reference No. T-2081 (FC-129), March 2, 1978 3) Primary Skin Irritation Study - Rabbits, Biosearch, Inc., Project No. 78-1191 A, 3M Reference No. T-2081 (FC-129), March 2, 1978 4) Acute Oral Toxicity Screen with T-3290CoC in Albino Rats, Safety Evaluation Laboratory, Riker Laboratories, Inc., Project No. 088AR0362, 3M Reference No. T3290 (40 % K+PFOSAA in 3 % EtOH, 17 % IPA and 40 % H20, L-6778, F-6873, Lot 501), November 5, 1982 5) Primary Skin Irritation Test with T-3290CoC in Albino Rabbits, Safety Evaluation Laboratory, Riker Laboratories, Inc., Project No. 088EB0423, 3M Reference No. T3290 (40 % K+PFOSAA in 3 % EtOH, 17 % IPA and 40 % H20, L-6778, F-6873, Lot 501), October 15, 1982 6) Acute Ocular Irritation Test with T-3290CoC in Albino Rabbits, Safety Evaluation Laboratory, Riker Laboratories, Inc., Project No. 088EB0424, 3M Reference No. T- -3- 000177 Attachments to Letter to C. Auer dated May 18,2000 Studies and Other Information on Certain Perfluorooctane Sulfonate-Related Compounds 3290 (40 % K+PFOSAA in 3 % EtOH, 17 % IPA and 40 % H20, L-6778, F-6873, Lot 501), October 26, 1982 Genotoxicitv 1) Bacterial Reverse Mutation Test of v-1, Hita Research laboratories, Chemical Biotesting Center, Chemicals Inspection and Testing Institute, Study Code: K011815, Report No. T-4663, 3M Reference No. T-6668.1, FC-129 (approximately 4050% in solution of water and organic solvent), October, 1996 2) In Vitro Microbiological Mutagenicity Assays of 3M Company's Compound T3290CoC, SRI International, Project No. 3145, 3M Reference No. T-3290 (40 % K+PFOSAA in 3 % EtOH, 17 % IPA and 40 % H20, L-6778, F-6873, Lot 501), November, 1982 Pharmacokinetic Studies 1) 28 Dermal Percutaneous Absorption Study with FC-128 in Albino Rabbits, Safety Evaluation laboratory, Riker Laboratories, Inc., Project No. 0979AB0629, 3M Reference No. T-3991, March 15, 1981 2) 28 Day Dermal Percutaneous Absorption Study with FC-129 in Albino Rabbits, Safety Evaluation laboratory, Riker Laboratories, Inc., Project No. 0979AB0627, 3M Reference No. T-3989, March 14, 1981 3) Final Report - Analytical Study: Single-Dose Dermal Absorption / Toxicity Study of T-6051 and T-6054 in Rabbits, 3M Environmental Laboratory, Study No. ADMT013195.1, in vivo Study Reference No. H W I6329-133 (Hazleton Wisconsin, Inc.), 3M Reference Nos. T-6051 (FC-129 treated fabric) and T-6054 (FC-129 solution), November 22, 1995 4) Final Report, Analytical Report and Single-Dose Intravenous Pharmacokinetic Study of T-6054 in Rabbits, 3M Environmental Technology & Services, In-Vivo Study Reference No. HWI#6329-138, Study No. AMDT-122094.2, 3M Reference No. FC129, November 22, 1995 Studies in Progress 1) Corporate Toxicology Study Outline, FC-129 Preliminary ADME Screen in Rats, 3M Strategic Toxicology Laboratory, July, 1998 -4- 000178 Attachments to Letter to C. Auer dated May 18,2000 Studies and Other Information on Certain Perfluorooctane Sulfonate-Related Compounds Pre-1976 Studies (bibliography only) 1) Skin and Eye Irritation Assay Report, WARF Institute, Project No. 2031046, 3M Reference No. FC-128, April 24, 1962 (plus December 29, 1966 letter containing individual eye scores) -5 000179 Submitted to: BIO SEA RC H , INC. p.o. box 8598 Philadelphia, Pennsylvania 19 10 1 telephone: (215) 8 4 8 - 4 4 9 9 Project Number - 77-1108A 3M Company 3M Center St- Paul, Minnesota 55101 Material: Sample Received: Date of Report: Test: Object of Test: Procedure: 3M Company - T-I983C0C 11/2/77 Study Initiated: 11/18/77 Study Completed:12/15/77 1/5/78 Acute Oral Toxicity - Rats To study the acute oral toxicity in rats of the subject material. Four groups of 5 male & 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 dosed by direct administration of the experimental material into the stomach by means of a syringe and dosing needle. The sample was dosed as a 50% w/v suspension in water. The following dosage levels were administered: 1.25 ml/kg. 2.50 ml/kg. 5.0 ml/kg. 10.0 ml/kg. Results: Conclusion : Following administration the animals were allowed food and water ad libitum for the 14 day observation period during which time the rats were observed for signs of toxicity and mortalities. See Table 1. The subject material when studied in male and female albino rats has an acute oral LD50 of approximately 2.5 ml/kg of a 50% w/v suspension in water or 1.25 gm/kg. of the original sample. 000180 Karl L. Gabriel, V.M.D., Di rector == 4 000181 TABLE 1 Acute Oral Toxicity Material : 3M Company - T-1983Co C, as a 50% w/v suspension in water. Dosage Level ml/kg 1.25 1.25 2 .5O 2.50 5.0 5.0 10.0 10.0 Number of Animals Dosed 5 males 5 females 5 males 5 females 5 males 5 females 5 males 5 females Mortali t ies Days 1 2 3 4 5 6 7 8 9 10 11 12 13 14 000000000 0 0 0 0 0 Total Dead 14 Days 0 Total Survived 14 Days 5 Initial Weight gm 230 Final Weight gm 260 000000000 0 0 0 0 0 0 5 250 275 0 1 10 0 0 0 0 0 0 0 0 0 0 2 3 250 215 02000000 1 0 0 0 0 0 3 2 240 220 5 41 5 0 235 5 0 250 5 5 0 240 5 5 0 265 The LD50 is approximately 2.5 ml/kg. of a 50% w/v suspension in water or 1.25 gm/kg. of the original sample. At 1.25 ml/kg. (0.625 gm/kg.) the animals were slightly lethargic for 24 hours and then appeared normal. At 2.5 ml/kg. (1.25 gm/kg.) the animals were depressed after 2 hours and did not regain normalcy throughout the observation period. Some deaths occurred as noted and the survivors were dehydrated and had lost weight. At 5-0 ml/kg and 10.0 ml/kg. (2.5 gm/kg. & 5-0 gm/kg.) the animals were severely depressed after 30 minutes and comatose within 2 hours. Gross pathologic examination revealed nothing remarkable.