Document 5bQBE8VYXGLr6RXOvmzB7BGRJ

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, L13364, Lot 1, FI 1426, sodium perfluorooctanoate solution, October 24, 1995 000029 1 v J ( f.t\':'* ^r . Bio/clynam ics Inc. Division of Biology and Safety Evaluation I PROJECT NO. 78-7184 AN ACUTE INHALATION TOXICITY STUDY OF T-2305 CoC IN THE RAT Submitted to: 3M Company St. Paul, Minnesota 55101 Attention: Frank Griffith, Ph.D. Date: May 3, 1979 000030 -1- Bio/ / dynami cs Im 78-7184 I. GENERAL An experiment was performed to investigate the acute inhalation toxicity of a dust of T-2305CoC in rats. The test material, received from 3M Company, was labeled "3M Company; T-2305CoC'' and was in the form of a fine white powder. II. EXPERIMENTAL The test material was sieved through a 60-mesh sieve and hand packed into the large diameter cylinder of a Wright dust-feed mechanism {gear ratio 1:6). Dry air, at a flow rate of 16.0 liters per minute, was passed through the dustfeed mechanism to generate the desired concentration. The resultant dust-laden air was passed, undiluted, into the 32.2-liter glass exposure chamber housing the test animals. The exposure lasted for 1.0 hour. The packed cylinder, cutting blade, and nozzle were weighed before and after the exposure. The weight loss was equal to the amount of material consumed during the exposure. The nominal concentration was determined by dividing this weight loss by the total air flow through the chamber during the exposure. The test animals consisted of five male and five female SpragueDawley rats obtained from Charles River Breeding Laboratories, Wilmington, Massachusetts. On the day of exposure (Day 0-January 23, 1979) the pre exposure weights ranged from 211 to 264 grams. The animals were observed prior to exposure to insure that they were free from abnormalities. Observations for abnormal signs were made at 15-minute intervals during the exposure, upon removal from the chamber, hourly for four hours post-exposure, and daily thereafter for 14 days. 000031 78-7184 II. EXPERIMENTAL (cont.) Individual body weights were recorded on Day 0 (prior to exposure), Day 1, Day 2, Day 4, Day 7, and Day 14 (terminus). On Day 14, all animals were sacrificed (ethly ether) and blood samples were drawn from the dorsal aorta of all animals. These samples were spun for serum, pooled according to sex, and sent to the sponsor packed in dry ice for analysis. Gross necropsy exam inations were also performed at this time. III. RESULTS AND DISCUSSION During the exposure, a total of 17.90 grams of test material was delivered in a total volume of 960 liters of dry air, yielding a nominal exposure concentration of 18.6 milligrams per liter. The chamber atmosphere appeared cloudy for the duration of the exposure and the chamber walls became coated with the test material. A second exit tube was added to the exposure chamber after the first half-hour of the exposure, when the first tube became obstructed with the test material. Five minutes after the exposure was initiated, all the rats that could be observed through the dust cloud exhibited excessive lacrimation and salivation, decreased activity, labored breathing, and gasping. At ten minutes into the exposure, most of the rats also had their eyes closed. At 20 minutes, some rats exhibited mucoid nasal discharge and at 30 minutes, some rats exhibited irregular breathing in addition to all the abnormalities previously mentioned. Upon removal from the chamber, red nasal discharge (ten of ten), yellow staining of the ano-genital fur (nine of ten), dry rales (six of ten), red material around the eyes (five of ten), excessive salivation (four of ten), excessive lacrimation (one of ten), and body tremors (one of ten) were observed in the rats. Excessive salivation and lacrimation and body tremors had abated by the 000032 -3- Bio/ / d y n a m i c s In< 78-7184 III. RESULTS AND DISCUSSION (cont.) one hour post-exposure observation and the rats did not exhibit red material around the eyes after the two hour post-exposure observation. Red nasal discharge (ten of ten), yellow staining of the ano-genital fur (six of ten), and dry rales (five of ten) were still seen at the four hour post-exposure observation. During the 14-day observation period, excessive lacrimation (six of ten, one observation each), excessive salivation (three of ten), mucoid nasal discharge (ten of ten), yellow staining of the ano-genital fur (four of ten), dry rales (eight of ten), dry red material around the nose (two of ten), and moist rales (one of ten) were observed in the rats. These observations were generally scattered in appearance. Individual body weights and necropsy observations are presented in Table 1. Weight gains appeared normal. Necropsy examinations revealed lung discoloration in eight of ten rats, which is a higher than normal incidence than that which is normally observed in Sprague-Dawley rats in this type of exposure. C00033 -4- 78-7184 IV. CONCLUSION A one-hour Inhalation exposure to a dust of T-2305CoC, at a nominal exposure concentration of 18.6 milligrams per liter, did not produce mortality in Sprague-Dawley rats. Immediate effects of the test material were excessive lacrimation and salivation, decreased activity, labored breathing, gasping, closing of the eyes, mucoid nasal discharge, irregular breathing, yellow staining of the ano-genital fur, and dry rales. The incidence of the lung discoloration at necropsy indi cated a possible residual effect of the material at 14 days post-exposure. George Vi. Rusch, Ph.D. Director, Inhalation Technology William E. Rinehart, Sc.D. Vice President, Science Report Preparation: Sandra J. Duckworth, B.A. Table 1 An Acute Inhalation Toxicity Study of T-2305 CoC in the Rat Individual Body Weights and Necropsy Observations 78-7184 Animal Body Weights (g) Number Sex Day 0 bay 1 Day z Day 4 bay 1 Day 14 Necropsy Observations* 10 M 234 210 201 208 222 264 B. lungs mottled red and pink with red and white foci on all lobes , 11 M 246 215 205 229 254 303 B. lungs mottled pink and tan with dark red foci on all lobes. 12 N 248 224 212 233 253 306 B. lungs mottled orange and white. 13 M 241 205 196 207 236 315 - B. lungs mottled orange and tan. 14 M 264 242 234 244 281 328 f. ' B. lungs mottled tan and dark pink with light tan < * and brown foci on all lobes, 20 F 232 201 199 233 242 257 3 f B. lungs mottled pink and tan. 21 F 216 204 208 217 229 255 M N.O.A. 22 F 234 205 199 223 240 240 ' B. lungs mottled orange and tan. 23 F 216 201 206 210 223 234 /v B. lungs mottled brown, dark pink, and tan. 24 F 211 192 196 212 226 237 ' N.O.A. * N.O.A. - no observed abnormalities Key: R * right; L = left; B * bilateral. 6 O o to cn I VI I