Document QgOadLRybQ542Q1Vov9g41D97

Attachments to Letter to C. Auer dated May 25, 2000 AR Toxicology Studies and Other Information on PFOA Acute Toxicity 1) Inhalation Toxicity Study ofT-2305 CoC - Rat a) Final Report, An Acute Inhalation Toxicity Studyof T-2305 CoC in the Rat, Bio/dynamics, Inc., Study No. 78-7184, May 3, 1979 b) Technical Report Summary, Analysis ofrat serumof FC-143, reported in termsoforganic and inorganic fluorine, Central Research Laboratories, June 20,1979 2) Final Report, Acute Oral Toxicity (LDso) 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 ofT-6669 in Rats, Coming Hazelton, Inc., Study No. CHW 61001760, 3M Ref. FC-143, January 10, 1997 4) Final Report, Primary Skin Irritation Stud-y 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 StudyofT-6342 in Rabbits, Coming Hazelton, Inc., Study No. HWI 50800374, 3M sodium perfluorooctanoate solution, Ref. No. October 2F4C,-11099950, L13364, Lot 1, F11426, C00029 1 Ey . [ Ei REESRaIlvve!en| are VEE f {rroome Division of Biology and Safety Evaluation PROJECT NO. 78-7184 AN ACUTE INHALATION TOXICITY STUDY OF T2305 CoC IN THE RAT Submitted to: S3tM. CPoamupla,nyMinnesota 55101 Attention: Frank Griffith, Ph.D. Date: May 3, 1979 00030 oo Ce ------------------ ""aynamiamn 78-1184 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 Targe 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 Toss 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 O-January 23, 1979) the preexposure 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, 00031 Lo "2 ST Yemen 78-1184 11. 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. 111. RESULTS AND DISCUSSION During the exposure, a total of 17.90 grams of test material was delivered in a total volume of 960 Titers of dry air, yielding a nominal exposure concentration of 18.6 milligrans 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 Tacrination (one of ten), and body tremors (one of ten) were observed fn the rats. Excessive salivation and lacrimation and body tremors had abated by the G0032 cr 3 : 78-7188 11. RESULTS AND DISCUSSION (cont.) one hour post-exposure observation around the eyes after the two hour and the rats post-exposure did not exhibit red material 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 (00 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 Tung discoloration in eight of ten rats, which is a higher than normal incidence than that which is nomally observed in Sprague-Dawley rats in this type of exposure. 00033 EE 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 Tacrimation 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 indicated a possible residual effect of the material at 14 days post-exposure. Lttrs Ze orge M. Rusch, Ph.D. Directr, InhalationTechnology Lots 8 pfu WIRTTiam nE ehSaebrt, Vice President, Science Report Preparation: Sandra J. Duckworth, B.A. 00034 rteuofte1I-g n8m3a0atCiooL ntnTotsheteRyee aries . ndtvidul Sods etohes and Necropsy Oxeratons Mnetelr se BUeiT ghts eyE Bow Necropsy tbsermttonss HMw as woonm a om om gg as my og gy wm wm o$no5ctai1`n0otng5emaBoortttEl1oeeeddrsSeindk and and pink tan Mth with redand whe dork red foct wo Em NEM sw mae mga pale eCP taint.e. Mum TEEmRTb and boem TontoneatTa Bink with ght tan N BPE E mam owEmE g, BOOT on tn. ngs moted orange and tan. m BPM mm mm mmm a gg gem gy gy brom, dak pink, and tan, @* HOA. Kr = mo observed Re HO Le sara Torts 6 reres = biatera), 8g8 &8 #:b