Document zQJxkB9v6dDjnb9JjwQeaZ0Oa

1 ' i. VJ O CN Chemical Manufacturers Association Cocrtnev m. price V!C: PRESIDENT ChSV,jTAR April i. 1 99S VIA CERTIFIED MAIL Document Processing Center Mail Code 7407 Room E-G99 East Tower Office of Pollution Prevention and Toxics Environmental Protection Agency 401 M Street, S.W. Washington. D.C. 20460 Attention: TSCA 8(e) Coordinator Dear Sir: The Vinyl Chloride Health Committee of the Chemical Manufacturers Association submits the enclosed preliminary results from ar. ongoing inhalation ; co generation reproductive toxicity study in Charles Raver CD rats sponsored oy tr.e . i-.i Committee. These results are submitted pursuant .o ? S(e of ihe Toxic Substarce. Control Act. As indicated in the enclosed preliminary macroscopic and microscopi.' p.mhci:. repon. microscopic changes were seen in the livers of high-dose U-100 parts per r.Mii'.iv (ppm)) parental rats of both generations. Hepatocellular hypertrophy was seer. ir. die liv., of all high-dose rats, and foci of cellular alteration in hepatocytes were significann> increased in the livers of P2 generation parental rats. An increased incidence of hepatocellular foci was seen in 18 of 30 high-dose males and 19 of 30 high-dosc rcin.de;. One focus of cellular alteration was seen in male controls: none was observed in females. These effects are largely corroborative of results previously reported. Til. 11 P. c: ai. observed a variety of treatment-related liver lesions in the high-dose (1.3 mg kg bo:!;, weight/day) group of Wistarrats tested in a lifetime oral carcinogenicity study of \ :n>l chloride. Food Chem. Toxicol. 29: 713-18 (1991). The lesions included increased incidences of liver cell polymorphism, hepatic cysts, foci of cellular alteration, neopias.u nodules, hepatocellular carcinomas, and angiosarcomas. Innovation TcChnOlOG ' anI---------------------------------------------------------------------------- L* A rUuAi--Cillf H*. 1 300 Wilson 3iO,, Aa.*: jnCT3n. \A 22299 T;.Toi-T-t-SsCC- "" r03-74*. -cC91 If AlXatEam'.T.wn BFG 01240 APR 10 '38 14;lb BFG41728 -i ' i'J/ Dec'-mer.t Processing Comer April 3. 1998 Paso : An earlier study of the age-dependence of the induction of pre-neoplastic enzyme-altered hepatic foci demonstrated that there is a penod of increased sensitivity t the production of liver foci in response to vinyl chloride exposure in newborn rats Lai R.L. et ai. Carcinogenesis 6: 65-68 (19851. This is consistent with the observation of hepauc foci induction in the P2, but not the PI. rats in the reproductive toxicity study The P2 rats would presumably have been exposed to vinyl chloride during the iactativn penod (days 4-25 after birth), whereas the PI animals would not. The penod of sensitivity' appears to correspond with the penod of rapid increase in the number of ceil of the liver (proliferation) in newborn rats. Any significant supplemental data obtained as a result of further pathology evaluation will be reported in a follow-up communication. The member companies of the CMA Vinyl Chloride Health Committee on ' > :w behalf this submission is being made include: Borden Chemicals and Plastics 180 E. Broad Street, 15th FI. Columbus, OH 43215 Panel Contact: Mr. Mark Gruenwald Telephone: (614) 225-3459 CONDEA Vista Company 900 Threadneedle P.O. Bex 19029 Houston. TX 7''079 Panel Contact: Dr. David A. Penne Telephone: ; 2S11 583-3059 The Dow Chemical Company 1803 Dow Center Midland, MI 48674 Panel Contact: Dr. Colin Park Telephone: (517) 636-1159 Formosa Plastics 9 Peachtree Hill Rd. Liv ingston. NJ 07039 Panel Contact: Mr. David Pun Telephone: (973) 716-7279 GEON Company One Geon Center Avon Lake, OH 44012 Panel Contact: Mr. Ed Beeler Telephone: (440) 930-3030 Georgia Gulf Corporation 26100 Highway 405 P.O. Box 629 Plaquemine, LA 10165 Panel Contact: Mr. Jay Strange Telephone: (504) 685-2642 APR 10 '38 14: is BFG41729 BFG 01241 rr.u -L V / wO Document Processing Csntir April 8. 1998 Page 3 Occidental Chemical Corp. P.0 Box 809050 5005 LBJ Freeway, Room 904 Dallas, TX 75380 Panel Contact: Dr. Steve Phillips Telephone: (972)404-2413 PPG Industries, Inc. One PPG Place - 36W Pittsburgh. PA 152": Panel Contact: Dr. James Saner Telephone: (412 < 434-280' Westlake Chemical Corp. 2801 Post Oak Blvd. Suite 600 Houston, TX 77056 Panel Contact: Mr. John Gamble Telephone: (713) 960-9111 If you have any questions regarding this letter, please contact Wendy Sherman o: my staff at (703) 741-5639. sinr^n*1v vnnrc Enclosure cc: Vinyl Chloride Health Committee APR 10 '98 14=16 BFG4I730 BFG 01242