Document jgJJR9Xd7bgyev21KEBgM23Qy

MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D. C. 20009 (202) 483-6126 August 10, 1973 URL 02278 Memorandum TO: A. C. Clark FROM: H. L. Slatin SUBJECT: Visit August 2, 1973 Industrial BIO-TEST Laboratories, Decatur, Illinois Inc. At the meeting of the Technical Task Group on Vinyl Chloride Research, July 11, 1973, considerable concern was expressed over certain aspects of the ani mal studies being performed by Industrial BIO-TEST Laboratories (IBL). To assure that discrepancies in the facilities and program noted during the visit to IBL by Drs. Torkelson and Johnson have been corrected, it was agreed to schedule a follow-up visit after the tests had been started. This will summarize discussions and observations during the conference on August 2, 1973, which I attended for Dr. K. D. Johnson. In attendance: For MCA IBL Dr. T. R. Torkelson Dr. Z. G. Bell, Jr. Dr. W. D. Harris Mr. H. L. Kusnetz Mr. H. L. Slatin Dr. J. W. Goode Mr. Ken Schadeberg Mr. Dennis Lindberg The difficulty Industrial BIO-TEST was having with the animals was discussed. The animals were received during a period of an air strike of Ozark, the only sched uled airline into Decatur. It was necessary to truck the animals from Northbrook, Illinois using temporary cages and an irregular schedule. It was felt this was an unusual stress to the animals, particularly the hamsters. 2- - The protocol required that food be taken away from the animals while they are exposed to inhalation of the mixture of vinyl chloride. In order to do this, special food racks were provided by IBL, which did not allow the animals, particularly the smaller ones, to eat the food. Consequently, they lost weight and some died. Industrial BIO-TEST felt it would be better to scrap these experiments and start anew. September 1, 1973 was suggested as the new starting date. By this date, IBL could effect the following additional improvements: construct a new air exhaust system? install a new gas chromatography unit to automatically and regularly monitor the vinyl chloride concentration in each of the different inhalation chambers? and provide a new feeding device which would allow the animals to get at the food. The starting delay means that we will not have test data for one year available until September 1974. The one year (12 month) data could be presented at the annual fall meeting of the Industrial Hygiene Foundation as the first part of the 24-month test period. Dr. Torkelson felt that the key part of the experi ment is the one wherein the food would be in the chamber at all times. This part had not been initiated to date, but will be an integral part of the experiment as it is restarted. It was indicated that restarting the study would involve no additional cost to the MCA sponsoring group. All in attendance favored the restart. It was also requested that Industrial BIO-TEST obtain from Charles River, at the start of the experiment, information on all of the animals as to their background and the number of multiparous litters from which they came. In any case, if everything was not ready by September 1, 1973, but the animals were, the experiment would start anyway. Dr. Goode noted that the high dose of 5,000 ppm v/v was a feasible testing dose. He also stated there are 18 different points from which the chambers are sampled. The Baffle plates and funnels do not affect the homogeneity URL 02279 -3- of the VCM/air mixtures. It took about 35 minutes for the chambers to reach equilibrium, which remained steady thereafter. The chambers have a complete air change every ten minutes. The current animals will be used to check out the feeding part of the experiment. Industrial BIO-TEST agreed to make suitable arrange ments for a possible leak and/or rupture of one or more containers of vinyl chloride. Changes will also be made to the air exhaust system so that the air intake will be at a point up and away from the air exhaust. Subsequent to the meeting, committee members M. N. Johnson, M. D., Dr. W, E. Rinehart, and Mr. R. N. Wheeler were contacted by phone and all concurred with the decision to restart the testing procedure September 1. URL 02280 HLS:mb H. L. Slatin ALBERT C. CLARK VICE PRESIDENT TECHNICAL DIRECTOR INFORMATION COPY MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D. C. 20009 (202) 463-6126 August 3, 1373 URL 02281 John W. Goode, Ph.D., Manager Decatur Research Laboratories Industrial Bio-Test Laboratories, 1800 East Pershing Road Decatur, Illinois 62526 Inc. Dear Dr. Goode: Thanh you for the courtesies extended to Mr. Harry Slatin and the representatives of our member companies. Dr. T. R. Torkeleon, Dr. Z. G. Bell, Dr. W. D. Harris, and Mr. H. L. Kusnetz in their visit to your laboratories August 2, 1973. We v.'ere all sorry to hear, as you told them and your letter of August 2, 1973, indicates, that the current start on the vinyl chloride inhalation project, IBT-663-03222, is such that you recommend a restart of the study on September 1, 1973. We understand from discussions at the time of the visit that the total cost of this study to MCA will remain as originally agreed. MCA and its member representatives concur with you that a restart of the study is desirable and advise you to proceed. It is appreciated that the changes you have made in your physical setup, as well as those you contemplate will help the study appreciably. If there are any other problems, please advise us Sincerely,