Document Zn6dVvx7L1m1QmnLRaweXaEzY

ASSIGNMENT OUTLINE & REl RT '* A -OUTLINE ^^^^ATION INTRA.CO. ASSIGNMENT department CONTACT MS* TITLE ASSIfiNCC W. A. ASSIONMENT No. _______ 817 ;napp * J SHEET _ OF, > 1 2; OUTSIDE ASSIGNMENT Name of Compahv food St Drug Admin, LOCATION Washington, D. C. Contact mh. >r. A. J. Lehman TITLE Chief, Dept, of pharma- ------------------ -------------------- Vinyl Chloride - Propellant 1140 PERIOD OF ANTICIPATES ABSENCE f.om.12-15 toi 12-15 B REPORT .68 FROMl SIGNATURE Original Jo Vs Swains t TO* Technical Director 1# Date 12-17-58 Call was made to review our proposal on vapor Inhalation toxicity of vinyl chloride* Present were Drs* Lehman, Kelson and Draize for Pood and Drug; Drs, Greenberg and Lester of Yale University) our toxicologists, Hr* P. J* Cambourells of Solvay Process Division for whom work is to be done, and the writer. Mr. Ramsey of PDA was present momentarily, but excused himself when It was determln d that we did not contemplate the use of vinyl chloride as a pro pellant In food products* Dr* Dralze thought the program completely satisfactory, but when Dr* Lehman mentioned complete pathology (some 24-26 tissues) on at least a couple of animals. Dr. Nelson was called in for his opinion. Dr* Kelson wants complete pathology on at least six animals (3 males and three females) and would like an exposure concentration which shows some deleterious effects* As a count r to the latter proposal. Dr* Greenberg explained our proposal to determine highest concentration not producing symptoms on acut exposure to man and tasting this concentration sub-acutely on rats (1-2 weeksj 8 hrs. dally exposure). This preliminary animal sere ning may or may not produce any pathology in the animals but Dr, Greenberg explained that It seemed rather ridiculous to expose at a higher concentration than produces symptoms on single short xposures In man* . It must be recognised that if toxic effects (sub normal weight gains, etc.) appear during this preliminary test exposure period we will probably have to do complete pathology on a few animals at this point which may Increase hlstopathology expense somewhat* However, If this occurs we will probably not have to examine as many tissues at the conclusion of the long term (3 mos.) test. In any case, all tissues will be preserved in formalin for future section and examination if necessary. It is not expected that revisions in program will appreciably alter total expense. 1. Summary report of work and results 2. Cover by separate letters, recommendations and suggestions make reference to letters in "Report* section above If report detailed in Research Triplicating Book give Book and page nos. 4. Where log is prepared reference is also suggested 780. PTD, IN U.S.A, signature Original Signed _______________ W _ ([ ^ ^0_______ ___ ____________ Research consudfetgo&i J. W. S'fai./O -----------Technical Director----------- t,re* J1348 DEC 2 3 1958 ASI 000015791 Other aspects of the program were favorably commented upon. Dr, Lehman likes preliminary human tests and was pleased with the transaminasevproposed as an indication of tissue damage, A On the question of Inhibitor, Dr, Lehman could visualize no effect arising from 50-100 ppm of phenol in the vinyl chloride and the writer still feels that maximum protection for the investment is obtained if inhibitor is included; Solvay can counter this opinion if they desire. On gas needed, based on 2.5$ gas, three complete changes of atmosphere per hour, 8 hr, exposure, 5 days per week for 15 weeks using Yale*s 1200 1, chamber we need about 332 lbs, of gas. To allow for waste and other factors, the writer suggests that 600 lbs. of gas be shipped to Yale. This should preferably all be from the same storage and all cylinders should contain the same amount of Inhibitor, We anticipate that experimental work should be underway within the first two weeks of January. WAK:ncm cc: Solvay Process Dlv., Mr. P. J. Cambourelis N.Y.O. > December 5, 1958 Dr. Leon Greenberg Yale University Laboratory of Applied Biodynaraics 53 Hillhouse Avenue New Haven, Connecticut Dear Leon: Appointment with Dr. A. J. Lehman is set for 9:00 A.M. on Monday, December 15th. If you and Dave are taking the night train, I suggest that we meet in the Washington Station between 7 and 0 A.M. I will probably also take the night train which I think must be vacated at 7 or 7s30 A.M,, so will probably see you at breakfast there. If we miss. Dr. Lehman*a office is in the South Agricul tural Building, corner of 12th and C Sts. Telephone num ber is REpublic 7-4142, Extension 4708* See you on the 15th - WAK:ncm Very truly your3. Original Sii>---- W. k, Knapp W. A, Knapp Research Consultant ooool5793 \Si December 3, 1958 Mr. P. J. Cambourella SOLVAY PROCESS DIVISION Allied Chemical Corporation 40 Rector Street New York 6, New York Dear Mr. Cambourella: Attached herewith la propoaed program of atudy which we intend to send to Dr. Lehman shortly before our pro posed conference with him. The program is essentially that proposed by Yale University with minor revisions by the writer. It is our plan to request (via telephone) an appoint ment for the week of December 15th. May we have your approval on program as outlined. Very truly yours. - ivuapp W. A. Knapp Research Consultant WAK:ncm enc. 1 cc: Dr. Leon Greenberg Yale University Laboratory of Applied Biodynamica Yale Station 52 Hillhouse Avenue New Haven, Connecticut ASI 000015 794