Document zdKaEJdE9jwZJKD5eJgXazxxz

The Cosmetic Toiletry and Fragrance Association Inc. - 1133 15th STREET N.W. WASHINGTON D.C. 20005202 20005202 331-1770 TELEX 85-2673 James H. Merritt President Norman F. Estrin Ph.D. Vice President January 3 1977 MINUTES E. Edward Kavanaugh Vice President- Congressional Relations Margaret W. Smith Executive Secretary INDUSTRY AEROSOL SAFETY COMMITTEE A meeting of the Industry Aerosol Safety held on Safety Safety Committee was 345 Tuesday Park Avenue December 14 1976 at Bristol Company New York City beginning at 1:30 P.M Those in attendance were Yale Gressel Avon Products Inc. CHAIRMAN James McDermott Procter Gamble VICE Frank Baker Procter & Gamble CHAIRMAN Richard Bourne Lehn & Fink Salvatore DeSalva Palmolive Pau>l Finkelstein Johnson & Johnson Lester Hardy Gillette Joseph Hiddemen Armour James Johnson Plough Inc. John McClement New York University Richard Schnetzinger Revlon William Leonard Troy Avon Products Inc. Vinson Lever Bros. Inc. John Willson Johnson & Johnson Richard Witkowski Faberge Inc. George Wolcott J. H. Breck Ronald Wulf Wallace Inc. RECEIVED RECEIVED JAN 11 1977 BIORGE BIORGE MEX James McNerney CTFA I. Opening Remarks : Chairman Gressel welcomed the attendees and the minutes of the October 19 1976 meeting were approved II Particulate Testing Program Dr. Wulf reported on the status of the proposed program including a meeting of the Particulate Protocol Development Subcommittee held on December December December December December The purposes for this proposed program include determining the inherant toxic potential and determining determining determining determining detrmin gdetermining determining hamsters and monkeys target organs exposed to three in rats product categories antiperspirants e.g. aluminum S> chlorohydrate e.g. resins and powders e.g. talc hairsprays by the inhalation route for days The resultant data will be used as the basis for developing industry comments on testing methods being proposed by the FDA Antiperspirant Panel Protected Document to Protective Order JNJTALC000587189 II Cont'd subcom it e @ The subcommittee is in the process of preparing an protocol A meeting to finalize the protocol will early in January and a draft should be distributed appropriate be held to the committee approval for review prior to cost estimates will the next meeting Following be obtained and site visits to begin potential contractors will probably Funding for the program will be attained through a procedure similar to that employed in the hair color re- search program i.e. one or more member companies may sub- scribe to have a specific product component studied The risk of testing cosmetic ingredients heretofore con- sidered safe by a new untried protocol was discussed Although a difference in opinion existed it was agreed benefits that risks versus of the program should be evaluated by the individual companies in their decision to subscribe or not An apparent majority of the atten- dees favored the program III NIEHS Studies on Aluminum Chlorohydrate Informal reports were presented by several members num chlorohydrate chronic inhalation studies being on alumiconducted by NIEHS These studies were initiated by Dr. Robert Drew who now is associated with Brookhaven National Laboratory m Hamsters 5 days rats and guinea pigs are being to 0.25 2.5 and 25 g of 2 chlorohydrate It has been reported that exposed 6 day micron aluminum after 6 months no gross lesions were observed but granuloma were found microscopically m3 microscopically in rats After 12 and guinea pigs of exposure exposed exposed lesions to 2.5 and were observed . grossly months grossly at 2.5 and 25 mr however microscopic examina- . tions paper were yet on these to be completed Dr. Drew will present a studies at the Society of Toxicology annual meeting in March 1977 Mr. for McNerney will contact Dr. William Busey the project and attempt to gain further pathologist information IV > Lovelace Foundation Program on Propelled Cosmetic Substances the Inhalation Biologoyf McNerney The Particulate Testing Protocol Development Development Subcommittee is considering a visit to Lovelace Foundation in conjunction with the next committee meeting Mr. will make arrangements with Dr. Jones V. University of Washington Epidemiology Study Mr. McNerney reported that he had contacted when CTFA had not received the draft of November 15 as the contractor had informed contacted Dr. Discher final report on Drs Wolcott and Wulf during their October visit to Washington He was told by Dr. Discher that the are yet to be written Discussion and Dr. Discher will Conclusion sections write these sections during the holidays to process the report of January Apparently it will take and CTFA should receive most of January it by the end Protected Document to Protective Order JNJTALC000587190 VI Propellants - Current Status Chlorofluorocarbons @ 1. It was reported that three FDA notices concerning the phase out of all essential uses of fully halogenated chlorofluoroalkanes such as 11 12 13 113 114 and 115 the labeling of products which contain 11 12 and 114 with a warning statement of their potential- harm to public health and environment and adoption of CTFA nomenclature for seven fluorocarbon propellants were published in the Federal Register of November 26 1976 Hydrochlorofluorocarbons 1 Fluorocarbon 22 has been reported by ICI Ltd. England to be weakly mutagenic and potentially carcinogenic based upon positive results in These findings were confirmed by Laboratory and has led Dupont to animal inhalation carcinogenesis DuPont's DuPont's Ames Test Haskell notify FDA to initiate studies and to recommend to their be taken including customers that certain precautions - we do not believe it would be people advisable to spray FC directly at or onto during any new product development studies or market testing of new products See Attachment 1 Fluorocarbon 142b also has been reported by ICI Ltd. England to give positive results in the modified Ames Test DuPont is repeating this test which should be completed by December 22 1976. However based upon the ICI findings both DuPont and Pennwalt allegedly have stopped shipment of this propellant Reference was made to an article by ICI Ltd. England which issue was to be of Nature 1976 published in the December 16 and which would contain the results screening battery of 120 chemicals including 142b by a batterbatteyry battery _ of six carcinogenicity short term tests This article was obtained subsequent to the meeting Attachment 2 However the detailed test results for for the 120 chemicals are not included but will be present- ed at a later date Hydrocarbons Mr. McNerney reported that he had contacted Dr. Richard Stewart Medical College of Wisconsin to determine the the the status of the final report on Propane and Isobutane which was long overdue Dr. Stewart regretted the delay and promised to submit the report by Christmas Methylene Chloride It was reported by Mr. McNerney that Jessie Norris Dow Chemical Company was invited to attend this meet- ing and report on the status of their toxicity pro- gram on methylene chloride She was not able to attend . but will prepare a written report Protected Document to Protective Order JNJTALC000587191 ao oO VII ~ ... Antiperspira Task Force The CTFA Antiperspirant Task ceeding this meeting Force | @ met immediately pre- During the task force meeting Chairman Giovacchini review- ed his Unofficial Minutes of Meeting XXIII of the OTC Panel 1976. on Antiperspirants These minutes had which was held on December 2-3 been distributed by mail to the task force members together with the official minutes of Meeting XXI held on August 26-27 1976 The Panel Report which is topic of discussion The plans were noted in preparation was the following developments chief and 1 The preliminary draft of the Panel report which was prepared by Panel Chairman Rosenberg was rewritten by subgroups during the meeting It will be retyped by the Executive Secretary and sent to the Panel for review prior to the next meeting has rewritten the minority report Chairman Rosenberg and the Panel has incorporated their answers into the body of the mono- graph 2 The redraft of the report will be polished at the next Panel meeting and then submitted to FDA for review 3 The next two Panel meetings have been scheduled for February 3-4 and March April 1 1977 probably 4 CTFA will receive an unofficial copy of the report aftearfter the April Panel meeting most likely | in early May ; The lished 5 The proposed proposed final monograph probably will be pub- lished lishedlishedlished in the Federal Register by August VIII Next and Future Meetings Mr. McNerney reported that during the November 23 1976 Committee meeting of the CTFA Pharmacology and Toxicology it was agreed to hold monthly meetings during 1977 and to hold them jointly with the Industry Aerosol Safety Committee The meetings will be held on the third Wednes- day of each month as a rule but subject to change due to conflicts with holidays scientific meetings etc The January meeting will be held in Scottsdale Phoenix Arizona at the Armour Research Center where the committee will be the guest of Dr. Hiddemen The attendees discussed these plans and Industry Aerosol Safety Committee and participate in the joint meetings agreed should that the cooperate McNerney will determine the members preferences for sites during 1977 and these will be discussed and confirmed at the January meeting Protected Document to Protective Order JNJTALC000587192 : < | G -5- -5- -5- VIII Cont'd The following meetings were noted 1 Industry Aerosol Safety Committee CTFA Pharmacology and Toxicology Committees Januar2y0 1977 - Armour Scottsdale Arizona Research Center 2 FDA Antiperspirant Panel February 3-4 1977 Rockville Maryland 3 CTFA Antiperspirant Task Force Februar8y 1977 New York City 10:00 A.M. - Bristol , There being no further business the meeting was adjourned Submitted by fum James M. Director McNerney of Toxicology JMM Attachments Protected Document to Protective Order JNJTALC000587193