Document nN36N7m3Ym5GVrOJVnz2gw288

e TO: Distribution Interoffice Communication FROM: DATE: SUBJ: T. G. Grumbles December 13, 1989 LAB SKIN PAINTING STUDIES "ESQ: Gm: ^6; RF XF: (o'*? \ VISTA Attached for your information is a summary of the meeting held with ECOSOL, P&G and Unilever Europe regarding the additional studies to be done to address recent concerns regarding potential health effects of LAB. Also attached is a letter indicating the specifics of Monsanto and Vista's participation. c T. G. Grumbles dlj .906 Attachment Distribution: J. C. Ledvina, M. S. Reynolds Surfactants Steering Team Jan Vogel, Bruce Larsen, Jim DeBernardi, G. W. Inbody, Mark Schneider, Bill Murray, Mike Sweet, Ron Bryan, Cornelia Schirber, V. W. Weiss sj 00000733* m To: From: Date: Interoffice Communication Subject: J. R. Roheim D. A. Penney December 6, 1989 LAB SKIN PAINTING MEETING LONDON, NOVEMBER 20 AND 21 VIS1A Attendees: Shell - W. Femley (Chair of the ECOSOL Committee, K. Kuckel (toxicologist); Petresa - J. Bema (Dir. R&D); Enichem Augusta SpA - A. Andretta (R&D Manager), Proctor and Gamble - G. Calvin (Toxicologist); Unilever - M. How and M. Richold (Environmental Safety Laboratory); Vista - D. Penney and T. Grumbles; CEFIC - C. Jassogne. The purpose of the meeting was to discuss recent LAB skin painting data being generated in Europe and to consider future action to be taken jointly by CLER and ECOSOL. The meeting was held under the auspices of CEFIC which is the European equivalent of CMA. ECOSOL functions under CEFIC. The meeting began with a historical review of the skin painting issue. It was obvious that Proctor has favored the conduct of a skin painting study on LAB all along and has put pressure on ECOSOL. Proctor maintains sort of a "counselor" role in ECOSOL, not being an actual member of the group, but obviously exerting great influence. Unilever does not appear to have played a significant role in pushing for a skin painting study with LAB, but is supportive. The group agreed with current plans to publish a rebuttal of Iverson's work and to a joint publication of genotoxicity studies conducted by Shell and Monsanto. The rebuttal is to be submitted to the same journal Iversen used for his first publication. The genotoxicity studies will be submitted to a reputable journal like Mutagenesis sometime in February 1990 with an anticipated publication date of July or October 1990. The group also agreed that it would be advantageous to publish the two 8week skin painting studies conducted by ECOSOL. These studies were conducted according to the proposed EPA guidelines for skin-painting studies and the resulting histopathology slides were reviewed by a group of pathologists which included an EPA representative. Based on these studies, a properly conducted skin painting study should utilize alkybenzene concentrations no greater than 5% to avoid irritant responses which could cloud interpretation. The intended publication will point out that Iversen exceeded the 5% level using concentrations of 16%, 40% and 80%. The paper will probably be authored by IRI (Inveresk Research International) which conducted the studies. r The group also agreed to the production of a position paper advocating the safety of LAB. Monsanto and P & G will draft the paper for review by all VVV 000007339 participants. Collectively, we have acute, mutagenicity, metabolism, teratology, reproductive and sub-chronic toxicity data. In discussing further safety testing, the group agreed that an epidemiology study was not practical because of the difficulty in identifying a suitable exposed population. We did agree that a dermal absorption and metabolism study as well as a skin painting study would go a long way in answering questions raised by Iversen's work. The total cost for these studies is estimated not to exceed $600K, vs. the original $1.6M estimate. We convinced ECOSOL that only one skin painting study with a high purity LAB is necessary. ERI has done the preliminary dermal irritation assays and is a likely candidate for the study. However, we will seek bids from other labs in Europe and the U.S. We will also get bids from several labs for the metabolism study. After the research program has been more fully developed, we will review our plans with a team of outside consultants with reputations in the relevant areas of expertise. The ECOSOL proposal that ECOSOL, CLER, P&G and Unilever each pay 25% of the cost was discussed. Neither P&G or Unilever appeared to object strongly to this proposal. CLER indicated that the split was not fair because ECOSOL could spread its 25% over 6 companies. J. Mieure of CLER proposed that each of the 8 producers pay an equal share of the producer's portion. ECOSOL representatives did not feel this was possible because some of its members were small producers and could not bear paying 1/8 of the ECOSOL/CLER share of the program. Femley of ECOSOL eventually divulged that ECOSOL had apportioned the members costs for its share of the proposed program on the basis of relative production volumes. Fernley also stated that ECOSOL had only endorsed an equal-share split between CLER and ECOSOL and that the CLER proposal would require another meeting of the general assembly for consideration. No agreement was reached on this issue at the meeting. The group present at this meeting will continue to function under the CEFIC and ECOSOL umbrella, so their CEFIC staff representatives will act as secretary for any future meetings. We elected Keith Huckle, Shell toxicologist, as chairman. cc: T. Grumbles A. Nielsen r VVV 000007340