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Cell Transformation Assays as Predictors of Human Carcinogenicity The Report and Recommendations of ECVAM Workshop 39

Robert Combes, Michael Balls, Rodger Curren, Michel Fischbach, Norbert Fusenig, David Kirkland, Claude Lasne, Joseph Landolph, Robert LeBoeuf, Hans Marquardt, Justin McCormick, Lutz Müller, Edgar Rivedal, Enrico Sabbioni, Noriho Tanaka, Paule Vasseur and Hiroshi Yamasaki

This is the report of the thirty-ninth of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). The workshop on Cell Transformation Assays as Predictors of Human Carcinogenicity was held in Angera, Italy on 12–16 October 1998. The principal aim of the workshop was to seek consensus on ways of increasing the use of mammalian cell transformation assays, especially in human cell systems, for fundamental and applied studies in carcinogenesis, and for the regulatory testing of carcinogens, and to make practical recommendations to facilitate this process. This was endorsed by the fundamental belief of all the participants that the further development, evaluation, routine use and eventual regulatory acceptance of cell transformation assays, in conjunction with other toxicity information, would improve the overall process of safety and risk assessment of carcinogenicity, for the protection of human health. This belief was based on the fundamental premise that the process of in vitro cell transformation closely models the carcinogenic process in vivo.