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Strategies to Replace In Vivo Acute Systemic Toxicity Testing The Report and Recommendations of ECVAM Workshop 50

Alessandra Gennari, Christine van den Berghe, Silvia Casati, José Castell, Cecilia Clemedson, Sandra Coecke, Alessandra Colombo, Rodger Curren, Gianni Dal Negro, Alan Goldberg, Catherine Gosmore, Thomas Hartung, Ingrid Langezaal, Iglika Lessigiarska, Wilfred Maas, Inge Mangelsdorf, Ralph Parchment, Pilar Prieto, Juan Riego Sintes, Michael Ryan, Gabriele Schmuck, Katherine Stitzel,William Stokes, Joan-Albert Vericat and Laura Gribaldo

This is the report of the fiftieth of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). This ECVAM workshop on strategies to replacein vivo acute systemic toxicity testing was held at ECVAM on 15–18 September 2003, under the chairmanship of Laura Gribaldo. The participants represented academia, national organisations, international regulatory bodies and industry. The aim of the workshop was to review the state-of-theart of in vitro methods for estimating acute systemic toxicity, and to develop research, development, and validation strategies necessary for the replacement of in vivo testing, with a focus on oral acute toxicity. The report describes the strategy proposed by the participants for using in vitro methods, and provides recommendations for the test method development and validation activities necessary to support such a strategy that might replace the use of animals for the acute toxicity testing of chemicals.