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Validation of the embryonic stem cell test in the international ECVAM validation study on three in vitro embryotoxicity tests
Authors:Genschow Elke  Spielmann Horst  Scholz Gabriele  Pohl Ingeborg  Seiler Andrea  Clemann Nicole  Bremer Susanne  Becker Klaus
Institution:Federal Institute for Risk Assessment (BfR), Diedersdorfer Weg 1, 12277 Berlin, Germany.
Abstract:A detailed report is presented on the performance of the embryonic stem cell test (EST) in a European Centre for the Validation of Alternative Methods (ECVAM)-sponsored formal validation study on three in vitro tests for embryotoxicity. Twenty coded test chemicals, classified as non-embryotoxic, weakly embryotoxic or strongly embryotoxic on the basis of their in vivo effects in animals and/or humans, were tested in four laboratories. The outcome showed that the EST can be considered to be a scientifically validated test, which is ready for consideration for use in assessing the embryotoxic potentials of chemicals for regulatory purposes.
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