Validation of the embryonic stem cell test in the international ECVAM validation study on three in vitro embryotoxicity tests |
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Authors: | Genschow Elke Spielmann Horst Scholz Gabriele Pohl Ingeborg Seiler Andrea Clemann Nicole Bremer Susanne Becker Klaus |
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Affiliation: | Federal Institute for Risk Assessment (BfR), Diedersdorfer Weg 1, 12277 Berlin, Germany. |
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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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