ATLA::Alternatives to Laboratory Animals

Volume 32, Number 3

Validation of the embryonic stem cell test in the international ECVAM validation study on three in vitro embryotoxicity tests

E. Genschow1, H. Spielmann2, G. Scholz2,3, I. Pohl2, A. Seiler2, N. Clemann4,5, S. Bremer6 & K. Becker7

1Federal Institute for Risk Assessment (BfR), Berlin, Germany; 2Centre for Documentation and Evaluation of Alternative Methods to Animal Experiments (ZEBET) at the BfR, Berlin, Germany; 4Novartis Pharma AG, Basel, Switzerland; 6European Centre for the Validation of Alternative Methods (ECVAM), Ispra, Italy; 7Schering AG, Berlin, Germany

SUMMARY

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.

Keywords: discriminant analysis, ECVAM, embryonic stem cells, embryonic stem cell test, EST, in vitro embryotoxicity test, in vitro toxicology, prediction model, prevalidation, validation