ATLA::Alternatives to Laboratory Animals

Volume 32, Number 3

Validation of the postimplantation rat whole-embryo culture test in the international ECVAM validation study on three in vitro embryotoxicity tests

A.H. Piersma1, E. Genschow2, A. Verhoef1, M.Q.I. Spanjersberg1, N.A. Brown3, M. Brady4, A. Burns4, N. Clemann5,6, A. Seiler7 & H. Spielmann7

1National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands; 2Federal Institute for Risk Assessment (BfR), Berlin, Germany; 3St George's Hospital Medical School, University of London, UK; 4Syngenta Central Toxicology Laboratory, Macclesfield, UK; 5Novartis Pharma AG, Basel, Switzerland; 7Centre for Documentation and Evaluation of Alternative Methods to Animal Experiments (ZEBET) at the BfR, Berlin, Germany

SUMMARY

A detailed report is presented on the performance of the postimplantation rat whole-embryo culture (WEC) test 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 WEC test 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: ECVAM, in vitro embryotoxicity test, in vitro toxicology, prediction model, prevalidation, WEC test, whole-embryo culture test