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

Altern Lab Anim. 2004 Sep;32(3):209-44. doi: 10.1177/026119290403200305.

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.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Animal Testing Alternatives*
  • Animals
  • Discriminant Analysis
  • Embryo, Mammalian / drug effects*
  • Europe
  • Fluorouracil
  • Humans
  • International Cooperation
  • Laboratories
  • Pharmaceutical Preparations / classification
  • Quality Control
  • Rats
  • Reproducibility of Results
  • Toxicity Tests* / methods
  • Toxicity Tests* / standards

Substances

  • Pharmaceutical Preparations
  • Fluorouracil