Validation of the embryonic stem cell test in the international ECVAM validation study on three in vitro embryotoxicity tests.
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.
Genschow
Elke
E
Federal Institute for Risk Assessment (BfR), Diedersdorfer Weg 1, 12277 Berlin, Germany.
Spielmann
Horst
H
Scholz
Gabriele
G
Pohl
Ingeborg
I
Seiler
Andrea
A
Clemann
Nicole
N
Bremer
Susanne
S
Becker
Klaus
K
D000826:Animal Testing Alternatives; D000818:Animals; D016002:Discriminant Analysis; D004622:Embryo, Mammalian / Q000187:drug effects*; D005060:Europe; D005472:Fluorouracil; D006801:Humans; D007391:International Cooperation; D007753:Laboratories; D004364:Pharmaceutical Preparations / Q000145:classification; D011786:Quality Control; D051381:Rats; D015203:Reproducibility of Results; D018675:Toxicity Tests / Q000379:methods / Q000592:standards
D004364:Pharmaceutical Preparations; D005472:Fluorouracil