title: Validation successes: chemicals.
abstract: The ECVAM validation concept, which was defined at two validation workshops held in Amden (Switzerland) in 1990 and 1994, and which takes into account the essential elements of prevalidation and biostatistically defined prediction models, has been officially accepted by European Union (EU) Member States and by the Federal regulatory agencies of the USA and the OECD. The ECVAM validation concept was introduced into the ongoing ECVAM/COLIPA validation study of in vitro phototoxicity tests, which ended successfully in 1998. The 3T3 neutral red uptake in vitro phototoxicity test was the first experimentally validated in vitro toxicity test recommended for regulatory purposes by the ECVAM Scientific Advisory Committee (ESAC). It was accepted by the EU into the legislation for chemicals in the year 2000. From 1996 to 1998, two in vitro skin corrosivity tests were successfully validated by ECVAM, and they were also officially accepted into the EU regulations for chemicals in the year 2000. Meanwhile, in 2002, the OECD Test Guidelines Programme is considering the worldwide acceptance of the validated in vitro phototoxicity and corrosivity tests. Finally, from 1997 to 2000, an ECVAM validation study on three in vitro embryotoxicity tests was successfully completed. Therefore, the three in vitro embryotoxicity tests, the whole embryo culture (WEC) test on rat embryos, the micromass (MM) test on limb bud cells of mouse embryos, and the embryonic stem cell test (EST) including a permanent embryonic mouse stem cell line, are considered for routine use in laboratories of the European pharmaceutical and chemicals industries.
authors.affiliation: National Centre for Documentation and Evaluation of Alternative Methods to Animal Experiments (ZEBET), Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV), Diedersdorfer Weg 1, 12277 Berlin, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Spielmann
authors.forename: Manfred
authors.initials: M
authors.lastname: Liebsch
mesh_terms: D016475:3T3 Cells / Q000187:drug effects / Q000378:metabolism; D000826:Animal Testing Alternatives; D000818:Animals; D005062:European Union; D015386:Hazardous Substances / Q000633:toxicity*; D066298:In Vitro Techniques; D007509:Irritants / Q000145:classification / Q000633:toxicity; D051379:Mice; D009499:Neutral Red / Q000378:metabolism; D017319:Photosensitizing Agents / Q000145:classification / Q000633:toxicity; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012867:Skin / Q000187:drug effects; D013723:Teratogens / Q000145:classification / Q000633:toxicity; D018675:Toxicity Tests
chemical_list: D015386:Hazardous Substances; D007509:Irritants; D017319:Photosensitizing Agents; D013723:Teratogens; D009499:Neutral Red