title: [Validation and regulatory acceptance of alternative methods for toxicity evaluation].
abstract: For regulatory acceptance of alternative methods (AMs) to animal toxicity tests, their reproducibility and relevance should be determined by intra- and inter-laboratory validation. Appropriate procedures of the validation and regulatory acceptance of AMs were recommended by OECD in 1996. According to those principles, several in vitro methods like skin corrosivity tests and phototoxicity tests were evaluated and accepted by ECVAM (European Center for the Validation of Alternative Methods), ICCVAM (The Interagency Coordinating Committee on the Validation of Alternative Methods), and OECD. Because of the difficulties in conducting inter-laboratory validation and relatively short period remained until EU's ban of animal experiments for safety evaluation of cosmetics, ECVAM and ICCVAM have recently started cooperation in validation and evaluation of AMs. It is also necessary to establish JaCVAM (Japanese Center for the Validation of AM) to contribute the issue and for the evaluation of new toxicity tests originated in Japan.
authors.affiliation: Division of Pharmacology, Center for Biological Safety and Research, National Institute of Health Sciences.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohno
mesh_terms: D000818:Animals; D005060:Europe; D007564:Japan; D007753:Laboratories; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D018675:Toxicity Tests / Q000379:methods* / Q000592:standards; D014481:United States