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国际替代方法验证与仲裁中心(ECVAM)对三项体外胚胎毒性试验进行的验证研究中胚胎干细胞试验的验证

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

作者信息

Genschow Elke, Spielmann Horst, Scholz Gabriele, Pohl Ingeborg, Seiler Andrea, Clemann Nicole, Bremer Susanne, Becker Klaus

机构信息

Federal Institute for Risk Assessment (BfR), Diedersdorfer Weg 1, 12277 Berlin, Germany.

出版信息

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.

摘要

一份关于胚胎干细胞试验(EST)在欧洲替代方法验证中心(ECVAM)赞助的一项针对三种胚胎毒性体外试验的正式验证研究中的表现的详细报告。根据在动物和/或人类中的体内效应,将20种编码的试验化学品分类为非胚胎毒性、弱胚胎毒性或强胚胎毒性,并在四个实验室进行了测试。结果表明,EST可被认为是一项经过科学验证的试验,已准备好供监管机构考虑用于评估化学品的胚胎毒性潜力。

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