Validation of alternative toxicity test systems: lessons learned and to be learned.

Molecular toxicology Pub Date : 1987-09-01
M Balls, R Clothier
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Abstract

Validation in the context of in vitro toxicity tests is defined, and various aspects of the validation process are discussed, including the design and conduct of interlaboratory validation schemes; the selection of tests, participating laboratories, and test chemicals; the selection and use of in vivo data; in vivo/in vitro data comparison; the question of "false" results; in vitro cytotoxicity as a predictor of actual lethal toxicity; and the validation of alternatives to the Draize eye irritancy tests. It is concluded that a thorough reevaluation of current practice is essential if the promise and potential of nonanimal toxicity tests are to be fully realized and if valid alternative tests acceptable to regulatory agencies are to be developed.

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替代毒性测试系统的验证:已吸取的教训和需要吸取的教训。
定义了体外毒性试验背景下的验证,讨论了验证过程的各个方面,包括实验室间验证方案的设计和实施;选择测试、参与实验室和测试化学品;体内数据的选择和使用;体内/体外数据比较;“假”结果的问题;体外细胞毒性作为实际致死毒性的预测因子;以及验证Draize眼睛刺激测试的替代方案。结论是,如果要充分实现非动物毒性试验的希望和潜力,如果要开发监管机构可接受的有效替代试验,就必须对目前的做法进行彻底的重新评价。
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