Gad S C
G.D. Searle & Company, Skokie, Illinois 60077.
Fundam Appl Toxicol. 1990 Jul;15(1):8-16. doi: 10.1016/0272-0590(90)90157-f.
Significant progress has been made in replacing animals in toxicology/safety assessment with in vitro systems, in reducing the number of animals used, and in refining how they are used. Review of annual reports of the numbers of animals used in testing in the United States, the United Kingdom, and Japan shows a continuing reduction in the numbers for all species. Multiple in vitro systems have been developed for screening/testing for eye and skin irritation, skin sensitization, teratology, and other endpoints and a scientific consensus has been formed on requirements and process for validation. However, the use of these test systems in place of existing in vivo tests is minimal. At the same time, innovative designs have been developed (and are in wide use) for in vivo tests which reduce both the numbers and the pain and distress of animals used in testing. Progress and dialogue continue on modification of both U.S. and international requirements and guidelines for testing, and for defining an "approval" process for alternatives and innovations.
在毒理学/安全性评估中用体外系统替代动物、减少所用动物数量以及优化动物使用方式方面已经取得了重大进展。对美国、英国和日本测试中所用动物数量的年度报告进行审查后发现，所有物种的动物数量都在持续减少。已经开发出多种体外系统用于眼部和皮肤刺激性、皮肤致敏性、致畸学及其他终点的筛查/测试，并且在验证的要求和流程方面已形成科学共识。然而，这些测试系统取代现有体内试验的使用情况极少。与此同时，已经开发出（并且广泛使用）用于体内试验的创新设计，这些设计减少了测试中所用动物的数量以及动物的疼痛和痛苦。关于修改美国和国际测试要求及指南，以及为替代方法和创新方法定义“批准”流程的工作仍在继续取得进展并进行对话。
