The tests used and the general principles behind test strategies are now often over 30 years old. It may be time by now, given that our knowledge of genetic toxicology has improved and that we also technically are better able to investigate DNA damage making use of modern molecular biological techniques, to start thinking on a new test strategy. In the present paper, it is discussed that the time is there to consider a new approach for genotoxicity assessment of substances. A fit for all test strategy was discussed making use of the most recent technological methods and techniques.

It was also indicated that in silico tools should be more accepted by regulatory institutes/bodies as supporting information to better conclude which tests should be required for each separate substance to demonstrate its genotoxic potency. Next to that there should be a good rationale for performing in vivo studies. Finally, the need for germ cell genotoxicity testing, essential when classification and labeling of substances is mandatory, was discussed. It was suggested to change the GHS for genotoxicity classification and labelling from in vivo tests in germ cells into in vivo tests in somatic cells.

Quantitative genotoxicology was also discussed. It appeared that we are currently at a transition, where the science developing to justify carrying out human health risk assessments based on genetic toxicology data sets supported by mechanistic data and exposure data. However, implementation will take time, and acceptance will be supported through the development of numerous case studies. Major remaining questions are: is genetic damage a relevant endpoint in itself, or should the risk assessment be carried out on the apical endpoint of cancer and which genotoxic endpoint should be used to derive the point of departure (PoD) for the human exposure limit?

所使用的测试和测试策略背后的一般原则现在通常已有 30 多年的历史。鉴于我们对遗传毒理学的了解有所提高，而且我们在技术上也能够更好地利用现代分子生物学技术研究 DNA 损伤，现在可能是时候开始考虑新的测试策略了。在本文中，讨论了现在是考虑物质遗传毒性评估的新方法的时候了。利用最新的技术方法和技术讨论了适合所有测试策略。

还指出，计算机工具应被监管机构/机构更多地接受为支持信息，以更好地得出结论，每种单独的物质应进行哪些测试以证明其遗传毒性效力。除此之外，进行体内研究应该有一个很好的理由。最后，讨论了生殖细胞遗传毒性测试的必要性，这在物质分类和标签是强制性的时必不可少。有人建议从改变基因毒性分类和标签的GHS体内生殖细胞测试到体内体细胞中测试。

还讨论了定量基因毒理学。看来我们目前正处于一个过渡阶段，科学正在发展以证明基于由机械数据和暴露数据支持的遗传毒理学数据集进行人类健康风险评估的合理性。但是，实施需要时间，并且将通过开发大量案例研究来支持接受。剩下的主要问题是：遗传损伤本身是一个相关的终点，还是应该对癌症的顶端终点进行风险评估，以及应该使用哪个基因毒性终点来推导出人类接触限值的起点 (PoD)？