GlaxoSmithKline, Ware, United Kingdom.
Mutat Res. 2011 Aug 16;723(2):91-100. doi: 10.1016/j.mrgentox.2010.10.010. Epub 2011 Feb 3.
A workshop to reappraise the previous IWGT recommendations for photogenotoxicity testing [E. Gocke, L. Muller, P.J. Guzzie, S. Brendler-Schwaab, S. Bulera, C.F. Chignell, L.M. Henderson, A. Jacobs, H. Murli, R.D. Snyder, N. Tanaka, Considerations on photochemical genotoxicity: report of the International Workshop on Genotoxicity Test Procedures working group, Environ. Mol. Mutagen., 35 (2000) 173-184] was recently held as part of the 5th International Workshop on Genotoxicity Testing (IWGT) meeting in Basel, Switzerland (August 17-19, 2009). An Expert Panel was convened from regulatory, academic and industrial scientists (with several members serving on the original panel) and chaired by Dr Peter Kasper (BfArM, Germany). The aim of the workshop was to review progress made in photo(geno)toxicity testing over the past decade; a period which saw the introduction of several regulatory photosafety guidances in particular in Europe and the USA. Based on current regulatory guidelines a substantial proportion of compounds trigger the requirements for photosafety testing. Moreover, there has been growing concern within industry about the performance of the in vitro photosafety tests in the "real world" of compound development. Therefore, the expert group reviewed the status of the current regulatory guidance's and the impact these have had on compound development in the context of the various triggers for photosafety testing. In addition, the performance of photogenotoxicity assays (old and new) was discussed, particularly in view of reports of pseudophotoclastogencity. The Expert Panel finished with an assessment of the positioning of photogenotoxicity testing within a photosafety testing strategy. The most significant conclusion made by the Expert Panel was that photogenotoxicity testing should no longer be recommended as part of the standard photosafety testing strategy. In addition, progress was made on the refinement of triggers for photosafety testing. For example, there was support for harmonisation of methods to determine the Molar Extinction Coefficient (MEC) and a consensus agreement that there should be no requirement for testing of compounds with a MEC<1000Lmol(-1)cm(-1).
最近，作为第五届国际遗传毒性测试研讨会（IWGT）会议的一部分，在瑞士巴塞尔（2009 年 8 月 17-19 日）举行了一次重新评估先前 IWGT 关于光遗传毒性测试建议的研讨会[E. Gocke、L. Muller、P.J. Guzzie、S. Brendler-Schwaab、S. Bulera、C.F. Chignell、L.M. Henderson、A. Jacobs、H. Murli、R.D. Snyder、N. Tanaka、关于光化遗传毒性的考虑因素：遗传毒性测试程序国际研讨会工作组的报告，环境分子突变，35（2000）173-184]。一个由监管机构、学术和工业科学家组成的专家小组（其中几位成员曾参与最初的小组）被召集起来，并由 Peter Kasper 博士（德国 BfArM）担任主席。研讨会的目的是审查过去十年中光（遗传）毒性测试取得的进展；在此期间，特别是在欧洲和美国，出台了几项监管光安全性指南。根据当前的监管指南，大量化合物触发了光安全性测试的要求。此外，业界对体外光安全性测试在化合物开发的“现实世界”中的表现越来越关注。因此，专家组审查了当前监管指南的现状，以及这些指南在各种光安全性测试触发因素下对化合物开发的影响。此外，还讨论了光遗传毒性测定法（旧的和新的）的性能，特别是鉴于假性光裂原性的报告。专家组最后评估了光遗传毒性测试在光安全性测试策略中的定位。专家组最重要的结论是，光遗传毒性测试不应再作为标准光安全性测试策略的一部分进行推荐。此外，在完善光安全性测试的触发因素方面取得了进展。例如，支持方法的协调一致，以确定摩尔消光系数（MEC），并达成共识，不应要求测试 MEC<1000Lmol(-1)cm(-1)的化合物。
