CAAT, Johns Hopkins University, Baltimore, USA.
Altern Lab Anim. 2009 Dec;37 Suppl 2:45-7. doi: 10.1177/026119290903702S10.
Taking the 110th anniversary of marketing of aspirin as starting point, the almost scary toxicological profile of aspirin is contrasted with its actual use experience. The author concludes that we are lucky that, in 1899, there was no regulatory toxicology. Adding, for the purpose of this article, a fourth R to the Three Rs, i.e. Realism, three reality-checks are carried out. The first one comes to the conclusion that the tools of toxicology are hardly adequate for the challenges ahead. The second one concludes that, specifically, the implementation of the EU REACH system is not feasible with these tools, mainly with regard to throughput. The third one challenges the belief that classical alternative methods, i.e. replacing animal test-based tools one by one, is actually leading to a new toxicology - it appears to change only patches of the patchwork, but not to overcome any inherent limitations other than ethical ones. The perspective lies in the Toxicology for the 21st Century initiatives, which aim to create a new approach from the scratch, by an evidence-based toxicology and a global "Human Toxicology Programme".
以阿司匹林上市 110 周年为起点，将阿司匹林几乎令人恐惧的毒理学特征与其实际应用经验进行对比。作者得出的结论是，幸运的是，在 1899 年，还没有监管毒理学。为了本文的目的，在三 R 原则（即减少、优化和替代）中增加第四个 R，即现实主义，进行了三次现实性检查。第一次检查的结论是，毒理学工具几乎无法应对未来的挑战。第二次检查的结论是，特别是，这些工具无法实施欧盟 REACH 系统，主要是在通量方面。第三次检查则质疑了一种信念，即经典的替代方法，即逐个替代基于动物试验的工具，实际上正在引领一种新的毒理学——它似乎只是改变拼凑的补丁，而不是克服除伦理问题之外的任何内在局限性。展望在于 21 世纪毒理学倡议，旨在通过基于证据的毒理学和全球“人类毒理学计划”从零开始创建一种新方法。
