A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing.

摘要: Systemic toxicity testing forms the cornerstone for safety evaluation of substances. Pressures to move from traditional animal models novel technologies arise various concerns, including: need evaluate large numbers previously untested chemicals and new products (such as nanoparticles or cell therapies), limited predictivity tests human health effects, duration costs current approaches, welfare considerations. The latter holds especially true in context scheduled 2013 marketing ban on cosmetic ingredients tested systemic toxicity. Based a major analysis status alternative methods (Adler et al., 2011) its independent review (Hartung 2011), present report proposes roadmap how overcome acknowledged scientific gaps full replacement using animals. Five whitepapers were commissioned addressing toxicokinetics, skin sensitization, repeated-dose toxicity, carcinogenicity, reproductive testing. An expert workshop 35 participants Europe US discussed refined these whitepapers, which subsequently compiled form report. By prioritizing many options field forward, group hopes advance regulatory science.