Science Inventory

A Roadmap for the Development of Alternative (Non-Animal) Methods for Systemic Toxicity Testing


BASKETTER, D. A., H. J. CLEWELL, I. KIMBER, A. ROSSI, B. BLAAUBOER, R. BURRIER, M. DANESHIAN, C. ESKES, A. GOLDBERG, N. HASIWA, S. HOFFMANN, J. JAWORSKA, T. B. KNUDSEN, R. LANDSIEDEL, M. LEIST, P. LOCKE, G. MAXWELL, J. MCKIM, E. A. MCVEY, G. OUEDRAOGO, G. PATLEWICZ, O. PELKONEN, E. ROGGEN, C. ROVIDA, I. RUHDEL, M. SCHWARZ, A. SCHEPKY, G. SCHOETERS, N. SKINNER, K. TRENTZ, M. TURNER, P. VANPARYS, J. YAGER, J. ZURLO, AND T. HARTUNG. A Roadmap for the Development of Alternative (Non-Animal) Methods for Systemic Toxicity Testing. SONJA von AULOCK, Editor in chief (ed.), ALTEX. Society ALTEX Edition, Kuesnacht, Switzerland, 1(29):1-91, (2012).


The framework for a strategy to replace animal tests has only been developed during the writing of the whitepapers. It has been applied to carcinogenicity (Chapter 5) and reproductive toxicity testing (Chapter 6), but not to the other three fields, namely toxicokinetics (Chapter 2), sensitization (3), repeated dose testing (Chapter 4).


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

Record Details:

Product Published Date: 01/01/2012
Record Last Revised: 03/30/2012
OMB Category: Other
Record ID: 241527