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

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David A. Basketter
Harvey Clewell
Ian Kimber
Annamaria Rossi
Bas Blaauboer
Robert Burrier
Mardas Daneshian
Chantra Eskes
Alan Goldberg
Nina Hasiwa
Sebastian Hoffmann
Joanna Jaworska
Thomas B. Knudsen
Robert Landsiedel
Marcel Leist
Paul Locke
Gavin Maxwell
James McKim
Emily A. McVey
Gladys Ouédraogo
Grace Patlewicz
Olavi Pelkonen
Erwin Roggen
Costanza Rovida
Irmela Ruhdel
Michael Schwarz
Andreas Schepky
Greet Schoeters
Nigel Skinner
Kerstin Trentz
Marian Turner
Philippe Vanparys
James Yager
Joanne Zurlo
Thomas Hartung


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.

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Basketter, D. A., Clewell, H., Kimber, I., Rossi, A., Blaauboer, B., Burrier, R., Daneshian, M., Eskes, C., Goldberg, A., Hasiwa, N., Hoffmann, S., Jaworska, J., Knudsen, T. B., Landsiedel, R., Leist, M., Locke, P., Maxwell, G., McKim, J., McVey, E. A., Ouédraogo, G., Patlewicz, G., Pelkonen, O., Roggen, E., Rovida, C., Ruhdel, I., Schwarz, M., Schepky, A., Schoeters, G., Skinner, N., Trentz, K., Turner, M., Vanparys, P., Yager, J., Zurlo, J. and Hartung, T. (2012) “A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing”, ALTEX - Alternatives to animal experimentation, 29(1), pp. 3–91. doi: 10.14573/altex.2012.1.003.

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