New ideas for non-animal approaches to predict repeated-dose systemic toxicity: Report from an EPAA Blue Sky Workshop

New ideas for non-animal approaches to predict repeated-dose systemic toxicity: Report from an EPAA Blue Sky Workshop

Regulatory Toxicology and Pharmacology

10.1016/j.yrtph.2020.104668

https://doi.org/10.1016/j.yrtph.2020.104668

Ruth A. Roberts, Thomas Steger-Hartmann, Evita Vanenbossche, Mark R. Viant, Matthieu Vinken, Maurice Whelan, Zvonar Zvonimir, Mark T. D. Cronin, Catherine Mahony, Randolph S. Ashton, Barbara Birk, Alan R. Boobis, Tom Cull, George P. Daston, Lorna Ewart, Thomas B. Knudsen, Irene Manou, Sebastian Maurer-Stroh, Luigi Margiotta-Casaluci, Boris P. Muller, Pär Nordlund

Repeated dose toxicity testing, Alternatives, Safety assessment, Chemical legislation, in vitroin silico, Read-across, ab initio

23 April 2020

Catherine Mahony, Randolph S. Ashton, Barbara Birk, Alan R. Boobis, Tom Cull, George P. Daston, Lorna Ewart, Thomas B. Knudsen, Irene Manou, Sebastian Maurer-Stroh, Luigi Margiotta-Casaluci, Boris P. Müller, Pär Nordlund, Ruth A. Roberts, Thomas Steger-Hartmann, Evita Vandenbossche, Mark R. Viant, Mathieu Vinken, Maurice Whelan, Zvonar Zvonimir, Mark T.D. Cronin, New ideas for non-animal approaches to predict repeated-dose systemic toxicity: Report from an EPAA Blue Sky Workshop, Regulatory Toxicology and Pharmacology, Volume 114, 2020, 104668, ISSN 0273-2300, https://doi.org/10.1016/j.yrtph.2020.104668.

The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a ‘Blue Sky Workshop’ on new ideas for non-animal approaches to predict repeated-dose systemic toxicity. The aim of the Workshop was to formulate strategic ideas to improve and increase the applicability, implementation and acceptance of modern non-animal methods to determine systemic toxicity. The Workshop concluded that good progress is being made to assess repeated dose toxicity without animals taking advantage of existing knowledge in toxicology, thresholds of toxicological concern, adverse outcome pathways and read-across workflows. These approaches can be supported by New Approach Methodologies (NAMs) utilising modern molecular technologies and computational methods. Recommendations from the Workshop were based around the needs for better chemical safety assessment: how to strengthen the evidence base for decision making; to develop, standardise and harmonise NAMs for human toxicity; and the improvement in the applicability and acceptance of novel techniques. “Disruptive thinking” is required to reconsider chemical legislation, validation of NAMs and the opportunities to move away from reliance on animal tests. Case study practices and data sharing, ensuring reproducibility of NAMs, were viewed as crucial to the improvement of non-animal test approaches for systemic toxicity.

http://creativecommons.org/licenses/by-nc-nd/4.0/

Dr Sebastian Maurer-Stroh is supported by the Agency for Science, Technology and Research ( A*STAR), Singapore, under its Industry Alignment Fund – Pre-Positioning Programme (IAF-PP) grant number H18/01/a0/B14 as part of the A*STAR Innovations in Food and Chemical Safety (IFCS) Programme.

https://oar.a-star.edu.sg/communities-collections/articles/15666

0273-2300
1096-0295

Bioinformatics Institute