Guidance on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed


EFSA Journal
EFSA Journal 2011;9(12):2438 [21 pp.].
Panel members at the time of adoption
Boris Antunović, Sue Barlow, Andrew Chesson, Albert Flynn, Anthony Hardy, Michael Jeger, Ada Knaap, Harry Kuiper, David Lovell, Birgit Nørrung, Iona Pratt, Ivonne Rietjens, Josef Schlatter, Vittorio Silano, Frans Smulders and Philippe Vannier

The Scientific Committee wishes to thank the members of the Working Group on 90-day feeding trials on whole food/feed: Gerrit Alink, Gianfranco Brambilla, Noel Albert Dierick, Michael Festing, Gerhard Flachowsky, Gijs Kleter, Joel Guillemain, Harry Kuiper (Chair), Morten Poulsen, Vittorio Silano and Hans Verhagen for the preparatory work on this scientific opinion, and EFSA staff Saghir Bashir, Bernard Bottex, David Carlander, Ellen van Haver, Daniela Maurici and Laura Martino for the support provided to this scientific opinion.

Guidance of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
9 novembre 2011
Published in the EFSA Journal
7 décembre 2011
European Food Safety Authority (EFSA), Parma, Italy

Following a request from the European Commission, the Scientific Committee developed principles and guidance for the establishment of protocols for 90-day whole food/feed studies in rodents. The guidance complements the OECD Test guideline 408 and provides specific advice for performing and reporting experiments carried out with whole food/feed. The conduct of the study and documentation should follow good laboratory practice. Preparation of appropriate test diets is a key element of the experiment with respect to the choice of the diet type, nutritional balance and necessary adjustments, processing, and storage. Since it is often not possible to include whole foods in high amounts in the test diet, fewer dose levels but more animals in control and top dose groups should be used to maximise the power of the study. In accordance with the European Directive 2010/063, the test animals should be housed socially. The guidance recommends that animals of the same sex are housed in pairs. A comprehensive set of endpoints as set out in the OECD TG 408 should be measured during and at the end of the 90-day period, as appropriate. The use of a power analysis to estimate a sample size capable of detecting a pre-specified biologically relevant effect size with a specified power and significance level is described. A randomised block design is recommended for 90-day toxicity studies when testing whole food/feed.

Repeated-dose toxicity study, 90-day, rodent, whole food/feed, experimental design, statistical analysis
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Food technology and food safety
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