Division 5.1 Studies on absorption, distribution, metabolism and excretion in mammals

Information on blood and tissues concentration of the active substance and relevant metabolites, for example around the time to reach the maximum plasma concentration (T_max), shall be generated in short and long-term studies on relevant species to enhance the value of the toxicological data generated in terms of understanding the toxicity studies.

The main objective of the toxicokinetic data is to describe the systemic exposure achieved in animals and its relationship to the dose levels and the time course of the toxicity studies.

Other objectives are:

1. (a)

   to relate the achieved exposure in toxicity studies to toxicological findings and contribute to the assessment of the relevance of these findings to human health, with a particular regard to vulnerable groups;

2. (b)

   to support the design of a toxicity study (choice of species, treatment regimen, selection of dose levels) with respect to kinetics and metabolism;

3. (c)

   to provide information which, in relation to the findings of toxicity studies, contributes to the design of supplementary toxicity studies as outlined in point 5.8.2;

4. (d)

   to compare the metabolism of rats with the metabolism in livestock as outlined in point 6.2.4.