Theoretical aspects pertinent to the interpretation of concentration data

Toxicological risk assessment requires knowledge of the kinetics of the test compound and its metabolites in the respective animal species. The toxic effects are dependent on the maximum, minimum, integral and mean systemic exposure as well as its fluctuation index at steady state. If these variables are set appropriately, defined toxicological hypotheses can be tested: the assessment of the no-effect dose level, the evaluation of the toxicological significance of high peak versus attenuated systemic exposure and the toxicological rating of species-specific metabolic pathways.