Division 5.8.1 Toxicity studies of metabolites

Supplementary studies, where they relate to substances other than the active substance, are not a routine requirement. Decisions as to the need for supplementary studies shall be made on a case by case basis.

Where as a result of metabolism or other processes, metabolites from plants or in animal products, soil, groundwater, open air differ from those in animals used for the toxicology studies or are detected in low proportions in animals, further testing shall be carried out on a case by case basis, taking into account the amount of metabolite and the chemical structure of the metabolite compared to the parent.