Division 3.2.1.1 Metabolic studies

The purpose of metabolic studies is to evaluate the absorption, distribution, biotransformation and excretion of the additive in the target species.

The studies required are:

1. (1)

   metabolic balance following a single dose administration of the active substance at the doses proposed for use (total amount corresponding to the daily intake) and possibly a multiple dose (if justified) to assess an approximate rate and extent of the absorption, distribution (plasma/blood) and excretion (urine, bile, faeces, milk or eggs, expired air, excretion via gills) in male and female animals, where appropriate; and

2. (2)

   metabolic profiling, identification of the metabolite(s) in excreta and tissues and distribution in tissues and products shall be established following repeated dose administration of the labelled compound to animals to the steady state (metabolic equilibrium) identified by plasma levels. The dose applied shall correspond to the highest dose proposed for use, and shall be incorporated into the feed.