Division 5.8.2 Supplementary studies on the active substanceF1

In certain cases it can be necessary to carry out supplementary studies to further clarify observed effects. These studies could include:

• studies on absorption, distribution, excretion and metabolism,

• studies on the neurotoxic potential,

• studies on the immunotoxicological potential,

• studies on other routes of administration.

Decisions as to the need for supplementary studies must be made on a case by case basis, taking into account the results of the available toxicological and metabolism studies and the most important exposure routes.

Studies required must be designed on an individual basis, in the light of the particular parameters to be investigated and the objectives to be achieved.