Division 5.8.2 Supplementary studies on the active substance

Supplementary studies shall be carried out where they are necessary to further clarify observed effects taking into account the results of the available toxicological and metabolism studies and the most important exposure routes. Such studies may include:

1. (a)

   studies on absorption, distribution, excretion and metabolism, in a second species;

2. (b)

   studies on the immunotoxicological potential;

3. (c)

   a targeted single dose study to derive appropriate acute reference values (ARfD, aAOEL);

4. (d)

   studies on other routes of administration;

5. (e)

   studies on the carcinogenic potential;

6. (f)

   studies on mixture effects.

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