Division 3.2.2.5 Reproduction toxicity studies (including prenatal developmental toxicity)

To identify possible impairment of male or female reproductive function or harmful effects on progeny resulting from the administration of the active substance, studies of reproductive function must be carried out by:

1. (1)

   two generation reproduction toxicity study; and

2. (2)

   prenatal developmental toxicity study (teratogenicity study).

For new trials validated alternative methods reducing the use of animals can be used.