Division 5.6.2 Developmental toxicity studies

The developmental toxicity studies reported, taken together with other relevant data and information on the active substance, shall be sufficient to permit the assessment of effects on embryonic and foetal development, following repeated exposure to the active substance, and in particular shall be sufficient:

1. (a)

   to identify direct and indirect effects on embryonic and foetal development resulting from exposure to the active substance;

2. (b)

   to identify any maternal toxicity;

3. (c)

   to establish the relationship between observed responses and dose in both dam and offspring;

4. (d)

   to establish NOAELs for maternal toxicity and pup development;

5. (e)

   to provide additional information on adverse effects in pregnant as compared with non-pregnant females;

6. (f)

   to provide additional information on any enhancement of general toxic effects of pregnant animals.