Considerations for the development of guidance on dose level selection for developmental and reproductive toxicity studies

In a Nutshell

The evaluation of ECHA's suggestion to increase dosage levels in reproductive (DART) studies reveals a  divergence from OECD guidelines and expert opinions within the field. Contrary to the recommended high dose criteria, experts caution against excessive levels, warning of potential secondary effects that could obscure relevant reproductive outcomes. Central to this debate is the need for dose selection to meticulously weigh the intricacies of the maternal-placental-fetal model, ensuring that studies effectively capture pertinent reproductive effects without introducing potentially confounding variables and unnecessary animal suffering.