ABSTRACT
The purposes of DART studies are to determine whether a test substance has the potential to cause adverse effects on the male and female reproductive system or the developing conceptus, and to determine a developmental and/or reproductive no-observable-effect-level (NOEL) or noobservable-adverse-effect-level (NOAEL) for the test substance. The developmental or reproductive NOEL is the highest treatment dosage tested that shows no developmental or reproductive effects, respectively, while the developmental or reproductive NOAEL is the highest treatment level tested that shows no adverse developmental or reproductive effects. It should be noted that DART study designs were not developed to cover every male and female reproductive parameter, developmental parameter, speci˜c target organ, or mechanism of toxicity. For example, traditional DART studies do not provide information on maternal or paternal endocrine status, the placental
transfer or milk transfer of an agent or its metabolites, placental pathology, or reproductive senescence.
