Final Report on the Developmental Toxicity of Melatonin (CAS No. 73-31-4)Administered by Gavage to Sprague-Dawley CD (Trade Name) Rats on Gestational Days 6 through 19

摘要

Melatonin (MEL), widely used as a nonprescription sleep aid, is also underinvestigation for contraceptive, antioxidant, anticancer, and antiaging effects. This study was performed due to the widespread use of MEL by the general population and the lack of pertinent developmental toxicity data. Dose selection was based on a screening study in which CD rats were treated by gavage with 0, 1, 10, 100, 150, or 200 mg MEL/kg body weight/day on gestational days (gd) 6 through 19 (NTP, 1997). In the screening study, prenatal growth, viability, and external morphological development were not affected. Mild material toxicity was noted at > or = mg/kg/day (NTP, 1997).