NTP Technical Report on the Reproductive Dose Range-Finding Toxicity Study of Genistein (CAS no. 446-72-0), Administered in Feed to Sprague-Dawley Rats

摘要

Genistein is a naturally occurring isoflavone that interacts with estrogen receptors and multiple other molecular targets. Human exposure to genistein is predominantly through consumption of soy products, including soy-based infant formula and dietary supplements. A series of short-term studies with genistein was conducted with two goals: (1) to obtain data necessary to establish dose levels for subsequent multigeneration reproductive and chronic toxicity studies and (2) to evaluate the effects of genistein on endpoints outside the reproductive tract. The data generated from these studies have been reported previously in the peer-reviewed literature or in technical reports. In addition, selected data from these studies were analyzed and discussed in the National Toxicology Programs Report of the Endocrine Disruptors Low-Dose Peer Review (NTP, 2001). The present report focuses on the reproductive and general toxicology endpoints evaluated. Data obtained in separate evaluations of behavioral, neuroanatomical, neurochemical, and immunological endpoints, as well as the assessment of serum genistein levels, are also discussed to put in better perspective the selection of doses for the multigenerational and chronic studies.