This report is prepared according to the Guidelines for CERHR Panel Members established by NTP/NIEHS. The guidelines are available on the CERHR web site (http://cerhr.niehs.nih.gov/). The format for Expert Panel Reports includes synopses of studies reviewed, followed by an evaluation of the Strengths/Weaknesses and Utility (Adequacy) of the study for CERHR evaluation. Statements and conclusions made under Strengths/Weaknesses and Utility evaluations are those of the Expert Panel and are prepared according to the NTP/NIEHS guidelines. In addition, the Panel often makes comments or notes limitations in the synopses of the study. Bold, square brackets are used to enclose such statements. As discussed in the guidelines, square brackets are used to enclose key items of information not provided in a publication, limitations noted in the study, conclusions that dif fer from those of the authors, and conversions or analyses of data conducted by the Panel.
NIH Public Access
PREFACEThe National Toxicology Program (NTP) and the National Institute of Environmental Health Sciences (NIEHS) established the NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) in June 1998. The purpose of the Center is to provide timely, unbiased, scientifically sound evaluations of human and experimental evidence for adverse effects on reproduction and development caused by agents to which humans may be exposed.Genistein was selected for expert panel evaluation because of public concern for the possible health effects of human exposures. Genistein is a phytoestrogen found in some legumes, especially soybeans. Phytoestrogens are non-steroidal, estrogenic compounds that occur naturally in many plants. In plants, nearly all genistein is bound to a sugar molecule and this genistein-sugar complex is called genistin. Genistein and genistin are found in many food products, especially soy-based foods such as tofu, soy milk, and soy infant formula, and in some over-the-counter dietary supplements.To obtain information about genistein for the CERHR evaluation, the PubMed (Medline) and Toxline databases were searched through February 2006 with genistein and its CAS RN (446-72-0), soy, soya, and relevant keywords. References were also identified from databases such as REPROTOX ® , HSDB, IRIS, and DART and from the bibliographies of reports being reviewed.This evaluation results from the effort of a 14-member panel of government and nongovernment scientists that culminated in a public expert panel meeting held March [15][16][17] 2006. This report is a product of the expert panel and is intended to (1) interpret the strength of scientific evidence that genistein is a reproductive or developmental toxicant based on data from in vitro, animal, or human studies, (2) assess the extent of human exposures to include the general public, occupational groups, and other sub-populations, (3) provide objective and scientifically thorough assessments of the scientific evidence that adverse reproductive/ developmental health effects may be associated wi...