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p53 Transgenic Mouse Evaluations of Genistein: 28-day and 36-week Studies

Investigators
Morris, Suzanne
Institutions
DHHS/FDA - National Center for Toxicological Research
Objective
Specific goals for the project are:
  1. To determine the toxicity of genistein in the C57Bl6/J strain and to select doses for the 36-week studies.
  2. To identify the potential carcinogenicity of genistein in the p53 transgenic mouse model.
  3. To determine if the potential carcinogenicity of genistein relates to changes in the rates of cell death and cell proliferation.
  4. To determine if exposure to genistein results in an increase in the mutant frequency in a reporter gene, (Hprt), in the splenic lymphocytes of the p53 mouse.
More information
The phytoestrogen genistein is a primary component of a high soy diet. There is currently widespread interest in the impact of a high soy diet on human health. While there is some indication that phytoestrogens may improve health in peri- and postmenopausal women, there is concern that these compounds may have the potential to be carcinogens. The study is being conducted to investigate this possibility. (Hprt), in the splenic lymphocytes of the p53 mouse.

FY 2000 Accomplishments:

  1. Protocol approved in FY 2000.
  2. Chemical ordered and analyzed by the Division of Chemistry, NCTR.
  3. Start-up meeting held to initiate study.
FY 2001 Plans:
  1. Conduct the 14-day dose-range-finding study.
  2. Initiate 9-month chronic study.
Funding Source
Nat'l. Center For Toxicological Research
Project number
E0213601
Categories
Sanitation and Quality Standards