13 WEEK ORAL TOXICITY OF BLACK TEA POLYPHENOLS

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Subchronic, 90-day, repeat-dose, oral studies of a characterized, complex mixture of polyphenols will be evaluated in rats and dogs. Endpoints will include food and water consumption, body weight, clinical observation, cardiac and ophthalmic assessment, clinical chemistry and hematology, plasma test agent levels, urinalysis, and anatomic and histologic pathology. Organ toxicities and dosages associated with a maximum tolerated dose and a no adverse effect level will be identified.