Thirteen-week Repeated Oral Dose Toxicity Study of EstroG-200 in Sprague-Dawley Rats
2009
Moon, J.H., Chungbuk National University, Cheongju, Republic of Korea | Lee, N.J., Chungbuk National University, Cheongju, Republic of Korea | Kwak, B.Y., Naturalendo Tech Co., Ltd., Seoul, Republic of Korea | Yi, K.T., Naturalendo Tech Co., Ltd., Seoul, Republic of Korea | Lee, J.K., Naturalendo Tech Co., Ltd., Seoul, Republic of Korea | Kim, J.S., Naturalendo Tech Co., Ltd., Seoul, Republic of Korea | Kim, E.J., National Institute of Food and Drug Safety Evaluation, Seoul, Republic of Korea | Kang, J.K., Chungbuk National University, Cheongju, Republic of Korea
Menopause is a natural phenomenon as women age and estrogen levels decline. Estrogen deficiency is the primary cause of menopause. Hormone replacement therapy with estrogen is a popular preventive therapy for prevention and treatment of menopause syndrome. Consequently, EstroG-200 was developed for a hormone replacement therapy. EstroG-200 is a mixture-extract of 3 herbs composed of dried radix of Angelica gigas, Cynanchum wilfordii and Phlomis umbrosa. This study was performed to evaluate the potential subchronic toxicity of EstroG-200 in Sprague-Dawley rats. EstroG-200 was administered once daily by oral gavage to male and female rats at dose levels of 0, 250, 500, and 1,000 mg/kg/day. All rats were sacrificed after 13 weeks of dosing. No adverse treatment related effects were evident in any parameters evaluated; clinical signs, mortality, body weights, food consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, necropsy findings, organ weights, and histopathological evaluations at any dose level. There were no indications of any adverse effects in any tissues, organs or organ systems. The no-observed-effect level (NOEL) was considered to be greater-than or equal to 1,000 mg/kg/day for both sexes under the conditions of this study.
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