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KMID : 0379520020180010031
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한국독성학회지
2002 Volume.18 No. 1 p.31 ~ p.41
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A 4-week Repeated Oral Dose Toxicity Study of Plant Sterol Esters in Sprague-Dawley Rats
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Kim Jong-Choon
Yang Byung-Chul
Lim Kwang-Hyeon
Kang Boo-Hyon
Kim Choong-Yong
Kim Kab-Sik
Chung Dae-Won
Chung Moon-Koo
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Abstract
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The present study was conducted to investigate the potential subacute toxicity of plant sterol esters by a 4-week repeated oral dose in Sprague-Dawley rats. The test article was administered once daily by gavage to rats at dose levels of 0, 1000, 3000, and 9000 mg/kg/day for 4 weeks. During the test period, clinical sign, mortality, body weights, food and water consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, gross finding, organ weight, and histopathology were evaluated. A reduction in the body weight was observed in females of the 9000 mg/kg group on day 27 after the initiation of treatment, but not in males of the group. There were no treatment-related effects on mortality, clinical sign, food and water consumption, ophthalmoscopy, urinarlysis, hematology, serum biochemistry, necropsy findings, organ weights, and histopathology in any treatment group. Based on these results, it was concluded that the 4-week repeated oral dose of plant sterol esters resulted in suppressed body weight in female rats at a dose level of 9000 mg/kg/day. In the condition of this study, target organ was not observed and the no-observed-adverse-effect level (NOAEL) was considered to be 9000 mg/kg/day for males and 5000 mg/kg/day for females.
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KEYWORD
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Plant sterol esters, Subacute toxicity study, NOAEL, Rats
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