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KMID : 0861020170320040033
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Korea Journal of Herbology
2017 Volume.32 No. 4 p.33 ~ p.38
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Acute toxicity test and safety classification for Termitomyces albuminosus containing pharmacologically similar ingredient of Aconitum koreanum
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An Min-Ji
Park Yeong-Chul
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Abstract
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Objectives : Termitomyces albuminosus (Berk.) Heim is one of the famous wild edible mushrooms in the southern part of China. It is known that Termitomyces albuminosus, like Aconitum koreanum used in Korean traditional medicine, contains a kind of cerebroside, termitomycesphin, causing a pharmacologic effect on the neuron system. The pharmacologic effect of Termitomyces albuminosus can be used to possibly replace Aconitum koreanum. However, It needs to be certified as safe before it can be used. Here, a single-oral toxicity test and safety classification was conducted to obtain acute information of the toxicity of dried-Termitomyces albuminosus powder and to secure its safety in clinical applications.
Methods : In order to calculate approximate lethal dose(ALD), test substance was orally administered to male and female SD-rat at dose levels of 5,000 and 0 (vehicle control) ㎎/㎏ (body weight). Based on the result of this toxicity, also the estimation of safety classification was calculated using the HED-based (human equivalent dose) MOS (margin of safety).
Results : There were no mortalities, test substances treatment-related clinical signs, no changes in the body or organ weights, and no gross or histopathological findings at 14 days after treatment with test substance. Thus, the approximate lethal dose of dried-Termitomyces albuminosus powder was considered over 5,000 ㎎/㎏ in both female and male mice.
Conclusions : Based on the limit dose, 5000 ㎎/㎏, it was estimated that dried-Termitomyces albuminosus powder is classified as “Specified class B” indicating that clinical dose is not limited to patients as safe as food.
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KEYWORD
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Termitomyces albuminosus, approximate lethal dose, Safety classification, Single oral toxicity test. margin of safety
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