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KMID : 1141020200200020033
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Journal of Applied Oriental Medicine
2020 Volume.20 No. 2 p.33 ~ p.48
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Single Oral Dose Toxicity Study of Aqueous Extracts of Arisaematis Rhizoma in ICR Mice
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Seong Hui-Jeong
Lee Sang-Nam
Park Ji-Ha
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Abstract
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Objective : The objective of this study was to obtain the primary safety information about AR extracts, lyophilized water extract of Arisaema amurense Maxim. var. serratum Nakai and further clarifies their safety for clinical use.
Methods : In order to observe the 50% lethal dose (LD50), approximate lethal dosage (ALD), maximum tolerance dosage (MTD) and target organs, test articles were once orally administered to female and male ICR mice at dose levels of 2,000, 1,000, 500 and 0 (control) ㎎/㎏ (body weight) according to the recommendation of KFDA Guidelines [2005-60, 2005]. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines [2005-60, 2005] with organ weights and histopathology of 12 types of principle organs.
Results : The LD50 and ALD of AR extracts in both female and male mice were considered as over 2,000 ㎎/㎏ because no mortalities were detected upto 2,000 ㎎/㎏ that was the highest dose recommended by KFDA and OECD Guidelines. Because increases of frequencies of hepatocyte acute cellular swelling and related pale yellow discolorization with increases of liver weights were detected from 1,000 ㎎/㎏ of AR extracts-treated male and from 2,000 ㎎/㎏ in female mice, and the liver is considered as a primary target organ of AR extracts in this study.
Conclusion : The results obtained in this study suggest that the overdose ( ~ 1,000 ㎎/㎏ in male and ~ 2,000 ㎎/㎏ in female) of AR extract has slight reversible hepatotoxicity (acute cellular swelling) in mice and is therefore carefully to be used for clinical use.
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KEYWORD
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Arisaematis Rhizoma, Aqueous Extracts, Single oral dose toxicity
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