Mouse Single Oral Dose Toxicity Test of Bupleuri Radix Aqueous Extracts.
- Author:
Kyung Hu KIM
1
;
Cheol Ou GAM
;
Seong Hun CHOI
;
Sae Kwang KU
Author Information
1. College of Oriental Medicine, Daegu Haany University, Gyeongsan 712-715, Korea. gucci200@hanmail.net
- Publication Type:Original Article
- Keywords:
Bupleuri Radix;
Single oral dose toxicity;
Mouse;
Histopathology
- MeSH:
Animals;
Body Weight;
Feces;
Female;
Humans;
Korea;
Lethal Dose 50;
Male;
Mice;
Mice, Inbred ICR;
Organ Size;
Toxicity Tests;
United States Food and Drug Administration
- From:Toxicological Research
2012;28(1):11-18
- CountryRepublic of Korea
- Language:English
-
Abstract:
The aim of this study was to evaluate the single oral dose toxicity of Bupleuri Radix (BR) aqueous extracts, it has been traditionally used as anti-inflammatory agent, in male and female mice. BR extracts (yield = 16.52%) was administered to female and male ICR mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 14 principal organs were examined. As the results, no BR extracts treatment related mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations against 14 principal organs were detected up to 2,000 mg/kg in both female and male mice, except for soft feces and related body weight decrease detected in male mice treated with 2,000 mg/kg. Therefore, LD50 (50% lethal dose) and approximate LD of BR aqueous extracts after single oral treatment in female and male mice were considered over 2000 mg/kg, respectively. Although it was also observed that the possibilities of digestive disorders, like soft feces when administered over 2,000 mg/kg of BR extracts in the present study, these possibilities of digestive disorders can be disregard in clinical use because they are transient in the highest dosages male only.