Evaluation of safety of the herbal formula Ojeok-san: acute and sub-chronic toxicity studies in rats.
OBJECTIVE
Ojeok-san (OJS; wuji powder in China and goshaku-san in Japan), a widely used herbal formula in traditional Korean medicine and Japanese herbal medicine (Kampo medicine), has been used to treat common cold and illnesses including fatigue and gastrointestinal disorders, but there is very little information on its safety. To provide information on the safety of OJS, we evaluated its acute and sub-chronic toxicity in rats.


METHODS
The single and sub-chronic toxicity of OJS was examined using male and female Sprague-Dawley rats. The rats were treated with the OJS extract orally at the highest dose level of 2000 mg/kg/day body weight. After single administration, signs of toxicity were observed every hour for the first 6h and every day for two weeks. In the sub-chronic toxicity study, OJS was administered for 13 weeks. Mortality, clinical signs, body weight changes, food and water consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights and histological markers were monitored during the study period.


RESULTS
We found no mortality and no abnormality in clinical signs, body weight, and necropsy findings for any of the animals in the acute and sub-chronic toxicity study following oral administration of OJS.


CONCLUSIONS
OJS may not have any single dose toxicity. The lethal dose with a 50% mortality rate (LD(50)) was over 2000 mg/kg. The no-observed adverse effects level (NOAEL) was considered to be 2000 and 1000 mg/kg/day for male and female rats, respectively.
Ha
Hyekyung
H
Herbal Medicine EBM Research Center, Korea Institute of Oriental Medicine, Yuseong-gu, Daejeon, Republic of Korea.
Lee
Jun Kyoung
JK
Lee
Ho Young
HY
Seo
Chang-seob
CS
Kim
Jung-Hoon
JH
Lee
Mee-young
MY
Koh
Woo Suk
WS
Shin
Hyeun Kyoo
HK
D000818:Animals; D004365:Drugs, Chinese Herbal / Q000633:toxicity*; D005260:Female; D007928:Lethal Dose 50; D019684:Magnoliopsida / Q000633:toxicity*; D008297:Male; D020835:Medicine, Kampo; D055441:Poria; D051381:Rats; D017207:Rats, Sprague-Dawley
D004365:Drugs, Chinese Herbal