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KMID : 0379520150310010077
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한국독성학회지
2015 Volume.31 No. 1 p.77 ~ p.88
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Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs
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Nam Chun-Ja
Hwang Jae-Sik
Kim Myoung-Jun
Choi Young-Whan
Han Kyoung-Goo
Kang Jong-Koo
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Abstract
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Lithospermum erythrorhizon has long been used in traditional Asian medicine for the treatment of diseases, including skin cancer. The oral toxicity of a hexane extract of Lithospermum erythrorhizon root (LEH) was investigated in Beagle dogs by using single escalating doses, two-week dose range-finding, and 4-week oral repeat dosing. In the single dose-escalating oral toxicity study, no animal died, showed adverse clinical signs, or changes in body weight gain at LEH doses of up to 2,000 mg/kg. In a 2 week dose range-finding study, no treatment-related adverse effects were detected by urinalysis, hematology, blood biochemistry, organ weights, or gross and histopathological examinations at doses of up to 500 mg LEH/kg/day. In the 4 week repeat-dose toxicity study, a weight loss or decreased weight gain was observed at 300 mg/kg/day. Although levels of serum triglyceride and total bilirubin were increased in a dose dependent manner, there were no related morphological changes. Based on these findings, the sub-acute no observable adverse effect level for 4-week oral administration of LEH in Beagles was 100 mg/kg/day.
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KEYWORD
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Lithospermum erythrorhizon extract, Sub-acute toxicity, Beagle dogs
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