Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs

• Published in: Toxicological research (Seoul) Vol. 31; no. 1; pp. 77 - 88
• Main Authors: Nam, Chunja, Hwang, Jae-Sik, Kim, Myoung-Jun, Choi, Young Whan, Han, Kyoung-Goo, Kang, Jong-Koo
• Format: Journal Article
• Language: English
• Published: Singapore 한국독성학회 01.03.2015; Springer Singapore; The Korean Society Of Toxicology
• Subjects: Biomedicine; Original; Original Article; Pharmacology/Toxicology; 예방의학; Lithospermum erythrorhizon extract; Sub-acute toxicity; Beagle dogs; extract
• ISSN: 1976-8257; 2234-2753; 2234-2753
• DOI: 10.5487/TR.2015.31.1.077

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.