title: Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs.
abstract: 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.
authors: Biotoxtech Co., Ltd., Cheongju, Korea.
authors: Chunja
authors: C
authors: Nam
authors: Biotoxtech Co., Ltd., Cheongju, Korea.
authors: Jae-Sik
authors: JS
authors: Hwang
authors: Biotoxtech Co., Ltd., Cheongju, Korea.
authors: Myoung-Jun
authors: MJ
authors: Kim
authors: Department of Horticultural Bioscience, Pusan National University, Miryang, Korea.
authors: Young Whan
authors: YW
authors: Choi
authors: Biotoxtech Co., Ltd., Cheongju, Korea.
authors: Kyoung-Goo
authors: KG
authors: Han
authors: Biotoxtech Co., Ltd., Cheongju, Korea ; Department of Laboratory Animal Medicine, College of Veterinary Medicine, Chungbuk National University, Cheongju, Korea.
authors: Jong-Koo
authors: JK
authors: Kang
keywords: Beagle dogs; Lithospermum erythrorhizon extract; Sub-acute toxicity