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Nam C, Hwang JS, Kim MJ, et al. Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs. Toxicol Res. 2015;31(1):77-88doi: 10.5487/TR.2015.31.1.077.
Nam, C., Hwang, J. S., Kim, M. J., Choi, Y. W., Han, K. G., & Kang, J. K. (2015). Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs. Toxicological research, 31(1), 77-88. https://doi.org/10.5487/TR.2015.31.1.077
Nam, Chunja, et al. "Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs." Toxicological research vol. 31,1 (2015): 77-88. doi: https://doi.org/10.5487/TR.2015.31.1.077
Nam C, Hwang JS, Kim MJ, Choi YW, Han KG, Kang JK. Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs. Toxicol Res. 2015 Mar;31(1):77-88. doi: 10.5487/TR.2015.31.1.077. PMID: 25874036; PMCID: PMC4395658.
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Toxicol Res. 2015 Mar;31(1):77-88. doi: 10.5487/TR.2015.31.1.077.

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

Toxicological research

Chunja Nam, Jae-Sik Hwang, Myoung-Jun Kim, Young Whan Choi, Kyoung-Goo Han, Jong-Koo Kang

Affiliations

  1. Biotoxtech Co., Ltd., Cheongju, Korea.
  2. Department of Horticultural Bioscience, Pusan National University, Miryang, Korea.
  3. Biotoxtech Co., Ltd., Cheongju, Korea ; Department of Laboratory Animal Medicine, College of Veterinary Medicine, Chungbuk National University, Cheongju, Korea.

PMID: 25874036 PMCID: PMC4395658 DOI: 10.5487/TR.2015.31.1.077

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.

Keywords: Beagle dogs; Lithospermum erythrorhizon extract; Sub-acute toxicity

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