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

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-findi...

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Autores principales: Nam, Chunja, Hwang, Jae-Sik, Kim, Myoung-Jun, Choi, Young Whan, Han, Kyoung-Goo, Kang, Jong-Koo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Korean Society Of Toxicology 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4395658/
https://www.ncbi.nlm.nih.gov/pubmed/25874036
http://dx.doi.org/10.5487/TR.2015.31.1.077
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author Nam, Chunja
Hwang, Jae-Sik
Kim, Myoung-Jun
Choi, Young Whan
Han, Kyoung-Goo
Kang, Jong-Koo
author_facet Nam, Chunja
Hwang, Jae-Sik
Kim, Myoung-Jun
Choi, Young Whan
Han, Kyoung-Goo
Kang, Jong-Koo
author_sort Nam, Chunja
collection PubMed
description 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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spelling pubmed-43956582015-04-13 Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs Nam, Chunja Hwang, Jae-Sik Kim, Myoung-Jun Choi, Young Whan Han, Kyoung-Goo Kang, Jong-Koo Toxicol Res Original Article 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. The Korean Society Of Toxicology 2015-03 /pmc/articles/PMC4395658/ /pubmed/25874036 http://dx.doi.org/10.5487/TR.2015.31.1.077 Text en Copyright © 2015, The Korean Society Of Toxicology http://creativecommons.org/licenses/by-nc/3.0/ This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Nam, Chunja
Hwang, Jae-Sik
Kim, Myoung-Jun
Choi, Young Whan
Han, Kyoung-Goo
Kang, Jong-Koo
Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs
title Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs
title_full Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs
title_fullStr Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs
title_full_unstemmed Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs
title_short Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs
title_sort single- and repeat-dose oral toxicity studies of lithospermum erythrorhizon extract in dogs
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4395658/
https://www.ncbi.nlm.nih.gov/pubmed/25874036
http://dx.doi.org/10.5487/TR.2015.31.1.077
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