A 4-week Repeated Dose Oral Toxicity and Cytotoxicity Study of Gumiganghwaltang in Crl:CD (SD) Rats

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Authors

  • Mee-Young Lee
     ,KP
  • In-Sik Shin
     Depatment of Herbal Medicine EBM Research Center, Korea Institute of Oriental Medicine, Yuseong-gu, Daejeon 305 811 ,KP
  • Chang-Seob Seo
     Depatment of Herbal Medicine EBM Research Center, Korea Institute of Oriental Medicine, Yuseong-gu, Daejeon 305 811 ,KP
  • Jung-Hoon Kim
     Depatment of Herbal Medicine EBM Research Center, Korea Institute of Oriental Medicine, Yuseong-gu, Daejeon 305 811 ,KP
  • Heykyung Ha
     Depatment of Herbal Medicine EBM Research Center, Korea Institute of Oriental Medicine, Yuseong-gu, Daejeon 305 811 ,KP
  • Jung-Im Huh
     Division of Nonclinical Studies, Korea Institute of Toxicology, Yuseong-gu, Daejeon 305 343, Korea ,KP
  • Hyeun-Kyoo Shin
     Depatment of Herbal Medicine EBM Research Center, Korea Institute of Oriental Medicine, Yuseong-gu, Daejeon 305 811 ,KP

Keywords:

Gumiganghwaltang, oriental herbal prescription, toxicity
Chronobiology

Abstract

Gumiganghwaltang (GGT) is a traditional oriental herbal prescription commonly used to treat colds and inflammatory diseases in Korea. This study reports the first evaluation of the oral toxicity and cytotoxicity effects of repeat doses of GGT. GGT was orally administered daily at doses of 0, 500, 1000, and 2000 mg/kg for 4 weeks. Analysis of body weight gain, mortality, clinical observations, urinalysis, blood biochemistry, hematology, organ weight, and histopathological data revealed no significant differences between the V.CONTROL and GGT-treated groups. In addition, we investigated the cytotoxicity of GGT against LNCaP, RBL-1, and BEAS-2B cell lines, and splenocytes. Based on the results, we conclude that GGT orally administered to rats is safe with no drug-related toxicity, even at the highest dose, in 4-week repeated dose studies. Thus, this concentration is considered the non-observable effect dose in rats.

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Published

2018-05-18

How to Cite

Lee, M.-Y., Shin, I.-S., Seo, C.-S., Kim, J.-H., Ha, H., Huh, J.-I., & Shin, H.-K. (2018). A 4-week Repeated Dose Oral Toxicity and Cytotoxicity Study of Gumiganghwaltang in Crl:CD (SD) Rats. Toxicology International, 18(2), 146–154. Retrieved from https://informaticsjournals.com/index.php/toxi/article/view/21263

Issue

Volume 18, Issue 2, July-December 2011

Section

Articles

 

References

Watanabe S, Imanishi J, Satoh M, Ozasa K. Unique place of Kampo (Japanese traditional medicine) in complementary and alternative medicine: a survey of doctors belonging to the regional medical association in Japan. Tohoku J Exp Med 2001;194:55-63.

Castro LS, Perazzo FF, Maistro EL. Genotoxicity testing of Ambelania occidentalis (Apocynaceae) leaf extract in vivo. Genet Mol Res 2009;8:440-7.

Rousseaux CG, Schachter H. Regulatory issues concerning the safety, efficacy and quality of herbal remedies. Birth Defects Res B Dev Reprod Toxicol 2003;68:505-10.

Firenzuoli F, Gori L. Herbal medicine today: clinical and research issues. Evid Based Complement Alternat Med 2007;4:37-40.

Tang JL, Liu BY, Ma KW. Traditional Chinese medicine. Lancet 2008;372:1938-40.

Lee JT. Research on intake of Chinese medicine by Korea. Korean: Korea Food and Drug Administration; 2007.

Kim SJ, Jeong HJ, Moon PD, Lee KM, Lee HB, Jung HJ, et al. Anti-inflammatory activity of Gumiganghwaltang through the inhibition of nuclear factor-kappa B activation in peritoneal macrophages. Biol Pharm Bull 2005;28:233-7

Stewart MJ, Moar JJ, Steenkamp P, Kokot M. Findings in fatal cases of poisoning attributed to traditional remedies in South Africa. Forensic Sci Int 1999;101:177-83.

Ernst E. Toxic heavy metals and undeclared drugs in Asian herbal medicines. Trends Pharmacol Sci 2002;23:136-9.

Veiga-Junior VF, Pinto AC, Maciel MA. Medicinal plants: safe cure? Quim Nova 2005;28:519-28.

Matsuo R, Yamauch Y, Kobashi M, Funahashi M, Adachi A. Role of parabrachial nucleus in submandibular salivary secretion induced by bitter taste stimulation in rats. Auton Neurosci 2001;88:61-73.

Kim JC, Kang BH, Shin CC, Kim YB, Lee HS, Kim CY, et al. Subchronic toxicity of plant sterol esters administered by gavage to Sprague–Dawley rat. Food Chem Toxicol 2002;40:1569-80.

Burns RA, Wibert GJ, Diersen-Schade DA, Kelly CM. Evaluation of single cell sources of docosahexaenoic acid and arachidoinc acid: 3 month rat oral safety study with an in utero phase. Food Chem Toxicol 1999;37:23-36.

Peters JM, Boyd EM. Organ weights and water levels of the rat following reduced food intake. J Nutr 1966;90:354-60.

Pfeiffer CJ. A mathematical evaluation of the thymic weight parameter. Toxicol Appl Pharmacol 1968;13:220-7.

Lina BA, Wolterbeek AP, Suwa Y, Fujikawa S, Ishikura Y, Tsuda S, et al. Sub chronic (13 week) oral toxicity study preceded by an in utero exposure phase with arachidonate enriched triglyceride oil (SUNTGA40S) in rats. Food Chem Toxicol 2006;44:326-35.

Burn CC, Peters A, Day MJ, Mason GJ. Long-term effects of cage-cleaning frequency and bedding type on laboratory rat health, welfare, and handleability: a cross-laboratory study. Lab Anim 2006;40:353-70.