• Toxicological Research
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• v.28 no.1
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• pp.11-18
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• 2012

The aim of this study was to evaluate the single oral dose toxicity of Bupleuri Radix (BR) aqueous extracts, it has been traditionally used as anti-inflammatory agent, in male and female mice. BR extracts (yield = 16.52%) was administered to female and male ICR mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 14 principal organs were examined. As the results, no BR extracts treatment related mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations against 14 principal organs were detected up to 2,000 mg/kg in both female and male mice, except for soft feces and related body weight decrease detected in male mice treated with 2,000 mg/kg. Therefore, $LD_{50}$ (50% lethal dose) and approximate LD of BR aqueous extracts after single oral treatment in female and male mice were considered over 2000 mg/kg, respectively. Although it was also observed that the possibilities of digestive disorders, like soft feces when administered over 2,000 mg/kg of BR extracts in the present study, these possibilities of digestive disorders can be disregard in clinical use because they are transient in the highest dosages male only.

• Nutrition Research and Practice
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• v.11 no.6
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• pp.452-460
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• 2017

BACKGROUD/OBJECTIVES: Turanose, ${\alpha}$-D-glucosyl-($1{\rightarrow}3$)-${\alpha}$-D-fructose, is a sucrose isomer which naturally exists in honey. To evaluate toxicity of turanose, acute and subchronic oral toxicity studies were conducted with ICR mice. MATERIALS AND METHODS: For the acute oral toxicity study, turanose was administered as a single oral dose [10 g/kg body weight (b.w.)]. In the subchronic toxicity study, ICR mice were administered 0, 1.75, 3.5, and 7 g/kg b.w. doses of turanose daily for 13 weeks. RESULTS: No signs of acute toxicity, including abnormal behavior, adverse effect, or mortality, were observed over the 14-day study period. In addition, no changes in body weight or food consumption were observed and the median lethal dose (LD50) for oral intake of turanose was determined to be greater than 10 g/kg b.w. General clinical behavior, changes in body weight and food consumption, absolute and relative organ weights, and mortality were not affected in any of the treatment group for 13 weeks. These doses also did not affect the macroscopic pathology, histology, hematology, and blood biochemical analysis of the mice examined. CONCLUSION: No toxicity was observed in the acute and 13-week subchronic oral toxicology studies that were conducted with ICR mice. Furthermore, the no-observed-adverse-effect level is greater than 7 g/kg/day for both male and female ICR mice.

• Biomedical Science Letters
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• v.18 no.1
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• pp.10-15
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• 2012

A 12-week repeated-dose oral toxicity study of water-soluble Orostachys japonicus extract (WOJ) was performed in Sprague-Dawley (SD) rats of both genders. Each group of ten rats was orally administered in doses of either 0 or 250 mg/day over a 12-week period. As a result, no WOJ-related changes were observed in terms of survival rate, clinical signs, body weight, or food intake. In addition, no difference in organ weight between the control and treated groups was detected. Furthermore, serum biochemistry parameters revealed some changes within normal ranges although significant decreases in total-bilirubin in the females. In spite of some alterations in serum biochemistry, the clinical signs, body weight changes from food intake, and autoptical remarks indicated that WOJ was not toxic. This study suggests that repeated treatment of O. japonicus very low toxicity and the NOAEL (no observed adverse effect dose) of WOJ exceeds 250 mg/kg in the SD rats.

• Toxicological Research
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• v.15 no.1
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• pp.9-17
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• 1999

This study was performed to evaluate the subacute toxicity of CJ-50002 (Vibrio Vaccine) in SPF Spraqur-Dawley (SD) rats. Vibrio vaccine was administered orally at a dose level of high (167mg/kg/day), medium (16.7mg/kg/day), and low (16.7mg/kg/day) once a day and repeated fro 4 weeks. Ten males and female rats were assigned to each group. After 4 week administration, no significant dose-dependent changes in body weight, water and food consumption rate or organ weight were noted dependent changes in body weight, water and food consumption rate or organ weight were noted among 4 groups. Urinanalysis, hematology, and serum chemistry, also fail to detect any dose-related change among 4 groups tested. During necropsy and histopathological examination, no specific toxicity related to treated material was found. The result of this study demonstrated that vibrio vaccine when administered orally for 4 weeks at a high dose of 167mg/kg/day, no dose-related toxicity was found in treated make and female rats.

• Proceedings of the Plant Resources Society of Korea Conference
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• 2021.04a
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• pp.65-66
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• 2021

Glycyrrhiza species (Licorice) are one of the most commonly used medicinal plants in Asian countries such as China, India and Korea. It has been traditionally used to treat many disease including cough, cold, asthma, fatigue, gastritis and respiratory tract infections. Glycyrrhiza new variety, Wongam (WG), have been developed by Korea Rural Development Administration and revealed several pharmacological effects. However, limited data are available on the potential adverse effects of the WG. Here, we evaluated the general toxicity of the WG extract through single oral dose toxicity study in Sprague-Dawley rats. After single oral dose administration, there was no mortality up to 5000 mg/kg during experiment period. In addition, there was no clinical signs including body weight change, gross findings and necropsy findings up to 5000 mg/kg during experiment period. To conclude, the no-observed-adverse-effect level (NOAEL) of WG was higher than 5000 mg/kg and no target organs were identified in male and female Sprague-Dawley rats.

• Journal of Physiology & Pathology in Korean Medicine
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• v.23 no.5
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• pp.1145-1153
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• 2009

The object of this study was to obtain acute information single oral dose toxicity of Mahwangbujaseshin-tang extracts, with mouse bone marrow cell micronucleus test for detecting possible genotoxicity. In order to observe the 50% lethal dose, approximate lethal dosage, maximum tolerance dosage and target organs, test articles were once orally administered to ICR mice at dose levels of 2000, 1000, 50 mg/kg according to the recommendation of KFDA Guidelines. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines with organ weights of 12 types of principle organs. In addition, after twice oral treatment of Mahwangbujaseshin-tang extracts 2000, 1000 and 500 mg/kg, we checked the changes on the number of MNPCE. We could not find any mortality, clinical signs, changes in the body weight and gross findings upto 2000 mg/kg treated group. The limited dosages in rodents except for increases of lymphoid organ weights and hypertrophy encounted as results from pharmacological effects of Mahwangbujaseshin-tang extracts, immune modulator effects with some sporadic accidental findings not toxicological signs. No evidence of increases of MNPCE numbers were also detected in all three different dosages of Mahwangbujaseshin-tang extracts treated mice. The results obtained in this study suggest that the LD50 and ALD of Mahwangbujaseshin-tang extracts in mice were considered as over 2000 mg/kg because no mortalities were detected upto 2000 mg/kg that was the highest dose recommended by KFDA and OECD. And the results of mouse bone marrow micronucleus test of Mahwangbujaseshin-tang extracts is negative results.

• Journal of Physiology & Pathology in Korean Medicine
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• v.24 no.1
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• pp.124-133
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• 2010

The object of this study was to obtain acute information single oral dose toxicity of Mahwangbujaseshin-tang extracts, with mouse bone marrow cell micronucleus test for detecting possible genotoxicity. In order to observe the 50% lethal dose, approximate lethal dosage, maximum tolerance dosage and target organs, test articles were once orally administered to ICR mice at dose levels of 2000, 1000, 50 mg/kg according to the recommendation of KFDA Guidelines. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines with organ weights of 12 types of principle organs. In addition, after twice oral treatment of Mahwangbujaseshin-tang extracts 2000, 1000 and 500 mg/kg, we checked the changes on the number of MNPCE. We could not find any mortality, clinical signs, changes in the body weight and gross findings upto 2000 mg/kg treated group. The limited dosages in rodents except for increases of lymphoid organ weights and hypertrophy encounted as results from pharmacological effects of Mahwangbujaseshin-tang extracts, immune modulator effects with some sporadic accidental findings not toxicological signs. No evidence of increases of MNPCE numbers were also detected in all three different dosages of Mahwangbujaseshin-tang extracts treated mice. The results obtained in this study suggest that the LD50 and ALD of Mahwangbujaseshin-tang extracts in mice were considered as over 2000 mg/kg because no mortalities were detected upto 2000 mg/kg that was the highest dose recommended by KFDA and OECD. And the results of mouse bone marrow micronucleus test of Mahwangbujaseshin-tang extracts is negative results.

• The Journal of Korean Medicine
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• v.32 no.3
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• pp.18-24
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• 2011

Objective: Leejung-tang (Rechu-to in Japanese) is a traditional Korean herbal formula used for treatment of gastrointestinal disorders such as vomiting, stomach pain, chronic gastritis and gastrointestinal ulceration. The present study was carried out to investigate the potential acute toxicity of Leejung-tang water extract (LJT) by a single oral dose in Crl:CD (SD) rats in compliance with current guidelines. Methods: In the preliminary study, there were no adverse effects such as death, clinical signs, and body weight changes at dose levels of 500, 1000, and 2000 mg/kg/day body weight. Based on the results, a dose of 2000 mg/kg was selected as the toxicological limited dose. LJT was administered once by gavage to male and female rats at dose levels of 0 and 2000 mg/kg bodyweight. During the study period, mortalities, clinical findings, and body weight changes were observed for 14 days following the administration. On day 14 after the treatment, the animals were sacrificed by carbon dioxide overdose and complete gross postmortem examinations were performed. Results: In present study, no treatment-related deaths were observed. There were no adverse effects on clinical signs and body weight changes. In addition, there were no observed gross findings in all groups except for a kidney cyst in the 2000 mg/kg/day female group. Conclusion: The results indicated that LJT did not induce toxic effects at a dose level up to 2000 mg/kg in rats and its median lethal dose ($LD_{50}$) was considered to be over 2000 mg/kg/day body weight for both genders.

• Biomolecules & Therapeutics
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• v.13 no.2
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• pp.123-126
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• 2005

The single dose toxicity of 3-methoxy-6-allylthiopyridazine (K-6) was studied with Sprague-Dawley rats. K-6 was administered orally with dosages of 4.0, 3.0, 1.5, 1.0, 0.5, 0.25 and 0.1 g/kg to the rats. We observed daily the number of death, clinical signs, body weights and gross findings. All rats (6) were dead within a day after administration when doses of 4.0and 3.0 g/kg were administered. When dose of 2.0 g/kg was administered, 2 rats among 3 rats were dead. Any significant toxicity below 1.5g/kg of K6 was not observed when the different doses of 1.5, 1.0, 0.5, 0.25 and 0.1 g/kg were administered to 6 rats respectively.

• Toxicological Research
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• v.17 no.3
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• pp.195-201
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• 2001

The OECD acute toxicity guideline has been revised recently to protect animal welfare. The GLP authority of the Ministry of Environment, the National Institute for Environmental Research, recommended GLP laboratories in Korea to ufo the revised acute toxicity guideline. This study was carried out to optimize newly adopted OECD test guideline 420 (TG 420). Bisphenol A was selected for test chemical. Following TG420, Bisphenol A was classified as class 5/unclassified group. The revised TG 420 was very effective test in minimizing animal number and classifying chemicals. The method, however had short-coming in evaluation of test results statistically because the test had no control group, and the test should be stopped when animals were dead at the lowest dose or alive at the highest dose. TG 420 required at Least 20 animals to complete the test, but it could result in producing unused animals that need to sacrifice.