• 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.

• Environmental Analysis Health and Toxicology
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• v.21 no.4 s.55
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• pp.331-335
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• 2006

The single dose toxicity of Buxus microphylla var koreana Nakai was evaluated in ICR mice. Twenty five mice of each sex were randomly assigned to five groups of 5 mice each and were administered singly by gavage at dose of 0, 222, 667, 2,000 and 5,000 mg/kg body weight. After single administration, signs of toxicity were observed every hour for the first 6 hours and every day for 14 days. At the end of 14-day observation period, all animals were sacrificed for gross postmortem examinations. Neither significant toxic signs nor death was observed during the observation period. In addition, no pathological changes were noticed in macroscopic examination at necropsy. These results indicate that the single oral administration of Buxus microphylla var. Koreana Nakai did not cause any toxic effect at the dose of 5,000 mg/kg body weight for both sexes and $LD_{50}$ of Buxus microphylla var. koreana Nakai is greater than 5,000 mg/kg body weight.

• 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.

• The Journal of Internal Korean Medicine
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• v.33 no.1
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• pp.62-68
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• 2012

Objectives : This study aimed to evaluate the single oral dose toxicity of Seonpyejeongcheon-tang (SJT) in male and female Sprague-Dawley rats. Methods : In this single oral toxicity study, rats were orally administrated in a single dose of 0 or 5,000 mg/kg SJT. There were 7 rats in each group. After single administration, mortality, clinical signs, body weight changes and gross pathological findings were observed for 14 days. Organ weight, clinical chemistry and hematology were tested after 14 days. Results : There was no mortality or other clinical signs for 14 days. There were also no significant differences in body weight, organ weights, hematological and serum chemical parameters between the SJT and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of SJT is over 5,000 mg/kg, so this finding can be expected to provide scientific evidence for the safety of SJT.

• The Korea Journal of Herbology
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• v.32 no.4
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• pp.33-38
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• 2017

Objectives : Termitomyces albuminosus (Berk.) Heim is one of the famous wild edible mushrooms in the southern part of China. It is known that Termitomyces albuminosus, like Aconitum koreanum used in Korean traditional medicine, contains a kind of cerebroside, termitomycesphin, causing a pharmacologic effect on the neuron system. The pharmacologic effect of Termitomyces albuminosus can be used to possibly replace Aconitum koreanum. However, It needs to be certified as safe before it can be used. Here, a single-oral toxicity test and safety classification was conducted to obtain acute information of the toxicity of dried-Termitomyces albuminosus powder and to secure its safety in clinical applications. Methods : In order to calculate approximate lethal dose(ALD), test substance was orally administered to male and female SD-rat at dose levels of 5,000 and 0 (vehicle control) mg/kg (body weight). Based on the result of this toxicity, also the estimation of safety classification was calculated using the HED-based (human equivalent dose) MOS (margin of safety). Results : There were no mortalities, test substances treatment-related clinical signs, no changes in the body or organ weights, and no gross or histopathological findings at 14 days after treatment with test substance. Thus, the approximate lethal dose of dried-Termitomyces albuminosus powder was considered over 5,000 mg/kg in both female and male mice. Conclusions : Based on the limit dose, 5000 mg/kg, it was estimated that dried-Termitomyces albuminosus powder is classified as "Specified class B" indicating that clinical dose is not limited to patients as safe as food.

• Toxicological Research
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• v.31 no.1
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• pp.61-68
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• 2015

The objective of this study was to obtain single oral dose toxicity information for concentrated and lyophilized powder of blue honeysuckle (Lonicera caerulea L., Caprifoliaceae; BHcL) in female and male ICR mice to aid in the process of developing natural origin medicinal ingredients or foods following proximate analysis and phytochemical profile measurement. The proximate analysis revealed that BHcL had an energy value of 3.80 kcal/g and contained 0.93 g/g of carbohydrate, 0.41 g/g of sugar, 0.02 g/g of protein, and 0.20 mg/g of sodium. BHcL did not contain lipids, including saturated lipids, trans fats, or cholesterols. Further, BHcL contained 4.54% of betaine, 210.63 mg/g of total phenols, 159.30 mg/g of total flavonoids, and 133.57 mg/g of total anthocyanins. Following administration of a single oral BHcL treatment, there were no treatment-related mortalities, changes in body weight (bw) or organ weight, clinical signs, necropsy or histopathological findings up to 2,000 mg/kg bw, the limited dosage for rodents of both sexes. We concluded that BHcL is a practically non-toxic material in toxicity potency.

• The Journal of Internal Korean Medicine
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• v.37 no.3
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• pp.427-441
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• 2016

Objectives: This study investigated the aconitine contents analysis of Buja extracts (raw material of Buja, hot water extract of Buja, and hot water extract of Sambu-tang) and the single oral dose toxicity of Sambu-tang-R in six-week-old Sprague-Dawley rats in order to compare the toxicity of Buja extracts.Methods: Aconitine content analysis is that Buja extracts were hold purity test. To detect single oral dose toxicity, six-week-old Sprague-Dawley rats were divided into two groups, a normal control group and a sambutang-R (2,000 mg/kg) group. For 14 days of treatment, clinical signs, body weight, clinical chemistry, necropsy, and histopathology were examined.Results: The aconitine contents of the Buja extracts were Buja-RH (0.1738%), Buja-RD (0.1746%), and Sambu-tang-R (0.0961%). There were no cases of death in either the control group or the experimental group. Nor was there any disorder to the clinical signs or any significant change in body weight in either group. There was no significant change of clinical chemistry or disorder of necropsy findings in either the control or the experimental group. And there was no difference in histopathological findings in comparing the control group with the experimental group.Conclusions: These results suggest that the aconitine content of the hot water extract of Buja was similar to the raw material of Buja, but the hot water extract of Sambu-tang had greatly decreased aconitine content. These results also suggest that a single oral lethal dose of Sambu-tang-R for Sprague-Dawley rats exceeds 2,000 mg/kg for both female and male rats.

• Journal of Physiology & Pathology in Korean Medicine
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• v.25 no.1
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• pp.100-108
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• 2011

The object of this study was two. One was if Polygonati Rhizoma preparata had a benzo(a)pyrene, the other was to evaluate the single dose toxicity of 9 repetitive steaming and fermenting processed Polygonati Rhizoma, dried root parts of Polygonati Rhozoma preparata extract, in male and female mice. We measured a content of benzo(a)pyrene in Polygonati Rhozoma preparata using a method with HPLC/FLD. And for single dose toxicity, aqueous extracts of Polygonati Rhozoma preparata (EPP; Yield = 35.4 %) 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 12 principle organs were examined. As results, we could not find any mortality, clinical signs, and changes in the body and organ weight except for slight soft feces sporadically detected in EPP treated male mice at 1 day after administration. In addition, no EPP-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. The results obtained in this study suggest that benzo(a)pyrene was not existed in Polygonati Rhozoma preparata and the 50% lethal dose and approximate lethal dose of EPP aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines. However, it also observed that the possibilities of digestive disorders, like soft feces when administered over 500 mg/kg of EPP aqueous extracts in the present study.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.21 no.1
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• pp.33-39
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• 2011

The present study was carried out to investigate the potential acute toxicity of methylcyclohexane (MCH) by a single oral dose in female rats. The test chemical was administered once by gavage to female rats at dose levels 0, 1,250, 2,500, and 5,000 mg/kg. Mortalities, clinical findings, and body weight changes were monitored for the 14-day period following the administration. At the end of 14-day observation period, all animals were sacrificed and complete gross postmortem and histopathological examinations were performed. Treatment-related clinical signs, as evidenced by depression, soft feces, decreased locomotion activity, solid perineal region, crouching position, and anorexia were observed in all treatment groups in a dose-dependent manner. At the dose level of 5,000 mg/kg, decreased or suppressed body weight gain was found during the study period. At the scheduled necropsy, one case of congestion of the intestine and an increase in the weights of liver and kidney were observed in the 5,000 mg/kg group. Histopathological examinations exhibited an increased incidence of glomerular atrophy, congestion/hemorrhage, and focal degeneration/necrosis in the liver and an increased incidence of congestion, and inflammatory cell infiltration in the kidney. On the basis of the results, it was concluded that a single oral administration of MCH resulted in some adverse effects on clinical sign, body weight gain, and organ weight and histopathology in the liver and kidney in female rats. In the experimental conditions, the minimal lethal dose ($LD_{10}$) of MCH was greater than 5,000 mg/kg.