• Journal of Applied Biological Chemistry
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• v.65 no.4
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• pp.397-403
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• 2022

Smilax sieboldii is one of the Smilax species. A number of Smilax plants have long been used in traditional medicine in the tropics and subtropics worldwide. Repeated dose oral toxicity test is an essential experiment for toxicity evaluation before efficacy evaluation. The purpose of this study is to evaluate toxicity and the no-observed adverse effect level (NOAEL) using oral administration of Smilax sieboldii extract (SSE) in male and female ICR mice for 4 weeks. SSE was orally administered daily for 4 weeks at a dose of 500, 1000, and 2000 mg/kg/day (MPK). There were no significant differences in mortalities, clinical signs, body weight changes, food intake, hematological analysis, serum clinical chemistry test and relative organ weights in all animals administrated with SSE. The results obtained in this study suggest that SSE did not show any toxic effect in ICR mice and the NOAEL of SSE was regarded as over 2000 MPK.

• The Journal of Korean Medicine
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• v.35 no.2
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• pp.28-33
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• 2014

Background: Samul-tang (Si-Wu-Tang, SMT) is a traditional herbal formula, which has been widely used to treat various diseases such as menstrual irregularity, bleeding and leucorrhea. Although many studies have investigated the pharmacological properties of SMT, its toxicity information has not yet been fully elucidated. Methods: Five Sprague Dawley (SD) rats of each sex were given a single dose (5000 mg/kg) of SMT by gavage; control rats received the vehicle only. After the single administration, mortality, clinical signs, body weight changes and gross findings were monitored for 15 days in accordance with Good Laboratory Practice (GLP) principles. Results: In a single oral dose toxicity study, there was no adverse effect on mortality, clinical sign, body weight change or gross finding in any treatment group. Conclusions: The results indicate that SMT did not induce toxic effects at a dose level up to 5000 mg/kg in rats and its median lethal dose ($LD_{50}$) was considered to be over 5000 mg/kg/day body weight for both genders.

• Toxicological Research
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• v.30 no.2
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• pp.121-130
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• 2014

The larval form of Tenebrio molitor (T. molitor) has been eaten in many countries and provides benefits as a new food source of protein for humans. However, no information exists regarding its safety for humans. The objective of the present study was to evaluate the genotoxicity and repeated dose oral toxicity of the freeze-dried powder of T. molitor larvae. The genotoxic potential was evaluated by a standard battery testing: bacterial reverse mutation test, in vitro chromosome aberration test, and in vivo micronucleus test. To assess the repeated dose toxicity, the powder was administered once daily by oral gavage to Sprague-Dawley (SD) rats at dose levels of 0, 300, 1000 and 3000 mg/kg/day for 28 days. The parameters which were applied to the study were mortality, clinical signs, body and organ weights, food consumption, ophthalmology, urinalysis, hematology, serum chemistry, gross findings and histopathologic examination. The freezedried powder of T. molitor larvae was not mutagenic or clastogenic based on results of in vitro and in vivo genotoxicity assays. Furthermore, no treatment-related changes or findings were observed in any parameters in rats after 28 days oral administration. In conclusion, the freeze-dried powder of T. molitor larvae was considered to be non-genotoxic and the NOAEL (No Observed Adverse Effect Level) was determined to be 3000 mg/kg/day in both sexes of SD rats under our experimental conditions.

• Journal of Korean Medicine Rehabilitation
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• v.21 no.4
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• pp.41-47
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• 2011

Objectives: This study was performed to investigate single oral dose toxicity of TB001, the extract mixture of Purple loosestrife and Aceriphyllum rossii. Methods: The mortality, general symptom, change of weight: and necropcy findings was investigated for 14 days after a dose(2000 mg/kg B.W.) of TB001 was given, using SD rats of both male and female according to "The guideline of toxicity test for medicine and others". Results: The death of rats and abnormal finding was not observed. There was no the significant difference of weight between control group and TB001 group. Conclusions: The abnormalities at the necropsy finding of all survived rats was not detected. The study suggested that there is no toxicity in single dose(2000 mg/kg B.W.) of TB001.

• Journal of Life Science
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• v.26 no.10
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• pp.1153-1162
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• 2016

Termitomyces albuminosus (Berk.) Heim is a well-known wild edible mushroom in the southern region of China. Novel cerebrosides, termed termitomycesphins, isolated from EtOH extract of T. albuminosus have shown significant neuritogenic activity. Neurotrophic factors have been targeted as potential therapeutic drugs for the treatment of neurodegenerative disorders. However, before expanding their applications to include food or therapeutic agents in Korea, a safety evaluation of T. albuminosus is needed. Herein, in a repeated-dose 90-day oral toxicity study, rats were exposed to a basal diet of powder ground from dried T. albuminosus at dose levels of 5%, 2.5%, 1.25%, and 0%. The following endpoints were evaluated: clinical observation, body weight, gross and microscopic pathology, clinical chemistry, and hematology. Significant dose-dependent increases in the weight of the left kidney were observed, possibly due to the test substance. Based on toxicity-decision criteria for minor compound-related changes (no observed adverse effect level [NOAEL] and no observed effect level [NOEL]), NOAEL was observed in male rats at a dose of 5% of dried T. albuminosus powder, and NOEl was observed in female rats at the same dose. The results point to the safety and potential use of T. albuminosus as a nontoxic neurotrophic factor.

• The Korea Journal of Herbology
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• v.25 no.3
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• pp.43-51
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• 2010

Objectives : We investigated the repeated-dose toxicity of Wenpitang-Hab-Wulingsan(WHW), a Korean traditional medicine prescribed with twelve herbs, which has been used for the treatment of renal disease. Methods : WHW extract prepared by GLP company. WHW was supplemented by gavage at 0, 100, 500 and 1000 mg/kg/day for 13-week consecutive days. We recorded the clinical signs of toxicity, body weight, organ weights, hematology, gross and histological changes in target organs rats and clinical chemistry analysis for all rats. Results : WHW extract at all doses was shown no mortality or abnormal clinical signs in rats during at the observation period. Furthermore, there was no difference in body weight and food-take consumption, organ weight, gross pathological findings, and urine analysis among the groups of rats treated with different doses of WHW extract. The hematological analysis and clinical blood chemistry data were revealed no toxic effects from WHW-treated rats. Conclusions : The results suggest that WHW extract in rats is a wide margin of safety on a acute toxicity.

• Toxicological Research
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• v.25 no.2
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• pp.101-106
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• 2009

This study was conducted to investigate the 2 week-oral toxicity of Paecilomyces sinclairii in Sprague-Dawley rats. P. sinclairii was daily administered to male and female rats for 2 weeks with different dose levels (0, 0.008, 0.04, 0.2, 1 and 5 g/kg). There were no clinical signs compared with control group, but a slight increase of white blood cell (WBC) was observed in the males rats receiving all dose levels of P. sinclairii. In biohematological analysis, the levels of glucose and cholesterol in the blood were decreased slightly in the males and females rats at doses of 0.008 or 1 g/ kg. At the all dose groups, there were no significant changes in the body weights, but autopsy findings of all organs showed reduced weights in the thymus of males in the high dose groups of 1 g/ kg and 5 g/kg. These results indicate that P. sinclairii does not induce any significant toxic effect on Sprague-Dawley rats treated for 2 weeks, but the reduced weights of thymus in males may require a further long-term investigation.

• Biomolecules & Therapeutics
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• v.15 no.4
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• pp.245-251
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• 2007

The object of this study was to evaluate the single dose toxicity of Kong-Jin-Dan (KJD), a polyherbal formula in male and female mice. KJD was administered to female and male ICR mice as an oral dose of 2000, 1000 and 500 mg/kg (body wt.) according to the recommendation of 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 increases of lymphoid organ weights in KJD-dosing groups. These increases of lymphoid organ weights considered that related to the immune modulate effect of KJD not toxicological signs. In addition, no KJD-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 the KJD does not cause any toxicological signs. The $LD_{50}$ and approximate LD of KJD extracts in both female and male mice were considered as over 2000 mg/kg.

• The Journal of Korean Medicine
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• v.44 no.3
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• pp.29-38
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• 2023

Objectives: This study aimed to investigate the acute oral toxicity of 77 herbal formulas and performed in male and female Sprague-Dawley (SD) rats as per the guidelines mentioned in Ministry of Food and Drug Safety. Methods: Each sex of SD rat were administered a single dose (2000 or 5000 mg/kg) of 77 herbal formulas via oral gavage; the control group received vehicle only. After administration, the mortality, clinical signs, gross findings, and body weight were followed up for 15 days. Results: After administration of 77 herbal formulas, mortality, clinical signs, body weight changes, and gross findings related to the test substances were not observed in both male and female groups. Conclusion: Our results demonstrate the single-dose oral administration of 77 herbal formulas produced no mortality indicating the approximate lethal dose is greater than 2000 or 5000 mg/kg body weight.

• Toxicological Research
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• v.22 no.2
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• pp.117-126
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• 2006

This study was conducted to obtain the acute information of the oral dose toxicity of lyophilized water extract of Picrorrhiza Rhizoma (PR) - dried underground stem of Picrorrhiza kurroa, having various pharmacological effects, in male and female mice. In order to calculate 50% lethal dose ($LD_{50}$), approximate lethal dose and target organs, test article was administered once by oral gavage to male and female ICR mice at 2000, 1000, 500 and 250 mg/kg. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing with organ weight and histopathology of 12 types of principle organs. As the results, we could not find any mortality, clinical signs, changes in the body weight and gross findings except for hair loss, a significantly (p<0.05) increase of body weight gains in 2000mg/kg of PR extracts-dosing male group and some sporadic gross findings. In addition, no meaningful changes on the organ weight and histopathology of 12 types of principle organs were detected in the present study except for significantly (p<0.05) but dose independent changes on thymus, spleen and popliteal lymph nodes weights, and some sporadic accidental histopathological findings. The results obtained in this study suggest that the PR extract is non-toxic in mice and is therefore likely to be safe for clinical use. The $LD_{50}$ and approximate lethal dose of PR extracts in both female and male mice were considered as over 2000 mg/kg.