• Toxicological Research
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• v.26 no.1
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• pp.53-59
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• 2010

This study was conducted to obtain acute information of the oral dose toxicity of DHU001, a polyherbal formula in male and female mice. In order to calculated 50% lethal dose ($LD_{50}$) and approximate lethal dose (LD), test material was once orally administered to male and female ICR mice at dose levels of 2000, 1000, 500, 250 and 0 (vehicle control) ml/kg (body weight). The mortality and changes on body weight, clinical signs, gross observation, organ weight and histopathology of principle organs were monitored 14 days after treatment with DHU001. We could not find any mortalities, DHU001 treatment-related clinical signs, changes on the body and organ weights, gross and histopathological findings. The results obtained in this study suggest that $LD_{50}$ and approximate LD in mice after single oral dose of DHU001 were considered over 2000 mg/kg in both female and male mice.

• 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.

• Biomolecules & Therapeutics
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• v.17 no.3
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• pp.325-331
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• 2009

The object of this study was to evaluate the single oral dose toxicity of Low Molecular Weight Fucoidan (LMF) in male and female rats. LMF was administered to female and male SD rats as an oral dose of 2,000, 1,000 and 500 mg/kg (body wt.). Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation organ weight and histopathology of 14 principle organs were examined upon necropsy. As the results, no LMF treatment related mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations against 14 principle organs were detected up to 2,000 mg/kg in both female and male rats except for some sporadic findings not LMF treatment related toxicological signs. Therefore, $LD_{50}$ (50% lethal dose) and approximate LD of LMF after single oral treatment in female and male rats were considered over 2,000 mg/kg - the limited dosages recommended by KFDA Guidelines [2005-60, 2005], respectively.

• Toxicological Research
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• v.24 no.1
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• pp.79-86
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• 2008

This study was conducted to obtain information of the oral dose toxicity of low molecular fucoidan (LMF) in male and female mice. In order to calculate 50% lethal dose ($LD_{50}$) and approximate lethal dose (LD), test material was once orally administered to male and female ICR mice at dose levels of 2000, 1000, 500, 250, 125 and 0 (vehicle control) mg/kg (body wt.). The mortality and the changes on body weight, clinical signs, gross observation and organ weight and histopathology of principle organs were monitored 14 days after LMF treatment. We could not find any mortalities, clinical signs, body weight changes and gross findings. In addition, significant changes in the organ weight and histopathology of principal organs were not observed except for some sporadic findings. The results obtained in this study suggest that LMF may not be toxic in mice and may be therefore safe for clinical use. The $LD_{50}$ and approximate LD in mice after single oral dose of LMF were considered over 2000 mg/kg in both female and male mice.

• Journal of Physiology & Pathology in Korean Medicine
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• v.27 no.3
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• pp.299-305
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• 2013

This study was to evaluate the single dose toxicity of Arecae Semen (AS) in male and female ICR mice. Aqueous extracts of AS (Yield = 13.15%) were administered 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. We could not find any mortality, clinical signs, and changes in the body and organ weight except for diarrhea. Diarrhea were observed in all three different dosage groups of male mice, and in 2000 mg/kg groups of female mice within 48hrs after administration. In addition, no AS extract related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. Although the 50% lethal dose and approximate lethal dose of AS aqueous extracts in female and male mice were detected as over 2,000 mg/kg - the limited highest dosage recommended by KFDA guidelines. It should be carefully used in clinics because AS may be induced severe digestive tract disorders.

• Biomolecules & Therapeutics
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• v.11 no.3
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• pp.200-203
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• 2003

The present study was carried out to investigate the potential acute toxicity of bamboo leaf water extract by a single oral dose in Sprague-Dawley rats. Twenty male and female rats aged 5 weeks were randomly assigned to four groups of 5 rats each and were administered singly by gavage at dose levels of 0, 1250, 2500, or 5000 mg/kg body weight. Mortalities, clinical findings, and body weight changes were monitored for the l4-day period following the administration. At the end of 14-day observation period, all animals were sacrificed and complete gross postmortem examinations were performed. Throughout the study period, no treatment-related deaths were observed. There were no adverse effects on clinical signs, body weight, and gross finding at any dose tested. The results showed that the single oral administration of bamboo leaf water extract did not induce any toxic effect at a dose level of below 5000 mg/kg in rats and that the minimal lethal dose were considered to be over 5000 mg/kg body weight for both sexes.

• Biomolecules & Therapeutics
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• v.15 no.2
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• pp.127-132
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• 2007

The object of this study was to evaluate the acute toxicity of lyophilized water extract of Radix Araliae Cordatae (RA) in male and female mice. The extract was administered to female and male ICR mice as an oral dose of 2000 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, changes in the body weight and gross findings except for increases of hypertrophy of lymph nodes in male RA extracts-dosing group. In addition, no RA extracts-treatment related abnormal changes in the organ weight and histopathology of principle organs except for some sporadic accidental findings. The results obtained in this study suggest that the RA extracts does not cause any toxicological signs. The LD$_{50}$ and approximate LD of RA extracts in both female and male mice were considered as over 2000 mg/kg.

• Journal of Society of Preventive Korean Medicine
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• v.15 no.2
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• pp.21-38
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• 2011

Objective : This study was to evaluate the single dose toxicity of Bojungikki-tang(Buzhongyiqi-tang, BJIKT) in male and female mice. Method : Aqueous extracts of BJIKT were 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. Results : we could not find any mortality, clinical signs, and changes in the body and organ weight. In addition, no BJIKT-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. Conclusion : The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of BJIKT aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines, and can be safety used in clinics.

• Journal of Physiology & Pathology in Korean Medicine
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• v.25 no.1
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• pp.122-131
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• 2011

The object of this study was to evaluate the single dose toxicity of Yukmijihwangtanggamibang (YMJHTGMB), a polyherbal formula have been traditionally used as prevention or treatment agent for various lung diseases including chronic obstructive pulmonary disease (COPD), in male and female mice. Aqueous extracts of YMJHTGMB (Yield = 16.33%) wasadministered 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 changesin the body and organ weight except for soft feces restricted to YMJHTGMB 2,000 mg/kg treated two male mice (2/5; 40%) at 1 day after administration. In addition, no YMJHTGMB-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 50% lethal dose and approximate lethal dose of YMJHTGMB aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines.

• Journal of radiological science and technology
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• v.14 no.2
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• pp.37-44
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• 1991

The combined effect of radiation and ultrasound has been studied in mouse embryos. Radiation and/or ultrasound were adminstered to ICR mice on day 8 of gestation. Intrauterine death, gross malformation, and fetal body weight were selected as indicators of effects. Does of whole-body ${\gamma}-irradiation$ were 0.5 to 2.5 Gy and those of ultrasound were $0.5\;W/cm^2$ to $3\;W/cm^2$. Intrautrine mortality increased with increasing radiation dose ; this trend was more remarkable in combination with ultrasound. Gross malformations such as exencephaly and anophthalmia/microphthalmia appeared frequently in the fetuses treated with both radiation and ultrasound. Decreased fetal weight was observed even in mice treated with 1.5 Gy of radiation or $1\;W/cm^2$ of ultrasound. There was a linear relationship between dose and reduction of fetal weight. The fetal weight was sensitive, precise and easy-to-handle indicator for the effects of growth retardation. Intrauterine mortality and frequencies of exencephaly and anophthalmia/microphthalmia were higher than the sum of those induced by radiation and by ultrasound. The results indicatied that the combined action of radiation and ultrasound on intrauterine death and malformations was synergistic.