• Toxicological Research
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• v.25 no.2
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• pp.79-84
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• 2009

Cerium oxide nanoparticles (size: 30 nm) were prepared by the supercritical synthesis method, Acute oral toxicity and tissue distribution of the nanoparticles were evaluated by a single administration in rats. Oral administration of the nanoparticles to the rats did not lead to death when the animals were treated by a dose of 5 g/kg (high dose) as well as 100 mg/kg (low dose). Abnormal clinical signs, changes in serum biochemistry and hematology were not observed in high-dose treated group compared to the vehicle control group. Lesions in liver, lung and kidney were not observed in high-dose treated group by histopathological examination. Tissue distribution analysis in liver, kidney, spleen, lung, testis and brain was performed on day 1, day 7 and day 14 after treatment. The average values of the accumulated cerium oxide nanoparticles were elevated in all tissues but statistical significance was only shown in lung. Low levels of tissue distributions after a single oral administration seem to be the low bioavailability of the nanoparticles.

• Journal of Oriental Neuropsychiatry
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• v.23 no.2
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• pp.121-128
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• 2012

Objectives : This research investigates the single oral dose toxicity of ACM in SD rats. Methods : ACMs were administered to female and male SD rats, as an oral dose of 5000 mg/kg. Animals were monitored for the mortality and changes in the body weight, clinical signs and gross observation during the 14 days after dosing, upon necropsy. Results : We could not find any mortality. Compared with the control group, significant weight change was not observed in the experimental group. First day after administration, compound-colored stool was observed in all rats. After the second day of administration, the more common symptoms were not observed. There were no gross abnormalities in all cases. [ED NOTE: highlight: given the context, this is very vague] Conclusions : The results obtained in this study suggest that the approximate lethal dose of ACM in both female and male rats were considered as over 5000 mg/kg.

• Biomolecules & Therapeutics
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• v.9 no.1
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• pp.46-50
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• 2001

The current study was performed to determine the acute oral toxicity of a crude extract of sanghwang mushroom (Phellinus linteus), in SD rats. 5 rats of each sex were orally treated with a single dose of extract of sanghwang mushroom at doses of 0, 500, 1,000, 2,000 mg/kg, respectively. After the treatment, clinical signs and body weight change, the food and water consumption were observed for 14 days. All animals survived during the study and did not show any clinical signs. Body weight gain showed no significant difference between the control and treated rats. However, body weight gain delayed in high dose group (2,000 mg/kg) on day 1~3 after administration. Another 5 rats of each sex were orally treated with a single dose of extract of sanghwang mushroom at dosages 4,000, 5,000 mg/kg respectively, but all animals survived during the study and did not show any clinical signs. It is suggested that LD$_{50}$ of extract of sanghwang mushroom by oral administration was estimated to be over 5,000 mg/kg in both sexes of rats.s.

• Journal of Physiology & Pathology in Korean Medicine
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• v.28 no.1
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• pp.53-58
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• 2014

The object of this study was to evaluate the single dose toxicity of Choweseuncheng-tang (CWS), a polyherbal formula have been traditionally used as prevention or treatment agent for various diseases as Tae-eumin prescription on Korean medicinal theory, Sasang-euihak, in male and female mice. Aqueous extracts of CWS (yield = 11.00%) was administered to female and male 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 principle organs were also examined. As results, we could not find any CWS treatment related mortality and clinical signs, changes in the body and organ weights, gross findings and changes in histopathology of principle organs, except for some dose-independent accidental findings. The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of CWS 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.

• The Journal of Internal Korean Medicine
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• v.39 no.4
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• pp.676-685
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• 2018

Objectives: The aim of this study was to estimate the single oral toxicity of Peucedani Radix (PR) ethanol extracts. PR is one of the important herbs for removal of phlegm, the viscous turbid pathological product that can accumulate in the body and cause a variety of diseases. However, research on the pharmacologic toxicity of PR is lacking. Methods: In this study, PR was orally administered to 5-week-old male ICR mice at an oral dose of 2,000, 3,000, or 5,000 mg/kg. After a single-dose administration, the mortality and behavioral changes were observed daily and body weights were measured every two days. After 14 days, the organ weight, organ index, macroscopy, hematological analysis, and serum biochemistry analysis were determined. Results: No mortality, body weight changes, abnormal behavioral changes, or anatomical signs of toxicity were found. The organ weight, organ index, hematological analysis, and serum biochemistry analysis were also within the normal ranges. Conclusions: These results suggest that the 50% lethal dose of PR is more than 5,000 mg/kg. This could indicate that PR is a safe drug without acute toxicity and side effects.

• Journal of Korean Medicine for Obesity Research
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• v.17 no.2
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• pp.96-100
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• 2017

Objectives: Samjung-hwan (SJH) is a Korean herbal formula that has been used for antilipidemic, antioxidant, and antidepressant effects. As a part of safety evaluation, single oral dose toxicity study of modified SJH in Sprague-Dawley (SD) rats was carried out. Methods: Modified SJH extract was administered orally in male and female SD rats at dose of 5,000 mg/kg. After single oral administration of modified SJH, we monitored the changes of mortalities, clinical signs, and body weight daily for 14 days. Gross necropsy findings were also evaluated at the end of the experiment. Results: Modified SJH extract did not induce any toxic signs in the changes of mortalities, clinical signs, and body weight. There were also observed no gross necropsy findings in rats. Conclusions: As results, the approximate lethal dose of modified SJH extract in SD rats was considered to be over 5,000 mg/kg. This suggests that modified SJH is safe herbal formula for the treatment with.

• Korean Journal of Oriental Medicine
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• v.15 no.1
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• pp.79-83
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• 2009

In this study, we investigated the single dose toxicity and safety about water-extracted Galgeuntang. To evaluate single dose toxicity, 20 male and 20 female ICR mice were observed survival rates, general toxicity, changes of body weight for 14 days after single oral administration of 0 (control group), 1250, 2500 and 5000mg/kg Galgeuntang. And after 14 day, We observed autopsy. Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). LD50 of Galgeuntang might be over 5000mg/kg and it is very safe to ICR mice.

• Korean Journal of Agricultural Science
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• v.48 no.4
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• pp.1003-1013
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• 2021

Thioredoxin (TRX) protein is an antioxidant responsible for reducing other proteins by exchanging cysteine thiol-disulfide and is also known for its anti-allergic and anti-aging properties. On the other hand, epidermal growth factor (EGF) is an important material used in the cosmetics industry and an essential protein necessary for dermal wound healing facilitated by the proliferation and migration of keratinocytes. EGF also assists in the formation of granulation tissues and stimulates the motility of fibroblasts. Hence, genetically modified soybeans were developed to overexpress these industrially important proteins for mass production. A single-dose oral-toxicity-based study was conducted to evaluate the potential toxic effects of TRX and EGF proteins, as safety assessments are necessary for the commercial use of seed-specific protein-expressing transgenic soybeans. To achieve this rationale, TRX and EGF proteins were mass purified from recombinant E. coli. The single-dose oral-toxicity tests of the TRX and EGF proteins were carried out in six-week old male and female Institute of Cancer Research (ICR) mice. The initial evaluation of the single-dose TRF and EGF treatments was based on monitoring the toxicity signatures and mortality rates among the mice, and the resultant mortality rates did not show any specific clinical symptoms related to the proteins. Furthermore, no significant differences were observed in the weights between the treatment and control groups of male and female ICR mice. After 14 days of treatment, no differences were observed in the autopsy reports between the various treatment and control groups. These results suggest that the minimum lethal dose of TRX and EGF proteins is higher than the allowed 2,000 mg·kg^-1 limit.

• The Journal of Dong Guk Oriental Medicine
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• v.11
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• pp.66-73
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• 2008

Objectives: The study was designed to evaluate the single dose toxicity of modified Bo-yang-Hwan-o-Tang (mBHT) in Sprague-Dawley (SD) rats. Methods: The mBHT was once administrated orally to both sexes of rats at dose 2,000 mg/kg body weight which are the recommended maximum limit dose for acute toxicity. We recorded clinical signs of toxicity, body weight, gross and histological changes in target organs for all rats. Results: Neither significant changes of body weight not death was observed during the observation period in mBHT-administrated rats. Neither significant toxic signs not histopathological changes were shown during the observation period. There were not observed significant gross abnormality between the control and mBHT-administrated rats. Conclusions: These results indicated that the toxicity of mBHT is greater than 2,000 mg/kg body weight in SD rats.

• Biomolecules & Therapeutics
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• v.9 no.2
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• pp.140-142
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• 2001

This study was performed to evaluate an single dose oral toxicity of a new hepatotherapeutic agent GODEX (HEPADIF-S) in Sprague-Dawley rats. Male and female rats were administered dosages of 5, 2.5, 1.25 ,0.625, 0.3125, and 0 g/kg B.W. of GODEX, respectively. After single oral administration of GODEX to rats, we observed them daily for 2 weeks. GODEX slid not induce any toxic signs in the mortalities, clinical signs, body weight changes, and gross necropsy findings of rats. Based on these results, it is concluded that GODEX may have no side effect and its LD$_{50}$ value may be over 5 g/kg B.W, in rats.s.