• Biomolecules & Therapeutics
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• v.8 no.1
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• pp.84-92
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• 2000

This Study was conducted to assess the single dose toxicity of DA-125, a new anthracycline anti-cancer agent, in rats and mice. The Drug was administered once intravenously to both sexes of rats and mice. Then followed a 14-day period of observation. The $LD_{50}$ Values (95% confidence limit) were estimated to be 60.9 mg/kg (57.5~64.3 mg/kg) for male rats and 60.2 mg/kg (56.2~64.5 mg/kg) for female rats, and 85.8 mg/kg (81.0~90.9 mg/kg) for male mice and 84.5 mg/kg (78.2~91.9 mg/kg) for female mice. Both sexes of rats and mice given the drug revealed the clinical sign of decreased locomotor activity, emaciation, hair loss, red-dish brown urine, salivation, and watery diarrhea. In addition, body weight from the next day to the 7th day tended to be decreased slightly in rats and mice treated with DA-125. Death occurred from the next day after administration to the 12th day. Macroscopically, congestion of gastrointestinal organ, lung, and adrenal glands were found in both sexes on the dead rats and mice. Histopathological examination of dead rats manifested atrophy of spleen, hypoplasia of bone marrow, hypcplasia and necrosis of lymphocyte in thymus, atrophy of villi in small intestine (duodenum, jejunum, and ileum), hyperplasia of granular epithelium in small intestine, degeneration of germinal epithelium in testis, defer oration of tubular epithelium in kidney, and vacuolation and myolysis of myocardium in heart. Histopathological examination of dead mice revealed hypoplasia of spleen and mesenteric lymph node, local necrosis of liver, atrophy of villi in small intestine, hyperplasia of glandular epithelium in small and large intestine, degeneration of tubular in kidney, degeneration of germinal cells in testis, and slight vacuolar degeneration of myocardium in heart.

• The Korea Journal of Herbology
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• v.23 no.4
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• pp.1-7
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• 2008

Objectives: Ephedrae herba, also known as Ma-huang, is a traditional Korean medicinal herb. It has been used to treat asthma, nose and lung congestion, and fever with anhidrosis for centuries. Recently, Ma-huang was used as a source of ephedrine in many dietary supplements for weight reduction in the United States. The objective of this study was to investigate the subacute toxicity of ephedrae herba extract in rats. Methods: SPF Sprague-Dawley male rats were administered orally with ephedrae herba extract for 4 weeks as several doses(0, 125, 250, 500, 1,000, and 2,000 mg/kg). We examined number of deaths, clinical signs, body weights and gross findings for experimental period. Results: No dead animals were found during the experimental period. In addition, no differences were found between control and treated groups in clinical signs, hematology, serum biochemistry, and other findings. Conclusions: In conclusion, above data suggest that no observed adverse effect level of ephedrae herba extract in SD rats might be over 2,000 mg/kg/day in this study.

• Journal of Physiology & Pathology in Korean Medicine
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• v.20 no.3
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• pp.572-574
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• 2006

The Dangguibohyel-tang (DBT) was used to treat anemia in traditional Korean medicine. Acute oral toxicity of DBT was studied in ICR mice. ICR mice were administered orally with dosages of 100 mg/kg (low dosage group), 200 mg/kg (middle dosage group), and 400 mg/kg (high dosage group) of DBT. We daily examined number of deaths, clinical signs, body weights and gross findings for 14 days. DBT did not show any toxic effect in ICR mice and oral LD50 value was over 400 mg/kg in ICR mice.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.29 no.4
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• pp.508-516
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• 2019

Objectives: The present study was performed to obtain acute toxicity information on glyoxal in male rats after intratracheal instillation. Methods: In order to calculate the LD₅₀ of glyoxal using Probit analysis with SAS, the test article was one intratracheal instillation to male Sprague-Dawley rats at dose levels of 0, 225, 451 or 902 mg/kg. During the test period, mortality, clinical signs, and body and organ weights were examined. At the end of the 14-day observation period, all animals were sacrificed and complete gross postmortem and histopathological examinations were performed. Results: Four animals of the 902 mg/kg group died within one week after the administration of glyoxal. All treatment group in a dose dependent manner, decreased body weight was found during the study period. The absolute and relative lung weight, and histopathological changes (bronchiolar-alveolar hyperplasia, chronic inflammation) of lung exhibited an increased in glyoxal treated groups in a dose dependent manner. However, there were no changes on the organ weights and histopathological changes of any other organ except lung. Conclusions: The results obtained in the present study suggest that the LD₅₀ in male Sprague-Dawley rats after a single intratracheal instillation of glyoxal was considered to be 866.9 mg/kg and the lung was found to be the target organ for glyoxal.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.31 no.4
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• pp.473-483
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• 2021

Objectives: The present study aimed to evaluate the potential toxicity of 2-butoxyethanol after intratracheal instillation in male rats. Methods: In order to calculate median lethal dose (LD₅₀) of 2-butoxyethanol using Probit analysis with SAS program, the 2-butoxyethanol was administered with dose levels of 0, 101.64, 203.28 and 406.56 mg/kg by once intratracheal instillation to male rats. During the test period, clinical signs, mortality, body weights, organ weights, hematology, and serum biochemistry were examined. At the end of 14 days observation period, all animals were sacrificed and gross finding and histopathological examination were performed. Results: All animals of 406.56 mg/kg group died within 2 weeks after the administration of 2-butoxyethanol. Treatment-related clinical signs, gross observation and histopathological changes (mucous cell hyperplasia, alveolar macrophage aggregation, and hemorrhage) of lung exhibited an increased in 2-butoxyethanol treated groups in a dose dependent manner. However, there were no changes in the organ weights, hematology and serum biochemistry, and histopathology of any other organ except lung. Conclusions: On the basis of the results, it was concluded that a single intratracheal instillation of 2-butoxyethanol in male Sprague-Dawley rats resulted in some adverse effects on mortality, clinical sign, and histopathology in the lung. In the experimental conditions, the LD₅₀ of 2-butoxyethanol was considered to be 287.2 mg/kg and lung was founded to be the target organ of 2-butoxyethanol.

• Korean Journal of Environmental Agriculture
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• v.36 no.4
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• pp.241-248
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• 2017

BACKGROUND: RNA interference (RNAi) eliminates or decreases gene expression by disrupting the target mRNA or by interfering with translation. Recently, RNAi technique was applied to generate new crop traits which provide protection against pests. To establish the environmental risk assessment protocol of RNAi LMO in lab scale, we developed dsRNA expression system using E. coli and tested acute oral toxicity assay to honey. METHOD AND RESULTS: The dsRNA expression vector, L4440, was chosen and cloned 240 bp of Snf7 and GFP gene fragment. To develop the maximum dsRNA induction condition in E. coli, we tested induction time, temperature and IPTG concentration in media. To estimate the risk assessment of dsRNA to honey bee, it has been selected and cultured with dsRNA supplement for 48 hours according to OECD guideline. As a result, the optimum condition of dsRNA induction was $37^{\circ}C$, 4 hours and 0.4 mM IPTG concentration and the difference between Snf7 and GFP dsRNA molecules from E. coli was not significant in survival and behavior to honey bee. Furthermore, blast search results indicated that effective match of predicted dsRNA fragments were not existed in honey bee genome. CONCLUSION: In this study, we developed and tested the acute oral toxicity of dsRNA using E. coli expression system to honey bee.

• Korean Journal of Food Science and Technology
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• v.11 no.4
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• pp.224-231
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• 1979

The safety of the sweetening component of stevia was studied by administrating it to the rats. The $LD_{50}$ determined by intraperitoneal injection was 3,400 mg/Kg as the stevia extract containing 50 % stevioside, i.e. $LD_{50}$ of stevioside was more than 1,700 mg/Kg. Oral administration of large quantities of the stevia extract for 56 days resulted in no effect on the growth of rats. The analyses of total blood (RBC, WBC, Hb and Hct), 17 blood serum components including total protein, glucose, cholesterol, GOT, and 11 items of findings on the liver tissues including nuclear deterioration of liver cells, proliferation of Kupffer cells, fibrosis of portal area showed no significant differences between control and treatments except lactate dehydrogenase activity after 56 day-oral administration of the extract. From the results obtained, it was supposed that the stevia extract/stevioside revealed no acute or sub-acute toxic effects on rats.

• Journal of Society of Preventive Korean Medicine
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• v.15 no.1
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• pp.37-47
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• 2011

Objectives : Previous studies have shown that Fructus mume (FM) has anti-platelet effects. The present study was performed to determine the acute oral toxicity and quality control of a crude extract of FM in ICR mice. Methods : We investigated the in vivo single dose acute toxicity of FM 95% ethanol extract. This test was orally administered once by gavage to 20 male and 20 female mice at dose levels of 0 (control group), 1250, 2500 and 5000mg/kg body weight, respectively. Mortalities, clinical findings, autopsy findings and body weight changes were monitored daily for the 14 days following the administration. HPLC analysis was performed for the simultaneous determination of ursolic acid and p-hydroxycinnamic acid in FM. Reverse-phase chromatography using a C18 column and photodiode array detection at 211 nm was used for quantification of the two maker components. The mobile phase for gradient elution consists of water and acetonitrile. Results : We observed survival rates, general toxicity, change of body weight, and autopsy. The mice did not die after single oral administration of maximum dose of FM. Autopsy of animal revealed no abnormal gross finding. Therefore, $LD_{50}$ value of FM for ICR mice was more than 5000mg/kg on oral route. The HPLC analysis showed that ursolic acid and p-hydroxycinnamic acid amounts to 9.75- and 0.12% in the extract with the retention times of 47.99- and 15.38 minutes, respectively. Conclusions : These results suggest that no toxic dose level of FM in mice is considered to be more than 5000mg/kg. Consequently, it was concluded that FM have no effect on acute toxicity and side effect in ICR mice. For the quality control of FM extract, simultaneous determination of ursolic acid and p-hydroxycinnamic acid was established.

• Journal of Life Science
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• v.29 no.1
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• pp.112-117
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• 2019

Herbal medicines are widely used as therapeutic products in many countries. Corni fructus (CF), the dried ripe sarcocarp of Cornus officinalis Sieb. et Zucc (Cornaceae), has been used for thousands of years in traditional medicine and has been reported to be effective for the prevention and treatment of various diseases, such as kidney diseases and diabetes. Recent research on CF has documented a wide spectrum of therapeutic properties, which include anti-inflammatory, ant-oxidative, immunomodulatory, and anti-cancer effects. However, there is no information on its safety. Therefore, in this study, the toxicity of water extract of CF to ICR mice was investigated. The mice received a single dose of water extract of CF (1,000, 2,000, and 5,000 mg/kg of body weight) via the oral route. Mortality, clinical signs, body weight changes, gross findings, and weights of the principal organs after 14 d were then assessed. The results revealed no adverse effects of CF as determined by clinical signs, body weights, or organ weights and no gross pathological findings in any of the treatment groups. These results suggest that the 50% lethal dose and approximated lethal dose of CF extract is over 5,000 mg/kg. The findings provide scientific evidence for the safety of CFs.

• Herbal Formula Science
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• v.24 no.4
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• pp.289-300
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• 2016

Objectives : Taglisodog-eum(TSE), a poly herbal formula, has been widely used to improve carbuncles by removing inflammation of the lymphatic channels in Traditional Korean Medicine. We previousely reported the action mechanism of TSE on experimental atopic dermatitis and the establishment of formulation for TSE ointment. In this study, we examined the toxicity test on skin and eye irritation by TSE ointment to prove the safety of Taglisodog-eum ointment in clinical use. Methods : Acute skin toxicity of the TSE ointment was evaluated in Sprague-Dawley(SD) rats. After dermal administration of TSE ointment(2,000mg/kg), body weight, mortality, and clinical signs of the rats were observed for 14days. Primary skin irritation and ocular irritation tests for TSE ointment were performed in male New Zealand White Rabbits. In dermal and ocular irritation test, body weight, mortality, clinical signs, Primary Irritation Index(P.I.I.), and The Index of Acute Ocular Irritaion(I.A.O.I.) of rabbit were observed after applying at abraded skin and eye balls with Taglisodog-eum ointment. Results : In the results of acute skin toxicity, no significant differences were found in body weight, the clinical sign and the mortality between control and TSE ointment treated group. In primary dermal irritation test, body weight, the clinical sign and the mortality were not significantly changed and Primary Irritation Index(P.I.I.) was 0.8, indicating TSE ointment as weak irritant material. In ocular irritation test, The Index of Acute Ocular Irritaion was 0.0, indicating TSE ointment as non-irritating to the eye of the rabbits. To evaluate toxicity of the TSE ointment in animal test, body weight, the clinical signs, the skin and eye irritation check were conducted; TSE ointment was considered to be weak dermal irritant in test animals. The no response of eye irritation test was observed in this experimental condition. Conclusions : According to the above toxicity test, We consider that this results is helpful for saying about the safety of TSE ointment in clinical use.