• Korean Journal of Medicinal Crop Science
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• v.26 no.2
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• pp.157-169
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• 2018

Background: Cassia tora L., an annual or perennial plant of the Fabaceae family, is traditional medicine with various biological activities, including anti-constipation and, anti-inflammation. Chemical compounds such as anthraquinone glycoside and naphthalene derivatives have been isolated from this plant. Cassia tora L. is a common contaminant of agricultural commodities, but is toxic to cattle and poultry. Methods and Results: To investigate the potential toxicity, Cassia tora L. aqueous extract (CO) was administered orally to rats for 26 weeks at 0 (control), 300, 1,500 and 3,000 mg/kg/day (n = 10 for male rats for each dose). The positive control comprised animals orally administered anthraquinone 100 mg/kg/day. There was no treatment-related mortality. An increase in the kidney weight was observed at 3,000 mg/kg/day of CO and anthraquinone 100 mg/kg/day. Macrophage infiltration in the colon was observed at CO 1,500 and 3,000 mg/kg/day and anthraquinone 100 mg/kg/day, but there were no significant toxicological changes in the incidence and severity of the finding. Conclusions: The oral no-observed-adverse-effect level (NOAEL) of CO was 3,000 mg/kg/day in male rats and no target organs were identified. In addition, 300 mg/kg was found to be the no-observed-effect level (NOEL) for systemic toxicity under the conditions of the study.

• Toxicological Research
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• v.22 no.2
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• pp.135-144
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• 2006

This study was performed to evaluate repeated-dose toxicities of STB-HO-BM in Sprague-Dawley rats. STB-HO-BM was administered orally to rats at dose levels of 0, 100, 300 and 1,000 mg/kg/day for 13 weeks. In recent study, there were no dose related changes in mortality, clinical signs, body weight changes, food and water consumption, opthalmoscopy, organ weights, urine analysis, hematological findings, and biochemical examination of all animals treated with STB-HO-BM. Gross and histopathological findings revealed no evidence of specific toxicity related to STB-HO-BM. These results suggest that the oral no observed adverse effect level (NOAEL) of STB-HO-BM may be over 1,000 mg/kg in rats.

• Toxicological Research
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• v.27 no.4
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• pp.261-267
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• 2011

Artemisia iwayomogi, a member of the Compositae, is a perennial herb easily found in Korea and used as a traditional medicine to treat liver disease. AIP1, a water-soluble carbohydrate fraction from Artemisia iwayomogi, showed anti-tumor and immuno-modulating activities in animal studies. A subacute toxicological evaluation of AIP1 was performed for 4 weeks in ICR mice. After administration of AIP1 (0, 20, 100, 500 mg/kg/day), the clinical signs, mortalities, body weight changes, hematology, blood clinical biochemistry, urinalysis, organ histopathology, organ weights and gross finding were examined. The results showed that there were no significant differences in body weight changes, food intakes, water consumptions, or organ weights among different dose groups. Also we observed no death and abnormal clinical signs during the experimental period. Between the groups orally treated with AIP1 and the control group, there was no statistical significance in hematological test or serum biochemical values. Histopathological examination showed no abnormal changes in AIP1 groups. These results suggest that no observed adverse effect level (NOAEL) of the oral administration of AIP1 for 4 weeks was considered to be more than 500 mg/kg/day in mice under the condition investigated in current study.

• Toxicological Research
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• v.20 no.4
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• pp.339-348
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• 2004

Paecilomyces sinclairii was administered ad libitum feeding at percentage levels of 0, 1.25, 2.5, 5 and 10 percentage (calculated about 8 g/kg)/feeder for a period of 3 months. There was no observed clinical signs or deaths related to treatment in all groups tested. Therefore, the approximate lethal dose of P. sinclairii was considered to be higher than 8 g/kg in rats. Mild decreases in body weight gain were observed dose-dependently in P. sinclairii treated groups in dose response manner after 2 weeks. Interestingly, the weight of abdominal adipose tissues surrounding epididymides were greatly reduced by this Dongchunghacho, in parallel with the mild increase in body weight gain. However, the absolute weight change of other organs was not observed. There were not significantly different from the control group in urinalysis, ocular examination, hematological, serum biochemical value and histopathological examination. From these results, it is concluded that the no-observed-adverse-effect level (NOAEL) of P. sinclairii is less than 1.25% (1 g/kg) in rats in the present study.

• Journal of Pharmacopuncture
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• v.19 no.3
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• pp.213-224
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• 2016

Objectives: Ginseng Rh2+ is enzyme-treated ginseng extract containing high amounts of converted ginsenosides, such as compound k, Rh2, Rg3, which have potent anticancer activity. We conducted general and genetic toxicity tests to evaluate the safety of ginseng Rh2+. Methods: An acute oral toxicity test was performed at a high-level dose of 4,000 mg/kg/day in Sprague-Dawley (SD) rats. A 14-day range-finding study was also conducted to set dose levels for the 90-day study. A subchronic 90-day toxicity study was performed at dose levels of 1,000 and 2,000 mg/kg/day to investigate the no-observed-adverse-effect level (NOAEL) of ginseng Rh2+ and target organs. To identify the mutagenic potential of ginseng Rh2+, we conducted a bacterial reverse mutation test (Ames test) using amino-acid-requiring strains of Salmonella typhimurium and Escherichia coli (E. coli), a chromosome aberration test with Chinese hamster lung (CHL) cells, and an in vivo micronucleus test using ICR mice bone marrow as recommended by the Korean Ministry of Food and Drug Safety. Results: According to the results of the acute oral toxicity study, the approximate lethal dose (ALD) of ginseng Rh2+ was estimated to be higher than 4,000 mg/kg. For the 90-day study, no toxicological effect of ginseng Rh2+ was observed in body-weight changes, food consumption, clinical signs, organ weights, histopathology, ophthalmology, and clinical pathology. The NOAEL of ginseng Rh2+ was established to be 2,000 mg/kg/day, and no target organ was found in this test. In addition, no evidence of mutagenicity was found either on the in vitro genotoxicity tests, including the Ames test and the chromosome aberration test, or on the in vivo in mice bone marrow micronucleus test. Conclusion: On the basis of our findings, ginseng Rh2+ is a non-toxic material with no genotoxicity. We expect that ginseng Rh2+ may be used as a novel adjuvant anticancer agent that is safe for long-term administration.

• Biomolecules & Therapeutics
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• v.12 no.1
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• pp.49-54
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• 2004

The present study was conducted to investigate the potential subacute toxicity of CKD-602 by a 5-day repeated intravenous administration in Sprague-Dawley rats. CKD-602 was administered intravenously to male rats at dose levels of 0, 0.08, 0.2, and 0.5 mg/kg for 5 days. Studies included general observation, body weight changes, ophthalmoscopic examination, hematology, se겨m biochemistry, gross findings at necropsy and organ weight measurement. There were no deaths in any treatment group and treatment related clinical sign was depilation in the 0.5 mg/kg groups. The decrease or suppression of body weight was also observed dose-dependently in all treatment groups. Decreased leukocyte in all treatment groups, decreased platelet in the above 0.2 mg/kg groups and increase in the serum levels of total cholesterol in the 0.5 mg/kg group were considered as a treatment related toxic effects. Decreased weight of thymus in all treatment groups anti decreased weight of spleen in the above 0.2 mg/kg group were observed. The intravenous administration of CKD-602 caused depilation and decreased weight and had toxic effect on the leukocyte, platelet, spleen and thymus. In the condition of this study, the target organs were spleen and thymus and the toxic effect level was determined to be 0.2 mg/kg, but no-observed-adverse-effect level (NOAEL) was considered to be lower than 0.08 mg/kg.

• Journal of Physiology & Pathology in Korean Medicine
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• v.21 no.4
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• pp.898-906
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• 2007

This study was to evaluate the effects of oral administration of Processed Sulphur on Hepatotoxicity. Processed Sulphur was administered orally to rats for 28 days. We measured the body and liver weight index, heamtological and biomedical parameters. We also observed the histopathological changes of liver in rats. No significant differences in body weight, liver weight index, heamtological and biomedical parameters and histopathological changes of hepatocyte between control and Processed Sulphur fed group were found. Our data indicate that hepatotoxicity was not caused by oral medication of Processed Sulphur up to 60mg/200g/day for 28 days in rats. Therefore, Processed Sulphur appears to be safe and non-toxic in these studies and a no-observed adverse effect level (NOAEL) in rats is established at 60mg/200g/day. The data could provide satisfactory preclinical evidence of safety to launch clinical trial on standardized formulation of mineral extracts.

• Journal of the Korean Society of Food Science and Nutrition
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• v.30 no.2
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• pp.234-238
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• 2001

In order to evaluate their possible subacute toxicity, groups of 40 male and female ICR mice were given to the diet with chickens irradiated up to 30 kGy for four weeks. During the experimental periods, appearance, behavior, mortality, food and water consumption of mice fed irradiated chickens were not affected compared to the control. In urine analysis, hematological as well as in serum biochemical findings, no significant differences were found between the control (non-irradiated) and the irradiated chickens. Although minor changes in biochemical parameters were observed, they were in the normal range and were not dose dependent. Spotty necrosis was found in the male liver administered with 30 kGy irradiated chicken. However, it seems not related with gamma irradiation, because it lacks either the dose dependency and the secondary changes accompanied. Our results indicate that the adverse effect of gamma irradiated chicken can be observed at more than 30 kGy level.

• Korean Journal of Veterinary Research
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• v.18 no.1
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• pp.1-7
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• 1978

In order to detect the clinical effect of combelen which is used for sedation of domestic animals, 10 heads of clinically healthy Korean native goats were used in this study. They were divided into two groups; one is dose level of 1ml per 10 kg of body weight with 1% combelen and the other is dose level of 3 ml. Clinical observations and changes in blood components after administration of combelen were made. 1. There was no adverse effect due to combelen, but sedative effect was insufficient. 2. During sedative period the changes in heart rate and respiratory rate showed noticeable change, and body temperature was slightly decreased. 3. In ECG recordings, except for slight changes in T wave, significant change was not observed. 4. Erythrocytes, leukocytes, hemoglobin concentration and packed cell volume showed tendency to decrease during the period of sedation. 5. SGOT activity showed a remarkable increase and BUN showed a great decrease 24 hours after administration in the group of 3ml/10kg. Blood glucose level increased during the period of sedation in both groups.

• Journal of Pharmacopuncture
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• v.17 no.2
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• pp.73-79
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• 2014

Objectives: This study was performed to analyze a 13-week repeated dose toxicity test of Sweet Bee Venom (SBV) extracted from bee venom and administered in Sprague-Dawley (SD) rats. Methods: Male and female 5-week-old SD rats were treated once daily with SBV (high-dosage group: 0.28 mg/kg; medium-dosage group: 0.14 mg/kg; or low-dosage group: 0.07 mg/kg) for 13 weeks. Normal saline was administered to the control group in a similar manner (0.2 mL/kg). We conducted clinical observations, body weight measurements, ophthalmic examinations, urinalyses, hematology and biochemistry tests, and histological observations using hematoxylin and eosin (H&E) staining to identify any abnormalities caused by the SBV treatment. Results: During this study, no mortality was observed in any of the experimental groups. Hyperemia and a movement disorder were observed around the area of in all groups that received SBV treatment, with a higher occurrence in rats treated with a higher dosage. Male rats receiving in the high-dosage group showed a significant decrease in weight during the treatment period. Compared to the control group, no significant changes in the ophthalmic parameters, the urine analyses, the complete blood cell count (CBC), and the biochemistry in the groups treated with SBV. Compared to the control group, some changes in organ weights were observed in the medium-and the high-dosage groups, but the low-dosage group showed no significant changes. Histological examination of thigh muscle indicated cell infiltration, inflammation, degeneration, and necrosis of muscle fiber, as well as fibrosis, in both the medium- and the high-dosage groups. Fatty liver change was observed in the periportal area of rats receiving medium and high dosages of SBV. No other organ abnormalities were observed. Conclusion: Our findings suggest that the No Observed Adverse Effect Level (NOAEL) of SBV is approximately 0.07 mg/kg in male and female SD rats.