• Journal of Pharmacopuncture
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• v.18 no.4
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• pp.45-50
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• 2015

Objectives: In this study, we investigated the 4-week repeated-dose oral toxicity of gami-jakyak gamcho buja decoction (Mecasin) to develop safe treatments. Methods: In order to investigate the 4-week oral toxicity of Mecasin, we administered Mecasin orally to rats. Sprague-Dawley (SD) rats were divided into four groups of five male and five female animals per group: group 1 being the control group and groups 2, 3, and 4 being the experimental groups. Doses of Mecasin of 500, 1,000, and 2,000 mg/kg of body weight were administered to the experimental groups, and a dose of normal saline solution of 10 mL/kg was administered to the control group. We examined the survival rate, weight, clinical signs, and gross findings for four weeks. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: No deaths occurred in any of the four groups. No significant changes in weights or food consumption between the control group and the experimental groups were observed. Serum biochemistry revealed that some groups showed significant decrease in inorganic phosphorus (IP) (P < 0.05). During necropsy on the rats, one abnormal macroscopic feature, a slight loss of fur, was observed in the mid dosage (1,000 mg/kg) male group. No abnormalities were observed in any other rats. In histopathological findings, the tubular basophilia and cast of the kidney and extramedullary hematopoiesis of the spleen were found. However, those changes were minimal and had occurred naturally or sporadically. No other organ abnormalities were observed. Conclusion: During this 4-week, repeated, oral toxicity test of Mecasin in SD rats, no toxicity changes due to Mecasin were observed in any of the male or the female rats in the high dosage group. Thus, we suggest that the doses in a 13-week, repeated test should be 0, 500, 1,000, and 2,000 mg/kg respectively.

• Natural Product Sciences
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• v.25 no.2
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• pp.157-164
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• 2019

The study was conducted to investigate the acute and sub-acute toxicity effect of Aquilaria malaccensis leaves aqueous extract (AEAM) towards male ICR mice in terms of body weight, relative organ weight, mortality rate and sperm parameters. In acute toxicity study, a single dose at of 2000 mg/kg was performed. In sub-acute toxicity study, the mice were received normal saline (control group), 50, 100, 150, 200, 500, or 1000 mg/kg of AEAM orally for 21 days of treatment. In sub-acute toxicity study, the number of abnormal sperm were significantly decreased in AEAM 100, 150, 200, 500, and 1000 when compared to the control group. While, the motility of sperm were found to be significantly increased in AEAM 100, 150, 200, and 1000 as compared to the control group. No mortality was recorded in the control group and treated groups in both toxicity studies except for one mouse from AEAM 1000 group. However, the mild sedative effect in terms of the tendency to sleep was clearly noticeable in both toxicity studies. Results indicated that the AEAM can be one of the useful alternative medicine to enhance fertility rate by increasing healthy sperm production.

• Biomedical Science Letters
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• v.22 no.2
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• pp.46-52
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• 2016

Salicornia herbacea L. (S. herbacea) is an annual herbaceous plant of Chenopodiaceae. It grows in groups on the coast or mud flat of Korea is known to be rich in minerals. S. herbacea has potent anti-cancer, antioxidant, anti-obesity, bowel function improvement. However, pharmacological mechanisms of S. herbacea extract (SHE) remain poorly understood. The aim of this study was to investigate the potential acute toxicity of SHE in ICR mice administered a single oral dose of 0, 500, 1,000, and 2,000 mg/kg by gavage. After administration of the extract, signs of toxicity were observed every day for 14 days. No mortality, abnormal clinical signs, body weight, organ weight or pathological changes were observed compared to a control group, and there were no differences in the body weights of the control and treatment groups. Biological serum activities and histological tests were not significantly changed in the treatment group compared to the control group. Especially, treatment of SHE was significantly decreased of total cholesterol and triglyceride levels. These results indicated that a single oral administration of SHE does not exerts any toxic effects at a dose of 2,000 mg/kg and that the $LD_{50}$ of SHE is greater than 2,000 mg/kg. Accordingly, SHE appears to have potential in various functional agents of foods, without toxicity.

• The Journal of Internal Korean Medicine
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• v.34 no.2
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• pp.155-164
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• 2013

Objectives : This study aimed to evaluate the single oral dose toxicity of Jaeumganghwa-tang (Ziyinjianghuo-tang) and Jaeumganghwa-tang (Ziyinjianghuo-tang) fermented with Lactobacillus acidophyllus in male and female ICR mice. Methods : In this single oral toxicity study, non-fermented and fermented Jaeumganghwa-tang (Ziyinjianghuo-tang) were administered to male and female ICR mice as an oral dose of 500, 1000 and 2000 mg/kg. After single administration, body weight changes, general behavior, adverse effects and mortality were determined for 14 days. Serum chemistry, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There were no mortality or signs of toxicity for 14 days. There were also no significant differences in body weights, organ weights, or serum chemistry values between treatment and control groups. Conclusions : These results indicate that the 50% lethal dose of Jaeumganghwa-tang (Ziyinjianghuo-tang) fermented with Lactobacillus acipophullus may be over 2000 mg/kg. This finding can be expected to provide scientific evidence for the safety of Jaeumganghwa-tang (Ziyinjianghuo-tang) fermented with Lactobacillus acidophyllus.

• Preventive Nutrition and Food Science
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• v.18 no.2
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• pp.111-116
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• 2013

Chrysanthemum indicum is widely used to treat immune-related and infectious disorders in East Asia. C. indicum flower oil contains 1,8-cineole, germacrene D, camphor, ${\alpha}$-cadinol, camphene, pinocarvone, ${\beta}$-caryophyllene, 3-cyclohexen- 1-ol, and ${\gamma}$-curcumene. We evaluated the safety of C. indicum flower oil by conducting acute oral toxicity, bone marrow micronucleus, and bacterial reverse mutation tests. Mortality, clinical signs and gross findings of mice were measured for 15 days after the oral single gavage administration of C. indicum flower oil. There were no mortality and clinical signs of toxicity at 2,000 mg/kg body weight/day of C. indicum flower oil throughout the 15 day period. Micronucleated erythrocyte cell counts for all treated groups were not significantly different between test and control groups. Levels of 15.63~500 ${\mu}g$ C. indicum flower oil/plate did not induce mutagenicity in S. Typhimurium and E. coli, with or without the introduction of a metabolic activation system. These results indicate that ingesting C. indicum flower oil produces no acute oral toxicity, bone marrow micronucleus, and bacterial reverse mutation.

• The Journal of Korean Medicine
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• v.37 no.1
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• pp.135-150
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• 2016

Research Methods: This research analyzed the data on those aged 20 and older from the Report on Korean Medicine Usage Research, which was conducted in 2011. The definitions of toxicity were defined by the presence of toxicity listed in the survey. The questions used in analysis were sex, age, household income, health insurance, medical fees, satisfaction rates on treatments, as well as the types of diseases and the presence of toxicity from treatments. The analysis was done through frequency analysis using SAS 9.2 and Fisher's Exact Test. Results: Toxicity occurred in 2.1% patients out of the 3518 studied. The types of toxicity were skin problems, such as hives and pruritus (34.7%), gastrointestinal problems (20.8%), neurological diseases (4.2%), liver(1.4%), kidney toxicity(1.4%), and others (22.2%). There were no differences in toxicity by sex, age, household income and the types of health insurances. However, toxicity were positively correlated with the increase in standard of education (p=0.0124). In addition, as treatment costs increased (p<0.0001) and satisfaction rates decreased, toxicity increased (p<0.0001). Toxicity increased in patients with low back pain (p=0.0429), hwabyung (p=0.0392), lumbar sprain (p=0.0004), correction body type (p=0.0118), growth (p=0.0045), and from motor accidents (p=0.0448). In logistic regression analysis, Toxicity were positively correlated with medical fees, and cancer treatment and negatively correlated with satisfaction rate on treatments. Conclusion: The toxicity that occurred in outpatients who used Korean medical clinics mostly happened in skin, digestive organs, nerves, livers, and kidneys toxicity. The occurrences differed by the Educational lengths, expensive costs of treatments, low satisfaction rates of the treatments, and cancer.

• Toxicological Research
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• v.18 no.2
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• pp.195-203
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• 2002

This study was performed to evaluate single and repeated-dose toxicities oj a new cophalosporin antibiotic agent IDC-7l81 in Sprague-Dawley rats. IDC-7181 was injected intravenously to rats at dose levels of 0, 3.2, 16, 80, 400 and 2,000 mg/kg/day for single-dose toxicity study and at dose levels of 0, 10, 50 and 250 mg/kg/day for 4-week repeated-dose toxicity study. In both studies, there were no dose-related changes in mortality clinical signs, body weight changes, food and water consumption, opthalmoscopy, organ weights, urine analysis, biochemical examination, and hematological findings of all animals treated with IDC-7l8l. Gross and histopathological findings revealed no evidence of specific toxicity related to IDC-7181. These results suggest that the intravenous maximum tolerated dose value of IDC-7181 may be over 250 mg/kg and $LD_{50}$ value may be over 2,000 mg/kg in rats.

• Toxicological Research
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• v.19 no.4
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• pp.259-266
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• 2003

Although 'Cinnamon' has been widely used for the food and biophamacy in the world, it's toxicity was not screened completely. Major component of 'cinnamon' is CB-OH and CB-PH. CB-PH has been reported to have antimutagenic effect. To investigate the toxicity of 2-o-Benzoylcinnama-Idehyde (CB-PH), repeated dose (4 weeks) oral toxicity test performed in SD rats. Results of repeated dose oral toxicity tests for 4 weeks (CB-PH; 500, 1000, 2000 mg/kg/day) suggested that the CB-PH treated group showed no significant toxicological findings with body weights, organ weights, hematological and histopathological findings. Therefore, these data indicated that the maximum tolerated dose of CB-PH was 2000 mg above/kg/day in the rats.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.32 no.3
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• pp.209-220
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• 2022

Objectives: This study was performed to suggest how to re-establish criterion for toxic substances under the Chemical Control Act (CCA) in South Korea by comparing the GHS (Globally Harmonized System of Classification and Labeling of Chemicals) score and toxic properties. Methods: Toxic substances were classified into seven groups (Acute toxicity (1A), Chronic toxicity (2C), Environmental hazards (3E), Acute toxicity & chronic toxicity (4AC), Chronic toxicity & environmental hazards (5CE), Acute toxicity & environmental hazards (6AE), and Acute toxicity & chronic toxicity & environmental hazards (7ACE)) according to their toxic properties. The GHS score was calculated to sum up five toxicity indicators (health acute toxicity, health repeated toxicity, carcinogenicity, health other chronic toxicity and environmental hazards). Results: The GHS score of 7ACE was higher by 7 times that of 1A. 1A is the only group which has lower than the total GHS score. The highest score was 47, for sodium chromate (CAS no. 7775-11-3), which belongs to group 7ACE. This is classified as acute toxicity, carcinogenicity, germ cell mutagenicity, reproductive toxicity, and acute and chronic environmental hazard. On the other hand, the lowest score was 2.75, which was assigned to 177 chemicals belonging to group 1A. When the health acute toxicity indicator was omitted from the toxic criterion, toxic substances could be divided into the sub-groups 'human chronic hazards group' (HCG) and 'environmental hazards group' (EG) according to their GHS score and properties. Conclusions: The proposed criterion for toxic substances is to establish sub-groups defined as HCG and EG for separate control and that the 1A group be moved to substances requiring preparation for accidents under the CCA.

• Toxicological Research
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• v.18 no.2
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• pp.139-147
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• 2002

Hantaan (HTNV) and Puumala (PUUV) viruses cause hemorrhagic fever with renal syndrome in human. In the present study, the repeated dose toxicity of the HTNV-PUUV combination vaccine was evaluated in Sprague-Dawley rats. Animals were injected subcutaneously for 28 days with dosages of 0, 0.017, 0.17 and 1.7 dose/kg body weight per day, respectively. No any significant changes of body weight, food and water consumptions were shown. There were no death and clinical findings during the experimental period. In both male and female rats, there were not significant changes in hematological and serum biochemical analysis, urinalysis, and ophthalmoscopic and histopathological examination. These results indicate that the HTNV-PUUV combination vaccine may have no toxic effects and no observed adverse effect level (NOAEL) may be over 1.7 dose/kg/day at subcutaneous route in rats.