• Journal of Life Science
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• v.26 no.2
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• pp.204-211
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• 2016

The objective of this study was to obtain acute (single) oral dose toxicity information on Lactobacillus-fermented Araliae Continentalis Radix aqueous extracts (fACR) in female and male ICR mice, as compared with Araliae Continentalis Radix aqueous extracts (ACR). After administering a single oral dose of fACR, no treatment-related mortalities were observed within 14 days after the end of treatment up to 2,000 mg/kg, the maximum dosage for rodents of both sexes; moreover, no fACR treatment-related changes in the body and organ weights, clinical signs, necropsy, and histopathological findings were detected in this experiment. In addition, no ACR 2,000 mg/kg treatment-related mortalities, clinical signs, body and organ weights, or gross and histopathological findings were observed, as compared with equal genders of vehicle control. The results obtained in this study suggest that fACR is non-toxic in mice and is, therefore, likely to be safe for clinical use. The LD₅₀ and approximate LD in female mice and male mice, respectively, were considered after a single oral dose of fACR over 2,000 mg/kg, the maximum dosage for rodents. In addition, no specific targets or clinical signs were detected in the present study. ACR 2,000 mg/kg-treated mice also did not show any treatment-related mortalities, clinical signs, changes to body and organ weights, or gross and histopathological findings, as compared with equal genders of vehicle control.

• Journal of the Korean Society of Food Science and Nutrition
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• v.44 no.1
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• pp.24-28
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• 2015

The present study was carried out to investigate the in vivo single-dose acute toxicity of Bacillus subtilis JNS isolated from Cheonggukjang, which is a probiotic candidate showing strong and broad antibacterial activity. The test sample was orally administrated to male and female ICR mice at a highest dose of 2,000 mg/kg for 14 days. No significant change in general conditions, mortalities, body weight changes, clinical signs, autopsy findings, or presence of gross lesions was observed in either sex of mice. The results indicate that up to 2,000 mg/kg of B. subtilis JNS had no adverse effect on ICR mice.

• Journal of Applied Biological Chemistry
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• v.65 no.1
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• pp.43-48
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• 2022

Medicinal herb demonstrated in many pharmacological effects and recognized to be safe has been used for a long time. However, side effects including safety of medicinal herb have not been identified yet. The aim of the study was to estimate safety evaluation of Magnoliae Flos used for the treatment of pain, rhinitis, and pneumonia in Korea, China and Japan through four-week dose range finding toxicity test in male and female Sprague-Dawley rats. Magnoliae Flos was orally administered to male and female SD rats once a day for 28 days at 1,500 and 3,000 mg/kg. The safety evaluation was determined to examine clinical signs, mortality, body weight, food intake, hematology, serum biochemistry and relative organ weights and there were no significant changes related toxicity. Consequently, these findings indicates that Magnoliae Flos did not show any side effects including toxicity in dose range finding toxicity test and the no observed adverse effect level for Magnoliae Flos was estimated as more than 3,000 mg/kg.

• Journal of Naturopathy
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• v.7 no.2
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• pp.63-69
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• 2018

Purpose: The purpose of this study was to investigate the effects of Bacillus fermentation broth (ENM) on the human NK cell activity, and bone matrix density, matrix content and area of hamsters fed ENM. Methods: NK cell activity was tested, and bone mineral density were measured by x-ray. Results: NK cell activity was significantly higher in the control group (644.71 pg/ml) and in the test group (1796.37 pg/ml) (p<.004). Test groups were significantly increased by 1110.37 pg/ml in the pre-test and 1796.37 pg/ml in the post-test(p<.001). Behavioral observations after feeding ENM to hamsters showed normal behavior with no difference between control and test groups. The hamster body weight of the control was 106 g at the initial and final 27 days. In the test group, the initial weight was 96.6 g and the final 27 days was 114 g. No morphological changes were observed in the X-ray photographs of the hamster hind legs. The bone matrix density was 0.059 g/cm³ in control and 0.062 g/cm³ in the test, which was increased by 0.003 g/cm³. The bone matrix content was 0.175 g in the control and 0.196 g in the test. The bone area was 2.95 cm² in the control and 3.19 cm² in the test, which was increased by 0.19 cm². In the autopsy, neither the control nor the test group showed any remarkable abnormality, and each organ was normal. Conclusions: It is thought that ingestion of ENM is useful for immunity enhancement.

• The Journal of Korean Obstetrics and Gynecology
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• v.33 no.3
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• pp.95-118
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• 2020

Objectives: The objective of this in vivo study is to observe the analgesic effects or improvements of Gyejibokryeong-hwan aqueous extracts (GJBRHe) on the Primary dysmenorrhea (PD) in rats as compared to those of Indomethacin (IND). Methods: The rats were administered with estradiol benzoate for 10 days and oxytocin 1 hour after the last 10th administration of estradiol benzoate to make the primary dysmenorrhea rat model. Gyejibokryeong-hwan aqueous extracts 500, 250 and 125 mg/kg were orally administrated, for 10 days once a day. Then the changes on the body weights and gains during experimental periods, uterine weights and gross inspections, abdominal writhing response for analgesic activities, uterus lipid peroxidation (malondialdehyde (MDA) levels), antioxidant defense system - glutathione (GSH) contents, activities of superoxide dismutase (SOD) and catalase (CAT), Nuclear factor-κB (NF-κB) and Cyclooxygenase (COX)-2 mRNA expressions, were monitored with uterus histopathology and immunohistochemistry for tumor necrosis factor (TNF)-α and inducible nitric oxide synthase (iNOS). The results of Gyejibokryeong-hwan aqueous extracts were compared to those of Indomethacin adminstered rats. Results: As results of estradiol benzoate and oxytocin treatment, noticeable decreases of body weights and gains, uterus GSH contents, SOD and CAT activities, increases of abdominal writhing responses, uterus lipid peroxidation (MDA level), uterus weights, NF-κB and COX-2 mRNA expressions were observed with increases of TNF-α and iNOS immunolabeled cells, inflammatory cell infiltrations, congestion and enlargement of the uterus at gross and histopathological inspections. These means classic inflammatory and oxidative stress mediated primary dysmenorrhea are relatively well induced. However, these signs were favorably and dose-dependently inhibited by administration of three different dosages of Gyejibokryeong-hwan aqueous extracts, but lesser than those of Indomethacin. Conclusions: The results obtained in this study suggest that Gyejibokryeong-hwan aqueous extracts has favorable analgesic and refinement activities dose-dependently on the estradiol benzoate and oxytocin treatment-induced primary dysmenorrhea signs.

• Journal of Food Hygiene and Safety
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• v.16 no.3
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• pp.212-220
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• 2001

To investigate the modifying effect of Kwao Kreu, Pueraria mirifica (PM), we performed two kind of studies which are the non-surgical medium-term carcinogenicity study and the modulation of gap junctional intercellular communication study. The first study, a non-surgical medium-term carcinogenicity bioassay was done to investigate the modifying effect of Kwao Keru, Pueyaria mirifca (PH), a rejuvenating folk medicine from Thailand, on the male F344 rat liver. Specific pathogen free, male 6-week-old F3444 rats were divided into ten groups. To induce hepatocarcinogenesis, those in all groups were given a single i.p. injection of DEN (200 mg/kg) and were received two i.p. injection of DGA (300 mg/kg) at the ends of weeks 2 and 5. Rats of group 3-6 were given sodium phenobarbital (PB 0.05% in drink). A diet containing 10 mg/kg PM was given to group 2 during the post-initiation phase and to groups 4 and 5 during promotion and initiation phase, respectively. Group 6 was given the experimental diet alone throughout the experiment (8 weeks). Rats of group 7, 8, 9 and 10 were fed 1000 mg/kg PH in the same manner as group 2, 4, 5 and 6. All animals were sacrificed at 8 weeks after DEN administration. Result of the immunohistochemical staining of the glutathione S-transferase placental form (GST-p) indicated that the numbers and areas of the preneoplastic leisions were not significantly changed in all PM treatment group comparing to control group. Also the numbers and areas of GST-p positive foci among group 7, 8, 9 and 10 were not significantly changed in comparing to control group. To study the effect of PM on the modulation of gap junctional intercellular communication, the present study was performed scrape-loading dye transfer (SL/DT) assay in human keratinocytes. The results showed that PM could not modulate GJIC. These results indicate that Pueraria mirifica may have no carcinogenic effects on experimental hepatocarcinogenesis in rats and gap junctional intercellular communication in human keratinocyte.

• Journal of Food Hygiene and Safety
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• v.21 no.2
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• pp.118-128
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• 2006

This study was conducted to determination of the endocrine distruptor function of 'Parabens' by dosing ethyl paraben, propyl paraben, isopropyl paraben, butyl paraben and isobutyl paraben to the immature SD rats. 18 groups were given vehicle control group, negative control group (Dibutyl phthalate), postive control group ($1'7-{\alpha}$ Ethynylestrdiol) and each paraben groups involved 3 dose level. Rats were injected with 62.5, 250 and 1,000mg/kg from postnatal day 19 till 21 once a day in subcutaneous and a total 3, times. There was no treatment related death. but, subcutaneous nodule, edema, alopecia and scrub formation on injection site was observed. These signs was become worse in high dose level. these signs was cause from physical stimulation by test substance which parabens were mix with com oil as vehicle. In the analysis of organ weights, absolute and relative weights of brain, spleen, liver, thymus, heart, kidneys, adrenals, ovaries and vagina were no difference with control group. but, wet and blotted weight of uterus was increased in every high dose parabens treat group. Especially, all dose level of isobutyl paraben was showed increment of uterus weight. uterus dilatation of parabens treated group was observed in gross anatomic pathology and these result was agree with wet and blotted weight of uterus. In the result of this study, estrogenic effect as endocrine distruptor was observed in ethyl paraben, propyl paraben, isopropyl paraben, butyl paraben and isobutyl paraben. and it was considered isobutyl paraben has highest estrogrnic effect under the condition of this study.

• Journal of the Korean Society of Food Science and Nutrition
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• v.40 no.2
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• pp.321-326
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• 2011

The aim of the present study was to investigate antihyperglycemic effect of Gleditschiae Spina (GS) in streptozotocin (STZ)-nicotinamide (NA)-induced type 2 diabetic rats. The rats were divided into four groups: normal control (NC), diabetic control (DC), diabetic rats supplemented with acarbose (AC, 4 mg/kg), and with GS ethanol extracts (GSE, 50 mg/kg). Weekly fasting blood glucose (FBG) for 10 weeks and oral glucose tolerance test (OGTT) at 10th week were monitored using glucose oxidase-peroxidase reactive strips. The FBG level was significantly reduced in AC group after 8 weeks and in GSE group at the end of period. The AUCs for the glucose response from OGTT and blood glucose level after sacrifice were significantly lower in the AC and GSE groups than the DC group. GSE supplementation significantly increased plasma total radical-trapping antioxidant potential (TRAP) in STZ-NA-induced diabetic rats, compared with DC group. The present study indicates that GSE could ameliorate type 2 diabetes and be comparable to acarbose, a standard hypoglycemic drug. Also, we suggest that GSE may possess antioxidant activity against the STZ-NA-induced oxidative stress.

• Journal of the Korean Society of Food Science and Nutrition
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• v.45 no.10
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• pp.1406-1413
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• 2016

This study was carried out to evaluate the toxicity of ethanolic extracts of Morus alba L. branch (ME). In the reverse mutation test, Salmonella Typhimurium TA98, TA100, TA1535, TA1357, and Escherichia coli WP2uvrA were used to estimate the mutagenic potential of ME. Sprague-Dawley rats were orally administered ME at levels of 1,250, 2,500, and 5,000 mg/kg for the single-dose toxicity test and 500, 1,000, and 2,000 mg/kg/d for the repeated-dose toxicity test for 28 consecutive days. As expected, reverse mutation was not detected at any concentration of ME, regardless of application of the metabolic activation system with or without S9 mix. In the single-dose toxicity test, ME caused neither significant visible signs of toxicity nor mortality in rats, and $LD_{50}$ was estimated to be over 5,000 mg/kg. In the repeated-dose toxicity test, ME administration at 500, 1,000, and 2,000 mg/kg for 28 days to male or female rats did not result in mortality. Similarly, no toxicologically significant treatment-related changes in body weight, food intake, or organ weights were noted. Several hematological and biochemical parameters in both genders showed significant differences, but these were within normal ranges. These results support the safe use of ME.

• Journal of Life Science
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• v.24 no.2
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• pp.191-195
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• 2014

Essential oils extracted or purified from various plants have shown various beneficial effects. Seed parts of Schizandra chinensis Baillon (Schisandrae Semen) have been used as a traditional medicine for thousands of years in parts of Asia, including Korea, China, and Japan. However, the pharmacological mechanisms of essential oils purified from S. fructus (S. chinensis Baillon) remain largely unresolved. The aim of this study was to investigate the safety of Schisandrae Semen essential oil (SSeo) by a single- dose toxicity study in mice. SSeo was orally administered at a dose of 5,000 mg/kg in ICR mice. All animals were sacrificed after 14 days of treatment. After a single administration, mortality, clinical signs, body weight changes, and gross pathological findings were observed for 14 days. We also measured parameters of organ weight, clinical chemistry, and hematology. No toxicological change related to the test substance or mortality was observed after administration of a single oral dose of SSeo. There were no adverse effects on clinical signs, body weight, or organ weight and no gross pathological findings in any treatment group. The clinical chemistry and hematological parameters were within the normal ranges except total bilirubin. Therefore, the approximate lethal dose for oral administration of SSeo in mice was considered to be over 5,000 mg/kg. The results on the single-dose toxicity of SSeo indicate that it is not possible to reach oral dose levels related to death or dose levels with any harmful side effects.