• The Korea Journal of Herbology
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• v.28 no.1
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• pp.15-21
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• 2013

Objectives : To evaluate the safety of KOB, a polyherbal medicine for allergic rhinitis, we conducted a subchronic toxicology study. Methods : Dried extract of KOB(Lot. No. 11003, yield : 41.1%) was prepared from GLP company (Hanpoong Pharm & Food Co., Ltd). KOB was repeatedly administrated orally of male SD rats at daily dose levels of 500 (G2), 1250 (G3) and 5000 (G4) mg/kg/day for 13 weeks. We recorded the clinical signs of toxicity, body weight, food intake/consumption, optometry, urine analysis, organ weights, hematology, and conducted serum biochemical analysis, necropsy, gross and histological changes in target organs of Sprague-Dawley rats, and clinical chemistry analysis. Results : Neither death nor any toxicological signs were obserbed in KOB at all doses of 500, 1250 and 5000 mg/kg/day during the administration period for thirteen-week. Furthermore, there was no difference in body weight and food-take consumption, optometry, necropsy, organ weight, gross pathological findings, and urine analysis among the groups of rats treated with different doses of KOB, during at the observation period for thirteen-week. The hematological analysis and clinical blood chemistry data were revealed no toxic effects from repeated-dose administration of KOB in rats during the observation period. Conclusions : Based on these results, the no observable adverse effect level (NOAEL) of KOB was considered to be 5000 mg/kg/day for male rats under these study conditions.

• Journal of Korean Medicine for Obesity Research
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• v.18 no.1
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• pp.36-49
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• 2018

Objectives: The study is aimed at evaluating the possible toxicity in 90-day repeated oral administration of modified Samjung-hwan (mSJH) in Sprague-Dawley (SD) rats. This study was conducted to detect the no-observed adverse effect level (NOAEL). Methods: Modified SJH extract was administered orally in male and female SD rats at dose of 0, 1,000, 2,000, 4,000 mg/kg. Each group consisted of 10 rats of each gender. The modified SJH extract was given once a day for 90 days. We monitored the changes of mortalities, clinical signs, body weight changes, food consumption, ophthalmologic findings, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histological markers of all animals treated with modified SJH extract during the study period. Results: There were no toxicologically significant changes in mortalities, clinical signs, body weight gains, food consumption, ophthalmologic findings, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histological markers in any of rats tested. Conclusions: The NOAEL of the modified SJH extract in male rats and no observed effect level (NOEL) in female rats are considered 4,000 mg/kg.

• Korean Journal of Plant Resources
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• v.28 no.4
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• pp.371-381
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• 2015

The object of this study was to obtain single oral dose toxicity of Arisaema Rhizome (Arisaema amurense f. serratum (Nakai) Kitag) aqueous extracts. Arisaema Rhizome (Chunnamsong in Korean) is one of the most important folk remedy plants used in Asia. In the study, a 28-day rat oral gavage study has been conducted with the extracts from Arisaema Rhizome at dose of 1,250, 2,500 and 5,000 ㎎/㎏/day. The following endpoints were evaluated: clinical observations, body weight, gross and microscopic pathology, clinical chemistry, and hematology. Based on the analysis of these endpoints, it was estimated that NOEL (no observed effect level) for male rats and NOAEL (no observed adverse effect level) for female rats are 5000 ㎎/㎏/day of the water-extracts from Arisaema Rhizome.

• International Journal of Industrial Entomology and Biomaterials
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• v.32 no.1
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• pp.12-25
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• 2016

Recently, research investment in the improvement of food safety as a food source and specializing of nutritional source of edible insects is being actively conducted. Cricket especially has been attracting considerable interest in entomophagy; however, research on the safety assessment of cricket is limited. This study investigated the effects of cricket ethanol extract when orally administrated in Sprague-Dawley rats. Here, we performed a 4 wk repeated oral dose toxicity test in Sprague-Dawley rats following the Organization for Economic Cooperation and Development test guidelines 407 under Good Laboratory Practice regulation. Rats were randomly allocated 4 groups: vehicle control, 250, 500, 1,000 mg/kg test groups and administrated based on body weight for 28 d. The animals were observed for mortalities and clinical signs, body weight changes, food and water consumption. At the end of treatment period, blood and urine were collected and analyzed. Subsequently, the animals were sacrificed and subjected to gross pathological examination and organ weight measurement. The organs were preserved for histopathological examination. The results showed that there were no systemic toxicological effects related with the cricket ethanol extract in the 4 wk oral repeated dose toxicity study. It is considered that NOAEL of cricket ethanol extract is greater than 1,000 mg/kg/d and there was no target organ detected.

• The Korea Journal of Herbology
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• v.36 no.5
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• pp.109-115
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• 2021

Objectives : 'Johyun' yulmoo which is a new variety of Coix lacryma-jobi var. ma-yuen Stapf sprout was developed and registered by Rural development administration in 2004. This variety was derived from the cross between single cross of Suwon-6 and Okayama and UCN300-25 as F1. It is characterized by early maturity, short plant height, a strong resistance, and a superior yield and is suitable for the central and northern regions. Accordingly, we were performed and evaluated single oral dose toxicity test of 'Johyun' yulmoo sprout (JYS) in Sprague-Dawley (SD) rats. Methods : Single oral dose toxicity test was performed using with male and female rats. Rats were divided into two groups: Group 1, vehicle-treated rats (Control); Group 2, JYS 5000 mg/kg-treated rats. JYS was orally administered to male and female rats at dose levels of 5000 mg/kg. Animals were monitored on the mortality, clinical signs, body weight changes, and necropsy findings for 14 days. groups : Group 1, vehicle-treated rats (Control); Group 2, JYS 5000 mg/kg-treated rats. JYS was orally administered to male and female rats at dose levels of 5000 mg/kg. Animals were monitored on the mortality, clinical signs, body weight changes, and necropsy findings for 14 days. Results : After oral treatment of JYS, we could not find any mortality at 5000 mg/kg. Compared with the control group, there were also no significant differences in clinical sign, weight changes, weight gain, and gross abnormalities in JYS 5000 mg/kg-treated group. Conclusions : Taken together, these results suggest that approximate lethal dose of JYS was considered as over 5000 mg/kg. Results from this study provide scientific evidence for the safety of JYS. Moreover, this study could be used as a basis for dose-setting data of the repeated dose 13-week oral toxicity test of JYS.

• Journal of Applied Biological Chemistry
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• v.62 no.2
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• pp.123-127
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• 2019

Medicinal herb in Asian countries has been traditionally used for a long time. However, the safety and adverse effect of medicinal herb have not been established yet. The aim of this study is to evaluate toxicity in the oral administration of Clausena excavata (C. excavata) in male ICR mice for 3 weeks and the noobserved adverse effect level (NOAEL). C. excavata has been used as a medicinal herb for the treatment of dermatopathy, malaria, abdominal pain, dysentery, and enteritis. C. excavata was orally administered daily for 21 days at a dose of 100, 250, 500, 1000, and 2000 mg/kg/day (MPK). There were no significant differences in mortalities, clinical signs, body weight changes, hematological, and serum biochemistry examination in all animals administrated with C. excavate. Consequently, these findings indicated that C. excavata did not affect the toxic effect in ICR mice and the NOAEL of C. excavata was considered as more than 2000 MPK.

• Biomolecules & Therapeutics
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• v.4 no.4
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• pp.354-363
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• 1996

This study was conducted to investigate the repeated dose toxicity of DA-9601, an antiulcer agent of Artemisia app. extract, in rats. DA-9601 was administered orally once a day for 4 weeks to 10 males and 10 females per group at doses of 0(vehicle control), 125, 500 or 2000 mg/kg/day. Throughout the study, no treatment-related deaths and clinical signs were observed. In female rats receiving 125 mg/kg of DA-9601, water consumption increased slightly on day 4, 11 and 25. Hematological examination showed a decrease of MCV and an increase of PLT in male rats at the doses of 500 and 2000 mg/kg groups. Blood biochemistry revealed slight decreases of cholesterol, BUN and Na in male rats and decreases of total bilirubin and creatinine and slight increases of globulin and Cl in female rats. The organ weights at the end of 4 weeks showed slight changes in some organs of treated groups. But, all these changes were not considered to be of toxicological importance, because they did not show dose-response relationship and relevance to gross and microscopic findings. Histopathologically, abnormal treatment-related changes were not observed in any organ and target organs were not detected. On the basis of these results, the NOAEL(no-observed-adverse-effect level) of DA-9601 was estimated to be more than 2000 mg/kg/day under the conditions tested.

• Biomolecules & Therapeutics
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• v.11 no.1
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• pp.72-79
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• 2003

The present study was conducted to investigate the potential subacute toxicity of AS6, [(3$\beta$, 4$\alpha$)-3,23-dihydroxyurs-12-en-28-oic acid], by a 4-week repeated oral administration in Sprague-Dawley rats. To test the subacute toxicity, AS6 was administered once daily by gavage to rats at dose levels of 0, 250, 500, and 1000 mg/kg/day for 4 weeks. There were no treatment-related effects on mortality, clinical signs, body weight, food and water consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, necropsy findings, organ weights, and histopathology in any treatment group. In the condition of this study, target organ was not observed and the no-observed-adverse-effect level (NOAEL) was considered to be 1000 mg/kg/day for both male and female rats.

• Toxicological Research
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• v.23 no.1
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• pp.87-96
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• 2007

Single and repeated-dose toxicity of anti-diabetic herb extract microcapsule (ADHEM) were evaluated according to Toxicity Test Guidelines of Korea Food and Drug Administration using Sprague-Dawley rats. For single-dose toxicity test, kneading ADHEM with sterilized water were administered orally once at dose levels of 0 and 2,000 mg/kg and examined for 14 days. No dead animals, clinical signs and abnormal necropsy findings were observed and also no significant difference in body weights was found. Therefore, the $LD_{50}$ of ADHEM was considered to be higher than 2,000 mg/kg in both male and female rats. For repeated-dose toxicity test, ADHEM were mixed with powder fodder and administerd orally for 28 days at dose levels of 0, 500, 1000 and 2000 mg/kg/day. No dead animals, clinical signs and significant difference in body weights were found. In hematology and serum biochemistry, all values were included within the normal ranges. In relative organ weights, kidney or liver were significantly increased in the 500, 1000 or 2000 mg/kg/day male groups, uterus was significantly increased in the 500 mg/kg/day female group and left adrenal glands were significantly decreased in the 2000 mg/kg/day female group. In histopathological examinations, vacuolation and microgranuloma in the liver, chronic progressive nephropathy and inflammation in the kidney were observed in the 500, 1000 or 2000 mg/kg/day both male and female groups. Therefore, the no observed adverse effect level (NOAEL) of ADHEM was considered to be lower than 500 mg/kg/day in both male and female rats.

• Proceedings of the Korean Society of Toxicology Conference
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• 2001.10a
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• pp.167-167
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• 2001

This study was designed to evaluate a repeated oral dose toxicity of Polyrhachis vicina Roger in 7-week-old Sprague-Dawley rats. Animals were orally administered with dosages of 0, 20, 100, and 500 mg/kg/day of Polyrhachis vicina Roger everyday for 26 weeks, respectively. There were no dose-related changes in clinical signs, body weight changes, food or water consumption, opthalmoscopy, and hematlogical and biochemical parameters by Polyrhachis vicina Roger treatment.(omitted)