• The Korean Journal of Food And Nutrition
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• v.11 no.1
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• pp.77-81
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• 1998

This study was performed to evaluate single-dose toxicity of the gardenia yellow pigment in Sprague-Dawley rats and New-Zealand White rabbits via oral routes. The yellow pigment was administered in rats at does levels of 5,000, 2,500, 1,250, 625, 312.5mg/kg and 9mg/kg. And also yellow pigment was administered in rabbits at does levels of 5,000, 2,500, 1,250mg/kg 0 unit /kg. The rats and rabbits of both sexes were observed daily for 14 days after single oral administration. Yellow pigment treated rats and rabbits did not induce any mortalities and abnormal signs in clinical findings, body weights, gross findings and histopathological finding. Based on these results, it is impossible to estimate LD50 values in rats and rabbits. Therefore, it was concluded that gardenia yellow pigment have no effect on acute toxicity and side effect in rats and rabbit.

• YAKHAK HOEJI
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• v.58 no.1
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• pp.62-70
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• 2014

A 28-day repeated-dose oral toxicity test was performed to determine the no-observed-effect level (NOEL) and establish an optimum dose of the highly toxic Aconiti Ciliare Tuber (ACT) used as a folk remedy. Repeated oral doses of 1,250, 2,500, and 5,000 mg/kg/day of the hot water extract of ACT were administered to five male and five female Sprague-Dawley rats in each group for 4 weeks. The indicators for toxicity included results of examination of common symptoms and changes in weight and feed intake, eye test, urinalysis, hematological and serum biochemical analyses, and post-mortem weight measurement of organs, and visual inspections. All animals survived at the end of the experiment; in addition, we observed no specific test substance-mediated symptoms. We observed no test substance-mediated changes in body weight and feed intake. We observed statistically significant changes in male OB and pH levels (p<0.05). Further, the biochemical test showed statistically significant changes in the IP value of male rats and $CL^-$valueoffemalerats (p<0.05). However, all changes were within historical data. The post-mortem examinations showed no test substance-mediated changes. Moreover, statistically significant changes under the test conditions were confirmed to have been caused by factors other than the test substance. Thus, the maximum NOEL of ACT extract in rats was estimated to be 5,000 mg/kg/day.

• Korean Journal of Veterinary Research
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• v.47 no.4
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• pp.379-387
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• 2007

This study was conducted to investigate the pathogenicity of Paenibacillus (R) polymyxa JB 115 and single oral dose toxicity of culture broth containing (${\beta}$-glucan (CBG-JB 115) produced from P. polymyxa JB 115 in Sprague-Dawely rats of both sexes for 14 days. After oral administration of P. polymyxa JB 115 into rats, we could not find any abnormal clinical signs and variation in the body weight and temperature as compared with control group. We also investigated the acute toxicity of CBG-JB 115. As the results, there were no clinical signs and variance in the body weight and temperature related with CBG-JB 115 in comparison with the control group. From the this experiment, we could not find out any significant pathogenicity and toxicity induced by P. polymyxa JB 115 or by CBG-JB 115. Results of this study demonstrated that consumption of P. polymyxa JB 115 and its culture broth containing (${\beta}$-glucan was not associated with any obvious signs of toxicity in Sprague-Dawely rats even following consumption of large quantities.

• Journal of Physiology & Pathology in Korean Medicine
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• v.25 no.4
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• pp.650-657
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• 2011

The object of this study was to obtain acute information (single oral dose toxicity) of Taraxaci Herba (Dried total parts of Taraxacum platycarpum. H.Dahlstedt (Compositae)), has been traditionally used in Korean medicine for treating various inflammatory diseases. In order to observe the 50% lethal dose (LD 50), approximate lethal dosage (ALD) and target organs, test articles were once orally administered to female and male ICR mice at dose levels of 2,000, 1,000, 500 mg/kg according to the recommendation of Korea Food and Drug Administration Guidelines. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after single oral treatment of Taraxaci Herba aqueous extracts according to KFDA Guidelines with organ weights and histopathological observations of 12 types of principle organs. After single oral treatment of Taraxaci Herba aqueous extracts, we could not find any mortality and toxicological evidences up to 2,000 mg/kg treated group, the limited dosages in rodents at body and organ weights, clinical signs, gross and histopathological observations. Except for slight soft feces, which were detected in male mice treated with 2,000 mg/kg of Taraxaci Herba aqueous extracts at 1 day after end of treatment. The results obtained in this study suggest that the LD 50 and ALD of Taraxaci Herba aqueous extracts in both female and male mice after single oral treatment were considered as over 2,000 mg/kg because no mortalities were detected up to 2000 mg/kg that was the highest dose recommended by KFDA and OECD. However, it also observed that the possibility of digestive disorders, like diarrhea when administered over 2,000 mg/kg of Taraxaci Herba aqueous extracts in the present study, but these possibilities of digestive disorders can be disregard in clinical use because they ate transient in the highest dosages male only.

• Korean Journal of Veterinary Research
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• v.48 no.4
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• pp.401-411
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• 2008

This study was performed to evaluate repeated-dose oral toxicities of Flos lonicerae extract in Fischer 344/n rats. Flos lonicerae was administered orally to rats at dose levels of 0, 37, 111, 333, 1,000 and 2,000 mg/kg/day. Each group consisted of 10 rats of each gender. The Flos lonicerae extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program and The Standards of Toxicity Study for Medicinal Products. In the present study, there were no toxicologically significant changes in mortality, clinical signs, body weight gains, ophthalmoscopy, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histopathology, estrus cycle and sperm examination of all animals treated with Flos lonicerae extract. These results suggest that the oral no observed adverse-effect level of the test item, Flos lonicerae extract, in rats is higher than 2,000 mg/kg/day in both genders. The target organs were not established.

• Korean Journal of Veterinary Research
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• v.49 no.1
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• pp.23-34
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• 2009

This study was performed to evaluate repeated-dose oral toxicities of Chelidonium majus extract in Fischer 344/N rats. Chelidonium majus extract was administered orally to rats at dose levels of 0, 25, 74, 222, 666 and 2,000 mg/kg/day. Each group consisted of 10 rats of each gender. The Chelidonium majus extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program (issued by National Institute of Toxicological Research) and The Standards of Toxicity Study for Medicinal Products (issued by Korea Food and Drug Administration). In the present study, There were no toxicologically significant changes in mortality, clinical signs, body weight gains, ophthalmoscopy, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histopathology, estrus cycle and sperm examination of all animals treated with Chelidonium majus extract. These results suggest that the oral no observed adverse-effect level of the test item, Chelidonium majus extract, in rats is higher than 2,000 mg/kg/day in both genders. The target organs were not established.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.14 no.2
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• pp.118-124
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• 2001

The single dose toxicity of Injinhotang, a herbal drug for treatment of hepatic injuries. was evaluated in Sprague-Dawley rats. Injinhotang was once administered to both sexes of rats at the dose levels of 2000, 1000, 500, 250 and 125 mg/kg for oral route. After single administration, clinical signs were observed every day for 14 days and body weights were measured 5 times including initial measurement on day 0 (the days of administration). When observation period was over, the animals were sacrificed and macroscopic examination of major organs was conducted. In addition, the histopathological profiles of these major organs were also conducted. Neither significant clinical signs nor death after administration was observed during the observation periods except for soft feces or diarrhea. In addition, no abnormal necropsy findings, changes of body weight and histopathological profiles were observed at terminal necropsy in both sexes. From these results, it is considered that $LD_{50}$ of Injinhotang is over 2000 mg/kg in oral administration in both sexes of rats.

• The Journal of Internal Korean Medicine
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• v.35 no.3
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• pp.223-243
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• 2014

Objectives: To provide information on the safety of GST (GamiSasangja-tang; CnidiiFructus, Sophora Root, Angelica Gigas Root, Clematidis Radix, Stemonae Radix, Spirodelae Herba), we carried out a 13-week repeated oral dose toxicity and a 4-week recovery test of GST in Sprague-Dawley rats. Methods: Female and male rats were treated with GST at oral doses of 1,250, 2,500, and 5000 mg/kg. The GST was administered for 13 weeks. Mortality, clinical signs, body weight changes, food consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights and histological markers were monitored during the study period. The rats were then monitored for 4 extra weeks to determine recovery time after the study period. Results: We found no mortality or abnormalities among clinical signs, body weight, food consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights or histological markers in any of the rats tested. Conclusions: The no-observed adverse effects level (NOAEL) is considered as over 5000 mg/kg for male and female rats.

• Journal of Oriental Neuropsychiatry
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• v.23 no.3
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• pp.143-160
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• 2012

Objectives : To provide information on the safety of ACM, we carried out a 13-week repeated oral dose toxicity and a 4-week recovery test of ACM in Sprague-Dawley rats. Methods : Female and male rats were treated with ACM with oral doses of 800, 2000, and 5000 mg/kg. The ACM was administered for 13 weeks. Mortality, clinical signs, body weight changes, food consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights and histological markers were monitored during the study period. Moreover, the rats were monitored for 4 extra weeks to determine recovery time after the study period. Results : We found no mortality and no abnormalities in clinical signs, body weight, food consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights and histological markers in any of the rats tested. Conclusions : The no-observed adverse effects level (NOAEL) was considered as over 5000 mg/kg for male and female rats.

• Toxicological Research
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• v.31 no.4
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• pp.403-414
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• 2015

Lithospermum erythrorhizon has long been used as a traditional oriental medicine. In this study, the acute and 28-day subacute oral dose toxicity studies of hexane extracts of the roots of L. erythrorhizon (LEH) were performed in Sprague-Dawley rats. In the acute toxicity study, LEH was administered once orally to 5 male and 5 female rats at dose levels of 500, 1,000, and 2,000 mg/kg. Mortality, clinical signs, and body weight changes were monitored for 14 days. Salivation, soft stool, soiled perineal region, compound-colored stool, chromaturia and a decrease in body weight were observed in the extract-treated groups, and no deaths occurred during the study. Therefore, the approximate lethal dose (ALD) of LEH in male and female rats was higher than 2,000 mg/kg. In the subacute toxicity study, LEH was administered orally to male and female rats for 28 days at dose levels of 25, 100, and 400 mg/kg/day. There was no LEH-related toxic effect in the body weight, food consumption, ophthalmology, hematology, clinical chemistry and organ weights. Compound-colored (black) stool, chromaturia and increased protein, ketone bodies, bilirubin and occult blood in urine were observed in the male and female rats treated with the test substance. In addition, the necropsy revealed dark red discoloration of the kidneys, and the histopathological examination showed presence of red brown pigment or increased hyaline droplets in the renal tubules of the renal cortex. However, there were no test substance-related toxic effects in the hematology and clinical chemistry, and no morphological changes were observed in the histopathological examination of the kidneys. Therefore, it was determined that there was no significant toxicity because the changes observed were caused by the intrinsic color of the test substance. These results suggest that the no-observed-adverse-effect Level (NOAEL) of LEH is greater than 400 mg/kg/day in both sexes.