• Journal of the Korean Society of Food Science and Nutrition
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• v.41 no.5
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• pp.612-620
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• 2012

This study was performed to investigate the 4-week repeated-dose toxicity of $Lactobacillus$ $plantarum$ AF1 ($Lb.$ $plantarum$ AF1), a lactic acid bacteria isolated from kimchi, in male and female rats. Sprague-Dawley male and female rats were divided into four groups, with 10 animals in each group. The test article was administered once daily by gavage to rats at dosage levels of 0, 0.5, 1.0, and 2.0 g/kg/day for 4-weeks. There were no test articlerelated deaths or abnormal clinical signs in either gender of rat during the observation period. Furthermore, no differences were found between the control and treatment groups in terms of body weight changes, food intake, and water consumptions. Hematological parameters, serum biochemical analysis, and any other findings also showed no significant or dose-dependent alterations. There were no alterations in organ weights upon administration of $Lb.$ $plantarum$ AF1. These results suggest that there were no adverse effects of oral application of $Lb.$ $plantarum$ AF1 up to a dosage level of 2.0 g/kg in both male and female rats.

• Journal of Physiology & Pathology in Korean Medicine
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• v.22 no.6
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• pp.1439-1443
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• 2008

The objective of this study was to evaluate the acute toxicity of Taeumjowi-tang in rats. SPF Sprague-Dawley male and female rats were administered orally with Taeumjowi-tang extract of 2,500 mg/kg(low dosage group), and 5,000 mg/kg(high dosage group). We daily examined number of deaths, clinical signs, body weights and gross findings for 14 days. No dead animal and no significant changes of body weights were found during the experimental period. In addition, no differences were found between control and treated groups in clinical signs, hematology, serum biochemistry, and other findings. In conclusion, Taeumjowi-tang extract did not show any toxic effects, and oral LD50 value was over 5,000 mg/kg in SD rats.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.8 no.2
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• pp.272-288
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• 1998

The purpose of this study was to investigate the acute(4 hrs) and repeated-dose(6 hrs a day, 5 days a week, 8 weeks) toxic effects of 1-bromopropane(1-BP) on Sprague-Dawley (SD) rats which were treated by inhalation. The results were as follows ; 1. The median lethal concentration($LC_{50}$) was estimated 14,374 ppm(confidence limit 95% ; 13,624~15,596 ppm) in acute inhalation. Abnormal clinical signs related to the 1-BP were not observed with the acute inhalation dose. Gross findings of necropsy revealed no evidence of specific toxicity related to the 1-BP. 2. By sub-acute inhalation the body weights of male and female were significantly reduced(p<0.001) by the dose of 1,800 ppm compared with control group, while the relative weights of liver were significantly increased(p<0.001) in both sexes. However there were no significant variation in food consumption, urine biochemistry, hematology and blood biochemistry for the exposed rats compared with the control rats. Abnormal clinical signs and gross findings of necropsy related to the 1-BP were not shown. No toxicologic lesions were observed by the histopathological test.

• Journal of Physiology & Pathology in Korean Medicine
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• v.22 no.4
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• pp.762-765
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• 2008

Ephedrae herba(Ma-huang) has been used to treat respiratory conditions for over 5,000 years. The early 1990s, the herbal ephedra and other products containing ephedrine began to be promoted as weight loss aids in United States. The objective of this study was to evaluate the acute toxicity of hebal ephedra in rats. SPF Sprague-Dawley male and female rats were administered orally with herbal ephedra extract of 2,500 mg/kg(low dosage group), and 5,000 mg/kg(high dosage group). We daily examined number of deaths, clinical signs, body weights and gross findings for 14 days. No dead animal and no significant changes of body weights were found during the experimental period. In addition, no differences were found between control and treated groups in clinical signs, hematology, serum biochemistry, and other findings. In conclusion, herbal ephedra extract did not show any toxic effects and oral LD50 value was over 5,000 mg/kg in SD rats.

• Nutrition Research and Practice
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• v.8 no.5
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• pp.539-543
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• 2014

BACKGROUND/OBJECTIVES: Soy isoflavones are structurally similar to estrogen and bind to estrogen receptors, suggesting that they exhibit estrogenic activities; therefore, they are referred to as phytoestrogens. Fermentation may affect the bioavailability of isoflavones altering soy isoflavone glycosides in the form of aglycones. Thus, this study investigated the effects of fermented soybeans by Rhizopus oligosporus on bone metabolism in both young rats as a pilot test and in ovariectomized (ovx) old rats as a model of menopause. MATERIALS/METHODS: In the pilot test, a total of 24 seven-week-old female Sprague-Dawley (SD) rats were fed one of three diets for a period of four weeks: casein, unfermented soybean product, or fermented soybean product by R. oligosporus. In the ovx rat model, 20-week-old SD rats weighing 260-290 g underwent either sham-operation (n = 10) or bilateral ovariectomy (n = 30) and were then fed the AIN-93M diet for one week. Thereafter, rats were fed sham-casein, ovx-casein, ovx-soybean, or ovx-fermented soybean diet for five weeks. After decapitation, femoral bones were isolated and preserved in 9% formalin for assessment of bone mineral density (BMD), bone mineral content (BMC), and bone-breaking strength (BBS). RESULTS: Ovx rats showed significantly increased weight gain and decreased uterine wet weight. Of particular interest, ovx rats fed fermented soybeans showed increased uterine wet weights compared to control rats. Fermented soybean diet caused a significant increase in plasma 17-${\beta}$ estradiol concentrations in young rats, and 17-${\beta}$ estradiol levels were enhanced in ovx rats to match those of sham-operated ones. Significantly lower femoral BMD and BMC were observed in ovx rats compared to sham-operated controls, whereas bone areas did not differ statistically among the groups. In addition, BBS tended to be increased in ovx rats fed soybeans and fermented soybeans. CONCLUSIONS: Supplementation of fermented soybeans could have preventive and therapeutic effects against osteoporosis in postmenopausal women.

• Herbal Formula Science
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• v.10 no.2
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• pp.73-83
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• 2002

The single dose toxicity of Jengjengamiyjintang, a herbal drug for duodenal ulcer was evaluated in male and female Sprague-Dawley (SD) rats. Jengjengamiyjintang was once administered to both sexes of rats at the dose levels of 2000, 1000, 500, 250 and 125mg／kg for oral route according to KFDA guidelines for single dose toxicity test (1999-61). In addition, vehicle control group was added in order to compare clinical signs, body weight changes and abnormal necropsy findings. After single administration, clinical signs were observed every twice a day for 14 days and body weights were measured 5 times including initial measurement on day 0. When observation period was over, the animals were sacrificed and macroscopic examination of major organs was conducted. Neither significant clinical signs nor death after administration was observed during the observation periods except for soft feces or diarrhea that were restricted to Day 1 of 2000 and 1000mg/kg-dosing groups. Although some accidental findings such as gross and histopathological changes of lung that were demonstrated in some animals of all experimental groups including vehicle control group, no abnormal necropsy findings and changes of body weight were observed at terminal necropsy in both sexes. From these results, it is considered that $LD_{50}$ of Jengjengamiyjintang is over 2000mg／kg in oral administration in both sexes of rats and approximated lethal dose was considered over 2000mg/kg.

• The Korea Journal of Herbology
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• v.39 no.2
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• pp.19-25
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• 2024

Objectives : Jeopgoltang (JGT) is a new Korean herbal medicine formulation that is used to treat bone fractures. Although JGT is frequently used in clinical practice, there is a lack of scientific evidence on its safety. This study aimed to evaluate the preclinical toxicity of JGT using a single oral dose toxicity test in Sprague-Dawley (SD) rats. Methods : Five male and female rats per group were orally administered 1,250, 2,500, or 5,000 mg/kg of JGT after fasting for 12 h. Mortality and changes in clinical signs, body weight, and necropsy findings were monitored for 14 days according to the guidelines of the Korean Ministry of Food and Drug Safety and Organisation for Economic Co-operation and Development (OECD). Results : No significant clinical signs or mortality were observed after a single administration of up to 5,000 mg/kg. In addition, no significant necropsy findings related to JGT administration were observed. Conclusions: In conclusion, these results suggest that approximate Lethal Dose (ALD) of JGT on SD rats is over 5,000 mg/kg.

• Toxicological Research
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• v.32 no.4
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• pp.327-335
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• 2016

This study aimed to evaluate the potential toxicity and safety of ethyl hydrogen adipate (EHA) by determining its effect on the reproductive function and development of Sprague-Dawley (SD) rats at dose levels of 0 (control), 200, 400, and 800 mg/kg/day. One male and five females of the 800 mg/kg/day died. Body weight loss was observed in the males of the 800 mg/kg/day and in females of the 400 and 800 mg/kg/day. In addition, mating indices decreased and pre-implantation loss rates increased in parental animals of the 400 and 800 mg/kg/day. The gestation index decreased in the male and female rats of the 800 mg/kg/day. Moreover, the body weight of the pups from the 800 mg/kg/day group decreased on post-parturition day 4. These results indicated that the no-observed-adverse-effect level of EHA for parental males and females was 400 mg/kg/day and 200 mg/kg/day, respectively, and that for pups was 400 mg/kg/day.

• Korean Journal of Veterinary Research
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• v.44 no.3
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• pp.373-378
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• 2004

To help the interpretation of causes of death, it is critical that the background incidence of factors contributing to death be recorded and archived. Information was gathered from the control groups of 19 rat carcinogenicity studies. All cases of death occurring within the 2-year period were reviewed. Out of 1124 males and 1084 females, 720 male (64.1%) and 689 female (63.6%) decedents were recorded. There was no difference in the probability of survival between two sexes. Analysis of factors contributing to death revealed that 400 males (48.7%) had neoplastic changes, 189 males (23.0%) had non-neoplastic lesions, and 232 males (28.3%) died from unknown causes. In females, these figures were 627 (76.4%), 62 (7.6%) and 132 (16.0%), for neoplastic, non-neoplastic and unknown findings, respectively. It could be suggested that the risk of death by non-neoplastic reasons was higher in the males than in the females, whereas females were more likely to be affected by tumours. In the neoplastic causes of death, pituitary tumours were the most common in both sexes, followed by mammary tumours in females, and haemopoietic tumours in males. In non-neoplastic cause of death, renal diseases were the most common in both sexes, followed by skin diseases and cardiovascular diseases in males, and skin diseases and poditis in males. A relatively large number of animals (28.3% in males and 16.0% in females) were found dead, without any significant clinical or histologically identifiable cause. Most of the animals with pituitary tumours were killed in extremis and the proportion of females (70.1%) being greater than males (46.8%). There were no case which died by accident, and also only minimal incidence which died by bleeding procedures.

• Journal of Korean Medicine Rehabilitation
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• v.28 no.2
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• pp.61-72
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• 2018

Objectives The purpose of this experiment is to evaluate 4 weeks DRF (Dose Rate Finding) and single oral dose toxicity of ChondroT in rats. Methods In 4-week DRF, male and female Sprague-Dawely rats were treated with ChondroT at oral dose of 0, 500, 1000, and 2000 mg/kg. clinical signs, body weight, food consumption, necropsy findings, organ weight, hematological and blood-chemical parameters, and histological findings were monitored for 4 weeks. Also, after single oral administration of ChondroT, mortality, clinical signs, body weight, and necropsy findings were minitored for 2 weeks. Results In 4-week DRF and single dose oral toxicity study of ChondroT in sprague-Dawley rats, ChondroT did not exhibit any toxicity under the study conditions employed. Conclusions The results suggested a no-observed adverse effects level (NOAEL) was over 2,000 mg/kg/day in SD rats after oral administration, this study could be used as basic study of the repeated dose 13-week oral toxicity study of ChondroT.