• Toxicological Research
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• v.31 no.4
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• pp.393-402
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• 2015

This study was conducted to measure toxicity of 1-chloropropane (CAS No. : 540-54-5). According to the OECD Test Guideline 413 (Subchronic inhalation toxicity: 90-day study), SD rats were exposed to 0, 310, 1,250, and 5,000 ppm of 1-chloropropane for 6 h/day, 5 day/week for 13 weeks via whole-body inhalation. Mortality, clinical signs, body weights, food consumption, motor activity, ophthalmoscopy, hematology, serum chemistry, urinalysis, organ weights, gross and histopathological findings were compared between control and all tested groups. No mortality or remarkable clinical signs were examined during the study. No gross lesions or adverse effects on body weight, food consumption, motor activity, ophthalmoscopy, urinalysis, hematology, organ weights were observed in any of male or female rats in all tested groups. In serum biochemistry, glucose was significantly decreased in males of 1,250 and 5,000 ppm groups compared to control group in dose-dependent relationship. In histopathological examination, vacuolation of acinar cells was observed in pancreas of all male and female groups exposed to 1-chloropropane. In conclusion, no observable adverse effect level (NOAEL) was considered to be below 310 ppm/6 h/day, 5 day/week for rats.

• Toxicological Research
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• v.31 no.1
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• pp.77-88
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• 2015

Lithospermum erythrorhizon has long been used in traditional Asian medicine for the treatment of diseases, including skin cancer. The oral toxicity of a hexane extract of Lithospermum erythrorhizon root (LEH) was investigated in Beagle dogs by using single escalating doses, two-week dose range-finding, and 4-week oral repeat dosing. In the single dose-escalating oral toxicity study, no animal died, showed adverse clinical signs, or changes in body weight gain at LEH doses of up to 2,000 mg/kg. In a 2 week dose range-finding study, no treatment-related adverse effects were detected by urinalysis, hematology, blood biochemistry, organ weights, or gross and histopathological examinations at doses of up to 500 mg LEH/kg/day. In the 4 week repeat-dose toxicity study, a weight loss or decreased weight gain was observed at 300 mg/kg/day. Although levels of serum triglyceride and total bilirubin were increased in a dose dependent manner, there were no related morphological changes. Based on these findings, the sub-acute no observable adverse effect level for 4-week oral administration of LEH in Beagles was 100 mg/kg/day.

• Toxicological Research
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• v.18 no.3
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• pp.241-248
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• 2002

The present study was conducted to investigate the potential subacute toxicity of CJ-10882 by a 4-week repeated oral dose in dogs. The test article was administered once dally by gavage to dogs at dose levels of 0, 2, 10, and 50 mg/kg/day for 4 weeks. During the test period, clinical signs, mortality, body weights, food consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, gross finding, organ weight, and histopathology were evaluated. Several clinical sign were observed in treated dogs at 50 mg/kg, including salivation and vomiting. Increase in the serum level of ALT and albumin observed in the female 50 mg/kg group was considered as a toxic effect related to the test article since the histopathological change in Liver was accompanied. There were no treatment-related effects on mortality, food and water consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, necropsy findings and organ weights in any treatment group. Based on these results, target organ was not observed and the no-observed-adverse-effect level (NOAEL) was 10 mg/kg/day and the absolute toxic dose was 50 mg/kg for both male and female dogs.

• Journal of Applied Biological Chemistry
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• v.65 no.4
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• pp.397-403
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• 2022

Smilax sieboldii is one of the Smilax species. A number of Smilax plants have long been used in traditional medicine in the tropics and subtropics worldwide. Repeated dose oral toxicity test is an essential experiment for toxicity evaluation before efficacy evaluation. The purpose of this study is to evaluate toxicity and the no-observed adverse effect level (NOAEL) using oral administration of Smilax sieboldii extract (SSE) in male and female ICR mice for 4 weeks. SSE was orally administered daily for 4 weeks at a dose of 500, 1000, and 2000 mg/kg/day (MPK). There were no significant differences in mortalities, clinical signs, body weight changes, food intake, hematological analysis, serum clinical chemistry test and relative organ weights in all animals administrated with SSE. The results obtained in this study suggest that SSE did not show any toxic effect in ICR mice and the NOAEL of SSE was regarded as over 2000 MPK.

• Nutrition Research and Practice
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• v.11 no.6
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• pp.452-460
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• 2017

BACKGROUD/OBJECTIVES: Turanose, ${\alpha}$-D-glucosyl-($1{\rightarrow}3$)-${\alpha}$-D-fructose, is a sucrose isomer which naturally exists in honey. To evaluate toxicity of turanose, acute and subchronic oral toxicity studies were conducted with ICR mice. MATERIALS AND METHODS: For the acute oral toxicity study, turanose was administered as a single oral dose [10 g/kg body weight (b.w.)]. In the subchronic toxicity study, ICR mice were administered 0, 1.75, 3.5, and 7 g/kg b.w. doses of turanose daily for 13 weeks. RESULTS: No signs of acute toxicity, including abnormal behavior, adverse effect, or mortality, were observed over the 14-day study period. In addition, no changes in body weight or food consumption were observed and the median lethal dose (LD50) for oral intake of turanose was determined to be greater than 10 g/kg b.w. General clinical behavior, changes in body weight and food consumption, absolute and relative organ weights, and mortality were not affected in any of the treatment group for 13 weeks. These doses also did not affect the macroscopic pathology, histology, hematology, and blood biochemical analysis of the mice examined. CONCLUSION: No toxicity was observed in the acute and 13-week subchronic oral toxicology studies that were conducted with ICR mice. Furthermore, the no-observed-adverse-effect level is greater than 7 g/kg/day for both male and female ICR mice.

• 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.

• The Journal of Internal Korean Medicine
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• v.32 no.3
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• pp.334-344
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• 2011

Objectives : Sipjeondaebo-tang is a medicine traditionally prescribed as a restorative. The aim of this study was to investigate the single oral dose toxicity and safety of extract of fermented Sipjeondaebo-tang in ICR mice. Methods : In single oral dose toxicity study, non-fermented or fermented Sipjeondaebo-tang were administered by oral gavage to ICR mice (5 males, 5 females) at single doses of varying concentrations: 1250, 2500 and 5000 mg/kg. Changes of body weight, general behavior, adverse effects and mortality were determined throughout the experimental period. Hematological parameters, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There were no mortality or signs of toxicity in single oral dose toxicity studies. There were also no significant differences in body weight, organ weight, or hematological parameters between the treatment and control groups. Conclusions : Fermented Sipjeondaebo-tang did not cause remarkable adverse effects in ICR mice. The oral lethal dose of fermented Sipjeondaebo-tang is more than 5000 mg/kg and no-observed-adverse-effect level (NOAEL) of the extract for both male and female mice is 5000 mg/kg.

• Journal of Pharmacopuncture
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• v.22 no.3
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• pp.192-199
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• 2019

Objectives: KCHO-1(Mecasin), also called Gamijakyakgamchobuja-tang originally, is a combination of some traditional herbal medicines in East Asia. This medicine has been used mainly for alleviating neuropathic pains for centuries in Korean traditional medicine. KCHO-1 was developed to treat pain, joint contracture and muscular weakness in patients with amyotrophic lateral sclerosis. This study was carried out to investigate the chronic toxicity of KCHO-1 oral administration in rats for 26 weeks. Methods: Sprague-Dawely rats were divided into four groups and 10 rats were placed in the control group and the high-dose group, respectively. Group 1 was the control group and the remaining groups were the experimental groups. In the oral toxicity study, 500 mg/kg, 1,000 mg/kg, and 2,000 mg/kg of KCHO-1 were administered to the experimental group, and 10 ml/kg of sterile distilled water was administered to the control group. Survival rate, body weight, feed intake, clinical signs, and visual findings were examined. Urinalysis, ophthalmologic examination, necropsy, organ weight, hematologic examination, blood chemical examination and histopathologic examination were performed. Results: Mortality and toxicological lesions associated with the administration of test substance were not observed in all groups. Conclusion: NOAEL(No observed adverse effect level) of KCHO-1 is higher than 2000 mg/kg/day. And, the above findings suggest that treatment with KCHO-1 is relatively safe.

• Toxicological Research
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• v.16 no.2
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• pp.151-161
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• 2000

The Three months subacute toxicity of water soluble dimethyl dimethoxy biphenylate derivative (DDB-S), newly formulated therapeutic agent for hepatitis, was invesgated in SD rats. The body weight and clinical signs were observed after intravenous injection of DDBs at doses of 57, 75 and 100 mg/kg/day for three months. Decrease in motor activity and tremor were observed above 75mg/kg treated groups. Statistically significant changes at serum biochemical analysis were found in some group, how-ever, those changes were within the normal range and had no relationship with dosage. There was no abnormal morphological and pathological findings in relation to DDB-S treatment. The no observable adverse effect level of DDB-S in rats was estimated to be 57 mg/kg/day in this study.

• Korean Journal of Veterinary Research
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• v.43 no.4
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• pp.657-666
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• 2003

The present study was undertaken to evaluate the potential adverse effects of 2-BP on pregnant dams and embryo-fetal development after maternal exposure during the gestational days (GD) 6 through 19 in Sprague-Dawley rats. The test chemical was administered subcutaneously to pregnant rats at dose levels of 0, 375, 750 and 1250 mg/kg/day. During the test period, clinical signs, mortality, body weights and food consumption were examined. All dams were subjected to caesarean section on GD 20 and their fetuses were examined for external, visceral and skeletal abnormalities. At above 750 mg/kg, toxic effects including signs of toxicity, suppressed body weight, decreased gravid uterine weight and reduced food intake were observed in pregnant dams. An increase in the fetal deaths, a decrease in the litter size, a reduction in the fetal body weight and an increase in the incidence of fetal morphological alterations were also found. There were no adverse effects on either pregnant dams or embryo-fetal development at a dose level of 375 mg/kg. These results suggest that a 14-day subcutaneous dose of 2-BP is embryolethal and teratogenic at above 750 mg/kg/day in pregnant rats. In the present experimental condition, the no-observed-adverse-effect level of 2-BP is considered to be 375 mg/kg/day for dams and embryo-fetuses, respectively.