• The Journal of Internal Korean Medicine
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• v.32 no.4
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• pp.599-609
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• 2011

Objectives : The aim of this study was to evaluate the single oral dose toxicity and safety of Bojungikgi-tang (Buzhongyiqi-tang) and fermented Bojungikgi-tang (Buzhongyiqi-tang) extracts in male and female ICR mice. Methods : In the single oral dose toxicity study, non-fermented and fermented Bojungikgi-tang (Buzhongyiqi-tang) were administered to male and female ICR mice as an oral dose of 1250, 2500 and 5000 mg/kg. Changes of body weights, general behaviors, adverse effects and mortality were determined throughout the experimental period. Hematological parameters, serum chemistry, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There was no mortality or sign of toxicity in the single oral dose toxicity study. There were also no significant differences in body weights, organ weights, and hematological parameters, serum chemistry values between treatment and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of fermented Bojungikgi-tang (Buzhongyiqi -tang) in both female and male mice can be considered as well over 5,000 mg/kg, so these medicines can be safe in clinics.

• Fire Science and Engineering
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• v.20 no.4 s.64
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• pp.26-32
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• 2006

Nowadays in Korea, KS F 2271 has been using for the test of fire safety performance of sandwich panels. Smoke toxicity test is the test for the toxicity evaluation of smoke and hazardous gas, caused by combustion of building materials and finishing materials. Smoke toxicity can be evaluated by the mean incapacitation time of mice; however this method is not a quantitative way. This test result can be influenced by the health status of mice and test condition. Specific optical density can be quantitatively measured by ISO 5659-2 single chamber method and toxic gases can be quantitatively measured by FTIR analysis. In this study, specific optical density of sandwich panel insulations, which are widely used in Korea, were tested using the ISO 5659-2 single chamber test method and compared with each test. Also, in the second test of three tests for each specimen, FTIR analysis was performed and quantitative test results(HCl, $NO_2$, etc) were compared with each test result.

• The Journal of Internal Korean Medicine
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• v.39 no.4
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• pp.676-685
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• 2018

Objectives: The aim of this study was to estimate the single oral toxicity of Peucedani Radix (PR) ethanol extracts. PR is one of the important herbs for removal of phlegm, the viscous turbid pathological product that can accumulate in the body and cause a variety of diseases. However, research on the pharmacologic toxicity of PR is lacking. Methods: In this study, PR was orally administered to 5-week-old male ICR mice at an oral dose of 2,000, 3,000, or 5,000 mg/kg. After a single-dose administration, the mortality and behavioral changes were observed daily and body weights were measured every two days. After 14 days, the organ weight, organ index, macroscopy, hematological analysis, and serum biochemistry analysis were determined. Results: No mortality, body weight changes, abnormal behavioral changes, or anatomical signs of toxicity were found. The organ weight, organ index, hematological analysis, and serum biochemistry analysis were also within the normal ranges. Conclusions: These results suggest that the 50% lethal dose of PR is more than 5,000 mg/kg. This could indicate that PR is a safe drug without acute toxicity and side effects.

• Journal of Pharmacopuncture
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• v.18 no.3
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• pp.42-48
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• 2015

Objectives: The aim of the study is to investigate both the single-dose intramuscular injection toxicity and the approximate lethal dose of water-soluble Carthami-flos and Cervi cornu parvum pharmacopuncture (WCFC) in male and female Sprague-Dawley (SD) rats. Methods: The study was conducted at Biotoxtech Co. according to the Good Laboratory Practice (GLP) regulation and the toxicity test guidelines of the Ministry of Food and Drug Safety (MFDS) after approval of the Institutional Animal Care and Use Committee. Dosages for the control, high dose, middle dose and low dose groups were 0.5 mL/animal of saline and 0.5, 0.25 and 0.125 mL/animal of WCFC, respectively. WCFC was injected into the muscle of the left femoral region by using a disposable syringe (1 mL, 26 gauge). The general symptoms and mortality were observed 30 minutes, 1, 2, 4, and 6 hours after the first injection and then daily for 14 days after the injection. The body weights of the SD rats were measured on the day of the injection (before injection) and on the third, seventh, and fourteenth days after the injection. Serum biochemical and hematologic tests, necropsy examinations, and histopathologic examinations at the injection site were performed after the observation period. Results: No deaths, abnormal clinical symptoms, or significant weight changes were observed in either male or female SD rats in the control or the test (0.125, 0.25, and 0.5 mL/animal) groups during the observation period. No significant differences in hematology and serum biochemistry and no macroscopic abnormalities at necropsy were found. No abnormal reactions at injection sites were noted on the topical tolerance tests. Conclusion: The results of this single-dose toxicity study show that WCFC is safe, its lethal doses in male and female SD rats being estimated to be higher than 0.5 mL/animal.

• Proceedings of the Korean Society of Applied Pharmacology
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• 2001.11a
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• pp.89-89
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• 2001

Paclitaxel is currently administered i.v. as a slow infusion of a solution of the drug in an ethanol: cremophor EL: saline admixture. However, poor solubilization and toxicity are associated with this drug therapy. We have tried to develop a new surfactant for paclitaxel to improve efficacy and reduce toxicity of solubilizer. We performed the hemolysis test for chemicals which passed the paclitaxel-stabilizing test and 5 chemicals showing relatively low hemolytic effects were tested for a single dosing toxicity test. And then aceporol 330, which showed the most favorable result, was introduced to the repeated dosing toxicity tests in mouse and beagle dog. According to data based on body weight, mortality, dissection, homological test and biochemical test, Aceporol 330 exhibited much more reduced toxicity than cremophor EL.

• Journal of Acupuncture Research
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• v.38 no.1
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• pp.47-59
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• 2021

Background: This study aimed to assess the toxicity of Aconitum sinomontanum Nakai (ASN) pharmacopuncture. Methods: To investigate the toxicity of ASN pharmacopuncture, single and 4-week repeated dose toxicity experiments were conducted on BALB/c mice. In the single-dose toxicity experiment, mice were assigned 1 of 4 groups (5 males, 5 females per group). Then, 31.25, 62.5, and 125 mg/kg of ASN pharmacopuncture were administered to the mice in the experimental groups at acupoint ST36, while 0.2 mL of normal saline was administered to the control group at ST36. After a 4-week repeated dose regimen, the mice were assigned into 4 groups (5 males, 5 females per group). Then, 15.625, 31.25, and 62.5 mg/kg of ASN pharmacopuncture at ST36 were administered to the mice in the experimental groups, while 0.2 mL of normal saline was administered to the control group at ST36. Mortality, morbidity, general body and organ weight changes (after 4 weeks repeated dose), serum hematological and biochemical values, and histopathological changes in the liver and kidney were observed. Results: In both single and 4-week repeated dose toxicity experiments, no deaths or symptoms occurred in any of the groups. There were no significant differences between groups in terms of body and organ weights, serum hematological and biochemical values, and specific organ histopathological changes. Conclusion: ASN pharmacopuncture injection did not demonstrate significant toxicity in BALB/c mice compared with the control group, with a no-observed-adverse-effect level for a single dose of >125 mg/kg, and for 4 weeks repeated dose it was more than 62.5 mg/kg/day.

• Toxicological Research
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• v.20 no.2
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• pp.123-129
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• 2004

The present study was conducted to investigate the single and 2-week repeated dose toxicity of DHP2, a hydrophobic drug delivery vehicle, in ICR mice. The test article was administered orally to mice at the dose levels of 2.5, 12.5 and 37.5 g/kg for single dose toxicity study and at the dose levels of 0, 2.5, 5, and 10 g/kg for repeated dose toxicity study. In both studies, there were no treatment-related effects on mortality, clinical signs, food and water consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, necropsy findings and organ weights of all animals treated DHP2. Based on these results, it was concluded that the 2-week repeated oral dose of DHP2 may have no toxic effect in mice at a dose level of 10 g/kg. In the condition of this study, the no-observed-adverse-effect level (NOAEL) was considered to be 10 g/kg/day for both sexes.

• Biomolecules & Therapeutics
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• v.16 no.1
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• pp.40-45
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• 2008

The objective of this study was to investigate the single dose and 2-week repeated dose toxicity of Aceporol 330 in ICR mice following single intravenous administration and to compare its toxicity with a commercially available solubilizer of paclitaxel, Cremophor EL. In single dose toxicity test, $LD_{50}$ of Aceporol 330 in mice was estimated to be greater than maximum applicable dose, 4 ml/kg. However, $LD_{50}$ of Cremophor EL in male mice was determined to be 4 ml/kg. Maximum tolerated dose (MTD) of males and females in Aceporol 330-treated group and MTD of females in Cremophor EL-treated group were 3 ml/kg. MTD of males in Cremophor EL-treated group was less than 3 ml/kg. Characteristic toxic symptoms, and hematological and blood chemical changes were not observed after single dose and repeated dose of Aceporol 330 or Cremophor EL. No histopathological abnormalities were found in organs of all animal groups. Based on the linear pharmacokinetic property of paclitaxel and the higher $LD_{50}$ in mice, Aceporol 330 has a potential for use as a safer solubilizer for paclitaxel than Cremophor EL.

• The Journal of Internal Korean Medicine
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• v.34 no.4
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• pp.349-361
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• 2013

Objectives : This study aimed to evaluate the single oral dose toxicity and four weeks repeated dose determination of Gamisasangja-tang (GST) in male and female Sprague-Dawley rats. Methods : In the single oral toxicity study, rats were orally administered a single dose of 0 and 5,000 mg/kg GST. There were 5 rats in each group. After single administration, mortality, clinical signs, body weight changes and gross pathological finding were observed for 14 days. In the 4-weeks repeated oral dose determination study, rats were orally administered a single dose of 0, 1,250, 2,500 or 5,000 mg/kg GST. There were 5 rats in each group. Mortality, clinical signs, body weight changes, food consumption and gross pathological finding were observed for 28 days. Organ weight, clinical chemistry and hematology were tested after 28 days. Results : There was no mortality in either of the two studies. There were also no significant differences in clinical sign, body weight, organ weights, hematological or serum chemical parameters between the GST and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of GST is over 5,000 mg/kg, so this finding would be expected to provide scientific evidence for the safety of GST.

• Herbal Formula Science
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• v.25 no.1
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• pp.11-28
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• 2017

Objectives : The contents of aconitine in aconiti radix lateralis preparata, purified hot water extract of Aconiti Radix lateralis preparata, and purified hot water extract of Sambutang-P that contains Aconiti Radix lateralis preparata was analyzed to compare toxicity. Toxicity of Sambutang-P that contains Aconiti Radix lateralis preparata was assessed with a single oral toxicity test on 6-week-old male and female Sprague-Dawley rats. Methods : 1. The contents of aconitine in Aconiti Radix lateralis preparata, purified hot water extract of Aconiti Radix lateralis preparata, and purified hot water extract of Sambutang-P that contains Aconiti Radix lateralis preparata was analyzed using the purity test according to the "Korean Herbal Pharmacopoeia". 2. 2,000mg/kg was injected for the single oral toxicity test of purified hot water extract of Sambutang-P that contains Aconiti Radix lateralis preparata, and the test was done for a test group (injection) and a control group, each with 5 male and 5 female rats. For 14 days after injection, rats were observed for general symptoms and changes in weight. Afterwards, blood biochemical test, autopsy, and histophathological exam of the liver was conducted. Results : 1. The contents of aconitine was 0.0785% for Aconiti Radix lateralis preparata, 0.1510% for purified hot water extract of Aconiti Radix lateralis preparata, and 0.1248% for purified hot water extract of Sambutang-P that contains Aconiti Radix lateralis preparata. 2. There was no death of either male or female rats in both the control group and the test group (injection of 2,000mg/kg). 3. No unusual symptom was observed in both the control group and the test group (injection of 2,000mg/kg). 4. No significant change in weight was observed for both male and female rats in the test group (2,000mg/kg). 5. The histopathological exam of ALT, AST, ALP, GGT and LDH showed no significant changes for both male and female rats in the test group (2,000mg/kg). 6. According to the autopsy results, no visible abnormality of organs or tissues was found in both the control group and the test group (2,000mg/kg). 7. According to the histopathological exam of the liver, the effect of the injected material was not observed for either male or female rats in the test group (2,000mg/kg). Conclusions : The contents of aconitine in Aconiti Radix lateralis preparata was lower for decoction of Sambutang-P with ginseng radix alba than for decoction of only Aconiti Radix lateralis preparata. This suggests that ginseng radix alba can dilute toxicity of Aconiti Radix lateralis preparata. As for a single oral toxicity test of Sambutang-P that contains Aconiti Radix lateralis preparata, no abnormal reaction was observed even when the injection amount far exceeded a toxic dose or a lethal dose. Thus, it is deemed that using Sambutang-P at a clinically prescribed dose would not lead to hepatoxicity.