• Title/Summary/Keyword: single-dose toxicity test

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Studies on Physicochemical and Biological Properties of Depolymerized Alginate from Sea tangle, Laminaria japonicus by Thermal Decomposition 8. Effects of Depolymerized Alginate on Serum Lipid Composition and Its Single-Dose Toxicity yin Oral Route in Rats (다시마 (Laminaria japonicus) Alginate의 가열가수분해에 따른 물리$\cdot$화학적 및 생물학적 특성에 관한 연구 8. 저분자 Alginate투여에 의한 랫드의 혈청지질의 성분 변화 및 경구급성독성 실험)

  • KIM Yuck-Yong;CHO Young-Je
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.34 no.3
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    • pp.173-178
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    • 2001
  • This study was performed to know the hypocholesterolemic effect of depolymerized alginate obtained by hydrolysis of alginate through a heating process at $121^{\circ}C$. The changes of total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and phospholipid levels in serum, as well as the atherogenic index were elucidated in rats for 35 days. In order to evaluate single-dose toxicity of HAG-50 in rats via oral routes, induction any mortalities and abnormal signs in clinical finding, body weight, gross findings and histopathological finding, and estimation of $LD_{50}$ were elucidated. Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and phospholipid levels in the serum significantly decreased and resulted in the decrease of atherogenic index in rats fed diets containing $5\%\;and\;10\%$ HAG-50 (p<0.01). HAG-50 did not induce any mortalities and abnormal signs in clinical findings, body weights, gross findings and histopathological findings in single-dose toxicity test via oral routes of rats, after which it was impossible to estimate $LD_{50}$ values.

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Intravenous Injection of Saeng Maek San - A Safe Method of Treatment in Rats

  • Choi, Min-Ji;Kim, Sung-Chul;Cho, Seung-Hun
    • Journal of Pharmacopuncture
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    • v.17 no.2
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    • pp.67-72
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    • 2014
  • Objectives: This study evaluated the single-dose toxicity of Saeng Maek San (SMS) in rats. Methods: All experiments were conducted at Biotoxtech (Chungwon, Korea), an institute authorized to perform non-clinical studies under the regulations of Good Laboratory Practice (GLP). A single-dose intravenous toxicity study was carried out on 40 6-week-old Sprague-Daley rats. The animals were randomly divided into the following four groups of ten animals each: Group 1 (G1) was the control group, with each animal receiving an intravenous injection of 1.0 mL of saline, and Groups 2, 3 and 4 (G2, G3 and G4) were the experimental groups, with the animals in the groups receiving an injection of 0.1, 0.5 and 1.0 mL of SMS, respectively. Mortality, clinical signs, body-weight changes and gross pathological findings were observed for 14 days following a single administration of SMS or saline. Organ weights, clinical chemistry and hematology were analyzed at 14 days. This study was conducted with the approval of the Institutional Animal Ethics Committee. Results: No deaths occurred in any of the four groups, indicating that the lethal dose of SMS in rats is greater than 1.0 mL/animal. Some changes in weights of male rats between the control group and the experimental groups were observed, but no significant changes in the weights of female rats were noted. To identify abnormalities in organs and tissues, we stained representative sections of each specified organ with hematoxylin and eosin for examination with a light microscope. No significant abnormalities were observed in any of the organs or tissues. Conclusion: The results suggest that intravenous injection of SMS is a safe method of treatment.

A 28 Day Repeated Dose-Oral Toxicity Studies of Arisaema Rhizome Aqueous Extracts in Sprague-Dawley Rats (천남성 추출물의 Sprague-Dawley 랫드를 이용한 28일 반복 경구투여 DRF독성시험)

  • Kim, Min-Kyeoung;Lee, Ji Sun;Park, Yeong Chul;Choi, Sun Mi;Lee, Sanghun
    • 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.

The Evaluation of the Acute Toxicity and Safety of Verbenalin in ICR Mice

  • Hyejeong, Shin;Yigun, Lim;Jisu, Ha;Gabsik, Yang;Taehan, Yook
    • Journal of Acupuncture Research
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    • v.39 no.4
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    • pp.310-316
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    • 2022
  • Background: Verbenalin is an iridoid glucoside, which is among the active components of some medicinal herbs such as Verbena officinalis Linn, and Cornus officinalis Siebold and Zucc. Previous studies have confirmed the antioxidant activity and neuroprotective potential of verbenalin. To confirm the safety of verbenalin, an approximate lethal dose was determined based on a single oral dose toxicity study. Methods: Institute of Cancer Research mice were randomly assigned to three verbenalin exposure groups (250, 500, and 1,000 mg/kg) and a control group (5% methylcellulose solution). There were (5 male and 5 female mice per group). Mortality, clinical signs, and body weight were monitored for 14 days, and necropsies were conducted. Results: No mortalities were observed in the control group or the verbenalin 250 mg/kg group, whereas mortalities were observed in the 500 mg/kg and 1,000 mg/kg verbenalin groups. During the observation period, stool abnormalities such as mucous stools were observed. Clinical signs such as loss of locomotor activity were observed in the 500 mg/kg and 1,000 mg/kg verbenalin groups. During the study period, significant changes in body weight were observed in the 500 mg/kg and 1,000 mg/kg verbenalin groups; however, no gross abnormalities were observed at necropsy. Overall, no toxicity was found in the 250 mg/kg group. Conclusion: The approximate lethal dose of verbenalin was estimated to be 500 mg/kg. For a more accurate assessment of the safety of verbenalin, other types of studies such as repeated-dose toxicity studies should also be conducted.

A Study on Single Oral Dose Toxicity of Highly-Developed Anthocyanin-Pigmented Rice Varieties (생리활성이 우수한 고품질 유색미의 단회 경구투여 안전성 연구)

  • Han, Hye-Kyoung;Choi, Sung-Sook;Shin, Jin-Chul;Chung, Ha-Sook
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.36 no.5
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    • pp.527-533
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    • 2007
  • The present study was carried out to investigate the potential toxicity of highly-developed rice varieties, Oryza sativa cvs. Jukjinjubyeo, Heuginjubyeo and Heughyangbyeo by a single oral dose in ICR mice. The test article was orally administered once by gavage at dose levels of 0, 2.5, 5.0, and 10.0 g/kg body weight (n=10 for male and female mice for each dose). We examined the number of deaths, general clinical signs, body weights and biochemical analysis for sexes and doses of mice between control and experimental groups. As a result all of the groups were alive during experimental periods and none of the significant clinical symptom and body weight changes were shown in all of the groups. Plasma glucose levels were valued for both control and experimental groups and there were no significant differences between the groups. The activities of aminotransferase were not increased in all experimental groups compared to control groups. The results suggest that the toxicity of the aleurone layer of Oryza sativa cvs. Jukjinjubyeo, Heugjinjubyeo and Heughyangbyeo are low and its $LD_{50}$ is over 10.0 g/kg body weight in both male and female mice.

Acute Toxicity Study of the Glyoxal by Intratracheal Instillation in Male Sprague-Dawley Rats (수컷 랫드(Sprague-Dawley)에서 글리옥살(glyoxal)의 단회 기도내 투여에 따른 급성 독성시험)

  • Kim, Hyeon-Young;Kim, Kicheon;Kim, In-Hyeon;Kim, Min-Seok;Kim, Sung-Hwan;Lee, Kyuhong
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.29 no.4
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    • pp.508-516
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    • 2019
  • Objectives: The present study was performed to obtain acute toxicity information on glyoxal in male rats after intratracheal instillation. Methods: In order to calculate the LD50 of glyoxal using Probit analysis with SAS, the test article was one intratracheal instillation to male Sprague-Dawley rats at dose levels of 0, 225, 451 or 902 mg/kg. During the test period, mortality, clinical signs, and body and organ weights were examined. At the end of the 14-day observation period, all animals were sacrificed and complete gross postmortem and histopathological examinations were performed. Results: Four animals of the 902 mg/kg group died within one week after the administration of glyoxal. All treatment group in a dose dependent manner, decreased body weight was found during the study period. The absolute and relative lung weight, and histopathological changes (bronchiolar-alveolar hyperplasia, chronic inflammation) of lung exhibited an increased in glyoxal treated groups in a dose dependent manner. However, there were no changes on the organ weights and histopathological changes of any other organ except lung. Conclusions: The results obtained in the present study suggest that the LD50 in male Sprague-Dawley rats after a single intratracheal instillation of glyoxal was considered to be 866.9 mg/kg and the lung was found to be the target organ for glyoxal.

Acute Toxicity of Yukmijihwang-tang in ICR Mice (육미지황탕(六味地黃湯)의 마우스에 대한 급성독성)

  • Jeon, Won-Kyung;Lee, Jae-Hoon;Lee, Ji-Hye;Kim, Mi-Yeon;Ma, Jin-Yeul
    • Herbal Formula Science
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    • v.17 no.2
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    • pp.65-72
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    • 2009
  • Objectives : Yukmijihwang-tang (YJT) is known as a tonifying formula for reinforcement of yin deficiency conditions. The present study was carried out to investigate the potential acute toxicity of YJT in ICR male and female mice. Methods : We investigated the acute toxicity about boiling water-extracted YJT. The test article was orally administered once by gavage to 20 male and 20 female mice at dose levels of 0 (control group), 1250, 2500 and 5000 mg/kg body weight. Mortalities, clinical findings, autopsy and body weight changes were monitored daily for the 14 days following the administration according to the Regulation of Korean Food and Drug Administration. Results : We observed survival rates, general toxicity, change of body weight, and autopsy. Single oral administration of YJT with different dosages, no animals died of the test drug. Autopsy of animal revealed no abnormal gross finding. Therefore, $LD_{50}$ value of YJT for ICR mice was more than 5000 mg/kg on oral route. Conclusions : These results suggest that no toxic dose level of YJT in mice is considered to be more than 5000 mg/kg. Consequently, it was concluded that YJT have no effect on acute toxicity and side effect in ICR mice.

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Acute Toxicity Study of Modified Je-Ho-Tang in ICR Mice

  • Lee, In-Sun;Lee, Jeong-Hwa;Han, Jae-ll;Song, Woon-Heung;Kim, Mi-Yeon;Jeon, Won-Kyung
    • Korean Journal of Clinical Laboratory Science
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    • v.44 no.2
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    • pp.59-65
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    • 2012
  • Previous studies have shown that modified Je-Ho-Tang (MJHT) has anti-platelet effects. Je-Ho-Tang (JHT), a Korean court beverage, is a traditional Korean herbal medicine that has been used for the treatment of a disease attended by great thirst, and for prevention of illness in hot summers. We made MJHT from JHT by excluding honey. The present study was performed to determine the acute oral toxicity of crude extract of MJHT in male and female ICR mice. We investigated the in vivo single dose acute toxicity of MJHT hot-water extraction. This test was orally administered once by gavage to 20 mice of each sex received doses of 0 (control group), 1250, 2500 and 5000 mg/kg body weight. Mortalities, clinical findings, autopsy findings and body weight changes were monitored daily for 14 days following the administration. We observed survival rates, general toxicities, changes of body weight, and autopsy. No significant lethality was observed after single oral administration of MJHT at the different dosages. Autopsies on the animals revealed no gross abnormalities. Therefore, the LD50 value of MJHT for ICR mice was estimated more than 5000 mg/kg by the oral route. These results suggest that no toxic dose level of MJHT in mice is considered to be more than 5000 mg/kg. Consequently, it was concluded that MJHT have no effect on acute toxicity and side effect in ICR mice.

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Mouse Single Oral Dose Toxicity Test of Lactobacillus-fermented Araliae Continentalis Radix Aqueous Extracts (fACR) (독활의 복합 유산균 발효 추출액의 마우스에 대한 단회경구투여 독성시험)

  • Jung, Young-Mi;Ku, Sae-Kwang;Lee, Dong Sub;Kwon, Kisang
    • Journal of Life Science
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    • v.26 no.2
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    • pp.204-211
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    • 2016
  • The objective of this study was to obtain acute (single) oral dose toxicity information on Lactobacillus-fermented Araliae Continentalis Radix aqueous extracts (fACR) in female and male ICR mice, as compared with Araliae Continentalis Radix aqueous extracts (ACR). After administering a single oral dose of fACR, no treatment-related mortalities were observed within 14 days after the end of treatment up to 2,000 mg/kg, the maximum dosage for rodents of both sexes; moreover, no fACR treatment-related changes in the body and organ weights, clinical signs, necropsy, and histopathological findings were detected in this experiment. In addition, no ACR 2,000 mg/kg treatment-related mortalities, clinical signs, body and organ weights, or gross and histopathological findings were observed, as compared with equal genders of vehicle control. The results obtained in this study suggest that fACR is non-toxic in mice and is, therefore, likely to be safe for clinical use. The LD50 and approximate LD in female mice and male mice, respectively, were considered after a single oral dose of fACR over 2,000 mg/kg, the maximum dosage for rodents. In addition, no specific targets or clinical signs were detected in the present study. ACR 2,000 mg/kg-treated mice also did not show any treatment-related mortalities, clinical signs, changes to body and organ weights, or gross and histopathological findings, as compared with equal genders of vehicle control.

Acute Toxicity of CKD-602, a New Anticancer Agent, in Rats

  • Kim, Jong-Choon;Shin, Dong-Ho;Kim, Sung-Ho;Kim, Joon-Kyun;Cha, Shin-Woo;Han, Jung-Hee;Suh, Jeong-Eun;Chung, Moon-Koo
    • Biomolecules & Therapeutics
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    • v.12 no.1
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    • pp.43-48
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    • 2004
  • The present study was carried out to investigate the potential acute toxicity of CKD-602 by a single intravenous dose in Sprague-Dawley rats. Ten males females were used in each test groups: a vehicle control, 34.7, 4l.7, 50.0, 60.0 and 72.0 mg/kg groups, and were given different single intravenous doses of CKD-602 to the test animals. Mortalities, clinical findings, and body weight changes were monitored for the 14-day period following the administration. At the end of l4-day observation period, all animals were sacrificed and complete gross postmortem examinations were performed. One, 1, 2, 8 and 9 cases of deaths occurred in the male dose groups of 34.7, 41.7, 50.0, 60.0 and 72.0 mg/kg, respectively, and 1, 5 and 9 cases in the female dose groups 50.0, 60.0 and 72.0 mg/kg, respectively. An increase in the incidence of clinical signs such as alopecia, skin pallor skin ulcerations, emaciation and change of fecal material was found in the both sexes of all treatment groups. A decrease or Suppression in the body weight was also observed in a dose-dependent manner. In autopsy, male and/or female rats of the treatment groups showed treatment-related gross findings such as splenomegaly, atrophy of the testis, epididymis, seminal vesicles, ovary, uterus and thymus which were dose-dependent in incidence and severity. Based on these results, it was concluded that a single intravenous injection of CKD-602 to rats caused significant toxicities in gastrointestinal, hematopoietic, and reproductive systems. The $LD_{50}$ value was 53.8 (95% confidence limit: 48.5~60.6) mg/kg for males and 60.l (95% confidence limit: 55.3~65.8) mg/kg for females. The $LD_{10}$ value was 39.9 (95% confidence limit: 3l.7~44.8) mg/kg for males and 50.3 (95% confidence limit: 40.6~54.8) mg/kg for females.