• Title/Summary/Keyword: Acute oral toxicity study

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Single Oral Dose Toxicity Study of Pinelliae Rhizoma Aqueous Extract in ICR Mice

  • Lim, Young-Kwon;Park, Ji-Ha;Seo, Bu-Il;Roh, Seong-Soo;Ku, Sae-Kwang
    • Toxicological Research
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    • v.25 no.3
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    • pp.147-157
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    • 2009
  • This study was conducted to obtain acute information of the oral dose toxicity of lyophilized water extract of Pinelliae Rhizoma, a dried tuber of Pinellia ternata (PR) in male and female mice. In order to calculated 50% lethal dose (LD$_{50}$) and approximate lethal dose (ALD), test material was once orally administered to male and female ICR mice at dose levels of 2000, 1000, 500, 250, 125 and 0 (vehicle control) ml/kg (body weight). The mortality and changes in body weight, clinical signs, gross observation, organ weight and histopathology of principle organs were monitored 14 days after treatment with PR extract. We could not find any mortalities, clinical signs, changes in the body and organ weights, gross and histopathological findings except for dose-dependent increases in the hepatic fatty change frequencies detected in PR extract 2000 and 1000mg/kg treated in both male and female mice. The results obtained in this study suggest that LD$_{50}$ and approximate LD in mice after single oral dose of PR extracts were considered over 2000 mg/kg in both and female male mice, but more than 1000mg/kg of PR extracts treatment could induce slight hepatotoxicity the fatty changes in mice.

Acute Toxicity of Leuconostoc kimchii GJ2, An Exopolysaccharide-Producing Lactic Acid Bacteria Isolated from Kimchi, in Mice (김치로부터 분리한 Exopolysaccharide생성 유산균 Leuconostoc kimchii GJ2의 마우스에 대한 급성독성)

  • Lee, Jae-Joon;Lee, Yu-Mi;Chang, Hae-Choon;Lee, Myung-Yul
    • Journal of Life Science
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    • v.17 no.4 s.84
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    • pp.561-567
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    • 2007
  • The present study was carried out to investigate the acute toxicity of Leuconostoc kimchii GJ2(Leu. kimchii GJ2), an exopolysaccharide-producing lactic acid bacteria isolated from kimchi, in ICR male and female mice. The test article was intraperitoneally or orally administered to both sexes of mice. Then followed a 14-day period of observation. In intraperitoneal acute toxicity test, mice were injected intraperitoneally with dosage of 0, 700, 900, 1,100, 1,300, 1,500, 1,700, 1,900, 2,100, 2,300 and 2,500 mg/kg. Intraperitoneal 50% lethal doses($LD_{50}$) of Leu. kimchii GJ2 was >2,500 mg/kg in male and female mice. In oral acute toxicity test, male and female mice were gavaged with Leu. kimchii GJ2 of five doses(0, 625, 1,500, 2,500 and 5,000 mg/kg). Oral $LD_{50}$ of Leu. kimchii GJ2 was consider to be higher than 5,000 mg/kg. Furthermore, no significant changes in general conditions, body weights, clinical signs and any gross lesions were observed in both sexes of mice administered intraperitoneally or orally with Leu. kimchii GJ2. In conclusion, our results suggest that no adverse effect level of Leu. kimchii GJ2 is estimated to be over 2,500 mg/kg in the intraperitoneal route and 5,000 mg/kg in the oral route, respectively.

RECLINICAL TOXICITY STUDY OF A NEW PHOSPHODIESTERASE-5 INHIBITOR (I) ACUTE TOXICITY STUDY AND MUTAGENICITY

  • Kim, Dong-Hwan;Hyeon Cho;Kang, Kyung-Koo;Ahn, Byoung-Ok;Kim, Won-Bae
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2001.05a
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    • pp.127-127
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    • 2001
  • Single-dose toxicity of a new phosphodiesterse inhibitor-5, DA -8159, was studied in rats via oral and intravenous routes and in mice via oral route. In addition, genotoxic potential of DA-8159 was investigated by using of the battery of test; reverse mutation test on bacteria, chromosomal aberration test on cultured mammalian cells and micronucleous test on mice.(omitted)

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General and Genetic Toxicology of Enzyme-Treated Ginseng Extract - Toxicology of Ginseng Rh2+ -

  • Jeong, Mi-Kyung;Cho, Chong-Kwan;Yoo, Hwa-Seung
    • Journal of Pharmacopuncture
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    • v.19 no.3
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    • pp.213-224
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    • 2016
  • Objectives: Ginseng Rh2+ is enzyme-treated ginseng extract containing high amounts of converted ginsenosides, such as compound k, Rh2, Rg3, which have potent anticancer activity. We conducted general and genetic toxicity tests to evaluate the safety of ginseng Rh2+. Methods: An acute oral toxicity test was performed at a high-level dose of 4,000 mg/kg/day in Sprague-Dawley (SD) rats. A 14-day range-finding study was also conducted to set dose levels for the 90-day study. A subchronic 90-day toxicity study was performed at dose levels of 1,000 and 2,000 mg/kg/day to investigate the no-observed-adverse-effect level (NOAEL) of ginseng Rh2+ and target organs. To identify the mutagenic potential of ginseng Rh2+, we conducted a bacterial reverse mutation test (Ames test) using amino-acid-requiring strains of Salmonella typhimurium and Escherichia coli (E. coli), a chromosome aberration test with Chinese hamster lung (CHL) cells, and an in vivo micronucleus test using ICR mice bone marrow as recommended by the Korean Ministry of Food and Drug Safety. Results: According to the results of the acute oral toxicity study, the approximate lethal dose (ALD) of ginseng Rh2+ was estimated to be higher than 4,000 mg/kg. For the 90-day study, no toxicological effect of ginseng Rh2+ was observed in body-weight changes, food consumption, clinical signs, organ weights, histopathology, ophthalmology, and clinical pathology. The NOAEL of ginseng Rh2+ was established to be 2,000 mg/kg/day, and no target organ was found in this test. In addition, no evidence of mutagenicity was found either on the in vitro genotoxicity tests, including the Ames test and the chromosome aberration test, or on the in vivo in mice bone marrow micronucleus test. Conclusion: On the basis of our findings, ginseng Rh2+ is a non-toxic material with no genotoxicity. We expect that ginseng Rh2+ may be used as a novel adjuvant anticancer agent that is safe for long-term administration.

Acute Toxicity Study on Coptidis Rhizoma in Mice (황련의 급성독성에 관한 연구)

  • 마진열;성현제;주혜정;김인락;황금희;정규용
    • Toxicological Research
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    • v.15 no.1
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    • pp.103-107
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    • 1999
  • In order to evaluate acute toxicity of Coptidis rhizoma, 6 week- and 13 week-old male ICR mice received Coptidis rhizoma extract (600~4,800 mg/kg body weight) orally, and toxicological responses were observed for consecutive 7 days. In the mice received relatively high concentration of Coptidis rhizoma($\geq$1,200mg/kg), death occurred within 3 hrs after oral administration, and its ratio in 13 week-old mice was conspicuously higher than that in 6 week-old mice. $LD_{50}$ of Coptidis rhizoma were estimated to bi 2,575 mg/kg and 1,490 mg/kg body weight in 6 week and 13 week-old mice, respectively. Coptidis rhizoma-treated animals manifested a variety of abnormal clinical findings such as ptosis, crouching, lethargy, convulsion, bizarre behavior and truning sideway. These abnormalities also ranked highly in the 13 week-old mice compared to those in the 6 week-old mice. In addition to abnormal behaviors, Coptidis rhizoma($\geq$1,200 mg/Kg) significantly elevated the urinary contents of bilirubin, urobilirubin, protein and glucose, and values in 13 week-old mice was higher than those in 6 week-old animals. No toxicological response was observed at concentration less than 600 mg/kg. Our results clearly demonstrate that susceptibility of mice to Coptidis rhizoma may be related with age, indicating that younger age mice is more resistant to the Coptidis rhizoma than the older, and toxicological mechanism of Coptidis rhizoma may be closely associated with its pharmacological mechanism.

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Single Oral Toxicity Study on the Polysaccharide Fraction of Pueraria lobata in Rats (갈근 다당체 분획의 단회경구투여 독성에 관한 연구)

  • Chang, Bo-Yoon;Cho, Houng-Kwon;Jun, Ki-Young;Hur, Jong-Moon;Park, Hyun;Kim, Sung-Yeon
    • Korean Journal of Pharmacognosy
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    • v.41 no.3
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    • pp.210-215
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    • 2010
  • Acute toxicity on the polysaccharide fraction of Pueraria lobata was examined using male and female Sprague-Dawley rats. The polysaccharide fraction of Pueraria lobata was orally administered at a dose of 5 mg/kg, 50 mg/kg, 500 mg/kg, 2,000 mg/kg and 5,000 mg/kg and observed for two weeks. No mortality and abnormal clinical signs were observed at the doses used. There were not any significant differences in parameters of blood biochemical values and urinalysis by the treatment of test material. All rats were appeared to be healthy and normal throughout the observation period. Also there was no difference in net body weight gain and gross pathological findings among the groups rats treated with different doses of the polysaccharide fraction with Pueraria lobata.

Intensity-Modulated Radiotherapy for Nasopharyngeal Carcinoma: Penang General Hospital Experience

  • Phua, Chee Ee;Tan, Boon Seang;Tan, Ai Lian;Eng, Kae Yann;Ng, Bong Seng;Malik, Rozita Abdul;Ishak, Wan Zamaniah Wan
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.7
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    • pp.3287-3292
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    • 2012
  • Purpose: To study the overall treatment time (OTT) and acute toxicity of intensity-modulated radiotherapy (IMRT) treatment for nasopharyngeal carcinoma (NPC). Methods: This retrospective study covered all NPC patients who underwent radical IMRT treatment at the Penang General Hospital from June 2011 to February 2012. Patients of any age and stage of disease with histologically proven diagnosis were included. Information was collected on patient demographics, clinical stage, treatment received, including any neoadjuvant and/or concurrent chemotherapy, acute toxity and completion of IMRT within the OTT. Results: A total of 26 NPC patients were treated with IMRT during the study period; 88.5% had stage III/IV disease. 45.2% received neo-adjuvant chemotherapy while 50.0% were given concurrent chemo-irradiation. All patients completed the treatment and 92.3% within the 7 weeks OTT. Xerostomia was present in all patients with 92.3% having grade 2. Severe grade III/IV acute toxicity occurred in 73.1% of patients, the commonest of which was oral mucositis (57.6%). This was followed by dysphagia which occurred in 53.8%, skin reactions in 42.3% and weight loss in 19.2%. However, haematological toxicity was mild with only one patient having leucopaenia. Conclusion: IMRT treatment for NPC is feasible in our center. More importantly, it can be delivered within the 7 weeks OTT in the majority of patients. Severe grade 3/4 toxicity is very common (73.1%) and thus maximal nutritional and analgesic support is required throughout the treatment.

Acute Oral Toxicity of Taeumjowi-tang in SD Rats (SD계 흰쥐에 대한 태음조위탕(太陰調胃湯)의 급성 경구 독성 시험 연구)

  • Chang, Mun-Seog;Shim, Kyung-Jun;Kim, Hyu-Young;Park, Eun-Hwa;Ko, Eun-Bit;Choi, Bong-Jae;Yang, Woong-Mo;Lim, Hyung-Ho;Lee, Myeong-Jong;Park, Seong-Kyu
    • 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.

Acute Oral Toxicity of Ephedrae Herba in SD Rats (SD계 흰쥐에 대한 마황 추출물의 급성 경구투여 독성 시험 연구)

  • Chang, Mun-Seog;Shim, Kyung-Jun;Oh, Ji-Hoon;Yoon, Ji-Won;Choi, Moon-Jung;Kim, Do-Rim;Yang, Woong-Mo;Lim, Hyung-Ho;Lee, Myeong-Jong;Park, Seong-Kyu
    • 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.

Acute Oral Toxicity of Surfactin C in Mice (마우스에 대한 Surfactin C의 급성경구독성시험)

  • Park, Byung-Kwon;Lim, Jong-Hwan;Hwang, Youn-Hwan;Kim, Myung-Seok;Song, In-Bae;Lee, Hong-Gee;Han, Sung-Jin;Hwang, Mi-Hyun;Kim, Jong-Woo;Rhee, Man-Hee;Park, Seong-Chung;Yun, Hyo-In
    • Toxicological Research
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    • v.22 no.4
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    • pp.453-458
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    • 2006
  • This study was carried out to investigate the acute toxicity of surfactin C in mice. Surfactin C was administered orally at does of 0, 381, 610, 977, 1562 and 2500 mg/kg. Number of deaths, clinical signs, body weights, feed and water consumptions, and biochemical examinations were investigated for 14 days after single oral administration of surfactin C. $LD_{50}$ value was over 2500mg/kg in mice. In addition, no differences were found between control and treated groups in clinical signs, body weight gains, hematology, serum chemistry, feed and water consumptions. The results indicate that surfactin C did not show any toxic effects at 2500 mg/kg in mice.