• Title/Summary/Keyword: oral toxicity

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Acute Oral Toxicity Studies of WHS-1 and WHS-2 in Rats (경구용 복합제 WHS-1,2의 급성독성시험 연구)

  • 조대현;황세진;이원용;이주영;윤형중;문병우
    • Biomolecules & Therapeutics
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    • v.1 no.2
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    • pp.275-279
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    • 1993
  • Single oral administration to SD rats of both sexes were performed to investigate the acute toxicity of two new cough and cold remedies, WHS-1 and WHS-2. WHS-1 is composed of acetaminophen, chlorpheniramine maleate, cloperastine hydrochloride, dl-methylephedrine hydrochloride, caffein anhydrous, thiamine hydrochloride, riboflavin and serratiopeptidase. WHS-2 is composed of similar formula except that thiamine hydrochloride and riboflavin is not added. The results were as follows. $LD_{50}$ values of WHS-1 were 4295.5 mg/kg for males and 4606.3 mg/kg for females, and $LD_{50}$ values of WHS-2 were 3236.7 mg/kg for males and 4360.5 mg/kg for females. Death occurred within 2~3 hours after administration at doses up to 2900 mg/kg in WHS-1 and 2500 mg/kg in WHS-2, the main cause of deaths seemed to be respiratory disturbance. General symptoms included decreased motor activity, salivation and loss of consciousness which were commonly observed in all dead animals treated with WHS-1 and WHS-2. No significant gross finding and body weight changes were observed at any dose level in the groups treated with WHS-1 and WHS-2.

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Oral Glutamine Supplementation Reduces Radiotherapy-induced Esophagitis in Lung Cancer Patients

  • Gul, Kanyilmaz;Muge, Akmansu;Taner, Atasever;Sehri, Elbag
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.1
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    • pp.53-58
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    • 2015
  • Background: The purpose of this study was to assess the the efficacy of oral glutamine (GLN) in prevention of acute radiation-induced esophagitis in patients with lung cancer and determine the predictive role of clinical and dosimetric parameters. Materials and Methods: Thirty-two patients diagnosed with lung cancer were studied prospectively. Sixteen patients (50%) received prophylactic powdered GLN orally in doses of 10g/8h. Patients were treated 2 Gy per fraction daily, 5 days a week. We evaluated the grading of esophagitis daily at the end of each fraction of each treatment day until a cumulative dose of 50 Gy was reached. The primary end point was radiation-induced esophagitis. Results: All patients tolerated GLN well. Toxicity grade, weight loss, serum cytokine levels and esophageal transit times exhibited statistically significant improvement in the GLN receiving group. GLN suppressed the inflammation related to the disease and treatment and reduced toxicity with statistical significance. Conclusions: This study suggests a benefical role of oral GLN use in prevention and/or delay of radiation-induced esophagitis, in terms of esophageal transit time and serum immunological parameters, as well as weight loss.

Toxicological Evaluation of Median Lethal Dose $(LD_{50})$ ($LD_{50}$의 독성학적 고찰)

  • 박현선;홍채영;오진아;윤승천;이병무
    • Toxicological Research
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    • v.12 no.2
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    • pp.143-154
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    • 1996
  • This paper reviews the toxicological role of median lethal dose ($LD_50$) based on animal and human data. Animal oral $LD_50$ values of eighty seven chemicals were collected and comparatively evaluated with human minimum toxic dose ($TD_50$). In general, animal $LD_50$ values were much higher than human $TD_50$. The ratios between $LD_50$ and TDlo were ranged from 0.01 and over 1000, suggesting safety factor of up to 1000 between humans and animals in the case of acute toxicity data. However, about 40% of chemicals investigated were within the ratio of 10. Although the cases (N=20) were small, $LD_50$ values of guinea pig were closer to human TDlo than those of other animal species. In interanimal species (rat, mouse, rabbit, dog), the ratios of $LD_50$ values were between 0.1 and 5 (up to 50-fold difference). When the data are analyzed by chemical strut-ares, human $TD_50$ values were very close to rat oral $LD_50$ values. These data suggest that rat oral $LD_50$ value might be a useful parameter predicting human TDlo and one animal species could be sufficient for acute toxicity test.

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A 4-week Repeated Oral Dose Toxicity Study of Plant Sterol Esters in Sprague-Dawley Rats

  • Kim, Jong-Choon;Yang, Byung-Chul;Lim, Kwang-Hyeon;Kang, Boo-Hyon;Kim, Choong-Yong;Kim, Kab-Sik;Chung, Dae-Won;Chung, Moon-Koo
    • Toxicological Research
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    • v.18 no.1
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    • pp.31-41
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    • 2002
  • The present study was conducted to investigate the potential subacute toxicity of plant sterol esters by a 4-week repeated oral dose in Sprague-Dawley rats. The test article was administered once daily by gavage to rats at dose levels of 0, 1000, 3000, and 9000 mg/kg/day for 4 weeks. During the test period, clinical sign, mortality, body weights, food and water consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, gross finding, organ weight, and histopathology were evaluated. A reduction in the body weight was observed in females of the 9000 mg/kg group on day 27 after the initiation of treatment, but not in males of the group. There were no treatment-related effects on mortality, clinical sign, food and water consumption, ophthalmoscopy, urinarlysis, hematology, serum biochemistry, necropsy findings, organ weights, and histopathology in any treatment group. Based on these results, it was concluded that the 4-week repeated oral dose of plant sterol esters resulted in suppressed body weight in female rats at a dose level of 9000 mg/kg/day. In the condition of this study, target organ was not observed and the no-observed-adverse-effect level (NOAEL) was considered to be 9000 mg/kg/day for males and 5000 mg/kg/day for females.

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.

Single Oral Dose Toxicity Study of the Methylcyclohexane in Female Rats (암컷 랫드에서 Methylcyclohexane의 단회 경구투여 독성시험)

  • Kim, Sung-Hwan;Lim, Jeong-Hyeon;Shin, In-Sik;Moon, Changjong;Kim, Sung-Ho;Shin, Dong-Ho;Kim, Jong-Choon
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.21 no.1
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    • pp.33-39
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    • 2011
  • The present study was carried out to investigate the potential acute toxicity of methylcyclohexane (MCH) by a single oral dose in female rats. The test chemical was administered once by gavage to female rats at dose levels 0, 1,250, 2,500, and 5,000 mg/kg. Mortalities, clinical findings, and body weight changes were monitored for the 14-day period following the administration. At the end of 14-day observation period, all animals were sacrificed and complete gross postmortem and histopathological examinations were performed. Treatment-related clinical signs, as evidenced by depression, soft feces, decreased locomotion activity, solid perineal region, crouching position, and anorexia were observed in all treatment groups in a dose-dependent manner. At the dose level of 5,000 mg/kg, decreased or suppressed body weight gain was found during the study period. At the scheduled necropsy, one case of congestion of the intestine and an increase in the weights of liver and kidney were observed in the 5,000 mg/kg group. Histopathological examinations exhibited an increased incidence of glomerular atrophy, congestion/hemorrhage, and focal degeneration/necrosis in the liver and an increased incidence of congestion, and inflammatory cell infiltration in the kidney. On the basis of the results, it was concluded that a single oral administration of MCH resulted in some adverse effects on clinical sign, body weight gain, and organ weight and histopathology in the liver and kidney in female rats. In the experimental conditions, the minimal lethal dose ($LD_{10}$) of MCH was greater than 5,000 mg/kg.

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.

Single Oral Dose Toxicity Study of an Alcohol Extract of Bombus ignitus pupae in Rats

  • Ahn, Mi-Young;Han, Jea-Woong;Yoon, Hyung-Ju;Hwang, Jae-Sam;Park, Hae-Chul;Seo, Yun-Jung;Chung, Wan-Tae
    • International Journal of Industrial Entomology and Biomaterials
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    • v.19 no.1
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    • pp.175-180
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    • 2009
  • Recently, as the male silkworm pupae, bee pupae have the potential that strengths men's vitality on vascular endothelial nitric oxide in endothelial cells. Especially we prepared alcohol extract of pupae of bumblebee, native bee named Hobakbul, Bombus ignitus. The alcohol extract of pupae of B. ignitus was administered to rats at doses of 0, 0.04, 0.2, 1 or 2 g/kg as a single oral dose. There were no observed clinical signs or deaths related to treatment in all the groups tested. Therefore, the approximate lethal dose of the alcohol extract B. ignitus pupae was considered to be higher than 2 g/kg in rats. Mild decreases in body weight gain in male were observed dose-dependently within B. ignitus pupae alcohol extract treated groups in dose response manner over 2 weeks. Throughout the administration periods, no significant changes in diet consumption, ophthalmologic findings, clinical pathology (hematology, clinical chemistry and coagulation) or gross pathology were detected. Minor changes in male and female rats were found in hematological parameters for all or partial of B. ignitus pupae extract treated groups but all the changes observed were within the physiological range. From these results, it was concluded that there was no-evidence of specific toxicity related to the ingestion of alcohol extract of B. ignitus pupae.

A 90-day repeated-dose oral toxicity study on Flos lonicerae extract in Fischer 344/N rats (금은화(Flos lonicerae) 추출물의 Fischer 344/N 랫드를 이용한 90일간 반복 경구투여 독성시험)

  • Han, Zhong-Ze;Zhang, Hu-Song;Kang, Sang-Chul;Gil, Ki-Hyun;Kong, Kwang-Han;Kim, Do-Hyung;Ahn, Tae-Hwan;Bae, Jin-Sook;Go, Hyeon-Kyu;Han, Myoung-Kyu;Kim, Hak-Soo;Heo, Hyun-Suk;Park, Eun-Mi;Song, Si-Whan;Kim, Kap-Ho;Park, Chan-Koo;Lee, Hyun-Kul
    • Korean Journal of Veterinary Research
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    • v.48 no.4
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    • pp.401-411
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    • 2008
  • This study was performed to evaluate repeated-dose oral toxicities of Flos lonicerae extract in Fischer 344/n rats. Flos lonicerae was administered orally to rats at dose levels of 0, 37, 111, 333, 1,000 and 2,000 mg/kg/day. Each group consisted of 10 rats of each gender. The Flos lonicerae extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program and The Standards of Toxicity Study for Medicinal Products. In the present study, there were no toxicologically significant changes in mortality, clinical signs, body weight gains, ophthalmoscopy, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histopathology, estrus cycle and sperm examination of all animals treated with Flos lonicerae extract. These results suggest that the oral no observed adverse-effect level of the test item, Flos lonicerae extract, in rats is higher than 2,000 mg/kg/day in both genders. The target organs were not established.

Single Dose Oral Toxicity Study of the Gwibi-tang Extract in ICR Mice (ICR 마우스를 이용한 귀비탕 열수 추출물의 단회투여 독성 실험)

  • Lee, Ji-Hye;Eum, Hyun-Ae;Chung, Tae-Ho;Lee, Yoon-Hee;Um, Young-Ran;Yim, Nam-Hui;Kim, Dong-Seon;Lee, Jae-Hoon;Ma, Jin-Yeul
    • The Journal of Korean Obstetrics and Gynecology
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    • v.23 no.4
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    • pp.47-56
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    • 2010
  • Purpose: This study was performed to evaluate the single dose oral toxicity of Gwibi-tang extract in ICR mice. Methods: 0(control group), 1250, 2500 and 5000 mg/kg of Gwibi-tang extracts were orally administered to 20 male and 20 female ICR mice. After single oral administration of Gwibi-tang extract to ICR mice, we observed number of the death, clinical signs, changes of body weights for 14 days. After 14 day of Gwibitang extract administration, all mice were sacrificed and major organs were observed. Results: Compared with the control group, we could not find any toxic signs in the mortalities, clinical signs, body weight changes, necropsy findings and hematological values in all treated groups(1250, 2500 and 5000 mg/kg). Conclusions: $LD_{50}$ value of Gwibi-tang extracts may be over 5000 mg/kg and it may have no side toxic effect to ICR mice.