• Title/Summary/Keyword: repeated oral toxicity

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Repeated Dose 4-Week Oral-Treatment for DRF Toxicity Test of HMC05 in Sprague-Dawley Rats (HMC05의 Sprague-Dawley 흰쥐를 이용한 4주 반복 경구투여 DRF 독성시험)

  • Shin, Heung-Mook
    • The Journal of Korean Medicine
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    • v.30 no.5
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    • pp.102-114
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    • 2009
  • Objectives: HMCO5 is an extract obtained from 8 different herbal mixtures. We undertook a safety evaluation of HMCO5 for a dose range finding (DRF) toxicity test in specific pathogen free (SPF) Sprague-Dawley (SD) male and female rats. Methods: The male and female rats were divided into 4 groups, respectively; G(0), treated with distilled water: G(1), treated with 222 mg/kg HMC05: G(2), treated with 667 mg/kg HMC05, and G(3), treated with 2,000 mg/kg HMC05; HMC05 was administered orally for 4 weeks. The safety evaluation examined clinical signs, mortality, body weight, food consumption, water consumption, ophthalmic findings, urinalysis, hematological values, absolute & relative organ weights, and necropsy findings during the tests. Results: There were no changes in clinical signs, mortality, body weight, food consumption, water consumption, and ophthalmic findings examined during the test periods. In serum biochemical values, triglyceride was increased in male group G(3) and Na$^+$ decreased significantly in male groups G(2), G(3) and G(4). In male group G(4), spleen weight decreased relatively and increases of absolute & relative left ovary weights were found. In addition, an adhesion of liver to diaphragm was found in male group G(2). However, we could not find any dose-interrelationships in these changes. Conclusions: These results indicate that HMC05 extract did not show any toxicity in the DRF toxicity study. Therefore, it suggests that establishment of 1,000, 333 and 111 mg/kg dosages are moderate in a repeated dose 26-week oral toxicity study of HMC05.

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Repeated Dose 90-Day Oral Toxicity Study of Dried Thermitomyces albuminosus Powder in Rats (Thermitomyces albuminosus powder의 랫드를 이용한 90일 경구투여독성시험)

  • An, Min Ji;Heo, Hye Seon;Lee, Ji Sun;Son, Hye Young;Lim, Hae Ok;Park, Gang Baek;Lee, Joon Heun;Jee, Jae Gyu;Park, Yeongchul
    • Journal of Life Science
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    • v.26 no.10
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    • pp.1153-1162
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    • 2016
  • Termitomyces albuminosus (Berk.) Heim is a well-known wild edible mushroom in the southern region of China. Novel cerebrosides, termed termitomycesphins, isolated from EtOH extract of T. albuminosus have shown significant neuritogenic activity. Neurotrophic factors have been targeted as potential therapeutic drugs for the treatment of neurodegenerative disorders. However, before expanding their applications to include food or therapeutic agents in Korea, a safety evaluation of T. albuminosus is needed. Herein, in a repeated-dose 90-day oral toxicity study, rats were exposed to a basal diet of powder ground from dried T. albuminosus at dose levels of 5%, 2.5%, 1.25%, and 0%. The following endpoints were evaluated: clinical observation, body weight, gross and microscopic pathology, clinical chemistry, and hematology. Significant dose-dependent increases in the weight of the left kidney were observed, possibly due to the test substance. Based on toxicity-decision criteria for minor compound-related changes (no observed adverse effect level [NOAEL] and no observed effect level [NOEL]), NOAEL was observed in male rats at a dose of 5% of dried T. albuminosus powder, and NOEl was observed in female rats at the same dose. The results point to the safety and potential use of T. albuminosus as a nontoxic neurotrophic factor.

13-Week Oral Gavage Toxicity with Sophora Japonica Linne Seed Extract in Sd Rats

  • Lee, Hye-yeong;Kim, Sun-hee;Park, Sun-hee;Kang, Seong-kwi;Lee, Jong-sung;Kwon, Suk-hyung;Sik Hwangbo;Kim, Kuk-hwan;Kang, Jong-koo
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2003.10b
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    • pp.132-132
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    • 2003
  • In this GLP study, 4 study groups of 12 Sprague-Dawley (SD) rats/sex were given vehicle, or 1,000, 1,500, or 2,000 mg/kg/day Sophora Japonica Linne Seed Extract (SE) for 13 weeks. Standard endpoints in this study included mortality, clinical observations, body weight, food and water consumption, ophthalmoscopic examination, urinalysis, hematology, serum biochemistry, organ weights, gross anatomic pathology and histopathology.(omitted)

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Repeated Dose 4-week Oral Toxicokinetic Study of DW-224a in Rats

  • Lee, Jong-Hwa;Lee, Han-Ok;Chung, Moon-Koo;Park, Dong-Rack;Gu, Se-Kwang;Yasuo Tarumoto;Shin, Ho-Chul
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2003.10b
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    • pp.170-170
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    • 2003
  • DW -224a is a fluoroquinolone antibiotics with a broad spectrum of activity against Gram-positive and Gram-negative bacteria. In order to clarify toxicokinetic profile of DW-224a, a 4-week repeated dose oral toxicokinetic study (dose level: 0, 63, 250, 1000 mg/kg) was conducted in groups of Sprague-Dawley rats.(omitted)

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Toxicokinetics and oral toxicity of Maesil-cheongs with reduced amygdalin levels (아미그달린 저감화 매실청의 독성동태학적 및 경구독성 연구)

  • Kim, Hyeon-Jin;Go, Mi-Ran;Yu, Jin;Hwang, Ji-Soo;Choi, Hyun Woo;Kim, Hyun-Seok;Choi, Soo-Jin
    • Korean Journal of Food Science and Technology
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    • v.50 no.6
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    • pp.629-635
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    • 2018
  • In this study, the safety aspect of Maesil-cheongs with reduced amygdalin levels was investigated in terms of toxicokinetics and repeated oral toxicity. Plasma or UVC treatment was utilized to obtain Maesil-cheongs with reduced amygdalin levels. The toxicokinetic study demonstrated that the oral absorption of amygdalin decreased remarkably after a single-dose oral administration of both plasma- and UVC-treated Maesil-cheongs. The fourteen-day repeated oral toxicity study revealed that plasma- or UVC-treated Maesil-cheongs did not cause changes in body weight, food intake, water consumption, and absolute and relative organ weights. No significant effects on hematological and serum biochemical parameters were found. Histopathological examination showed no abnormality or toxicological change. These findings suggest that plasma- and UVC-treated Maesil-cheongs have no toxicity potential, and these processes will be useful to obtain products with safe, reduced amygdalin levels.

Oral Etoposide for Platinum-Resistant and Recurrent Epithelial Ovarian Cancer: a Study by the Anatolian Society of Medical Oncology

  • Kucukoner, Mehmet;Isikdogan, Abdurrahman;Yaman, Sebnem;Gumusay, Ozge;Unal, Olcun;Ulas, Arife;Elkiran, Emir T.;Kaplan, Muhammed A.;Ozdemir, Nuriye;Inal, Ali;Urakci, Zuhat;Buyukberber, Suleyman
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.8
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    • pp.3973-3976
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    • 2012
  • Background: The aim of this study was to evaluate the efficacy and toxicity of long-term, low-dose oral etoposide as an advanced treatment option in patients with platinum resistant epithelial ovarian cancer. Materials and Methods: For the purposes of this study, 51 patients with histologically-confirmed, recurrent or metastatic platinum-resistant epithelial ovarian cancer (EOC) treated at six different centers between January 2006 and January 2011 were retrospectively evaluated. Patients were treated with oral etoposide (50 mg/day for a cycle of 14 days, repeated every 21 days). Results: Among the 51 platinum-resistant patients, 17.6% demonstrated a partial response and 25.5% a stable response. The median progression-free survival (PFS) was 3.9 months (95% CI, 2.1-5.7), while the median overall survival was 16.4 months (11.8.20.9). No significant relationship was observed between the pre-treatment CA 125 levels, post-treatment CA-125 levels and the treatment response rates (p=0.21). Among the 51 patients who were evaluated in terms of toxicity, grade 1 or 4 hematologic toxicity was observed in 19 (37.3%); and grade 1-4 gastrointestinal toxicity occurred in 15 patients (29.4%). Conclusions: Chronic low-dose oral etoposide treatment is generally effective and well-tolerated in platinum-resistant ovarian cancer patients.

Necrotizing fasciitis of the head and neck: a case report

  • Choi, Moon-Gi
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.41 no.2
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    • pp.90-96
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    • 2015
  • Necrotizing fasciitis (NF) is an infection that spreads along the fascial planes, causing subcutaneous tissue death characterized by rapid progression, systemic toxicity, and even death. NF often appears as a red, hot, painful, and swollen wound with an ill-defined border. As the infective process continues, local pain is replaced by numbness or analgesia. As the disease process continues, the skin initially becomes pale, then mottled and purple, and finally, gangrenous. The ability of NF to move rapidly along fascial planes and cause tissue necrosis is secondary to its polymicrobial composition and the synergistic effect of the enzymes produced by the bacteria. Treatment involves securing the airway, broad-spectrum antimicrobial therapy, intensive care support, and prompt surgical debridement, repeated as needed. Reducing mortality rests on early diagnosis and prompt aggressive treatment.

Acute and Sub-chronic Oral Toxicity Study of Ammonium Persulfate in Spraque-Dawley Rats

  • Kim, Yong-Soon;Baek, Min-Won;Sung, Jae-Hyuck;Ryu, Hyun-Youl;Kim, Jin-Sik;Cho, Hyun-Sun;Choi, Byung-Gil;Song, Min-Sub;Song, Moon-Yong;Baik, Eun-Ju;Choi, Young-Kuk;Kim, Jong-Kyu;Yu, Il-Je;Song, Kyung-Seuk
    • Toxicological Research
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    • v.25 no.3
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    • pp.132-139
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    • 2009
  • The toxicity test of ammonium persulfate was conducted to ensure of its potential toxic effects according to the single-dose acute oral toxicity study (OECD Guideline 423) and 90-day repeated dose sub-chronic oral toxicity study guideline (OECD Guideline 408) for establishing national chemical management system, and matching in the Globally Harmonized Classification System (GHS) category. In acute oral toxicity study, pasty stool, perineal contamination and temporary body weight decrease were observed after dosing 1st and 2nd challenge (300 mg/kg body weight). All test animals were dead within 6 hours after dosing at 3rd challenge (2000 mg/kg body weight). Therefore, the GHS class of test substance is considered class 4. In sub-chronic toxicity study, body weight changes, food consumptions, hematological, biochemical and pathological examination did not show any noticeable and significant differences between the administered (5, 20, 80 mg/kg body weight) and control (vehicle only) group animals. Based on these results, the no observed adverse effect level (NOAEL) is considered above 80 mg/kg body weight.