• 제목/요약/키워드: Repeated oral toxicity

검색결과 151건 처리시간 0.024초

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

  • 신흥묵
    • 대한한의학회지
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    • 제30권5호
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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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Thermitomyces albuminosus powder의 랫드를 이용한 90일 경구투여독성시험 (Repeated Dose 90-Day Oral Toxicity Study of Dried Thermitomyces albuminosus Powder in Rats)

  • 안민지;허혜선;이지선;손혜영;임해옥;박강백;이준헌;지재규;박영철
    • 생명과학회지
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    • 제26권10호
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    • pp.1153-1162
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    • 2016
  • 계종버섯(Thermitomyces albuminosus)의 안정성을 입증하기 위하여 사료에 계종버섯의 분말을 5%, 2.5%, 1.25%, 0%를 혼합하여 90일 동안 랫드에 자유 급이 시켜 실험동물의 일반증상, 체중변화, 혈액학적 검사, 부검소견, 임상병리, 조직병리학적 검사의 결과를 토대로 독성을 평가하였다. 독성판정기준은 독성의 정도와 양상에 따라 weight-based classification (독성 강도에 따른 분류)로 분류 하였는데 비시험물질-유래 변화인 NOEL, 시험물질-유래 경미한 변화는 NOAEL, 시험물질-유래 중요한 변화는 LOAEL을 기준으로 나누었다. 시험결과, 수컷 좌, 우측 신장 중량이 용량의존적으로 증가하여 고용량군에서는 12%, 8% 증가 하였다. 하지만 임상, 조직병리학적 결과 독성으로 판단되는 소견이 관찰되지 않아 시험물질-유래 경미한 변화로 판단으로 분류하였다. 따라서 판정기준에 따라 수컷은 NOAEL 암컷은 NOEL이 식이함량 5%로 추정되지만 식약처고시에 따라 암수 모두 NOAEL이 식이함량의 5%로 추정할 수 있다. 따라서 계종버섯은 식품 또는 기능성식품으로의 개발에 문제가 없을 것으로 사료된다.

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
    • 한국독성학회:학술대회논문집
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    • 한국독성학회 2003년도 추계학술대회
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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
    • 한국독성학회:학술대회논문집
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    • 한국독성학회 2003년도 추계학술대회
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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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아미그달린 저감화 매실청의 독성동태학적 및 경구독성 연구 (Toxicokinetics and oral toxicity of Maesil-cheongs with reduced amygdalin levels)

  • 김현진;고미란;유진;황지수;최현우;김현석;최수진
    • 한국식품과학회지
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    • 제50권6호
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    • pp.629-635
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    • 2018
  • 본 연구에서는 플라즈마 및 UVC 처리에 의해 매실청에 존재하는 아미그달린 저감화 공정을 개발하여 아미그달린 저감화 매실청에 대한 독성을 독성동태학적 및 14일 반복 경구투여에 의해 평가하였다. 독성동태학적 연구 결과, 플라즈마 및 UVC 처리에 의한 아미그달린 저감화 매실청 투여에 의해 아미그달린의 경구 흡수량이 약 3.7, 3.4배 감소하여 저감화 효과를 확인할 수 있었다. 아미그달린 저감화 매실청의 14일 반복 경구독성시험 결과를 종합하면, 몸무게 변화, 식이 및 물 섭취량, 절대장기 및 상대 장기 무게, 혈액학적 및 혈청학적 분석, 조직 병리학적 분석에서 유의미한 독성현상이 관찰되지 않았다. 따라서 본 연구에서 개발 플라즈마 및 UVC 처리에 의한 아미그달린 저감화 매실청의 독성영향은 없는 것으로 보이며, 이러한 공정은 매실청뿐만 아니라 아미그달린 함유 다양한 제품의 저감화 공정에 활용될 수 있을 것이다.

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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    • 제13권8호
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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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    • 제41권2호
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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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    • 제25권3호
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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.