• 제목/요약/키워드: 13-Week toxicity

검색결과 103건 처리시간 0.179초

Kidney Toxicity Induced by 13 Weeks Exposure to the Fruiting Body of Paecilomyces sinclairii in Rats

  • Jeong, Mi-Hye;Kim, Young-Won;Min, Jeong-Ran;Kwon, Min;Han, Beom-Suk;Kim, Jeong-Gyu;Jeong, Sang-Hee
    • Toxicological Research
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    • 제28권3호
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    • pp.179-185
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    • 2012
  • Paecilomyces sinclairiis (PS) is known as a functional food or human health supplement. However concerns have been raised about its kidney toxicity. This study was performed to investigate the kidney toxicity of PS by 13 week-oral administration to rats. Blood urea nitrogen (BUN), serum creatinine, and kidney damage biomarkers including beta-2-microglobulin (${\beta}2m$), glutathione S-transferase alpha (GST-${\alpha}$), kidney injury molecule 1 (KIM-1), tissue inhibitor of matrix metalloproteinase 1 (TIMP-1), vascular endothelial growth factor (VEGF), calbindin, clusterin, cystatin C, neutrophil gelatinase-associated lipocalin (NGAL) and osteopontin were measured during or after the treatment of PS. BUN, creatinine and kidney damage biomarkers in serum were not changed by PS. However, kidney cell karyomegaly and tubular hypertrophy were observed dose-dependently with higher severity in males. KIM-1, TIMP-1 and osteopontin in kidney and urine were increased dose dependently in male or at the highest dose in female rats. Increased urinary osteopontin by PS was not recovered at 2 weeks of post-exposure in both genders. Cystatin C in kidney was decreased at all treatment groups but inversely increased in urine. The changes in kidney damage biomarkers were more remarkable in male than female rats. These data indicate that the PS may provoke renal cell damage and glomerular filtration dysfunction in rats with histopathological lesions and change of kidney damage biomarkers in kidney or urine. Kidney and urinary KIM-1 and cystatin C were the most marked indicators, while kidney weight, BUN and creatinine and kidney damage biomarkers in serum were not influenced.

Safety Evaluation of Ethanol Extract from Unripe Fruit of Bitter Melon (Momordica Charantia L.) in Sprague-Dawley Rats (랫드를 이용한 여주 추출물의 안전성 평가)

  • Ryu, Hyeon Yeol;Lee, Somin;Ahn, Kyu Sup;Yong, Yeon;Kim, Hye Jin;Kim, Seong-Eun;Lee, Hak Sung;Hong, Su-Young;Kim, Hyun-Kyu;Hwang, In Guk;Song, Kyung Seuk
    • Journal of the Korean Society of Food Science and Nutrition
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    • 제46권4호
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    • pp.490-500
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    • 2017
  • This study was performed to evaluate repeated dose oral toxicity upon administration of the test substance 1,2-benzisothiazolin-3-one for 90 days and to determine NOAEL (no observed adverse effect level) and target organs in Sprague-Dawley rats. Single, 2-week repeated, and 13-week repeated oral dose toxicity studies were conducted in Sprague-Dawley rats. The dose levels of groups were 1,250, 2,500, and 5,000 mg/kg/d. All dose groups were compared with the vehicle control group. The animals were observed for clinical signs and weekly body weight. Urinalysis, hematology, and serum biochemistry analyses were conducted. Subsequently, animals were sacrificed and subjected to histopathological examination. For the result, NOAEL of ethanol extract from unripe fruit of bitter melon had an optimal dose of 5,000 mg/kg/d and acceptable daily intake up to 3,000 mg/man. There was no target organ detected. Therefore, bitter melon, which contains a variety of bioactive substances, could be widely used as a health functional food ingredient.

Study on Inhalation Toxicity of Iso-butylalcohol Using SD Rats (Rats를 이용한 Iso-butylalcohol의 아만성 흡입독성 연구)

  • Kin, Hyeon Yeong;Yun, Hyo In;Lee, Sung Bea;Chang, Beom Su;Jeong, Jae Hwang;Lim, Cheol Hong;Chung, Yong Hyun;Han, Jeong Hee;Zeon, Yoon Seok;Jang, Dong Hyuk;Ha, Chang Soo;Kim, Jong Chun;Lee, Yong Mook
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • 제9권2호
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    • pp.66-78
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    • 1999
  • The purpose of this study was to investigate the toxic effects of iso-butylalcohol on Sprague-Dawley (SD) rats which were treated 0, 333, 1,000 and 3,000 ppm for 6 hours a day, 5 days a week for 13 weeks by inhalation. Iso-butylalcohol did not induce any abnormal change in the viewpoint of clinical signs, feed consumption, ophthalmic test, urinalysis, hematology and blood biochemistry during and at the termination of the inhalation toxicity test. We did not find any abnormal findings in the gross and microscopic observations due to the inhalation of iso-butylalcohol. There was no alteration in relative organ weight owing to the inhalation of the iso-butylalcohol. In conclusion, concentration was 3,000 ppm in rats under the inhalation of 6 hours a day, 5 days a week for 13 week. Iso-butylalcohol did not show any change in the clinical signs, feed consumption, ophthalmic test, urinalysis, hematology and blood biochemistry, together with no alteration in the gross and pathological findings.

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Reference Values of Organ Weights in Sprague-Dawley Rats (Ktc: Sprague-Dawley 랫드의 장기중량치의 자료분석)

  • Kang, Boo-Hyon;Kim, Il-Hwan;Kim, Yong-Bum;Kim, Young-Hee;Lee, Hyun-Sook;Ha, Chang-Su
    • Korean Journal of Veterinary Pathology
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    • 제5권2호
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    • pp.39-42
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    • 2001
  • A reference range data base containing organ weight values on animals used in 4 week and 13 week toxicity tests is described. Data listed include the values of minimum, maximum, mean and standard deviation for each of the following organ weights. Organs: Brain, heart, liver, spleen, kidney, adrenal gland, testis, ovary. This study was undertaken to determine organ weight reference values of Ktc: SD rats

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THIRTEEN-WEEK REPEATED INTRAVENOUS TOXICITY STUDY OF A NEW ANTICANCER AGENT, SB IN BEAGLE DOGS

  • Jung, Eun-Yong;Lee, Soo-Hae;Zhang, Hu-Song;Huang, Zai-Zhi;Sin, Ji-Soon;Zheng, Mei-Shu;Kang, Min-Joung;Roh, Kyoung-Ok;Kim, Dae-Joong;Nam, Sang-Yoon;Kang, Jong-Koo
    • Proceedings of the Korean Society of Toxicology Conference
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    • 한국독성학회 2001년도 International Symposium on Dietary and Medicinal Antimutgens and Anticarcinogens
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    • pp.170-170
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    • 2001
  • This study was designed to evaluate a repeated intravenous dose toxicity of a new anticancer agent, SB extracted from Pulsatilla korean Nakai in Beagle dogs. Animals were intravenously injected with dosages of 0, 0.062, 0.25, and 1 mg/kg of SB everyday for 13 weeks, respectively. There were no dose-related changes in clinical signs, body weight changes, food and water consumptions, opthalmoscopy, and urine analysis. There were somewhat significant differences compared with control group in organ weight, biochemical examination, and hematology findings of animals treated with SB. However, these changes were not dose-related changes. Gross and histopathological findings revealed no evidence of specific toxicity related to SB. These indicate that intraveous maximum tolerated dose value of SB may be over 1mg/kg in rats.

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Study on Subchronic Inhalation Toxicity of 1, 1-dichloro-1-fluoroethane using S.D. Rats (S.D. Rats를 1, 1-Dichloro-1-fluoroethane의 아만성 흡입독성 연구)

  • 김현영;이성배;임철홍;김철우;정용현;한정희;전윤석;최수영;강대봉
    • Environmental Analysis Health and Toxicology
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    • 제17권1호
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    • pp.81-93
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    • 2002
  • There were no specific effects for test materials on Sprague-Dawiey (S.D.) rats in clinical symptoms, amounts of food intakes, weight changes, laboratory findings, and pathology after whole body 1, 1-Dichloro-1-fluoroethane (used as coolant, metal cleaner and solvents) exposure (0, 1,500, 3,000, and 6,000 ppm) for 13 weeks (6 hour/day, 5 days/week). However, the loss of capillary vessels in eyeball (pupil) was observed in a female rat among 6,000 ppm group. Though there was a tendency for MCHC (Mean Corpuscular Hemoglobin Concentration) in rat to be decreased (p<0.05), it was not regarded as abnormal because the values were within normal limits. In asthma-stimulation related evaluations. there was also a tendency for inflammatory cell counts in bronchoalveolar lavages to be increased. But it had no statistical significance, and also no dependency on sex and the exposed concentration . Based on this result, the non observed effect level (NOEL) induced by 1, 1-Dichloro-1-fluoroethane inhalation was evaluated in groups with 3,000 ppm below (S.D. Rats, 13 weeks). Finally, it was concluded that the short term exposal of 1, 1-Dichloro-1-fluoroethane is not considered as a asthma stimulant by inhalation despite of some study limitations such as test animals use and short-term exposure.

Thirteen-Week Repeated Oral Toxicity Study of Leaf Folder (Cnaphalocrocis medinalis) Resistant Rice (Nakdongbyeb) in Sparague-Dawely Rats (SD 랫드에서 혹명나방 저항성 유전자 변형 낙동벼의 13주 경구 반복투여 독성에 관한 연구)

  • Seo, Dong-Seok;Kwon, Min;Sung, Ha-Jung;Park, Cheol-Beom
    • The Korean Journal of Pesticide Science
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    • 제15권2호
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    • pp.104-113
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    • 2011
  • We investigated the systemic effects of leaf folder (Cnaphalocrocis medinalis) resistant rice (transgenic rice, Nakdongbyeb) in Sprague-Dawley rats for 13 weeks. Leaf folder resistant rice was added to the diet at percentage levels of 0, 5 and 20 percentage/feeder and was administered for 13 weeks. The results did not show any changes in food and water intake. There were also no biologically significant changes in both body and organ weights, hematological and blood biochemical parameters, autopsy and histopathology between the treatment and control groups. Based on these results, no observed adverse effect level (NOAEL) of transgenic rice was considered to be more than 10,000 mg/kg b.w. under the conditions of the present study.

Chemoradiation Related Acute Morbidity in Carcinoma Cervix and Correlation with Hematologic Toxicity: A South Indian Prospective Study

  • Kumaran, Aswathy;Guruvare, Shyamala;Sharan, Krishna;Rai, Lavanya;Hebbar, Shripad
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권11호
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    • pp.4483-4486
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    • 2014
  • Purpose: To assess chemoradiation related acute morbidity in women with carcinoma cervix and to find and correlation between hematologic toxicity and organ system specific damage. Materials and Methods: A prospective study was carried out between August 2012 and July 2013 enrolling 79 women with cancer cervix receiving chemo-radiotherapy. Weekly assessment of acute morbidity was done using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4 and the toxicities were graded. Results: Anemia [77 (97.5%)], vomiting [75 (94.8%)] and diarrhea [72 (91.1%)], leukopenia [11 (13.9%)], cystitis [28 (35.4%], dermatitis [19 (24.1%)] and fatigue [29 (36.71%)] were the acute toxicities noted. The toxicities were most severe in $3^{rd}$ and $5^{th}$ week. All women could complete radiotherapy except two due to causes unrelated to radiation morbidity; seven (8.86%) had to discontinue chemotherapy due to leukopenia and intractable diarrhea. Though there was no correlation between anemia and other toxicities, it was found that all with leukopenia had diarrhea. Conclusions: Chemoradiation for cancer cervix is on the whole well tolerated. Leukopenia and severe diarrhea were the acute toxicities that compelled discontinuation of chemotherapy in two women. Though anemia had no correlation with gastrointestinal toxicity, all of those with leukopenia had diarrhea.

A Study on the Subchronic Inhalation Toxicity of 2-Butanethiol Using SD Rats (2-부탄티올의 SD Rats를 이용한 아만성 흡입독성연구)

  • Kim, Hyeon-Yeong;Lee, Sung-Bae;Lim, Cheol-Hong;Cho, Hae-Won;Kang, Min-Gu;Lee, Jun-Yeon
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • 제17권3호
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    • pp.181-191
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    • 2007
  • With the 2-Butanethiol, which is an unidentified inhalation toxic material, acute inhalation toxicity was tested with SD rats. The $LC_{50}$ was evaluated to be 2,500 ppm (9.22 mg/L) or higher which falls under the criteria of acute toxicity Category 3 (500<$LC_{50}$<2,500 ppm) in the Industrial Safety and Health Act. In the subchronical inhalation toxicity test by 0, 25, 100, and 400 ppm, 6 hours a day, 5 days a week, for 13 weeks repeated exposure, though no death or particular clinical presentation was observed, in the female 25 and 400 ppm group, including weight change, and in each concentration group including 400 ppm, change of feed rate, eye stimulation, motility change in male group, and lesions in blood and blood biochemical were observed. In the internal organs weight, 25, 100, and 400 ppm groups in male and 400 ppm group in female showed significant (p<0.05) changes in kidney, liver, thymus, and lung. In the pathological tissue test, severe cortical tubular hyaline droplets were observed in the male 400 ppm group, and all male rats of 400 ppm group and 2 female individuals showed tubular degeneration/regeneration accompanied with pigmentation, showing that the target organs of inhalation exposure of 2-Butanethiol are spleen, kidney, nasal cavity, and adrenal. Through the tests, the NOEL of 2-Butanethiol was evaluated to be 25 ppm (0.092 mg/L) or less for both male and female.

Toxicity Assessment of Phytolaccae Radix Aqueous Extract Orally Administered to F344 Rats for Two Consecutive Weeks (상륙 추출물의 F344 랫드에서 2주 반복 경구투여 독성평가)

  • Han, Hyoung-Yun;Kang, Myung-Gyun;Yoon, Seokjoo;Seok, Ji-Hyeon;Kim, Jeong Ah;Kim, Tae-Won;Min, Byung Sun
    • Korean Journal of Pharmacognosy
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    • 제49권2호
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    • pp.124-131
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    • 2018
  • Phytolaccae Radix has long been used as a traditional indigenous medicine to cure edema and rheumatism. However, there is insufficient background information on toxicological evaluation of Phytolaccae Radix extract to support the safe use. Therefore, we conducted a series of standardized, OECD and KFDA guidelines compliant in vivo study, to find a dose levels for the 13 weeks toxicity study. The extract of Phytolaccae Radix was administered orally to F344 rats at dose levels of 0, 500, 1000 and 2000 mg/kg/day for 2 weeks. Each group was composed to five male and five female rats. In the result, there were no test article-related adverse changes in clinical signs, body weight, food consumption, ophthalmology, hematology, clinical chemistry, gross finding at necropsy and organ weight examination. Therefore, we recommend that 2000 mg/kg/day is a highest treatment group in 13-week exposure study.