关键词: ALB, Albumin ALP, Alkaline phosphatase ALT, Alanine Aminotransferase APTT, Activated partial thromboplastin time AST, Aspartate Aminotransferase And Repeated dose BAS, Basophils BUN, Blood Urea Nitrogen BW, Body weight CRE, CreatinineRBC, Erythrocyte count Ca, Calcium Capsanthin 50% w/w Capsicum annum Cl, Chloride EOS, Eosinophils FBW, Fasting Body Weight GGT, Gamma Glutamyl Transpeptidase GLOB, Globulin Glu, Glucose HCT, Haematocrit HDL, High Density Lipoprotein HGB, Hemoglobin K, Potassium LDL, Low Density Lipoprotein LYM, Lymphocytes MCH, Mean Corpuscular Haemoglobin MCHC, Mean Corpuscular Haemoglobin Concentration MCV, Mean Corpuscular Volume MON, Monocytes NEU, Neutrophils NOAEL NOAEL, No Observed Adverse Effect Level Na, Sodium PHO, Phosphate PLT, Platelet PT, Partial Thromboplastin time Retic, Reticulocytes SD Rats SD, Sprague-Dawley Saponified Capsicum annum fruit extract T3, Triiodothyronine T4, Thyroxine TBA, Total bile acids TBIL, Total Bilirubin TCHO, Total Cholesterol TP, Total protein TRIG, Triglycerides TSH, Thyroxine stimulating Hormone Toxicity WBC, Total leukocyte count

来  源:   DOI:10.1016/j.toxrep.2022.03.007   PDF(Pubmed)

Abstract:
A ninety-day oral toxicity study of saponified Capsicum annum fruit extract with 50% (w/w) capsanthin (SCFE-50 C) was performed by oral gavage administration to male and female Sprague-Dawley (SD) rats at doses of 0, 500, 1000 and 2000 mg/kg BW/day for a period of ninety consecutive days. To assess the reversal of toxicity, the treatment phase was followed with a twenty-eight-day recovery period. The treatment with SCFE-50 C in both male and female SD rats showed no mortality, and no treatment-related toxicologically significant changes were observed in any groups. No significant differences between treated and control groups were found in feed consumption, body weight gain, individual organ weights, ocular examination, clinical chemistry or blood biochemistry. The necroscopy and histopathology examination did not reveal any clinically significant changes in male and female rats from the 2000 mg/kg BW/day group. According to this study, the no observable adverse effect level (NOAEL) for saponified Capsicum annum fruit extract with 50% (w/w) capsanthin (SCFE-50 C) administered by oral gavage for 90-days is > 2000 mg/kg BW/day in SD rats.
摘要:
通过以0、500、1000和2000mg/kgBW/天的剂量对雄性和雌性Sprague-Dawley(SD)大鼠进行连续90天的口服管饲法,对具有50%(w/w)辣椒素(SCFE-50°C)的皂化辣椒果实提取物进行90天的口服毒性研究。为了评估毒性的逆转,治疗期后为28天恢复期.在雄性和雌性SD大鼠中用SCFE-50C处理没有显示死亡,并且在任何组中均未观察到与治疗相关的毒理学上的显着变化。处理组和对照组在饲料消耗方面没有显着差异。体重增加,个体器官重量,眼部检查,临床化学或血液生物化学。尸检和组织病理学检查未发现2000mg/kgBW/day组的雄性和雌性大鼠的任何临床显着变化。根据这项研究,在SD大鼠中,通过口服管饲法给予50%(w/w)辣椒素(SCFE-50C)的皂化辣椒果实提取物90天,没有可观察到的不良反应水平(NOAEL)>2000mg/kgBW/天。
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