Safety assessment of (S)-Equol: Subchronic toxicity study in Sprague Dawley Rats.

Q1 Environmental Science
Toxicology Reports Pub Date : 2024-11-19 eCollection Date: 2024-12-01 DOI:10.1016/j.toxrep.2024.101823
Seethakallu Ramachandraiah AnandaKumar, Mukund Handral, Srinivas Seekallu
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Abstract

(S)-Equol is a chemically synthesized nutraceutical compound and its consumption provides several health benefits for humans. The new nutraceutical, enantiopure (S)-Equol was studied for acute and sub-chronic toxicity in Sprague Dawley Rats. The oral acute toxicity study showed that (S)-Equol is safe > 2000-5000 mg/kg body weight and it classified into GHS category 5/Unclassified. The repeated dose administration of (S)-Equol at dose levels of 20, 60, and 160 mg/kg body weight for 14 days and 250, 500, and 1000 mg/kg body weight for 90-consecitve days. The 14 days repeated-dose toxicity study showed no adverse effects in Sprague Dawley rats. The 90-day repeated dose toxicity study showed a reduction in body weight gain than that of control group. No treatment-related contrary effects were perceived on haematology, clinical chemistry, coagulation, urine parameters analysed, organ weights (absolute and relative), neurological and ophthalmological examination. No treatment-related abnormal gross pathological findings were obtained from gross necropsy. However, as a treatment-related effect, a significant decrease in cholesterol levels for 14 and 90 days of repeated dose administration was observed, which is considered as a pharmacological class effect of the (S)-Equol. In comparison to the corresponding vehicle control group, the high dose treatment group for both sexes showed no treatment-related histopathological abnormalities. For female rats, the no-observed-adverse-effect-level (NOAEL) was 250 mg/kg/day and for male rats, the lowest-observed-adverse-effect level (LOAEL) was 250 mg/kg/day.

(S)-雌马酚安全性评价:大鼠亚慢性毒性研究。
(5)-马雌酚是一种化学合成的营养化合物,食用马雌酚对人类的健康有多种好处。研究了新型营养保健品对马酚对大鼠的急性和亚慢性毒性。口服急性毒性研究表明,(S)-马雌酚在2000-5000 mg/kg体重范围内是安全的,属于GHS第5类/未分类。(S)-雌马酚以20、60和160 mg/kg体重的剂量水平连续给药14天,250、500和1000 mg/kg体重连续给药90天。14天的重复给药毒性研究显示,Sprague Dawley大鼠无不良反应。90天的重复给药毒性研究表明,与对照组相比,体重增加有所减少。在血液学、临床化学、凝血、尿液参数分析、器官重量(绝对和相对)、神经和眼科检查方面未发现与治疗相关的不利影响。大体尸检未见与治疗相关的大体病理异常。然而,作为治疗相关的效应,在14天和90天的重复给药中观察到胆固醇水平显著降低,这被认为是(S)-马雌酚的药理学类效应。与相应的载体对照组相比,男女高剂量治疗组均未出现与治疗相关的组织病理学异常。雌性大鼠无观察到的不良反应水平(NOAEL)为250 mg/kg/天,雄性大鼠最低观察到的不良反应水平(LOAEL)为250 mg/kg/天。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Toxicology Reports
Toxicology Reports Environmental Science-Health, Toxicology and Mutagenesis
CiteScore
7.60
自引率
0.00%
发文量
228
审稿时长
11 weeks
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