藻种钝顶节旋藻（TetraSOD®）冻干生物量的 90 天喂养研究安全性评估。
Safety assessment of a lyophilized biomass of Tetraselmis chuii (TetraSOD®) in a 90 day feeding study.
机构信息
Fitoplancton Marino S.L. Dársena Comercial S/N (Muelle Pesquero), 11500 El Puerto de Santa María, Cádiz, Spain.
Department of Pharmacology, Toxicology and Legal and Forensic Medicine, University of Córdoba, Campus de Rabanales, Carretera Madrid-Cádiz s/n, Córdoba, 14071, Spain.
出版信息
Food Chem Toxicol. 2019 Nov;133:110810. doi: 10.1016/j.fct.2019.110810. Epub 2019 Sep 7.
TetraSOD® is a powder of the lyophilized biomass of Tetraselmis chuii strain CCFM03, a marine microalga with a history of use as feed in the aquaculture industry. Recently, algae including T. chuii have been investigated for their potential use in human food. However, published toxicology studies addressing the safety of T. chuii as a food ingredient are not available. To address this issue, the toxicity of TetraSOD® was evaluated using a 90-day oral toxicology study in rats following the Organisation for Economic Co-operation and Development (OECD) test guideline 408. No treatment-related mortality or clinical signs were noted with TetraSOD® at doses of 625, 1667, or 2500 mg/kg/day. Additionally, no adverse effects on haematology, blood biochemistry, organ weights, gross or histopathology were observed. The Non Observed Adverse Effect Level (NOAEL) for TetraSOD® is greater than the highest tested dose of 2500 mg/kg/day.
TetraSOD® 是一种冻干生物质粉末，由 Tetraselmis chuii 菌株 CCFM03 制成，这是一种海洋微藻，历史上一直被用作水产养殖行业的饲料。最近，人们研究了包括 T. chuii 在内的藻类在人类食品中的潜在用途。然而，目前尚没有关于 T. chuii 作为食品成分的安全性的已发表毒理学研究。为了解决这个问题，按照经济合作与发展组织（OECD）的测试指南 408，使用大鼠进行了为期 90 天的口服毒理学研究，对 TetraSOD® 的毒性进行了评估。在剂量为 625、1667 或 2500mg/kg/天时，TetraSOD® 没有引起与治疗相关的死亡率或临床症状。此外，血液学、血液生化学、器官重量、大体和组织病理学也没有观察到任何不良反应。TetraSOD® 的无观察不良效应水平（NOAEL）大于最高测试剂量 2500mg/kg/天。
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