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食品级二氧化E171的扩展一代生殖毒性研究,重点是生殖和内分泌终点

Rodger V Battersby¹, Janine Adam¹, Amy L Williams²

¹EBRC Consulting, Kirchhorster Straße 27, Hannover 30659, Germany.

Reproductive toxicology (Elmsford, N.Y.)

|August 22, 2024

概括

食品级二氧化 (E171) 在一代扩展研究中没有对老鼠繁殖或发育产生不良影响. 微不足道的吸收表明通过饮食摄入的系统风险较低.

科学领域:

毒理学毒理学毒理学
食品安全食品安全
生殖毒理学生殖毒理学

背景情况:

二氧化 (E171) 是一种广泛使用的食品添加剂.
人们对其潜在的健康影响,特别是对生殖和发育的毒性存在担忧.
强大的安全数据对于监管评估至关重要.

研究的目的:

为了评估食品级二氧化 (E171) 在Sprague Dawley大鼠中的生殖毒性.
通过饮食暴露后评估发育神经毒性和免疫毒性.
为了确定E171.1.的全身吸收和预新生潜力.

主要方法:

扩展一代生殖毒性 (EOGRT) 研究 (经合组织测试443) 在斯普拉格·道利大鼠中.
饮食中使用E171的剂量为0,100,300或1000毫克/公斤体重/天.
评估生殖参数,后代发育,神经毒性,免疫毒性,结肠异常密室焦点 (ACF) 和系统吸收.

主要成果:

在F0动物中没有系统性毒性,生殖效应或病理学变化.
没有对F1后代发育,F1生殖能力或F2幼发育产生不良影响.
没有观察到与治疗相关的发育神经毒性;由于控制问题,免疫毒性段需要重复.
从胃肠道中E171的系统吸收是可以忽略不计的.
没有观察到结肠ACF,这表明没有 preneoplastic潜力.

结论:

食品级二氧化 (E171) 对生殖毒性,后代毒性和发育神经毒性 (1000 mg/kg/天) 显示出高无观察到不良影响水平 (NOAEL).
E171的全身吸收率微不足道,没有预先形成的潜力.
该研究提供了强有力的安全数据,支持E171在食品中的使用,但警告说免疫毒性部分需要进一步调查.

关键词:

E171 一种食物欧洲农业组织 (EOGRT)一代扩展的生殖毒性研究.食品级的二氧化二氧化可以用于食品.经合组织 443 443 经合组织 443 生殖生殖的繁殖

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