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双A替代品风险评估的新先进模型 (NAM)

Tatiana Honza¹, Naouale El Yamani¹, Maria Dusinska¹

¹The Climate and Environmental Research Institute (NILU) Norway.

EFSA journal. European Food Safety Authority

|December 23, 2024

概括

对双A (BPA) 安全性的担忧促使开发了诸如双E (BPE) 和双P (BPP) 等替代品. 这项研究使用先进的人类细胞模型评估了BPE和BPP的基因毒性,为监管评估提供了关键数据.

科学领域:

毒理学毒理学毒理学
遗传学是一个遗传学.
生物技术是生物技术.

背景情况:

双A (BPA) 的安全问题和监管转变需要评估BPA替代品.
对比斯E (BPE) 和比斯P (BPP) 等BPA替代品的毒理学数据不足带来了风险.
新方法方法 (NAMs) 对于下一代风险评估 (NGRA) 和与3Rs (取代,减少,完善) 保持一致至关重要.

研究的目的:

评估两个与监管相关的BPA替代品BPE和BPP的基因毒性.
验证和标准化用于基因毒性测试的高级3D肝球形模型.
为了将3D肝球体与标准基因毒性模型的结果进行比较.

主要方法:

使用多个终点测试BPE和BPP的基因毒性测试:彗星测试 (DNA链断裂,氧化基) 和体外微核测试 (克拉斯托基性,无菌性).
使用的人类模型:2D HepG2 肝细胞,3D 肝球体和初级人体外周血液淋巴细胞.
3D肝球形模型的标准化和预验证.

主要成果:

该研究应用了多个基因毒性测定来评估BPE和BPP在各种人类模型中.
从先进的3D肝球形模型的结果与标准的基因毒性模型进行了比较.
细胞毒性与基因毒性终点一起评估.

结论:

该研究为BPE和BPP提供了重要的基因毒性数据,这对于监管决策至关重要.
3D肝球体的验证证明了它们作为基因毒性测试的可靠NAM的潜力.
对于监管机构的接受和推进NGRA,NAM的标准化是必要的.

关键词:

BPA的替代品其他替代品这些是NAMs.彗星测试试验彗星测试试验遗传毒性遗传毒性遗传毒性遗传毒性代谢过程中的代谢.微核测试试验微核测试试验球状肝细胞是球状的肝细胞.

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