Approaches to the safety assessment of engineered nanomaterials (ENM) in food
Approaches to the safety assessment of engineered nanomaterials (ENM) in food
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DOI：
10.1016/j.fct.2011.12.029
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发表时间：
2012-06-01
影响因子：
4.3
通讯作者：
Wildemann, Tanja
中科院分区：
文献类型：
--
作者：
Cockburn, Andrew;Bradford, Roberta;Wildemann, Tanja
提出了一种系统的、分层的方法来评估食品中工程纳米材料 (ENM) 的安全性。首先将 ENM 与其非纳米形式对应物进行比较，以确定是否需要 ENM 特定评估。从毒理学角度来看，最受关注的是 ENM，它们具有全身易位的潜力，随着时间的推移不溶或仅部分溶解，或者呈颗粒状和生物持久性。触发 ENM 特定评估的地方。 1 级筛选考虑跨生物屏障易位的可能性、细胞毒性、活性氧的产生、炎症反应、遗传毒性和一般毒性。在二氧化硅和体外研究中，以及亚急性重复剂量啮齿动物研究，可以考虑用于这一阶段。 2 级危险特征描述基于为期 90 天的啮齿动物哨点研究，具有扩展的终点范围，并正在逐案调查其他参数。应在一系列食品和生物基质中进行物理化学表征。 ENM 100% 生物利用度的默认假设提供了“最坏情况”暴露情景，随着更多数据的出现，该情景可以得到完善。该安全测试策略被认为适用于纳米级 ENM 尺寸的变化以及新一代 ENM。 (C) 2012 Elsevier Ltd. 保留所有权利。
A systematic, tiered approach to assess the safety of engineered nanomaterials (ENMs) in foods is presented. The ENM is first compared to its non-nano form counterpart to determine if ENM-specific assessment is required. Of highest concern from a toxicological perspective are ENMs which have potential for systemic translocation, are insoluble or only partially soluble over time or are particulate and bio-persistent. Where ENM-specific assessment is triggered. Tier 1 screening considers the potential for translocation across biological barriers, cytotoxicity, generation of reactive oxygen species, inflammatory response, genotoxicity and general toxicity. In silica and in vitro studies, together with a sub-acute repeat-dose rodent study, could be considered for this phase. Tier 2 hazard characterisation is based on a sentinel 90-day rodent study with an extended range of endpoints, additional parameters being investigated case-by-case. Physicochemical characterisation should be performed in a range of food and biological matrices. A default assumption of 100% bioavailability of the ENM provides a 'worst case' exposure scenario, which could be refined as additional data become available. The safety testing strategy is considered applicable to variations in ENM size within the nanoscale and to new generations of ENM. (C) 2012 Elsevier Ltd. All rights reserved.