U.S. Department of Commerce, National Institute of Standards and Technology, Gaithersburg, MD, USA.
Integrated Laboratory Systems, LLC, P.O. Box 13501, Research Triangle Park, NC 27709, USA.
ALTEX. 2022;39(2):183–206. doi: 10.14573/altex.2105041. Epub 2021 Dec 3.
Engineered nanomaterials (ENMs) come in a wide array of shapes, sizes, surface coatings, and compositions, and often possess novel or enhanced properties compared to larger sized particles of the same elemental composition. To ensure the safe commercialization of products containing ENMs, it is important to thoroughly understand their potential risks. Given that ENMs can be created in an almost infinite number of variations, it is not feasible to conduct in vivo testing on each type of ENM. Instead, new approach methodologies (NAMs) such as in vitro or in chemico test methods may be needed, given their capacity for higher throughput testing, lower cost, and ability to provide information on toxicological mechanisms. However, the different behaviors of ENMs compared to dissolved chemicals may challenge safety testing of ENMs using NAMs. In this study, member agencies within the Interagency Coordinating Committee on the Validation of Alternative Methods were queried about what types of ENMs are of agency interest and whether there is agency-specific guidance for ENM toxicity testing. To support the ability of NAMs to provide robust results in ENM testing, two key issues in the usage of NAMs, namely dosimetry and interference/bias controls, are thoroughly discussed.
工程纳米材料（ENMs）具有广泛的形状、大小、表面涂层和组成，与相同元素组成的较大颗粒相比，通常具有新颖或增强的特性。为了确保含有 ENMs 的产品能够安全商业化，彻底了解它们的潜在风险非常重要。鉴于可以制造出几乎无数种不同的 ENMs，对每种类型的 ENM 进行体内测试是不切实际的。相反，可能需要新的方法学（NAMs），如体外或化学测试方法，因为它们具有更高的吞吐量测试、更低的成本和提供毒理学机制信息的能力。然而，与溶解化学品相比，ENMs 的不同行为可能会对使用 NAMs 对 ENMs 的安全性测试构成挑战。在这项研究中，间协调委员会（ICCM）内的各成员机构被询问了哪些类型的 ENMs 是机构感兴趣的，以及是否有针对 ENM 毒性测试的特定机构指南。为了支持 NAMs 在 ENM 测试中提供可靠结果的能力，对 NAMs 使用中的两个关键问题，即剂量测定和干扰/偏差控制，进行了深入讨论。
