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Alternative Testing Strategies for Nanomaterials: State of the Science and Considerations for Risk Analysis

机译：纳米材料的替代测试策略：科学现状和风险分析注意事项

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摘要

The rapid growth of the nanotechnology industry has warranted equal progress in the nanotoxicology and risk assessment fields. In vivo models have traditionally been used to determine human and environmental risk for chemicals; however, the use of these tests has limitations, and there are global appeals to develop reliable alternatives to animal testing. Many have investigated the use of alternative (nonanimal) testing methods and strategies have quickly developed and resulted in the generation of large toxicological data sets for numerous nanomaterials (NMs). Due to the novel physicochemical properties of NMs that are related to surface characteristics, the approach toward toxicity test development has distinct considerations from traditional chemicals, bringing new requirements for adapting these approaches for NMs. The methodical development of strategies that combine multiple alternative tests can be useful for predictive NM risk assessment and help screening-level decision making. This article provides an overview of the main developments in alternative methods and strategies for reducing uncertainty in NM risk assessment, including advantages and disadvantages of in vitro, ex vivo, and in silico methods, and examples of existing comprehensive strategies. In addition, knowledge gaps are identified toward improvements for experimental and strategy design, specifically highlighting the need to represent realistic exposure scenarios and to consider NM-specific concerns such as characterization, assay interferences, and standardization. Overall, this article aims to improve the reliability and utility of alternative testing methods and strategies for risk assessment of manufactured NMs.
机译：纳米技术行业的快速发展已确保在纳米毒理学和风险评估领域取得同等进步。传统上，使用体内模型来确定人类和环境中化学品的风险；但是，使用这些测试存在局限性，并且在全球范围内呼吁开发可靠的动物测试替代方法。许多人已经研究了替代（非动物）测试方法的使用，并且迅速开发了策略，并导致了许​​多纳米材料（NMs）的大量毒理学数据集的产生。由于NMs具有与表面特性相关的新的理化特性，因此毒性试验开发方法与传统化学方法有着不同的考虑，从而为使这些方法适用于NMs带来了新的要求。结合多种替代测试的策略性方法开发，对于预测性NM风险评估和筛查级决策很有帮助。本文概述了减少NM风险评估不确定性的替代方法和策略的主要发展，包括体外，离体和计算机方法的优缺点，以及现有综合策略的示例。此外，发现了知识缺口，需要改进实验和策略设计，特别强调需要代表现实的暴露场景并考虑NM特定问题，例如表征，测定干扰和标准化。总体而言，本文旨在提高制造NM的替代测试方法和策略的可靠性和实用性。

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