先进纳米材料的下一代风险评估方法:现状与未来展望。

IF 4.7 3区 环境科学与生态学 Q2 ENVIRONMENTAL SCIENCES
Danail Hristozov , Elena Badetti , Paolo Bigini , Andrea Brunelli , Susan Dekkers , Luisa Diomede , Shareen H. Doak , Wouter Fransman , Agnieszka Gajewicz-Skretna , Elisa Giubilato , Laura Gómez-Cuadrado , Roland Grafström , Arno C. Gutleb , Sabina Halappanavar , Roland Hischier , Neil Hunt , Alberto Katsumiti , Ali Kermanizadeh , Antonio Marcomini , Elisa Moschini , Alex Zabeo
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引用次数: 0

摘要

本手稿讨论了在先进纳米材料 (AdNM) 的安全设计和监管风险评估中应用新方法 (NAM) 所面临的挑战。作者提出了一个下一代 AdNMs 风险评估框架,其中涉及与传统风险评估范式相一致的 NAMs。该框架以暴露为导向,针对特定终端,充分利用已有信息,并可根据所采用的纳米有 机材料的特异性和复杂性的增加而分层实施。该方法的分层结构有效地将现有数据的使用与有针对性的测试结合起来,这将使安全评估具有成本效益,并尽可能减少对脊椎动物的使用。从透明度、可靠性、可获取性、适用性、相关性和完整性等方面评估了最先进的新兴营养监测方法的监管准备情况,并结合风险评估范式的每个步骤讨论了这些方法与 AdNMs 的相关性,同时为各科学和监管领域的未来发展提供了展望。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives

Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives

This manuscript discusses the challenges of applying New Approach Methodologies (NAMs) for safe by design and regulatory risk assessment of advanced nanomaterials (AdNMs). The authors propose a framework for Next Generation Risk Assessment of AdNMs involving NAMs that is aligned to the conventional risk assessment paradigm. This framework is exposure-driven, endpoint-specific, makes best use of pre-existing information, and can be implemented in tiers of increasing specificity and complexity of the adopted NAMs. The tiered structure of the approach, which effectively combines the use of existing data with targeted testing will allow safety to be assessed cost-effectively and as far as possible with even more limited use of vertebrates. The regulatory readiness of state-of-the-art emerging NAMs is assessed in terms of Transparency, Reliability, Accessibility, Applicability, Relevance and Completeness, and their appropriateness for AdNMs is discussed in relation to each step of the risk assessment paradigm along with providing perspectives for future developments in the respective scientific and regulatory areas.

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来源期刊
NanoImpact
NanoImpact Social Sciences-Safety Research
CiteScore
11.00
自引率
6.10%
发文量
69
审稿时长
23 days
期刊介绍: NanoImpact is a multidisciplinary journal that focuses on nanosafety research and areas related to the impacts of manufactured nanomaterials on human and environmental systems and the behavior of nanomaterials in these systems.
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