经合组织纳米材料基因毒性测试指南的现状和未来挑战:研讨会报告。

IF 2.5 4区 医学 Q3 GENETICS & HEREDITY
Mutagenesis Pub Date : 2023-08-24 DOI:10.1093/mutage/gead017
Shareen H Doak, Cristina Andreoli, Michael J Burgum, Qasim Chaudhry, Eric A J Bleeker, Cecilia Bossa, Josefa Domenech, Damjana Drobne, Valerie Fessard, Nina Jeliazkova, Eleonora Longhin, Elise Rundén-Pran, Maciej Stepnik, Naouale El Yamani, Julia Catalán, Maria Dusinska
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引用次数: 0

摘要

纳米材料的基因毒性测试仍然具有挑战性,因为标准测试方法需要一些调整,并且需要进一步制定针对纳米材料的经合组织测试指南和指导文件。然而,基因毒理学领域仍在继续发展,正在开发新的方法论,可以提供有关纳米材料可能产生的基因毒性作用机制的相关信息。人们认识到,有必要在纳米材料的遗传毒性测试框架内实施新的和/或经调整的经合组织技术转让文书、新的经合组织通用数据以及利用非农产品名称。因此,在监管背景下应用新的实验方法和数据对纳米材料进行遗传毒性评估的要求既不明确,也没有在实践中使用。因此,召开了一次由监管机构、行业、政府和学术科学家代表参加的国际研讨会,讨论这些问题。专家讨论强调了暴露制度下标准测试方法目前存在的缺陷、理化特征不足、缺乏细胞或组织摄取和内化的证明,以及基因毒性作用模式的覆盖范围有限。关于后一个方面,就利用非农产品市场准入支持纳米材料遗传毒性评估的重要性达成了共识。还强调了科学家和监管机构之间密切接触的必要性,以(i)明确监管需求,(ii)提高对不结盟运动产生的数据的接受和使用,以及(iii)确定如何将不结盟运动用作监管风险评估中使用的证据权重方法的一部分。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Current status and future challenges of genotoxicity OECD Test Guidelines for nanomaterials: a workshop report.

Genotoxicity testing for nanomaterials remains challenging as standard testing approaches require some adaptation, and further development of nano-specific OECD Test Guidelines (TGs) and Guidance Documents (GDs) are needed. However, the field of genotoxicology continues to progress and new approach methodologies (NAMs) are being developed that could provide relevant information on the range of mechanisms of genotoxic action that may be imparted by nanomaterials. There is a recognition of the need for implementation of new and/or adapted OECD TGs, new OECD GDs, and utilization of NAMs within a genotoxicity testing framework for nanomaterials. As such, the requirements to apply new experimental approaches and data for genotoxicity assessment of nanomaterials in a regulatory context is neither clear, nor used in practice. Thus, an international workshop with representatives from regulatory agencies, industry, government, and academic scientists was convened to discuss these issues. The expert discussion highlighted the current deficiencies that exist in standard testing approaches within exposure regimes, insufficient physicochemical characterization, lack of demonstration of cell or tissue uptake and internalization, and limitations in the coverage of genotoxic modes of action. Regarding the latter aspect, a consensus was reached on the importance of using NAMs to support the genotoxicity assessment of nanomaterials. Also highlighted was the need for close engagement between scientists and regulators to (i) provide clarity on the regulatory needs, (ii) improve the acceptance and use of NAM-generated data, and (iii) define how NAMs may be used as part of weight of evidence approaches for use in regulatory risk assessments.

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来源期刊
Mutagenesis
Mutagenesis 生物-毒理学
CiteScore
5.90
自引率
3.70%
发文量
22
审稿时长
6-12 weeks
期刊介绍: Mutagenesis is an international multi-disciplinary journal designed to bring together research aimed at the identification, characterization and elucidation of the mechanisms of action of physical, chemical and biological agents capable of producing genetic change in living organisms and the study of the consequences of such changes.
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