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将新的体外方法整合到危害测试和风险评估中的机遇与挑战。

Opportunities and Challenges for Integrating New In Vitro Methodologies in Hazard Testing and Risk Assessment.

机构信息

NC3Rs, Gibbs Building, 215 Euston Road, London, NW1 2BE, UK.

In Vitro Toxicology Group, Swansea University Medical School, Institute of Life Sciences, Singleton Park Campus, Swansea, Wales, SA2 8PP, UK.

出版信息

Small. 2021 Apr;17(15):e2006298. doi: 10.1002/smll.202006298. Epub 2021 Jan 22.

DOI:10.1002/smll.202006298
PMID:33480476
Abstract

Nanomaterials are defined as materials with at least one dimension of 100 nm or less. Their small size confers unique properties that may alter the toxicity profile when compared to larger forms of the same material, requiring additional considerations for safety assessment. There has been a rise in the development of nanomaterials for many applications, and although traditional approaches for toxicity testing may address some of the new toxicity concerns, many may not be directly applicable to nanomaterials and new tools or approaches may need to be developed. Since nanomaterials can exist in many different forms, each of which may cause different adverse biological effects, reliance on traditional in vivo models for safety assessment will simply not be feasible or sustainable, given the volume of materials that may need to be tested. It is essential to consider and develop new in vitro methods that can be applied for hazard identification and risk assessment. Many challenges are associated with using alternative approaches to ensure they are as robust and reliable as traditional in vivo approaches, but by overcoming these issues and adopting new testing strategies there are opportunities to improve safety assessments and reduce the reliance on animal-based toxicity testing strategies.

摘要

纳米材料被定义为至少有一个维度为 100nm 或更小的材料。它们的小尺寸赋予了独特的性质,与同一种材料的较大形式相比,可能会改变其毒性特征,因此需要对安全性评估进行额外的考虑。由于许多应用都需要开发纳米材料,因此尽管传统的毒性测试方法可能解决了一些新的毒性问题,但许多方法可能不适用于纳米材料,可能需要开发新的工具或方法。由于纳米材料可以以许多不同的形式存在,每种形式都可能引起不同的不良生物学效应,因此仅依靠传统的体内模型进行安全性评估在可操作性或可持续性方面都是不可行的,因为需要测试的材料数量可能非常庞大。因此,考虑并开发可用于危害识别和风险评估的新的体外方法是至关重要的。使用替代方法存在许多挑战,需要确保其与传统的体内方法一样稳健和可靠,但通过克服这些问题并采用新的测试策略,就有机会改进安全性评估并减少对基于动物的毒性测试策略的依赖。

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