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Approaches to Develop Alternative Testing Strategies to Inform Human Health Risk Assessment of Nanomaterials

机译：制定替代测试策略以告知人类对纳米材料的健康风险评估的方法

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摘要

The development of alternative testing strategies (ATS) for hazard assessment of new and emerging materials is high on the agenda of scientists, funders, and regulators. The relatively large number of nanomaterials on the market and under development means that an increasing emphasis will be placed on the use of reliable, predictive ATS when assessing their safety. We have provided recommendations as to how ATS development for assessment of nanomaterial hazard may be accelerated. Predefined search terms were used to identify the quantity and distribution of peer-reviewed publications for nanomaterial hazard assessment following inhalation, ingestion, or dermal absorption. A summary of knowledge gaps relating to nanomaterial hazard is provided to identify future research priorities and areas in which a rich data set might exist to allow ATS identification. Consultation with stakeholders (e.g., academia, industry, regulators) was critical to ensure that current expert opinion was reflected. The gap analysis revealed an abundance of studies that assessed the local and systemic impacts of inhaled particles, and so ATS are available for immediate use. Development of ATS for assessment of the dermal toxicity of chemicals is already relatively advanced, and these models should be applied to nanomaterials as relatively few studies have assessed the dermal toxicity of nanomaterials to date. Limited studies have investigated the local and systemic impacts of ingested nanomaterials. If the recommendations for research prioritization proposed are adopted, it is envisioned that a comprehensive battery of ATS can be developed to support the risk assessment process for nanomaterials. Some alternative models are available for immediate implementation, while others require more developmental work to become widely adopted. Case studies are included that can be used to inform the selection of alternative models and end points when assessing the pathogenicity of fibers and mode of action of nanomaterial toxicity.
机译：科学家，资助者和管理者的议事日程上，开发用于评估新材料和新兴材料的危害的替代测试策略（ATS）的工作十分重要。市场上和正在开发的纳米材料数量相对较多，这意味着在评估其安全性时，将越来越重视使用可靠的，可预测的ATS。我们提供了有关如何加速用于纳米材料危害评估的ATS开发的建议。使用预定义的搜索字词来确定经过同行评审的出版物的数量和分布，以进行吸入，摄入或皮肤吸收后的纳米材料危害评估。提供了与纳米材料危害有关的知识空白的摘要，以识别未来的研究重点和可能存在丰富数据集以进行ATS识别的领域。与利益相关者（例如，学术界，行业，监管机构）进行磋商对于确保反映当前专家的意见至关重要。差距分析显示，大量研究评估了吸入颗粒的局部和全身影响，因此ATS可立即使用。用于评估化学药品的皮肤毒性的ATS的开发已经相对先进，并且这些模型应该应用于纳米材料，因为迄今为止很少有研究评估纳米材料的皮肤毒性。有限的研究已经调查了摄入纳米材料的局部和全身影响。如果采纳了建议的研究优先级建议，则可以预见可以开发出一系列的苯丙胺类兴奋剂，以支持纳米材料的风险评估过程。有些替代模型可立即实施，而另一些则需要更多的开发工作才能被广泛采用。包括案例研究，可用于评估纤维的致病性和纳米材料毒性的作用方式时，为替代模型和终点的选择提供信息。

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  • 来源
    《Risk analysis》 |2016年第8期|1538-1550|共13页
  • 作者

    Stone Vicki; Johnston Helinor J.; Balharry Dominique; Gernand Jeremy M.; Gulumian Mary;

  • 作者单位

    Heriot Watt Univ, Sch Life Sci, Nano Safety Res Grp, Edinburgh EH14 4AS, Midlothian, Scotland;

    Heriot Watt Univ, Sch Life Sci, Nano Safety Res Grp, Edinburgh EH14 4AS, Midlothian, Scotland;

    Heriot Watt Univ, Sch Life Sci, Nano Safety Res Grp, Edinburgh EH14 4AS, Midlothian, Scotland|Univ Edinburgh, Inst Genet & Mol Med, Ctr Genom & Expt Med, Edinburgh, Midlothian, Scotland;

    Penn State Univ, Dept Energy & Mineral Engn, University Pk, PA 16802 USA;

    Toxicol & Biochem Sect NIOH, Johannesburg, South Africa|Univ Witwatersrand, Haematol & Mol Med Dept, Sch Pathol, Johannesburg, South Africa;

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  • 正文语种 eng
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  • 关键词

    Alternative testing strategy; gap analysis; hazard; nanomaterials; risk; 3Rs;

    机译：替代测试策略;缺口分析;危害;纳米材料;风险;3Rs;

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