Empa, Swiss Laboratory for Materials Science and Technology, Lerchenfeldstrasse 5, 9014 St. Gallen, Switzerland.
Acc Chem Res. 2013 Mar 19;46(3):863-72. doi: 10.1021/ar3000458. Epub 2012 Oct 31.
Although researchers have intentionally produced and used nanomaterials for more than a century, nanotechnology has made its mark in most areas of daily life in the past 20 years. Now thousands of products contain nanoparticles, nanofibers, or nanostructured parts. Because some chemical products have caused severe problems to human health and to the environment, we should consider the overall biological and toxicological effects of nanomaterials as we decide whether to use them in various products. We should also reflect on the mechanisms for making these decisions, which may greatly influence the development, production, and use of such products. The preselection of appropriate materials during the early product design state should allow industry and applied researchers to mitigate the risks of these new materials. However, currently the human and ecological risks of the applied nanomaterials during their life cycle are unknown. A large set of physicochemical characteristics can determine the potential human and environmental exposure to and hazards from nanomaterials. Thus, researchers will need many years to gather and analyze all the data to perform a comprehensive risk assessment for engineered nanomaterials and to develop a sound decision making process. The ideal risk assessment approach would include cost-effective screening processes to target resources toward the risks of greatest concern. The outcome of the risk assessment is only as good as the quality of the data used. Unfortunately, the actual review process of most journals that publish on nanotoxicology focuses on "mechanistic studies and results" rather than a toxicologically relevant outcome. For example, journals often do not include studies that show no effect as worthy of publication ("no-effect-studies" dilemma), which can lead to misleading interpretations of toxicological data for hazard identification. However, even with insufficient data sets, researchers can produce a preliminary comparable risk assessment ("approximate" risk assessment). Researchers have already performed risk-based evaluations of nanomaterials grounded on the comparison of exposure concentrations with no-effect levels (as required for chemical risk assessment), examining generic nanomaterials such as "nano-TiO₂" but not specific forms or modifications. Even though these data sets on hazard and exposure are incomplete, they already provide the basis to illustrate the current state of knowledge and uncertainties. Therefore industry and applied researchers can calculate the probability that an adverse effect might occur and begin to balance the benefits and potential risks of an innovation. Based on the increasing numbers of nanotoxicology publications and funding programs, this Account reviews the decision support approaches that already exist to safely implement engineered nanomaterials during an early phase of innovation.
尽管研究人员在一个多世纪以来一直有意地生产和使用纳米材料,但在过去的 20 年里,纳米技术已经在日常生活的大部分领域留下了印记。现在,数千种产品都含有纳米颗粒、纳米纤维或纳米结构部件。由于一些化学产品对人类健康和环境造成了严重问题,因此,在决定是否将它们用于各种产品时,我们应该考虑纳米材料的整体生物和毒理学效应。我们还应该反思做出这些决策的机制,因为这些机制可能会极大地影响这些产品的开发、生产和使用。在早期产品设计阶段选择合适的材料,可以使工业界和应用研究人员减轻这些新材料的风险。然而,目前这些纳米材料在其生命周期中的人类和生态风险尚不清楚。大量理化特性可以决定纳米材料对人类和环境的潜在暴露和危害。因此,研究人员需要多年时间来收集和分析所有数据,以对工程纳米材料进行全面的风险评估,并制定健全的决策过程。理想的风险评估方法将包括具有成本效益的筛选过程,以便将资源集中用于最受关注的风险上。风险评估的结果与所使用数据的质量一样好。不幸的是,发表纳米毒理学研究的大多数期刊的实际审查过程都侧重于“机制研究和结果”,而不是与毒理学相关的结果。例如,期刊通常不包括显示无影响的研究作为值得发表的内容(“无效应研究”困境),这可能导致对危害识别的毒理学数据产生误导性解释。然而,即使数据组不足,研究人员也可以进行初步的可比风险评估(“近似”风险评估)。研究人员已经基于暴露浓度与无影响水平的比较,对纳米材料进行了基于风险的评估(如化学风险评估所要求的),考察了“纳米-TiO₂”等通用纳米材料,但没有考察具体的形式或改性。尽管这些关于危害和暴露的数据还不完整,但它们已经为说明当前知识状况和不确定性提供了依据。因此,工业界和应用研究人员可以计算出不良反应发生的可能性,并开始平衡创新的收益和潜在风险。基于越来越多的纳米毒理学出版物和资助计划,本报告回顾了现有的决策支持方法,以便在创新的早期阶段安全地实施工程纳米材料。