Hansen Steffen Foss, Sørensen Sara Nørgaard, Skjolding Lars Michael, Hartmann Nanna B, Baun Anders
Department of Environmental Engineering, Technical University of Denmark, DTU-building 115, 2800 Kgs. Lyngby, Denmark.
Environ Sci Eur. 2017;29(1):14. doi: 10.1186/s12302-017-0111-3. Epub 2017 Mar 9.
The European Chemical Agency (ECHA) is in the process of revising its guidance documents on how to address the challenges of ecotoxicological testing of nanomaterials. In these revisions, outset is taken in the hypothesis that ecotoxicological test methods, developed for soluble chemicals, can be made applicable to nanomaterials. European Research Council project EnvNano-Environmental Effects and Risk Evaluation of Engineered, which ran from 2011 to 2016, took another outset by assuming that: ". The aim of this paper is to present the findings of the EnvNano project and through these provide the scientific background for specific recommendations on how ECHA guidance could be further improved. Key EnvNano findings such as the need to characterize dispersion and dissolution rates in stock and test media have partially been addressed in the updated guidance. However, it has to be made clear that multiple characterization methods have to be applied to describe state of dispersion and dissolution over time and for various test concentration. More detailed information is called for on the specific characterization methods and techniques available and their pros and cons. Based on findings in EnvNano, we recommend that existing algal tests are with tests where suspensions of nanomaterials are aged for 1-3 days for nanomaterials that dissolve in testing media. Likewise, for daphnia tests we suggest to supplement with tests where (a) exposure is shortened to a 3 h pulse exposure in daphnia toxicity tests with environmentally hazardous metal and metal oxide nanomaterials prone to dissolution; and (b) food abundance is three to five times higher than normal, respectively. We further suggest that the importance of considering the impact of shading in algal tests is made more detailed in the guidance and that it is specified that determination of uptake, depuration and trophic transfer of nanomaterials for each commercialized functionalization of the nanomaterials is required. Finally, as an outcome of the project a method for assessing the regulatory adequacy of ecotoxicological studies of nanomaterials is proposed.
欧洲化学品管理局（ECHA）正在修订其关于如何应对纳米材料生态毒理学测试挑战的指导文件。在这些修订中，开始基于这样一种假设：为可溶性化学品开发的生态毒理学测试方法可以适用于纳米材料。欧洲研究理事会2011年至2016年开展的“EnvNano-工程纳米材料的环境影响与风险评估”项目则基于另一种假设：“本文旨在介绍EnvNano项目的研究结果，并借此为关于如何进一步改进ECHA指南的具体建议提供科学依据。EnvNano的关键研究结果，如需要表征储备液和测试介质中的分散和溶解速率，在更新后的指南中已部分得到解决。然而，必须明确的是，必须应用多种表征方法来描述不同时间和各种测试浓度下的分散和溶解状态。需要更多关于可用的具体表征方法和技术及其优缺点的详细信息。基于EnvNano的研究结果，我们建议对于可在测试介质中溶解的纳米材料，现有的藻类测试应与纳米材料悬浮液老化1至3天的测试相结合。同样，对于水蚤测试，我们建议补充以下测试：（a）对于易于溶解的环境有害金属和金属氧化物纳米材料，在水蚤毒性测试中将暴露时间缩短为3小时脉冲暴露；（b）食物丰度分别比正常情况高3至5倍。我们还建议在指南中更详细地说明考虑藻类测试中遮光影响的重要性，并明确规定需要针对每种商业化功能化的纳米材料测定其摄取、净化和营养转移情况。最后，作为该项目的成果，提出了一种评估纳米材料生态毒理学研究监管充分性的方法。
