The carcinogenic potential of nanomaterials, their release from products and options for regulating them
The carcinogenic potential of nanomaterials, their release from products and options for regulating them
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DOI：
10.1016/j.ijheh.2010.11.004
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发表时间：
2011-06-01
影响因子：
6
通讯作者：
Kolossa-Gehring, Marike
中科院分区：
文献类型：
--
作者：
Becker, Heidi;Herzberg, Frank;Kolossa-Gehring, Marike
德国联邦环境署和德国联邦风险评估研究所的一个工作组对纳米材料的致癌潜力进行了严格审查。在对现有数据进行严格审查后，我们得出结论，目前只能根据具体情况评估纳米材料的潜在致癌风险。有一定的证据表明，不同形式的CNT（碳纳米管）和纳米级TiO 2颗粒可能会在敏感的动物模型中诱发肿瘤。据推测，石棉样纤维和低毒性生物持久性细粉尘（纳米二氧化钛）的可吸入部分的吸入毒性的作用模式与慢性炎症过程有关。关于这些人造纳米材料致癌性的现有流行病学研究还没有充分的结论性，一般而言，数据库不足以评估纳米材料的致癌潜力。虽然一些研究提供了纳米特异性诱发肿瘤的潜力的证据，但其他研究没有。这可能是由于试验材料的特性描述不充分、实验设计的差异、使用不同的动物模型和物种和/或剂量测定的差异（关于适当的剂量度量和估计的有效剂量）。此外，无法对观察到的致癌作用的纳米特异性进行最终评价。纳米材料的特定致癌效应可能是定量和定性的。在定量方面，纳米颗粒的致癌作用被认为比相应的散装材料更明显（例如，由于相对于质量浓度的相当大的表面积和更多的颗粒数量）。另一方面，某些纳米性质，例如小尺寸、形状和反应性、克服生物屏障后在体内的保留时间和分布，以及亚细胞和分子相互作用，可能在定性确定毒性方面发挥作用，即纳米材料和非纳米材料的致癌潜力。所有这些因素都毫无疑问地表明，在这一领域有很大的研究需求，需要开发新的标准化测试方法，现有的标准至少要进行调整，以获得关于纳米材料致癌潜力的有效答案。未来几年，全球纳米材料的产量将增加，具有新特性的新材料将被开发出来，因此必须预期人类将更多地接触到纳米材料。目前还不能得出关于纳米颗粒接触及其从产品中释放的可靠结论。首先，关于产品和制剂中纳米材料加工的信息严重不足。第二，关于纳米颗粒释放的研究数量很少，而且测量和监测不同环境介质中纳米材料的可靠技术仍在开发中，这既复杂又昂贵。尽管存在不确定性，但必须认真对待迄今为止关于纳米材料致癌潜力的研究结果，和预防措施，以尽量减少接触应该携手并进，发展一个全面的和结论性的毒理学方法和测试程序的纳米结构材料，包括所有可能的接触关于纳米材料可能的法律的分类及其非纳米材料对应物分类的可转移性，我们认为有必要对纳米和非纳米形式制定单独的程序。此外，评估纳米特定致癌特性的标准应不断更新，并适应知识的发展状况。有必要对欧盟立法进行修正，因为目前纳米形式本身并不代表一个单独的物质类别。(C)2010年Elsevier GmbH。All rights reserved.
A summary of a critical review by a working group of the German Federal Environment Agency and the German Federal Institute for Risk Assessment on the carcinogenic potential of nanomaterials is presented. After a critical review of the available data, we conclude that the potential carcinogenic risk of nanomaterials can currently be assessed only on a case-by-case basis. There is certain evidence that different forms of CNTs (carbon nanotubes) and nanoscale TiO2 particles may induce tumours in sensitive animal models. It is assumed that the mode of action of the inhalation toxicity of asbestos-like fibres and of inhalable fractions of biopersistent fine dusts of low toxicity (nano-TiO2) is linked to chronic inflammatory processes. Existing epidemiological studies on carcinogenicity for these manufactured nanomaterials are not sufficiently conclusive.Generally speaking, the database is not adequate for an assessment of the carcinogenic potential of nanomaterials. Whereas a number of studies provide evidence of a nano-specific potential to induce tumours, other studies did not. This is possibly due to insufficient characterisation of the test material, difference in the experimental design, the use of different animal models and species and/or differences in dosimetry (both with regard to the appropriate dose metric and the estimated effective dose quantities).An assessment of the carcinogenic potential and its relevance for humans are currently fraught with uncertainty. Furthermore, the nano-specificity of the carcinogenic effects observed cannot be conclusively evaluated. Specific carcinogenic effects of nanomaterials may be both quantitative and qualitative. In quantitative terms, the carcinogenic effects of nanoparticles are thought to be simply more pronounced compared to the corresponding bulk material (due, for example, to the considerably larger surface area and higher number of particles relative to the mass concentration). On the other hand, certain nano-properties such as small size, shape and reactivity, retention time and distribution in the body after overcoming biological barriers, as well as subcellular and molecular interactions may play a role in determining the toxicity in qualitative terms, i.e. the carcinogenic potential of the nanomaterial and the non-nanoscale comparison substance may be fundamentally different.All of these factors leave no doubt about the fact that there is a great need for research in this area and that new standardised test methods need to be developed or existing ones adapted at the very least to achieve valid answers regarding the carcinogenic potential of nanomaterials. Global production of nanomaterials is set to increase in the years to come, and new materials with new properties will be developed, so that greater human exposure to them must be anticipated.No reliable conclusions can currently be drawn about exposure to nanoparticles and their release from products. Firstly, there are substantial deficits in information about the processing of nanomaterials in products and preparations. Secondly, there are only a small number of studies on nanoparticle release, and reliable techniques for measuring and monitoring nanomaterials in different environmental media are still being developed which is both complex and costly.Despite the uncertainties, the findings to date on the carcinogenic potential of nanomaterials must be taken seriously, and precautionary measures to minimise exposure should go hand in hand with the development of a comprehensive and conclusive toxicological methodology and testing procedure for nanostructured materials that includes all possible exposure routes.With regard to possible legal classification of nanomaterials and the transferability of classifications of their non-nanomaterial counterparts, we believe it is necessary to have separate procedures for nano and non-nano forms. Furthermore, criteria for evaluating nano-specific carcinogenic properties should be constantly updated and adapted to the state of knowledge. There is a need here for amendments to be made to EU legislation, as currently nanoforms do not represent a separate category of substance in their own right. (C) 2010 Elsevier GmbH. All rights reserved.