Aalto University, Design Factory, Espoo, Finland.
Integr Environ Assess Manag. 2019 Nov;15(6):1000-1011. doi: 10.1002/ieam.4186. Epub 2019 Oct 9.
Titanium dioxide (TiO ) is in the process of being classified as a suspected carcinogenic substance (Carc 2). The present case study probes the outcomes of this potential classification in terms of the reduction of hazardous exposure to TiO due to its classification. Furthermore, the case study examines the elements that are causing ambiguity during the classification process. This study was conducted by walking through the process from the present exposure to TiO to the hazard assessment associated with TiO exposure, to the regulatory classification process, and to practical outcomes affecting TiO usage. Finally, the impact of the classification on exposure, which was originally considered potentially hazardous, is evaluated. The case study shows that TiO classification as a carcinogen will not directly reduce respiratory exposure to TiO , which was the original reason for the classification. Instead, the classification will lead to restrictions on recycling. Moreover, the classification will have an impact on certain solid artifacts and liquid mixtures for which hazardous exposure was not detected. Altogether, the present case raises questions concerning hazard communications associated with the Carc 2 classification; treatment of poorly soluble low toxicity (PSLT) particles and nanoparticles in the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the Classification, Labelling and Packaging (CLP) classifications; and use of human exposure studies for the purposes of chemical regulations. Based on the present study, the following recommendations are made: the final decision on the TiO classification should be reconsidered together with those of other PSLT particles and take into account extensive developments in the field of nanoscience. Furthermore, the European Chemicals Agency (ECHA) should develop state-of-the-art guidance on how to use the available human exposure data. Finally, the authorities that are in charge of European Union chemicals management are advised to further develop the regulatory network to utilize the information generated in REACH processes as efficiently as possible and to verify that the connections between the regulations result in the intended outcome. Integr Environ Assess Manag 2019;00:1-12. © 2019 SETAC.
二氧化钛 (TiO ) 正被归类为疑似致癌物质 (Carc 2)。本案例研究探讨了由于其分类，TiO 危害性暴露减少的潜在结果。此外，案例研究还考察了在分类过程中引起歧义的因素。本研究通过从当前 TiO 暴露到与 TiO 暴露相关的危害评估、法规分类过程以及影响 TiO 使用的实际结果，逐步研究了这个过程。最后，评估了分类对最初被认为具有潜在危害的暴露的影响。案例研究表明，将 TiO 归类为致癌物不会直接降低 TiO 的呼吸暴露，这也是最初分类的原因。相反，分类将导致对回收的限制。此外，分类将对某些未检测到危害性暴露的固体文物和液体混合物产生影响。总的来说，本案例提出了与 Carc 2 分类相关的危害沟通、在注册、评估、授权和化学品限制 (REACH) 及分类、标签和包装 (CLP) 分类中处理低毒性难溶性 (PSLT) 颗粒和纳米颗粒、以及将人体暴露研究用于化学法规等问题。基于本研究，提出以下建议：应重新考虑 TiO 分类的最终决定，以及其他 PSLT 颗粒的分类决定，并考虑到纳米科学领域的广泛发展。此外，欧洲化学品管理局 (ECHA) 应制定关于如何使用现有人体暴露数据的最新指南。最后，建议负责欧盟化学品管理的机构进一步发展监管网络，以尽可能有效地利用 REACH 流程中产生的信息，并验证法规之间的联系是否产生预期的结果。综合环境评估与管理 2019;00:1-12。©2019 SETAC。
