Suchergebnisse

Abstract
The HARMLESS project focusses upon assessment approaches to support Safe-and-Sustainable-by-Design (SSbD) development of advanced materials (AdMa). Case studies comprise several industry sectors. Specifically for the construction sector we study façade insulation by fibre-aerogel-mats. Beyond the relatively simpler mono-component organic aerogels presented earlier (Keller et al. 2021), here we deal with multi-component materials: Glass fibers provide structural integrity for the silica-based aerogel that provides the thermal insulation performance, though is coated by organosilane as a hydrophobizing agent to prevent moisture uptake. Optionally, an additional inorganic coating can be applied to enhance mechanical stability. Here we explored this wide SSbD design space by four industrially relevant SSbD-versions of fibre-aerogel-mats; these were ranked and compared against each other as well as conventional insulation material (i.e. stone wool). We assessed the release by performing several typical occupational operations under clean-air conditions within a laboratory setting. Up to 106/ccm particles are released, with respirable aerodynamic diameters. We collected the dust and assessed the structure and behavior with respect to its biological reactivity and biodissolution, focusing on the screening and ranking of inhalation hazards. The data on exposure and hazard was complemented by data on functionality in the intended use, where all SSbD versions performed significantly better than the conventional alternative. The new data refines the risk screening and categorisation schemes for advanced materials, including Early4AdMa (RIVM 2022), AdmGRID (Kennedy et al. 2019), InnoMat.Life (Wohlleben et al. 2022) and an environmental risk screening (Arvidsson et al. 2022).

Abstract
Dustiness is a key parameter describing the ability of powder materials to generate dust during agitation. The main goal of this work was to generate and assess the scientific basis for the validation and applicability of 6 dustiness methods to nanomaterials, and development of a subsequent OECD testing guideline. Six dustiness methods (rotating drum, small rotating drum, continuous drop, vortex shaker, fluidizer and venturi) were subjected to an intra- and inter-laboratory comparison (ILC) in which 15 international laboratories participated. ILC tests were conducted for 6 materials (3 TiO2 and 3 SiO2) of different chemical natures and dustiness levels. Each participating laboratory conducted at least 3 replicates per material. Harmonization of procedures, methods and data treatment took place prior to testing. Results from the ILC were assessed considering the different reported metrics such as respirable mass and particle number dustiness index. Overall, the intralaboratory variability for the different methods and metrics was under 30%. Variation between laboratories was generally higher for respirable mass than particle number dustiness index. These variations were mostly attributed to differences in setups such as tubing length or instrumentation. All methods except the venturi, which was characteristic for presenting low differences between materials and opposed classification to the rest of the methods, showed relatively similar material ranking. For all methods and laboratories the calculated z-score (measure of the deviation of each laboratory from the true value) was <2 as based on ISO 13528, which indicates gratifying results.
Funding: EU H2020 Research and Innovation Programme under Grant Agreement 814401.

Abstract
There has been an increasing use of manufactured nanomaterials in industrial applications and consumer products. It has instigated concerns about the sustainability, risks and uncertainties regarding the interactions of the nanomaterials with humans and the environment. Consequently, significant resources in Europe have been invested into tool and method development to support risk mitigation and management, facilitating the research and innovation process of manufactured nanomaterials. Extended risk analysis, including socio-economic impact and sustainability assessment is moving the conventional risk-based approach towards a wider safety-and-sustainability-by-design perspective. Despite growing tool and method developments, the level of awareness and use by stakeholders is still limited. Regulatory compliance and acceptance, reliability and trust, user-friendliness and compatibility with the users' needs are important factors traditionally known to hinder their widespread use. Therefore, a framework is presented to quantify the readiness of different tools and methods towards their wider regulatory acceptance and downstream use by different stakeholders. The framework, developed within Gov4Nano, diagnoses barriers which hinder regulatory acceptance and wider usability of a tool/method based on their Transparency, Reliability, Accessibility, Applicability and Completeness (TRAAC framework). An online TRAAC tool is being developed within HARMLESS that will be freely available on https://diamonds.tno.nl/#traac. Fourteen tools and methods were assessed using the TRAAC framework as proof-of-concept. The results provide insights into any gaps, opportunities, and challenges in the context of each of the 5 pillars of the TRAAC framework.

Abstract
Risk governance, sustainability and safety-by-design have high attention in current research projects and policy. In the EU H2020 Gov4Nano project, we refined the EU H2020 caLIBRAte phase-gate nano-risk innovation governance framework, its guidance and expanded the list of supporting risk governance tools. Stakeholder wishes were mapped from previous projects and consultations made within Gov4Nano and across the two other EU H2020 NMBP-13 governance projects (NANORIGO and RiskGone) and considered in the refinement. The revised framework considers three pre-defined phase-gate models for minor (fast-track/low risk), intermediate (medium risk) and novel (high-risk) developments. The guidance was further elaborated to direct users though sustainability and safety-by-design considerations and risk mitigation actions. ISO21505 was used as the backbone for the risk governance framework. The approach allows design of the specific nano-risk governance project and information requirements for decision-making. The list of recommended nano-risk governance tools was expanded and selected considering their reliability and performance. An important step in this process was an evaluation of tools made under the umbrella of the OECD (ENV/CBC/MONO(2021)23; ENV/CBC/MONO(2021)27/REV; ENV/CBC/MONO(2021)28; ENV/CBC/MONO(2021)29/REV) and development of a new tool assessment framework called TRAAC (Transparency, Reliability, Accessibility, Applicability and Reliability). Limitations in application domains remains an issue for future developments. The approach and tools are made accessible via a nano-risk governance portal produced by the three NMBP-13 projects (http://nanoriskgov.eu/).
Funding: European Union's Horizon 2020 Research and Innovation Programme under Grant Agreement 814401.

Advanced material development, including at the nanoscale, comprises costly and complex challenges coupled to ensuring human and environmental safety. Governmental agencies regulating safety have announced interest toward acceptance of safety data generated under the collective term New Approach Methodologies (NAMs), as such technologies/approaches offer marked potential to progress the integration of safety testing measures during innovation from idea to product launch of nanomaterials. Divided in overall eight main categories, searchable databases for grouping and read across purposes, exposure assessment and modeling, in silico modeling of physicochemical structure and hazard data, in vitro high-throughput and high-content screening assays, dose-response assessments and modeling, analyses of biological processes and toxicity pathways, kinetics and dose extrapolation, consideration of relevant exposure levels and biomarker endpoints typify such useful NAMs. Their application generally agrees with articulated stakeholder needs for improvement of safety testing procedures. They further fit for inclusion and add value in nanomaterials risk assessment tools. Overall 37 of 50 evaluated NAMs and tiered workflows applying NAMs are recommended for considering safer-by-design innovation, including guidance to the selection of specific NAMs in the eight categories. An innovation funnel enriched with safety methods is ultimately proposed under the central aim of promoting rigorous nanomaterials innovation. ; acceptedVersion ; Peer reviewed

AbstractIn this article, we have responded to the key statements in the article by Koivisto et al. (2022) that were incorrect and considered to be a biased critique on a subset of the exposure models used in Europe (i.e. ART and Stoffenmanager®) used for regulatory exposure assessment. We welcome scientific discussions on exposure modelling (as was done during the ISES Europe workshop) and criticism based on scientific evidence to contribute to the advancement of occupational exposure estimation tools. The tiered approach to risk assessment allows various exposure assessment models from screening tools (control/hazard banding) through to higher-tiered approaches. There is a place for every type of model, but we do need to recognize the cost and data requirements of highly bespoke assessments. That is why model developers have taken pragmatic approaches to develop tools for exposure assessments based on imperfect data. We encourage Koivisto et al. to focus on further scientifically robust work to develop mass-balance models and by independent external validations studies, compare these models with alternative model tools such as ART and Stoffenmanager®.