Reporting Requirements and Analyses Needed to Establish Confidence in NAMs for Nano-Safety Assessment

Presentation focuses on current challenges and strategies for evidence integration in risk assessment, including comprehensive source to outcome characterization and using AEP and AOP frameworks to create a conceptual mechanistic scaffold by which to evaluate and integrate NAMs into assessments.  Emphasis is placed on exposure alignment across experimental platforms and the critical role of dosimetry modeling in assessment work flows to link exposure with various key events in an AOP.  Reporting standards are presented as a roadmap for advancing characterization of exposure and responses of emerging assays in context with extant data via integrated approaches to testing and assessment (IATA).

Impact/Purpose

Invited presentation to the general assembly of the EU 2020 Horizon project called HARMLESS, being held in Turku, Finland on June 13 and 14, 2023, hosted by one of the main research groups (Misvik Biology Oy) participating in the project.  HARMLESS is an acronym for High Aspect Ratio and Multicomponent Materials: towards comprehensive intelLigent tEsting and Safe by design Strategies.  Because risk assessment for nanomaterials focused predominantly on a few types of monocomponent materials, current product designs and regulations may be outpaced by development of next generation multicomponent nanomaterials.  This is a significant cause for concern to the manufacturer as well as for human health and the environment.  Complex multi-component, hybrid nanomaterials and High Aspect Ratio Nanoparticles (MCNM and HARNs) exhibit different rates of fragmentation, degredation, and leaching, differing toxicity of the separate and interacting components, and different interactions with biological and environmental systems.  The HARMLESS project is aimed at developing strategies and decision support tools for the entire life cycle of such materials.  This invited presentation will address issues of reporting and contextualization of NAMs for inhaled particles needed to reliably establish exposure alignment across experimental platforms and support evidence integration. 

Citation

Jarabek, A. Reporting Requirements and Analyses Needed to Establish Confidence in NAMs for Nano-Safety Assessment. HARMLESS General Assembly Spring 2023, Turku, FINLAND, June 14, 2023.