Data-rich OECD WPMN test materials - suitable for etablishment and testing of grouping, read-across and risk assessment models?

Konferenceabstrakt til konference - 2018

Resume

About a decade ago, the OECD Working Party on Manufactured Nanomaterials (WPMN) launched its so-called sponsorship program in which a number of industrially relevant MN and a few non-MNs were characterized and tested in a number of national and internationally supporting research projects. Usually these characterization data were collated in local project data libraries, but never really assessed and collected in validated and accessible data bases. A major attempt was made in the e.g., the NANOGENOTOX and NANoREG projects to establish physicochemical characterization data on many of the OECD WPMN test materials using mutually (within project) accepted protocols. In NANoREG data were compiled in ISA TAB-like data templates or uploaded to the NANoREG data base. However, this endeavor was not fully successful. In current work in the EU H2020 caLIBRAte and NanoReg2 projects, the uploaded and additional hard-copy-filed NANoREG data, as well as published and other accessible data generated by other projects are being procured and important data gaps covered.
In this paper, we critically map the historical data development on the OECD WPMN test materials considering data sources, abundance, variability, and protocol developments. Second, considering that the OECD WPMN test materials are some of the most studied industrially produced MN, we discuss how representative the OECD WPMNM test materials are for grouping and model development considering ranges in key physicochemical properties and use multiparametric statistical analysis to assess how the OECD WPMN test materials group alone and across a larger suite of different MN. This study brings important elements into the current in silico hazard model developments and the expressed regulatory need to establish and demonstrate read-across and grouping principles. We demonstrate that focusing on the OECD WPMN test material is not sufficient to demonstrate grouping principles. However, the data may be suitable for testing and demonstrating elements of risk assessment tools. However, the ranges in some parameters, such as shapes and higher generation NMs with different surface chemical modifications are by far inadequate for model demonstration and to establish grouping principles.

Acknowledgement: The research leading to these results has received funding from the European Union's Horizon 2020 research and innovation program under Grant Agreement No.686239 ‘caLIBRAte’.

Reference

Data-rich OECD WPMN test materials - suitable for etablishment and testing of grouping, read-across and risk assessment models?. 2018.

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caLIBRAte - test, kalibrering og implementering af et nyt model-baseret system til risikostyring under innovation og produktion af tekniske nanomaterialer