How to overcome the data gaps in nanomaterial risk assessment
Between 500 and 2,000 nanomaterials (NMs) are expected to be placed on the EU market at volumes of at least 1 ton/year and are consequently affected by registration obligations under REACH and other legislations (e.g., for cosmetics). Testing of these NMs and updating the registration dossiers would entail costs of between €50 million and €315 million based on the proposed amendments to REACH guidelines for nanoforms. In silico approaches like QSAR, grouping or read-across, which are currently absent for NMs in large part as a result of data fragmentation and inaccessibility, would reduce this cost dramatically by removing the need for extensive laboratory and animal testing and would additionally improve our understanding of the biological and molecular mechanisms of toxicity of NMs. Douglas Connect will present at Nano Korea 2018 efforts for building a pan-European nanosafety knowledge infrastructure for organizing data, making it publicly accessible as well as integrating computational tools for risk assessment and decision support. Special focus will be on collection and management of data and experimental procedures annotated with rich metadata towards a complete characterization of the tested NM with respect to its physicochemical properties as well as human and environmental adversity.
This work was started in the eNanoMapper project delivering a nanomaterial ontology and a database concept and will be now continued in the NanoCommons and OpenRiskNet projects. Besides the successes in harmonization of data formats for standard methods, the ACEnano data warehouse concept will be presented as a specific example imposing high demands on the protocol and data management since early stages of method development and optimization without clear standard procedures have to be covered.