The aim of the PATROLS (Physiologically Anchored Tools for Realistic nanOmateriaL hazard aSsessment) project is to establish and standardise a battery of innovative, next generation physiologically anchored, hazard assessment tools that accurately predict adverse effects caused by long-term (chronic), low dose ENM exposure in human and environmental systems to support regulatory risk decision making. PATROLS will advance the current state-of-the-art by aiming to deliver: 1) more realistic and predictive, in vitro three dimensional (3D) lung, gastrointestinal tract (GIT) and liver models for mechanism-based hazard assessment; 2) cross-species models linking human and environmental systems; 3) innovative methods for sub-lethal hazard endpoints in ecologically relevant test systems and organisms, selected according to their position in the food chain; 4) robust in silico methods for exposure and dosimetry modelling, as well as hazard prediction.
To accomplish this, a modular set of innovative bioassays and advanced, dynamic 3D multitissue models available in the PATROLS consortium and in the aligned EU-ToxRisk project, at Technology Readiness Level (TRL) 4 will be further developed to allow more realistic ENM exposure and hazard identification and characterisation tests5-11. New in silico models to understand dosimetry, enable in vitro-to-in vivo extrapolation (IVIVE), and address long-term (eco)toxicological effects of ENM will also be established. Input from international stakeholders is vital to ensure the future adoption of the technologies delivered and influence change to current regulatory practice. We have therefore secured the participation of these key end-users within PATROLS and they will play an active role in the development and evaluation process (e.g. BASF, RIVM, NRCWE, HC, KRISS, OECD). This will facilitate progression of the technologies to TRL6 through evaluation by stakeholders to demonstrate inter-laboratory transferability and reproducibility supporting pre-validation activities. PATROLS will hence close the gap between scientific excellence and both industrial and regulatory relevance for ENM risk assessment.
For further information please visit the project's website.