In vitro and in vivo investigations to obtain validated toxicity data of graphene nanoplatelets
The PLATOX project funded within the FP7-SIINN (Safe Implementation of Innovative Nanoscience and Nanotechnology) ERA-NET on Nanosafety, proposes a tiered approach to address the existing toxicological data gaps for graphene family nanoparticles (GFN). GFN are part of the group of carbon-based synthetic nanomaterials and are already on the market in multiple variants. GFN are currently subject of studies to accelerate their toxicological characterisation. Based on the existing toxicological database a very high toxic potential is not expected, however, the characterisation is presently incomplete and should be expanded to facilitate a proper risk assessment. The workflow of PLATOX therefore aims to link several steps (i) selection of typical candidates, representing the graphene family, (ii) performance of in vitro screening for the selected GFN, (iii) conduct of an in vivo 28-day inhalation test with two representative GFN, thereby generating toxicological in vivo data, which should be acceptable for authorities and should enable (iv) risk assessment and derivation of DNEL for the two selected GFN according to REACH procedures. The in vitro screening methodology uses lung relevant cell models and is focussed on (geno)toxicity testing and measurement of cytokine/eicosanoid release. The subsequent 28-day inhalation toxicity test will include inflammatory, (geno)toxicity and histopathological endpoints. The results will finally be evaluated and a GFN risk assessment will be done by establishing DNELs. In summary, the expected outcome of the project will be a toxicological ranking of the tested GNF species, providing an improved basis for risk assessment of these nanomaterials.