Safety classification for nanomaterials

ENMs have improved products and devices in fields from coatings and composites to electronics, biomedicine, energy and the environment. The very small size of these materials — at least one dimension less than 100 nm to qualify — imparts very high reactivity and, simultaneously, the ability to cross biological barriers. This is a potentially dangerous combination and standardisation of testing and classification of risk to humans and the environment is imperative.

Thirty-five partners with extensive expertise in omics research (transcriptomics, proteomics and epigenomics) are identifying the characteristics of ENMs that determine their biological hazard potential with EU funding of the project NANOSOLUTIONS. The consortium plans to establish biomarkers of ENM toxicity to be used in assessments of safety and toxicity across species. The overarching goal is to provide the tools to develop an ENM safety classifier based on materials characteristics. The resulting classifier will do for ENM what the material safety data sheets do for chemicals.

In particular, it will enable manufacturers to select the appropriate ENM for a job with minimal risk, meeting regulations and reducing required testing costs and time. Regulatory officials will be able to prioritise safety issues and the general public will have greater confidence that their health and the environment will not be harmed.

All issues regarding the computational background and data formats have been addressed along with computational methods for feature selection using fuzzy logic. ENM material has been produced and functionalised, testing protocols for many of the tests have been established, and testing has begun across a variety of experimental paradigms. These include cell cultures of human endothelial cells with surface modifications and in vivo positron emission tomography studies of the biodistribution of titanium oxide nanoparticles. The team has successfully established an ex vivo placenta perfusion model as well.

Testing and validation of the tool will be done in close collaboration with ENM manufacturers and results will be distributed to relevant regulatory agencies. NANOSOLUTIONS will thus ensure that the comprehensive studies have the largest possible impact.