Moving towards a safe by design approach for ENM: linking ENM relevant properties  to toxicological concerns

Borges, Teresa; Silva, Maria João; Louro, Henriqueta

http://hdl.handle.net/10400.18/3414

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Authors

Borges, Teresa

Silva, Maria João

Louro, Henriqueta

Abstract(s)

Within the Safe by Design concept, the functionality of a material and its toxicity are considered in an integrated way. The central goal of this presentation is to discuss some fundamental principles of engineered nanomaterials (ENM) interactions with biological systems relevant to human exposure and biological responses. Major factors to consider in the ENM safe-by-design approach are surface modification to reduce the potential hazardous properties of target nanoparticles (NP), compatibility between NP coatings and their matrix, as well as biopersistence, considering the relevant exposure scenarios across the life cycle of the target NP and products. This is a cross-disciplinary field that needs to identify, at earlier stages of the ENM R&D process, the physicochemical properties that may act as good predictors of toxicity, e.g. crystal structure/reactivity, zeta potential/surface charge/dynamic properties. Furthermore, it is also needed to build adequate screening in vitro testing strategies (realistic doses, exposure duration and target tissues), incorporating relevant hazard endpoints that can give an insight about the toxicological mode of action (MoA) with relevance to human health and environment, taking into account the uses and applications along the lifecycle (EHS roadmap). These topics will be illustrated by a cytotoxicity and genotoxicity study performed with a set of ENM with identical chemistry but different physicochemical characteristics that highlighted the importance of investigating each ENM individually, instead of assuming a common MoA. The findings, although creating a dilemma for developing criteria for categorization and read-across, are also suggestive of the importance of considering the functionality of a material and its toxicity in an integrated way, enabling a safe-by-design concept. Ultimately, the overall safety data is intended to best support the decision of IND developers and risk managers during the ENM design and development processes.