Towards a nanospecific approach for risk assessment

Abstract

In the current paper, a new strategy for risk assessment of nanomaterials is described, which builds upon previous project outcomes and is developed within the FP7 NANoREG project. NANoREG has the aim to develop, for the long term, new testing strategies adapted to a high number of nanomaterials where many factors can affect their environmental and health impact. In the proposed risk assessment strategy, approaches for (Quantitative) Structure Activity Relationships ((Q)SARs), grouping and read-across are integrated and expanded to guide the user how to prioritise those nanomaterial applications that may lead to high risks for human health. Furthermore, those aspects of exposure, kinetics and hazard assessment that are most likely to be influenced by the nanospecific properties of the material under assessment are identified. These aspects are summarised in six elements, which play a key role in the strategy: exposure potential, dissolution, nanomaterial transformation, accumulation, genotoxicity and immunotoxicity. With the current approach it is possible to identify those situations where the use of nanospecific grouping, read-across and (Q)SAR tools is likely to become feasible in the future, and to point towards the generation of the type of data that is needed for scientific justification, which may lead to regulatory acceptance of nanospecific applications of these tools.

Decision tree models to classify nanomaterials according to theDF4nanoGroupingscheme

“…Finally, in vivo studies addressed in Tier 3 are aimed to confirm the distinction between passive and active nanomaterials (Arts et al 2014). While others have proposed different grouping schemes they, all boil down to the same principle: identifying key descriptors of nanomaterials that are most straightforward to experimentally determine and relate these to the respective biological effects (Oomen et al 2014;Dekkers et al 2016).…”

Safety assessment of nanomaterials using an advanced decision-making framework, the DF4nanoGrouping

“…It allows rapid material categorization according to hazard potential, founded on scientifically justifiable categories, so that materials of high concern can be targeted for additional scrutiny, while material categories that pose the least risk can receive expedited review (Godwin et al 2015; Dekkers et al 2016). …”

Characterisation of particles in solution – a perspective on light scattering and comparative technologies

“…As per the European Commission definition, a nanomaterial is such that 50% or more of the particles in a sample have a dimension in the 1–100 nm size range [1]. These same properties may also give rise to unique biological reactivity [2–4], and thus, this has led to mounting concerns over the safety of nanomaterials, and pressure to control the potential risks [5]. To ensure compliance with environmental protection guidelines [6], nanoparticles (NPs) produced, either directly or indirectly, must be fully characterised [7,8].…”