Guaranteeing that products containing nanoparticles or nanomaterials are fundamentally safe, with minimal risk of hazardous exposure to man or the environment is clearly in the interests of all manufacturing industries. A lack of reliable (validated?) data on the effects of physico-chemical parameters on EHS means that regulators tend to over-rely on the results of toxicologists. The costs of validating individual nanomaterials are currently too high for most SME innovators. On the one hand there is a need for cost effective, high throughput screening methodologies, while on the other, manufacturers would greatly benefit from implementing those criteria which can be derived from Safe by Design practices. This RfP aims to position the industry in the process of developing criteria for safe by design, while setting up a multidisciplinary, science-based approach to EHS and nanomaterials.
The scientific and technical objectives of the topic are:
- To develop science based criteria for grouping nanoparticles and nanomaterials taking account of their behaviour and mode of toxicological action.
- To develop state of the art modelling of both nanoparticles and in-silico behaviour as a tool supporting grouping strategies.
- To evaluate the Mode of Action (MoA) of in vitro versus in vivo tox testing as tools towards the principles of Safe by Design.
- To address barriers for the application of Safe-by-Design as standard industry practice.
Current practice is that Regulators evaluate the risk from nanoparticles along the whole value chain, from manufacture through application in products to end of life disposal. This project must provide clear input to the evaluation of nanomaterial value chains. Two examples will be used which are industrially important, nano-silica (SiO2) and nano-titania (TiO2). Cross cutting research must look at theoretical modelling studies as well as practical, laboratory investigations.
Dedicated theoretical work will develop nanoparticle model systems, as well as in-silico (QSAR) modelling, both of which will lead to an initial grouping of the nanoparticles. Models that will predict the interaction of NM with biological matrices (e.g. "clustering models") should result.
The different data obtained from in vivo and in vitro testing will be evaluated. While the direct Mode of Action of a nanoparticle on different cell cultures can be assessed through in-vitro studies, the ability of particles to cross barriers is also key to understanding the potential toxicological impact of a nanomaterial. Grouping of particles based on in vivo or in vitro studies will result.
A major result of the project will be the prediction the behaviour of nanoparticles in different matrices, defining the important divisions or steps along a value chain. This fundamental knowledge will lead to a better control on the engineering and manufacture of nanoparticles and materials, as well as supporting safer use in the application of Safe by Design.
Download here the full version of the RfP LRI-N4.