A fundamental part of developing a classification system for nanomaterial safety is to identify the toxic effects that different ENMs have across a wide range of organisms, from microbes to mammals, and on different body systems. These effects are assessed by their overall magnitude of toxicity ¬– low toxicity, toxic, very toxic – using detailed experimentation.
There are two main objectives. Firstly, the traditional hazard classification approach will provide both regulators and industry with information in a format they can use now, within the current regulatory process, meaning the experiments will have an immediate impact. Secondly, the samples from the experiments will be used in the molecular biology and systems biology approaches being used in WP10 (Omics Methodologies) and WP11 (Systems biology analysis), the Nanosolutions project to provide the information needed for the ENM Safety Classifier.
The WP7 team will be exposing a variety of organisms to the nanomaterials, with the test methods varying from organism to organism. With the fresh water marine organisms, for example, the nanomaterial is added to the water and a short-term study over a couple of weeks is made, during which the physiological effects on the organisms are monitored. Subtle changes are observed, as the team is not trying to produce overt toxicity, but instead trying to understand the organism response to the material.
We will collect a high standard data set from these experiments so that we have the exact chemistry of each nanomaterial, as well as the environment (e.g. the bodily fluids), to which they are being exposed. The biological responses of the organisms at different levels, from molecular through to organism biology, will all be put into a systems biology model, where we are able to predict the biological hazard from the chemistry and behaviour of the nanomaterial. We will also be able to do the reverse, so from a known biological hazard, we will be able to work out what type of material we would need to generate that or to remove that hazard.
The project is working with a completely new data set of organisms in order to ensure the quality of the data used in the systems biology models. This ensures that the model will be robust and the data will all be connected in some way. The molecular biology data will come from the same tissue as the histology and biochemistry data, and all will have been exposed to the same material. We are trying to remove all those methodology biases by doing original experiments in a very precise way that allows us to make a good model.