Community Research and Development Information Service - CORDIS



Project ID: 604602
Funded under: FP7-NMP
Country: Ireland

Periodic Report Summary 2 - FUTURENANONEEDS (Framework to respond to regulatory needs of future nanomaterials and markets)

Project Context and Objectives:
The last decade has seen the emergence of numerous nano-enabled devices (NED). Nano and small submicron particles are becoming more common in both consumer goods and industrial, and public large scale use. Industries impacted range from cosmetics and food to aerospace engineering. An example of this trend is the global nano-enabled packaging market which in 2015 was valued at USD 23 billion and is forecast to possibly double in the next decade according to a Grand View Research forecast report. While it is too early to tell, many believe that the major advantages in functionality and economy will come from ‘materials of the future’, far removed from those legacy materials in common use today. Applications in nano-energy harvesting, nano-enabled batteries. Telecommunications, structural materials and others may be important. The parameters describing these are typically complex in many aspects, for example, shape, composition, surface, and the role of FutureNanoNeeds has been to explore some of those new kinds of nanoparticle states, to see if there are unexpected risks associated with them.

The FutureNanoNeeds framework is pursuing two parallel strategies in trying to understand the potential risks of novel materials. In the first approach we explore value chains, specific industry applications, for potential materials of the future, those that by virtue of their commercial promise seem most likely to be widely used, and evaluate their potential hazards and exposure scenarios. These were identified in part by an extensive exploration of value chains, a processes driven by the value chain advisory committee of the project.

In the second approach, we explore model materials with properties that are deemed likely to appear in future materials. Given the limited range of materials that have been explored in the nanosafety community until now, mostly informed by existing materials already familiar, it was considered important to go far beyond typical parameters and deal with variations in shape and composition, and seek to pick up any anomalies in the biological interactions.

Overall the first approach has the advantage in directly studying the most promising materials (for example perovskites) but potentially yielding only limited and disconnected information. The second approach has the advantage that one can make homologous series of materials with key parameters varied, but of course, one loses the immediacy and familiarity of real applications. In practice, the best solution in exploring the space of possibilities was in balancing both lines of enquiry. Throughout this phase of the project the proportionating between these approaches was investigated, in an effort to identify any potential hazards that had not previously been explored. Several instances of new and subtle effects requiring further consideration were observed, and are being pursued in more depth.

Project Results:
At the beginning of the first period we attempted to systematically address much of this uncertainty related to the toxicity of mostly known nanomaterials which existed within the project. Many observations were explained by artefacts related to study conditions or dissolution of the material to known toxic compounds. In the remainder of cases toxicity observations were a product of known processes such as phototoxicity. A consensus was reached on the absence of acute toxicity effects caused by the nano-scale of material on its own. A summary review of the whole arena of acute toxicity of such materials is under way, in which it is suggested that for the most part, short term toxicity, where it is found, is associated with effects such as nanoparticle dissolution and release of materials for which toxicity parameters are already established. This is in line with what has been reported for previous nanomaterials of all types.

In the second period the focus within the project has shifted to the search for potential sources of hazard from entirely novel materials and a deeper study of potentially harmful complex behaviours, including novel shape specific phenomena and possible new diseases prompted by complex bio – nano interactions (e.g. the Trojan horse effect). In implementing this strategy we face many challenges related to the synthesis, analysis and classification of such novel materials, the presence of contamination which would impact hazard studies, and the complication of novel or uncommon biological studies.

The synthesis of such new materials had not previously been optimized for biological use and suffered from problems due to the contamination by chemicals, catalysts, and (almost universally) biological contamination. Comprehensive analysis of such materials, anisotropic or composite, presents several hurdles. Most notably there is a lack of consensus in both naming and categorizing, a problem which will be discussed in more detail below. This leads to a lack of tools and understanding to assess fundamental physico-chemical properties such as size and shape, properties which are essential to biological and toxicological studies. In the last period we worked on a series of solutions, not only for a basis for particle classification and accurate assessment of fundamental properties, but also analysis of anisotropic particles in complex media. A significant amount of attention was given to developing endotoxin free and surfactant free synthesis procedures or alternatively quantifying endotoxin content in samples so that appropriate conclusions are made. Even after all of these precautions to avoid confounding contamination, we have observed several new biological effects that could relate to the nature of their shape. These effects will be studied in more depth to eliminate their role in any potential form of toxicity.

Potential Impact:
The first major outcome of the project are expected to be that for exemplar composite materials, and new parameters for materials under consideration for future exploitation, we can confirm that no exceptional acute toxicity except what we have so far observed in this community (e.g. based on dissolution of toxic components).

The second outcome is likely to be some early progress on linking the issue of naming to the concept of identity, including in situ. By ‘identity’ we mean that minimal number of material features and properties which characterise the interactions of the nanomaterial with the biological. This would have significant ramifications for the nanosafety community and possibly broader consequences for regulators and industries.

The third and potentially most promising outcome is expected to be identification of specific material features to new biological responses not usually observed in conventional nanomaterials studied so far. While this project may only begin this process of uncovering those features, it is hoped it will open the way for an understanding of what, if anything, will be required to secure safety, in addition to current requirements in nanosafety ‘testing’. Ideally we would be able to connect specific structural features to potential downstream hazard effects, and begin to understand how to group materials by the features that cause novel effects.

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