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Timing, hosts and locations of (grouped) events of NanoImpactNet

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NanoSafetyCluster - Compendium 2012<br />

results; 4) Creation <strong>of</strong> an EU laboratory service; 5) Tools <strong>and</strong> data<br />

to inform EU Regulation; 6) Risk assessment procedures.<br />

2 Background – The ENNSATOX Project<br />

2.1 Introduction, Scientific / Industry Needs &<br />

Problem Addressed<br />

Nanomaterials are becoming increasingly important in their<br />

applications <strong>and</strong> uses in many industries, consumer products <strong>and</strong><br />

healthcare (The Nanotech Report, 6 th Edition, Lux Inc, New York,<br />

2008). Current worldwide sales <strong>of</strong> products incorporating<br />

nanomaterials are €1.1 trillion <strong>and</strong> are expected to rise to €4.1<br />

trillion by 2015. Engineered nanoparticles represent a major part <strong>of</strong><br />

this growth. However an underst<strong>and</strong>ing <strong>of</strong> their toxicological<br />

properties has not kept pace with the exponential rate <strong>of</strong> increase<br />

<strong>of</strong> research into their synthesis, characterisation <strong>and</strong> applications.<br />

Research into their behaviour, impact <strong>and</strong> fate in aquatic<br />

environments is at a very early stage. Out <strong>of</strong> 14 funded FP5/FP6<br />

nanotoxicology projects only one is dedicated fully to this area<br />

(“EU Nanotechnology R&D in Health <strong>and</strong> Environmental Impact <strong>of</strong><br />

Nanoparticles” http://cordis.europa.eu/nanotechnology/home.html<br />

report, Jan 2008). This report details the member states with the<br />

largest number <strong>of</strong> nanotoxicity research projects as follows: UK<br />

(46), Switzerl<strong>and</strong> (24) <strong>and</strong> Denmark (12) <strong>of</strong> which the numbers<br />

dedicated to the fate <strong>of</strong> nanoparticles <strong>and</strong> their impact in the<br />

aquatic environment are UK (6), Switzerl<strong>and</strong> (2) <strong>and</strong> Denmark (1)<br />

respectively. The majority <strong>of</strong> risk studies are concentrated on<br />

airborne particulates. A similar situation is also seen in the recently<br />

updated US National Nanotechnology Initiative (NNI) Strategy for<br />

Nanotech-related Research for the Environment, Health <strong>and</strong> Safety<br />

Research, Feb 2008 http://www.nano.gov/NNI EHS Research<br />

Strategy.pdf where the focus for aquatic environmental research is<br />

into environmental transport mechanisms <strong>and</strong> st<strong>and</strong>ardisation <strong>of</strong><br />

nanoparticles rather than their ecotoxicological effects.<br />

The toxic effects <strong>of</strong> nanomaterials are poorly understood <strong>and</strong> their<br />

effects on aquatic wildlife are largely unknown. In the absence <strong>of</strong><br />

such basic toxicological information, it is difficult to set<br />

environmental quality st<strong>and</strong>ards or perform risk assessments for<br />

these materials. As a result two EU Member States have recently<br />

recommended a voluntary moratorium on the release <strong>of</strong><br />

engineered nanoparticles into the environment backed by a<br />

voluntary reporting system. These Member States are Germany<br />

(Nanotechnology: Health <strong>and</strong> Environmental Risk <strong>of</strong> Nanoparticles,<br />

Joint Working Party Report, Aug 2006, http://www.baua.de/nn<br />

49456/en/Topics-from-A-to-Z/Hazardous-<br />

Substances/Nanotechnology/pdf/draft-research-strategy.pdf <strong>and</strong><br />

the UK (Council for Science & Technology Review <strong>of</strong> Government<br />

Progress <strong>of</strong> its Action Plan for Nanoscience <strong>and</strong> Technology, March<br />

2007, http://www.baua.de/nn 49456/en/Topics-from-A-to-<br />

Z/Hazardous-Substances/Nanotechnology/pdf/draft-researchstrategy.pdf),<br />

to be administered by the Department <strong>of</strong><br />

Environment, Food <strong>and</strong> Rural Affairs (DEFRA). On 17 th January 2008<br />

the UK’s Soil Association, the national organic food certification<br />

body, issued a complete moratorium on the use <strong>of</strong> engineered<br />

nanoparticles for organic food production<br />

(http://www.soilassociation.org). More recently, Pol<strong>and</strong> et al. (20 th<br />

May 2008), described important findings relating the dimensional<br />

characteristics <strong>of</strong> carbon nanotube <strong>and</strong> inorganic fibres to the<br />

inability <strong>of</strong> macrophages to prevent mesothelioma risks in rat<br />

lungs. http://www.nature.com/nnano/journal/v3/n7/abs/<br />

nnano.2008.111.html.<br />

ENNSATOX addresses this crucial uncertainty by seeking to relate<br />

the structure <strong>and</strong> functionality <strong>of</strong> a well known class <strong>of</strong><br />

nanoparticles <strong>of</strong> varying morphology to its biological activity at<br />

successive levels <strong>of</strong> molecular, cellular <strong>and</strong> organism organisation.<br />

Its research will focus in particular on the impact <strong>of</strong> nanoparticles<br />

on these biological systems in aqueous environments with<br />

relevance to the interpretation <strong>of</strong> their effects on ecosystems. The<br />

work programmes will examine the importance <strong>of</strong> the biological<br />

membrane in the toxicology <strong>and</strong> bioaccumulation <strong>of</strong> nanoparticles<br />

in aquatic organisms. The study will thus operate at a series <strong>of</strong><br />

levels <strong>and</strong> will take into account not only the responses <strong>of</strong> the<br />

individual organism to the specific agent but also relate this to the<br />

mechanism <strong>of</strong> activity <strong>of</strong> the agent. This goal will be achieved by<br />

engaging in a multidisciplinary approach <strong>and</strong> integrating the results<br />

in a multi component model. In so doing it will fill an important<br />

knowledge gap <strong>and</strong> inform the EU’s code <strong>of</strong> conduct for responsible<br />

nanosciences <strong>and</strong> nanotechnologies research,<br />

ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/nanocoderecommendation-pe0894c08424<br />

en.pdf for the purpose <strong>of</strong> future<br />

regulation by the EU (REACH Directive) <strong>and</strong> Member states.<br />

The underlying concept <strong>of</strong> the proposed research is to address the<br />

current uncertainty <strong>of</strong> nanoparticle toxicity <strong>and</strong> environmental<br />

impact using an integrated multidisciplinary approach<br />

The philosophy <strong>of</strong> ENNSATOX’s work plan is to initially produce<br />

<strong>and</strong> thoroughly characterise different morphologies <strong>and</strong> sizes <strong>of</strong> a<br />

model nanoparticle, such as zinc oxide (ZnO), using the most<br />

advanced state-<strong>of</strong>-the-art methods in physical chemistry <strong>and</strong><br />

microscopy. This will be extended to additional classes <strong>of</strong><br />

nanoparticles in particular silicon dioxide (SiO 2) <strong>and</strong> titanium<br />

dioxide (TiO 2). At the same time the programme will look at the<br />

nanoparticles' activity towards a series <strong>of</strong> biological models <strong>of</strong><br />

increasing complexity <strong>and</strong> organisation. Next, the behaviour <strong>of</strong> the<br />

nanoparticles in environmentally relevant aquatic systems will be<br />

examined see whether the environment alters the chemical <strong>and</strong>/or<br />

structural nature <strong>of</strong> these particles. Throughout the study an<br />

integrative model will be used to plan the activities <strong>and</strong> at the end<br />

<strong>of</strong> the programme, a predictive mathematical model will be<br />

developed incorporating all <strong>of</strong> the elucidated parameters.<br />

The hypothesis is:<br />

The biological activity <strong>and</strong> environmental impact <strong>of</strong> nanoparticles is<br />

directly dependent on their structure <strong>and</strong> functionality. By<br />

evaluating these relationships we can develop predictive models<br />

which can be deployed for statutory controls <strong>of</strong> nanoparticle use.<br />

Toxicity assays will be performed using in vitro models <strong>of</strong> cell <strong>and</strong><br />

tissue culture <strong>and</strong> in vivo models <strong>of</strong> several different aquatic<br />

species <strong>of</strong> key indicator organisms. As part <strong>of</strong> this proposal, all the<br />

procedures for toxicity testing will be selectively developed <strong>and</strong><br />

optimised for nanoparticles. This means that streamlined protocols<br />

for nanoparticle toxicity testing will be formulated which can later<br />

be exploited as routine tests for nanomaterials.<br />

4 Compendium <strong>of</strong> Projects in the European NanoSafety Cluster

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