Download: PDF RTF XML Booklet: Review (0) Retrieve Add item
Safety evaluation of manufactured nanomaterials by characterisation of their potential genotoxic hazard [NANOGENOTOX] [20092101] - Joint Actions
General objectives

Human exposure to manufactured nanomaterials (MNs) used in consumer products may occur during several phases of their life cycle. The lack of scientific knowledge makes regulation difficult.

The aim of the Joint Action is to establish a robust methodology to assess the potential genotoxicity of MNs and to generate data on the genotoxic effect of certain reference materials (

The JA specific objectives are:
To obtain detailed physicochemical properties for each selected MN
To determine the influence of exposure media on MNs dispersability and to identify the optimum preparation protocols for the specific MNs
To generate in vitro genotoxicity data on MNs
To perform a round robin test on in vitro genotoxicity testing of MNs
To determine relevant doses and sampling time for biodistribution and in vivo genotoxicity studies, and to identify MN accumulation in organs for in vivo genotoxicity tests
To generate data from in vivo genotoxicity selected tests, and to assess the correlation between in vivo and in vitro results taking into account the kinetic results

Strategic relevance and contribution to the public health programme

The NANOGENOTOX JA general objective is to support and add value to the Member States’ policies for nanomaterial safety and to contribute to increasing the safe use of MNs in the European Union. It targets crucial items, identified in the 2nd Health programme, providing a genuine European dimension as 17 institutions from 11 MS, including new MS, are involved. The action contributes to the EU’s leadership position in the field of Nanotoxicology as well as in ongoing international work (OECD, ISO…).
Genotoxicity tests contribute to the assessment of long-term risk such as carcinogenicity and reprotoxicity. A highly relevant aspect is to achieve the development of reliable and cost-effective assays, with the potential to be used by industries and EU regulatory bodies.

Methods and means

The methods and means are implemented with the aim of:
- Strengthening, expanding and sharing the knowledge required for hazard, exposure and overall risk assessment of MNs, in particular by building a strategy able to generate relevant and reliable data for EU public health authorities.
- Accelerating the exploitation of existing data and the exchange of best practices in risk assessment and management, thus contributing to giving society alert signals for genotoxic substances.
- Promoting the establishment of a robust methodology to screen potentially genotoxic MNs. To achieve this, fully characterised MNs widely used in consumer products are tested with standard in vitro assays completed with specific tests. Using these results, a ring test for the relevant assays is performed. This methodology may be used to check for possible genotoxicity as alternative techniques to animal experimentation. In vivo assays are conducted to characterise the toxicokinetics of selected MNs and validate the in vitro data. Standard operating procedures will be used.

Expected outcomes period

Major expected outcomes are:
1)Increasing health information and knowledge about the human and environmental safety of MNs by generating relevant and reliable data sets by: (i)Distinguishing specific hazards regarding the physical and chemical parameters of MNs;(ii)Establishing a correlation between in vivo and in vitro genotoxicological data and completing information on MN bioaccumulation by identifying target organs.
2)Promoting a robust reliable methodology for testing potential genotoxicity of MNs by exchanging best practices through a round robin test. The MNs to be tested are widely available in many kinds of products, namely TiO2 and SiO2 MNs, but also carbon nanotubes (CNT) which, according to the literature, might present toxicological effects in experimental animals similar to asbestos.
The JA will provide quick, reliable and economical tests to assess potential genotoxicity of MNs with alert signals useful for society and industries.

Start date: 01/03/2010
End date: 01/03/2013
Duration: 36 month(s)
Current status: Finalised
Programme title: Second Programme of Community action in the Field of Health 2008-2013
EC Contribution: € 2 890 268,00
Portfolio: Nanotechnology