- Exposure assessment
- Grouping of substances
- Hazard assessment
- Physico-chemical characterization
- Risk assessment
- Toxic Substances Control Act
In a Nutshell
It is well-accepted that nanomaterials need to be safe. However, conducting a full testing scheme for each and every variant of each nanomaterial will lead to an enormous amount of data that may not be necessary for risk assessment. This would be a waste of time, money, and even worse, laboratory animals. A solution to this dilemma is the so-called ‘grouping of chemicals’. Science-based grouping approaches allow the prediction of a substance’s toxicity by comparing it to other similar substances. For conventional non-nanosized substances, grouping is already allowed, for example by European Chemicals Regulation. However, grouping nanomaterials is more complex as it requires the consideration of physical, chemical and biological properties and, although various agencies and consortia have made proposals, there is currently no unified global grouping concept.
To develop a consistent approach for grouping nanomaterials, the ECETOC Nano Task Force first reviewed the available schemes but concluded that none cover all aspects relevant to nanomaterial safety assessment. In a second step, the Task Force will identify the best available concepts to combine into a comprehensive unified framework that can be applied internationally for the grouping of nanomaterials. As described above, if the scheme is accepted, it will save time, money and animal experimentation.
The Task Force review of available proposed schemes is published as an Open Access article in Regulatory Toxicology and Pharmacology and a proposed unified framework is expected in 2015.
Arts J, Hadi M, Keene A, Kreiling R, Lyon D, Maier M, Michel K, Petry T, Sauer U, Warheit D, Wiench K, Landsiedel R. 2014.
A Critical Appraisal of Existing Concepts for the Grouping of Nanomaterials.
Regulatory Toxicology and Pharmacology 70(2):492-506 (Open Access)