Case studies putting the decision-making framework for the grouping and 4 testing of nanomaterials (DF4nanoGrouping) into practice

ECETOC concept allows assessing the safety of nanomaterials  undertaking animal testing only as a very last resort

Brussels, December 2015

The safety of nanomaterials can be ensured by testing and grouping based on material properties and interactions, undertaking animal testing only as a very last resort. This is the outcome of the now published Case studies putting the decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping) into practice. DF4nanoGrouping is a comprehensive concept to group and test nanomaterials that the ECETOC Nano Task Force developed and published earlier this year.

Science-based grouping approaches allow the prediction of a substance?s toxicity by comparing it to other similar substances. Thereby, substance safety may be determined while considerably saving time, money and animal testing. However, due to the complex interactions of nanomaterials with their environment, a comprehensive grouping concept for nanomaterials has not yet been available. DF4nanoGrouping helps close this gap for hazard assessment. In three tiers, DF4nanoGrouping takes into consideration all relevant properties of nanomaterials. Step-by-step, potential hazards are ruled out. Hazardous nanomaterials are identified using non-animal testing, which may then be further examined applying animal tests.

Now, case studies using a total of 24 materials confirmed the usefulness of DF4nanoGrouping. For 21 materials the non-animal testing tiers correctly predicted the outcome of the animal tests. For 3 further materials, the non-animal tiers ?over-predicted? concerns that were not confirmed in the animal tests. This shows that DF4nanoGrouping is conservative: All materials that may be hazardous are recognized in the non-animal tiers. Consequently, DF4nanoGrouping provides a sound scientific basis for hazard assessment.

The ECETOC Nano Task Force Case studies putting the decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping) into practice are published as an Open Access article in Regulatory Toxicology and Pharmacology.

Arts J, Irfan MA, Keene AM, Kreiling R, Lyon D, Maier M, Michel K, Neubauer N, Petry T, Sauer UG, Warheit D, Wiench K, Wohlleben W, Landsiedel R. 2015
Case studies putting the decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping) into practice
Regulatory Toxicology and Pharmacology  (In press - corrected proof)
DOI:10.1016/j.yrtph.2015.11.020 (Open Access)

The following shortcut can be used to download the article from the publisher's website:
http://bit.ly/ecetoc-arts-et-al-2015b

2 earlier publications from this Task Force are also available online. For more details see: