Decision-making framework for testing and grouping of nanomaterials

A ‘multiple perspective’ framework for the grouping of nanomaterials

Robert Landsiedel k, Josje H.E. Arts a, Mackenzie Hadi b, Athena M. Keene c, Reinhard Kreiling d, Delina Lyon e, Monika Maier f, Karin Michel g, Thomas Petry h, Ursula G. Sauer i, David Warheit j, Karin Wiench k

a AkzoNobel, Technology and Engineering, Arnhem, Netherlands

b Shell Health, Shell International B.V., The Hague, Netherlands

c Afton Chemical, Richmond, VA, USA

d Clariant Produkte GmbH, Sulzbach, Germany

e Shell Health, Shell Oil Company, Houston, TX, USA

f Evonik Degussa GmbH, Hanau, Germany

g Henkel AG & Co. KGaA, Düsseldorf, Germany

h Toxminds BVBA, Brussels, Belgium

i Scientific Consultancy – Animal Welfare, Neubiberg, Germany

j DuPont Haskell Global Centers For HES, Newark, DE, USA

k BASF SE, Ludwigshafen, Germany

The grouping of substances serves to streamline testing for regulatory purposes. Currently, specific regulatory frameworks for the grouping of nanomaterials are unavailable. Notwithstanding, this topic is addressed in different publications, and preliminary guidance is provided in the context of substance-related legislation or the occupational setting. A review of available concepts conducted by the European Centre for Ecotoxicology and Toxicology of Chemicals Task Force on the Grouping of Nanomaterials (ECETOC Nano TF) came to the conclusion that all approaches for the grouping of nanomaterials for human health risk assessment go beyond the determination of structure-activity relationships. They are founded on different aspects of a nanomaterial’s life cycle, including its material properties and biophysical interactions, specific types of use and exposure, uptake and kinetics, and potential early and apical biological effects. None of the available grouping concepts takes into account all aspects of the nanomaterial’s life cycle. To promote application of nanomaterial grouping in practice, the ECETOC Nano TF is putting forward a comprehensive ‘multiple perspective’ framework for the grouping of nanomaterials. This framework allows for a combined, sequential grouping of nanomaterials by all aspects of their life cycles that are relevant for risk assessment, starting from their use, to release, uptake and finally the toxic effects of the material in different life-stages of the product. The ‘multiple perspective’ framework can be applied to determine needs to address different exposure scenarios, to prioritize potential risks, to apply read-across techniques, to justify waiving of testing, or to define criteria for testing strategies.