Real-life study shows ECETOC’s nanoApp consistent with data gathered from animal tests

A team of scientists has carried out a series of real-life studies on nanoforms using the nanoApp designed and developed by the Centre for chemical safety assessment (ECETOC). The results of the study can be found here.

The web-based app helps companies follow The European Chemical Agency (ECHA)’s registration requirements for nanomaterials under the EU’s REACH legislation, as well as  European regulators evaluate the registration dossiers. It is an effective way to minimise the need for animal testing, while still providing trusted and transparent information that fulfils regulatory requirements.

The nanoApp works by creating and justifying ‘sets of similar nanoforms’ for a joint human health and environmental hazard, exposure and risk assessment to help companies register nanoforms under REACH.

Olivier De Matos, Secretary General of ECETOC, commented: “All of the outcomes of this study were consistent (and sometimes even more conservative) with the available data that had been based on animal tests.”

The study was carried out to illustrate the use of the nanoApp, as well as the outcome of assigning real nanoforms to sets of similar nanoforms according to the decision criteria implemented in the nanoApp.

The study focused mainly on human health hazards, especially from exposure via inhalation. The app’s decision rules were applied to a series real nanoforms: two barium sulfate nanoforms, four colloidal silica nanoforms, eight ceria nanoforms, and four copper phthalocyanine nanoforms. For each set of nanoforms, the study demonstrates step-by-step how the ECETOC nanoApp rules are applied.

The case studies included nanoforms that are justified as members of the same set of similar nanoforms based on their intrinsic properties being sufficiently similar (which are termed ‘Tier 1’). They also included other nanoforms with a relatively high (but insufficient) similarity of intrinsic properties, but whose similarity could be justified by functional properties (called ‘Tier 2’). In certain cases, the app determined that the nanoforms did not belong to the same set of similar nanoforms.

De Matos added: “We expect that more data on the intrinsic and extrinsic properties and hazards of nanoforms will become available in the future. This will allow our team to re-assess the nanoApp and may trigger changes to its decision rules, as well as potentially also the rules provided in the ECHA guidance document.”

The ECETOC nanoApp is available free of charge to all users – login credentials can be requested on the main page of the tool.