Abstract
Due to the exponentially growing number of substances requiring safety evaluation, efficient prioritisation strategies are needed to identify those of highest concern. To limit unnecessary animal testing, such strategies should respect the 3R principles (Replacement, Reduction, Refinement). In the present study, a strategy based on non-animal approaches was developed to prioritize non-evaluated printed paper and board food contact material (FCM) substances for further in-depth safety evaluation. Within the strategy, focus was put on genotoxicity, a key toxicological endpoint when evaluating safety. By combining in silico predictions with existing in vitro and in vivo genotoxicity data from publicly available literature sources and results from in vitro gene mutation experiments, the 106 study substances could all be assigned to one of the four priority classes (ranging from low to very high concern). Importantly, 19 substances were considered of very high concern due to in vivo genotoxicity. Five of these are furthermore listed as a Substance of Very High Concern (SVHC) by the European Chemicals Agency (ECHA), in addition to demonstrating physicochemical properties linked to a high migration potential as well as oral bioavailability and being used in primary food packaging materials. The current animal-free strategy proved useful for the priority ranking of printed paper and board FCM substances, but it can also be considered to prioritize other substances of emerging concern.
Highlights
Over the last decades, the number of substances suspected of posing a risk to human health and/or the environment has significantly increased (Sauvé and Desrosiers, 2014; Alphenaar and van Houten, 2016)
We have shown that 106 printed paper and board substances were predicted to induce gene mutations by up to 4 structure-activity relationship ((Q)SAR) tools and, they are of high priority for further investigation (Van Bossuyt et al, 2017)
Tab. 3: Overview of in vitro and in vivo genotoxicity data for the 49 substances for which no previous European evaluation is available but that are present in the European Chemicals Agency (ECHA) and/or EURL ECVAM database For each endpoint, the results are expressed as positive (+), negative (–), equivocal/insufficient (±) or not available (NA)
Summary
The number of substances suspected of posing a risk to human health and/or the environment has significantly increased (Sauvé and Desrosiers, 2014; Alphenaar and van Houten, 2016). We recently reported that more than 6000 substances can be used in the manufacture of printed paper and board FCM, of which 77% have not been officially evaluated for their safe use in FCM Based on their physicochemical characteristics, the majority of these non-evaluated substances is expected to migrate from the FCM and become bioavailable after intake of the contaminated food (Van Bossuyt et al, 2016). When an official evaluation in a non-FCM context had not been performed or no clear conclusion on in vivo genotoxicity was formulated, two publicly available inventories, i.e., (i) the Genotoxicity and Carcinogenicity Consolidated Database of Ames Positive Chemicals of the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM database) (EU, 2017b) and (ii) the European Chemicals Agency (ECHA) database were consulted It was verified whether the substance had been classified for mutagenicity under the Classification, Labelling and Packaging (CLP) regulation (EU, 2008). Based on the collected experimental data, printed paper and board FCM substances were further ranked according to the need for an in-depth evaluation of their toxicity, migration potential into food, and actual use in FCM
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