On the uses of predictive toxicology to approve the use of engineered nanomaterials as biocidal active substances under the Biocidal Products Regulation

4th International Conference on Structural NanoComposites

Blázquez, M.^1^2 ; Fernández-Cruz, M.L.^3 ; Gajewicz, A.^4 ; Puzyn, T.^4 ; Benfenati, E.^5

Inkoa Sistemas, Ribera de Axpe 11, Edificio D1, Dpto 208, Erandio

48950, Spain^1

CBET Research Group, Department of Zoology and Animal Cell Biology, Faculty of Science and Technology, Research Centre for Experimental Marine Biology and Biotechnology PIE, University of the Basque Country UPV/EHU, Barrio Sarriena s/n, Bizkaia

48940, Spain^2

Instituto Nacional de Investigación y Tecnología Agraria y Alimentaria (INIA), Ctra. de la Coruña km 7.5, Madrid

28040, Spain^3

University of Gdansk, Faculty of Chemistry, Laboratory of Environmental Chemometrics, With Stwosza 63, Gdansk

80-308, Poland^4

Istituto di Ricerche Farmacologiche Mario Negri, Via La Masa 19, Milano

20156, Italy^5

关键词: Active substance;    Biocidal products;    Ecotoxicological;    Engineered nanomaterials;    Innovative approaches;    Nanometric scale;    Quantitative structure activity relationship;    Regulatory approvals;   

Others  :  https://iopscience.iop.org/article/10.1088/1757-899X/499/1/012007/pdf
DOI  :  10.1088/1757-899X/499/1/012007

来源: IOP

【 摘 要 】

To date only two engineered nanomaterials (ENMs) have been approved to be used as biocidal active substances in the formulation of biocidal products under product type 18 (insecticides, acaricides and products to control other arthropods). Such materials are silicon dioxide (as a nanomaterial formed by aggregates and agglomerates) and synthetic amorphous silicon dioxide (nano). The use of non-animal alternative test methods has been foreseen in the Biocides Product Regulation, Regulation (EU) 258/2012 (BPR). Further, the BPR is one of the existing regulations that includes a specific definition of nanomaterials. On the present article, a review is made on the potential uses of Quantitative Structure-Activity Relationship approach (Nano-QSARs) to be used as a non-testing method for the generation of ecotoxicological data required for the approval of new active substances in the nanometric scale. Relevant challenges are to be faced in the application of computational chemistry but it could meet the needs imposed by the BPR in relation to the use of non-testing methods. However nanospecific adaptations need to be implemented further on ecotoxicological testing so that obtained results are considered a suitable input for models' building. The BPR, thus, sets the framework for innovative approaches in the regulatory approval of new chemicals that integrate special considerations derived from the chemical nature of ENMs and the application of non-testing methods but, to date, the implementation of such actions is not feasible in practical terms.