Use of in vitro methods according to OECD GD 129 and OECD TG 439 to classify children′s articles aligned with the UN GHS principles

Abstract

Alternative Methods Network (RENAMA), National Institute of Metrology, Quality and Technology (INMETRO), Rio de Janeiro, Brazil, 4Schools Articles Safety Brazilian Technical Committee (CEE 102), Brazilian Association of Technical Standards (ABNT), São Paulo, Brazil, 5Biotechnology Department, Nuclear and Energy Research Institute (IPEN/CNEN-SP), São Paulo, Brazil, 6Research and Innovation, L’Oréal Research and Innovation, Aulnay-sous-bois, France, 7Research and Innovation, Episkin Academy, Lyon, France Schools Articles Safety Brazilian Technical Committee (TC/ABNT CEE 102) has taken up the challenge to update the national safety standard ABNT NBR 15236:2016 that complies with the regulations and guidelines on alternatives testing. The current aim was to provide an in vitro strategy for risk assessment of school articles with data integration following OECD GD129 & TG439. In Vitro Acute Toxicity and SkinEthicTM Reconstructed Human Epidermis Skin Irritation methods were adapted from medical devices protocols by measuring cytotoxic effects of extracts prepared according ISO10993. Results obtained on >150 school articles (pens, pencils, crayons, watercolor, adhesives, correction fluid) were reproducible. 100% concordance with UN GHS classification for discriminating approval (95%) versus non-approval (5%) was observed. In conclusion, these results are important to ensure that regulatory authorities in Brazil are provided with the appropriate data required for decision-making.