| dc.description | 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), S??o Paulo, Brazil, 5Biotechnology Department, Nuclear and Energy Research
Institute (IPEN/CNEN-SP), S??o Paulo, Brazil, 6Research and Innovation, L???Or??al 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. | |
