Sensitization properties of acetophenone azine, a new skin sensitizer identified in textile

BACKGROUND: Acetophenone azine (CAS no. 729‐43‐1) present in sports equipment (shoes, socks and shin pads) has been suspected to induce skin allergies. Twelve case reports of allergy in children and adults from Europe and North America were published between 2016 and 2021. OBJECTIVES: The objective of this study was to confirm that acetophenone azine is indeed a skin sensitizer based on in vitro/ in vivo testings derived from the Adverse Outcome Pathway (AOP) built for skin sensitization by OECD in 2012. METHODS: Acetophenone azine was tested in vitro according to the human cell line activation test (h‐CLAT) and the ARE‐Nrf2 Luciferase Test (KeratinoSens) and in vivo using the Local Lymph Nodes Assay (LLNA). RESULTS: Both the h‐CLAT and the KeratinoSens were positive whereas the LLNA performed at 5, 2.5 and 1% (wt/vol) of acetophenone azine, was negative. CONCLUSION: Based on these results, acetophenone azine was considered as a skin sensitizer. This was recently confirmed by its classification under the CLP regulation.