Alternative Methods for Assessing Local Toxicity of Perfume and Cosmetic Products – a Real Step Forward or a Cosmetic Measure?
Abstract
Under pressure to reduce the use of laboratory animals in testing of perfume and cosmetic products (PCP), the importance of alternative methods (AM) in vitro, ex vivo, and in chemico is increasing. In this context, in 2023, the Technical Regulation of the Customs Union TR CU 009/2011 “On the Safety of Perfume and Cosmetic Products” (TR CU 009/2011) was supplemented with a list of standards incorporating relevant alternative methods (AM). The aim of this study is to assess the applicability of AM for confirming the compliance of PCP with the requirements of TR CU 009/2011 in terms of toxicological indicators: skin irritation, mucosal irritation, as well as sensitization potential. A comparison was conducted between in vivo methods used for PCP testing to evaluate skin and mucosal irritation and the in vivo methods applied for classification of chemicals under the hazard classes skin corrosion/irritation and serious eye damage/eye irritation. A comparative analysis was conducted of the threshold values of toxicological indicators established by TR CU 009/2011 and the corresponding hazard classes within the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The discriminative capacity of AM was also evaluated. Significant discrepancies between the criteria of TR CU 009/2011 and those of the GHS were identified, attributed to the stricter safety requirements for PCP and their specific modes of use. It was demonstrated that in vivo methods used for chemicals are not equivalent to those used for PCP safety assessment. Most AM analyzed were found to have insufficient discriminative ability. It was concluded that the application of AM for PCP risk assessment is currently limited. The need to refine the calculation methods for the skin irritation index (Icut) and the mucosal irritation index (Iir) was substantiated. Directions were proposed for updating Annexes 8 and 9 of TR CU 009/2011 and for the development of AM with improved discriminative capacity. The role of AM in assessing the sensitization potential of PCP was also considered.
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