Abstract: Up to today, product safety evaluation in the EU is predominantly based on\ndata/information on their individual ingredients. Consequently, the quality and reliability of\nindividual ingredient data is of vital interest. In this context, the knowledge about skin sensitization\npotential is an explicit need for both hazard and risk assessment. Proper skin sensitization data of\nthe individual chemicals is essential, especially when dermal contact is intended, like for cosmetics.\nIn some cases, e.g., in the presence of irritating chemicals, the combination of individual ingredients\nmay also need to be evaluated to cover possible mixture effects. Today, it seems unlikely or even\nimpossible that skin sensitization in humans can be adequately described by a single test result or\neven by a simple combination of a few data points (in vivo or in vitro). It is becoming evident that a\nset of data (including human data and market data) and knowledge about the ingredient�s specific\nsensitizing potency needs to be taken into account to enable a reliable assessment of skin sensitization.\nA more in-depth understanding on mechanistic details of the Adverse-Outcome-Pathway of skin\nsensitization could contribute key data for a robust conclusion on skin sensitization.
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