OpenTox Euro 2019 talk: Defined approaches for skin sensitization hazard and potency assessment

The skin sensitization endpoint is the first endpoint that has been described as an adverse outcome pathway covered by different key events (KE). The OECD has issued three guidelines covering KE1, KE2 and KE3. A number of tests in each these KE has been validated and included in these guidelines. In parallel the OECD has issued a guidance document on how to report defined approaches (DA) which integrate, in a defined way, results from multiple tests and has also published 12 cased studies of DAs which have been reported in this way. Some of the DAs have been taken forward for guideline implementation to describe the skin sensitization hazard. More challenging is the assessment of skin sensitization potency. Here I will summarize different DA and show our own analysis of data form the different KE and their contribution to sensitizer potency. I will then discuss our case study on how to predict a point of departure for quantitative risk assessment for fragrance chemicals.