In vitro sensitization

This test procedure according to OECD 442D in conjunction with ISO 10993-10 is used to assess the potential of chemicals and medical devices to cause skin sensitization (allergic reaction).

It measures the activation of a cytoprotective signaling pathway (the Keap1-Nrf2-ARE pathway) in keratinocytes. This pathway is an important regulator of the response to oxidative stress and therefore relevant for skin sensitization. The method uses a keratinocyte cell line transfected with a selective plasmid containing the luciferase gene.

Substances are classified as sensitizing if they trigger a statistically significant induction of the luciferase gene above a certain threshold value in at least two experiments on different days.

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