Skin Sensitization Test

The skin sensitization test is an in vitro skin model that can assess the potential of almost any product to cause dermal sensitization, or more specifically, allergic contact dermatitis (ACD).

ACD, like most allergic responses, develops in two phases and depends on the induction of an immune response. The first phase, usually called the induction phase or sensitization phase, is initiated when the skin comes into contact with a hapten, which is sufficient to trigger an immune response resulting in the priming of specific immune cells. This phase typically has no clinical symptoms. The second phase is referred to as the elicitation phase and is characterized as allergic contact dermatitis.

ACD is not life-threatening, but it is long-lasting. Therefore, there is a continuing need for accurate identification and characterization of products that have the potential to cause skin sensitization.

Skin sensitization has been established in the past using animal models and has been well-served in these methods. However, there is now significant interest in new methods that will reduce the need for animal testing or replace animals altogether. The development of the adverse outcome pathway (AOP) and related alternative in vitro assays have changed the evaluation of skin sensitizers. These in vitro skin sensitization models provide a useful tool for identifying products as skin sensitizers without the use of animals.

Creative Bioarray provides three-tiered in vitro skin sensitization tests based on the principle of AOP and an alternative to replace the current prevalent in vivo methods. Using this set of assays enables weight of evidence approaches to be adopted for the hazard assessment of potential skin sensitizers, without the use of laboratory animals. Our team of experts can support you in delivering the correct combination of these assays for your project, along with interpretation of the results with regards to the AOP.

• Direct peptide reactivity assay (DPRA) investigates the molecular initiating event of the AOP. The depletion of synthetic peptides in solution following exposure to test chemicals is detected.
• ARE-Nrf2 luciferase test investigates key event two in the AOP. The luciferase signal is measured as an indicator of the activity of the Nrf2 transcription factor in cells following exposure to electrophilic test substances.
• Human cell line activation test (h-CLAT) investigates the third key event of the AOP. The changes in the expression of cell surface markers (CD86 and CD54) in human leukemia cell line THP-1 is assessed by flow cytometry.

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