Objective  To explore the skin irritation test in vitro as a substitute test for rabbit skin irritation to detect skin irritation, and to analyze the molecular markers related to the test model.

Methods  Two kinds of medical devices were selected, and skin irritation was detected by reconstructing human epidermis (RhE) model in vitro skin stimulation test. Skin tissue substrates were collected, and the contents of interleukin (IL) -1α and IL-8 in the substrate were determined by enzyme-linked immunosorbent assay (ELISA).

Results  The histopathology showed that the epithelial cells with 4% lactate were atrophied and the cuticle was exfoliated; there was no obvious abnormality in epithelial tissue by other methods. Epithelial cells were degenerate and necrotic in 1% sodium dodecyl sulfate (SDS) polar positive control with sodium chloride injection and 1% non-polar nonpolar positive control with sesame oil. ELISA results showed that IL-1α expression in substrate was positively correlated with skin irritation index, but IL-8 was negatively correlated with skin irritation index.

Conclusion  IL-1α can be used as a molecular marker for RhE model skin irritation test in vitro to analyze skin irritation of medical devices.