In Vitro Skin Irritation.

OECD TG 439: Reconstructed Human Epidermis Test Method

This in vitro skin irritation test uses a Reconstructed Human Epidermis (RhE) model to distinguish between skin irritants and non-irritants, providing a clear binary hazard classification.

Fully accepted by regulatory authorities, the test follows the guidelines outlined in OECD Test Guideline 439. It supports classification according to the UN Globally Harmonized System (GHS) for Classification and Labelling.

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Why testing with SenzaGen?

At a glance

Test system3D RECONSTRUCTED HUMAN EPIDERMIS.
ComplianceOECD TG 439.
What it measures VIABILITY OF SKIN CELLS.
ReadoutIRRITANT OR NON-IRRITANT (UN GHS CATERGORY 2).
Turnaround time6-8 weeks for standard studies.
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How it works

The skin model used in this method is based on a three-dimensional (3D) reconstituted human epidermis, composed of human-derived keratinocytes. These cells closely mimic the properties of in vivo skin, including the presence of a multi-layered stratum corneum that provides a realistic barrier function.

To evaluate skin irritation potential, test items are directly applied to the surface of the tissue at the air-liquid interface. Following exposure, cell viability is assessed using the MTT assay, which measures mitochondrial activity as an indicator of cytotoxicity.

Based on the results, a substance is classified as an irritant if it reduces cell viability below a defined threshold—specifically, 50% according to the United Nations Globally Harmonized System (UN GHS) for Category 2. Conversely, if cell viability remains above 50%, the test item is considered non-irritant.

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