Irritation.

ISO 10993-23: Skin Irritation

We help you access the skin irritation potential of Medical Devices, Medical Device components or extracts using 3D Reconstructed Human Epidermis (RhE) models.

The test method classifies your Medical Devices or materials as skin irritants or non-irritants based on the cell viability outcomes after 24h exposure and 50% cell viability threshold.

Polar and non-polar extracts of the test item are prepared according to ISO 10993-12.

Special irritation tests

In accordance with ISO 10993-23, we offer irritation testing on a range of tissues other than skin, including:

  • Corneal
  • Vaginal
  • Oral
  • Esophageal
  • Nasal
  • Ocular
  • Colorectal
  • Intestinal

An ethical and accurate alternative to animal testing

Our GLP-compliant laboratories provide in vitro biocompatibility testing addressing the three endpoints that all medical devices are subjected to assess:

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Testing with SenzaGen

At a glance

Skin irritation

Test system3D RECONSTRUCTED HUMAN EPIDERMIS.
ComplianceISO 10993-23: 2021.
What it measures VIABILITY OF SKIN CELLS.
ReadoutIRRITANT OR NON-IRRITANT (UN GHS CATERGORY 2).
Turnaround time6-8 weeks for standard studies.
Fast track available.

How it works

Skin irritation

The skin model is based on a 3D reconstructed human epidermis which consists of human-derived keratinocytes that mimic the properties of in vivo skin, including a multi-layered stratum corneum.

The test item extracts, prepared according to ISO 10993-12, are directly applied to the skin tissue surface at the air-liquid interface, and skin irritancy is determined by measuring the cell viability with the MTT assay.

Irritants are classified as such if the polar and/or non-polar extract of the test item decreases the cell viability below a defined threshold level (50% for UN GHS category 2) and as non-irritant if the viability is greater than 50%.

  • In vitro biocompatibility testing

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