Eye Irritation Test using Reconstructed Human Corneal Epithelium (RhCE) Models (EIT, OECD 492)

The Eye Irritation Test (EIT) is an OECD-approved in vitro non-animal test method for identifying chemicals and mixtures that may be irritating to the corneal epithelium.  The test method utilizes an in vitro reconstructed human corneal epithelium (RhCE) model (EpiOcular™, MatTek Corp. or HCE, SkinEthic™), in an acute exposure assay to support international regulatory labeling requirements, according to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS).

The Eye Irritation Test can be used to support European Cosmetics dossier and REACH registration requirements.  Test materials that result in a relative tissue viability >60% do not require classification for eye irritation or serious eye damage.

Quick Facts
  • In vitro RhCE models are made from human-derived cells, which are cultured on specially designed cell culture inserts. The cells are cultured to form a multi-layered structure which closely models the corneal epithelium.
  • 3-D reconstructed epithelial tissues model the barrier properties of the native epithelium, thus providing a relevant platform for modeling the permeation kinetics of chemicals and ingredients.
  • Since test materials can be applied topically, tissue exposures occur just as they do in vivo.
  • IIVS participated in the original EIT test method validation by Cosmetics Europe, and supplied the test method SOPs.
  • The inclusion of relevant benchmark chemicals may be used to support the irritation assessment of tested materials.
  • The Eye Irritation Test (EIT) is ideal for meeting international regulatory requirements (GHS classification, European Cosmetics dossier and REACH registrations).
  • The assay is compatible with both water soluble and insoluble raw materials and formulations.
  • In vitro RhCE models are suitable for testing liquids, creams, pastes, highly viscous materials, and solids.
  • IIVS has extensive experience handling challenging or novel physical forms and chemistries. We recommend contacting one of IIVS’ Study Directors to address your specific needs.

Please contact IIVS for more information on the Eye Irritation Test and how it may be suitable for your organization’s testing needs.

3D Tissue: Each tissue is comprised of human cells in a 3-dimensional multi-layered epithelium. Upon receipt, tissues are inspected and then transferred to pre-labeled plates containing pre-warmed medium. The plates are then placed in a humidified incubator to equilibrate the tissues.