Ocular Irritection

The Ocular Irritection test method addresses the eye irritation and serious eye damage endpoint.  It intends to identify chemicals potentially inducing eye irritation and/or serious eye damage on the basis of the United Nations (UN) Global Harmonized Systems for classification and labelling (GHS), as well as those not inducing ocular toxicity. 

The test system is composed of a macromolecular reagent containing a mixture of proteins and glycoproteins, carbohydrates, lipids and low molecular weight components. After rehydration, this reagent forms a macromolecular matrix, which mimics the cornea.  The test chemical is applied on a membrane disc which delivers it to the matrix. Chemicals being ocular toxic will induce a turbidity of the macromolecular matrix by interacting with its components and disrupting its conformation.

The Ocular Irritection protocol is intended to be potentially used for the prediction of acute eye irritation and serious eye damage in regulatory safety testing under the UN GHS, REACH, EU Classification, Labelling and Packaging of substances and mixtures (CLP) or Cosmetic Directive for chemicals. Currently, the sequential TD and BU approaches are considered for taking place in a wider strategy such as an Integrated Approach on Testing and Assessment (IATA). This IATA would be similar to the already validated one for skin irritation and corrosion. If validated—e.g., at the OECD—this ocular toxicity strategy may be included in a revised version of the "REACH Guidance on Information Requirements and Chemical Safety Assessment" published by ECHA.