Regulatory Acceptance of Three-Dimensional Tissue Constructs for Testing of Eye Irritation - Bioscience Labs
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Regulatory Acceptance of Three-Dimensional Tissue Constructs for Testing of Eye Irritation

Posted On: Aug 20, 2015

An in vitro method for assessment of Ocular Irritation potential of chemicals has been recently accepted by the regulatory authorities as an alternative to in vivo Draize rabbit eye irritation test. This alternative method utilizes reconstructed human cornea-like epithelium which closely mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium. The EpiOcular (MatTek, Corp.) Eye Irritation Test was extensively validated by ECVAM (the European Centre for the Validation of Alternative Methods) and now accepted by the OECD (Organization for Economic Co-operation and Development) and the US EPA (Environmental Protection Agency).

According to the EPA, EpiOcular Eye Irritation testm along with BCOP test (Bovine Corneal Opacity and Permeability) and Cytosensor Microphysiometer assaym “can be used to satisfy the in vivo data requirement for eye irritation in 40 CFR Part 158W for Antimicrobial Cleaning Products. For other classes of pesticides and pesticide products, including conventional, biochemical, and other antimicrobial pesticides not in the scope of those with cleaning claims, the agency will consider alternative tests conducted and submitted on a case-by-case basis [1].” These tests can be used to differentiate among the four eye irritation hazard categories currently utilized by the EPA. The BCOP method can classify irritation potential into Category I through III, EpiOcular Eye Irritation test, and Cytosensor Microphysiometer – into Category I through IV. In the majority of cases two of the in vitro methods such as BCOP and EpiOcular are sufficient for classification. The Category I (corrosive/severe irritant) labeling statements can also be accepted by the EPA in lieu of testing for eye irritation.

The new OECD Test Guideline 492 recommends “the EpiOcular Eye Irritation test to identify chemicals that do not require classification for eye irritation or serious eye damage according to the UN Globally Harmonized System [2]”. In other words, the EpiOcular Eye Irritation test allows for identification of chemicals and chemical mixtures that are not corrosive or sever irritants and do not require labeling.

The regulatory acceptance of this alternative Eye Irritation testing method undoubtedly provides industry with the clear instructions and data requirements but very importantly, it provides a reliable and fast non-animal model for testing of products under development which, ultimately, can move formulations in the marketplace to be milder and safer to the consumer.

The EPA and OECD published protocols for EpiOcular Eye Irritation test which are available

USE OF AN ALTERNATE TESTING FRAMEWORK FOR CLASSIFICATION OF EYE IRRITATION POTENTIAL OF EPA PESTICIDE PRODUCTS. 3-2-2015. Office of Pesticide Programs. U.S. Environmental Protection Agency, Washington DC, 20460;
OECD GUIDELINE FOR THE TESTING OF CHEMICALS 492. Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage. 28 July 2015.

BioScience Laboratories has an extensive experience in irritation testing and offers GLP and non-GLP options for BCOP and EpiOcular testing.

Contact our team today to learn more!

written by
Volha Dzyakanava, Ph.D.
Manager of Virology Laboratory
BioScience Laboratories, Inc,.