For Release: June 4, 2015

EPA has updated its science policy document “Use of an Alternate Testing Framework for Classification of Eye Irritation Potential of EPA Pesticide Products.” This policy document describes testing to assess eye irritation potential of EPA-registered antimicrobial cleaning products using three in vitro/ex vivo eye irritation tests:

• Bovin Corneal Opacity and Permeability Assay (BCOP),
• Epiocular Assay (EO) and
• Cytosensor Microphysiometer Assay (CM).

This updated policy document expands the scope of the BCOP assay. Previously, the BCOP could be used to identify antimicrobial cleaning product Toxicity Category I and II eye irritants.  EPA is now expanding the applicability of the BCOP assay for identifying toxicity category III eye irritants for antimicrobial cleaning products.  This document provides a framework for determining eye hazard classification and required labeling for antimicrobial cleaning products using a non-animal testing approach. The testing scheme can be used to satisfy the in vivo data requirement for eye irritation in 40 CFR Part 158W for antimicrobial cleaning products. This means that fewer animals will have to be tested to determine whether a product causes eye irritation.
The agency will consider on a case-by-case basis such alternative tests for other types of pesticide products, including conventional, biochemical and other antimicrobial pesticides not within the scope of those with cleaning claims.
For more information, please visit the Alternate Testing Framework for Classification of Eye Irritation Potential of EPA Pesticide Products Web page. 

For an explanation of the toxicity categories, see “Signal Word” on the first page of this site.