Non-Animal Testing Approach to EPA Labeling for Eye Irritation
This document is an update to EPA’s 2013 published alternative testing approach (using in vitro/ex vivo assays) for determination of eye irritation potential in the pesticide program under EPA's classification and labeling system. This update includes additional analysis that expands the applicability of the Bovine Corneal Opacity and Permeability (BCOP) assay for identifying toxicity category III eye irritants for antimicrobial cleaning products (AMCPs). Previously, the BCOP was applicable only to identification of AMCP category I and II eye irritants. We have concluded that the additional analysis supports the use of the BCOP for identification of toxicity category III eye irritants for AMCPs.
The overall testing approach presented in this document is acceptable for determining the appropriate eye hazard classification and labeling for AMCPs (see section II of this document). Thus, the testing scheme presented in this document can be used to satisfy the in vivo data requirement for eye irritation in 40CFR Part 158W for AMCPs.
The methods contained in this approach are strongly recommended for generating the data that are the subject of the document, but EPA recognizes that departures may be appropriate in specific situations. In such cases, proposed alternatives to the methods recommended in the document can be submitted, with supporting rationale. The Agency will assess such proposals on a case-by-case basis.