Use of an Alternate Testing Framework for Classification of Eye Irritation Potential of EPA Pesticide Products
A collaboration led by IIVS, in conjunction with the Accord Group, seven manufacturers of anti-microbial cleaning products, and the US EPA resulted in the development of a decision tree approach (See figure 1) using three in vitro or ex vivo assays under the United States Environmental Protection Agency (U.S. EPA) Office of Pesticide Programs (OPP). The three assays are:
- Bovine Corneal Opacity and Permeability test (BCOP)
- EpiOcular assay (EO)
- Cytosensor Microphysiometer assay (CM)
Data analyses show that these assays can be used either singly or in combination to appropriately label anti-microbial cleaning products (AMCPs) with one of the four US EPA OPP eye irritation hazard categories. Key Points
- 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 US EPA will consider alternative tests conducted and submitted on a case-by-case basis. An IIVS scientist can discuss approaches with you.
- Assay can be used in a top-down approach for determination of EPA Toxicity Categories I, II, and III for eye irritation while the CM and EO assays can be used in a bottom-up approach for determining Toxicity Category IV, III, or I AMCPs.
- The first step in determining the appropriate assay is whether the test material has oxidizing chemistry (e.g., hypochlorite, peroxide, percarbonate, oxygen bleaches, strong acids, etc.) or may be expected to be a severe or moderate eye irritant. If yes to either of these questions, the BCOP assay should be used.
- If the test material does not possess oxidizing chemistry or is not expected to be a severe or moderate eye irritant, the CM or EO assays can be conducted.
- These assays are sensitive to small amounts of damage, and thus are well suited to resolve away the mildest AMCP formulations.
Following the guidance provided by: Use of an Alternate Testing Framework for Classification of Eye Irritation Potential of EPA Pesticide Products, US Environmental Protection Agency, Office of Pesticide Programs, Washington, DC, 3/2/2015.