From the EPA web
site<http://www2.epa.gov/pesticide-registration/alternate-testing-framework-classification-eye-irritation-potential-epa>:
Alternate Testing Framework for Classification of Eye Irritation Potential of
EPA Pesticide Products
In May 2015, EPA released updated guidance for testing antimicrobial cleaning
products for their potential to cause eye irritation.
Read the “Use of an Alternate Testing Framework for Classification of Eye
Irritation Potential of EPA Pesticide
Products<http://www2.epa.gov/pesticide-registration/non-animal-testing-approach-epa-labeling-eye-irritation>”.
This updated guidance document, effective immediately, describes a testing
framework for assessing eye irritation potential of EPA-registered
antimicrobial cleaning products using three in vitro/ex vivoassays (non-animal
tests):
* Bovine Corneal Opacity and Permeability assay (BCOP).
* EpiOcular assay (EO).
* Cytosensor Microphysiometer (CM) assay.
The same testing approach is currently considered on a case-by-case basis for
other classes of pesticides and pesticide products.
This updated guidance document replaces the 2013 version of this document.
Learn more about the 2015 eye irritation alternate testing framework for
antimicrobial cleaning products:
What’s New in the 2015 Guidance
The testing framework in the updated guidance 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.
Scope of the Use of this Guidance
After additional analysis, the agency concluded that the testing approach in
the 2015 guidance is acceptable for determining the eye hazard classification
and labeling for antimicrobial cleaning products. Thus, 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. See antimicrobial product data
requirements<http://www.ecfr.gov/cgi-bin/text-idx?SID=3294f5b1abd78dc592aba981afeec378&mc=true&node=sp40.24.158.w&rgn=div6>.
For other pesticides, including conventional, biochemical, and other
antimicrobial pesticides that do not include cleaning claims, the agency will
consider alternative tests on a case-by-case basis. In these situations, the
registrant is encouraged to consult with the EPA or submit the proposed test
protocol to the EPA for review before conducting the study. EPA will determine
the acceptability of test results on these other classes using a weight of
evidence approach. That is, the results of the non-animal tests will be
considered along with additional information on the chemical, including but not
limited to structure-activity relationships and results of in vivo testing of
the same or similar chemicals to support a classification under this testing
scheme
Background
In 2009, the agency initiated a pilot program through publication of a document
entitled “Non-Animal Testing Approach to EPA Labeling for Eye
Irritation<http://www2.epa.gov/pesticide-registration/non-animal-testing-approach-epa-labeling-eye-irritation>.”
This pilot encouraged antimicrobial pesticide registrants to submit studies on
eye irritation for antimicrobial cleaning products using the in vitro and ex
vivo testing methods mentioned above (BCOP, EO, and CM). The purpose of this
pilot was to determine whether labeling decisions for eye irritation could be
made using this approach.
As a result of this pilot program, and based on analyses conducted by the
Interagency Coordinating Committee on the Validation of Alternative Methods
(ICCVAM), the agency established as science policy the use of this approach for
antimicrobial cleaning products in general and for other classes of pesticides
and pesticide products on a case-by-case basis.
The agency recently conducted additional analysis to determine whether the BCOP
assay could be used to identify Toxicity Category III eye irritants. This use
of the BCOP assay is supported and has been incorporated into the updated
guidance document.
