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Evaluation of a Testing Strategy for Ocular Hazard Classification and Labeling of Antimicrobial Cleaning Products

In 2008, the U.S. Environmental Protection Agency (EPA) submitted to NICEATM a testing strategy to assess the eye irritation potential of antimicrobial cleaning products (AMCPs) that avoided the use of live animals. The proposed testing strategy used the bovine corneal opacity and permeability, Cytosensor microphysiometer, and EpiOcular™ test methods to determine the EPA hazard category and labeling requirements for these products. ICCVAM evaluated the proposed strategy and recommended further studies to characterize its usefulness and limitations.

Test method evaluation report

In 2013, the EPA Office of Pesticide Programs established the use of an alternative testing approach to assess the eye irritation potential for AMCPs in general and for other classes of pesticides and pesticide products on a case-by-case basis. This testing approach modified the 2008 proposal to consider the ICCVAM evaluation and studies submitted by product registrants. A detailed policy document is available on the EPA website.

Background on the AMCP Testing Strategy Evaluation

The EPA collaborated with seven consumer product companies to develop the 2008 proposal. The Institute for In Vitro Sciences, Inc., (IIVS) coordinated the collaboration, performed additional testing to complete parallel sets of in vivo and in vitro data, and prepared a background review document describing the final approach.

The EPA and the consumer product companies requested that NICEATM and ICCVAM to conduct a technical review of the scientific validity of the AMCP testing strategy. The goal of the review was to determine whether the AMCP testing strategy could, with a reasonable degree of certainty, be used to make appropriate hazard classification and labeling decisions for AMCPs.

NICEATM and ICCVAM used the IIVS background review document and additional data and information as the basis for a draft summary review document (SRD) and draft ICCVAM recommendations. The draft SRD and draft recommendations were reviewed in May 2009 by an independent international scientific peer review panel. ICCVAM considered the panel's comments, as well as comments from the Scientific Advisory Committee on Alternative Toxicological Methods and the public, before finalizing its recommendations for Federal agencies.

Summary of the Peer Review Panel meeting

Peer Review Panel Report (July 2009)

List of relevant references

ICCVAM concluded that, at that time, there were insufficient data with which to adequately demonstrate that the proposed strategy could classify test substances to all four EPA ocular hazard categories. ICCVAM recommended future studies that could further characterize the usefulness and limitations of a testing strategy for AMCPs.

Submission Letter from Dr. Rodger Curren, IIVS, to Dr. William Stokes, NICEATM

The ICCVAM recommendations and ICCVAM-recommended protocols for the test methods are contained in the ICCVAM Test Method Evaluation Report: Current Validation Status of a Proposed In Vitro Testing Strategy for U.S. Environmental Protection Agency Ocular Hazard Classification and Labeling of Antimicrobial Cleaning Products (2010).

The ICCVAM recommendations were transmitted to Federal agencies in September 2010. Agency responses indicated acceptance or endorsement of the ICCVAM recommendations.

Background on the ICCVAM Evaluation of the Low Volume Eye Test

As part of its evaluation of the AMCP testing strategy, ICCVAM also reviewed the validation status of the low volume eye test (LVET). The LVET is similar to the traditional in vivo rabbit eye test, but uses a smaller volume of test substance and a different application procedure. Data generated using the LVET was used as reference data to partially substantiate the validity of the in vitro test methods used in the AMCP testing strategy.

ICCVAM recommended that the LVET should not be used for future regulatory testing. If animals must be used in ocular safety testing, ICCVAM recommends use of a modified rabbit eye test as recommended with topical anesthetics, systemic analgesics, and humane endpoints. The ICCVAM recommendations are included in the ICCVAM Test Method Evaluation Report: Recommendation to Discontinue Use of the Low Volume Eye Test for Ocular Safety Testing.

Recommendations and Agency Responses

The ICCVAM recommendations were communicated to Federal agencies in letters from Dr. Linda Birnbaum, Director, NIEHS. These letters and responses received from Federal agencies are available below.