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ICCVAM Biennial Report 2014-2015

Biennial Progress Report 2014-2015 Interagency Coordinating Committee on the Validation of Alternative Methods

Ocular Toxicity Testing

Manufacturers test personal care products, household cleaning supplies, and other substances to determine if they could cause temporary or permanent eye damage. Test results are used to classify these substances using appropriate national and international hazard classification systems. These systems direct how substances must be packaged, labeled, and handled in order to prevent injury to the eyes.

Nearly all of this testing, referred to as ocular toxicity testing, has been conducted using the rabbit eye test. Evaluation of alternatives to animal use for ocular toxicity testing is a high priority for ICCVAM agencies. Past ICCVAM ocular toxicity test method evaluations identified in vitro test methods that could replace animal use in some applications. For applications where animal use is still necessary, ICCVAM recommended approaches to reduce the number of animals used and minimize pain and distress in those animals.

ICCVAM and ICCVAM Agency Activities

  • ICCVAM and National Institute of Environmental Health Sciences (NIEHS): NICEATM is coordinating the validation of the in vitro OptiSafe ocular irritation test method. In this method, a test substance is applied to a semipermeable membrane and damage to macromolecules in the membrane is measured to assess the substance’s potential to cause eye irritation. NICEATM staff and members of the ICCVAM Ocular Toxicity Working Group will serve on a validation management team to provide oversight and direction for a multilaboratory validation study. Testing should be completed in 2016, along with a study report detailing the results.
  • U.S. Environmental Protection Agency (EPA): In March 2015, EPA updated its guidance document describing a non-animal testing scheme for assessing eye irritation potential of EPA-registered antimicrobial cleaning products. The testing scheme uses the bovine corneal opacity and permeability, EpiOcular, and cytosensor microphysiometer assays to classify antimicrobial cleaning products as Toxicity Category I (corrosive or severely irritating to the eye), Category II (moderately irritating), and Category III (mildly irritating) without using live animals.
  • NIEHS: In 2013, NICEATM prepared a summary review document describing their evaluation of data submitted by Kao Corporation, the test method sponsor, in support of the short time exposure (STE) test. The STE is an in vitro test proposed to identify the eye injury hazard potential of chemicals and products by measuring cultured rabbit corneal epithelial cell viability following test substance exposure.
    After a National Toxicology Program-sponsored peer review of the final NICEATM summary review document, Kao Corporation submitted it and other documents to the Organisation for Economic Co-operation and Development (OECD) in 2014 for consideration of the STE as an in vitro alternative to current ocular hazard identification tests. In July 2015, OECD adopted a new Test Guideline 491 describing the use of the STE to identify (1) chemicals inducing serious eye damage and (2) chemicals not requiring eye hazard classification.
  • NIEHS: NICEATM scientists participated on management teams for two validation studies of in vitro methods to identify potential eye irritants, the SIRC-CVS assay and the Vitrigel-EIT assay, coordinated by the Japanese Center for the Validation of Alternative Methods. Laboratory work on the Vitrigel-EIT assay is in progress; study results on the SIRC-CVS assay are undergoing peer review.