Environmental Health Perspectives Article on Federal Agency Acceptance of ICCVAM-Recommended In Vitro Ocular Safety Test Methods


The Forum section of the September 2008 issue of Environmental Health Perspectives (EHP) features an article on Federal regulatory agency acceptance of two toxicological test methods that can reduce live animal use for ocular safety testing. EHP is a peer-reviewed publication of the Public Health Service, U.S. Department of Health and Human Services, and is a forum for the discussion and dissemination of news, scientific research, and ideas relating to the effect of the environment on human health.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) recommended the two alternative test methods, the bovine corneal opacity and permeability (BCOP) assay and the isolated chicken eye (ICE) assay, following an extensive evaluation of their scientific validity.The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) provided scientific support for the evaluation, which included independent scientific peer review by an international expert panel and consideration of public comments.

The BCOP and ICE do not involve the use of live animals, and the tissues used are obtained from animals intended for food consumption. If a positive response is obtained using either of the two new approved alternative methods, the product can be labeled as causing irreversible or severe eye damage without animal testing. These are the first scientifically valid in vitro alternative methods to gain regulatory acceptance for ocular safety testing. To broaden their impact on reducing animal use, ICCVAM and NICEATM are working to gain international approval of the BCOP and ICE by the 30 member countries of the Organisation for Economic Co-operation and Development.

The full text of the EHP Forum article (September 2008) can be found at: http://www.ehponline.org/docs/2008/116-9/forum.html#ocul

Information about the NICEATM-ICCVAM evaluation of the eye safety test methods, including the Test Method Evaluation Report, the ICCVAM recommendations, and the agency responses, can be found at: http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox.htm