Overview
In October 2007, ICCVAM forwarded recommendations on two in vitro test methods to identify ocular
corrosives or severe irritants to Federal agencies for their consideration of regulatory acceptance as required by the ICCVAM Authorization
Act of 2000 (42 U.S.C. 285l-3). These are the first alternative non-animal test methods for ocular safety testing
reviewed by ICCVAM and transmitted to agencies. The ICCVAM recommendations were accepted by the Federal agencies,
and the two in vitro test methods may now be used
instead of conventional tests for certain regulatory testing purposes. The use of these two alternative
test methods will likely reduce the use of live animals for eye safety testing by 10 percent or more. More
importantly, the use of these tests will eliminate eye safety testing in animals of most substances likely to
cause the most severe pain and discomfort.
The ICCVAM test method recommendations to agencies and the agency responses can be found on the Test
Method Recommendations page.
NIH Press Release (June 23, 2008):
Newly Approved Ocular Safety Methods Reduce Animal Testing [PDF]
View press release on NIH Website
Background
Accidental eye injury is a leading cause of visual impairment in the U.S., and many of these injuries occur due to contact with workplace or household chemicals.
According to the National Institute of Occupational Safety and Health (NIOSH), each day
about 2000 U.S. workers have a job-related eye injury that requires medical treatment. Even more eye injuries
occur in the home, with about 125,000 eye injuries a year caused by accidents involving common household products
such as oven cleaner and bleach (source, American Academy of Ophthalmology). Federal agencies require safety testing to determine whether consumer products or other substances may cause
temporary or permanent damage to the eye. In October 2003, the U.S. Environmental Protection Agency (EPA)
nominated four in vitro ocular toxicity test methods for evaluation as
potential screening methods for eye corrosion or severe irritation. The
four nominated test methods were:
- The Isolated Rabbit Eye (IRE) Test Method
- The Isolated Chicken Eye (ICE) Test Method
- The Bovine Corneal Opacity and Permeability (BCOP) Test Method
- The Hen's Egg Test - Chorioallantoic Membrane (HET-CAM) Test Method
NICEATM compiled data and information on each test method and released four comprehensive draft Background
Review Documents (BRDs) for public comment in November 2004. ICCVAM, in collaboration with NICEATM, convened an
independent Expert Panel in January 2005 to determine the validation status of these
methods. The
Expert Panel Report: Evaluation of the Current Validation
Status of In Vitro Test Methods for Identifying Ocular Corrosives and
Severe Irritants, was made available in March 2005.
Submission of additional data after the Expert Panel Meeting
led to release of addenda to the BRDs. The Expert Panel was subsequently
reconvened in September 2005 to reconsider their evaluation. The Expert Panel Report of the Current
Validation Status of In Vitro Test Methods for Identifying Ocular
Corrosives and Severe Irritants:
Addendum
was made available in November 2005.
Final BRDs
were published in 2006. ICCVAM and its Ocular Toxicity Working Group considered the Expert Panel report and Addendum,
the revised accuracy and reliability analyses, all public comments, and the comments of the Scientific Advisory Committee
on Alternative Toxicological Methods in preparing the final
Test Method Evaluation Report,
published in November 2006.
ICCVAM recommended that the BCOP Test Method and the ICE Test Method can be used in a tiered testing strategy
to determine ocular hazards, with specific limitations for certain chemical classes and/or physical properties.
Substances that test positive in these assays can be classified as ocular corrosives or severe irritants without
further testing in animals. The report also recommends that these in vitro test methods should be considered
before using animals for ocular testing and used when determined appropriate. These recommendations, which have been accepted by
Federal agencies, will result in a reduction of the number of animals used for safety testing to determine permanent
or temporary damage to the eye.
ICCVAM evaluated two other in vitro test methods, the Isolated Rabbit Eye (IRE) Test Method and
the Hen's Egg Test - Chorioallantoic Membrane (HET-CAM) Test Method. Before these two methods can
be recommended for use as screening tests for the identification of ocular corrosives and severe
irritants, the protocol and decision criteria for the identification of ocular corrosives and severe
irritants need to be optimized and undergo further validation.
Federal Register Notice
(Vol. 72, No. 226, page 65964-65965, November 26, 2007):
Availability of the ICCVAM Test Method Evaluation Report on In Vitro Ocular Toxicity Test Methods for Identifying Severe Irritants and Corrosives
and Final In Vitro Ocular Test Method Background Review Documents; Notice of Transmittal of ICCVAM Test Method Recommendations to Federal Agencies
View Federal Register Notice
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