OECD Test Guideline Proposals
In October 2007, ICCVAM forwarded its first recommendations for the use of in vitro methods for ocular
safety testing to Federal agencies. ICCVAM recommended that two methods, the Bovine Corneal Opacity and Permeability (BCOP) test method and the Isolated Chicken Eye (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. The ICCVAM recommendations were accepted by the Federal agencies in June 2008,
and the two in vitro test methods may now be used instead of conventional tests for certain regulatory testing purposes.
A validated test method can achieve acceptance on the international level when it is included in a test guideline developed by the
Organisation for Economic Co-operation and Development (OECD). To maximize the potential impact of these approved
test methods on reducing animal use, NICEATM and the ICCVAM Ocular Toxicity Working Group (OTWG) prepared draft
OECD Test Guidelines for the BCOP and ICE test methods. The draft Test Guidelines were forwarded to
the U.S. National Coordinator to the OECD Test Guidelines Programme, and were formally accepted by OECD
in September 2009. The acceptance of these two test guidelines in less than one year is notable, as this process typically requires several years.
The rapid acceptance of the test guidelines was due in part to the comprehensive NICEATM-ICCVAM
evaluation; key contributors to this effort were the members of the OTWG, which includes scientists
from FDA, EPA, CPSC, DOD, DOT, NIEHS, and OSHA.
Formal adoption of these methods by OECD allow them to now be used in the other 29 OECD member countries,
which include Japan, Canada and most countries in the European Union. There is considerable interest in these methods in Europe
due to the ban by the EU on the use of animals for testing cosmetic ingredients and the EU chemicals
legislation, REACH (Registration, Evaluation, Authorisation and Restriction of Chemical substances), which may require
testing of thousands of existing chemicals.
OECD Test Guidelines: Adopted September 2009
Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and
Severe Irritants [PDF]
Test Guideline 438: Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants
[PDF]
NIH Press Release (June 23, 2008):
Newly Approved Ocular Safety Methods Reduce Animal Testing [PDF]
View press release on NIH Website
View more
information about the OECD Test Guidelines Programme (on OECD website)
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