Performance of the Isolated Rabbit Eye (IRE) test method in detecting ocular corrosives and severe irritants JF Truax1, DG Allen1, BC Blackard1, NY Choksi1,
CJ Inhof1, RR Tice1, WS Stokes2
1. Integrated Laboratory Systems, Inc./NICEATM, RTP, NC, USA
Ethical (animal welfare), economic (development of
higher throughput testing), and scientific (development of mechanistic
studies) concerns have led researchers to develop in vitro alternatives
for the current in vivo rabbit eye test. NICEATM evaluated four in
vitro test methods for their ability to identify substances that cause
ocular corrosion or severe irritation. One of these test methods, IRE,
is an organotypic model that provides short-term maintenance of the
rabbit eye in an isolated system. The ability of IRE to correctly
identify ocular corrosives and severe irritants using available IRE and
corresponding in vivo rabbit eye test data was evaluated according to
current hazard classification schemes for the U.S. Environmental
Protection Agency, the European Union, and the UN Globally Harmonized
System of Classification and Labeling of Chemicals. Based on an interim
analysis, IRE appears useful in a weight-of-evidence tiered testing
strategy, pending corroboration of existing data with a larger database.
Accordingly, positive results could be used to classify and label a
substance, while substances with negative results would undergo
additional testing. This approach would reduce the number of animals
used for eye irritation testing and the number of animals experiencing
pain and distress. A proposed standardized test method protocol and a
proposed list of reference substances have been developed for use in
future validation and/or testing studies to further characterize the
accuracy, the reliability, and the applicability domain of IRE for the
detection of ocular corrosives and severe irritants. ILS staff
supported by NIEHS contract N01-ES 35504. P158 Date: Tuesday, August 23, 2005, 13.00-14.00 h 5.5 Session: Advancements and Needs for Developing and Validating Alternatives for Ocular Irritancy and Corrosivity Testing. This page was last updated May 9, 2007 Contact the webmaster Return to the NICEATM/ICCVAM Home Page |