The Draize rabbit eye test has been in use since 1944 to evaluate the risk of substances to cause
irritation or corrosion to the eyes. This test presents the potential for pain and distress in
rabbits after application of a severely irritating or corrosive substance. Alternative approaches
have been proposed and developed to reduce the number of animals used or refine (reduce pain and suffering)
these tests. In 2005, experts at a 2005 symposium Minimizing Pain and Distress in Ocular Toxicity Testing
(see below) made the following recommendations:
- Topical anesthetics and systemic analgesics should routinely be administered before ocular
testing to avoid or minimize pain and distress that might occur during and after the initial
application of test articles.
- Systemic analgesics should routinely be administered when there is evidence of potentially
painful ocular damage or when there are clinical signs indicative of pain or distress.
- Specific ocular injuries identified by the experts that would not be expected to reverse
within 21 days could be used as humane endpoints to end a study early.
ICCVAM requested data (see Federal Register notice below) and then compiled available
information on using topical anesthetics or systemic analgesics.
An independent scientific peer review panel meeting in May 2009 will review the available information and
comment on draft ICCVAM recommendations for the routine use of analgesics, anesthetics,
and humane endpoints.
Federal Register Notice
(Vol. 74, No. 60, page 14556-14557, March 31, 2009):
Announcement of an Independent Scientific Peer Review Panel on Alternative Ocular Safety
Testing Methods; Availability of Draft Background Review Documents (BRD); Request for Comments
View Federal Register notice [PDF]
Submit comment in response to the Federal Register notice
Federal Register Notice
(Vol. 72, No. 89, page 26396, May 9, 2007):
Request for Data on the Use of Topical Anesthetics and Systemic Analgesics for In Vivo Eye Irritation Testing
View Federal Register Notice
View comments submitted on Federal Register Notice
Using data generated during testing of test substances to comply with regulatory requirements of governmental agencies,
NICEATM staff conducted analyses evaluating of the effect of topical application of a tetracaine hydrochloride ophthalmic anesthetic solution
on the irritancy potential of test substances evaluated using a sequential testing scheme. The results of these analyses were presented by NICEATM
staff at two major scientific meetings in 2007.
View the NICEATM 2007 SOT Poster
View the NICEATM Sixth World Congress Poster
Abstract
of platform presentation, "Alternatives for Ocular Toxicity Testing: ICCVAM and NICEATM Recent and Planned Initiatives", given by Dr. William Stokes at
the Sixth World Congress
Symposium on Minimizing Pain and Distress in Ocular Toxicity Testing
In May 2005, ICCVAM, NICEATM, and the European Centre for the Validation of Alternative Methods (ECVAM), organized a
Symposium on Minimizing Pain and Distress in Ocular Toxicity Testing. The symposium was sponsored by ICCVAM,
NICEATM, ECVAM, and the European Cosmetic, Toiletry and Perfumery Association. The goals of this symposium were to:
- Review current understanding of the sources and mechanisms of pain and distress in ocular toxicity testing
- Identify current best practices for preventing, recognizing, and alleviating ocular pain and distress
- Identify additional research, development, and validation studies necessary to support scientifically
valid ocular toxicity testing procedures that avoid pain and distress
The participants in the symposium made the following recommendations:
- Pre-treatment with topical or general anaesthesia should be used routinely to avoid pain from topical application
of test substances
- Systemic analgesics should be administered prior to test article application and continued until injuries resolve
or the study is terminated
- Ocular injuries predictive of severe or irreversible ocular damage should be used as earlier humane endpoints
- Objective, quantitative measurements should be collected during ocular studies to assist in identifying earlier,
more humane endpoints. Data from these measurements are also critical to the development and validation of more predictive
in vitro methods.
View information about the Symposium
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