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In 2010, ICCVAM issued recommendations on the use of five in vitro
test methods for identifying
reversible and nonsevere eye injuries:
- The bovine corneal opacity and permeability (BCOP) test method
- The Cytosensor® microphysiometer (CM) test method
- The hen's egg test - chorioallantoic membrane (HET-CAM) test method
- The isolated chicken eye (ICE) test method
- The isolated rabbit eye (IRE) test method
These recommendations have been
accepted by ICCVAM member agencies.
ICCVAM recommended that the CM test method can be used as a
screening test to identify some types of water-soluble substances that may
cause permanent or severe eye injuries. Substances that are appropriate for testing
using the CM test method and yield positive results can
be classified as having the potential to cause severe or permanent eye injuries without
additional testing using animals. However, a substance that tests negative with
the CM test method would need to be tested using
another test method capable distinguishing
between different hazard classifications of substances that can cause reversible and nonsevere eye injuries.
ICCVAM also recommended that the CM test method can be used, for a limited range of substances
(water-soluble surfactants and surfactant-containing formulations such as cosmetics and personal
care products), to determine that chemicals and products do not present sufficient potential
to cause eye injuries to require eye hazard labeling. The CM test method is the first in vitro
test method available in the U.S. for this purpose.
ICCVAM concluded that the performance of the other four test methods must be improved before they can
be used in regulatory safety testing to classify substances as having the potential to cause
reversible, nonsevere eye injuries or as not requiring hazard labeling for eye irritation.
The 2010 report on the ICCVAM evaluation of these test methods includes recommendations for future studies that could
potentially improve these test methods.
These test methods were previously evaluated by ICCVAM for
their usefulness to identify substances that may cause permanent or severe eye injuries.
Background on the ICCVAM Evaluation of the In Vitro Test Methods
In 2006, ICCVAM made recommendations on the use of
the BCOP, HET-CAM, ICE, and
IRE test methods to identify substances that may cause permanent or
severe eye injuries. One of the ICCVAM recommendations resulting from that evaluation
was to determine the ability of these test methods to identify substances that
may cause reversible and nonsevere eye injuries. ICCVAM also reviewed the validation
status of the CM test method, which was not part of the 2006 evaluation.
NICEATM and ICCVAM prepared draft background review documents (BRDs) that summarized the current
validation status of the BCOP, HET-CAM, ICE, and IRE test methods. A BRD summarizing the
available data on the CM test method was obtained from the European Centre for the Validation of
Alternative Methods. Data in these documents were used as the basis for developing draft ICCVAM
recommendations. The draft BRDs and draft ICCVAM recommendations were reviewed in May 2009 by an
independent international peer review panel. ICCVAM considered the peer review panel's comments, as
well as comments from the public and from the Scientific Advisory Committee on Alternative
Toxicological Methods, before finalizing its recommendations for Federal agencies.
ICCVAM recommendations regarding the usefulness and limitations of the BCOP, CM, HET-CAM, ICE,
and IRE test methods are contained in the ICCVAM Test Method Evaluation Report: Current Validation
Status of In Vitro Test Methods Proposed for Identifying Eye Injury Hazard Potential of Chemicals
and Products (2010). The report also includes ICCVAM-recommended test method protocols for future studies,
as well as recommendations to further characterize and potentially improve the usefulness and
applicability of the test methods.
The ICCVAM recommendations were tranmitted to Federal agencies in September 2010.
Agency responses,
received within 180 days of transmittal as required by the ICCVAM Authorization Act, indicated
acceptance or endorsement of the ICCVAM recommendations.
View Federal Register notice announcing agency responses to recommendations
Recommendations on In Vitro Ocular Safety Testing Methods and Strategies and Routine Use of
Topical Anesthetics, Systemic Analgesics, and Humane Endpoints for Ocular Safety Testing
(76 FR 20672, April 13, 2011) [PDF]
View Federal Register notice announcing transmittal of recommendations
Availability of Test Method Evaluation Reports:
In Vitro Ocular Safety Testing Methods and Strategies, and Routine Use of Topical Anesthetics,
Systemic Analgesics, and Humane Endpoints for Ocular Safety Testing; Notice of Transmittal
to Federal Agencies
(75 FR 57027, September 17, 2010) [PDF]
View transmittal letters, agency responses,
and summary of all September 2010 ICCVAM recommendations on ocular test methods transmitted to
Federal agencies
Read the Test Method Evaluation Report
Read the Peer Review Panel Report
[PDF]
Federal Register Notice:
Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of Alternative Ocular Safety Testing
Methods and Approaches: Notice of Availability and Request for Public Comments (74 FR 33444, July 13, 2009)
View Federal Register notice [PDF]
View comments submitted on Federal Register notice
Federal Register Notice:
Announcement of an Independent Scientific Peer Review Panel on Alternative Ocular Safety
Testing Methods; Availability of Draft Background Review Documents (BRD); Request for Comments (74 FR 14566, March 31, 2009)
View Federal Register notice [PDF]
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