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In 2008, NICEATM received a submission, sponsored by the U.S. Environmental Protection Agency (EPA),
for a testing strategy to assess the eye irritation potential of antimicrobial cleaning products (AMCPs)
without using live animals. This proposed testing strategy utilized the bovine corneal opacity and
permeability (BCOP), Cytosensor microphysiometer (CM), and EpiOcular™ (EO) test
methods to determine the EPA hazard category and labeling requirements for these substances.
ICCVAM conducted an evaluation of the proposed strategy and recommended further studies to
characterize its usefulness and limitations. As part of this evaluation, ICCVAM recommended that the
low volume eye test (LVET), a test method that was used to generate data supporting the
validity of the proposed testing strategy, should not be used for future regulatory testing.
Background on the AMCP Testing Strategy Evaluation
The EPA collaborated with a group of seven consumer
product companies to develop a testing strategy for evaluating the eye irritation potential of AMCPs that does not use live animals.
The Institute for In Vitro Sciences, Inc. (IIVS Inc.) coordinated the collaboration, performed additional
testing to complete parallel sets of in vivo and in vitro data, and prepared a background review document
(BRD) describing the final approach.
IIVS Inc. submitted this BRD, In Vitro Approach for EPA Toxicity Labeling of Anti-Microbial Cleaning Products,
to NICEATM. The EPA and the consumer product companies requested that NICEATM and ICCVAM
use the information in the BRD to conduct a technical review of the scientific validity of the AMCP testing strategy.
The goal of the review was to determine
whether ICCVAM could assure the EPA, with a reasonable degree of certainty, that the AMCP testing strategy
would be useful
for making hazard classification and labeling decisions for AMCPs that appropriately inform users.
NICEATM and ICCVAM reviewed the BRD and requested additional data and information prior to preparing a draft
Summary Review Document (SRD) and draft ICCVAM recommendations. The draft
SRD and draft ICCVAM recommendations were reviewed in May 2009
by an independent international scientific 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 concluded that there is currently insufficient data with which to adequately demonstrate
that the proposed strategy can classify test substances to all four EPA ocular hazard categories.
ICCVAM also concluded that the data were insufficient to support definitive recommendations on an
alternate AMCP testing strategy to classify substances in all four EPA ocular hazard categories.
ICCVAM recommended future studies that could further characterize the usefulness and limitations of
a testing strategy for AMCPs.
The ICCVAM recommendations on the proposed AMCP testing strategy
are contained in the ICCVAM Test Method Evaluation Report: Current Validation
Status of a Proposed In Vitro Testing Strategy for U.S. Environmental Protection Agency Ocular Hazard
Classification and Labeling of Antimicrobial Cleaning 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 AMCP Test Method Evaluation Report
Background on the ICCVAM Evaluation of the Low Volume Eye Test
ICCVAM also reviewed the validation status of the low volume eye test (LVET). The LVET is
a rabbit eye test that, like the Draize test, was designed to determine the extent of
potential ocular hazard of a test substance. It is similar to the Draize rabbit eye test, but uses
a smaller volume of test substance and a different application procedure. Data generated using the
LVET was used as reference data to partially substantiate the validity of the in vitro
test methods used in the AMCP testing strategy.
ICCVAM recommended that the LVET should not be used for future regulatory testing.
If animals must be used in ocular safety testing, ICCVAM recommends use of a modified Draize rabbit
eye test as recommended with topical anesthetics, systemic analgesics, and humane endpoints.
The ICCVAM recommendations on the LVET are included in the ICCVAM
Test Method Evaluation Report: Recommendation to Discontinue Use of the Low Volume Eye Test
for Ocular Safety Testing.
Read the LVET 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]
View comments submitted on Federal Register notice
View Submission Letter from Dr. Rodger Curren, Institute for In Vitro Sciences, Inc. (IIVS)
to Dr. William Stokes, NICEATM [PDF]
Federal Register Notice:
Non-Animal Methods and Approach for Evaluating Eye Irritation Potential and Labeling Requirements for Antimicrobial
Cleaning Products (AMCPs): Request for Nominations for an Independent Expert Panel and Submission of Relevant Data (73 FR 18535, April 4, 2008)
View Federal Register notice [PDF]
View comments submitted on Federal Register notice
Related Federal Register notice previously published
Federal Register Notice:
Request for Data on Non-Animal Methods and Approaches for Determining Skin and Eye Irritation Potential
of Antimicrobial
Cleaning Product Formulations: Request for Nominations for an Independent Expert Panel (70 FR 13512, March 21, 2005)
View Federal Register notice [PDF]
View comments submitted on Federal Register notice
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