|
Below are summaries of recent NICEATM-ICCVAM activities through March 2009.
Back to Home page of NICEATM-ICCVAM website
Test Guidelines for In Vitro Ocular Safety Testing Methods Approved by OECD National Coordinators
The National Coordinators for the Test Guidelines Program of the Organisation for Economic
Co-operation and Development (OECD) have approved the first in vitro OECD international test
guidelines for ocular safety testing. These test guidelines are based on the bovine corneal opacity
and permeability and isolated chicken eye test methods. The test guidelines were developed and proposed to
the OECD in 2008 by NICEATM and ICCVAM, in cooperation with the Japanese Center for the Validation of
Alternative Methods (JaCVAM) and the European Centre for the Validation of Alternative Methods
(ECVAM), following an extensive review of their validation status.
U.S. agencies endorsed the methods in 2008 following receipt of recommendations from ICCVAM. The
test methods can be used to identify and label substances that cause severe irritation or permanent
eye injuries without the need to use animals, thus providing for animal reduction and
refinement.
The guidelines will now be forwarded to the OECD Joint Meeting and Council for formal adoption,
which should occur by early summer.
The acceptance and expected formal adoption 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 prior comprehensive NICEATM-
ICCVAM evaluation, which included international scientific peer review and the preparation and
publication of an ICCVAM Test Method Evaluation Report and Test Method Background Review Documents.
Key contributors to this effort were the members of the ICCVAM interagency Ocular Toxicity Working
Group, which includes scientists from FDA, EPA, CPSC, DOD, DOT, NIEHS, and OSHA.
NICEATM Announces Peer Review Panel Meeting on the Murine Local Lymph Node Assay and
Availability of Revised Draft Background Review Documents and Draft ICCVAM Test Method
Recommendations
NICEATM, in collaboration with ICCVAM, will convene an independent scientific peer review panel
meeting to evaluate updated information on three non-radioactive modified versions and new
applications for the Murine Local Lymph Node Assay (LLNA). The Panel meeting will take place April
28-29, 2009, at the Natcher Conference Center, National Institutes of Health, Bethesda, MD, and is
open to the public.
The LLNA is a test method used to determine the allergic contact
dermatitis potential of chemicals and products for regulatory hazard classification and labeling
purposes. As an accepted alternative to traditional guinea pig tests, the LLNA uses fewer animals
and eliminates pain and distress. The proposed applications could expand the range of substances
and products that can be tested in the LLNA, while the proposed new versions may allow for broader
use of the LLNA and also avoid the need for radioactive markers.
The draft ICCVAM test method recommendations and draft background review documents are available
on the NICEATM-ICCVAM website.
If you wish to attend the meeting, please register by April 14, 2009.
Link to online registration form
NICEATM Announces Peer Review Panel Meeting on Alternative Methods for Ocular Safety Assessments
and the Availability of Draft Background Review Documents and Draft ICCVAM Test Method
Recommendations
NICEATM, in collaboration with ICCVAM, will convene an independent scientific peer review panel
to evaluate several alternative ocular toxicity testing methods and approaches. The panel will
evaluate a proposal for the routine use of topical anesthetics, systemic analgesics, and humane
endpoints to avoid or minimize pain and distress during in vivo ocular irritation safety testing.
Methods to be reviewed by the Panel include a testing strategy using in vitro test methods to assess
the eye irritation potential of antimicrobial cleaning products and the validation status of four
test methods for identifying moderate and mild irritants, and products that do not require labeling
for eye hazards. The panel will also consider the validation status of the in vivo low volume eye
test. The Panel meeting will take place May 19-21, 2009, at the CPSC Headquarters, Bethesda Towers
Building, 4330 East West Highway, Bethesda, MD, The meeting is open to the public.
Additional information about the Panel meeting and review materials are available
on the NICEATM-ICCVAM website.
If you wish to attend the meeting, please register by May 15, 2009.
Link to online registration form
New Page Summarizing Test Method Evaluation Activities Now Available on NICEATM-ICCVAM Website
NICEATM has added a new page to its website that provides a current summary of the status of
ongoing and completed NICEATM-ICCVAM alternative test method evaluation projects, as well as updates
on collaborative projects with other validation organizations.
The page provides a graphic representation of the progress towards evaluation and acceptance
milestones. Links from this list lead to tables that provide more details for each project
milestone, including peer review reports, other publications, and national and international
regulatory acceptance consideration and decisions. The tables include links to the relevant
documents or pages on the NICEATM-ICCVAM website. This page should be a useful resource for NICEATM
and ICCVAM stakeholders seeking readily accessible information on the current status of specific
projects.
View the new webpage on the
NICEATM-ICCVAM website
View a similar page summarizing the status
of projects that have led to U.S. regulatory acceptance
Progress of Agency Responses on In Vitro Pyrogenicity Test Method Recommendations
NICEATM, on behalf of ICCVAM, forwarded the ICCVAM Test Method Evaluation Report: Validation
Status of Five In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity of
Pharmaceuticals and Other Products (NIH Publication Number 08-6392) to U.S. Federal agencies in
November 2008 for regulatory consideration. The report includes ICCVAM recommendations regarding the
usefulness and limitations of the five test methods based on their current validation status. ICCVAM
recommended that these and other in vitro alternative test methods should be considered prior to
conducting in vivo pyrogenicity testing, and should be used where determined appropriate for
specific testing situations.
View agency responses received to date
Progress on Validation Studies of In Vitro Methods for the Endocrine Disruptor Screening
Program
A NICEATM-sponsored multi-phased international validation study of the LUMI-CELL®
test method is in progress in collaboration with ECVAM and JaCVAM. The LUMI-CELL assay is an in
vitro test method that measures whether chemicals interact with estrogen receptors as agonists or
antagonists. The first and second phases of the validation study involving laboratory qualification
and protocol optimization have been completed. Phase III of the study is currently underway and
involves testing 41 additional ICCVAM-recommended reference substances at the three participating
laboratories (Xenobiotic Detection Systems, Inc. [Durham, NC], Hiyoshi Corporation [Japan], and
ECVAM [Italy]). This phase will evaluate the interlaboratory reproducibility of the optimized test
method protocols and provide expanded information on test method accuracy for a wide range of
chemical substances with a wide range of biological activity.
View more information about the LUMI-CELL® validation study
NICEATM-ICCVAM Presentations at the 2009 Society of Toxicology Meeting
NICEATM staff and
ICCVAM members presented four posters at the 48th Annual Meeting of the Society of Toxicology (SOT) in
Baltimore, MD. The poster presentations described ICCVAM recommended performance standards for the
LLNA, ICCVAM test method recommendations for the reduced LLNA and an updated LLNA test method
protocol, establishment of a laboratory historical databases for the international validation study
of the LUMI-CELL® test method, and the NICEATM-ICCVAM International Scientific Workshop on Acute
Chemical Safety Testing held in February 2008.
View posters and abstracts presented by NICEATM and ICCVAM at SOT 2009
Questions about NICEATM and ICCVAM activities can be directed to Dr. William S. Stokes, Director, NICEATM: phone 919-541-2384; fax 919-541-0947.
|
