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The U.S. Environmental Protection Agency (EPA) has collaborated with the Alternative Testing Working Group (ATWG) to develop a nonanimal approach for
evaluating the eye irritation potential of AMCPs. The ATWG is comprised of seven consumer
product companies (Clorox, Colgate Palmolive, Dial, EcoLabs, Johnson Diversey, Procter & Gamble, and SC Johnson).
The Institute for In Vitro Sciences, Inc. (IIVS) coordinated the EPA-ATWG 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 has submitted this BRD, In Vitro Approach for EPA Toxicity Labeling of Anti-Microbial Cleaning Products,
to NICEATM. The EPA and the ATWG have requested that NICEATM and ICCVAM
use information within the BRD to conduct a technical review of the proposed approach to determine
whether ICCVAM could assure the EPA, with a reasonable degree of certainty, that the approach would be useful
for making labeling decisions for AMCPs that appropriately inform the user.
NICEATM and ICCVAM are conducting a preliminary evaluation of the submission for completeness and for adherence
with ICCVAM guidelines.
If they decide to move forward with an evaluation, NICEATM and ICCVAM will convene a peer review panel
to review the validation status of the proposed approach.
On behalf of ICCVAM, NICEATM has requested:
- Nominations of expert scientists to serve as members of a possible peer review panel
More information on submitting nominations
- Submission of relevant data and information on AMCPs or related substances obtained from
(1) human testing or experience including reports from accidental exposures, (2) rabbits
using the standard eye test or the low volume eye test, and (3) in vitro test
methods for assessing ocular irritation, such as the Bovine Corneal Opacity and Permeability
test, the Cytosensor Microphysiometer test, and the EpiOcular test, and data supporting
the accuracy and reproducibility of these methods
More information on submitting data
Submission of an In Vitro Test Method for Assessment of the Eye Irritation Potential of
Antimicrobial Cleaning Products
View Submission Letter from Dr. Rodger Curren, Institute for In Vitro Sciences, Inc. (IIVS)
to Dr. William Stokes, NICEATM [PDF]
Federal Register Notice
(Vol. 73, No. 66, page 18535-18536, April 4, 2008):
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
View Federal Register notice [PDF]
View comments submitted on Federal Register notice
Related Federal Register notice previously published
Federal Register Notice
(Vol. 70, No. 53, page 13512-13513, March 21, 2005):
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
View Federal Register notice
View comments submitted on Federal Register notice
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