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 antimicrobial cleaning products (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 submitted this BRD, In Vitro Approach for EPA Toxicity Labeling of Anti-Microbial Cleaning Products,
to NICEATM. The EPA and the ATWG 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 reviewed the BRD and requested additional data and information prior to compiling an
ICCVAM Summary Review Document and ICCVAM recommendations. These documents will be evaluated in May 2009
by an independent scientific peer review panel. The Panel will also review the validation status of the
in vivo low volume eye test, which is proposed as reference data to partially substantiate
the validity of the in vitro test methods used in the test strategy.
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
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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