National Toxicology Program

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

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

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