Sauers1, L., Acuff1, K., Marsman1, D., Vedula2, U., Cuellar2, N., Curren3, R., Harbell3, J., Quinn4, P. 1The Proctor & Gamble Co., Cincinnati, Ohio, USA; 2S.C. Johnson, Racine, Wisconsin, USA; 3Institute for In Vitro Sciences, Gaithersburg, Maryland, USA; 4The Accord Group, Washington, DC, USA.

This study by scientists at Proctor & Gamble, S.C. Johnson, the Institute for In Vitro Sciences (IIVS) and The Accord Group, in conjunction with the US EPA, documented how MatTek’s EpiDerm in vitro human skin tissue equivalent and EpiOcular in vitro human corneal tissue equivalent can be used to assess the dermal and eye irritation of antimicrobial cleaning products, defined specific formulation types to be included in the ICCVAM evaluation of these assays, and provided all animal and non-animal data necessary to demonstrate the predictability of these assays to determine appropriate cautionary labeling. In the United States, antimicrobial cleaning products are registered as pesticides with the US Environmental Protection Agency (EPA). To support registration, an assessment of dermal and eye irritation must be completed. Normally required for such assessments are data from Draize Eye Irritation Test and the Draize Skin Irritation Test. For antimicrobial cleaning products, much research has been done to develop non-animal alternatives to these tests, among them MatTek Corp.’s EpiDerm and EpiOcular human tissue equivalents, and today these alternatives are routinely used by many to make safety and labeling decisions. However, because these tests have not undergone formal validation, there are barriers to their acceptance by the EPA. Although the database is sufficient to support use of these alternatives for antimicrobial cleaning products, there are data gaps for some materials outside this specific category, which inhibits validation for all formulations. Therefore the companies that manufacture antimicrobial cleaning products, including The Proctor & Gamble Co. and S.C. Johnson, have embarked on a novel, modular program with the US EPA to obtain acceptance of alternative methods specifically for this limited category of products – antimicrobial cleaning products. These companies have come together to define specific formulation types that are to be included in this evaluation and to provide all animal and non-animal data necessary to demonstrate the predictability of these assays for the purpose of determining appropriate cautionary labeling. This information will be assembled and submitted for a technical review by an expert panel organized by ICCVAM. A favorable review by this panel would lead to new EPA guidelines, allowing the use of these alternative, non-animal testing approaches for these specific formulation types.


Anti-microbial, Anti-microbial cleaning product, Antimicrobial, Antimicrobial cleaning product, Cutaneous irritancy, Cutaneous irritation, Dermal and eye irritation, Dermal irritancy, Dermal irritation, Draize Eye Irritation test, Draize Skin Irritation test, Environmental Protection Agency (EPA), EpiDerm assay, EpiOcular assay, In vitro testing, Ocular Irritation, Skin irritancy, Skin irritation

Request a copy of this paper, click here.