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ICCVAM Biennial Report 2016-2017

Biennial Progress Report 2016-2017 Interagency Coordinating Committee on the Validation of Alternative Methods

Ocular and Dermal Irritation Testing

Chemicals and substances such as personal care products, cleaning supplies, and pesticides are tested to determine if they present eye and skin injury hazards and to classify them for appropriate labeling and packaging. Ocular irritation testing assesses the potential for substances to injure eyes, and dermal irritation testing assess the potential for substances to injure skin. Nearly all of this testing has been conducted using rabbit tests; evaluation of alternatives to these tests that replace, reduce, or refine animal use is a high priority for NICEATM and ICCVAM.

ICCVAM/NIEHS: Validation Study of the OptiSafe Test Method

OptiSafe is an in vitro test method in which a test substance is applied to a semipermeable membrane. Damage to macromolecules in the membrane is measured to assess the test substance’s potential to cause eye irritation.

NICEATM reviewed a validation study conducted by the OptiSafe test method developer, Lebrun Labs, and concluded that the OptiSafe method compared favorably to other in vitro ocular toxicity testing methods. NICEATM is currently coordinating a validation study of the OptiSafe test method to demonstrate the reliability of the method among Lebrun Labs and two naïve laboratories. Members of the ICCVAM Ocular and Dermal Irritation Workgroup comprise the validation management team for the study, and the study received support from an NIEHS Small Business Innovation Research grant. Testing was completed in late 2017 and data analyses and an associated report will be submitted for publication in 2018.

ICCVAM/NIEHS: Defined Approaches for Eye Irritation Testing of Agrochemical Formulations

NICEATM and the ICCVAM Ocular and Dermal Irritation Workgroup are collaborating with CropLife America to develop defined approaches for assessing eye irritation potential of agrochemical formulations. CropLife America provided in vivo eye irritation test data for over 200 products, along with data from the same substances from one or more in vitro assays. NICEATM evaluated the available data and determined that some of the assays represented in the data set appear promising for building a defined approach for eye irritation testing. However, prospective in vitro testing would be needed to fill data gaps before a definitive approach could be identified. This testing will begin in early 2018 and will be coordinated by a validation management team comprised of ICCVAM Ocular and Dermal Irritation Workgroup members, NICEATM staff, and representatives from industry and animal welfare organizations.

Supplies for the OptiSafe test method