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RESULTS OF A TWO LABORATORY REPRODUCIBILITY STUDY USING A HARMONIZED BOVINE CORNEAL OPACITY AND PERMEABILITY (BCOP) PROTOCOL
Published: October 5th, 2009
by Cater, K; Cerven, D; Curren, R; Donovan, A; Wilt, N; Raabe, H
SUMMARY
The Bovine Corneal Opacity and Permeability assay (BCOP), an internationally recognized alternative to the Draize eye irritation test, uses excised bovine corneas to predict ocular irritation. Originally developed by Gautheron (1992) and utilizing the irritation class prediction established by Sina (1994), BCOP has been used independently at MB Research and at the Institute for in Vitro Sciences (IIVS) for over fifteen years for product development, worker safety, and safety claims substantiation. The assay is currently under regulatory review by EPA, ECVAM and ICCVAM, and has recently been endorsed for prediction and labeling of severe/corrosive eye irritants. Since MB Research and IIVS have extensive experience performing the BCOP assay utilizing a variety of specific protocols to discriminate among mild and moderate,
as well as severe/corrosive eye irritants, they agreed to develop and evaluate the reproducibility of a standard harmonized protocol for regulatory labeling. Nine blind-coded chemicals, primarily comprised of surfactant dilutions, as well as imidazole and pyridine, were tested in three independent GLP-compliant trials using exactly the same protocol. Intra-laboratory and inter-laboratory reproducibility evaluations showed that both laboratories typically obtained the same irritation class predictions. The resulting In Vitro Scores were compared to Draize MMAS results (ECETOC, 1998). Some of the surfactant dilutions (sodium dodecyl sulfate, cetyl pyridinium bromide) were found to be under-predicted using the standard
BCOP protocol for liquid test chemicals.
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