抄録
The Bovine Corneal Opacity and Permeability Assay (BCP-P assay) has been accepted by the EU national coordinators at their 28th meeting as an alternative to the Draize rabbit eye irritation test and is used to classify a chemical as irritant (R41). The BCO-P assay may be routinely used for assessment of safety and as a test to classify and label chemicals as “severely irritating to the eyes”. This organotypic assay is considered acceptable by the national authorities where a positive result in respect to severe irritancy is obtained. In this case no further animal testing is necessary. Normally in the BCO-P assay the bovine eyes are collected as fresh as possible after slaughter from an abattoir. The corneas are isolated shortly and the tests are performed as soon as possible (no longer than 12 hours). In order to optimize the test conditions, we have performed some validation studies to estimate the differences of the test results between applying fresh bovine eyes and using eyes which are preserved in MEDIUM 199 Modified supplemented with Dextran. We have also compared the BCO-P results, in which the corneas from the animals in different ages were used. In the validation studies three positive control substances, 2-ethoxyethanol, imidazol (20%) and benzalkoniumchlorid, have been tested for various treatment times. The validation studies are useful for further optimizing the BCO-P test conditions and increasing the reliability of this method.
