Division 5.2.5 Eye irritation

The results of the study shall provide the potential of eye irritancy of the active substance including, where relevant, the potential reversibility of the effects observed.

Before undertaking in vivo studies for eye corrosion/irritation of the active substance, a weight-of-evidence analysis shall be performed on the existing relevant data. Where available data are considered insufficient, further data may be developed through application of sequential testing.

The testing strategy shall follow a tiered approach:

1. (1)

   the use of an in vitro dermal irritation/corrosion test to predict eye irritation/corrosion;

2. (2)

   the performance of a validated or accepted in vitro eye irritation study to identify severe eye irritants/corrosives (such as Bovine Corneal Opacity and Permeability (BCOP) assay, Isolated Chicken Eye (ICE) assay, Isolated Rabbit Eye (IRE) assay, Hen's Egg Test - Chorio-Allantoic Membrane assay (HET-CAM)), and where negative results are obtained, the assessment of eye irritation using an in vitro test method for identification of non-irritants or irritants, and where not available;

3. (3)

   an initial in vivo eye irritation study using one animal, and where no adverse effects are noted;

4. (4)

   confirmatory testing using one or two additional animals.