Division 7.1.5 Eye irritation

The results of the study shall provide the potential for eye irritation of the plant protection product, including the potential reversibility of the effects observed.

Before undertaking in vivo studies for eye corrosion/irritation of the plant protection product, 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 BCOP, ICE, IRE, HET-CAM), and where negative results are obtained;

3. (3)

   the assessment of eye irritation using an available, in vitro test method validated for plant protection products for identification of non-irritants or irritants, and when not available;

4. (4)

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

5. (5)

   confirmatory testing using one or two additional animals.