Division 5.2.4 Skin irritation

The results of the study shall provide information on the potential for skin irritancy of the active substance including, where relevant, the potential reversibility of the effects observed.

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

The testing strategy shall follow a tiered approach:

1. (1)

   the assessment of dermal corrosivity using a validated in vitro test method;

2. (2)

   the assessment of dermal irritation using a validated in vitro test method (such as human reconstituted skin models);

3. (3)

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

4. (4)

   confirmatory testing using one or two additional animals.