ANNEX

PART ACHEMICAL ACTIVE SUBSTANCES

SECTION 5Toxicological and metabolism studies

5.2.Acute toxicity

5.2.7.Phototoxicity

The study shall provide information on the potential of certain active substances to induce cytotoxicity in combination with light, for example active substances that are phototoxic in vivo after systemic exposure and distribution to the skin, as well as active substances that act as photoirritants after dermal application. A positive result shall be taken into account when considering potential human exposure.

Circumstances in which required

The in vitro study shall be required where the active substance absorbs electromagnetic radiation in the range 290-700 nm and is liable to reach the eyes or light-exposed areas of skin, either by direct contact or through systemic distribution.

If the Ultraviolet/visible molar extinction/absorption coefficient of the active substance is less than 10 L × mol–1 × cm–1, no toxicity testing is required.