Division Circumstances in which required

The acute dermal toxicity of the active substance shall be reported unless waiving is scientifically justified (for example where oral LD₅₀^f1 is greater than 2 000 mg/kg). Both local and systemic effects shall be investigated.

Findings of severe skin irritation (Grade 4 erythema or oedema) in the dermal study shall be used instead of performing a specific irritation study.