Objective of the study

The test will provide the potential of skin irritancy of the active ingredient and the formulated product, including the potential reversibility of the effects observed.

Circumstances under which the study is recommended to be required

The skin irritation study should always be conducted.

The study is normally not required if the pesticide is a gas or highly volatile liquid, or if it is corrosive to skin or has a pH of < 2 or > 11.5

Test organism

The study in vivo is normally conducted with the rabbit. Alternatively, studies with skin disks of the rat or human skin models are used.

Test substance

• Technical grade active ingredient
• Formulated product

Typical endpoints of the study

Animal irritant responses can be quite variable, but may include values/categories for erythema/eschar formation, oedema formation, inflammation, as well as reversibility of skin lesions.

Test guidelines

The following test guidelines may be used for determination dermal irritation:

• OECD Guidelines for the Testing of Chemicals. Test No. 404: Acute dermal irritation/corrosion
   
• OECD Guidelines for the Testing of Chemicals. Test No. 439: In vitro skin irritation – Reconstructed human epidermis test method
   
• US EPA Health Effects Test Guidelines. OPPTS 870.2500: Acute dermal irritation
   
• EC Testing Method B.4. Acute toxicity: dermal irritation/corrosion. Council Regulation (EC) No 440/2008 – Part B.
   
• EC Testing Method B.46. In vitro skin irritation: reconstructed human epidermis model test. Council Regulation (EC) No 440/2008 – Part B.