Division 3.3.1.2 Effects on the eyes and skin

Where available, direct evidence of absence of irritancy and/or sensitisation shall be provided from known human situations. This shall be supplemented by findings from validated animal tests for skin and eye irritation, and for sensitisation potential using the appropriate additive. Allergic potential — skin sensitisation potential shall also be assessed. Protocols for these studies should be in line with OECD Guidelines 404 (Dermal Irritation/Corrosion), 405 (Eye Irritation/Corrosion), 406 (Skin Sensitisation), 429 (Skin Sensitisation — local lymph-node assay).

If corrosive properties are known, either from published data or specific in vitro tests, then further in vivo tests shall not be performed.

Dermal toxicity must be considered, if the additive is toxic by inhalation. Studies must be in line with OECD Guideline 402 (Acute Dermal Toxicity).