IN VITRO APPROACHES FOR PREDICTING IRRITATION POTENTIAL OF TOPICAL EXPOSURES TO THE SKIN AND EYES.

Outline: Focus on topical exposure toxicity measures …Skin ……Corrosion ……Irritation –Chemicals ……Mildness –Formulations …Eye ……Physiology and modes of action –eye irritation ……Human Reconstructed Tissues ………Ingredients ………Mild formulation assessment …BCOP ……Moderate formulation assessment histology Conclusions: Skin Irritation/Corrosion …Validated methods are in place for testing chemicals for corrosion and irritation (EU). …Methods for determining mildness of formulations have not been through formal validation but have over a decade of use by industry. Eye Irritation …Formal validation is limited to severe/corrosive (positive only) …Formal validation study(s) for prediction of chemical irritation will eventually be conducted in Europe. …Corporate programs for evaluating formulations for irritation and mildness are a routine part of pre-clinical product development