Irritation and toxicity studies with fenticonazole applied topically to the skin and mucous membranes.

Various tests were used in order to ascertain any irritating, sensitising or toxic potential of alpha-(2,4-dichlorophenyl)-beta,N-imidazolylethyl 4-phenylthiobenzyl ether nitrate (fenticonazole, Rec 15/1476) when applied to the skin or to mucous membranes in gel or cream formulation. When instilled into the conjunctival sac in rabbits fenticonazole led to a slight reddening of the mucosa in only one animal. The reddening appeared 1 h after treatment and disappeared within 24 h. Guinea pigs topically treated for 20 days with fenticonazole 2% gel or cream showed mild erythema which appeared 5 days after the beginning of the treatment and virtually disappeared at the end of the treatment. The treatment with fenticonazole 2% gel or cream did not induce sensitisation. Fenticonazole was not phototoxic or photosensitising when a 2% gel or cream formulation was applied topically to guinea pigs, at the dosage of 0.1 ml per animal.