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.
D000287:Administration, Topical; D000818:Animals; D003231:Conjunctivitis / Q000139:chemically induced; D006118:Griseofulvin / Q000633:toxicity; D006168:Guinea Pigs; D007093:Imidazoles / Q000008:administration & dosage / Q000633:toxicity*; D008825:Miconazole / Q000633:toxicity; D009092:Mucous Membrane / Q000187:drug effects*; D009761:Nystatin / Q000633:toxicity; D010787:Photosensitivity Disorders / Q000139:chemically induced; D011817:Rabbits; D012867:Skin / Q000187:drug effects*
D007093:Imidazoles; D009761:Nystatin; D006118:Griseofulvin; D008825:Miconazole; C033486:fenticonazole