Dermal tolerance and phototoxicity studies of sertaconazole.

The local dermal tolerance of 7-chloro-3-[1-(2,4-dichlorophenyl)-2-(1H- imidazol-1-yl)ethoxy-methyl]benzo[b] thiophene (sertaconazole, FI 7045, CAS 99592-32-2) was evaluated in hairless rats and albino rabbits. Test substance was applied in 2% powder (0.5 g), gel (0.5 ml) and solution (0.5 ml) formulations to rats (this is the concentration intended for the pharmaceutical preparation) and in 6% cream (0.5 ml) to rabbits (this concentration was used to estimate an overdose maximal effect). After 3- and 24-h exposure of the test substance to animals, they were observed for erythema and oedema. Sertaconazole may be considered as non irritant, since its primary irritation index was less than 0.5 in all the tests. A phototoxicity study was also carried out on guinea pigs with 1 ml 2% cream per animal, compared with psoralene as a positive control. Sertaconazole did not present any risk, since the phototoxicity level reached was null, with 2 being the minimum value considered as having toxic significance.