Evaluation of skin sensitization response of dialkyl (C6-C13) phthalate esters.

Isolated case reports suggest that dermal contact with some phthalate esters may result in skin sensitization. This issue was investigated in guinea pig sensitization tests, but the results were inconclusive. Consequently, 7 dialkyl phthalate esters, (diisohexyl, diisoheptyl, di(2-ethylhexyl), diisononyl, diisodecyl, diundecyl and ditridecyl phthalates), ranging in carbon number from C6 to C13, were tested in a 104-person panel human repeated insult patch test (HRIPT) using the modified Draize procedure. Test concentrations of 100% were selected for the induction and challenge phases of the HRIPT based upon a 24-h occluded irritation test on 15 panelists. Under the conditions of this HRIPT, no evidence of dermal irritation or sensitization for any of the 7 phthalate esters was observed in the 104-person panel. These HRIPT data provide evidence for the lack of experimental skin sensitization potential for the phthalate esters tested.