Registration Dossier

Administrative data

Description of key information

Skin sensitisation (HRIPT, 10% in DEP): Negative

Phototoxicity (humans): Negative

Additional information

One study in humans has been conducted to assess sensitisation and another to assess the potential for phototoxicity.

The potential for the substance to cause skin sensitisation was evaluated in a human repeated insult patch test (HRIPT) (TKL Research, 2002). In this study, 107 volunteer subjects underwent 9 induction applications of the test substance [10% in diethyl phthalate (DEP), 0.2 mL applied, 2 cm x 2cm patch, occluded] followed by a challenge test (10% in DEP, 0.2 mL applied, 2 cm x 2 cm patch, occluded). No positive responses were observed in any of the subjects as evaluated 48 and 72 hours after challenge. Based on the results, there was no evidence of sensitization to the substance when applied at 10.0% in DEP.

In a phototoxicity study completed in 21 healthy volunteers, the substance showed no evidence of phototoxicity (TKL Research, 2004). No adverse events were reported and there was no evidence of irritation (i.e., application of the test substance in the absence of irradiation) and no difference from control skin sites following irradiation.