1,2-Benzisothiazolin-3-one (Proxel): irritant or allergen? A clinical study and literature review.

The isothiazolinone, 1,2-benzisothiazolin-3-one (Proxel), is a popular preservative, as well as a skin sensitizer and irritant. Patch test studies have been performed with different concentrations and vehicles. The current suggested patch test concentration is 0.1% BIT in petrolatum (pet). This article evaluates the effects of patch testing at this concentration and reviews the current literature. An irritancy patch test was performed on 56 controls, using BIT in concentrations of 0.002% and 0.05% in aqueous dipropylene glycol (Proxel GXL) and 0.1% in pet. 10 had positive readings at 4 days with 0.1% BIT in petrolatum, 9 of which were negative at retest. 0.1% BIT is, therefore, irritant and not a suitable concentration for patch testing. Literature review revealed 15 patch test studies, with varying testing techniques. Additional studies with adequate controls and experimental tests should be invaluable in furthering our insight into BIT sensitization and irritation.