Skin absorption from patch test systems

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Abstract
The development of topical drug products requires testing for skin toxicology reactions. A variety of patch test systems are available with which chemicals are applied to skin. The purpose of this study was to determine the skin absorption of paraphenylenediamine (PPDA) from a variety of such systems. (14C)‐PPDA (1% pet., USP) was placed in a variety of patch lest systems at a concentration normalized to equal surface area (2 mg/mm2. Skin absorption was determined in the guinea pig by urinary excretion of 14C. There was a six‐fold difference in the range of skin absorption (pTeflon Control Patch (29.8 ± 9.0)>Large Small Finn Chamber with paper disc insert (34.1 ± 19.8)>Small Finn Chamber (29.8 ± 9.0)> Large Finn Chamber (23.1 ± 7.3)> AL‐Test Chamber (8.0 ± 0.8). Thus, the choice of patch system could produce a false negative error if the system inhibits skin absorption, with a subsequent skin toxicology reaction.

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