An interlaboratory evaluation of the Buehler test for the identification and classification of skin sensitizers.

Abstract

The correct identification of potential skin sensitizers is an essential first step in enabling a proper risk assessment to be made and to permit the implementation of appropriate risk management practices designed to avoid the induction of sensitization. Consequently, regulatory guidelines around the world demand that new substances are evaluated to assess their skin sensitization potential. There are two guinea pig test methods which are generally recognised, the guinea pig maximisation test (GPMT) and the occluded patch test described by Buehler. In different countries, one procedure seems to be more prevalent and acceptable to regulatory authorities than the other. Notably, in the European Union, the latest revision of the Annex V (Directive 92/32/EC) Test Method for skin sensitization asks that justification should be given in the situation where the notifier does not use the GPMT, which is the preferred method. Thus in this paper, the validity of the Buehler protocol in the context of European legislation is critically examined. Results from two laboratories are collated, showing that the method can identify significant contact allergens, particularly those which would be registered formally as such according to European legislation. It is demonstrated that minor methodological variations can be tolerated without compromising test sensitivity, but it is recommended that suitable positive control testing is the best way to ensure proper test conduct.