ABSTRACT
Times are changing and increasingly regulatory positions in relation to toxicology must be scientifically sound and fully explained. Contact hypersensitivity has probably generated more discussion, regarding both the validity of test protocols and the interpretation of test results for classification purposes, than any other single toxicological endpoint in regulatory programmes for industrial chemicals. The overriding need of the regulatory authority is to be convinced that the test performed on a particular chemical has been done stringently, so that there is a minimal likelihood that a falsenegative or, indeed, a false-positive result has been obtained. Against this background, the present chapter aims to address some of the issues that engage regulatory toxicologists when they assess reports of contact hypersensitivity studies conducted for these programmes. It is hoped that it will be of value to those who need to submit contact hypersensitivity tests for regulatory appraisal.
The Guidance Available
