Monograph 029 – Skin Sensitisation Testing for the Purpose of Hazard Indentification and Risk Assessment

Abstract

Mono 029 : Skin Sensitisation Testing for the Purpose of Hazard Indentification and Risk Assessment | September 2000

The first step in any toxicological evaluation is the accurate identification of hazard. However, for an effective assessment of risk, some knowledge of relative potency is necessary. This certainly applies to contact allergy where there is evidence that the relative skin sensitising potency of chemicals may vary by many orders of magnitude. In this monograph, skin sensitisation test methods are considered in the context of their ability to provide estimates of relative potency and to contribute to the risk assessment/risk management process. The application of guinea pig tests (the guinea pig maximisation test, the occluded patch test and the open epicutaneous test) a mouse test (the local lymph node assay) and human sensitisation testing, is considered. Recommendations are made for the use of relevant skin sensitisation test methods for the purposes of determining relative potency and the threshold dose necessary for the induction of skin sensitisation and for risk assessment. A Technical Report (ECETOC Technical Report No. 78, Skin Sensitisation Testing: Methodological Considerations) was recently published which focussed exclusively on a review of relevant skin sensitisation test methods. For ease of reference this has been reproduced in full as the first part of the current monograph.