Prevalidation of a novel 2-tiered approach to determine the skin sensitising capacity and potency of chemicals

Project team HU

Ing. Mieke Smits; Dr. Raymond Pieters; Dr. Cyrille Krul; Dr. Marc Teunis (Project Leader)


skin, sensitization, tiered testing, in-vitro, reconstituted skin models, keratinocytes


ZonMw (40-40100-94-9015) and The EU FP6 Integrated Programme Sens-it-iv (LSHB-CT-2005-018681)

Project summary

This project aims to (pre)validate a method to evaluate the potential of a chemical to induce allergic dermatitis (or skin sensitization). The potential of a chemical to induce allergic reactions of the skin is an important health issue. It can be relevant in the context of cosmetics ingredients or dyes for e.g. clothing.

The current method to asses this property of a substance is by exposing mice or Guinea Pigs to a chemical of interest. Because of a strong demand for alternative methods caused by ethical debate, new laws and legislation and cost aspects, a lot of effort has been put into the development of such a method. The test that is under current validation has been developed within a large consortium of research groups and industry. In this project, 6 different laboratories from 4 different countries are performing the validation study of the developed method. At the end of the project, the predictive value of the method, for a limited number of substances, should be known.

Furthermore, limitations, transferability and application domain, can be evaluated during and at the end of the project. Currently, the first phase of the project is concluded. Meaning: the standard operating procedures are completely in place, the chemical selection has been performed by an independent laboratory and the test is operational in all of the labs. The coming year, the participating labs will test the complete panel of 20 chemicals in the assay.

The partners in this projects are: Novozymes A/S, Denmark; BASF, Germany, Milan University, Italy; VU Medical Centre, The Netherlands; The Danish Food Institute, Denmark; RIVM, The Netherlands; TNO, The Netherlands


Innovative Testing in Life Sciences and Chemistry

Innovative Testing in Life Sciences and Chemistry

About the Research Group