Intercomparisons and development of reference materials for short-term mutagenicity testing

Abstract

Every new product to be put on the market must be checked by a range of testing procedures so as to assess its toxicity (directive 67/548/EEC). Results from the prescribed reverse mutation assay (Ames test) are part of the consideration of whether the introduction of the product into trade is allowed. Using the above test, European testing laboratories achieved different results for the same substances, false negative and false positive results being obtained. The Community Bureau of Reference (BCR) was requested to undertake a project on short-term mutagenicity testing in order to harmonize results at the European level. The results obtained by a first intercomparison using four direct mutagens showed that further work in this field is necessary. Before starting a second intercomparison using two indirect mutagens, a preliminary study was initiated in order to examine the influence of several important parameters. The aim of this project is to certify highly purified 2-aminoanthracene and benzo(a)pyrene for their mutagenic activity.