Testing of Medicines for Their Mutagenic Potency. Proposition from a French Working Party

Abstract

At present, most mutagenicity tests are carried out in only a few very specialized laboratories and even for the tests most used, differences in the results obtained between laboratories are not infrequent. It is therefore too early to define a rigid list of tests to be carried out. Our group which is composed of both general toxicologists and specialists in mutagenesis propose the following points:

• criteria of validation and of liability for mutagenic test procedures should be established,

• a strategy in two steps, the first one for all new medicinal products to detect gene 1 mutations (one test), chromosomal mutations 1 (one test) and if possible primary DNA damage, the second one including additional tests for drugs found positive in the first step, for drugs related to known mutagens, for drugs showing specific signs in the other toxicological studies, or for drugs employed for certain welldefined uses,

• general rules for the conduct of studies should be laid down,

• information required for reports should be stated.