The rodent dominant lethal assay: a proposed format for data presentation that alerts to pseudo-dominant lethal effects

Abstract

The rodent dominant lethal (DL) germ cell mutagenicity assay is the primary test for possible human germ cell mutagens. As such, it occupies a critical regulatory position. DL assay data are often difficult to assess because of the quantity of data involved, and because several related assay parameters require to be considered simultaneously. To reduce this difficulty a schematic method of data presentation is proposed and illustrated. This method enables the most pertinent assay data and parameters to be viewed and considered simultaneously. Using this format of data presentation, existing DL studies on cyclophosphamide, methylnitrosourea, diethylhexylphthalate, divinyl sulphone, methyl methanesulphonate, 6-mercaptopurine and ethylenethiourea are re-analysed.