Investigation to detect a possible sensitizing effect of Scheriproct or of the active ingredients contained therein has not been carried out. According to relevant data gained from spontaneous reports as well as contained in the literature, it is possible that not only individual ingredients of the formulation base but also the active ingredients themselves are responsible for the allergenic skin reactions which were observed only sporadically after the use of Scheriproct. There is, however, no risk of a sensitizing effect occurring other than in sporadic cases.
Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.