[Mutagenicity tests on mequitazine (author's transl)]

Microbial backward mutation test, Ames Salmonella/microsome plate assay, on six bacterial strains (Salmonella typhimurium TA 98, 100, 1535, 1537, 1538 and E. coli WP 2uvrA) and micronucleus test in mice were carried out to detect mutagenic activity of mequitazine. Mequitazine caused no increases of revertants at doses from 1 to 1000 microgram/plate in every bacterial strains irrespective of metabolic activation. Similarly, mequitazine induced no significant increases of micronucleated polychromatic erythrocytes in mice over the control level at doses from 0.12 (clinical dose) to 48 mg/kg (approx. LD 50). From above results, we concluded that mequitazine has no mutagenic activity per se.