Mutagenicity tests on propiverine hydrochloride
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1Drug Safety Laboratory, Taiho Pharmaceutical Co., Ltd. Tokusima, Japan.
Abstract:
1. The reverse mutation test was carried out on propiverine hydrochloride (P-4) at dose range of 5-500 micrograms/plate use Salmonella typhimurium strains, TA100, TA98, TA1535 and TA1537, and Escherichia coli strain WP2uvrA. As compared with solvent-treated control, no significant increases were observed in the number of revertant colonies in all tester strains in both systems with and without mammalian metabolic activation (S9 Mix). 2. The chromosomal aberration test was also carried out on P-4 using cultured Chinese hamster lung cells (CHL). The cells were treated with P-4 at the doses of 5, 10, 20 and 40 microM without S9 Mix and at 62.5, 125, 250 and 500 microM with S9 Mix. No significant differences were found in the incidence of structural- and numeral-aberrations of chromosomes in both systems with and without S9 Mix. 3. These results indicate that P-4 has no mutagenic activity.