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[Reverse mutation test of trandolapril (RU44570) with bacteria]
F Aruga1, Y Nagasawa, R Tanaka
1Hashima Laboratory, Nihon Bioresearch Inc., Japan.
The Journal of Toxicological Sciences
|February 1, 1993
Summary
Trandolapril (RU44570) was tested for its potential to cause gene mutations in bacteria. The study found no evidence of mutagenicity for trandolapril under the tested conditions.
Area of Science:
- Pharmacology
- Toxicology
- Microbiology
Background:
- Trandolapril is an angiotensin-converting enzyme (ACE) inhibitor used to treat hypertension.
- Assessing the mutagenicity of pharmaceutical compounds is crucial for drug safety evaluations.
Purpose of the Study:
- To evaluate the mutagenic potential of trandolapril (RU44570) using bacterial reverse mutation tests.
- To determine if trandolapril induces gene mutations in bacterial strains, with and without metabolic activation.
Main Methods:
- Bacterial reverse mutation assay (Ames test) was performed using Salmonella typhimurium strains TA100, TA98, TA1535, TA1537, and Escherichia coli WP2uvrA.
- The preincubation method was employed, with and without metabolic activation (S9 mix).
- Bacterial cultures were exposed to trandolapril at various concentrations.
Main Results:
- The number of revertant colonies in all bacterial strains did not significantly increase compared to the solvent control, both in the absence and presence of metabolic activation.
- No dose-dependent increase in revertant colonies was observed across the tested concentrations of trandolapril.
- The results indicate that trandolapril did not induce gene mutations in the bacterial strains under the study conditions.
Conclusions:
- Trandolapril (RU44570) demonstrated no mutagenic activity in the bacterial reverse mutation test.
- The study concludes that trandolapril does not possess genotoxic potential based on these in vitro findings.