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Abstract:
N-2-(p-Chlorophenoxy)-isobutyryl-N'-morpholinomethylurea (plafibride, ITA 104) was tested for mutagenic activity of the Ames Salmonella/mammalian microsome test. Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 were employed. Two of these strains (TA 1535 and TA 100) are sensitive to base pair substitution mutagens, whilst the remaining three are sensitive to frame-shift mutagens. No evidence of mutagenic activity of plafibride was observed either in the presence or absence of a liver microsomal supplement.
Insights
Plafibride (ITA 104) was evaluated for its potential to cause genetic mutations using the Ames test. This study found no evidence of mutagenic activity for plafibride in bacterial strains, with or without liver microsome activation.
Area of Science:
- Pharmacology
- Toxicology
- Genetics
Background:
- Plafibride (ITA 104) is a compound requiring assessment for potential genotoxicity.
- Mutagenicity testing is crucial for evaluating drug safety and regulatory approval.
Purpose of the Study:
- To determine the mutagenic potential of plafibride (ITA 104).
- To assess plafibride's mutagenicity using the Ames Salmonella/mammalian microsome test.
Main Methods:
- Utilized Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100.
- Tested for mutagenicity in both the presence and absence of a liver microsomal supplement.
- Employed strains sensitive to base pair substitution and frame-shift mutagens.
Main Results:
- No mutagenic activity was detected for plafibride across all tested Salmonella strains.
- The results remained consistent regardless of the addition of a liver microsomal supplement.
Conclusions:
- Plafibride (ITA 104) does not exhibit mutagenic properties in the Ames test.
- The compound is considered non-mutagenic under the conditions tested, suggesting a favorable genotoxic profile.