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Micronucleus test of mofezolac (N-22)
1Drug Safety Laboratory, Taiho Pharmaceutical Co., Ltd., Tokushima, Japan.
The Journal of Toxicological Sciences
|June 1, 1990
Summary
Mofezolac (N-22) was evaluated for in vivo mutagenicity using a micronucleus test in male mice. The study found no significant differences in micronucleated erythrocytes, indicating N-22 is not mutagenic in vivo.
Area of Science:
- Toxicology
- Genetics
- Pharmacology
Background:
- Assessing the in vivo mutagenicity of pharmaceutical compounds is crucial for drug safety.
- Mofezolac (N-22) is an anti-inflammatory drug requiring mutagenicity evaluation.
- The micronucleus test is a standard assay for detecting genotoxicity.
Purpose of the Study:
- To evaluate the in vivo mutagenicity of mofezolac (N-22).
- To determine if N-22 induces genetic damage in mammalian cells.
Main Methods:
- A micronucleus test was performed on BDF1 male mice.
- Mofezolac (N-22) was administered orally at doses of 75, 150, 300, and 600 mg/kg.
- Polychromatic erythrocytes were analyzed for micronuclei formation 24 hours post-administration.
Main Results:
- The frequency of micronucleated polychromatic erythrocytes in N-22 treated groups ranged from 0.07% to 0.08%.
- These frequencies were not significantly different from the vehicle control group (0.13%).
Conclusions:
- Mofezolac (N-22) does not exhibit in vivo mutagenic properties.
- The study supports the safety profile of N-22 regarding genotoxicity.