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Oncogenicity study of macrodantin in Swiss mice
W H Butler1, T C Graham, M L Sutton
1British Industrial Biological Research Association, Carshalton, Surrey, UK.
Abstract:
A carcinogenicity study of nitrofurantoin formulated as Macrodantin was undertaken. The doses used were 0.0, 50.0, 100.0 and 200.0 mg/kg/day. Increased mortality was observed in male mice given 200 mg/kg/day. Chronic toxicity was observed in the kidneys of male mice: the normally occurring chronic nephropathy was somewhat increased in severity. The gonads of both male and female mice showed evidence of atrophy and degeneration. The ovaries showed an increased incidence of multilobular cysts but no evidence of neoplasia. A significantly higher incidence of malignant lymphoma in the top-dose males was offset by a non-significant difference in the opposite direction in females. Reasons are given for regarding this as a chance finding. The observations in this study indicate that the therapeutic uses of nitrofurantoin would not present a carcinogenic hazard to man.
Insights
This carcinogenicity study found nitrofurantoin (Macrodantin) did not pose a carcinogenic risk in mice. While some toxicity was observed, particularly in male mice, no evidence suggested a cancer hazard for therapeutic use.
Area of Science:
- Toxicology
- Pharmacology
- Oncology
Background:
- Nitrofurantoin is a widely used antibiotic.
- Assessing the long-term safety and potential carcinogenicity of pharmaceuticals is crucial.
Purpose of the Study:
- To evaluate the carcinogenic potential of nitrofurantoin (Macrodantin) in a long-term animal study.
Main Methods:
- Mice were administered nitrofurantoin at doses of 0.0, 50.0, 100.0, and 200.0 mg/kg/day.
- Mortality, chronic toxicity (kidney, gonads), and tumor incidence were monitored.
Main Results:
- Increased mortality and kidney toxicity were noted in male mice at the highest dose (200 mg/kg/day).
- Gonadal atrophy and degeneration were observed in both sexes.
- A higher incidence of malignant lymphoma in high-dose males was considered a chance finding.
Conclusions:
- Nitrofurantoin did not demonstrate clear carcinogenic activity in this study.
- The observed toxicities did not indicate a significant carcinogenic hazard for human therapeutic use.