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Evaluation of the reproductive toxicity of gallium nitrate in mice
M T Colomina1, J M Llobet, J J Sirvent
1Laboratory of Toxicology and Biochemistry, School of Medicine, Rovira i Virgili, University, Reus, Spain.
Abstract:
Reproduction studies were performed with gallium nitrate, an antihypercalcaemic drug that is also used as a chemotherapeutic agent for the treatment of certain malignancies. Male mice were injected subcutaneously with gallium nitrate at doses of 0 (controls), 24, 48 and 96 mg/kg/day every other day for 14 days before mating with untreated females. Fertility and reproductive performance in the gallium nitrate-treated groups did not differ significantly from controls. No significant changes were observed in the relative testes and epididymis weights. Sperm counts in the gallium nitrate-dosed groups were comparable with those in the control group, whereas the percentage of motile cells was similar between treated and untreated animals. Histopathological examination of the testes and epididymis did not reveal any changes at any dose of gallium nitrate. The no-observed-adverse effect level was 96 mg/kg body weight. This dose is about 30 times higher than the current doses of gallium nitrate administered to humans.
Insights
Gallium nitrate, used for hypercalcemia and cancer, did not affect male mouse reproduction. High doses showed no adverse effects on fertility, sperm, or reproductive organs.
Area of Science:
- Toxicology
- Reproductive Toxicology
- Pharmacology
Background:
- Gallium nitrate is an antihypercalcemic drug and chemotherapeutic agent.
- Its effects on male reproductive function are not well-established.
Purpose of the Study:
- To evaluate the effects of gallium nitrate on male reproductive parameters in mice.
- To determine the no-observed-adverse-effect level (NOAEL) for reproductive toxicity.
Main Methods:
- Male mice were administered gallium nitrate subcutaneously every other day for 14 days prior to mating.
- Doses ranged from 0 (control) to 96 mg/kg/day.
- Fertility, reproductive performance, organ weights, sperm analysis, and histopathology were assessed.
Main Results:
- No significant differences were observed in fertility, reproductive performance, or relative testes and epididymis weights between treated and control groups.
- Sperm counts and motility remained comparable across all groups.
- Histopathological examination revealed no adverse changes in testes or epididymis at any dose.
Conclusions:
- Gallium nitrate did not adversely affect male reproductive parameters in mice at doses up to 96 mg/kg/day.
- The NOAEL for reproductive toxicity was determined to be 96 mg/kg/day, which is approximately 30 times higher than human therapeutic doses.