| Summary: | The available literature on the safety profile of tamoxifen in human patients and in experimental animals is mostly contradictory. The present study was therefore, designed to understand the safety profile of tamoxifen using Swiss albino mice. Swiss albino mice of age 13 weeks were orally administered tamoxifen (35 mg/kg/day) for 80 days. The breast, liver, and ovaries were used to evaluate the toxicity of tamoxifen in these organs using histopathology by H& E staining, the organ indices, estimation of liver enzymes, sex hormones, and antioxidant enzymes were compared with control mice group. The histopathological profiles indicated that breasts of the treated mice were not affected; however, it caused major damage to the liver, uterus, and ovaries. Tamoxifen also induced a moderate level of apoptosis by elevating the level of caspase-3 in the liver, uterus, and ovaries of the treated mice. The estrogen and progesterone levels were also significantly reduced. Tamoxifen induced hyper ovulation in treated mice group which has never been reported before. These data suggest that hepatotoxicity and hyper ovulation associated with tamoxifen could not be overruled and hence an alternate hormone disruptors other than tamoxifen should be investigated.
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