Genotoxicity assessment of Elaeagnus angustifolia L. fruit extract (senjed) nanocapsule by in vitro and in vivo methods

Background: Although initial studies on Elaeagnus Angustifolia L. Fruit Extract (Senjed) Nanocapsule showed its efficacy in osteoporosis in rat model as well as its significant role in elevating the serum calcium levels, there is no study on its possible genotixic potentials which is necessary for developing all nanopharmaceuticals. Objective: This study aimed to evaluate the genotoxicity of Senjed nanocapsule using Ames and Micronucleus tests as two necessary steps for developing it as a new nanopharmaceutical. Methods: Salmonella typhimurium TA100 and TA98 strains were used for Mutagenicity and antimutagenicity assays by counting the number of colonies in the sample plates, negative and positive control plates. Micronucleus (MN) test was performed in male and female rats after oral administration of 1000 µg/kg/day of senjed nanocapsule and lymphocyte separation from the spleen of animals. Results: Observations from Ames test didn't indicate any mutagenic effect for this nanocapsule, moreover the anti-mutagenicity of the extract in both strains of salmonella typhimurium (P < 0.001) showed a concentration dependent antimutagenic properties of this nanocapsule in the presence of sodium Azide but in vivo micronucleus test showed a significant increase in the number of MN, Nucleoplasmic Bridges (NPB) and Nuclear Bud formation (NBUD) compared to the control group in both genders (P < 0.001). Conclusion: Based of the possible clinical values of this future nanopharmaceutical, it seems necessary to continue its in vivo genotoxicity assessments in lower doses after revising the composition of nanocarriers and before starting any clinical evaluation.