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Morinda citrifolia L (noni) is an evergreen or small tree that grows in many tropical regions of the world. The use of the noni leaves has not been so studied however; there are reports of its pharmacological benefits. Aims: The objective of this investigation was to assess the genotoxicity, short-term, and subchronic oral toxicity of Morinda citrifolia L leaves aqueous extract. Methods: The genotoxicity of the M. citrifolia extract was investigated by measuring the frequency of micronuclei in mice bone marrow cells. The animals were treated with three doses of the extract (500, 1000, and 2000 mg/kg). For short-term toxicity, both sexes Wistar rats received 1000 mg/kg/day for 28 days. Animals were sacrificed for hematological and biochemical evaluation. For the subchronic study, Wistar rats were administered with three doses of M. citrifolia extract (100, 300, and 1000 mg/kg) by oral route for 90 days. Mortalities, clinical signs, body weight changes, food and water consumption, hematological and biochemical parameters, gross findings, organ weights, and histological examination were monitored during the study period. Results: Genotoxicity and short-term toxicity test resulted in absence of toxicity at doses between 500 and 2000 mg/kg. Significant differences were observed in hemoglobin, and differential leukocyte count after subchronic dosing of the extract. Histology evaluation did not reveal treatment-related abnormalities. Variations observed were within to normal range and reversible. Conclusions: In summary, 1000 mg/kg orally was the NOAEL for M. citrifolia extract for effects other than transient variations in some hematological parameters within normal range. [J Intercult Ethnopharmacol 2013; 2(1.000): 15-22

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The objective of this investigation was to assess the toxicological potential of nasal formulation of erythropoietin with low sialic acid content (Neuro EPO) after 28 days of intra-nasal dosing in rats besides to evaluate the immunogenicity and erythropoietic effect of the test substance. Healthy Wistar rats of both sexes were used for 28 days subacute toxicity and immunogenicity assays. Doses evaluated were 3450, 4830 and 6900 UI/kg/day. The toxicological endpoints examined included animal body weight, food consumption, hematological and biochemical patterns, antibodies determination, selected tissue weights and histopathological examination. Reversibility of toxic effects was evaluated at high dose 14 days after treatment period. Female B6D2F1 mice were used for evaluated erythropoietic effect of the nasal formulation. Hematological endpoints were examined every week during 28 days of intra-nasal dosing of 6900 UI/kg/day. Variations of hematological patterns were not observed after 28 days of intranasal dosing. A slight increase in glucose level of treated animals within the normal range was observed. This effect was not dose related and was reversible. Antibody formation was not observed in any of the test doses. Histopathological examination of organs and tissues did not reveal treatment induced changes. The administration of Neuro EPO in normocythaemic mice did not produce erythropoietic effect. These results suggest that Neuro EPO could be used as a neuroprotective agent, without significant systemic haematological side effects.