Toxicologic evaluation of Dichrostachys glomerata extract: Subchronic study in rats and genotoxicity tests

•Subchronic toxicity and genotoxicity of Dichrostachys glomerata extract was investigated.•No adverse effects of D. glomerata extract were noted in rats at doses up to 2500mg/kg/day.•Dichrostachys glomerata extract was not genotoxic as evaluated by in vitro and in vivo studies.•The No Observed-Adverse-Effect Level (NOAEL) for D. glomerata extract was >2500mg/kg/day. In western Cameroon, edible fruits and seeds from the plant Dichrostachys glomerata are commonly used as spices. Extract from the fruit pods has been reported as a good natural source of antioxidants and may provide health benefits. The objective of the present study was to investigate potential adverse effects, if any, of D. glomerata fruit pod extract (Dyglomera™) in a subchronic toxicity study and in genotoxicity studies. In the toxicity study, Sprague Dawley rats (20/sex/group) were gavaged with D. glomerata extract at dose levels of 0, 100, 1000 and 2500mg/kg body weight (bw)/day for 90-days. Dyglomera™ administration did not result in mortality or show treatmentrelated changes in clinical signs of toxicity, body weights, body weight gain or feed consumption. Similarly, no toxicologically significant treatment-related changes in hematological, clinical chemistry, urine analysis parameters, and organ weights were noted. Macroscopic and microscopic examinations did not reveal treatment-related abnormalities. Mutagenic and clastogenic potentials as evaluated by Ames assay, in vitro and in vivo chromosomal aberration test and in vivo micronucleus test did not reveal any genotoxicity of the extract. The results of subchronic toxicity study supports the no-observed-adverse-effect level (NOAEL) for D. glomerata extract as 2500mg/kg bw/day, the highest dose tested.