Toxicologic evaluation of Dichrostachys glomerata extract: subchronic study in rats and genotoxicity tests.
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 2500 mg/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 2500 mg/kg bw/day, the highest dose tested.
Gateway Health Alliances Inc., 4769 Mangels Blvd, Fairfield, CA 94534, USA.
Shil C
SC
Kothari
Anthem Biosciences Pvt. Ltd., #49, Canara Bank Road, Bommasandra Industrial Area, Phase I, Hosur Road, Bangalore 560099, Karnataka, India.
Prasad
P
Shivarudraiah
Anthem Biosciences Pvt. Ltd., #49, Canara Bank Road, Bommasandra Industrial Area, Phase I, Hosur Road, Bangalore 560099, Karnataka, India.
Suresh Babu
SB
Venkataramaiah
Anthem Biosciences Pvt. Ltd., #49, Canara Bank Road, Bommasandra Industrial Area, Phase I, Hosur Road, Bangalore 560099, Karnataka, India.
Swapna
S
Gavara
Anthem Biosciences Pvt. Ltd., #49, Canara Bank Road, Bommasandra Industrial Area, Phase I, Hosur Road, Bangalore 560099, Karnataka, India.
Shri Natrajan
SN
Arumugam
Soni and Associates Inc., 973 37th Place, Vero Beach, FL 32960, USA. Electronic address: msoni@soniassociates.net.
Madhu G
MG
Soni
D000818:Animals; D001835:Body Weight / Q000187:drug effects; D002163:Cameroon; D002869:Chromosome Aberrations; D004435:Eating / Q000187:drug effects; D007887:Fabaceae / Q000737:chemistry*; D005260:Female; D008297:Male; D015162:Micronucleus Tests; D009152:Mutagenicity Tests / Q000379:methods*; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D010936:Plant Extracts / Q000633:toxicity*; D017207:Rats, Sprague-Dawley; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D059550:Toxicity Tests, Subchronic / Q000379:methods*
D010936:Plant Extracts
Dichrostachys glomerata; Dietary supplement; Safety; Toxicity