Genotoxicity testing of a Salacia oblonga extract.
Salacia oblonga has been used for thousands of years in Ayurvedic medicine for the oral treatment of diabetes. The root extract has been shown to inhibit the activity of intestinal alpha-glucosidases, therefore S. oblonga holds potential as a natural method to mitigate the blood glucose response for people with diabetes. As part of a safety evaluation of novel ingredients for use in blood glucose control, the potential genotoxicity of a S. oblonga root extract (SOE) was evaluated using the standard battery of tests (reverse mutation assay; chromosomal aberrations assay; mouse micronucleus assay) recommended by US Food and Drug Administration (FDA) for food ingredients. SOE was determined not to be genotoxic under the conditions of the reverse mutation assay and mouse micronucleus assay, and weakly positive for the chromosomal aberrations assay. A reproducible, although weak, positive chromosomal aberrations response in human lymphocytes is of concern and further toxicity research is recommended. Use of SOE is presently expected to be safe, as anticipated intake is small compared to the doses administered in the genotoxicity assays and may, after further toxicity research, may prove be a useful ingredient in foodstuffs.
Flammang
A M
AM
Ross Products Division Abbott Laboratories, 3300 Stelzer Road, 625 Cleveland Avenue, Columbus, OH 43215-1724, USA. ann.flammang@abbott.com
Erexson
G L
GL
Mecchi
M S
MS
Murli
H
H
D000818:Animals; D002869:Chromosome Aberrations / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004791:Enzyme Inhibitors / Q000633:toxicity*; D004926:Escherichia coli / Q000187:drug effects / Q000235:genetics / Q000378:metabolism; D065089:Glycoside Hydrolase Inhibitors; D006801:Humans; D008297:Male; D008515:Medicine, Ayurvedic; D051379:Mice; D008815:Mice, Inbred Strains; D048629:Micronuclei, Chromosome-Defective / Q000139:chemically induced; D009152:Mutagenicity Tests; D009153:Mutagens / Q000145:classification / Q000378:metabolism / Q000633:toxicity*; D010936:Plant Extracts / Q000145:classification / Q000378:metabolism / Q000633:toxicity*; D010946:Plants, Medicinal; D051381:Rats; D017207:Rats, Sprague-Dawley; D000091243:Ribosomal Protein S9; D012269:Ribosomal Proteins / Q000187:drug effects / Q000378:metabolism; D049918:Salacia / Q000737:chemistry*; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics / Q000378:metabolism
D004791:Enzyme Inhibitors; D065089:Glycoside Hydrolase Inhibitors; D009153:Mutagens; D010936:Plant Extracts; D000091243:Ribosomal Protein S9; D012269:Ribosomal Proteins