Safety and toxicologic evaluation of Edible Pongamia Oil: A novel food ingredient

Abstract

Edible Pongamia Oil (EPO) was evaluated in an acute oral toxicity study, GLP 14-Day and 90-Day repeated dose isocaloric dietary toxicity studies in rats, and in vitro Bacterial Reverse Mutation, and in vivo Mammalian Bone Marrow Chromosome Aberration genotoxicity studies for potential use as a food ingredient. In a non-GLP acute study, an LD50 > 5000 mg/kg was determined. Subacute 14-day repeated dose dietary administration of 0, 5, 10 and 15% oil revealed no adverse changes in clinical pathology, liver histology, body weight or weight gain, food consumption or food efficiency. In a 90-day dietary study fed 0, 2.5, 5.0, 7.5 and 10.0%, no mortalities, clinical or ophthalmologic signs, body weight, body weight gain, food consumption, food efficiency or Functional Observational Battery/Motor Activity changes occurred with EPO consumption, nor were there any adverse changes in hematology, clinical chemistry, coagulation, urinalysis, or thyroid hormone values. There were no adverse macroscopic, estrus cycle, histopathologic or spermatogenesis findings, or absolute or relative organ weight changes related to administration of EPO. The No-Adverse-Effect-Level (NOAEL) was 10% in the diet, the highest dose tested, equivalent to 5163 (male) and 6469 (female) mg/kg/day in rats. No mutagenic or clastogenic genotoxic potential was reported.