Toxicological evaluation of pomegranate seed oil

• Published in: Food and chemical toxicology 2009-06, Vol.47 (6), p.1085-1092
• Main Authors: Meerts, I.A.T.M., Verspeek-Rip, C.M., Buskens, C.A.F., Keizer, H.G., Bassaganya-Riera, J., Jouni, Z.E., van Huygevoort, A.H.B.M., van Otterdijk, F.M., van de Waart, E.J.
• Format: Article
• Language: English
• Subjects: 28-day toxicity; Acute oral toxicity; acute toxicity; animal models; Animals; anti-inflammatory activity; Biological and medical sciences; Blood Cell Count; Cells, Cultured; Chemical mutagenesis; Chromosome Aberrations - drug effects; Diet; dietary exposure; Escherichia coli - genetics; fatty acid composition; Female; fruits (food); Humans; Liver Function Tests; Lymphocytes - drug effects; Male; Medical sciences; Mutagenicity; Mutagenicity Tests; Mutagens - toxicity; Organ Size - drug effects; Plant Oils - toxicity; Plant poisons toxicology; plant residues; Pomegranate seed oil; pomegranates; Punica granatum; Punicaceae - toxicity; Rats; Rats, Wistar; Salmonella typhimurium - genetics; seed oils; seeds; Seeds - toxicity; Sex Characteristics; Subcellular Fractions - drug effects; toxicity testing; Toxicology
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2009.01.031

In this manuscript, the toxicology and safety of pomegranate seed oil (PSO) was evaluated by in vitro (Ames, chromosomal aberration), and in vivo toxicity tests (acute toxicity and 28-day toxicity in Wistar rats). No mutagenicity of PSO was observed in the absence and presence of metabolic activation up to precipitating concentrations of 5000μg/plate (Ames test) or 333μg/ml (chromosome aberration test). The acute oral toxicity study revealed no significant findings at 2000mg PSO/kg body weight. In the 28-day dietary toxicity study PSO was dosed at concentrations of 0, 10,000, 50,000 and 150,000ppm, which resulted in a mean intake of 0–0, 825–847, 4269–4330 and 13,710–14,214mg PSO/kg body weight per day in males–females, respectively. At 150,000ppm dietary exposure to PSO, a much higher dose than the level of PSO that elicits antidiabetic and anti-inflammatory efficacy, increased hepatic enzyme activities determined in plasma (aspartate, alanine aminotransferase and alkaline phosphatase) and increased liver-to-body weight ratios were observed. However, these effects might be the result of a physiological response to exposure to a very high level of a fatty acid which is not part of the normal diet, and are most likely not toxicologically relevant. The no observable adverse effect level (NOAEL) was 50,000ppm PSO (=4.3g PSO/kg body weight/day).