Subchronic (90‐day) toxicity assessment of Somacy‐FP100, a lipopolysaccharide‐containing fermented wheat flour extract from Pantoea agglomerans

• Published in: Journal of applied toxicology 2020-10, Vol.40 (10), p.1342-1352
• Main Authors: Phipps, Kirt R., Sulaiman, Christina, Simon, Ryan, Holalagoudar, Shivakumar, Kohchi, Chie, Nakata, Yoko
• Format: Article
• Language: English
• Subjects: Aging; Body weight; Cotton; Fermented food; fermented wheat flour extract; Flour; Food; Food consumption; food ingredient; Genotoxicity; lipopolysaccharide; Lipopolysaccharides; Pantoea agglomerans; Safety; subchronic toxicity; Toxicity; Wheat
• ISSN: 0260-437X; 1099-1263
• DOI: 10.1002/jat.3987

Pantoea agglomerans is a Gram‐negative bacterium that is ubiquitous in the environment, colonizing animals, humans, and numerous plants, including cotton and wheat. A lipopolysaccharide‐containing fermented wheat flour extract from P. agglomerans (Somacy‐FP100) is proposed for use as a food ingredient for individuals seeking foods for healthy aging. Previously published genotoxicity studies with Somacy‐FP100 reported its lack of genotoxicity in vitro, but a subchronic toxicity study has not yet been performed. Therefore, to demonstrate the safety of Somacy‐FP100 for use as a food ingredient, a 90‐day oral (gavage) toxicity study in rats was conducted. Male and female Han Wistar rats were administered vehicle (control) or Somacy‐FP100 at 500, 1500, or 4500 mg/kg body weight/day at a dose volume of 10 mL/kg body weight, for at least 90 days. No test article‐related adverse clinical signs or effects on body weight, food consumption, or clinical pathology were observed, and there were no macroscopic or microscopic findings related to the test article. Therefore, 4500 mg/kg body weight/day (the highest dose tested and highest feasible dose) was established as the no‐observed‐adverse‐effect level. This absence of subchronic toxicity, in addition to the previously reported lack of genotoxicity, demonstrates the safety of Somacy‐FP100 for use as a food ingredient. To demonstrate the safety of a lipopolysaccharide‐containing fermented wheat flour extract from Pantoea agglomerans (Somacy‐FP100) for use as a food ingredient, a 90‐day oral (gavage) toxicity study in rats was conducted. There were no test article‐related adverse effects on any of the evaluated parameters. Therefore, 4500 mg/kg body weight/day (the highest dose tested and highest feasible dose) was established as the no‐observed‐adverse‐effect level.