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

Abstract

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.

Mining the Microbiome of Key Species from African Savanna Woodlands: Potential for Soil Health Improvement and Plant Growth Promotion

“…On the other hand, Pseudomonas gessardii has been indicated as a potential biocatalyst for the synthesis of bromohydrins [ 106 ] and for enzyme therapy [ 107 ]. Additionally, P. agglomerans is a promising multifunctional microorganism in biorefineries, namely in converting the hemicellulose fraction of plant biomass into valued-added products [ 108 ] and in producing plant-based food ingredients [ 109 ]. It is also a source of antibiotics against multidrug-resistant bacteria [ 110 ] and able to degrade waste [ 111 ].…”

Oral route lipopolysaccharide as a potential dementia preventive agent inducing neuroprotective microglia

“…In other words, we humans have already unconsciously orally ingested LPS derived from food. In fact, animal safety studies have confirmed that LPS is not toxic when administered orally, even at doses of 500-4500 mg/kg, which are far higher than doses that are toxic when administered intravenously (16)(17)(18). Therefore, it is thought that the pharmacokinetics of LPS are completely different between intravenous and oral administration, resulting in different pharmacological effects.…”

“…In fact, the bacteria are also used as a food preservative ( 39 , 40 ). In addition, the safety of oral administration of P. agglomerans -derived LPS is guaranteed by objective tests based on Organization for Economic Co-operation and Development (OECD) standards ( 17 ). Therefore, we focused on this P. agglomerans -derived LPS as a food-experienced LPS, and elucidated the preventive and therapeutic effects of OAL in various disease models.…”

Utility of In Vitro Cellular Models of Low-Dose Lipopolysaccharide in Elucidating the Mechanisms of Anti-Inflammatory and Wound-Healing-Promoting Effects of Lipopolysaccharide Administration In Vivo

“…However, environment- or food-derived LPS does not seem to induce inflammatory responses [ 8 , 12 ]. In addition, no toxicity or exacerbated inflammatory responses after oral and transdermal LPS administration have been observed in animal models [ 12 , 13 ]. This means that the response varies depending on the LPS dose and route of administration.…”