Journal of Food: Microbiology, Safety & Hygiene

Journal of Food: Microbiology, Safety & Hygiene
Open Access

ISSN: 2476-2059

Abstract

A toxicological assessment of a single-cell protein from Methylovorus menthalis J25 (PsomiTM

Sandra K. Szlapinski*

Objectives: Protein is an essential macronutrient required for metabolic and physiological functions. As the global population expands, identifying sustainable protein sources is increasingly important for meeting rising demands in animal feed and human food markets. Methylovorus menthalis J25 (Psomi™) is a single-cell protein derived from Methylovorus menthalis that has been reported as a sustainable protein source. This study evaluated the toxicity of J25 through a battery of toxicological studies conducted in accordance with international guidelines. Materials and Methods: These studies evaluated the potential mutagenicity (Ames test, in vitro and in vivo mammalian chromosomal aberration assays), genetic toxicity (in vitro mammalian cell gene mutation) and acute, sub-acute and sub-chronic oral toxicity of J25 in Sprague Dawley rats. Results: There was no evidence of genetic toxicity or mutagenicity in the in vitro studies. An acute oral LD50 of >5000 mg/kg Body Weight (bw) was established. There were no mortalities or any treatment-related adverse effects in the 14-day repeat dose oral toxicity study, wherein rats received low, mid, or high doses of J25 (2500, 3750, or 5000 mg/kg bw/day, n=5 rats/sex/group). These findings were repeated in the subchronic repeat-dose 90-day oral toxicity study at the same daily doses of J25 (n=10 animals/sex/group). Conclusion: Therefore, the No-Observed-Adverse-Effect-Level (NOAEL) was established to be ≥5000 mg/kg bw. The results of these safety studies support the safe use of DeNova’s protein-rich biomass ingredient (J25) for use as a novel, sustainable protein source in animal feed, companion animal supplements and human foods.

Published Date: 2026-03-31; Received Date: 2026-03-18

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