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A 90-day oral toxicity study of heat-treated Bifidobacterium longum CECT 7347 (ES1 HT) Postbiotic in rats.

  • 2026-06
  • Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association 212
    • Jay S Petrick
    • Roger Mariné-Casadó
    • Richard Day
    • Patricia Martorell
    • Carolina C Venditti
    • Empar Chenoll

Study Design

Population
10 Wistar rats/sex/group
Methods
90-day toxicology study with 10 Wistar rats/sex/group using a study design adapted from the OECD test guideline for the 90-day repeated dose toxicology test in rodents (OECD TG 408); heat-treated B. longum CECT 7347 (ES1 HT) was tested at a limit dose of 1000 mg/kg (5 x 10^10 CFUeq/kg) body weight per day
  • Animal Study
Probiotic organisms have a long history of safe consumption in foods and dietary supplements. Probiotics can be inactivated using a method such as heat treatment, creating more shelf stable, non-viable biotics, termed postbiotics. Heat-treated Bifidobacterium longum CECT 7347 (ES1 HT), a postbiotic derived from the probiotic strain B. longum CECT 7347 was tested in a 90-day toxicology study with 10 Wistar rats/sex/group using a study design adapted from the OECD test guideline for the 90-day repeated dose toxicology test in rodents (OECD TG 408). Heat-treated B. longum CECT 7347 (ES1 HT) was tested at a limit dose of 1000 mg/kg (5 x 1010 CFUeq/kg) body weight per day. Evaluated endpoints included detailed clinical observations, body weights, food/water consumption, grip strength, clinical chemistry, hematology, urinalysis, thyroid hormone analysis, organ weights, and histopathology. There were no treatment-related effects observed in this study. Based on the observed results, the NOAEL for heat-treated B. longum CECT 7347 (ES1 HT) in male and female Wistar rats following 90-days of repeated dose oral exposure was 5 x 1010 CFUeq/kg (1000 mg/kg limit dose) per day. These data support the safety of heat-treated B. longum CECT 7347 (ES1 HT) for food and dietary supplement applications.

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