The Journal of Phytopharmacology 2026; 15(1):35-45 ; DOI:10.31254/phyto.2026.15105
ImmunoDefender: acute safety profile of a novel essential oil antiviral formulation
Anis Klouz1 , Henda Ferchichi2 , Ayoub Ksouri3 , Oumayma Abidi4 , Asma Louati4 , Ouajdi Souilem4 , Mounir Bezzarga4,5 , Balkiss B. Zahar6 , Zakaria Benlasfar7
1. Faculté de Médecine de Tunis, Universite Tunis El Manar, Tunis, Tunisia
2. Faculte des Sciences de Tunis, Universite Tunis El Manar, Tunis, Tunisia
3. Sydney Brenner Institute for Molecular Bioscience, Wits University, Johannesburg, South Africa
4. Laboratoire de Modélisation Mathématique, Faculté des Sciences de Tunis, Université Tunis El Manar, Tunis, Tunisia
5. Institut Préparatoire aux Etudes d’Ingénieur de Tunis, Universite de Tunis, Tunis, Tunisia
6. Laboratoire des Biomolécules, Venins et Applications Théranostiques, Institut Pasteur de Tunis, Tunis, Tunisia
7. Ecole Nationale de Médecine Vétérinaire, Sidi Thabet, Tunis
*Author to whom correspondence should be addressed.
Received: 30th September, 2025 / Accepted: 4th March, 2026 / Published : 30th March, 3036
Background: Essential oils (EOs) exhibit significant antiviral properties, making them promising candidates for COVID-19 treatment. ‘ImmunoDefender’ is a novel EO-based formulation designed to inhibit SARS-CoV-2 through in silico molecular docking studies. Objective: This study evaluates the In vitro mutagenicity and In vivo acute oral toxicity of ‘ImmunoDefender’ as a first step in its safety assessment. Materials and Methods: Mutagenic potential was assessed using the Ames test with Salmonella typhimurium strains (TA98, TA100, TA1535, TA1537) and Escherichia coli WP2 uvrA, both with and without metabolic activation (S9 mix), at concentrations up to 2500 µg/plate (TA98, TA100, TA1535, TA1537) and 316 µg/plate (WP2 uvrA). Acute oral toxicity was evaluated in Wistar rats following OECD 423 guidelines, with single doses up to 10 times the therapeutic level (2000 mg/kg), followed by 14-day observation. Results: No mutagenic activity was observed in any bacterial strains. In vivo, no mortality, body weight alterations, or significant biochemical and histopathological changes were noted over 14 days post-administration. Conclusion: These findings indicate that ‘ImmunoDefender’ is non-mutagenic and non-toxic under acute exposure conditions, supporting its safety for further preclinical investigations. Future studies should assess long-term toxicity and clinical efficacy in COVID-19 management.
Essential Oils, COVID-19, Mutagenicity Tests, Acute Toxicity, Salmonella typhimurium, Escherichia coli
HOW TO CITE THIS ARTICLE
Klouz A, Ferchichi H, Ksouri A, Abidi O, Louati A, Souilem O, et al. ImmunoDefender: acute safety profile of a novel essential oil antiviral formulation. J Phytopharmacol 2026; 15(1):35-45. doi: 10.31254/phyto.2026.15105
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