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                <full_title>The Journal of Phytopharmacology</full_title>
                <abbrev_title>J Phytopharmacol</abbrev_title>
                <issn media_type="electronic">2320480X</issn>
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                  <month>03</month>
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                  <year>2026</year>
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                  <volume>15</volume>
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                  <title>ImmunoDefender: acute safety profile of a novel essential oil antiviral formulation</title>
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                  <person_name sequence="first" contributor_role="author">
                    <given_name>Anis</given_name>
                    <surname>Klouz</surname>
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                    <given_name>Henda</given_name>
                    <surname>Ferchichi</surname>
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                    <given_name>Ayoub</given_name>
                    <surname>Ksouri</surname>
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                    <given_name>Oumayma</given_name>
                    <surname>Abidi</surname>
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                  <person_name sequence="additional" contributor_role="author">
                    <given_name>Asma</given_name>
                    <surname>Louati</surname>
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                  <person_name sequence="additional" contributor_role="author">
                    <given_name>Ouajdi</given_name>
                    <surname>Souilem</surname>
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                  <person_name sequence="additional" contributor_role="author">
                    <given_name>Mounir</given_name>
                    <surname>Bezzarga</surname>
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                  <person_name sequence="additional" contributor_role="author">
                    <given_name>Balkiss B.</given_name>
                    <surname>Zahar</surname>
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                  <person_name sequence="additional" contributor_role="author">
                    <given_name>Zakaria</given_name>
                    <surname>Benlasfar</surname>
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                  <jats:p>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.</jats:p>
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                  <month>03</month>
                  <day>30</day>
                  <year>2026</year>
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                <pages>
                  <first_page>35</first_page>
                  <last_page>45</last_page>
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                  <doi>10.31254/phyto.2026.15105</doi>
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