Unprecedented multi-endpoint safety assessment of Bacillus coagulans MBBCM9™ dermal and oral toxicity in rabbits and rats across diverse exposure periods

Unprecedented multi-endpoint safety assessment of Bacillus coagulans MBBCM9™ dermal and oral toxicity in rabbits and rats across diverse exposure periods | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Unprecedented multi-endpoint safety assessment of Bacillus coagulans MBBCM9™ dermal and oral toxicity in rabbits and rats across diverse exposure periods Mruduka Patel, Gaurav Kaushik, Sonal Pandey, Pankita Ahir, Nikhil Gangurde, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7874369/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 10 You are reading this latest preprint version Abstract Bacillus coagulans MBBCM9™ is a probiotic strain with potential therapeutic utility, necessitating thorough safety evaluation. This study aimed to assess its dermal and oral toxicity profile following internationally recognized guidelines. Dermal irritation/corrosion potential was evaluated in New Zealand White rabbits (OECD 404). Acute oral toxicity (OECD 425) using a limit dose of 2000 mg/kg, and repeated-dose 28-day (OECD 407) and 90-day (OECD 408) oral toxicity studies using doses of 0, 0.65, 35.72, and 74.76 mg/kg/day were conducted in Sprague-Dawley rats. Assessments included mortality, clinical signs, body weight, food consumption, hematology, clinical biochemistry, urinalysis, and histopathology. Results indicated that MBBCM9™ was non-irritant and non-corrosive upon dermal application. The acute oral LD50 was determined to be greater than 2000 mg/kg. In both the 28-day and 90-day repeated-dose studies, no mortality or significant treatment-related adverse effects were observed in any parameter evaluated, including clinical signs, body weight, food intake, hematological and biochemical markers, or organ pathology, even at the highest dose. The No-Observed-Adverse-Effect Level (NOAEL) for MBBCM9™ was established as 74.76 mg/kg/day for both 28 and 90 days of oral administration. These comprehensive findings demonstrate a robust safety profile for Bacillus coagulans MBBCM9™, supporting its potential for further development and safe use in human therapeutic or supplementary applications. Bacillus coagulans MBBCM9™ Probiotic safety Dermal irritation Oral toxicity Preclinical efficacy Full Text Additional Declarations No competing interests reported. Supplementary Files tables.xlsx Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 10 Mar, 2026 Reviews received at journal 16 Feb, 2026 Reviews received at journal 10 Feb, 2026 Reviewers agreed at journal 06 Feb, 2026 Reviewers agreed at journal 05 Feb, 2026 Reviewers agreed at journal 02 Dec, 2025 Reviewers invited by journal 28 Nov, 2025 Editor assigned by journal 04 Nov, 2025 Submission checks completed at journal 04 Nov, 2025 First submitted to journal 16 Oct, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7874369","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":552274022,"identity":"9f74a462-6620-44cc-b2d2-7bb6bceb1d02","order_by":0,"name":"Mruduka Patel","email":"","orcid":"","institution":"Meteoric Biopharmaceuticals Pvt. 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