Lyophilized B. subtilis ZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study In Wistar Rats release_vvg7hlvmqffc3kfikdyuljfuge

Abstract

A 90-day repeated-dose oral toxicological evaluation was conducted according to GLP and OECD guidelines on lyophilized spores of the novel genetically modified strain <jats:italic>B. subtilis</jats:italic> ZB183. Lyophilized spores at doses of 10<jats:sup>9</jats:sup>, 10<jats:sup>10</jats:sup>, and 10<jats:sup>11</jats:sup> CFU/kg body weight/day were administered by oral gavage to Wistar rats for a period of 90 consecutive days. <jats:italic>B. subtilis</jats:italic> ZB183 had no effect on clinical signs, mortality, ophthalmological examinations, functional observational battery, body weights, body weight gains and food consumption in both sexes. There were no test item-related changes observed in haematology, coagulation, urinalysis, thyroid hormonal analysis, terminal fasting body weights, organ weights, gross pathology and histopathology. A minimal increase in the plasma albumin level was observed at 10<jats:sup>10</jats:sup> and 10<jats:sup>11</jats:sup> CFU/kg/day doses without an increase in total protein in males or females and was considered a non-adverse effect. The No Observed Adverse Effect Level (NOAEL) is defined at the highest dose of 10<jats:sup>11</jats:sup> CFU/kg body weight/day for lyophilized <jats:italic>B. subtilis</jats:italic> ZB183 spores under the test conditions employed.
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