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

Appala Naidu Barla, Kamala Kannan, Dharmapura Parshwanathaiah Santhosh Kumar, John WK Oliver, Zachary D Abbott
doi: https://doi.org/10.1101/724542
Appala Naidu Barla
Department of Safety Assessment, Eurofins Advinus Limited, Post Box No. 5813, Plot Nos. 21 & 22 Peenya Ii Phase, Bengaluru 560 058, India
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Kamala Kannan
Department of Safety Assessment, Eurofins Advinus Limited, Post Box No. 5813, Plot Nos. 21 & 22 Peenya Ii Phase, Bengaluru 560 058, India
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Dharmapura Parshwanathaiah Santhosh Kumar
Department of Safety Assessment, Eurofins Advinus Limited, Post Box No. 5813, Plot Nos. 21 & 22 Peenya Ii Phase, Bengaluru 560 058, India
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John WK Oliver
ZBiotics Company, 181 2nd St., San Francisco, CA 94105 USA
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Zachary D Abbott
ZBiotics Company, 181 2nd St., San Francisco, CA 94105 USA
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  • For correspondence: zack@zbiotics.com
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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 B. subtilis ZB183. Lyophilized spores at doses of 109, 1010, and 1011 CFU/kg body weight/day were administered by oral gavage to Wistar rats for a period of 90 consecutive days. B.Subtilis ZB183 had no effects 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 1010 and 1011 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 1011 CFU/kg body weight/day for lyophilized B.Subtilis ZB183 Spores under the test conditions employed.

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Posted August 05, 2019.
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Lyophilized B. subtilis ZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study In Wistar Rats
Appala Naidu Barla, Kamala Kannan, Dharmapura Parshwanathaiah Santhosh Kumar, John WK Oliver, Zachary D Abbott
bioRxiv 724542; doi: https://doi.org/10.1101/724542
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Lyophilized B. subtilis ZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study In Wistar Rats
Appala Naidu Barla, Kamala Kannan, Dharmapura Parshwanathaiah Santhosh Kumar, John WK Oliver, Zachary D Abbott
bioRxiv 724542; doi: https://doi.org/10.1101/724542

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