Lyophilized B. subtilis ZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study in Wistar Rats
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 Wist...
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| Format: | Article |
| Language: | English |
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Wiley
2019-01-01
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| Series: | Journal of Toxicology |
| Online Access: | http://dx.doi.org/10.1155/2019/3042108 |
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| author | B. Appala Naidu Kamala Kannan D. P. Santhosh Kumar John W. K. Oliver Zachary D. Abbott |
| author_facet | B. Appala Naidu Kamala Kannan D. P. Santhosh Kumar John W. K. Oliver Zachary D. Abbott |
| author_sort | B. Appala Naidu |
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| description | 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 nonadverse 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. |
| format | Article |
| id | doaj-art-15f3e9d06087496daf9cc779b7667986 |
| institution | Kabale University |
| issn | 1687-8191 1687-8205 |
| language | English |
| publishDate | 2019-01-01 |
| publisher | Wiley |
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| series | Journal of Toxicology |
| spelling | doaj-art-15f3e9d06087496daf9cc779b76679862025-02-03T05:55:18ZengWileyJournal of Toxicology1687-81911687-82052019-01-01201910.1155/2019/30421083042108Lyophilized B. subtilis ZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study in Wistar RatsB. Appala Naidu0Kamala Kannan1D. P. Santhosh Kumar2John W. K. Oliver3Zachary D. Abbott4Department of Safety Assessment, Eurofins Advinus Limited, Post Box No. 5813, Plot Nos. 21 & 22 Peenya II Phase, Bengaluru 560 058, IndiaDepartment of Safety Assessment, Eurofins Advinus Limited, Post Box No. 5813, Plot Nos. 21 & 22 Peenya II Phase, Bengaluru 560 058, IndiaDepartment of Safety Assessment, Eurofins Advinus Limited, Post Box No. 5813, Plot Nos. 21 & 22 Peenya II Phase, Bengaluru 560 058, IndiaZBiotics Company, 181 2nd St., San Francisco, CA 94105, USAZBiotics Company, 181 2nd St., San Francisco, CA 94105, USAA 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 nonadverse 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.http://dx.doi.org/10.1155/2019/3042108 |
| spellingShingle | B. Appala Naidu Kamala Kannan D. P. Santhosh Kumar John W. K. Oliver Zachary D. Abbott Lyophilized B. subtilis ZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study in Wistar Rats Journal of Toxicology |
| title | Lyophilized B. subtilis ZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study in Wistar Rats |
| title_full | Lyophilized B. subtilis ZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study in Wistar Rats |
| title_fullStr | Lyophilized B. subtilis ZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study in Wistar Rats |
| title_full_unstemmed | Lyophilized B. subtilis ZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study in Wistar Rats |
| title_short | Lyophilized B. subtilis ZB183 Spores: 90-Day Repeat Dose Oral (Gavage) Toxicity Study in Wistar Rats |
| title_sort | lyophilized b subtilis zb183 spores 90 day repeat dose oral gavage toxicity study in wistar rats |
| url | http://dx.doi.org/10.1155/2019/3042108 |
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