Research Article

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

Table 1

Details of CFU/g for both lot numbers of test item, doses administered and treatment days.

Test item lot no.CFU (billion/g)Calculated CFUGroup Dose (mg/kg/day) Dose volume (mL/kg) Concentration (mg/mL)Treatment period
NANANAVehicle control (G1)0100Days 1–90

300L engineering batch ZBT-002a58.5~109 CFULow dose (G2)20102Days 1–66
~1010 CFUMid dose (G3)2001020
~1011 CFUHigh dose (G4)200010200

300L engineering batch ZBT-002a part 2135~109 CFULow dose (G2)10101Days 67–90
~1010 CFUMid dose (G3)1001010
~1011 CFUHigh dose (G4)100010100