Five-month oral (diet) toxicity/infectivity study of Bacillus thuringiensis insecticides in sheep

Bacillus thuringiensis insecticides (Bt) [Dipel (test substance D or Thuricide-HP (test substance T)] were administered in the diet for 5 months to castrated mixed rambouillet/merino sheep (24-34 kg at the beginning of the study) at a dose of 500 mg/kg/day (approximately 10(12) spores per day). No treatment-related effect was seen on weight gain or clinical chemistry parameters nor were significant gross clinical changes observed. Several blood and tissue samples taken just prior to the time the animals were killed or at necropsy were found to be positive for Bt when cultured. Detailed gross and microscopic pathologic examination of the sheep revealed several incidental lesions. However, the only lesion that may have been associated with the treatment was lymphocytic hyperplasia in Peyer's patches seen in the cecum of three sheep and it was not considered to be clinically significant.