Table 15: Summary of notable histopathology findings in the 90-day repeated oral toxicity study.

OrgansObservationsDose groups (mg/kg bw/day)
Control100360720
Main Recovery MainRecovery

Male
Adrenal glandIncreased cytoplasmic vacuolation0/100/50/100/10 6/100/5
KidneyCyst1/100/50/1/0/100/5
Mineral deposits0/100/51/1/0/100/5
LungsAlveolar emphysema0/100/5// 1/101/5
Alveolar histiocytosis2/100/5// 1/100/5

Female
Adrenal glandIncreased cytoplasmic vacuolation0/100/50/100/10 8/100/5
KidneysFocal fibrosis0/100/51/10/10/100/5
LungsAlveolar emphysema1/100/5//0/101/5
Acute hemorrhage0/101/5//0/100/5
Alveolar histiocytosis1/100/5//3/100/5
UterusDilatation4/103/5//2/101/5

/, not examined.
Data represent the number of animals with observation per number of animals observed.