Rupture of the posterior lens capsule with extrusion of lens fibers or
entire lens cortex and nucleus was found in Sprague-Dawley rats. The
lesion was detected during an ophthalmoscopic examination as round sha
dows that interfered with the view of the fundus. By slit-lamp biomicr
oscopic and dissecting microscopic examinations, the shadows were rela
ted to opaque plaques located on the posterior capsule. By light micro
scopic examination, the posterior lens capsule was ruptured and lens f
ibers extruded into the vitreous. Mononuclear and multinucleared giant
cells were present at the site of rupture, however, few other inflamm
atory responses were present. Although the incidence and pathogenesis
of the lesion is unknown, the lesion should be considered along with o
ther spontaneous ocular changes when evaluating safety assessment stud
ies.