Incidences and Range of Spontaneous Microscopic Lesions in the Eye of Sprague-Dawley Rats and Han Wistar Rats Used in Toxicity Studies.

The incidence and range of spontaneous microscopic lesions were determined in the eyes of male and female control Sprague-Dawley and Han Wistar rats. Data were collected retrospectively from 1411, 817, 970, 658, and 3999 rats from control groups of 4-, 13-, 26-, 52-, and 104-week studies, respectively, carried out between 1997 and 2019. Microscopic lesions of the eye were rare in 4- and 13-week studies, uncommon in 26- and 52-week studies, and were of relatively higher incidence in 104-week studies. Neoplastic lesions were sporadic and were only observed in 104-week studies. In Sprague-Dawley rats, the most common lesions (>1% in 104-week studies) were retinal degeneration, retinal rosettes/folds, and lenticular degeneration. The Han Wistar rats presented a range of ocular lesions similar to the Sprague-Dawley rats. However, retinal degeneration occurred with an earlier onset and at higher incidences, ranging from >5% in 26-week studies up to 45.72% in 104-week studies. In both strains, females exhibited higher incidences and severities of retinal degeneration. It is hoped that reference to the incidences reported here will facilitate the differentiation of spontaneous lesions from test article-induced lesions in toxicology studies in these strains of rat.