Abstract:
Degenerative lesions specific to the basal nuclei have not been described as a background finding in Beagle dogs. This report comprises a documentation of seven cases. In the context of a nonclinical safety studies, the authors suggest documenting the lesion descriptively as degeneration neuropil, basal nuclei, bilateral as it is characterized by (1) vacuolation, neuropil; (2) gliosis (astro- and/or microgliosis); and (3) demyelination. This novel lesion is considered a potential new background change for several reasons: (1) It occurred in animals from test item-treated and also vehicle-treated groups; (2) no dose dependency was observed; (3) in one of six affected test item-treated dogs, the given compound was shown not to penetrate the blood-brain barrier; and (4) statistical comparison between the proportions of affected dogs in the treatment and control groups did not yield a statistically significant difference. The etiology remains unknown and is subject to further investigations.
摘要:
尚未将基底核特有的退行性病变描述为比格犬的背景发现。该报告包括七个案件的文件。在非临床安全性研究的背景下,作者建议将病变描述为变性神经纤维,基底核,双侧,因为它的特征是(1)空泡,神经纤维;(2)神经胶质增生(星形胶质增生和/或小胶质增生);和(3)脱髓鞘。这种新的病变被认为是潜在的新背景变化,原因有几个:(1)它发生在测试项目处理和媒介物处理组的动物中;(2)没有观察到剂量依赖性;(3)在六只受影响的测试项目处理的狗中的一只中,结果显示,给定的化合物不穿透血脑屏障;(4)治疗组和对照组中受影响的狗的比例之间的统计学比较没有产生统计学上的显著差异.病因尚不清楚,有待进一步研究。