Kuno H, Usui T, Eydelloth R S, Wolf E D
Banyu Pharmaceutical Co., Ltd., Development Research Laboratories, Osato-gun, Japan.
J Vet Med Sci. 1991 Aug;53(4):607-14. doi: 10.1292/jvms.53.607.
Eight hundred eight Sprague-Dawley rats were examined for ophthalmic abnormalities during a pretest period in various preclinical safety assessment studies. Persistent pupillary membrane, corneal crystal, healed minor trauma, synechia, coloboma of the iris, lens luxation, cataract, persistent hyperplastic primary vitreous, vitreous hemorrhage, coloboma of the optic disc or choroid, remnant of hyaloid arterial system, retinal hemorrhage, retinal detachment, retinal folding and choroidal defect were observed. The incidences of corneal crystal, synechia, and nuclear cataract in this survey were higher than those reported previously. On the other hand, retinal folding in this survey was less common than that reported previously. These results suggest that background data of eye problems in albino rats should be accumulated in each own laboratory colony. In addition, since spontaneous eye problems are common in young albino rats, elimination of rats with ophthalmic abnormalities from study groups by an ophthalmic examination during a pretest period would facilitate to evaluate toxicity potential of test compounds in safety assessment studies.
在各项临床前安全性评估研究的预试验期间，对808只Sprague-Dawley大鼠进行了眼科异常检查。观察到持续性瞳孔膜、角膜晶体、轻微创伤愈合、虹膜粘连、虹膜缺损、晶状体脱位、白内障、持续性增生性原发性玻璃体、玻璃体出血、视盘或脉络膜缺损、玻璃体动脉系统残余、视网膜出血、视网膜脱离、视网膜折叠和脉络膜缺损。本次调查中角膜晶体、虹膜粘连和核性白内障的发生率高于先前报道。另一方面，本次调查中视网膜折叠比先前报道的少见。这些结果表明，应在每个实验室种群中积累白化大鼠眼部问题的背景数据。此外，由于年轻白化大鼠中自发性眼部问题很常见，在预试验期间通过眼科检查从研究组中剔除有眼科异常的大鼠，将有助于在安全性评估研究中评估受试化合物的潜在毒性。
