SUZUTOS豚鼠皮肤致敏GLP试验研究  

SUZUTOS Skin Sensitization GLP Test Research in Guinea Pigs

作　　者：梁震 黄耀师[2] 梁虓 张博 袁建华 马洪英 

机构地区：[1]国家沈阳新药安全评价中心,辽宁沈阳110021 [2]沈阳化工研究院,辽宁沈阳110021 [3]沈阳兴华航空电器有限责任公司,辽宁沈阳110021 [4]沈阳市电信工程局,辽宁沈阳110023 [5]山东兖州市新兖镇畜牧兽医站,山东兖州272100

出　　处：《动物医学进展》2008年第S1期3-4,共2页Progress In Veterinary Medicine

摘　　要：试验采用Buehler斑贴法,用豚鼠50只,共分4组,受试物诱导组20只,受试物非诱导组10只,阳性对照物诱导组和阳性对照物非诱导组各10只。受试物(SUZUTOS)诱导剂量为0.2 g/(只.次),受试物的激发剂量为0.1 g/(只.次)。受试物诱导和激发最大剂量限值为0.2 g/只,激发剂量为不引起皮肤刺激的最高剂量。试验期间对各受试动物一般状态、给药部位皮肤有无异常进行观察。于激发给药后24h及48 h,对受试动物涂药部位皮肤红斑和水肿进行评分,求出致敏率。结果表明,受试物诱导组及阳性对照物诱导组动物皮肤致敏率分别为20%和50%,SUZUTOS对豚鼠皮肤为轻度致敏。In accordance with the Buehler's closed patch method,SUZUTOS was tested for its skin sensitizing effect on adult albino guinea pigs.50 male animals were selected and allocated in four groups randomly,twenty of them in induced test substance group,each ten of them in non-induced test substance group,as well as in induced positive control group and in non-induced positive control group.2,4 dinitrochlorobenzene(DNCB) was employed as positive control substance.Dosage: 0.2g-test substance per animal for induction,and 0.1g-test substance per animal for challenge.According to the regulations of the method,the maximum dose should be limited to 0.2g or 0.2ml-test substance per animal,and the challenge dose has to be under the highest non-irritating dose.The clinical signs and skin reactions in the treated sites of all animals in four groups were observed,and the sensitization rates were calculated at 24 h and 48 h after removal of the patch.According to the results of the GLP test,the sensitization rates of animals in induced test substance group and induced positive control group were 20% and 50%,respectively.Based on the negative result and the toxicity grading criteria in the Guidelines for the Testing of Chemicals,the test substance,SUZUTOS,was concluded to be classified as a mild skin sensitizer in guinea pigs under the experiment condition of this study.

关 键 词：豚鼠 致敏 过敏反应 

分 类 号：R96[医药卫生—药理学]