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标题：Impact Assessment of Skin Irritation, Hematological Profile and Skin Sensitivity by SMA-DMSO
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作者：Pallavi Singh ; Chaiti Ganguly ; F.W.Bansode 等
期刊名称：International Journal of Innovative Research in Science, Engineering and Technology
印刷版ISSN：2347-6710
电子版ISSN：2319-8753
出版年度：2016
卷号：5
期号：4
页码：6265
DOI：10.15680/IJIRSET.2016.0504219
出版社：S&S Publications
摘要：SMA-DMSO (RISUG) is a high efficacy male anti-fertility drug, currently in clinical trial phase III. Toevaluate the allergenicity of SMA-DMSO, invivo skin allergenicity and sensitivity tests were conducted using Charlesfoster rats and guinea pigs. Skin Sensitization test was conducted in Charles foster rats in two phases – induction phaseand Challenge phase. After the induction phase, there was a rest period of 2-weeks, during which an immune responsecould develop, and then the animals were exposed to a challenge dose. The extent and degree of skin reaction to thechallenged dose in the test animals was compared with control animals which undergone sham treatment duringinduction and received the challenge exposure. Sensitization severity grading, based on incidence of positive responses,(i.e., irritation score of 1.00 or more) in comparison to control animals indicate that the test sample may be a Mild toModerate sensitizer. The test sample of SMA–DMSO has been recommended as “Mild Irritant”, since the dermalirritation index was found to be 0.79 which as per the OECD indexing, is a mild irritant. Occlusive patching procedurehas been used in test animals followed by investigation of erythema and odema in the period of 24 to 72 hours to assessskin sensitivity.Moreover, assessment of Haematological parameters in rats showed no variation in PCV, Leukocytecount and mean haemocrit value after injection of SMA-DMSO leading to conclusion that SMA-DMSO does notinduce any kind of changes in haematological and histological profile of mammals.
关键词：SMA-DMSO; Skin sensitivity; Charles foster rats; Hematological profile; Irritation score