方法
试验系统
种属：家兔
品种：新西兰白色纯种
来源：苏州大学实验动物中心[许可证号：SCXK（苏）2002-0008]
体重：1.8 – 2.0kg
年龄：年轻成兔
训化期：至少5天
动物数：3只
标识：耳穿孔
实验系统阐述
依据现行ISO试验标准，家兔被指定作为评价原发性皮肤刺激作用合适的动物模型。为此目的，家兔被广泛采用，作刺激反应测定。
动物管理
饲养：参照ISO10993 – 10 – 2002附录C：Animal and husbandry
食物：由苏州双狮实验动物饮料科技服务有限公司提供全价颗粒饮料。
水：提供符合卫生标准的《生活饮用水》。
饲养地：家免单个饲养在悬挂的不锈钢笼子内。附上卡片：标明编号、动物号、实验代号、性别及每天用量。
环境：每天记录室温，推荐温度20——25℃。
每天记录温度，推荐温度30——70%。
人员：需经培训和有资质的人员。
选择：取健康，未例行这的无刺激或皮肤损伤的家兔，因为刺激和损伤会干扰结果。
实验程序
用75%乙醇清洁暴露皮肤，在兔背一侧先10个点，每点间隔2cm。各点注射0.2ml供试品浸提液；兔背另一侧选5点，每点间隔2cm，各点注射0.2ml空白对照液。
注射后24h、48h和72h观察注射局部及周围皮肤组织瓜，包括红斑、水肿和坏死等记录之。根据红斑、水肿发生情况可记分为0、1、2、3、4标准记录等级。详见表1。
Result
据观察，试验侧皮肤反应未超过空白对照侧皮肤反应，记分为0。见表1。
Conclusion
经试验表明，供试品浸提液对皮肤无刺激作用。
资料保存
所有原始记录及报告资料均保存于苏州大学放射医学研究所检验检测中心。
苏州大学放射医学研究所检验检测中心于2004年11月1日已通过并获得国家技术监督局颁发及评审的认可证书[*04（量认苏字（S0174）号]。
华译网上海翻译公司曾经翻译过大量有关家兔试验系统资料文件。Beijing Chinese Subtitling Translation Service Agency has translated many technical documents about Rabbit test system.
Method
System
Species: Rabbit
Variety: New Zealand White Purebred
Source: Experimental Animal Center of Suzhou University (License No.: SCXK (Jiangsu) 2002-0008)
Weight: 1.8 – 2.0kg
Age: Young adult rabbit
Training duration: at least 5 days
Animal number: 3
Mark: perforation on ears
Statements on experimental system
Rabbit is specified as animal model to evaluate primary skin irritation, according to current test standards of ISO. Therefore, rabbit is generally used for irritation test.
Administration of animals
Breed: Accordance with ISO10993 – 10 – 2002 Appendix C: Animal and husbandry
Feed: Shuangshi complete pellet feed by Suzhou Shuangshi Laboratory Animal Feed Science Co., Ltd.
Water: Drinking water in accordance with sanitary standards.
Breeding location: Rabbit was separately bred in suspended stainless steel cage. With cards including serial number, animal code, experiment code, gender and day dosage.
Environment: Room temperature was recorded every day. 20~25℃ is recommended.
Humidity was recorded every day. 30~70% is recommended.
Personnel: Relevant individual should be qualified and trained.
Selection: the qualified animal should be healthy rabbits without irritation or skin injure because irritation hand injure would interfere the results.
Procedure:
Exposure skin was cleaned by 75% ethanol. 10 points with interval of 2cm were marked on one side of the rabbit. 0.2ml tested leaching liquor was injected into each point; On the other side of rabbit back, 5 points with interval of 2cm were chosen to inject 0.2ml blank control solution.
Parts and periphery skin tissues, including erythema, edema and necrosis were observed and recorded 24h, 48h and 72h after injection. Score (0, 1, 2, 3, 4) was graded and recorded according to degree of erythema and edema. See Table 1.
Result
According to the observation, skin of tested side did not react over that of control side, scores as 0.See Table 1.
Conclusion
The experiment demonstrated that the test sample leaching liquor has no irritation effect on skin.
Data conservation
All original records and data are conserved at Inspection and Testing Center of Radiation Medicine Institution of Suzhou University.
Inspection and Testing Center of Radiation Medicine Institution of Suzhou University was authorized and obtain approval certification issued by State Bureau of Quality and Technical Supervision on 1st Nov., 2004 (*04 Quality Certificated by Suzhou (No. S0174)).
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