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Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation 原发性皮肤刺激用兔子试验材料的标准实施规程
发布日期: 2020-04-01
1.1 本规程涵盖了一种程序,通过该程序可以通过接触磨损的完整兔子皮肤来评估材料的刺激性。 1.2 该实践的结果取决于皮肤与试验材料之间建立和保持接触的有效性。由于执行该测试时包括操作员技术,因此由经过适当培训的人员执行测试很重要。 1.3 以国际单位制表示的数值应视为标准值。 本标准不包括其他计量单位。 1.4 本标准可能涉及危险材料、操作和设备。本标准并非旨在解决与其使用相关的所有安全问题(如有)。本标准的用户有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 与皮肤接触的材料不应对皮肤造成刺激。由于可能是从材料中渗出的物质引起刺激,本规程规定了直接材料皮肤接触试验或皮肤暴露于试验材料的液体提取物中。这种兔子试验的基本原理是,它是一种相对快速和敏感的方法,经过多年的使用,已成为普遍接受的方法。 此外,白化兔可以很容易地看到红斑和水肿,这是皮肤刺激的主要症状。
1.1 This practice covers a procedure by which the irritancy of a material may be assessed through contact with abraded and intact skin of rabbits. 1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from a material that cause the irritation, this practice provides for direct material-skin contact testing or for skin exposure to the liquid extract of the test material. The rationale for this rabbit test is that it is a comparatively quick and sensitive method which, through use over the years, has become a generally accepted method. Additionally, the albino rabbit allows for easy visualization of erythema and edema, which are the cardinal signs of skin irritation.
分类信息
发布单位或类别: 美国-美国材料与试验协会
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研制信息
归口单位: F04.16
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