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Standard Test Method for Estimating Sensory Irritancy of Airborne Chemicals 估计气载化学品感官刺激性的标准试验方法
发布日期: 2019-02-01
1.1 该实验室试验方法提供了一种快速测定空气中化学物质或混合物的感官刺激潜力的方法。它也可用于估计man的阈值极限值(TLV)。然而,它不能用于评估气味的相对厌恶性。 1.2 本试验方法旨在作为慢性吸入研究的补充,而不是替代,用于确定允许的人类耐受水平。 1.3 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。 第节给出了具体的危险信息 6. . 1.4 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====== 3.1 制定本试验方法是为了满足以下标准: 3.1.1 它提供了对各种效力的感觉刺激物的积极识别。 3.1.2 它足够简单,可以对大量材料进行测试。 3.1.3 该试验方法能够生成浓度响应曲线,用于化合物比较。 3.1.4 该试验方法具有良好的再现性。 3.2 该试验方法可用于各种不同的目的,包括评估化合物或制剂的相对刺激性,以及设置工作场所的临时暴露水平 ( 1. , 2. ) . 2. 3.3 研究表明,对于多种化学品和混合物,小鼠呼吸频率的下降与人类感觉刺激的主观报告之间存在完美的秩序相关性 ( 1. , 3. , 4. , 5. ) . 3.4 可以从浓度中定量估计各种材料的感觉刺激性- 使用该方法绘制的响应曲线 ( 1. , 3. , 4. , 6. , 7. , 8. , 9 ) . 3.5 虽然本试验方法旨在测量鼻粘膜的感觉刺激,但角膜受同一神经支配。因此,这种动物模型可以估计化妆品成分或其他家用产品对眼睛的刺激潜力,假设它们可以雾化 ( 10 ) . 3.6 建议使用本试验方法制定工作场所中人类暴露于化学品的临时指南,以评估家用产品意外泄漏引起的急性感官刺激,并评估用于各种用途的配方或材料的相对刺激性(见 附录X2 ). 图1 正常小鼠呼吸的典型追踪(顶部)和“中度”感觉刺激反应(底部) 注1: 摘自Ref。 ( 3. ) . 图2 正常小鼠呼吸的典型追踪(顶部)、中度肺刺激反应(中部)和极端肺刺激反应(底部) 注1: 摘自Ref。 ( 8. ) . 3.7 本试验方法将检测远低于观察到病理变化浓度的刺激作用 ( 9 ) . 注1: 参考文献对刺激性化合物的毒理学评估进行了详细概述 ( 8. ) .
1.1 This laboratory test method provides a rapid means of determining sensory irritant potential of airborne chemicals or mixtures. It may also be used to estimate threshold limit values (TLV) for man. However, it cannot be used to evaluate the relative obnoxiousness of odors. 1.2 This test method is intended as a supplement to, not a replacement for, chronic inhalation studies used to establish allowable human tolerance levels. 1.3 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. Specific hazard information is given in Section 6 . 1.4 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 ====== 3.1 This test method was developed to meet the following criteria: 3.1.1 It provides positive recognition of sensory irritants of widely varying potencies. 3.1.2 It is sufficiently simple to permit the testing of large numbers of materials. 3.1.3 This test method is capable of generating concentration-response curves for purposes of compound comparison. 3.1.4 This test method has good reproducibility. 3.2 This test method can be used for a variety of divergent purposes, including the assessment of comparative irritancy of compounds or formulations and setting interim exposure levels for the workplace ( 1 , 2 ) . 2 3.3 It has been shown that for a wide variety of chemicals and mixtures, a perfect rank order correlation exists between the decreases in respiratory rate in mice and subjective reports of sensory irritation in man ( 1 , 3 , 4 , 5 ) . 3.4 A quantitative estimate of the sensory irritancy of a wide variety of materials can be obtained from concentration-response curves developed using this method ( 1 , 3 , 4 , 6 , 7 , 8 , 9 ) . 3.5 Although this test method is intended to measure sensory irritation of the nasal mucosa, the cornea is innervated by the same nerve. This animal model will, therefore, allow an estimate of the irritant potential of cosmetic ingredients or other household products to the eye, assuming that they can be aerosolized ( 10 ) . 3.6 This test method is recommended for setting interim guidelines for exposure of humans to chemicals in the workplace, to assess acute sensory irritation resulting from inadvertent spills of household products, and to assess the comparative irritancy of formulations or materials intended for a variety of uses (see Appendix X2 ). FIG. 1 Typical Tracing of Normal Mouse Respiration (Top), and of a“ Moderate” Sensory Irritant Response (Bottom) Note 1: Taken from Ref. ( 3 ) . FIG. 2 Typical Tracing of Normal Mouse Respiration (Top), a Moderate Pulmonary Irritant Response (Center), and an Extreme Pulmonary Irritant Response (Bottom) Note 1: Taken from Ref. ( 8 ) . 3.7 This test method will detect irritating effects at concentrations far below those at which pathological changes are observed ( 9 ) . Note 1: A good overview of the toxicological evaluation of irritant compounds is given in Ref ( 8 ) .
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归口单位: E50.47
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