1.1 本规程描述了用于观察和记录接受毒理学试验的动物的皮肤、胃肠道、呼吸、生殖、神经肌肉、眼部和一般临床症状的术语。这种做法也有助于正确观察和评估实验动物的疾病迹象或复方给药的不良影响。 1.2 该实践包括各种临床体征、解剖位置和其他描述性限定词的代码和描述，以及对临床体征的程度或严重程度进行评分的技术。 1.3 本实践假设读者熟悉动物毒理学和相关领域，并接受过临床观察方面的培训。 1.4 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者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====== 3.1 本规程适用于通过任何给药途径（吸入、口服、皮肤、眼部或其他）进行的所有形式的毒理学测试（急性、亚慢性或慢性）。 3.2 美国环境保护局《非临床实验室研究的良好实验室实践》，如40 CFR所列，要求测试设施维护特定的标准操作程序（SOP），包括涵盖测试动物临床观察的SOP。 3.3 这种做法是临床观察一致性的基础，并不意味着是可以观察到的全面观察列表。 记录观察结果时使用的实际程序和表格必须在单独的研究方案中描述。

1.1 This practice describes the terms used in observing and recording cutaneous, gastrointestinal, respiratory, reproductive, neuromuscular, ocular, and general clinical signs of animals undergoing toxicological testing. This practice also assists in properly observing and assessing laboratory animals for signs of disease or adverse effects of compound administration. 1.2 This practice includes codes and descriptions for a wide variety of clinical signs, anatomical locations, and other descriptive qualifiers, and a technique for scoring the extent or severity of clinical signs. 1.3 This practice assumes that the reader is knowledgeable in animal toxicology and related pertinent areas and is trained in making clinical observations. 1.4 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 ====== 3.1 This practice pertains to all forms of toxicological testing (acute, subchronic, or chronic) performed by any route of administration (inhalation, oral, dermal, ocular, or other). 3.2 The U.S. Environmental Protection Agency, Good Laboratory Practices for Nonclinical Laboratory Studies, as listed in 40 CFR, requires that a testing facility maintain specific standard operating procedures (SOPs) including an SOP covering clinical observations in test animals. 3.3 This practice serves as a basis for consistency in clinical observations and is not meant to serve as a comprehensive list of observations that may be observed. Actual procedures and forms to be used in recording observations must be described in individual study protocols.