世界各地的化学监管机构需要通过口服急性暴露的全身毒性数据,真皮,和人体健康风险评估的吸入途径。为了确定这些测试的非动物替代品的监管用途的机会,我们审查了参与替代测试方法国际合作(ICATM)的司法管辖区的急性全身毒性测试要求:巴西,加拿大,中国,欧洲联盟,Japan,韩国,台湾,和美国。我们对每个司法管辖区的审查中包括的化学部门是化妆品,消费品,工业化学品,制药,医疗器械,和杀虫剂。我们发现急性全身毒性数据通常是危险评估所需要的,分类,和标签,以及在较小程度上的定量风险评估。如果需要动物方法,通常推荐动物减少方法。对于许多司法管辖区和化学部门来说,不接受非动物替代品,但是一些司法管辖区提供了指导,以支持使用测试豁免,以减少特定应用中的动物使用。了解急性全身毒性试验的国际法规要求将为ICATM的发展战略提供信息,接受,和实施非动物替代品,以评估与急性毒性相关的健康危害和风险。
Chemical regulatory authorities around the world require systemic toxicity data from acute exposures via the oral, dermal, and inhalation routes for human health risk assessment. To identify opportunities for regulatory uses of non-animal replacements for these tests, we reviewed acute systemic toxicity testing requirements for jurisdictions that participate in the International Cooperation on Alternative Test Methods (ICATM): Brazil, Canada, China, the European Union, Japan, South Korea, Taiwan, and the USA. The chemical sectors included in our review of each jurisdiction were cosmetics, consumer products, industrial chemicals, pharmaceuticals, medical devices, and pesticides. We found acute systemic toxicity data were most often required for hazard assessment, classification, and labeling, and to a lesser extent quantitative risk assessment. Where animal methods were required, animal reduction methods were typically recommended. For many jurisdictions and chemical sectors, non-animal alternatives are not accepted, but several jurisdictions provide guidance to support the use of test waivers to reduce animal use for specific applications. An understanding of international regulatory requirements for acute systemic toxicity testing will inform ICATM\'s strategy for the development, acceptance, and implementation of non-animal alternatives to assess the health hazards and risks associated with acute toxicity.