GENETIC TOXICOLOGY SUPPORT FOR THE NTP AND THE NIEHS

这项基因毒理学测试合同支持了转化毒理学部门（DTT）的总体使命，即提供详细的毒理学概况，包括感兴趣的化合物的潜在致癌性，已有30多年的历史。基因损伤是癌症、出生缺陷、衰老过程和其他对人类健康不利影响的发生和发展的一个重要因素，评估遗传损伤是任何化学品或产品的深入毒理学概况的关键组成部分。评估环境引起的遗传损害影响的一个重要问题是，在生命早期，甚至在出生前引起的遗传损害可能直到几十年后的成年期才表现为对健康的不利影响。这种表现的延迟，加上缺乏任何直接的遗传损伤症状，使得很难将早期暴露导致遗传损伤与成年疾病联系起来。由于了解潜在的诱发基因损伤的重要性，在批准使用之前，食品和药物管理局和环境保护局等监管机构要求详细描述新药和农药产品以及人类接触可能引起关注的其他类型产品的潜在基因毒性。这份遗传毒性测试合同向地面电视提供了关于各种类型的与接触有关的遗传损害的信息，使用了全球公认的标准测试协议以及必要和适用时的创新方法，以补充从标准测试中获得的信息。本合同中使用的测试系统包括体外（动物和人类细胞以及细菌）和体内（大鼠和小鼠）检测。这一遗传毒性测试合同的能力不断得到更新，以跟上该领域最新的科学方法，并符合进行这类测试的国际准则。该领域目前正经历着快速的发展，技术能力正在发生许多戏剧性的变化。

This genetic toxicology testing contract has supported the overall mission of the Division of Translational Toxicology (DTT) to provide detailed toxicological profiles, including potential for carcinogenicity, of compounds of interest for over 30 years. Assessment of genetic damage, an important factor in the initiation and development of cancer, birth defects, aging processes, and other adverse human health effects, is a critical component of any in-depth toxicological profile of a chemical or product. An important complication in assessing the impact of environmentally induced genetic damage is that genetic damage induced early in life, even prior to birth, may not manifest as an adverse health effect until decades later, during adulthood. This delay in manifestation, along with a lack of any immediate symptoms of genetic damage, makes it difficult to link early life exposures that cause genetic damage with adult disease. Because of the importance in understanding potential for induced genetic damage, a detailed characterization of the genotoxic potential of new pharmaceutical and pesticide products, as well as other types of products for which human exposure is a concern, is required by regulatory agencies such as the Food and Drug Administration and the Environmental Protection Agency prior to approval for use. This Genetic Toxicity Testing contract provides information to the DTT on various types of exposure-related genetic damage using globally accepted standard testing protocols as well as innovative approaches, when necessary and applicable, to supplement the information obtained from standard tests. Testing systems employed under this contract include both in vitro (animal and human cell-based, and bacterial) and in vivo (rats and mice) assays. The capabilities of this genetic toxicity testing contract are continuously updated to remain current with the latest scientific approaches in the field and consistent with international guidelines for conducting these kinds of tests. The field is currently undergoing rapid evolution with the many dramatic changes in technological capabilities that are occurring today.