GENETIC TOXICOLOGY SUPPORT FOR THE NTP AND THE NIEHS

NTP 和 NIEHS 的遗传毒理学支持

基本信息

批准号：
10918014
负责人：
LESLIE RECIO
金额：
$ 75.47万
依托单位：
INTEGRATED LABORATORY SYSTEMS, LLC
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-06 至 2024-09-05
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10918014
关键词：
Adopted Adult Adverse effects Aging Animal Model Animal Testing Animals Biological Biological Assay Biological Monitoring Biotechnology Birth Blood specimen Botanicals Brain Carcinogens Cells Chemical Exposure Chemicals Clinic Clinical Clinical Research Colon Comet Assay Complication Contracts DNA Damage DNA sequencing Data Development Diagnosis Disasters Disease Early Diagnosis Economics Environment Environmental Exposure Erythrocytes Event Evolution Exposure to Family suidae Frequencies Future Gene Expression Gene Mutation Generations Genes Genetic Genetic Induction Genomics Guidelines Health Human In Vitro Induced Mutation International Kidney Laboratories Life Link Liver Malignant Neoplasms Mammalian Cell Methods Micronucleus Tests Mission Monitor Mus Mutagenicity Tests Mutation Mutation Detection Mutation Spectra National Institute of Environmental Health Sciences Neurodegenerative Disorders Neurodevelopmental Disorder Neurologic Oncology Participant Pesticides Pharmaceutical Preparations Pharmacologic Substance Process Protocols documentation Rattus Resources Rodent Sampling Source Stomach Study models Symptoms System Technology Testing Tissues Toxic effect Toxicity Tests Toxicogenetics Toxicology Translating United States Environmental Protection Agency United States Food and Drug Administration Update West Virginia carcinogenicity contaminated water dietary supplements early life exposure environmental chemical exposed human population flexibility genotoxicity human study in vitro testing in vivo innovation interest micronucleus multiplex assay mutation assay novel strategies peripheral blood response treatment response tumor

项目摘要

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.

30 多年来，这份遗传毒理学测试合同一直支持转化毒理学部 (DTT) 的总体使命，即提供感兴趣的化合物的详细毒理学概况，包括潜在的致癌性。遗传损伤是癌症、出生缺陷、衰老过程和其他不利人类健康影响的发生和发展的重要因素，遗传损伤的评估是化学品或产品任何深入毒理学分析的关键组成部分。在评估环境引起的遗传损伤的影响时，一个重要的复杂问题是，生命早期（甚至出生前）引起的遗传损伤可能要到几十年后的成年时期才会表现出对健康的不利影响。这种表现的延迟，加上缺乏任何遗传损伤的直接症状，使得很难将导致遗传损伤的早期暴露与成人疾病联系起来。由于了解诱发遗传损伤的可能性非常重要，因此食品和药物管理局等监管机构要求对新药品和农药产品以及其他类型的人类接触问题产品的遗传毒性潜力进行详细表征。在批准使用之前，请先征得药物管理局和环境保护局的同意。该基因毒性测试合同使用全球公认的标准测试协议以及创新方法（在必要和适用时）向 DTT 提供有关各种类型的暴露相关基因损伤的信息，以补充从标准测试中获得的信息。该合同下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）测定。该遗传毒性测试合同的功能不断更新，以与该领域最新的科学方法保持同步，并与进行此类测试的国际准则保持一致。该领域目前正在快速发展，技术能力发生了许多巨大的变化。