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.

这项遗传毒理学测试合同支持了转化毒理学（DTT）的总体使命，以提供30多年的感兴趣化合物的详细毒理学特征，包括潜在的致癌性。评估遗传损害，这是癌症的启动和发展，先天缺陷，衰老过程和其他不良人类健康影响的重要因素，是化学或产品深入毒理学特征的关键组成部分。评估环境引起的遗传损害影响的重要并发症是，即使在出生前，甚至在成年后几十年后，生命早期诱发的遗传损害也可能表现为不利的健康效应。这种表现的延迟，以及缺乏遗传损害的任何直接症状，使得很难将造成遗传损害的早期生命暴露与成人疾病联系起来。由于在理解诱导遗传损害的潜力方面的重要性，因此对新药毒性和农药产品的遗传毒性潜力的详细表征以及其他类型的人类暴露是一种关注的产品，是食品和药物管理和环境保护机构在批准之前的监管机构所需的。该遗传毒性测试合同使用全球接受的标准测试方案以及适用的创新方法为DTT提供有关各种类型与暴露有关的遗传损害的信息，以补充从标准测试中获得的信息。根据本合同使用的测试系统包括体外（动物和人类细胞基于细胞，细菌）和体内（大鼠和小鼠）测定法。该遗传毒性测试合同的能力不断更新，以通过该领域的最新科学方法保持最新状态，并与进行此类测试的国际指南一致。该领域目前正在快速发展，今天发生的技术能力发生了许多巨大变化。