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：
10281726
负责人：
LESLIE RECIO
金额：
$ 93.48万
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 2021-09-05
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10281726
关键词：
Adult Adverse effects Aging Anabolism Animal Model Animal Testing Animals Biological Biological Assay Biological Effect of Chemicals Biological Monitoring Biotechnology Birth Blood specimen Botanicals Brain Carcinogens Cells Chemical Exposure Chemicals Chromosomes Clinic Clinical Clinical Research Colon Comet Assay Complication Congenital Abnormality Contracts DNA Damage DNA Sequence Alteration DNA sequencing Data Databases Development Diagnosis Disasters Disease Down Syndrome Early Diagnosis Environmental Exposure Environmental Impact Erythrocytes Event Evolution Exposure to Family suidae Freezing Frequencies Future Gene Expression Gene Expression Profile Gene Mutation Generations Genes Genetic Genetic Diseases Genomic DNA Guidelines Health Heritability Human In Vitro Induced Mutation International Investigation Kidney Laboratories Life Link Liver Malignant Neoplasms Mammalian Cell Methods Micronucleus Tests Mission Mitochondrial Diseases Modeling Monitor Mouse Strains Mus Mutagenicity Tests Mutation Mutation Detection Mutation Spectra National Institute of Environmental Health Sciences Neurodegenerative Disorders Neurodevelopmental Disorder Neurologic Oncology PI-Glycan Participant Pesticides Pharmaceutical Preparations Pharmacologic Substance Process Protocols documentation Rattus Resources Rivers Rodent Sampling Source Sprague-Dawley Rats Stomach Study models Symptoms System Technology Testing Tissue Sample Tissues Toxic effect Toxicity Tests Toxicogenetics Toxicology Translating United States Environmental Protection Agency United States Food and Drug Administration Update West Virginia autism spectrum disorder autistic base carcinogenicity contaminated water dietary supplements early life exposure environmental chemical exposed human population flexibility genetic profiling genotoxicity human study in vitro testing in vivo innovation interest micronucleus mutation assay novel strategies peripheral blood reproductive reproductive toxicity response treatment response tumor

项目摘要

This genetic toxicology testing contract has supported the overall mission of NTP 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 as well as neurodegenerative diseases such as ALS, neurological conditions such as autism, aging processes, birth defects such as Down syndrome, mitochondrial diseases, 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 NTP on various types of exposure-related genetic damage using universally 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NTP的整体使命，以提供30多年来感兴趣的化合物的详细毒理学特征，包括潜在的致癌性。评估遗传损伤，这是癌症开始和发育以及神经退行性疾病的重要因素，例如ALS，诸如自闭症，衰老过程，唐氏综合症，线粒体疾病以及其他不良人类健康效应等神经系统疾病，例如唐氏综合症，唐氏综合症，诸如唐氏综合症，诸如唐氏综合症，人类健康疾病，是任何化学物质或化学物质的重要组成部分。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普遍接受的标准测试方案以及适用的创新方法为NTP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。