Toxicology Specifications

The Division of Translational Toxicology (DTT) at the National Institute of Environmental Health Sciences ([NIEHS], which is part of the National Institutes of Health), offers a unique venue for the testing, research, and analysis of agents of concern to identify toxic and biological effects, provide information that strengthens the science base in toxicology, and inform decisions by health regulatory and research agencies to safeguard public health. Many of these studies are conducted in support of the interagency National Toxicology Program.

Test agents (e.g., chemicals, physical agents, and mixtures) are selected for study primarily depending on level of human exposure, amount of commercial production, and chemical structure. Many of these studies are conducted in compliance with laboratory health and safety guidelines and the Food and Drug Administration Good Laboratory Practice Regulations and meet or exceed all applicable federal, state, and local health and safety regulations. Animal care and use are in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals.

The Specifications for the Conduct of Toxicity Studies by the Division of Translational Toxicology at the National Institute of Environmental Health Sciences are used to outline expectations and provide guidance for the conduct of toxicology studies by DTT. Since the 1980s, DTT and its predecessor units within NIEHS have provided contract research organizations with specifications documents to inform the conduct of their toxicology and carcinogenicity studies. In 2011, DTT published its specifications for the conduct of developmental and reproductive toxicology studies, and in 2015, released a specifications document on the conduct of neurobehavioral studies. To facilitate use and increase transparency, DTT has now compiled into a single document its specifications for studies that investigate toxicologic, carcinogenic, developmental, reproductive, or neurobehavioral outcomes. This document defines the expectations and requirements (e.g., facility, personnel, quality assurance, and health and safety) for testing facilities and provides instructions on the conduct of specific study elements (e.g., necropsy, tissue trimming). Previously, DTT’s specifications documents also included protocol requirements for its studies; however, they are not included here because over time DTT testing strategies have evolved and protocols to study specific agents are now tailored to address the identified data needs and research hypotheses. Research elements such as data analysis and pathology peer review are also not included because these are outside the scope of the specifications document.

For questions about this document, please email [email protected] or call 984-287-3209.