A REGULATORY GUIDE TO THE HISTOPATHOLOGICAL ASSESSMENT OF NEUROTOXICITY STUDIES

Abstract

The purpose of this project is to help those involved in the conduct of neurotoxicity studies by providing an efficient way to access a variety of regulatory guidelines in one convenient guide. Testing new and existing chemicals for neurotoxicity in animals is a monumental task both practically and economically, yet it is critical in understanding their potential effect on man. Regulatory guidelines allow scientists to produce reliable data. With this data, it is possible to develop a database of information to screen chemicals efficiently and eliminate unnecessary testing. Regulatory agencies gather protocols from experts in the field and form guidelines for testing chemicals in animals. Even though these guidelines can be obtained from the Internet or by contacting individual agencies, accessing specific guidelines from a variety of organizations on a specific topic can be complex. Sixteen guidelines for neurotoxicity testing from the United States Environmental Protection Agency (EPA), the United States Food and Drug Administration (FDA) and the Organisation for Economic Co-operation and Development (OECD) were collected into a guide. This guide encompasses general, delayed and developmental neurotoxicity test methods. Only the portions of the guidelines have been included specifically referring to clinical observations prior to necropsy, the processing of the tissues to slides and the microscopic evaluation. This project intends to be an important resource for the histopathological techniques for testing neurotoxicity currently provided by the EPA, FDA and OECD. Scientists are now able to easily access test methods from a single regulatory guide. The guidelines are presented in a condensed yet accurate form. Important references are included so specific topics can be further researched. Providing such a guide allows scientist to evaluate their current techniques and have access to important industry standards.