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Regulatory Considerations in Toxicological Neuropathology
Citation:
JENSEN, K. F. AND K. C. Raffaele. Regulatory Considerations in Toxicological Neuropathology. First, Chapter 31, Mark T. Butt, DVM and Brad Bolon, DVM (ed.), Fundamental Neuropathology for Pathologists and Toxicologists: Principles and Techniques. John Wiley & Sons Incorporated, New York, NY, , 501-505, (2011).
Impact/Purpose:
Neuropathology is an essential aspect of neurotoxicity assessment and is included in several US Environmental Protection Agency [US EPA or Agency] and Organisation for Economic Cooperation and Development [OECD] testing guidelines for health effects of chemicals. A variety of considerations are important to determine whether or not effects are treatment-related, adverse and dose-dependent. These considerations include the number of animals employed, appropriate sampling and preparation oftissues, control groups, the qualitative and quantitative assessments and the content of report.
Description:
Pathological assessment of the nervous system is included in several US Environmental Protection Agency [US EPA or Agency] and Organization for Economic Cooperation and Development [OECD] testing guidelines for health effects of chemicals. A variety of considerations are important when attempting to use neuropathologic findings in determining whether or not effects are treatment-related, adverse and dose-dependent. These considerations include the number of animals employed, appropriate sampling and preparation of tissues, control groups, the qualitative assessment, assessment of dose-dependence of effects and the content of report.
