Regulatory Position

Regulatory agencies in the United States and Europe require the inclusion of anumberofendpoints in standard toxicology studies. Weights ofimmunocompe-

tent organs and histopathology are required. Extensive examinations of the spleen, thymus, lymph nodes (one node covering the route of administration and another distal node covering systemic effects), Peyer's patches, and the bone marrow are required by the EPA, FDA, and OECD. Lymphocyte phenotyping is listed as an optional assay in the harmonized FIFRA/TSCA guidelines.

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