The toxicological testing of metabolites

Abstract

The 1978 Office of Pesticide Programs Guidelines gave guidance to the registrant as to the type and nature of the toxicological studies required to register a pesticide in the United States (Federal Register, Aug. 22, 1978, Part II). The most rigorous data requirements are for pesticides used on food or feed. Usually for major studies such as oncogenicity, chronic feeding and multigeneration reproduction, the test substance is the technical material. The highest dose in these tests is one which is either the maximum tolerated dose or one which induces some toxic effects. Presently the Agency is attempting to harmonize Pesticide Guidelines with those acceptable to the Organization for Economic Cooperation and Development (OECD). When significant pesticide metabolites are found in food residues and these differ from animal metabolites then toxicity testing is needed for these products. The type and duration of testing is determined on an individual basis.