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Relevance of parameters related to fertility and reproduction in toxicity testing

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Author: Koëter, H.B.W.M.
Institution: Centraal Instituut voor Voedingsonderzoek TNO
Source:American Journal of Industrial Medicine, 1-2, 4, 81-86
Identifier: 229347
Keywords: Antibiotic agent · Chemical agent · Chlorinated hydrocarbon · Heavy metal · Insecticide · Chemical teratogenesis · Drug toxicity · Female genital system · Fertility · Fetus · Intoxication · Male genital system · Nonhuman · Pregnancy · Reproduction · Short survey · Toxicity testing · Animal · Drug Evaluation, Preclinical · Female · Fertility · Pregnancy · Rats · Reproduction · Support, Non-U.S. Gov't · Toxicology · Zoology · Medicine · Geneeskunde · Pharmacology


Toxicity data of 37 compounds tested in both a subchronic study and one or more studies focused on reproduction were evaluated to obtain information on the significance of fertility and reproduction parameters in setting no-effect levels (NEL). It appeared that a) the test system aimed at reproduction and development was more sensitive than the subchronic study for 35% of the selected compounds and was equally sensitive for another 35%; b) for 65% of these compounds parameters related to reproduction and development were at least codecisive in determining the minimal-effect level (MEL); c) for 21% of all compounds, parameters related to reproduction were the most sensitive and therefore decisive for the MEL. It was concluded that reproduction in its broadest sense is a very sensitive tool in toxicity testing. The possibilities of either applying a simple screen of fertility and reproduction at an early stage of toxicity testing or incorporating fertility and reproduction parameters in the current subchronic study are discussed.