1 The design of the classical three segment reproductive test for new drugs is described and the relative merits of the USA/EEC and the Japanese guidelines are discussed.
2 The importance of pharmacokinetic studies in the interpretation of teratology studies and extrapolation to humans is mentioned in relation to caffeine, sodium valproate and cyclophosphamide.
3 Changing ideas on the design of multi-generation studies are reviewed.
4 Recent developments in the fields of behavioural teratology, chemicals in breast milk and transplacental carcinogenesis are described.
Get full access to this article
View all access options for this article.
References
1.
Ecetoc.Identification and assessment of the effects of chemicals on reproduction and development. ECETOC Monograph No. 5. Publ. European Chemical Industry Ecology and Toxicology Centre, Brussels, 1983.
2.
Tanimura T.Prospects of the reproductive toxicology. Congenital Anomalies1984; 24: 319-28.
3.
Ikeda GJ, Sapienza PP, McGinnis ML, Bragg LE, Walsh JJ & Collins Tfx.Blood levels of caffeine and results of fetal examination after oral administration of caffeine to pregnant rats. Journal of Applied Toxicology1982; 2: 307-14.
4.
Elmazar Mma, McElhatton PR & Sullivan FMStudies on the teratogenic effects of different oral preparations of caffeine in mice. Toxicology1982; 23: 57-71.
5.
Smith SE, McElhatton PR & Sullivan FMEffects of administering caffeine to pregnant rats either as a single daily dose or as divided doses four times a day. Food and Chemical Toxicology1987; 25: 125-33.
6.
Nau H. & Scott WJPharmacokinetics in Teratogenesis. Volume 1. Boca Raton, Florida: CRC Press Inc., 1987.
7.
Fitzhugh OGReproduction tests. In: Modern Trends in Toxicology , eds E Boyland & R Goulding, pp. 75-85. London: Butterworths , 1968.
8.
UsfdaToxicological Principles for the safety assessment of direct food additives and color additives used in food. US Food and Drug Administration, Bureau of Foods, 1982.
9.
Werboff J. & Gottlieb JSDrugs in pregnancy: behavioural teratology. Obstetrical and Gynecological Survey1963; 18: 420-3.
10.
Rogan WJ, Bagniewska A. & Damstra T.Pollutants in breast milk. New EnglandJournal of Medicine1980; 302: 1450-3.
11.
Jensen AAChemical contaminants in human milk. Residue Reviews1983; 89: 1-127.
12.
Tomatis L.Role of prenatal events in determining cancer risks. In: Modern Trends in Toxicology, Volume 2, eds E Boyland & R Goulding , pp. 163-178. London: Butterworths , 1974.
