OECD Guidelines for the Testing of Chemicals, Section 4
- 2074-5788 (online)
The OECD Guidelines for the Testing of Chemicals is a collection of about 150 of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of chemicals. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification, chemical registration and in chemical evaluation. They can also be used for the selection and ranking of candidate chemicals during the development of new chemicals and products and in toxicology research. This group of tests covers health effects.
Test No. 414: Prenatal Development Toxicity Study
- 22 Jan 2001
- 9789264070820 (PDF)
This Test Guideline for developmental toxicity testing is designed to provide general information concerning the effects of prenatal exposure on the pregnant test animal and on the developing organism.
The test substance is normally administered to pregnant animals at least from implantation to one day prior to the day of scheduled kill, which should be as close as possible to the normal day of delivery. This Test Guideline is intended for use with rodent (rat preferably) and non-rodent (rabbit preferably). Each test and control group should contain a sufficient number of females to result in approximately 20 female animals with implantation sites at necropsy. Three concentrations, at least, should be used. The test substance or vehicle is usually administered orally by intubation. A limit test may be performed if no effects would be expected at a dose of 1000 mg/kg bw/d. The results of this study include measurements (weighing) and clinical daily observations, each day preferably at the same time. Shortly before caesarean section, the females are killed (one day prior to the expected day of delivery), the uterine contents are examined, and the foetuses are evaluated for soft tissue and skeletal changes. In any study which demonstrates an absence of toxic effects, further investigation to establish absorption and bioavailability of the test substance should be considered.