Division 1.1 INTRODUCTION

This method 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 in utero; this may include assessment of maternal effects as well as death, structural abnormalities, or altered growth in the foetus. Functional deficits, although an important part of development, are not an integral part of this test method. They may be tested for in a separate study or as an adjunct to this study using the test method for developmental neurotoxicity. For information on testing for functional deficiencies and other postnatal effects the Test Method for the two-generation reproductive toxicity study and the developmental neurotoxicity study should be consulted as appropriate.

This test method may require specific adaptation in individual cases on the basis of specific knowledge on e.g. physicochemical or toxicological properties of the test substance. Such adaptation is acceptable, when convincing scientific evidence suggests that the adaptation will lead to a more informative test. In such a case, this scientific evidence should be carefully documented in the study report.