ABSTRACT

Globally harmonized reproductive toxicity testing protocols have been in use since the 1980s. In recent years, these tests have become the subject of renewed discussion. This has led to changes in existing protocols as well as to the development of new study designs. As a consequence and in parallel, testing strategies for regulatory safety assessment of chemicals are also being reformulated. This chapter gives an overview of existing test systems and current activities worldwide, with an outlook

8.2.5 Extended One-Generation Study ...................................................... 176 8.2.5.1 Principle and Status ........................................................... 176 8.2.5.2 Test Protocol ...................................................................... 176 8.2.5.3 Application in the Testing Strategy ................................... 177

8.2.6 Direct Pup Exposure for Juvenile Toxicity Testing .......................... 177 8.2.7 Alternative Test Systems for Reproductive Hazard Identification .... 178

8.2.7.1 Rodent Postimplantation Embryo Culture ......................... 178 8.2.7.2 Embryonic Stem Cell Test ................................................. 180 8.2.7.3 Zebrafish Embryotoxicity Assay ........................................ 180

8.2.8 In Silico Nontesting Methods for Hazard Identification .................. 181 8.3 Conclusions ................................................................................................... 181 References .............................................................................................................. 182

toward developments in the future. This section will give a bird’s-eye view of current developments, whereas details of guidelines and test systems are discussed in Section 8.2. Conclusions follow in Section 8.3.