Current status of behavioral teratology: science and regulation

The field of behavioral teratology has advanced rapidly in recent years since the advent of recommendations or requirements by several countries for behavioral teratology testing as part of safety evaluation procedures for pharmaceutical agents. A number of large-scale efforts in methods development have been undertaken and supported by U.S. regulatory agencies, and several recent documents have reviewed the state of the science and identified research needs in this area. Although U.S. regulatory agencies do not routinely require behavioral teratology testing, data on existing chemicals are reviewed and evaluated in the risk-assessment process. Currently, such data can be of value in at least three ways: (1) data from postnatal studies may be useful in elucidating the consequences of perinatal findings; (2) behavioral data may help to further define the lower end of the dose response curve; and (3) for chemicals where human exposure is likely, behavioral studies may help to focus on types of effects that may be important to monitor in the exposed human population.