Division Test conditions

Developmental toxicity shall be determined for rat and rabbit by the oral route; the rat study shall not be conducted if developmental toxicity has been adequately assessed as part of an extended one-generation reproductive toxicity study.

Additional routes may be useful in human risk assessment. Malformations and variations shall be reported separately and combined in such a way that all relevant changes which are observed to occur in characteristic patterns in individual foetuses or those that can be considered to represent different grades of severity of the same type of change are reported in a concise manner.

Diagnostic criteria for malformations and variations shall be given in the report. The glossary of terminology under development by the International Federation of Teratology Societies shall be considered where possible.

When indicated by observations in other studies or the mode of action of the test substance, supplementary studies or information may be required to provide information on the postnatal manifestation of effects such as developmental neurotoxicity.