Division 5.6 Reproductive toxicityF1

The adverse reproductive effects are of two main types:

• impairment of male or female fertility, and

• impacts on the normal development of progeny (developmental toxicity).

Possible effects on all aspects of reproductive physiology in both males and females, as well as possible effects on pre-natal and post-natal development, must be investigated and reported. If in exceptional circumstances, it is claimed that such testing is unnecessary, that claim must be fully justified.

While the standard reference point for treatment responses are concurrent control data, historical control data may be helpful in the interpretation of particular reproductive studies. Where submitted, historical control data shall be from the same species and strain, maintained under similar conditions and shall be from contemporaneous studies. The information on historical control data provided must include:

• identification of species and strain, name of the supplier, and specific colony identification, if the supplier has more than one geographical location,

• name of the laboratory and the dates when the study was performed,

• description of the general conditions under which animals were maintained, including the type or brand of diet and, where possible, the amount consumed,

• approximate age, in days, of the control animals at the beginning of the study and at the time of killing or death,

• description of the control group mortality pattern observed during or at the end of the study, and other pertinent observations (e.g. diseases, infections), and

• name of the laboratory and the examining scientist responsible for gathering and interpreting the toxicological data from the study.