Table II.
Abnormality | Incidence in rat studiesb | Number of affected marmosetsc |
|
---|---|---|---|
Expected | Observed | ||
Hypospadias | 17% | 2 | 0 |
Cryptorchidism | ≥70% | ≥7 | 0 |
Small testes/impaired spermatogenesis | ≥70% | ≥7 | 0 |
Focal testicular dysgenesis | ≥50% | ≥5 | 0 |
aAs MBP is considered to be the active moiety, exposure of the marmosets to MBP should have been at least equivalent (and probably more) to that in rats administered the same dose of DBP; bIncidence observed in previous studies (Fisher et al., 2003; Mahood et al., 2007); cExpected number based on 11 MBP-exposed offspring studied at birth or in adulthood and assuming the same % incidence as found in our rat studies.