Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: T003474 is an intermediate in the synthesis of abiraterone acetate. T003474 is the last step before the API. Both compounds have a silimar structure. Therefore, read-across from the API abiraterone acetate is performed.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2010

Materials and methods

Results and discussion

Applicant's summary and conclusion

Executive summary:

While no formal abiraterone acetate developmental or reproductive toxicology studies have been conducted to date, in all animal toxicology studies, reproductive organ changes were considered consistent with the expected antiandrogenic activity of abiraterone, thus reflecting the intended pharmacological activity of this compound.

In the 28-day repeated-dose toxicity study in cynomolgus monkeys, organ weight, morphological and/or histopathological changes were observed in the adrenals, mammary gland and reproductive organs. All changes showed complete or partial reversibility after a 1-month recovery period. In the 13-week repeated-dose toxicity studies, both rats and cynomolgus monkey showed similar toxicity profiles to the 28-day studies. The findings were consistent with the established pharmacology of abiraterone acetate / abiraterone.