Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vitro
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 similar 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

Conclusions:
Not mutagenic in Ames test.
Executive summary:

In the bacterial mutation test, no substantial increases in the revertant colony counts were obtained with any strain following exposure to either a single lot of abiraterone or two lots of abiraterone acetate in either the initial or confirmatory tests in the absence or presence of S9 mix—a rat liver microsomal enzyme preparation. The results indicated that abiraterone and abiraterone acetate show no evidence of genotoxic activity in this in vitro mutagenicity assay.