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Administrative data

genetic toxicity in vitro
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
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.
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
other company data

Materials and methods

Results and discussion

Applicant's summary and conclusion

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.