Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 931-336-4 | CAS number: -
Genetic toxicity: in vitro
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 for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 010
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
