Registration Dossier
Registration Dossier
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EC number: 604-165-5 | CAS number: 139893-43-9
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- genetic toxicity in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- other: no data
- GLP compliance:
- no
Test material
- Reference substance name:
- Simvastatin
- IUPAC Name:
- Simvastatin
Constituent 1
Test animals
- Species:
- mouse
Results and discussion
Test results
- Genotoxicity:
- negative
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Genotoxicity – No evidence of mutagenicity was observed in the Ames microbial mutagenicity test with or without rat or mouse liver metabolic activation2. In addition, no evidence of damage to genetic material was noted in an in vitro alkaline elution assay using rat hepatocytes, a V-79 mammalian cell forward mutation study, an in vitro chromosome aberration study in CHO cells, or an in vivo chromosomal aberration assay in mouse bone marrow. - Executive summary:
Genotoxicity – No evidence of mutagenicity was observed in the Ames microbial mutagenicity test with or without rat or mouse liver metabolic activation2. In addition, no evidence of damage to genetic material was noted in an in vitro alkaline elution assay using rat hepatocytes, a V-79 mammalian cell forward mutation study, an in vitro chromosome aberration study in CHO cells, or an in vivo chromosomal aberration assay in mouse bone marrow.
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