Registration Dossier
Registration Dossier
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EC number: 213-563-4 | CAS number: 981-34-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15/09/2016-06/10/2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione
- EC Number:
- 213-563-4
- EC Name:
- 9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione
- Cas Number:
- 981-34-0
- Molecular formula:
- C22H28O5
- IUPAC Name:
- 17,21-dihydroxy-16-methyl-9,11-epoxypregna-1,4-diene-3,20-dione
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Vehicle / solvent:
- - Vehicle used:Dimethyl sulfoxide
- Justification for choice of vehicle: Based on the solubility test
Results and discussion
Test results
- Species / strain:
- other: all strain tested
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
Applicant's summary and conclusion
- Conclusions:
- On the basis of the results of this study, it is concluded that Beta-methylepoxy is non mutagenic as it did not induce (point) gene mutation at histidine locus by base pair changes or frameshift in the presence and absence of metabolic activation system in all five tester strains of salmonella typhimurium TA 1537, TA 1535, TA 100 and TA 102.
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