Registration Dossier
Registration Dossier
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EC number: 427-230-8 | CAS number: 5571-36-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EC Directive 92/69/EEC, B.14 OECD Guideline no. 471: Genetic Toxicology: Salmonella typhimurium Reverse Mutation Assay. Ames test.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 427-230-8
- EC Name:
- -
- Cas Number:
- 5571-36-8
- Molecular formula:
- C20H26O3
- IUPAC Name:
- (3bS,11aS)-11a-methyl-1,2,3,3a,3b,4,5,6,8,9,11,11a-dodecahydrospiro[cyclopenta[a]phenanthrene-7,2'-[1,3]dioxolan]-1-one
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella thyphimurium TA98, TA100, TA1535 and TA1537
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9 homogenate.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 10 ... 1000 μg/plate
Concentration range in the main test (without metabolic activation): 10 ... 1000 μg/plate - Vehicle / solvent:
- Solvent: dimethylsulphoxide or saline
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 1000 μg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 5000 μg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 5000 μg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 1000 μg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 1000 μg/plate)
- Additional information on results:
- Observations:
The bacterial background lawn was not reduced at all
concentrations tested and no decrease in the number of
revertants was observed.
All bacterial strains showed negative responses over the
entire dose range, i.e. no dose-related, two-fold, increase
in the number of revertants in two independently repeated
experiments.
The negative and strain-specific positive control values
were within laboratory background historical control data
ranges indicating that the test conditions were adequate and
that the metabolica activation system functioned properly. - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Genotoxicity is not available.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
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