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EC number: 207-355-2 | CAS number: 464-49-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- 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:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008, L142, Annex Part B, B 17, "In vitro Mammalian Cell Gene Mutation Test", dated May 30, 2008.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Bornan-2-one
- EC Number:
- 200-945-0
- EC Name:
- Bornan-2-one
- Cas Number:
- 76-22-2
- Molecular formula:
- C10H16O
- IUPAC Name:
- 1,7,7-trimethylbicyclo[2.2.1]heptan-2-one
- Test material form:
- solid: crystalline
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Test concentrations with justification for top dose:
- Experiment I
without metabolic activation:
0.1, 0.2, 0.5, 1.0, 2.0, 3.0, 3.5 and 4.0 mM
and with metabolic activation:
0.1, 0.2, 0.5, 1.0, 2.0, 3.0, 3.5, 4.0 and 4.5 mM
Experiment II
without metabolic activation:
0.1, 0.2, 0.5, 1.0, 1.5, 2.0, 2.5 and 3.0 mM
and with metabolic activation:
0.3, 0.6, 1.1, 2.2, 3.2, 3.7, 4.0 and 4.2 mM - Vehicle / solvent:
- 1% DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Evaluation criteria:
- -The induced mutant frequency meets or exceeds the Global Evaluation
factor (GEF) of 126 mutants per 106 cells
- A dose-dependent increase in mutant frequency is detected.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion, in the described mutagenicity test under the experimental conditions
reported, the test item Bornan-2-one (EC# 200-945-0, CAS# 76-22-2) is considered to
be non-mutagenic in the in vitro mammalian cell gene mutation assay (thymidine kinase
locus) in mouse lymphoma L5178Y cells.
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