Registration Dossier
Registration Dossier
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EC number: 444-110-0 | CAS number: 16510-27-3
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
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 444-110-0
- EC Name:
- -
- Cas Number:
- 16510-27-3
- Molecular formula:
- C11H14O
- IUPAC Name:
- 1-(cyclopropylmethyl)-4-methoxybenzene
- Details on test material:
- Batch No LDP0200015
Purity 99.1%
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Experiment I : 10;33;100;333;1000; and 2500 microg/plate
Experiment II : 3;10;33;100;333 and 1000 microg/plate
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Concurrent untreated and solvent controls were performed
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Concurrent untreated and solvent controls were performed
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 and TA100 with a concentration of 10 microg/plate without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- Concurrent untreated and solvent controls were performed
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Concurrent untreated and solvent controls were performed
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- TA1537 and TA98 with a concentration of 10 microg/plate and 50 microg/plate respectively without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- Concurrent untreated and solvent controls were performed
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Concurrent untreated and solvent controls were performed
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA102 with a concentration of 4 microg/plate without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- Concurrent untreated and solvent controls were performed
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Concurrent untreated and solvent controls were performed
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA1535, TA1537, TA98, TA100 and TA102 with a concentration of 2.5 microg/plate with metabolic activation
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- toxic effects, evident as a reduction in the number of revertants was observed at the higher concentration with and without metabolic activation in all strains used.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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
Therefore Cyclopropenyl Estragole is considered to be non-mutagenic in this Samonella Typhimurium reverse mutation assay.
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