Registration Dossier
Registration Dossier
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EC number: 241-318-1 | CAS number: 17283-81-7
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:
- October 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)butan-2-one
- EC Number:
- 241-318-1
- EC Name:
- 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)butan-2-one
- Cas Number:
- 17283-81-7
- Molecular formula:
- C13H22O
- IUPAC Name:
- 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)butan-2-one
- Reference substance name:
- rel-4-((1R,6R)-2,2,6-trimethylcyclohexyl)butan-2-one
- Cas Number:
- 60761-23-1
- Molecular formula:
- C13H24O
- IUPAC Name:
- rel-4-((1R,6R)-2,2,6-trimethylcyclohexyl)butan-2-one
- Test material form:
- liquid
Constituent 1
impurity 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:
- Dihydro Ionone Beta was tested up to concentrations of 5000 ug/plate in the dose range finding test.
In the first direct plate assay Dihydro Ionone Beta was tested up to concentrations of 1000 ug/plate in the strain TA102 and up to concentrations of 333 ug/plate in the strains TA1535, TA1537 and TA98. - Vehicle / solvent:
- Negative control - Dimethyl sulfoxide
Controls
- Untreated negative controls:
- yes
- Remarks:
- Dimethyl Sulfoxide
- Positive controls:
- yes
- Details on test system and experimental conditions:
- All bacteria incubations were carried out in the dark at 37'C. The temperature was monitored during the experiment.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Executive summary:
DIHYDRO IONONE BETA did not induce a dose-related increase in the number of revertant (His+) colonies in each of the five tester strains (TA1535, TA1537, TA98, TA100, TA102) both in the absence and presence of S9 -metabolic activation. These results were confirmed in repeated experiments.
Based on the results of the study therefore, it is concluded that DIHYDRO IONONE BETA is not mutagenic in the Salmonella typhimurium revese mutation.
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