Registration Dossier
Registration Dossier
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EC number: 204-841-6 | CAS number: 127-41-3
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source
Data source
Reference
- Reference Type:
- other: Secondary source
- Title:
- Gene mutation toxicity study of the test chemical
- Author:
- Scientific Opinion on Flavouring Group Evaluation
- Year:
- 2 014
- Bibliographic source:
- EFSA Journal
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- In vivo Chromosome aberration study was performed to determine the mutagenic nature of the test chemical
- GLP compliance:
- not specified
- Type of assay:
- mammalian bone marrow chromosome aberration test
Test material
- Reference substance name:
- 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
- EC Number:
- 204-841-6
- EC Name:
- 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
- Cas Number:
- 127-41-3
- Molecular formula:
- C13H20O
- IUPAC Name:
- 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
- Details on test material:
- - Name of test material: α- Ionone
- Molecular formula: C13-H20-O
- Molecular weight: 192.3 g/mol
- Substance type: organic
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Corn oil
- Justification for choice of solvent/vehicle: The test chemical was soluble in corn oil
- Concentration of test material in vehicle: 0, 300, 600, or 1200 mg/kg
- Amount of vehicle (if gavage or dermal): No data
- Type and concentration of dispersant aid (if powder): No data
- Lot/batch no. (if required): No data
- Purity: No data - Details on exposure:
- No data
- Duration of treatment / exposure:
- No data
- Frequency of treatment:
- No data
- Post exposure period:
- No data
Doses / concentrations
- Remarks:
- 0, 300, 600 or 1200 mg/Kg day
- No. of animals per sex per dose:
- 0 mg/Kgday: 5 males and 5 females
300 mg/Kgday: 5 males and 5 females
600 mg/Kgday: 5 males and 5 females
1200 mg/Kgday: 5 males and 5 females - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- No data
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- No data
- Evaluation criteria:
- The bone marrow cells were observed for the presence of micronucleated polychromatic erythrocytes
- Statistics:
- No data
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: No mutagenic potential
- Additional information on results:
- No data
Applicant's summary and conclusion
- Conclusions:
- The test chemical did not cause statistically significant increases in the incidence of micronucleated polychromatic erythrocytes and hence is not likely to be mutagenic in vivo.
- Executive summary:
A mouse micronucleus test was also performed with the test chemical in order to evaluate the biological significance of the positive in vitro chromosome aberration assay. The test chemical at doses of 300, 600, or 1200 mg/kg in corn oil was administered by intraperitoneal injection to male and female ICR mice (5/sex/dose). Reductions (up to 21%) in the ratio of polychromatic erythrocytes to total erythrocytes were observed in some of the a-ionone treated groups relative to the respective vehicle controls. These reductions suggest the bioavailability of the test chemical to the bone marrow. There were no statistically significant increases in the incidence of micronucleated polychromatic erythrocytes in the test chemical treated groups relative to their respective vehicle control in either male or female mice, regardless of dose level or bone marrow collection time. The test chemical was concluded to be negative in the mouse micronucleus assay and hence is considered to be non-mutagenic in vivo.
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