Registration Dossier

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:
2014
Bibliographic source:
EFSA Journal

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: α- Ionone
- Molecular formula: C13-H20-O
- Molecular weight: 192.3 g/mol
- Substance type: organic

Test animals

Species:
mouse
Strain:
ICR
Sex:
male/female
Details on test animals 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.