4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Gene mutation toxicity study of the test chemical

Author:

Kasamaki et al

Year:

1982

Bibliographic source:

Mutation Research

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

The genotoxicity of test substance widely used in everyday foods was studied by a bacterial mutation test in the Salmonella/microsome system

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

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: C13H20O
- Molecular weight: 192.3 g/mol
- Substance type: organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98 and TA100

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

S9 metabolic activation system

Test concentrations with justification for top dose:

0.01 to 50 μg/pl

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Sterilized DMSO

- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

2-nitrofluorene

benzo(a)pyrene

other: Aflatoxin B1

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: No data available
- Exposure duration: No data available
- Expression time (cells in growth medium): No data available
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: No data available

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other:

OTHER: No data available

Evaluation criteria:

For mutagenic potency, a positive result was defined as a reproducible, dose-related increase in the number of revertant colonies per plate, and a greater than 2-fold increase in spontaneous mutation rate was obtained, according to the protocol of Ames

Statistics:

No data available

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98 and TA100

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

True negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

No data available

Remarks on result:

other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:

Gene toxicity in vitro profile for the test material is negative in the presence and absence of rat liver microsome fraction S9 using Salmonella typhimurium strains TA98 and TA100 and hence it is not likely to classify as a gene mutant in vitro.

Executive summary:

The genotoxicity of the flavoring agent widely used in everyday foods was studied by a bacterial mutation test in the Salmonella/microsome system. The study was performed using Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system. The test chemical was dissolved in DMSO and used at dose levels of 0.01 to 50 μg/pl. In the mutation test, the test material did not exhibit significant induction of his⁺revertants in Salmonella typhimurium TA98 or TA100, either with or without rat liver microsome as the metabolic activation system. Gene toxicity in vitro profile for the test material test substance is negative with and without rat liver microsome fraction S9 using Salmonella typhimurium strains TA98 and TA100 and hence the test chemical is not likely to classify for gene mutation in vitro.