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Toxicological information

Genetic toxicity: in vitro

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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.