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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
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:
Screening Of Tobacco Smoke Constituents For Mutagenicity Using The Ames' Test
Author:
Inger Florin , Lars Rutberg , Margareta Curvall And Curt R. Enzell
Year:
1980
Bibliographic source:
Toxicology, 18 (1980) 219-232

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Gene mutation toxicity study was performed to determine the mutagenic nature of the test compound Cyclohexanone
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Cyclohexanone
- IUPAC name: 2,2,6-trimethylcyclohexanone
- Molecular formula: C9H16O
- Molecular weight (if other than submission substance): 140.224 g/mol
- Substance type: Organic
Specific details on test material used for the study:
- Name of test material: Cyclohexanone
- IUPAC name: 2,2,6-trimethylcyclohexanone
- Molecular formula: C9H16O
- Molecular weight (if other than submission substance): 140.224 g/mol
- Substance type: Organic
- Physical state: No data available
Purity No data available
- Impurities (identity and concentrations): No data available

Method

Target gene:
Histidine
Species / strain
Species / strain:
other: LT-2 strains TA 98 and TA 100
Details on mammalian cell lines (if applicable):
Not applicable
Additional strain characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
Liver fraction (S-9) from Aroclor 1254 or methylcholanthrene induced rats
Test concentrations with justification for top dose:
0 or 3 µmole/plate
Vehicle:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data available
Controls
Negative controls:
not specified
Solvent controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: N-methyl-N'-nitro-N-nitrosoguanidin (without metabolic activation) and 2-aminoanthracene (with activation)
Details on test system and conditions:
METHOD OF APPLICATION: Spot test (in agar)

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: No data available

OTHER: No data available
Rationale for test conditions:
No data
Evaluation criteria:
1. Increase in the number of spontaneous revertants
2. The presence of the rfa-mutation was checked by crystal violet inhibition;
3. The presence of the plasmid pKM 101 in strains TA 98 and TA 100 was checked by resistance to ampicillin
Statistics:
No data

Results and discussion

Test results
Species / strain:
other: LT-2 strains TA 98, TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
yes
Additional information on results:
No data

Applicant's summary and conclusion

Conclusions:
Cyclohexanone is not mutagenic in the bacterium Salmonella typhimurium LT-2 strains TA 98, TA 100 with and without S9 metabolic activation system and hence is not likely to classify as gene mutant in vitro.
Executive summary:

Gene mutation toxicity study was performed to determine the mutagenic nature of Cyclohexanone (IUPAC name: 2,2,6-trimethylcyclohexanone; EC name: 2,2,6-trimethylcyclohexan-1-one). The material was dissolved in dimethysulphoxide and applied at a concentration of 3 µmole/plate in the spot test performed. Cyclohexanone did not induce reversion of mutant strains and henceis not mutagenic in the bacteriumSalmonella typhimurium LT-2 strains TA 98, TA 100 with and without S9 metabolic activation system and hence is not likely to classify as gene mutant in vitro.