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EC number: 619-547-7 | CAS number: 211515-46-7
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:
- other information
- Study period:
- 07. 01. 2009 to 26. 01. 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: EEC (1992). Methods for the determination of physio-chemical properties, toxicity and ecotoxicity: Annex V to Directive 79/831/EEC. B.14. Salmonella typhimurium - Reverse mutation assay. Not carried out under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not specified
- Principles of method if other than guideline:
- CAT-Acid Chloride was evaluated for mutagenic activity in the Ames test. A standard plate
incorporation assay was performed in absence and in presence of an exogenous metabolic
activation system (S9). Five Salmonella typhimurium tester strains (TA1535, TA97,
TA98, TA100, and TA102) were employed. The activity of the S9-mix and the
responsiveness of the tester strains were verified by including appropriate controls into
each experiment. The mutant frequencies of the controls were in the range of our
historical control values and the data published in the literature.
CAT-Acid Chloride was dissolved in DMSO. Based on toxicity observed in the range finder
assay concentrations between 31.6 and 3160 µg/plate were selected for the main
experiment. - GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- CAT-Acid Chloride / 1-(2-Ethylbuty)-cyclohexanecarbonyl chloride
- IUPAC Name:
- CAT-Acid Chloride / 1-(2-Ethylbuty)-cyclohexanecarbonyl chloride
- Details on test material:
- Name: CAT-Acid Chloride / 1-(2-Ethylbuty)-cyclohexanecarbonyl chloride
Molecular Weight: 230.7770
Storage conditions: Room temperature, under nitrogen
Constituent 1
Method
- Target gene:
- Five Salmonella typhimurium reverse mutation strains (TA1535, TA97,
TA98, TA100, and TA102) were employed.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- between 31.6 and 3160 µg/plate
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: ICR 191
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- weak, dose related increase of the of the colony numbers in absence of S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The test item did not induce any dose related increase in the number of revertant colonies
in four of the five tester strains. However, strain TA98 showed a weak, dose related
increase of the of the colony numbers in absence of S9. The weak increase was confirmed
in a repeat assay conducted with this strain.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive without metabolic activation weak, dose related increase of the of the colony numbers in absence of S9
Thus, it has to be concluded that CAT-Acid Chloride shows a weak mutagenic activity in the
Ames test under the described experimental - Executive summary:
Title:
CAT-Acid Chloride: Bacterial reverse mutation test (Ames test)
Method and Material:
CAT-Acid Chloride was evaluated for mutagenic activity in the Ames test. A standard plate
incorporation assay was performed in absence and in presence of an exogenous metabolic
activation system (S9). Five Salmonella typhimurium tester strains (TA1535, TA97,
TA98, TA100, and TA102) were employed. The activity of the S9-mix and the
responsiveness of the tester strains were verified by including appropriate controls into
each experiment. The mutant frequencies of the controls were in the range of our
historical control values and the data published in the literature.
CAT-Acid Chloride was dissolved in DMSO. Based on toxicity observed in the range finder
assay concentrations between 31.6 and 3160 µg/plate were selected for the main
experiment.
Resultes:
The test item did not induce any dose related increase in the number of revertant colonies
in four of the five tester strains. However, strain TA98 showed a weak, dose related
increase of the of the colony numbers in absence of S9. The weak increase was confirmed
in a repeat assay conducted with this strain.
Conclusion:
Thus, it has to be concluded that CAT-Acid Chloride shows a weak mutagenic activity in the
Ames test under the described experimental
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