Registration Dossier

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:
2009
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

Constituent 1
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

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