Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019.04.11~2019.05.27
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
Section 4, TG. No. 471 'Bacterial Reverse Mutation Test' (1997-07-21).
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Trimethyloctylammonium methyl sulphate
EC Number:
265-332-2
EC Name:
Trimethyloctylammonium methyl sulphate
Cas Number:
65059-42-9
Molecular formula:
C11H26N.CH3O4S
IUPAC Name:
trimethyl(octyl)azanium methyl sulfate
Test material form:
solid: bulk
Specific details on test material used for the study:
Salmonella typhimurium
TA100, TA1535
TA98, TA1537
Escherichia coli WP2uvr A

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
positive
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
furylfuramide

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
it was concluded that Trimethyloctylammonium methyl sulphate was not mutagenic
under the conditions employed in the present study (negative).
Executive summary:

Based on the results of the concentration range-finding test and main test, the number of

revertant colonies in the test substance-treated groups were less than twice that in the

corresponding negative (vehicle) control in any test strain regardless of the presence and

absence of S9 mix. The reproducibility of the test results were confirmed with the

concentration range-finding test and main test.

The numbers of revertant colonies in the negative (vehicle) control and positive control groups in

the present study were within the acceptable ranges stipulated at the testing facility (Annex 1).

The positive controls used in the assays with the presence or absence of S9 mix showed

positive responses by the respective test strains, as evidenced by the number of revertant

colonies being greater than 2-fold of the respective negative (vehicle) control value. In each

test, there were 4 or more concentrations giving no microbial toxicity and at least 5 analyzable

concentrations for all strains in the presence and absence of S9 mix. Consequently, the

validity of the present study was confirmed.