Trimethyloctylammonium methyl sulphate

Genetic toxicity: in vitro

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

Test material information

Constituent 1

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.