Benzyl-C12-14-alkyldimethylammonium chlorides

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:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides

EC Number:

270-325-2

EC Name:

Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides

Cas Number:

68424-85-1

Molecular formula:

C12-14H25-29-(CH3)2-C6H5-N.CL

IUPAC Name:

Quaternary ammonium compounds, benzyl C12-C16 (even numbered)-alkyldimethyl chlorides

Test material form:

liquid

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100.

Metabolic activation:

with and without

Metabolic activation system:

liver microsome fraction of Aroclor-induced rats for metabolic activation (S9-mix)

Test concentrations with justification for top dose:

0, 0.31, 0.93, 2.78, 8.33 and 25 µg/plate.

Details on test system and experimental conditions:

Salmonella typhimurium reverse mutation assay

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>= 50.0 µg per plate

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>= 50.0 µg per plate

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>= 50.0 µg per plate

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>= 50.0 µg per plate

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>= 50.0 µg per plate

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: not mutagenic

Any other information on results incl. tables

For result tables, kindly refer to the attached background material section of the IUCLID.

Applicant's summary and conclusion

Conclusions:

Under the study conditions, the test substance was not considered to be mutagenic in the presence and absence of exogenous metabolic activation.

Executive summary:

A study was conducted to determine the in vitro genetic toxicity of the test substance, C12-16 ADBAC (50% active in water) according to OECD Guideline 471 (Ames test), in compliance with GLP. The substance was examined for mutagenic activity in the Ames test using the histidine-requiring Salmonella typhimurium mutant strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100, and a liver microsome fraction of Aroclor-induced rats for metabolic activation (S9-mix). The substance was tested at doses of 0, 0.31, 0.93, 2.78, 8.33 and 25 µg/plate. Based on preliminary test in TA 98, 25 µg/plate was chosen as the highest dose level. The test was carried out twice. Under the study conditions, the substance was considered to be non-mutagenic in the presence and absence of exogenous metabolic activation (Wilmer, 1986).