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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
Reference substance name:
N-benzyl-N,N-dimethyltetradecan-1-aminium chloride
EC Number:
939-253-5
Cas Number:
68424-85-1
Molecular formula:
C12-14H25-29-(CH3)2-C6H5-N.Cl
IUPAC Name:
N-benzyl-N,N-dimethyltetradecan-1-aminium chloride
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 resultsopen allclose all
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
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
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
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
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).