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:
key study
Study period:
Details not available
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data has been provided by ECHA from a previous notification. The data has been reviewed by a suitable Competent Authority and adjudged to be suitable for registration.

Data source

Reference
Reference Type:
other: Provided by ECHA
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Version / remarks:
"Concrete techniques for the Mutagenicity test using micro- organisms" issued by the Japanese Ministry of Labour.
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyltributylammonium 4-hydroxynaphthalene-1-sulfonate
EC Number:
402-240-5
EC Name:
Benzyltributylammonium 4-hydroxynaphthalene-1-sulfonate
Cas Number:
102561-46-6
Molecular formula:
C29H41NO4S
IUPAC Name:
benzyltributylazanium 4-hydroxynaphthalene-1-sulfonate
Test material form:
not specified
Details on test material:
Details not available

Method

Target gene:
Not specified
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Details not available
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 1538
Details on mammalian cell type (if applicable):
Details not available
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli WP2 uvr A
Details on mammalian cell type (if applicable):
Details not available
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 10 ... 5000 μg/plateConcentration range in the main test (without metabolic activation): 10 ... 5000 μg/plate
Vehicle / solvent:
Solvent: Methanol
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
Details not available
Evaluation criteria:
Not specified
Statistics:
Not specified

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
The concentration of the test substance resulting in precipitation: >5000 μg/plate.The test substance shows no evidence of mutagenic activity when tested in this bacterial system.
Remarks on result:
other: other: main test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):negative with and without metabolic activationThe test substance shows no evidence of mutagenic activity.
Executive summary:

The in vitro genetic toxicity was determined using Japanese test methods. Details are not available, but the data has been reviewed by a suitable EU Competent Authority and provided by ECHA. The test substance is not mutagenic.