Registration Dossier
Registration Dossier
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EC number: 402-240-5 | CAS number: 102561-46-6 BONTRON P-51
Genetic toxicity: in vitro
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:
- 2 004
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
- 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:
- benzyltributylammonium 4-hydroxynaphthalene-1-sulfonate
- Test material form:
- not specified
- Details on test material:
- Details not available
Constituent 1
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.
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