Registration Dossier
Registration Dossier
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EC number: 203-927-0 | CAS number: 112-00-5
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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dodecyltrimethylammonium chloride
- EC Number:
- 203-927-0
- EC Name:
- Dodecyltrimethylammonium chloride
- Cas Number:
- 112-00-5
- Molecular formula:
- C15H34N.Cl
- IUPAC Name:
- N,N,N-trimethyldodecan-1-aminium chloride
- Reference substance name:
- Trimethyl(tetradecyl)ammonium chloride
- EC Number:
- 224-958-6
- EC Name:
- Trimethyl(tetradecyl)ammonium chloride
- Cas Number:
- 4574-04-3
- Molecular formula:
- C17H38N.Cl
- IUPAC Name:
- N,N,N-trimethyltetradecan-1-aminium chloride
- Reference substance name:
- Cetrimonium chloride
- EC Number:
- 203-928-6
- EC Name:
- Cetrimonium chloride
- Cas Number:
- 112-02-7
- Molecular formula:
- C19H42N.Cl
- IUPAC Name:
- N,N,N-trimethylhexadecan-1-aminium chloride
- Test material form:
- liquid
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- purity : 24.7% aqueous solution
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- not specified
- Test concentrations with justification for top dose:
- 0.004 - 0.4 µL per plate
- Vehicle / solvent:
- Dimethylsulphoxide (DMSO)
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Remarks:
- remarks on positive and negative control : not stated
- Details on test system and experimental conditions:
- Method/Guideline followed: Ames, B. N. 1975. Mut. Res. 31:347.
Type: Reverse mutation assay
Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537
and TA1538
Statistical methods: none.
The test was run in triplicate and a three-fold increase in back mutations was considered as the criterion for a positive test for mutagenicity. Plate incorporation assay was used. Vehicle used was dimethylsulphoxide.
Vehicle used: Yes
Vehicle Name: DMSO
Metabolic Activation: With and Without
Species or Vitro System: Salmonella typhimurium
Number of Replicates Used: 3 - Evaluation criteria:
- A three-fold increase in back mutations was considered as the criterion for a positive test for mutagenicity.
- Statistics:
- statistical methods : none
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: cytotoxic concentration
- Remarks:
- 0.1 µL/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Cytotoxic Concentration:
- Remarks:
- 0.1 µL/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Cytotoxic Concentration:
- Remarks:
- 0.1 µL/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Cytotoxic Concentration:
- Remarks:
- 0.1 µL/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Conclusions:
- Negative genotoxic effect.
Negative with and awithout metabolic activation. - Executive summary:
Negative with and without metabolic activation
Strain text description: TA98, TA100, TA1535, TA1537
Genotoxic Effect: Negative
Cytotoxic Concentration: 0.1 µl/plate
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