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EC number: 203-929-1 | CAS number: 112-03-8
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:
- From December 07, 1994 to December 16, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trimethyloctadecylammonium chloride
- EC Number:
- 203-929-1
- EC Name:
- Trimethyloctadecylammonium chloride
- Cas Number:
- 112-03-8
- Molecular formula:
- C21H46NCl
- IUPAC Name:
- N,N,N-trimethylhexadecan-1-aminium chloride
- Test material form:
- solid: flakes
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 0.8, 4, 20, 100, 500 and 2,500 µg/plate (for both with and without metabolic activation)
- Vehicle / solvent:
- Ethanol
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Tested for TA 100, TA 1535 in the absence of S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Tested for TA 1537 in the absence of S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Tested for TA 98 in the absence of S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-amino anthracene
- Remarks:
- Tested for TA 100, TA 1535, TA 1537, TA 98 in presence of S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation)
DURATION:
- Preincubation period: 48h - Evaluation criteria:
- The test substance is classified as mutagenic if it has either of the following effects:
- 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn.
- Dose related increase in the mean number of revertants per plate of atleast one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in atleast two to three concentration of the test substance at complete bacterial background lawn.
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
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Remarks:
- Conducted according to old OECD guideline
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Additional information on results:
- Solubility: Visible precipitation of the test substance on the plates was observed at 5,000 µg/plate in the first experiment.
Toxicity: The test substance was toxic to most of the bacterial strain at doses of 100 µg/plate and above. Thinning of the bacterial lawn and a reduction in the number of colonies were observed at this dose.
Any other information on results incl. tables
The test compound did not cause a significant increase in the number of revertant colonies with any of the tester strains either in the absence or in the presence of S-9 Mix. No dose dependent effect was obtained. The test was performed in two independent experiments. It was concluded that the test substance not mutagenic in these bacterial test systems either in the absence or in the presence of an exogenous metabolizing system.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance was not mutagenic in Salmonella typhimurium strain TA97, TA98, TA100 or TA1535, with or without metabolic activation.
- Executive summary:
A study was conducted to determine the in vitro genetic toxicity of the test substance, C18 TMAC (79.8% active) according to a method similar to OECD Guideline 471, in compliance with GLP. Salmonella typhimurium strains TA97, TA98, TA100 and TA1535 were treated with the test substance using the Ames plate incorporation method. Tests were carried out in triplicate, both with and without the addition ofmetabolic activation (S9-mix). The concentration range of the test substance was 0.8 to 2500 µg/plate. Cytotoxicity was observed at ≥100 µg/plate. Control plates without mutagen showed that the number of spontaneous revertant colonies was similiar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies. No significant increase in the frequency of revertant colonies was recorded for any of the bacterial strains at any of the test substance concentrations tested, either with or without metabolic activation. Under the study conditions, the test substance was not mutagenic in Salmonella typhimurium strain TA97, TA98, TA100 or TA1535, with or without metabolic activation (Muller, 1995).
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