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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:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see remarks
- Remarks:
- Study was performed according to OECD guideline published at that time and according to GLP. E. coli WP2 strain was not used. The second experiment was performed as a plate incorporation assay, but not as a preincubation assay. Since the effects were clearly negative, these limitations are not considered to decisively limit the reliability of the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
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
- Reference substance name:
- Docosyltrimethylammonium chloride
- EC Number:
- 241-327-0
- EC Name:
- Docosyltrimethylammonium chloride
- Cas Number:
- 17301-53-0
- Molecular formula:
- C25H54N1Cl
- IUPAC Name:
- N,N,N-Trimethyl-1-docosanaminium chloride
- Test material form:
- solid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Pre-Experiment and Experiment I: 0 (control), 4, 20, 100, 500, 2500, 5000 µg/plate
Experiment II: 0 (control), 4, 20, 100, 500, 2500, 5000 µg/plate - Vehicle / solvent:
- Ethanol
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene (with metabolic activation for all strains)
- Remarks:
- See below for additional information
- Details on test system and experimental conditions:
- The assay was performed in two independent experiments:
experiment I: plate incorporation assay with and without induced rat liver S9 mix
experiment II: plate incorporation assay with and without induced rat liver S9 mix
Rat liver S9 mix from Aroclor 1254 induced rats was used.
Top agar was prepared for the Salmonella strains by mixing 100 ml agar (0.6% (w/v) agar, 0.5% (w/v) NaCI) with 10 ml of a 0.5 mM histidine-biotin solution. After mixing, the liquid was poured into a petridish with minimal agar (1.5 % (w/v) agar, Vogel-Bonner E medium with 2 % (wlv) glucose). After incubation for approximately 48 hours at approx. 37 °C in the dark, colonies (hi? revertants) were counted.
DURATION
- Exposure duration: after solidification the plates were incubated upside down for approx. 48 hours at 37°C in the dark
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY: The first experiment was performed with all tester strains using three plates per dose to get information on mutagenicity and toxicity for calculating an appropriate dose range. A reduced rate of spontaneously occuring colonies and visible thinning of the bacterial lawn were used as toxicity indicators. Thinning of the bacterial lawn was evaluated microscopically.
In combination with the second experiment, toxicity testing was performed as follows: 0.1 ml of the different dilutions of the test compound were thoroughly mixed with 0.1 ml of 108 dilution of the overnight culture of TA 100 and plated with histidine and biotin rich top agar (3 plates per dose). The solvent control is compared with the number of colonies per plate in the presence of the test compound. Results are given as a ratio of these values (= surviving fraction).
POSITIVE CONTROL SUBSTANCES:
without metabolic activation: sodium azide (TA 1535, TA 100), 9-aminoacridine (TA 1537), 2-nitrofluorene (TA 98);
with metabolic activation: 2-aminoanthracene (all strains) - Evaluation criteria:
- A test substance is classified as mutagenic if it has either of the following effects:
a) a test substance produces at least a 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
b) a test substance induces a dose-related 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 in at least two to three concentrations of the test substance at complete bacterial background lawn.
The test results must be reproducible.
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- See below for additional information
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test substance was tested at doses of 4 to 5000 microgram/plate and proved to be toxic to most of the bacterial strains at doses of 2500 microgram/plate and above. Thinning of the bacterial lawn and a reduction in the number of colonies were observed at this dose.
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Mean mutant number
Exp. I: plate incorporation method without S9 mix
Concentrations given in µg/plate
Strain -- 0 -- 4 -- 20 -- 100 -- 500 -- 2500 -- 5000
TA100 -- 176.7 -- 168.0 -- 201.0 -- 217.0 -- 25.0 -- 1.3 -- 1.0
TA1535 -- 10.7 -- 6.3 -- 8.3 -- 8.0 -- 1.3 -- 1.0 -- 0.3
TA1537 -- 7.0 -- 10.7 -- 9.7 -- 11.3 -- 5.0 -- 0.0 -- 0.0
TA98 -- 27.7 -- 24.0 -- 31.3 -- 23.0 -- 7.3 -- 1.0 -- 0.0
Exp. I: plate incorporation method with rat S9 mix
Concentrations given in µg/plate
Strain -- 0 -- 4 -- 20 -- 100 -- 500 -- 2500 -- 5000
TA100 -- 137.7 -- 207.0 -- 182.7 -- 185.0 -- 165.7 -- 43.0 -- 6.0
TA1535 -- 9.3 -- 11.7 -- 14.7 -- 12.3 -- 10.0 -- 5.0 -- 1.0
TA1537 -- 11.7 -- 8.7 -- 10.0 -- 8.3 -- 6.3 -- 2.3 -- 0.7
TA98 -- 36.3 -- 34.7 -- 36.7 -- 41.7 -- 37.0 -- 15.0 -- 2.0
Exp. II: plate incorporation method without S9 mix
Concentrations given in µg/plate
Strain -- 0 -- 4 -- 20 -- 100 -- 500 -- 2500 -- 5000
TA100 -- 141.7 -- 184.3 -- 146.3 -- 145.7 -- 2.0 -- 1.0 -- 1.0
TA1535 -- 16.0 -- 12.7 -- 7.7 -- 8.7 -- 3.3 -- 0.0 -- 0.0
TA1537 -- 7.7 -- 7.7 -- 8.7 -- 8.3 -- 4.3 -- 0.0 -- 0.0
TA98 -- 26.3 -- 24.3 -- 22.0 -- 31.0 -- 9.3 -- 1.3 -- 0.0
Exp. II:
plate incorporation method with rat liver S9 mix
Concentrations given in µg/plate
Strain -- 0 -- 4 -- 20 -- 100 -- 500 -- 2500 -- 5000
TA100 -- 176.3 -- 172.7 -- 170.3 -- 170.3 -- 123.3 -- 98.7 -- 24.0
TA1535 -- 19.3 -- 13.0 -- 16.7 -- 13.3 -- 15.0 -- 1.3 -- 1.0
TA1537 -- 8.0 -- 7.0 -- 9.7 -- 10.3 -- 6.0 -- 9.3 -- 0.3
TA98 -- 36.7 -- 33.3 -- 36.3 -- 29.3 -- 30.7 -- 8.3 -- 1.3
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance was determined to be non-mutagenic in Ames test, with or without metabolic activation.
- Executive summary:
An in vitro study was conducted to determine the mutagenic potential of the test substance, C20-22 TMAC (active content not specified), using bacterial reverser mutation assay (Ames test), according to OECD Guideline 471, in compliance with GLP. Salmonella typhimurium strains TA 98, TA100, TA 1535 and TA 1537 was used in this experiment. The assay was performed in two phases, using the plate incorporation method. The first phase, the initial toxicity-mutation assay, was used to establish the dose-range for the confirmatory mutagenicity assay and to provide a preliminary mutagenicity evaluation. The second phase, i.e., the confirmatory mutagenicity assay, was used to evaluate and confirm the mutagenic potential of the test substance. The plates were inverted and incubated for 48 h at 37±2°C in dark, colonies were counted. The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. The test substance was dissolved in ethanol and 6 test concentrations ranging from 4 μg /plate to 5000 μg/plate (i.e., 0, 4, 20, 100, 500, 2500 and 5000 μg per plate) was used. The number of spontaneous revertant colonies in the control plates (without the mutagen) was similar to that described in the literature.Toxicity was observed at 2500 μg/plate and above in the bacterial strains; therefore 5000 μg/plate was chosen as top dose level for the mutagenicity study. The test substance did not show a dose dependent increase in the number of revertants in any of the bacterial strains in the presence or absence of metabolic activation system. The negative and positive controls gave results within the expected range; hence the experiment was considered valid. Under the study conditions, the test substance was determined to be non-mutagenic in Ames test, with or without metabolic activation (Muller, 1995).
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