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EC number: 214-290-3 | CAS number: 1119-94-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In a Bacterial Reverse Mutation Test according to OCED guideline 471, dodecyltrimethylammonium bromide did not induce gene mutations by base-pair or frameshift changes in the genome of the strains used. Therefore, it was concluded that with and without addition of S9 mix as the exogenous metabolizing system, the test item was not mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation test (reference 7.6.1-1).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-02-12 to 2018-04-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guidelines for this test system (Sofuni, 1993)
- Version / remarks:
- 1993
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from Phenobarbital/ β-Naphthoflavone-pretreated rats
- Test concentrations with justification for top dose:
- 1st Series (+/- S9): 5, 15.8, 50, 158, 500, 1580 and 5000 µg/plate (S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2)
2nd Series (+/- S9): 15.8, 50, 158, 500 and 889 µg/plate (S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2)
3rd Series (-S9): 5, 15.8, 50, 88.9 and 158 µg/plate (S. typhimurium TA 98, TA 100, TA 1535) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ultra-pure water
- Justification for choice of solvent/vehicle: The selection of the solvent for this assay was based on the available information from the preliminary solubility test. Ultrapure water showed best performance and was thus used for this experiment at a maximum concentration of 100 μL/plate. - Untreated negative controls:
- no
- Remarks:
- The corresponding solvent control was used as negative control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Daunomycin (DAUN) in H2O
- Remarks:
- without S9 mix (TA 98)
- Untreated negative controls:
- no
- Remarks:
- The corresponding solvent control was used as negative control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9 mix (WP2 uvrA)
- Untreated negative controls:
- no
- Remarks:
- The corresponding solvent control was used as negative control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 mix (TA 100, TA 1535)
- Untreated negative controls:
- no
- Remarks:
- The corresponding solvent control was used as negative control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix (TA 1537)
- Untreated negative controls:
- no
- Remarks:
- The corresponding solvent control was used as negative control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2-AA) in DMSO
- Remarks:
- with S9 mix (TA 98, TA 100, TA 1535, TA 1537, WP2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
The incubation of plates was performed at 36 - 38 °C for 2 days.
NUMBER OF REPLICATIONS:
3 parallel plates were used for each concentration step of the test material and the positive controls. Twice as many solvent control plates were used for each bacterial strain.
DETERMINATION OF CYTOTOXICITY
- Method: Reduced background lawn
- Evaluation criteria:
- A test material was to be defined as positive or mutagenic in this assay if
- the assay is considered valid and
- a biologically relevant increase in the mean number of revertants above a threshold of 2-fold (TA 98, TA 100, WP2 uvrA) or 3-fold (TA 1535, TA 1537) as compared to the concurrent negative controls is observed
- an increase exceeding the threshold at only one concentration is considered as biologically meaningful if reproduced in a second independent experiment
- a concentration-dependent increase is considered biologically meaningful if the threshold is exceeded at more than one concentration
A test material is defined as negative or non-mutagenic in this assay if
- the assay is considered valid and
- none of the above-mentioned criteria are met
Whenever colony counts remain within the historical range of negative controls, such increases are considered as biologically not meaningful. In general, two series of experiments must be performed. However, there is no requirement for verification of a clear positive response (OECD TG 471, 1997).
Results which only partially satisfied the above criteria were dealt with on a case-by-case basis. Biological relevance was considered, for example consistency of response within and between concentrations and (where applicable) between experiments. - Key result
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >= 158 µg/ plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >= 500 µg/ plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test material on the agar plates accurred.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data:
DAUN (TA 98, -S9): 68 - 779 (mean: 243)
2-AA (TA 98, + S9): 112 - 3015 (mean: 738)
NaN3 (TA 100, - S9): 821 - 2376 (mean: 1550)
2-AA (TA 100, + S9): 437 - 3429 (mean: 1386)
9-AA (TA 1537, -S9): 247 - 1485 (mean: 736)
2-AA (TA 1537, +S9): 72 - 705 (mean: 293)
NaN3 (TA 1535, -S9): 351 - 2149 (mean: 867)
2-AA (TA 1535, +S9): 43 - 758 (mean: 168)
NQO (WP2 uvrA, -S9): 317 - 2275 (mean: 1677)
2-AA (WP2 uvrA, +S9): 154 - 696 (mean: 353)
- Negative (solvent/vehicle) historical control data:
Solvent (TA 98, -S9): 19 - 52 (mean: 36)
Solvent (TA 98, +S9): 20 - 58 (mean: 42)
Solvent (TA 100, -S9): 94 - 159 (mean: 118)
Solvent (TA 100, +S9): 90 - 172 (mean: 123)
Solvent (TA 1537, -S9): 4 - 11 (mean: 8)
Solvent (TA 1537, +S9): 6 - 16 (mean: 10)
Solvent (TA 1535, -S9): 15 - 38 (mean: 24)
Solvent (TA 1535, +S9): 6 - 28 (mean: 20)
Solvent (WP2 uvrA, -S9): 19 - 44 (mean: 30)
Solvent (WP2 uvrA, +S9): 28 - 47 (mean: 37)
- Conclusions:
- Under the experimental conditions dodecyltrimethylammonium bromide did not induce gene mutations by base-pair or frameshift changes in the genome of the strains used. Therefore, it was concluded that with and without addition of S9 mix as the exogenous metabolizing system, the test item was not mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation test.
- Executive summary:
Dodecyltrimethylammonium bromide was examined for its mutagenic activity according to OECD Guideline 471 in three series of an in vitro bacterial reverse mutation test employing Salmonella typhimurium TA 98, TA 100, TA 1535 and TA 1537 and Escherichia coli WP2 uvrA as indicator organisms.
The plate incorporation test with and without addition of liver S9 mix from Phenobarbital/β-Naphthoflavone-pretreated rats was used. In this study, three experimental series were performed. In the experiments with S9 mix, 10% and 20% S9 in the S9 mix were used. Treatments of all tester strains were performed using dodecyltrimethylammonium bromide formulations prepared in ultra-pure water in the absence and in the presence of S9 mix, using final concentrations between 5 and 5000 μg/plate, plus vehicle and positive controls. The mean numbers of revertant colonies of the current negative controls were within the range of historical negative control values. The strain-specific positive controls, namely daunomycin, sodium azide, 4-nitroquinolin-N-oxide, and 9-aminoacridine in the absence of S9 mix, yielded the expected mutant frequencies that were greatly exceeding the negative controls. The genotype of the tester strains used was thus confirmed. 2-Aminoanthracene which requires metabolic activation, was strongly mutagenic. This indicates that the exogenous metabolizing system used in the present investigation (S9 mix) was active. Thus, the study is considered valid.
Following treatment with dodecyltrimethylammonium bromide, no precipitation of the test material on the agar plates occurred. Toxicity to the bacteria was observed at concentrations >= 158 μg/plate. Under the conditions described, there were no relevant increases in revertant numbers observed after exposure to dodecyltrimethylammonium bromide in the absence and presence of S9 mix, thus the test item was not mutagenic under the described experimental conditions.
Reference
In this study, three experimental series were performed. The S9 mix used contained 10% S9 in the 1st and 20% S9 in the 2nd series, respectively. In the 3rd series no S9 mix was used. The results are summarised in the tables 1 - 3 below.
Table 1: Summary 1st Series
Test material |
Concentr. [µg/plate] |
Revertants per plate (Mean ± SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
||
Without Activation (-S9) |
||||||
H2O |
|
30 ± 8 |
107 ± 6 |
19 ± 3 |
7 ± 2 |
30 ± 6 |
Test item |
5.00 |
34 ± 10 |
107 ± 13 |
21 ± 3 |
7 ± 1 |
31 ± 7 |
15.8 |
29 ± 9 |
117 ± 13 |
19 ± 5 |
7 ± 2 |
29 ± 6 |
|
50.0 |
24 ± 5 |
110 ± 10 |
19 ± 5 |
9 ± 5 |
36 ± 5 |
|
158 |
16 ± 3 |
36 ± 6T |
9 ± 1 |
7 ± 8 |
23 ± 2 |
|
500 |
0 ± 0T |
0 ± 0T |
0 ± 0T |
0 ± 0T |
21 ± 5T |
|
1580 |
0 ± 0T |
0 ± 0T |
0 ± 0T |
0 ± 0T |
0 ± 0T |
|
5000 |
0 ± 0T |
0 ± 0T |
0 ± 0T |
0 ± 0T |
0 ± 0T |
|
DAUN |
2.00 |
317 ± 26 |
|
|
|
|
NaN3 |
2.00 |
|
1650 ± 38 |
764 ± 64 |
|
|
9-AA |
50.0 |
|
|
|
1722 ± 293 |
|
NQO |
2.00 |
|
|
|
|
1956 ± 145 |
With Activation (+S9) |
||||||
H2O |
|
40 ± 6 |
121 ± 9 |
22 ± 5 |
6 ± 3 |
47 ± 11 |
Test item |
5.00 |
37 ± 9 |
112 ± 11 |
16 ± 4 |
6 ± 3 |
42 ± 6 |
15.8 |
38 ± 6 |
121 ± 11 |
12 ± 4 |
7 ± 4 |
39 ± 3 |
|
50.0 |
32 ± 9 |
137 ± 7 |
18 ± 2 |
10 ± 5 |
40 ± 10 |
|
158 |
37 ± 7 |
100 ± 6 |
15 ± 4 |
11 ± 8 |
37 ± 16 |
|
500 |
15 ± 3T |
0 ± 0T |
7 ± 1T |
7 ± 5T |
29 ± 3 |
|
1580 |
0 ± 0T |
0 ± 0T |
0 ± 0T |
0 ± 0T |
0 ± 0T |
|
5000 |
0 ± 0T |
0 ± 0T |
0 ± 0T |
0 ± 0T |
0 ± 0T |
|
2-AA |
2.00 |
932 ± 24 |
2225 ± 252 |
|
|
|
2-AA |
5.00 |
|
|
82 ± 17 |
320 ± 51 |
|
2-AA |
10.0 |
|
|
|
|
522 ± 141 |
Table 2: Summary 2nd Series
Test material |
Concentr. [µg/plate] |
Revertants per plate (Mean ± SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
||
Without Activation (-S9) |
||||||
H2O |
|
31 ± 15 |
144 ± 8 |
26 ± 7 |
12 ± 4 |
35 ± 7 |
Test item |
15.8 |
34 ± 4 |
142 ± 8 |
25 ± 11 |
10 ± 3 |
42 ± 7 |
50.0 |
38 ± 7 |
135 ± 8 |
28 ± 5 |
13 ± 5 |
38 ± 10 |
|
158 |
11 ± 3 |
62 ± 6 |
8 ± 0 |
8 ± 4 |
41 ± 6 |
|
500 |
T |
T |
T |
T |
24 ± 3T |
|
889 |
T |
T |
T |
T |
T |
|
DAUN |
2.00 |
366± 25 |
|
|
|
|
NaN3 |
2.00 |
|
1640 ± 55 |
885 ± 22 |
|
|
9-AA |
50.0 |
|
|
|
1947 ± 315 |
|
NQO |
2.00 |
|
|
|
|
2495 ± 78 |
With Activation (+S9) |
||||||
H2O |
|
36 ± 10 |
126 ± 13 |
17 ± 5 |
11 ± 3 |
40 ± 8 |
Test item |
15.8 |
32 ± 5 |
137 ± 13 |
10 ± 3 |
11 ± 3 |
34 ± 2 |
50.0 |
41 ± 8 |
144 ± 5 |
17 ± 2 |
17 ± 2 |
44 ± 4 |
|
158 |
39 ± 11 |
128 ± 8 |
10 ± 1 |
16 ± 4 |
39 ± 12 |
|
500 |
T |
T |
6 ± 1 |
8 ± 3 |
34 ± 5 |
|
889 |
T |
T |
T |
T |
22 ± 10T |
|
2-AA |
2.00 |
351 ± 19 |
585 ± 17 |
|
|
|
2-AA |
5.00 |
|
|
260 ± 11 |
132 ± 6 |
|
2-AA |
10.0 |
|
|
|
|
215 ± 3 |
Table 3: Summary 3rd Series
Test material |
Concentr. [µg/plate] |
Revertants per plate (Mean ± SD) |
||
TA 98 |
TA 100 |
TA 1535 |
||
Without Activation (-S9) |
||||
H2O |
|
31 ± 12 |
104 ± 10 |
16 ± 4 |
Test item |
5.00 |
36 ± 8 |
106 ± 13 |
20 ± 2 |
15.8 |
36 ± 10 |
117 ± 1 |
20 ± 3 |
|
50.0 |
33 ± 6 |
96 ± 8 |
18 ± 2 |
|
88.9 |
26± 5 |
61± 7 |
19 ±5 |
|
158 |
14± 2 |
26± 3T |
8± 2 |
|
DAUN |
2.00 |
500± 44 |
|
|
NaN3 |
2.00 |
|
1450 ± 60 |
811 ± 72 |
NaN3: Sodium azide
2-AA: 2-Aminoanthracene
9-AA: 9-Aminoacridine
DAUN: Daunomycin
NQO: 4-Nitroquinoline-N-oxide
T: Toxicity = red- bact. background lawn
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Dodecyltrimethylammonium bromide was examined for its mutagenic activity according to OECD Guideline 471 in three series of an in vitro bacterial reverse mutation test employing Salmonella typhimurium TA 98, TA 100, TA 1535 and TA 1537 and Escherichia coli WP2 uvrA as indicator organisms (reference 7.6.1-1).
The plate incorporation test with and without addition of liver S9 mix from Phenobarbital/β-Naphthoflavone-pretreated rats was used. In this study, three experimental series were performed. In the experiments with S9 mix, 10% and 20% S9 in the S9 mix were used. Treatments of all tester strains were performed using dodecyltrimethylammonium bromide formulations prepared in ultra-pure water in the absence and in the presence of S9 mix, using final concentrations between 5 and 5000 μg/plate, plus vehicle and positive controls. The mean numbers of revertant colonies of the current negative controls were within the range of historical negative control values. The strain-specific positive controls, namely daunomycin, sodium azide, 4-nitroquinolin-N-oxide, and 9-aminoacridine in the absence of S9 mix, yielded the expected mutant frequencies that were greatly exceeding the negative controls. The genotype of the tester strains used was thus confirmed. 2-Aminoanthracene which requires metabolic activation, was strongly mutagenic. This indicates that the exogenous metabolizing system used in the present investigation (S9 mix) was active. Thus, the study is considered valid. Following treatment with dodecyltrimethylammonium bromide, no precipitation of the test material on the agar plates occurred. Toxicity to the bacteria was observed at concentrations >= 158 μg/plate. Under the conditions described, there were no relevant increases in revertant numbers observed after exposure to dodecyltrimethylammonium bromide in the absence and presence of S9 mix, thus the test item was not mutagenic under the described experimental conditions.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The results indicate that the substance is non-mutagenic. Based on available data on genetic toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EC) No 2017/776.
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