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EC number: 241-644-4 | CAS number: 17671-26-0
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:
- 15 Mar - 24 May 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Departement of Health of the Government of the United Kingdom
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dodecyl nonan-1-oate
- EC Number:
- 241-644-4
- EC Name:
- Dodecyl nonan-1-oate
- Cas Number:
- 17671-26-0
- Molecular formula:
- C21H42O2
- IUPAC Name:
- dodecyl nonanoate
Constituent 1
Method
- Target gene:
- his operon, trp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor-supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats
- Test concentrations with justification for top dose:
- Following concentrations were used in the main experiments:
First experiment (plate ioncorporation, all strains): 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate with and without metabolic activation (tested up to the limit concentration)
Second experiment (pre-incubation, all strains): 15, 50, 150, 500, 1500 and 5000 μg/plate with and without metabolic activation (based on results of first experiment, tested up to the limit concentration) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in ditilled water and DMSO, acetone was selected as the vehicle.
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation) (first experiment); preincubation (second experiment)
DURATION
- Preincubation period: 20 min
- Exposure duration: approx. 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: inspection of bacterial background lawn - Evaluation criteria:
- Acceptance criteria
The study was considered valid if:
- the bacterial strains demonstrate the required strain characteristics
- the number of revertant colonies of the negative (solvent) and positive controls are in the historical control range in all strains of the main tests
- all tester strain cultures should be in the range of 0.9 - 9 x 10^9 bacteria/mL.
- diagnostic mutagens (positive control chemicals) must be included to demonstrate both the intrinsic sensitivity of the tester strains to mutagen exposure and the integrity of the S9-mix
- a minimum of four non-toxic test item dose levels
- no evidence of excessive contamination
Evaluation criteria
A positive result is determined by any, one or all of the following:
- dose-related increase in mutant frequency over the dose range tested
- a reproducible increase at one or more concentrations
- biological relevance against in-house historical control ranges
- statistical analysis of data as determined by UKEMS
- at least 2-fold increase compared to the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response)
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
In some instances the data generated will prohibit making a definite judgment about test item activity. Results of this type will be reported as equivocal. - Statistics:
- Statistical significance was confirmed by using Dunnetts Regression Analysis (* = p < 0.05) for those values that indicate statistically significant increases in the frequency of revertant colonies compared to the concurrent solvent control.
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:
- no cytotoxicity, but tested up to precipitating concentrations
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: started at a concentration of 1500 μg/plate in all strains in both experiments
RANGE-FINDING/SCREENING STUDIES: first main test was used to detremine concentrations of secon main test
Any other information on results incl. tables
Table 1: Summary of test results (main experiment 1 (Plate Incorporation Method)
With or without S9 Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
Frameshift type |
Base-pair substitution type |
|||||
TA 98 |
TA 1537 |
TA 100 |
TA 1535 |
WP2 uvrA |
||
– |
Solvent control (Acetone) |
22 ± 7.1 |
10 ± 2.3 |
101 ± 11.0 |
16 ± 5.0 |
39 ± 12.0 |
1.5 |
19 ± 2.5 |
12 ± 3.0 |
103 ± 10.6 |
20 ± 5.0 |
44 ± 3.5 |
|
5 |
22 ± 1.2 |
11 ± 0.6 |
*122 ± 12.3 |
18 ± 1.5 |
38 ± 3.8 |
|
15 |
19 ± 7.0 |
11 ± 4.7 |
114 ± 13.9 |
18 ± 2.5 |
36 ± 4.2 |
|
50 |
18 ± 2.6 |
10 ± 0.0 |
108 ± 5.2 |
19 ± 2.1 |
41 ± 4.0 |
|
150 |
18 ± 4.7 |
12 ± 3.2 |
116 ± 14.2 |
19 ± 2.9 |
37 ± 4.2 |
|
500 |
15 ± 4.2 |
13 ± 1.7 |
*125 ± 3.8 |
18 ± 0.6 |
38 ± 8.4 |
|
1500 |
20 ± 3.2 P |
15 ± 4.0 P |
*127 ± 6.8 P |
17 ± 1.0 P |
43 ± 10.5 P |
|
500 |
19 ± 2.1 P |
12 ± 4.6 P |
**129 ± 6.1 P |
21 ± 3.8 P |
38 ± 2.5 P |
|
Positive controls (µg/plate) |
4NQO (0.2) |
9AA (80) |
ENNG (3) |
ENNG (5) |
ENNG (2) |
|
Mean (No. of colonies/plate) |
202 ± 3.8 |
232 ± 30.5 |
496 ± 25.1 |
437 ± 56.9 |
724 ± 33.0 |
|
+ |
Solvent control (Acetone) |
35 ± 3.2 |
10 ± 1.2 |
121 ± 5.6 |
11 ± 2.0 |
47 ± 6.0 |
1.5 |
30 ± 7.0 |
11 ± 4.5 |
107 ± 8.7 |
10 ± 3.2 |
43 ± 6.5 |
|
5 |
30 ± 6.8 |
11 ± 2.3 |
122 ± 6.8 |
11 ± 0.6 |
50 ± 4.5 |
|
15 |
23 ± 3.5 |
15 ± 1.5 |
121 ± 8.5 |
13 ± 0.0 |
42 ± 6.0 |
|
50 |
28 ± 6.7 |
13 ± 1.2 |
107 ± 13.3 |
10 ± 1.2 |
49 ± 1.2 |
|
150 |
26 ± 3.6 |
14 ± 2.5 |
122 ± 16.5 |
11 ± 1.2 |
46 ± 4.0 |
|
500 |
24 ± 8.2 |
11 ± 0.6 |
123 ± 8.5 |
14 ± 4.6 |
45 ± 8.2 |
|
1500 |
25 ± 5.5 P |
15 ± 4.2 P |
97 ± 15.4 P |
11 ± 2.0 P |
48 ± 7.0 P |
|
500 |
19 ± 3.1 P |
12 ± 3.5 P |
100 ± 4.9 P |
9 ± 2.1 P |
41 ± 1.5 P |
|
Positive controls (µg/plate) |
B(a)P (5) |
2AA (2) |
2AA (1) |
2AA (2) |
2AA |
|
Mean (No. of colonies/plate) |
316 ± 22.5 |
394 ± 64.0 |
1215 ± 120.6 |
261 ± 3.1 |
374 ± 23.1 |
|
2AA = 2-aminoanthracene
4NQO = 4-nitroquinoline-N-oxide
9AA = 9-aminoacridine
B(a)P = benzo(a)pyrene
ENNG = N-ethyl-N-nitro-N-nitrosoguanidine
P = precipitate
* = p ≤ 0.05
** = p ≤ 0.01
Table 2: Summary of test results (main experiment 2 (Pre-Incubation Method))
With or without S9 Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
Frameshift type |
Base-pair substitution type |
|||||
TA 98 |
TA 1537 |
TA 100 |
TA 1535 |
WP2 uvrA |
||
– |
Solvent control (Acetone) |
19 ± 2.3 |
9 ± 1.2 |
107 ± 21.9 |
13 ± 3.0 |
31 ± 3.0 |
15 |
21 ± 0.6 |
8 ± 2.3 |
115 ± 9.7 |
8 ± 0.0 |
34 ± 3.2 |
|
50 |
20 ± 6.8 |
10 ± 3.5 |
110 ± 5.5 |
9 ± 1.7 |
36 ± 1.2 |
|
150 |
25 ± 4.7 |
8 ± 2.1 |
111 ± 16.0 |
13 ± 5.0 |
30 ± 7.6 |
|
500 |
22 ± 1.2 |
10 ± 2.5 |
120 ± 8.2 |
12 ± 1.0 |
30 ± 3.8 |
|
1500 |
24 ± 5.8 P |
9 ± 2.1 P |
102 ± 5.0 P |
13 ± 1.7 P |
32 ± 2.1 P |
|
500 |
18 ± 2.6 P |
10 ± 4.4 P |
104 ± 3.1 P |
10 ± 0.0 P |
35 ± 4.0 P |
|
Positive controls (µg/plate) |
4NQO (0.2) |
9AA (80) |
ENNG (3) |
ENNG (5) |
ENNG (2) |
|
Mean (No. of colonies/plate) |
235 ± 33.6 |
261 ± 57.0 |
840 ± 44.8 |
557 ± 25.6 |
811 ± 64.8 |
|
+ |
Solvent control (Acetone) |
28 ± 1.7 |
10 ± 2.5 |
109 ± 17.5 |
12 ± 3.2 |
42 ± 5.5 |
15 |
29 ± 8.4 |
11 ± 1.2 |
102 ± 5.2 |
11 ± 3.1 |
43 ± 5.9 |
|
50 |
24 ± 4.9 |
13 ± 1.2 |
121 ± 5.8 |
12 ± 3.8 |
35 ± 11.7 |
|
150 |
30 ± 1.5 |
13 ± 1.5 |
116 ± 13.1 |
10 ± 2.0 |
41 ± 0.6 |
|
500 |
22 ± 4.4 |
12 ± 1.5 |
127 ± 2.6 |
13 ± 4.9 |
44 ± 6.6 |
|
1500 |
27 ± 7.8 P |
12 ± 1.5 P |
119 ± 13.2 P |
10 ± 2.6 P |
40 ± 4.7 P |
|
500 |
25 ± 0.6 P |
9 ± 0.6 P |
125 ± 13.6 P |
14 ± 0.6 P |
42 ± 2.0 P |
|
Positive controls (µg/plate) |
B(a)P (5) |
2AA (2) |
2AA (1) |
2AA (2) |
2AA |
|
Mean (No. of colonies/plate) |
135 ± 14.4 |
301 ± 26.2 |
1296 ± 155.1 |
206 ± 15.8 |
200 ± 24.3 |
|
2AA = 2-aminoanthracene
4NQO = 4-nitroquinoline-N-oxide
9AA = 9-aminoacridine
B(a)P = benzo(a)pyrene
ENNG = N-ethyl-N-nitro-N-nitrosoguanidine
P = precipitate
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the conducted study the test substance did not exhibit mutagenic properties in bacterial cells.
CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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