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EC number: 947-919-1 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 30 Jul - 07 Aug 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The analytical purity of the test substance was not reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted Jul 1997
- Deviations:
- yes
- Remarks:
- analytical purity of the test substance was not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- analytical purity of the test substance was not reported
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Direccion General de Farmacia y Productos Sanitarios, Consejera de Sanidad y Consumo, Madrid, Spain
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-octyldodecyl myristate
- EC Number:
- 245-205-8
- EC Name:
- 2-octyldodecyl myristate
- Cas Number:
- 22766-83-2
- Molecular formula:
- C34H68O2
- IUPAC Name:
- 2-octyldodecyl myristate
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- his 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 pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- Cofactor supplemented post-mitochondrial fraction (S9-mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- 0.05, 0.15, 0.5, 1.5, 5 µL/plate, with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: no data
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- solvent type not reported
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-nitrofluorene, sodium azide, 9-aminoacridine, 4-nitroquinoline-N-oxide, 2-aminoanthracene
- Remarks:
- See 'Any other information on material and methods incl. tables' for details on positive controls
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); if the first assay result was negative the second assay was performed as a preincubation assay, and if the first assay result was positive the second assay was performed as a plate incorporation assay
DURATION
- Preincubation period: 20 min (second assay)
- Exposure duration: 48 hrs
NUMBER OF REPLICATIONS: 3 replications in 2 independent assays
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- A test substance is considered positive (mutagenic) in the test if:
It induces a dose-resonse in the range tested and/or
a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with ot without mutagenic activation is observed. - Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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 was observed at any dose level, with and without metabolic activation.
COMPARISON WITH HISTORICAL CONTROL DATA: yes, the negative control and test substance results fell within the historical control data range (see Table 1 under 'Any other information on material and methods incl. tables').
ADDITIONAL INFORMATION ON CYTOTOXICITY: no cytotoxicity was observed up to and including the highest dose level, which is the limit dose level recommended in the OECD 471 guideline.
OTHER: Only 2-amino anthracene was used as a positive control, however, dilutions of the sample S9-mix were tested and confirmed to activate benzo(a)pyrene and 2-amino anthracene.
Any other information on results incl. tables
Table 2. Test results of experiment 1 (plate incorporation method)
With or without S9-Mix |
Test substance concentration (μL/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
WP2 uvR |
TA98 |
TA1537 |
||
- |
Solvent |
49.7 ± 26.1 |
14.7 ± 1.5 |
76.0 ± 8.2 |
14.7 ± 2.5 |
27.3 ± 5.5 |
- |
0.05 |
41.0 ± 4.0 |
14.7 ± 3.8 |
77.3 ± 22.9 |
21.3 ± 3.8 |
28.0 ± 8.9 |
- |
0.15 |
37.7 ± 3.8 |
11.0 ± 1.0 |
59.7 ± 7.2 |
16.0 ± 7.1 |
29.0 ± 3.0 |
- |
0.5 |
36.3 ± 6.8 |
13.3 ± 3.1 |
59.7 ± 4.9 |
20.0 ± 4.6 |
40.0 ± 21.0 |
- |
1.5 |
42.7 ± 4.7 |
12.0 ± 2.6 |
55.7 ± 21.1 |
16.3 ± 4.9 |
34.3 ± 9.6 |
- |
5.0 |
47.3 ± 10.1 |
10.3 ± 2.1 |
43.3 ± 18.1 |
17.0 ± 1.0 |
37.3 ± 8.6 |
Positive controls, –S9 |
Name |
NaN3 |
NaN3 |
4 -NNO |
2-NF |
9-AA |
Concentrations positive controls (μg/plate) |
10 |
30 |
7 |
90 |
100 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
556.3 ± 55.2 |
184.7 ± 46.8 |
610.0 ± 30.3 |
399.3 ± 25.0 |
215.0 ± 1.0 |
|
+ |
Solvent |
44.0 ± 2.0 |
15.7 ± 7.4 |
71.7 ± 14.7 |
20.3 ± 4.7 |
8.7 ± 3.1 |
+ |
0.05 |
52.0 ± 6.1 |
14.3 ± 7.8 |
90.7 ± 17.5 |
27.7 ± 1.5 |
10.0 ± 5.6 |
+ |
0.15 |
67.0 ± 14.7 |
15.3 ± 5.1 |
76.0 ± 39.9 |
27.0 ± 5.3 |
5.7 ± 2.1 |
+ |
0.5 |
47.0 ± 10.1 |
15.7 ± 3.5 |
87.3 ± 29.9 |
26.3 ± 5.0 |
8.7 ± 0.6 |
+ |
1.5 |
49.7 ± 13.3 |
10.7 ± 1.2 |
80.7 ± 24.0 |
21.7 ± 4.5 |
9.0 ± 2.6 |
+ |
5.0 |
61.3 ± 9.0 |
10.7 ± 2.5 |
64.7 ± 29.7 |
19.7 ± 4.7 |
7.0 ± 4.6 |
Positive controls, +S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μL/plate) |
10 |
30 |
7 |
10 |
30 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
305.0 ± 41.6 |
326.0 ± 10.8 |
320.0 ± 6.2 |
611.3 ± 108.1 |
320.0 ± 6.2 |
|
2-NF: 2-nitrofluorene
NaN3: sodium azide
9-AA: 9-aminoacridine
4-NNO: 4-nitroquinoline-N-oxide
2-AA: 2-aminoanthracene
Table 3. Test results of experiment 2 (preincubation method)
With or without S9-Mix |
Test substance concentration (μL/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard Deviation ) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
WP2 uvR |
TA98 |
TA1537 |
||
- |
Solvent |
64.3 ± 5.1 |
9.7 ± 5.5 |
74.7 ± 19.0 |
22.7 ± 6.5 |
9.7 ± 3.2 |
- |
0.05 |
39.0 ± 1.0 |
12.3 ± 5.8 |
113.0 ± 15.7 |
23.3 ± 3.1 |
11.3 ± 3.1 |
- |
0.15 |
44.3 ± 4.2 |
12.3 ± 5.0 |
103.7 ± 17.6 |
24.0 ± 2.0 |
11.0 ± 3.5 |
- |
0.5 |
38.7 ± 14.2 |
9.0 ± 6.9 |
116.3 ± 10.8 |
22.7 ± 2.1 |
10.7 ± 1.5 |
- |
1.5 |
34.0 ± 3.0 |
16.7 ± 4.9 |
107.3 ± 10.1 |
29.3 ± 7.6 |
11.7 ± 5.5 |
- |
5.0 |
43.3 ± 10.7 |
10.0 ± 2.6 |
116.7 ± 10.1 |
19.3 ± 9.9 |
11.0 ± 5.2 |
Positive controls, –S9 |
Name |
NaN3 |
NaN3 |
4-NNO |
2-NF |
9-AA |
Concentrations (μL/plate) |
10 |
30 |
7 |
90 |
100 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
580.0 ± 8.2 |
504.0 ± 27.6 |
810.0 ± 77.3 |
544.3 ± 417.5 |
682.7 ± 91.5 |
|
+ |
Solvent |
47.0 ± 9.8 |
17.7 ± 5.5 |
45.3 ± 5.9 |
15.0 ± 4.0 |
19.3 ± 9.1 |
+ |
0.05 |
52.0 ± 6.6 |
18.0 ± 3.0 |
74.0 ± 5.6 |
17.3 ± 3.8 |
25.7 ± 1.5 |
+ |
0.15 |
51.3 ± 9.0 |
13.0 ± 7.9 |
80.0 ± 6.1 |
18.0 ± 4.4 |
24.7 ± 8.7 |
+ |
0.5 |
58.7 ± 8.5 |
16.0 ± 5.0 |
63.7 ± 14.5 |
17.7 ± 1.5 |
18.7 ± 3.1 |
+ |
1.5 |
58.7 ± 4.2 |
19.0 ± 6.2 |
76.0 ± 18.0 |
14.0 ± 3.6 |
18.3 ± 6.0 |
+ |
5.0 |
56.3 ± 4.1 |
15.7 ± 3.1 |
78.7 ± 26.1 |
16.0 ± 4.4 |
32.0 ± 6.9 |
Positive controls, +S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μL/plate) |
10 |
30 |
7 |
10 |
30 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
352.7 ± 62.0 |
284.7 ± 11.7 |
475.7 ± 84.4 |
299.7 ± 79.6 |
161.7 ± 27.5 |
|
2-NF: 2-nitrofluorene
NaN3: sodium azide
9-AA: 9-aminoacridine
4-NNO: 4-nitroquinoline-N-oxide
2 -AA: 2 -aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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