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EC number: 811-605-1 | CAS number: 37318-95-9
- 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
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 17 Jan - 17 Aug 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted: 21 Jul 1997
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dodecanoic acid, ester with 1,2,3-propanetriol
- Cas Number:
- 37318-95-9
- Molecular formula:
- C12 mono: C15H30O4 C12 di: C27H52O5 C12 tri: C39H74O6
- IUPAC Name:
- Dodecanoic acid, ester with 1,2,3-propanetriol
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- other: TA1535, TA102, TA100, TA98 and TA97a
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with 500 mg Aroclor 1254/kg body weight intra-peritoneally
- Test concentrations with justification for top dose:
- Dose-range-finding experiments
Experiment 1c:
50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation
Experiment 1d:
0.05, 0.15, 0.5, 1.5, 5 and 15 µg/plate with and without metabolic activation
Main experiments
Experiment 1e:
0.05, 0.15, 0.5, 1.5, 5 and 15 µg/plate with and without metabolic activation
Experiment 2b:
0.23, 0.47, 0.94, 1.88, 3.75, 7.5 and 15 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: The solvent was chosen because of the solubility of the test substance in the vehicle and the relative nontoxicity of the vehicle to the bacteria evaluated in a pre-experiment.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- demineralised water, DMSO and ethanol (including solvents for positive controls)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: see below
- Details on test system and experimental conditions:
- Experiments 1a, 1b and 2a were declared invalid and were therefore not reported here.
METHOD OF APPLICATION: Experiment 1e: in agar (plate incorporation); Experiment 2b: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications per experiment
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants and reduction in bacterial background lawn - Evaluation criteria:
- A substance is considered to have mutagenic potential, if a reproducible increase of revertant colonies per plate exceeding an increase factor of 2 in at least one strain can be observed. A concentration-related increase over the range tested is also taken as a sign of mutagenic activity.
- Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp 1e and 2b: at 15 µg/plate in all strains +/- S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test item was observed up to 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES: In the dose range finding studies cytotoxicity was observed in all strains from 15 µg/plate.
Any other information on results incl. tables
Table 1. Mean revertants Experiment 1e
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
83 |
69 |
52 |
50 |
82 |
102 |
356 |
345 |
24 |
22 |
sd |
6.7 |
5 |
5.2 |
10.7 |
20.6 |
18.5 |
62.9 |
72.6 |
8 |
7.5 |
|
DMSO |
Mean |
85 |
78 |
43 |
39 |
110 |
101 |
257 |
324 |
21 |
21 |
sd |
5.6 |
13.6 |
5.5 |
11.9 |
6 |
21.2 |
26.6 |
20.8 |
0.6 |
5.3 |
|
Ethanol |
Mean |
78 |
70 |
47 |
39 |
107 |
127 |
292 |
258 |
23 |
22 |
sd |
11 |
5.9 |
3.8 |
10.7 |
6.4 |
3.1 |
58.9 |
24 |
3.6 |
3.1 |
|
Positive |
Mean |
343 |
657 |
560 |
487 |
404 |
1001 |
689 |
1083 |
265 |
132 |
Controls* |
sd |
35.9 |
24.1 |
146 |
123.3 |
17.4 |
0 |
60.2 |
400 |
59.5 |
15.2 |
|
f(I) |
4.04 |
8.42 |
13.02 |
12.49 |
4.93 |
9.91 |
2.68 |
3.34 |
11.04 |
6.29 |
15 µg/plate |
Mean |
14 |
21 |
2 |
4 |
22 |
17 |
165 |
149 |
1 |
2 |
sd |
6 |
7.2 |
1.2 |
1.7 |
9 |
4 |
16.8 |
20.2 |
0 |
1.2 |
|
f(I) |
0.18 |
0.3 |
0.04 |
0.1 |
0.21 |
0.13 |
0.57 |
0.58 |
0.04 |
0.09 |
|
5 µg/plate |
Mean |
116 |
68 |
26 |
37 |
97 |
86 |
311 |
387 |
16 |
21 |
sd |
15.6 |
15.7 |
3.5 |
13.7 |
13.5 |
10 |
49.4 |
31.1 |
4.4 |
1.7 |
|
f(I) |
1.49 |
0.97 |
0.55 |
0.95 |
0.91 |
0.68 |
1.07 |
1.5 |
0.7 |
0.95 |
|
1.5 µg/plate |
Mean |
84 |
90 |
32 |
43 |
104 |
97 |
309 |
356 |
25 |
19 |
sd |
2.1 |
18.7 |
8.1 |
11.4 |
26.5 |
8.1 |
32.6 |
69.3 |
4.4 |
2.9 |
|
f(I) |
1.08 |
1.29 |
0.68 |
1.1 |
0.97 |
0.76 |
1.06 |
1.38 |
1.09 |
0.86 |
|
0.5 µg/plate |
Mean |
82 |
83 |
30 |
37 |
94 |
93 |
360 |
432 |
18 |
22 |
sd |
12.1 |
25.2 |
9.6 |
6.8 |
9.1 |
14.7 |
34.2 |
52.5 |
2.6 |
1.2 |
|
f(I) |
1.05 |
1.19 |
0.64 |
0.95 |
0.88 |
0.73 |
1.23 |
1.67 |
0.78 |
1 |
|
0.15 µg/plate |
Mean |
76 |
86 |
28 |
40 |
103 |
92 |
312 |
259 |
22 |
22 |
sd |
11.9 |
4.4 |
1.5 |
3.2 |
18 |
10.4 |
60.5 |
78.2 |
3.8 |
3.5 |
|
f(I) |
0.97 |
1.23 |
0.6 |
1.03 |
0.96 |
0.72 |
1.07 |
1 |
0.96 |
1 |
|
0.05 µg/plate |
Mean |
79 |
95 |
27 |
38 |
103 |
123 |
337 |
305 |
25 |
21 |
sd |
25.7 |
21.7 |
6.7 |
10 |
33.8 |
5.8 |
14 |
98 |
5.6 |
4 |
|
f(I) |
1.01 |
1.36 |
0.57 |
0.97 |
0.96 |
0.97 |
1.15 |
1.18 |
1.09 |
0.95 |
f(I) = increase factor
* Different positive controls were used
Table 2. Mean revertants Experiment 2b
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
83 |
91 |
33 |
36 |
88 |
100 |
289 |
348 |
17 |
19 |
sd |
8.7 |
5.6 |
5.3 |
5 |
3 |
15 |
12.2 |
25 |
6.8 |
3.8 |
|
DMSO |
Mean |
96 |
89 |
30 |
39 |
99 |
98 |
336 |
295 |
18 |
15 |
sd |
13.9 |
18.7 |
4.4 |
2.1 |
16.3 |
9.2 |
32.7 |
73.2 |
1.7 |
3.2 |
|
Ethanol |
Mean |
73 |
103 |
37 |
37 |
83 |
95 |
280 |
316 |
15 |
15 |
sd |
2.6 |
7 |
10.2 |
7.6 |
10.4 |
15 |
62.9 |
63.5 |
3.6 |
4.2 |
|
Positive |
Mean |
338 |
533 |
493 |
260 |
579 |
897 |
1235 |
1251 |
457 |
157 |
Controls* |
sd |
31 |
50.3 |
188.7 |
10.6 |
83.3 |
180.7 |
364.5 |
226.9 |
55.5 |
9.2 |
|
f(I) |
3.52 |
5.99 |
16.43 |
6.67 |
6.58 |
9.15 |
3.68 |
4.24 |
26.88 |
10.47 |
15 µg/plate |
Mean |
10 |
3 |
1 |
2 |
3 |
2 |
18 |
63 |
3 |
2 |
sd |
1.7 |
1.5 |
0 |
1 |
0 |
1 |
1.2 |
20.3 |
4 |
1.2 |
|
f(I) |
0.14 |
0.03 |
0.03 |
0.05 |
0.04 |
0.02 |
0.06 |
0.2 |
0.2 |
0.13 |
|
7.5 µg/plate |
Mean |
83 |
82 |
32 |
36 |
83 |
98 |
243 |
273 |
16 |
21 |
sd |
5.8 |
20.5 |
4.4 |
1.2 |
5.8 |
10.5 |
20.5 |
45.1 |
4.4 |
1.5 |
|
f(I) |
1.14 |
0.8 |
0.86 |
0.97 |
1 |
1.03 |
0.87 |
0.86 |
1.07 |
1.4 |
|
3.75 µg/plate |
Mean |
94 |
85 |
30 |
32 |
81 |
100 |
247 |
275 |
15 |
14 |
sd |
6.7 |
4.2 |
6.1 |
7.8 |
7.8 |
3.1 |
46.4 |
74.6 |
2.1 |
1.5 |
|
f(I) |
1.29 |
0.83 |
0.81 |
0.86 |
0.98 |
1.05 |
0.88 |
0.87 |
1 |
0.93 |
|
1.88 µg/plate |
Mean |
78 |
91 |
32 |
31 |
92 |
102 |
335 |
224 |
14 |
18 |
sd |
10.4 |
12.1 |
1.7 |
4.6 |
9.2 |
6.1 |
8.3 |
2 |
4.6 |
4 |
|
f(I) |
1.07 |
0.88 |
0.86 |
0.84 |
1.11 |
1.07 |
1.2 |
0.71 |
0.93 |
1.2 |
|
0.94 µg/plate |
Mean |
95 |
99 |
30 |
44 |
85 |
90 |
223 |
244 |
16 |
10 |
sd |
11 |
11.1 |
8.3 |
10.1 |
13.8 |
8.5 |
62 |
10.6 |
2.5 |
0.6 |
|
f(I) |
1.3 |
0.96 |
0.81 |
1.19 |
1.02 |
0.95 |
0.8 |
0.77 |
1.07 |
0.67 |
|
0.47 µg/plate |
Mean |
107 |
110 |
36 |
33 |
82 |
95 |
205 |
239 |
18 |
12 |
sd |
4.6 |
17.1 |
4 |
4.7 |
6.9 |
11.4 |
36.3 |
84.3 |
1 |
1.7 |
|
f(I) |
1.47 |
1.07 |
0.97 |
0.89 |
0.99 |
1 |
0.73 |
0.76 |
1.2 |
0.8 |
|
0.23 µg/plate |
Mean |
89 |
76 |
31 |
36 |
85 |
88 |
209 |
249 |
14 |
11 |
sd |
15 |
12.5 |
6 |
6.2 |
14 |
15.3 |
48.1 |
14 |
2 |
1 |
|
f(I) |
1.22 |
0.74 |
0.84 |
0.97 |
1.02 |
0.93 |
0.75 |
0.79 |
0.93 |
0.73 |
f(I) = increase factor
* Different positive controls were used
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the Ames test the substance was not mutagenic in any of the five bacterial strains (TA1535, TA98, TA100, TA102 and TA97a) tested with and without metabolic activation.
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