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EC number: 298-078-6 | CAS number: 93777-46-9
- 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:
- key study
- Study period:
- 21 July - 18 Aug 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- / In the pre-incubation assay, 0.05 μL of test item or of the vehicle control was added to the top agar; no untreated and vehicle controls for positive controls (DMSO and Saline); less than 5 analysable concentrations in exp 2 for 4/5 strains
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- 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:
- yes
- Remarks:
- / In the pre-incubation assay, 0.05 μL of test item or of the vehicle control was added to the top agar; no untreated and vehicle controls for positive controls (DMSO and Saline); less than 5 analysable concentrations in exp 2 for 4/5 strains
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- yes
- Remarks:
- / In the pre-incubation assay, 0.05 μL of test item or of the vehicle control was added to the top agar; no untreated and vehicle controls for positive controls (DMSO and Saline); less than 5 analysable concentrations in exp 2 for 4/5 strains
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Health Care Inspectorate of the Ministry of Health, Welfare and Sport, Utrecht, The Netherlands
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Decyl 2-ethylhexanoate
- EC Number:
- 298-078-6
- EC Name:
- Decyl 2-ethylhexanoate
- Cas Number:
- 93777-46-9
- Molecular formula:
- C18H36O2
- IUPAC Name:
- decyl 2-ethylhexanoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
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 male rats, treated with Aroclor 1254 (500 mg/kg body weight)
- Test concentrations with justification for top dose:
- Based on a range-finding study (plate incorporation assay) (performed in tester strains TA 100 and E. coli WP2 uvr A; doses applied 1.7 - 5000 μg/mL), the following concentrations were used in the main experiments:
First experiment (all strains): 52, 164, 512, 1600 and 5000 μg/plate with and without metabolic activation (tested up to the limit concentration)
Second experiment (all strains): 52, 164, 512, 1600 and 5000 μg/plate with and without metabolic activation (tested up to the limit concentration) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in DMSO, ethanol was selected as the vehicle.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- sodium azide
- methylmethanesulfonate
- other: ICR-191, 2-nitrofluorene (NF), 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation) (first experiment); preincubation (second experiment)
- Cell density at seeding (if applicable): 10^8 cells
DURATION
- Preincubation period: 30 min
- Exposure duration: 48 ± 4 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: inspection of revertant colony number, bacterial background lawn and size of microcolonies
OTHER: Each S9 batch was characterised with the mutagens benzo-(a)-pyrene (Sigma) and 2-aminoanthracene, which require metabolic activation, in tester strain TA100 at concentrations of 5 μg/plate and 2.5 μg/plate, respectively. - Evaluation criteria:
- Acceptance criteria
The study was considered valid if:
- the number of revertant colonies of the negative (solvent) and positive controls were in the historical control range in all strains of the main tests
- the selected dose range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range-finding test or should extend to 5 mg/plate
- not more than 5% of the plates are lost through contamination or some other unforeseen event
A reduction in the number of revertant colonies below the laboratory historical control data range, but no less than 20% compared to the number of revertants in the solvent control will be not considered to be caused by toxicity of the test item.
Evaluation criteria
When the test substance shows a biologically relevant increase in the number of revertant colonies of more than two times (TA100, and WP2uvrA) or three times (TA98, TA1535 and TA1537) compared to that of the solvent control at one or more concentrations with or without metabolic activation and/ or dose-related increase is detectable, the response is judged to be positive. Additionally, in case of an additional experiment, the positive response should be reproducible in at least one follow-up experiment.
The test item was considered to have shown no mutagenic activity in this study if it produces neither an biologically relevant increase in the number of revertants (as described above) nor a reproducible positive response at any of the dose groups, with or without metabolic activation. - Statistics:
- Mean values and standard deviations were calculated.
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:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased extremely in exp. 2 at 5000 μg/plate (-S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased extremely in exp. 2 at 1600 + 5000 μg/plate (-S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased extremely in exp. 2 at 1600 + 5000 μg/plate (-S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased slightly in exp.1 at 52 + 1600 μg/plate (-S9) (69%) and at 52 μg/plate (+S9) (73%) and extremely in exp.2 at 1600 + 5000 μg/plate (-S9) and slightly at 1600 + 5000 μg/plate (+S9) (68%)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Slight precipitate was detected in both experiments on the plates of all examined strains with and without metabolic activation at least at the highest concentration tested (for more details, see table in section any other information on results).
- Other confounding effects: In exp. 2 without S9 mix the formation of microcolonies could be detected in the strains TA1535, 1537 and 100 at 1600 and 500 μg/plate and in TA98 at 5000 μg/plate.
RANGE-FINDING/SCREENING STUDIES: All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants. No toxicity appeared.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data:
TA1535, -S9: 78 - 1381, mean ± SD: 785 ± 167
TA1535, +S9: 78 - 1058, mean ± SD: 228 ± 105
TA1537, -S9: 55 - 1565, mean ± SD: 653 ± 290
TA1537, +S9: 55 - 1112, mean ± SD: 387 ± 143
TA98, -S9: 410 - 2057, mean ± SD: 1155 ± 370
TA98, +S9: 263 - 1907, mean ± SD: 860 ± 323
TA100, -S9: 549 - 1848, mean ± SD: 892 ± 178
TA100, +S9: 620 - 2651, mean ± SD: 1404 ± 327
WP2uvrA, -S9: 127 - 1951, mean ± SD: 1263 ± 461
WP2uvrA, +S9: 85 - 1390, mean ± SD: 342 ± 165
- Negative (solvent/vehicle) historical control data:
TA1535, -S9: 4 - 36, mean ± SD: 14 ± 6
TA1535, +S9: 3 - 34, mean ± SD: 13 ± 5
TA1537, -S9: 3 - 25, mean ± SD: 7 ± 3
TA1537, +S9: 3 - 28, mean ± SD: 9 ± 4
TA98, -S9: 9 - 50, mean ± SD:17 ± 5
TA98, +S9: 9 - 57, mean ± SD: 25 ± 7
TA100, -S9: 63 - 153, mean ± SD: 100 ± 16
TA100, +S9: 60 - 156, mean ± SD: 103 ± 18
WP2uvrA, -S9: 12 - 68, mean ± SD: 26 ± 7
WP2uvrA, +S9: 12 - 70, mean ± SD: 32 ± 8
Any other information on results incl. tables
Table 1: Summary of test results (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 |
||||||
TA1537 |
TA98 |
TA100 |
TA1535 |
WP2 uvrA |
|||
– |
Solvent control (ethanol) |
13 ± 8 |
15 ± 2 |
117 ± 28 |
19 ± 6 |
22 ± 10 |
|
52 |
4 ± 3 |
15 ± 2 |
92 ± 7 |
13 ± 8 |
26 ± 3 |
||
164 |
8 ± 4 |
18 ± 4 |
88 ± 9 |
11 ± 1 |
21 ± 4 |
||
512 |
7 ± 6 |
20 ± 5 |
86 ± 9 SP |
12 ± 2 |
24 ± 5 SP |
||
1600 |
4 ± 1 SP |
15 ± 3 SP |
96 ± 9 SP |
23 ± 5 SP |
21 ± 4 SP |
||
5000 |
8 ± 1 SP |
20 ± 3 SP |
88 ± 7 SP |
10 ±3 SP |
15 ± 10 SP |
||
Positive controls (µg/plate) |
ICR-191 |
NF |
MMS |
SAZ |
4-NQO |
||
Mean No. of colonies/plate (average of 3 plates) |
846 ± 70 |
1136 ± 258 |
1209 ± 71 |
886 ± 51 |
1430 ± 210 |
||
+ |
Solvent control (distilled water) |
15 ± 7 |
34 ± 8 |
100 ± 8 |
13 ± 8 |
28 ± 18 |
|
52 |
4 ± 4 |
26 ± 2 |
96 ± 4 |
11 ± 3 |
34 ± 7 |
||
164 |
8 ± 3 |
30 ± 4 |
92 ± 15 |
9 ± 4 |
21 ± 6 |
||
512 |
8 ± 7 |
32 ± 9 |
97 ± 11 SP |
14 ± 5 |
26 ± 10 SP |
||
1600 |
9 ± 3 SP |
31 ± 10 SP |
91 ± 7 SP |
13 ± 3 SP |
28 ± 1 SP |
||
5000 |
11 ± 7 SP |
36 ± 8 SP |
89 ± 4 SP |
16 ± 6 SP |
26 ± 4 SP |
||
Positive controls (µg/plate) |
2AA |
2AA |
2AA |
2AA |
2AA |
||
Mean No. of colonies/plate (average of 3 plates) |
389 ± 40 |
1140 ± 129 |
1044 ± 40 |
308 ± 39 |
460 ± 47 |
NF = 2-nitrofluorene
MMS = methyl-methanesulfonate
SAZ = sodium azide
4-NQO = 4-nitroquinoline N-oxide
2AA = 2-aminoanthracene
SP = slight precipitate
Table 2: Summary of test results (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 |
||||||
TA1537 |
TA98 |
TA100 |
TA1535 |
WP2 uvrA |
|||
– |
Solvent control (ethanol) |
6 ± 2 |
18 ± 0 |
88 ± 14 |
8 ± 1 |
20 ± 4 |
|
52 |
12 ± 6 |
19 ± 3 |
78 ± 2 |
7 ± 2 |
21 ± 7 |
||
164 |
5 ± 2 |
22 ± 10 |
90 ± 12 |
9 ± 2 |
24 ± 8 |
||
512 |
5 ± 3 |
20 ± 8 |
75 ± 20 |
4 ± 1 |
18 ± 3 |
||
1600 |
e MC |
15 ± 6 |
e MC |
e MC |
18 ± 4 |
||
5000 |
e SP MC |
e SP MC |
e SP MC |
e SP MC |
12 ± 3 s SP |
||
Positive controls (µg/plate) |
NF |
NF |
MMS |
SAZ |
4-NQO |
||
Mean No. of colonies/plate (average of 3 plates) |
79 ± 13 |
1328 ± 270 |
724 ± 73 |
831 ± 9 |
192 ± 27 |
||
+ |
Solvent control (distilled water) |
12 ± 4 |
31 ± 2 |
107 ± 9 |
12 ± 1 |
32 ± 6 |
|
52 |
5 ± 2 |
28 ± 5 |
108 ± 4 |
7 ± 3 |
29 ± 6 |
||
164 |
9 ± 5 |
30 ± 2 |
101 ± 10 |
8 ± 4 |
37 ± 8 |
||
512 |
8 ± 1 |
29 ± 3 |
82 ± 9 |
13 ± 3 |
24 ± 9 |
||
1600 |
5 ± 3 |
33 ± 9 |
88 ± 6 |
10 ± 4 |
28 ± 6 |
||
5000 |
5 ± 2 SP |
19 ± 0 SP |
75 ± 9 SP |
9 ± 2 SP |
30 ± 1 SP |
||
Positive controls (µg/plate) |
2AA |
2AA |
2AA |
2AA |
2AA |
||
Mean No. of colonies/plate (average of 3 plates) |
287 ± 36 |
628 ± 16 |
1328 ± 274 |
152 ± 22 |
574 ± 11 |
NF = 2-nitrofluorene
MMS = methyl-methanesulfonate
SAZ = sodium azide
4-NQO = 4-nitroquinoline N-oxide
2AA = 2-aminoanthracene
e = bacterial background lawn extremely reduced
s = bacterial background lawn slightly reduced
SP = slight precipitate
MC = microcolonies
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.
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