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EC number: 614-590-8 | CAS number: 68552-19-2
- 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
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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 Apr - 11 May 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- 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 (incl. QA statement)
- Remarks:
- THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters
- EC Number:
- 500-214-9
- EC Name:
- Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters
- Cas Number:
- 68440-06-2
- Molecular formula:
- C44H84O4
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: yellow liquid
- Storage condition of test material: room temperature in the dark
- Expiration date of the lot/batch: 05 May 2016
Constituent 1
Method
- Target gene:
- his/trp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: All TA strains carry a mutation of the uvr B gene coding for the DNA excision repair system (uvr B) and the deep rough mutation (rfa), TA100 and TA98 contain the R-factor plasmid (pkM101) to detect weak mutagens.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: The E.coli tester strain contains an uvr A DNA repair deficiency which enhances its sensitivity to some mutagenic compounds.
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9-mix), prepared from the livers of rats induced with phenobarbitone/β-naphthoflavone
- Test concentrations with justification for top dose:
- Experiment I:
- 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate (with and without metabolic activation)
Experiment II:
- 15, 50, 150, 500, 1500 and 5000 μg/plate (with and without metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: The test item was immiscible in sterile distilled water and DMSO at 50 mg/mL, but was fully miscible in acetone at 100 mg/mL in solubility checks performed in-house. Acetone was therefore selected as the vehicle.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- 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
- Remarks:
- - S9: ENNG: 2 µg/plate (WP2uvr A), 3 µg/plate (TA100), 5 µg/plate (TA1535); 9AA: 80 µg/plate (TA1537); 4NQO: 0.2 µg/plate (TA98); +S9: 2AA: 1 µg/plate (TA100), 2 µg/plate (TA1535, TA1537), 10 µg/plate (WP2uvr A); BP: 5 µg/plate (TA98)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation, pre-incubation
NUMBER OF REPLICATIONS: 3 plates for each test concentration
DETERMINATION OF CYTOTOXICITY
- Method: The condition of the bacterial background lawn was evaluated for evidence of test article toxicity (relative total growth) and precipitate by using a dissecting microscope. - Evaluation criteria:
- A test system is considered as mutagenic if there is
- a dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979)
- a reproducible increase at one or more concentrations
- biological relevance against in-house historical control ranges
- statistical analysis of data as determined by UKEMS (Mahon et. al., 1989)
- a fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response (Cariello and Piegorsch, 1996).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met. - Statistics:
- For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated and are reported.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: S. typhimurium TA1535, TA1537, TA98 and TA100
- 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
- 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:
- TESTSPECIFIC CONFOUNDING FACTORS: Precipitation of the test material was recorded at concentrations equal or greater than 1500 μg/plate in both independent experiments (with and without metabolic activation).
COMPARISON WITH HISTORICAL CONTROL DATA: The results were within range of historical control data.
ADDITIONAL INFORMATION ON CYTOTOXICITY: The test material did not induce cytotoxicity in any of the tested strains at any tested concentration.
Any other information on results incl. tables
Table 1: Test results: Experiment 1 – Plate incorporation
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
– |
0 |
124 ± 5.5 |
17 ± 2.1 |
32 ± 6.1 |
21 ± 2.5 |
11 ± 2.6 |
– |
1.5 |
126 ± 13.1 |
17 ± 0.6 |
24 ± 5.8 |
21 ± 4.7 |
12 ± 3.0 |
– |
5 |
130 ± 12.1 |
14 ± 2.3 |
24 ± 11.5 |
24 ± 6.1 |
14 ± 1.2 |
– |
15 |
115 ± 3.1 |
17 ± 3.8 |
25 ± 1.7 |
21 ± 9.5 |
14 ± 2.6 |
– |
50 |
126 ± 13.1 |
15 ± 3.5 |
23 ± 2.5 |
23 ± 2.5 |
16 ± 0.0 |
– |
150 |
123 ± 4.0 |
13 ± 5.6 |
24 ± 5.0 |
23 ± 9.5 |
16 ± 0.6 |
– |
500 |
125 ± 9.5 |
15 ± 6.0 |
20 ± 3.5 |
22 ± 1.2 |
13 ± 2.0 |
– |
1500 P |
121 ± 11.0 |
17 ± 4.9 |
24 ± 3.5 |
20 ± 0.6 |
13 ± 5.3 |
– |
5000 P |
121 ± 9.5 |
11 ± 1.7 |
24 ± 5.1 |
23 ± 7.6 |
12 ± 4.0 |
Positive controls, –S9 |
Name |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
Concentrations (μg/plate) |
3 |
5 |
2 |
0.2 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
983 ± 56.6 |
271 ± 9.5 |
1220 ± 41.7 |
192 ± 14.6 |
1719 ± 200.1 |
|
+ |
0 |
119 ± 8.5 |
15 ± 3.5 |
24 ± 4.6 |
24 ± 7.5 |
15 ± 3.5 |
+ |
1.5 |
115 ± 3.6 |
17 ± 6.7 |
32 ± 5.9 |
21 ± 1.7 |
15 ± 5.1 |
+ |
5 |
122 ± 7.9 |
9 ± 1.5 |
34 ± 6.0 |
29 ± 5.3 |
12 ± 1.0 |
+ |
15 |
140 ± 7.2 |
11 ± 1.5 |
24 ± 2.3 |
23 ± 2.1 |
15 ± 3.5 |
+ |
50 |
126 ± 8.0 |
10 ± 3.1 |
29 ± 10.5 |
23 ± 8.2 |
13 ± 3.5 |
+ |
150 |
133 ± 8.7 |
16 ± 4.2 |
24 ± 3.6 |
24 ± 8.1 |
9 ± 3.8 |
+ |
500 |
133 ± 2.1 |
11 ± 3.5 |
20 ± 1.0 |
27 ± 4.7 |
15 ± 3.5 |
+ |
1500 P |
121 ± 14.9 |
12 ± 4.5 |
28 ± 6.1 |
24 ± 7.0 |
15 ± 2.1 |
+ |
5000 P |
118 ± 20.4 |
10 ± 2.0 |
27 ± 5.0 |
26 ± 7.4 |
13 ± 6.1 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1878 ± 130.8 |
330 ± 12.2 |
331 ± 24.2 |
239 ± 14.4 |
406 ± 10.4 |
ENNG: N-ethyl-N-nitro-N-nitrosoguanidine
4NQO: 4-nitroquinoline-N-oxide
9AA: 9-aminoacridine
2AA: 2-aminoanthracene
BP: Benzo(a)pyrene
P: Precipitate
Table 2: Test results: Experiment 2 – Pre-incubation
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
– |
0 |
138 ± 28.6 |
18 ± 4.2 |
29 ± 2.5 |
30 ± 7.0 |
20 ± 3.5 |
– |
15 |
137 ± 24.9 |
15 ± 5.3 |
29 ± 3.2 |
29 ± 5.3 |
28 ± 2.3 |
– |
50 |
119 ± 3.6 |
22 ± 4.2 |
33 ± 5.5 |
29 ± 4.0 |
24 ± 4.0 |
– |
150 |
138 ± 24.9 |
16 ± 3.5 |
24 ± 6.4 |
29 ± 7.6 |
21 ± 5.5 |
– |
500 |
136 ± 9.3 |
21 ± 6.4 |
27 ± 5.9 |
28 ± 4.2 |
20 ± 8.0 |
– |
1500 P |
131 ± 17.9 |
22 ± 6.1 |
26 ± 4.9 |
27 ± 4.5 |
22 ± 9.5 |
– |
5000 P |
135 ± 12.5 |
17 ± 4.0 |
33 ± 4.9 |
29 ± 6.4 |
20 ± 2.3 |
Positive controls, –S9 |
Name |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
Concentrations (μg/plate) |
3 |
5 |
2 |
0.2 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1094 ± 52.9 |
1087 ± 103.1 |
1277 ± 159.0 |
258 ± 24.7 |
1318 ± 75.5 |
|
+ |
0 |
146 ± 15.8 |
17 ± 2.3 |
42 ± 6.6 |
29 ± 5.0 |
27 ± 3.5 |
+ |
15 |
134 ± 13.5 |
16 ± 5.3 |
28 ± 6.1 |
33 ± 2.9 |
25 ± 1.5 |
+ |
50 |
132 ± 1.5 |
13 ± 2.1 |
34 ± 8.3 |
29 ± 9.8 |
18 ± 2.1 |
+ |
150 |
126 ± 10.1 |
14 ± 2.5 |
35 ± 5.7 |
33 ± 3.8 |
18 ± 4.0 |
+ |
500 |
118 ± 12.7 |
16 ± 3.1 |
31 ± 9.2 |
30 ± 7.5 |
19 ± 5.0 |
+ |
1500 P |
117 ± 21.7 |
15 ± 6.4 |
33 ± 0.6 |
34 ± 6.2 |
19 ± 6.4 |
+ |
5000 P |
117 ± 23.9 |
12 ± 5.0 |
36 ± 8.3 |
36 ± 3.8 |
21 ± 4.4 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
921 ± 86.1 |
297 ± 6.7 |
210 ± 54.3 |
462 ± 58.0 |
556 ± 28.2 |
ENNG: N-ethyl-N-nitro-N-nitrosoguanidine
4NQO: 4-nitroquinoline-N-oxide
9AA: 9-aminoacridine
2AA: 2-aminoanthracene
BP: Benzo(a)pyrene
P: Precipitate
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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