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EC number: 297-443-7 | CAS number: 93572-14-6
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 17 - 25 Feb 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions (analytical purity of test substance not specified, incomplete strain selection, only 2-AA used as positive control in the presence of S9 mix).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified, incomplete strain selection, only 2-AA used as positive control in the presence of S9 mix
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C16-18, 2-ethylhexyl esters
- EC Number:
- 292-951-5
- EC Name:
- Fatty acids, C16-18, 2-ethylhexyl esters
- Cas Number:
- 91031-48-0
- IUPAC Name:
- 91031-48-0
- Details on test material:
- - Name of test material (as cited in study report): Isooctylstearate, Fatty acids, C16-18, 2-ethylhexyl esters
- Physical state: clear liquid
- Analytical purity: no data
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
- Additional strain / cell type characteristics:
- other: rfa-; uvrB- (R+ for TA 98 and TA100)
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- other: rfa-; uvrB-
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix (Spraque Dawley rats, male, Aroclor 1254 induced)
- Test concentrations with justification for top dose:
- 8, 40, 200, 1000 and 5000 µg/plate in both experiments
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween 80/bidest. water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tween 80/bidest. water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 and TA100 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tween 80/bidest. water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tween 80/bidest. water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-o-phenylenediamine
- Remarks:
- TA1538 and TA98 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Tween 80/bidest. water
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- All test strains with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 2 experiments were performed in triplicates each
DETERMINATION OF CYTOTOXICITY
- Method: Inspection of the bacterial background lawn
OTHER: The spontaneous mutation rates of each tester strain were within the characteristic spontaneous mutation rates - Evaluation criteria:
- A combination of the following criteria was considered as a positive result:
1) The plate background of non-reverted bacteria did not show any growth reduction versus the respective negative controls.
2) The spontaneous mutation rates of each tester strain per plate were within the characteristic spontaneous mutation range.
3) As a rule, the positive controls showed mutation rates exceeding the control values of TA 100 at least by the factor 2.0 and those of the other tester strains at least by the factor 3.0.
4) At more than one dose tested, the test substance caused at least a 2.0-fold increase in comparison with the negative controls in the tester strain TA 100. For the other tester strains, an increase in the mutation rate of more than 3.0 above the corresponding negative controls was considered positive.
Reproducibility:
If the test substance induces reverse mutations in only one test, and if this effect cannot be reproduced in one or several repeated tests, the initially positive test data will lose their significance. - Statistics:
- Mean and standard deviation were calculated
Revertant colonies were counted and the mean and standard deviation were calculated and compared to the controls. The tester strains were regulary tested for their genetic markers.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Yes
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Mutagenicity on bacteria - Experiment I
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
TA 1535 |
TA 100 |
TA 1537 |
TA 1538 |
TA 98 |
||
- |
Solvent (Tween 80) |
7 |
71 |
6 |
10 |
15 |
- |
8 |
8 |
73 |
4 |
7 |
13 |
- |
40 |
8 |
85 |
5 |
8 |
16 |
- |
200 |
12 |
80 |
9 |
6 |
21 |
- |
1000 |
8 |
83 |
7 |
11 |
16 |
- |
5000 |
11 |
107 |
5 |
9 |
13 |
Positive controls - S9 |
Name |
SA |
SA |
9AA |
4ND |
4ND |
Concentrations (μg/plate) |
2 |
2 |
80 |
40 |
40 |
|
Number of colonies/plate |
307 |
256 |
198 |
1014 |
483 |
|
+ |
Solvent (Tween 80) |
10 |
78 |
4 |
16 |
16 |
+ |
8 |
13 |
95 |
5 |
16 |
13 |
+ |
40 |
11 |
95 |
6 |
16 |
16 |
+ |
200 |
10 |
95 |
4 |
11 |
11 |
+ |
1000 |
11 |
106 |
6 |
25 |
14 |
+ |
5000 |
11 |
97 |
7 |
20 |
15 |
Positive controls + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.5 |
5 |
2.5 |
5 |
5 |
|
Number of colonies/plate |
104 |
1242 |
35 |
459 |
741 |
9AA = 9-Aminoacridine
2AA = 2-Aminoanthracene
SA = Sodium Acide
4ND = 4-Nitro-o-phenylenediamine
Table 2: Mutagenicity on bacteria - Experiment II
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
TA 1535 |
TA 100 |
TA 1537 |
TA 1538 |
TA 98 |
||
- |
Solvent (Tween 80) |
7 |
81 |
6 |
9 |
16 |
- |
8 |
10 |
65 |
3 |
6 |
16 |
- |
40 |
13 |
83 |
6 |
6 |
18 |
- |
200 |
10 |
75 |
6 |
7 |
17 |
- |
1000 |
11 |
75 |
5 |
6 |
18 |
- |
5000 |
10 |
71 |
6 |
7 |
12 |
Positive controls - S9 |
Name |
SA |
SA |
9AA |
4ND |
4ND |
Concentrations (μg/plate) |
2 |
2 |
80 |
40 |
40 |
|
Number of colonies/plate |
355 |
337 |
203 |
892 |
440 |
|
+ |
Solvent (Tween 80) |
11 |
89 |
7 |
13 |
17 |
+ |
8 |
7 |
78 |
6 |
9 |
18 |
+ |
40 |
12 |
90 |
6 |
12 |
18 |
+ |
200 |
12 |
90 |
6 |
11 |
19 |
+ |
1000 |
14 |
89 |
6 |
16 |
17 |
+ |
5000 |
13 |
89 |
5 |
13 |
20 |
Positive controls + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.5 |
5 |
2.5 |
5 |
5 |
|
Number of colonies/plate |
126 |
1164 |
51 |
354 |
619 |
9AA = 9-Aminoacridine
2AA = 2-Aminoanthracene
SA = Sodium Acide
4ND = 4-Nitro-o-phenylenediamine
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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