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EC number: 500-018-3 | CAS number: 9005-64-5 1 - 6.5 moles ethoxylated
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- (solvent control of positive control substances was not investigated)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- (solvent control of positive control substances was not investigated)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sorbitan monolaurate, ethoxylated
- EC Number:
- 500-018-3
- EC Name:
- Sorbitan monolaurate, ethoxylated
- Cas Number:
- 9005-64-5
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Sorbitan monolaurate, ethoxylated (1-6.5 moles ethoxylated)
- Details on test material:
- - Name of test material: PC-2012-412
- Molecular formula: UVCB
- Physical state: yellow viscous liquid
- Analytical purity: 100%
- Batch No.: ES61C86614
- Expiration date of the batch: 05 January 2014
- Storage condition of test material: at room temperature in the dark
Constituent 1
Method
- Target gene:
- his and trp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Glucose agar medium contained: 18 g/L purified agar in Vogel-Bonner Medium E, 20 g/L glucose. The agar plates also contained 12.5 µg/plate biotin and 15 µg/plate histidine.
Strains were regularly checked to confirm their histidine-requirement, crystal violet sensitivity, ampicillin resistance (TA98 and TA100), UV-sensitivity and the number of spontaneous revertants.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Glucose agar medium contained: 18 g/L purified agar in Vogel-Bonner Medium E, 20 g/L glucose. The agar plates also contained 15 µg/plate tryptophan.
The sensitivity of the strain to a wide variety of mutagens was enhanced by permeabilization of the strain using Tris-EDTA treatment. The strain was regularly checked to confirm the tryptophan-requirement, UV-sensitivity and the number of spontaneous revertants.
- 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:
- Experiment 1 : 10, 33, 100, 333, 1000, 3330 µg/plate in the presence and abscence of 5% S9-mix (all strains); 3 and 5000 µg/plate were additionally tested in TA100 and WP2uvrA (testing 3-5000 µg/plate in tester strains TA100 and WP2uvrA was the dose-range finding test of the study and reported as part of the first experiment)
Experiment 2: 33, 100, 333, 1000, 3330, 5000 µg/plate in the presence and abscence of 5% S9-mix (only tested in TA1535 and TA98 since no biologically relevant toxicity or precipitate on the plates was observed in theses strains in experiment 1)
Experiment 3: 33, 100, 333, 1000, 3330, 5000 µg/plate in the presence and absence of 10% S9-mix (all strains) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol (test substance), DMSO and saline (positive controls)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol (vehicle of the negative control)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see "Details on test system and conditions"
- Details on test system and experimental conditions:
- Positive control substances:
-S9: sodium azide (5 μg/plate in saline) for TA1535; ICR-191 (2.5 μg/plate in DMSO) for TA1537; 2-nitrofluorene (10 μg/plate in DMSO) for TA98, methylmethanesulfonate (650 μg/plate in DMSO) for TA100, 4-nitroquinoline N-oxide (10 μg/plate in DMSO) for WP2uvrA
+S9 (5%): 2-aminoanthracene in DMSO for all strains (TA1535, TA1537: 2.5 µg/plate; TA98, TA100: 1 µg/plate; WP2uvrA: 10 µg/plate)
+S9 (10%): 2-aminoanthracene in DMSO for all strains (TA1535, TA100: 2.5 µg/plate; TA1537: 5 µg/plate; TA98: 1 µg/plate; WP2uvrA: 10 µg/plate)
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 ± 4h at 37°C in the dark
NUMBER OF REPLICATIONS: 3 replications each in 2 (for tester strains TA 1537, TA 100 and WP2 uvrA) or 3 independent experiments (for TA 1535 and TA 98)
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- A test substance was considered negative (not mutagenic) in the test if:
The total number of revertants in tester strain TA100 was not greater than two times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA was not greater than three times the concurrent vehicle control.
The negative response was reproducible in at least one independently repeated experiment.
A test substance was considered positive (mutagenic) in the test if:
The total number of revertants in tester strain TA100 was greater than two times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA was greater than three times the concurrent vehicle control.
In case a repeat experiment was performed when a positive response was observed in one of the tester strains, the positive response was reproducible in at least one independently repeated experiment.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100; E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- see "Additional information on results"
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: not observed
RANGE-FINDING/SCREENING STUDIES: In a dose range finding test (reported as part of experiment 1), the test substance was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. The test substance did not precipitate on the plates at this dose level. In tester strain TA100, toxicity was observed at dose levels of 3330 and 5000 μg/plate in the absence of S9-mix and at 1000 µg/plate and above in the presence of S9-mix. In tester strain WP2uvrA, no toxicity was observed at any of the dose levels tested.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In experiment 2, cytotoxicity was observed in tester strain TA1535 at the test substance concentrations of 3330 and 5000 µg/plate in the absence of S9-mix and at 5000 µg/plate in the presence of S9-mix. In the third experiment, cytotoxic effects were observed in strains TA1535 and TA100 at 3330 and 5000 µg/plate and in TA1537 at 5000 µg/plate without metabolic activation as well as in TA1535 at 5000 µg/plate, in TA1537 at 3330, 5000 µg/plate and in TA100 at 333, 1000, 3330, 5000 µg/plate with metabolic activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1 (Experiment 1): Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and one Escherichia coli strain (the S9 -mix contained 5% (v/v) S9 fraction)
Dose (µg/plate) |
S9-mix |
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
Positive control |
- |
854 ± 6 |
811 ± 35 |
1011 ± 17 |
879 ± 7 |
1131 ± 4 |
Solvent control |
- |
12 ± 5 |
5 ± 3 |
30 ± 8 |
120 ± 5 |
22 ± 4 |
3 |
- |
n.d. |
n.d. |
n.d. |
128 ± 24 |
30 ± 3 |
10 |
- |
7 ± 1 |
4 ± 2 |
29 ± 6 |
141 ± 25 |
19 ± 8 |
33 |
- |
12 ± 2 |
5 ± 2 |
29 ± 5 |
113 ± 7 |
21 ± 1 |
100 |
- |
12 ± 3 |
3 ± 2 |
31 ± 2 |
104 ± 9 |
29 ± 4 |
333 |
- |
11 ± 4 |
6 ± 2 |
32 ± 5 |
98 ± 8 |
28 ± 1 |
1000 |
- |
9 ± 3 |
6 ± 2 |
29 ± 4 |
64 ± 17 |
31 ± 7 |
3330 |
- |
3 ± 1 |
0 ± 0 |
34 ± 6 |
26 ± 2 |
29 ± 5 |
5000 |
- |
n.d. |
n.d. |
n.d. |
16 ± 5 |
30 ± 7 |
Positive control |
+ |
389 ± 16 |
387 ± 29 |
1059 ± 76 |
1289 ± 33 |
538 ± 17 |
Solvent control |
+ |
11 ± 3 |
4 ± 1 |
41 ± 9 |
105 ± 7 |
22 ± 4 |
3 |
|
n.d. |
n.d. |
n.d. |
104 ± 18 |
21 ± 2 |
10 |
+ |
9 ± 1 |
4 ± 1 |
38 ± 1 |
109 ± 2 |
27 ± 3 |
33 |
+ |
10 ± 6 |
4 ± 1 |
41 ± 6 |
103 ± 9 |
21 ± 1 |
100 |
+ |
12 ± 3 |
2 ± 2 |
39 ± 11 |
96 ± 27 |
22 ± 3 |
333 |
+ |
9 ± 3 |
4 ± 2 |
36 ± 4 |
128 ± 33 |
26 ± 4 |
1000 |
+ |
5 ± 3 |
2 ± 1 |
35 ± 4 |
57 ± 6 s |
32 ± 8 |
3330 |
+ |
3 ± 1 |
0 ± 1 |
41 ± 3 |
3 ± 2 m |
39 ± 6 |
5000 |
+ |
n.d. |
n.d. |
n.d. |
MC m/e |
27 ± 6 |
(testing 3-5000 µg/plate in tester strains TA100 and WP2uvrA represent the dose-range finding test of the study and were reported as part of the first experiment)
solvent control: 0.1 mL ethanol
s: Bacterial background lawn slightly reduced
m: Bacterial background lawn moderately reduced
e: Bacterial background lawn extremely reduced
MC: Microcolonies
Table 2 (Experiment 2): Mean number of revertant colonies/3 replicate plates (± S.D.) with two strains of Salmonella typhimurium (the S9 -mix contained 5% (v/v) S9 fraction)
Dose (µg/plate) |
S9-mix |
TA1535 |
TA98 |
Positive control |
- |
648 ± 54 |
845 ± 15 |
Solvent control |
- |
9 ± 3 |
21 ± 5 |
33 |
- |
6 ± 2 |
19 ± 1 |
100 |
- |
8 ± 2 |
22 ± 3 |
333 |
- |
8 ± 2 |
22 ± 3 |
1000 |
- |
7 ± 1 |
21 ± 1 |
3330 |
- |
2 ± 1 |
20 ± 2 |
5000 |
- |
1 ± 1 |
17 ± 3 |
Positive control |
+ |
218 ± 24 |
838 ± 39 |
Solvent control |
+ |
6 ± 2 |
29 ± 6 |
33 |
+ |
5 ± 1 |
23 ± 2 |
100 |
+ |
8 ± 2 |
26 ± 3 |
333 |
+ |
9 ± 0 |
24 ± 1 |
1000 |
+ |
7 ± 2 |
23 ± 4 |
3330 |
+ |
4 ± 1 |
21 ± 3 |
5000 |
+ |
0 ± 0 |
15 ± 4 |
(only TA1535 and TA98 were tested in experiment 2, since no biologically relevant toxicity or precipitate on the plates were observed in theses strains in experiment 1)
solvent control: 0.1 mL ethanol
Table 3 (Experiment 3): Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and one Escherichia coli strain (the S9 -mix contained 10% (v/v) S9 fraction)
Dose (µg/plate) |
S9-mix |
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
Positive control |
- |
792 ± 19 |
878 ± 44 |
949 ± 46 |
813 ± 44 |
837 ± 105 |
Solvent control |
- |
11 ± 2 |
2 ± 1 |
15 ± 4 |
95 ± 9 |
29 ± 5 |
33 |
- |
11 ± 3 |
3 ± 1 |
21 ± 4 |
104 ± 7 |
n.d. |
100 |
- |
12 ± 4 |
5 ± 2 |
18 ± 3 |
101 ± 10 |
26 ±6 |
333 |
- |
10 ± 1 |
6 ± 3 |
22 ± 4 |
99 ± 8 |
29 ± 7 |
1000 |
- |
9 ± 4 |
4 ± 2 |
18 ± 2 |
66 ± 13 |
29 ± 4 |
3330 |
- |
2 ± 2 |
2 ± 2 |
17 ± 1 |
23 ± 2 |
24 ± 2 |
5000 |
- |
1 ± 1 |
0 ± 1 |
17 ± 2 |
3 ± 3 |
20 ± 4 |
Positive control |
+ |
161 ± 23 |
293 ± 33 |
1007 ± 123 |
966 ± 45 |
300 ± 45 |
Solvent control |
+ |
6 ± 3 |
6 ± 3 |
23 ± 6 |
69 ± 2 |
23 ± 5 |
33 |
+ |
6 ± 1 |
2 ± 1 |
29 ± 2 |
71 ± 7 |
n.d. |
100 |
+ |
7 ± 3 |
6 ± 3 |
26 ± 2 |
65 ± 2 |
27 ± 2 |
333 |
+ |
9 ± 1 |
8 ± 2 |
28 ± 3 |
49 ± 15 |
23 ± 5 |
1000 |
+ |
6 ± 2 |
2 ± 2 |
22 ± 3 |
37 ± 4 s |
23 ± 4 |
3330 |
+ |
3 ± 2 |
0 ± 0 |
22 ± 4 |
10 ± 2 m |
23 ± 3 |
5000 |
+ |
1 ± 1 |
0 ± 1 |
22 ± 2 |
MC m/e |
21 ± 4 |
solvent control: 0.1 mL ethanol
s: Bacterial background lawn slightly reduced
m: Bacterial background lawn moderately reduced
e: Bacterial background lawn extremely reduced
MC: MicrocoloniesApplicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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