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EC number: - | CAS number: -
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 - 24 Sep 2012
- 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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Oleic acid, monoester with oxybis(propanediol)
- EC Number:
- 256-367-4
- EC Name:
- Oleic acid, monoester with oxybis(propanediol)
- Cas Number:
- 49553-76-6
- Molecular formula:
- C24H46O6
- IUPAC Name:
- 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl octadec-9-enoate
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium) and trp operon (for E. coli)
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:
- co-factor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- Preliminary cytotoxicity test (Experiment I): 33.3, 66.7, 100, 333, 667, 1000, 3333, and 5000 µg/plate with and without metabolic activation
Main assay (Experiment II): 333, 667, 1000, 3333, and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: DMSO was chosen as the dosing vehicle based on the solubility of the test substance and compatibility with the target cells. The test substance was soluble in DMSO at 50 mg/mL, the highest stock concentration that was prepared for use on this study.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- -S9: 2-NF (1 µg/plate, TA 98), SA (2 µg/plate, TA 100 and TA 1535), ICR-191 (2 µg/plate, TA 1537), 4-NQO (1 µg/plate, WP2 uvrA); +S9: BaP (2.5 µg/plate, TA 98); 2-AA (2.5 µg/plate, TA 100, TA 1535 and TA 1537; 25 µg/plate, WP2 uvrA)
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: acridine mutagen ICR-191 and 2-aminoanthracene
- Remarks:
- BaP: benzo[a]pyrene; 4-NQO: 4-nitroquinoline N-oxide; acridine mutagen ICR-191: ICR-191; SA: sodium azide; 2-aminoanthracene: 2-AA; 2-NF: 2-nitrofluorene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48-72 h
NUMBER OF REPLICATIONS: duplicate plates in the preliminary cytotoxicity test and triplicate plates in the main assay
DETERMINATION OF CYTOTOXICITY
- Method: mean number of revertant colonies, inspection of bacterial background lawn - Evaluation criteria:
- Criteria for a positive response:
- Strains TA1535 and TA1537: data were judged positive if the increase in mean revertants at the highest numerical dose response was ≥ 3.0-fold the mean concurrent negative control value (vehicle control). This increase in the mean number of revertants per plate had to be accompanied by a dose response associated with increasing concentrations of the test substance unless observed at the top dose level only.
- Strains TA98, TA100 and WP2uvrA: data sets were judged positive if the increase in mean revertants at the highest numerical dose response was ≥ 2.0-fold the mean concurrent negative control value (vehicle control). This increase in the mean number of revertants per plate has to be accompanied by a dose response associated with increasing concentrations of the test substance unless observed at the top dose level only. - Statistics:
- For each tester strain, the mean of the number of revertants and the standard deviations were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate: TA 1535 (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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:
- 5000 µg/plate: TA 1537 (-S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: in the absence of S9 mix, test substance precipitation was observed starting at 3333 μg/plate for all tester strains with the exception of WP2 uvrA where precipitation was observed only at 5000 μg/plate. In the presence of S9 mix, precipitation was observed starting at 3333 μg/plate for all tester strains with the exception of TA 100 and WP2uvrA. Precipitation was not observed with WP2 uvrA in the activated condition and was only observed at 5000 μg/plate with tester strain TA 100. However, none of the precipitates prevented accurate colony counting.
RANGE-FINDING/SCREENING STUDIES: in the preliminary cytotoxicity test, a 50% reduction in revertant colonies was observed with TA 1537 in the presence of metabolic activation starting at 3333 µg/plate. No cytotoxicity was observed in any of the other tester strains after treatment with concentrations ranging from 33.3 to 5000 µg/plate in the presence and absence of metabolic activation, respectively.
COMPARISON WITH HISTORICAL CONTROL DATA: the mean revertant number of the vehicle and positive controls was within their respective historical ranges.
ADDITIONAL INFORMATION ON CYTOTOXICITY: a >50% reduction in revertant colonies was observed at 5000 μg/plate for both TA1537 in the absence of S9 activation, as well as for TA1535 in the presence of S9 activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table1. Test results of first experiment – preliminary cytotoxicity test
Bacterial Reverse Mutation Assay, mean revertant colonies/plate (n=2 ± SD) |
|||||
EXPERIMENT I (plate incorporation) |
|||||
S9-Mix
|
Without
|
||||
Concentration (per plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
SC (DMSO) |
17 ± 1 |
111 ± 4 |
16 ± 0 |
5 ± 1 |
31 ± 1 |
Test item |
|
|
|
|
|
33.3 µg |
20 ± 4 |
98 ± 6 |
20 ± 2 |
14 ± 1 |
38 ± 7 |
66.7 µg |
24 ± 6 |
110 ± 11 |
11 ± 3 |
10 ± 1 |
33 ± 8 |
100 µg |
23 ± 6 |
101 ± 16 |
14 ± 7 |
3 ± 3 |
33 ± 4 |
333 µg |
25 ± 5 |
91 ± 0 |
14 ± 4 |
5 ± 0 |
35 ± 4 |
667 µg |
21 ± 4 |
84 ± 18 |
18 ± 4 |
4 ± 1 |
39 ± 6 |
1000 µg |
28 ± 1 |
100 ± 6 |
9 ± 6 |
7 ± 0 |
38 ± 14 |
3333 µg |
22 ± 4P |
80 ± 4P |
9 ± 6P |
10 ± 7P |
39 ± 8 |
5000 µg |
23 ± 7P |
89 ± 1P |
18 ± 0P |
6 ± 6P |
26 ± 4P |
PC |
|
|
|
|
|
2-NF (1.0 µg) |
143 ± 0 |
- |
- |
- |
- |
SA (2.0 µg) |
- |
1295 ± 50 |
1115 ± 115 |
- |
- |
ICR-191 (2.0 µg) |
- |
- |
- |
1440 ± 53 |
- |
4-NQO (1.0 µg) |
- |
- |
- |
- |
540 ± 13 |
S9-Mix
|
With |
||||
Concentration (per plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
SC (acetone) |
33 ± 8 |
139 ± 1 |
12 ± 2 |
15 ± 4 |
56 ± 2 |
Test item |
|
|
|
|
|
33.3 µg |
41 ± 9 |
132 ± 4 |
17 ± 1 |
11 ± 1 |
61 ± 4 |
66.7 µg |
39 ± 6 |
135 ± 8 |
11 ± 3 |
10 ± 1 |
49 ± 5 |
100 µg |
27 ± 4 |
140 ± 11 |
11 ± 1 |
13 ± 0 |
54 ± 8 |
333 µg |
33 ± 4 |
116 ± 7 |
11 ± 1 |
12 ± 3 |
55 ± 8 |
667 µg |
32 ± 4 |
73 ± 7 |
12 ± 2 |
11 ± 4 |
45 ± 4 |
1000 µg |
34 ± 0 |
87 ± 20 |
11 ± 1 |
12 ± 6 |
49 ± 1 |
3333 µg |
31 ± 6P |
80 ± 9 |
10 ± 4P |
5 ± 6P |
47 ± 4 |
5000 µg |
25 ± 1P |
94 ± 16P |
8 ± 2P |
7 ± 1P |
51 ± 8 |
PC |
|
|
|
|
|
BP (2.5 µg) |
485 ± 87 |
- |
- |
- |
- |
2-AA (2.5 µg) |
- |
2501 ± 137 |
196 ± 1 |
181 ± 45 |
- |
2-AA (25 µg) |
- |
- |
- |
- |
257 ± 8 |
SC = Solvent control; PC = Positive control substances; SD = standard deviation; BaP: benzo[a]pyrene; 4-NQO: 4-nitroquinoline N-oxide; acridine mutagen ICR-191: ICR-191; SA: sodium azide; 2-aminoanthracene: 2-AA; 2-NF: 2-nitrofluorene P = precipitate; M = manual counting necessary |
Table 2. Test results of second experiment – Main assay
Bacterial Reverse Mutation Assay, mean revertant colonies/plate (n=3 ± SD) |
|||||
EXPERIMENT II (plate incorporation) |
|||||
S9-Mix
|
Without
|
||||
Concentration (per plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
SC (DMSO) |
18 ± 2 |
86 ± 7 |
11 ± 8 |
8 ± 2 |
25 ± 3 |
Test item |
|
|
|
|
|
333 µg |
18 ± 3 |
74 ± 2 |
6 ± 4 |
5 ± 1 |
25 ± 5 |
667 µg |
14 ± 3 |
74 ± 3 |
9 ± 3 |
4 ± 1 |
28 ± 6 |
1000 µg |
16 ± 1 |
69 ± 2 |
8 ± 3 |
5 ± 1 |
24 ± 2 |
3333 µg |
18 ± 5P |
78 ± 16P |
9 ± 3P |
6 ± 3P |
26 ± 4 |
5000 µg |
19 ± 3P |
74 ± 3P |
6 ± 4P |
3 ± 1P, M |
26 ± 3P |
PC |
|
|
|
|
|
2-NF (1.0 µg) |
150 ± 3 |
- |
- |
- |
- |
SA (2.0 µg) |
- |
1031 ± 19 |
956 ± 37 |
- |
- |
ICR-191 (2.0 µg) |
- |
- |
- |
1649 ± 123 |
- |
4-NQO (1.0 µg) |
- |
- |
- |
- |
456 ± 90 |
S9-Mix
|
With |
||||
Concentration (per plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
SC (acetone) |
28 ± 6 |
99 ± 11 |
15 ± 2 |
5 ± 1 |
33 ± 1 |
Test item |
|
|
|
|
|
333 µg |
27 ± 1 |
94 ± 24 |
8 ± 2 |
9 ± 2 |
32 ± 5 |
667 µg |
23 ± 4 |
72 ± 5 |
7 ± 3 |
6 ± 1 |
29 ± 3 |
1000 µg |
20 ± 4P |
72 ± 13 |
8 ± 2 |
5 ± 4 |
29 ± 4 |
3333 µg |
19 ± 2P |
63 ± 6P |
8 ± 3P |
5 ± 3P |
35 ± 9P |
5000 µg |
22 ± 6P |
63 ± 7P |
6 ± 4P |
4 ± 2P |
30 ± 10P |
PC |
|
|
|
|
|
BP (2.5 µg) |
284 ± 12 |
- |
- |
- |
- |
2-AA (2.5 µg) |
- |
2337 ± 174 |
155 ± 5 |
119 ± 22 |
- |
2-AA (25 µg) |
- |
- |
- |
- |
200 ± 19 |
SC = Solvent control; PC = Positive control substances; SD = standard deviation; BaP: benzo[a]pyrene; 4-NQO: 4-nitroquinoline N-oxide; acridine mutagen ICR-191: ICR-191; SA: sodium azide; 2-aminoanthracene: 2-AA; 2-NF: 2-nitrofluorene P = precipitate |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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