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EC number: 287-828-8 | CAS number: 85586-25-0
- 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:
- key study
- Study period:
- February 10th, 1988 - February 26th, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
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:
- , incomplete strain selection; lack of details on test substance specification;
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C14-18 and C16-18-unsatd., Me esters
- EC Number:
- 267-007-0
- EC Name:
- Fatty acids, C14-18 and C16-18-unsatd., Me esters
- Cas Number:
- 67762-26-9
- Molecular formula:
- UVCB substance, not univocal molecular formula available
- IUPAC Name:
- Fatty acids, C14-18 and C16-18 unsaturated, methyl esters
- Details on test material:
- - Name of test material: Methyl Oleate
- Physical state: milky white, waxy
Constituent 1
Method
- Target gene:
- Genes involved in Histidine synthesis
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:
- 0, 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
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 and TA100 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-o-phenyldiamin
- Remarks:
- TA1538 and TA98 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracen
- Remarks:
- All test strains with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
- Expression time (cells in growth medium): 48 h
NUMBER OF REPLICATIONS: 3
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:
- 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.
All cultures must demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls. - Statistics:
- Mean and standard deviation were calculated
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
- 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
- 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 |
TA100 |
TA1537 |
TA1538 |
TA98 |
||
- |
Solvent (Tween80/H2O) |
5 |
109 |
6 |
12 |
13 |
- |
8 |
6 |
108 |
8 |
3 |
14 |
- |
40 |
4 |
107 |
4 |
7 |
12 |
- |
200 |
7 |
101 |
5 |
5 |
15 |
- |
1000 |
5 |
111 |
9 |
8 |
14 |
|
5000 |
7 |
120 |
9 |
12 |
16 |
Positive controls - S9 |
Name |
SA |
SA |
9AA |
4ND |
4ND |
Concentrations (μg/plate) |
2 |
2 |
80 |
40 |
40 |
|
Number of colonies/plate |
241 |
420 |
156 |
892 |
351 |
|
+ |
Solvent (Tween80/H2O) |
11 |
114 |
7 |
13 |
17 |
+ |
8 |
11 |
112 |
5 |
11 |
16 |
+ |
40 |
12 |
112 |
6 |
10 |
15 |
|
200 |
6 |
115 |
4 |
8 |
18 |
+ |
1000 |
10 |
127 |
4 |
7 |
18 |
+ |
5000 |
10 |
119 |
5 |
8 |
12 |
Positive controls + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.5 |
5 |
2.5 |
5 |
5 |
|
Number of colonies/plate |
117 |
1316 |
170 |
187 |
826 |
9AA = 9-Aminoacridine
2AA = 2-Aminoanthracene
SA = Sodium Acide
4ND = 4-Nitro-o-phenylendiamine
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 |
TA100 |
TA1537 |
TA1538 |
TA98 |
||
- |
Solvent (Tween80/H2O) |
10 |
81 |
5 |
7 |
18 |
- |
8 |
7 |
87 |
6 |
9 |
22 |
- |
40 |
7 |
90 |
5 |
6 |
17 |
- |
200 |
12 |
97 |
5 |
11 |
21 |
- |
1000 |
8 |
93 |
6 |
10 |
19 |
|
5000 |
7 |
87 |
8 |
7 |
20 |
Positive controls - S9 |
Name |
SA |
SA |
9AA |
4ND |
4ND |
Concentrations (μg/plate) |
2 |
2 |
80 |
40 |
40 |
|
Number of colonies/plate |
251 |
262 |
230 |
1038 |
401 |
|
+ |
Solvent (Tween80/H2O) |
11 |
91 |
7 |
12 |
16 |
+ |
8 |
14 |
96 |
10 |
11 |
20 |
+ |
40 |
9 |
109 |
7 |
13 |
23 |
|
200 |
18 |
105 |
7 |
13 |
17 |
+ |
1000 |
13 |
107 |
8 |
13 |
20 |
+ |
5000 |
11 |
101 |
6 |
18 |
12 |
Positive controls + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.5 |
5 |
2.5 |
5 |
5 |
|
Number of colonies/plate |
131 |
1285 |
51 |
366 |
618 |
9AA = 9-Aminoacridine
2AA = 2-Aminoanthracene
SA = Sodium Acide
4ND = 4-Nitro-o-phenylendiamine
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative Under the tested experimental conditions the test substance did not induce gene mutations in S. typhimurium strains up to the maximum dose.
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