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EC number: 271-880-3 | CAS number: 68610-90-2
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 21 May 2013 - 23 Sep 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- Justification for read-across is given in Section 13 of IUCLID.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- adopted 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- adopted Aug 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Didodecyl fumarate
- EC Number:
- 219-280-2
- EC Name:
- Didodecyl fumarate
- Cas Number:
- 2402-58-6
- Molecular formula:
- C28H52O4
- IUPAC Name:
- didodecyl but-2-enedioate
- Details on test material:
- - Name of test material (as cited in study report): Didodecyl fumarate; fumaric acid, di-dodecyl ester
- Physical state: solid, melt, white
- Analytical purity: 93.8 area-%
- Lot/batch No.: 0008043725
- Expiration date of the lot/batch: Dec 2013
- Stability under test conditions: guaranteed until Dec 2013
- Storage condition of test material: room temperature
Constituent 1
Method
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 phenobarbital/beta-naphtoflavone
- Test concentrations with justification for top dose:
- 33, 100, 333, 1000, 2 700 and 5400 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: due to the insolubility of the test substance in ultrapure water, acetone was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation
- 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
- other: N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylenediamine
- Remarks:
- without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation
DURATION
- Preincubation period: 20 min.
- Exposure duration: 48 – 72 h.
NUMBER OF REPLICATIONS: 3 plates in 2 independent experiments.
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertants, clearing or diminution of the background lawn.
OTHER: a sterility control was conducted to exclude contamination of the plates. - Evaluation criteria:
- The experiment is considered valid if the following criteria are met:
- The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
- The sterility controls revealed no indication of bacterial contamination.
- The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above.
The test substance is considered positive in this assay if a dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system is observed.
A test substance is generally considered non-mutagenic in this test if the number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitation of the test substance was found from about 333 μg/plate onward with and without S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA: the results of the negative and positive controls are within the historical control data.
Any other information on results incl. tables
The revertans per plate for both plate incorporation and pre-incubation tests are presented in the following tables.
Table: Plate incorporation – without metabolic activation
Treatment |
Dose [µg/plate] |
Revertants/plate (mean±SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
||
vehicle control# |
19±5 |
47±2 |
12±2 |
7±1 |
78±10 |
|
Test item |
33 |
22±1 |
44±8 |
14±4 |
7±1 |
69±1 |
100 |
20±1 |
42±2 |
12±3 |
6±2 |
70±5 |
|
333 |
21±4 |
45±3 |
13±7 |
6±1 |
72±7 |
|
1000 |
18±6 |
46±3 |
12±3 |
7±2 |
73±9 |
|
2700 |
18±1 |
43±4 |
13±2 |
7±2 |
68±6 |
|
5400 |
11±2 |
31±3 |
9±1 |
4±1 |
62±8 |
|
Positive control## |
828±85 |
939±13 |
884±40 |
338±21 |
638±22 |
#vehicle control = acetone
##positive control = N-methyl-N'-nitro-N-nitrosoguanidine 5 μg/plate in DMSO (TA 1535, TA 100), 4-nitro-o-phenylenediamine 10 μg/plate in DMSO (TA 98), 9-aminoacridine 100 μg/plate in DMSO (TA 1537), 4-nitroquinoline-N-oxide 5 μg/plate in DMSO (WP2 uvrA)
Table: Plate incorporation – with metabolic activation
Treatment |
Dose [µg/plate] |
Revertants/plate (mean±SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
||
vehicle control# |
26±3 |
46±3 |
14±3 |
7±1 |
82±1 |
|
Test item |
33 |
33±1 |
45±6 |
12±2 |
8±2 |
88±9 |
100 |
31±2 |
42±2 |
15±1 |
8±2 |
88±2 |
|
333 |
27±3 |
45±5 |
13±2 |
8±3 |
81±2 |
|
1000 |
27±2 |
45±7 |
15±3 |
6±1 |
74±11 |
|
2700 |
20±1 |
42±5 |
12±2 |
6±1 |
62±3 |
|
5400 |
19±4 |
43±2 |
9±1 |
7±1 |
73±5 |
|
Positive control## |
992±74 |
1089±89 |
384±21 |
219±20 |
280±9 |
#vehicle control = acetone
##positive control = 2-aminoanthracene 2.5 μg/plate in DMSO (TA 1535, TA 100, TA 1537, TA 98) and 60 μg/plate in DMSO (WP2 uvrA)
Table: Pre-incubation – without metabolic activation
Treatment |
Dose [µg/plate] |
Revertants/plate (mean±SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
||
vehicle control# |
27±5 |
39±4 |
12±3 |
7±2 |
55±6 |
|
Test item |
33 |
29±6 |
40±7 |
11±4 |
6±1 |
63±17 |
100 |
25±5 |
44±12 |
11±1 |
8±1 |
59±4 |
|
333 |
27±6 |
40±10 |
11±3 |
8±3 |
59±4 |
|
1000 |
24±4 |
42±9 |
12±3 |
7±3 |
58±5 |
|
2700 |
18±3 |
33±4 |
11±3 |
7±2 |
50±3 |
|
5400 |
14±2 |
35±2 |
9±1 |
6±1 |
46±10 |
|
Positive control## |
664±9 |
1205±65 |
1418±18 |
881±8 |
695±76 |
#vehicle control = acetone
##positive control = N-methyl-N'-nitro-N-nitrosoguanidine 5 μg/plate in DMSO (TA 1535, TA 100), 4-nitro-o-phenylenediamine 10 μg/plate in DMSO (TA 98), 9-aminoacridine 100 μg/plate in DMSO (TA 1537), 4-nitroquinoline-N-oxide 5 μg/plate in DMSO (WP2 uvrA)
Table: Pre-incubation – with metabolic activation
Treatment |
Dose [µg/plate] |
Revertants/plate (mean±SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
||
vehicle control# |
29±5 |
46±8 |
18±3 |
14±2 |
57±8 |
|
Test item |
33 |
32±6 |
45±9 |
17±3 |
15±5 |
61±7 |
100 |
29±6 |
53±17 |
21±4 |
16±2 |
58±3 |
|
333 |
31±2 |
51±6 |
15±2 |
12±1 |
58±7 |
|
1000 |
26±2 |
48±7 |
18±3 |
16±3 |
56±8 |
|
2700 |
27±3 |
41±7 |
16±7 |
12±1 |
59±5 |
|
5400 |
28±4 |
37±3 |
13±2 |
10±2 |
58±8 |
|
Positive control## |
1113±10 |
778±14 |
335±10 |
330±13 |
172±12 |
#vehicle control = acetone
##positive control = 2-aminoanthracene 2.5 μg/plate in DMSO (TA 1535, TA 100, TA 1537, TA 98) and 60 μg/plate in DMSO (WP2 uvrA)
Applicant's summary and conclusion
- Conclusions:
- not mutagenic with and without metabolic activation.
- Executive summary:
The potential mutagenicity of the category substance was tested in a bacterial gene mutation assay according to OECD Guideline 471, EU Method B.13/14 and EPA OPPTS 870.5100. In two independent experiments, the S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A were exposed to the test substance at six concentrations (33, 100, 333, 1000, 2700 and 5400 µg/plate). Both experiments were performed in the absence or presence of a liver microsomal activation system (S9 mix) using either the plate incorporation or the pre-incubation method (20 min pre-incubation time).
No cytotoxicity was noted in the treated bacteria strains up to precipitating concentrations when compared to controls. Precipitation of the test substance was observed at 333 µg/plate onward with and without S9 mix. The mean number of revertant colonies per plate was not significantly increased at any test concentration. The solvent and the positive control substances proved the validity of the study for each tester strain.
Under the conditions of this assay, the substance was found to be non-mutagenic in the tested strains, both in the presence and absence of metabolic activation.
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