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EC number: 221-178-8 | CAS number: 3025-30-7
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 20-31, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethyl (2E,4Z)-2,4-decadienoate
- EC Number:
- 221-178-8
- EC Name:
- Ethyl (2E,4Z)-2,4-decadienoate
- Cas Number:
- 3025-30-7
- Molecular formula:
- C12H20O2
- IUPAC Name:
- ethyl deca-2,4-dienoate
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0007631647
- Expiration date of the lot/batch: 10/2018
- Purity test date: September 27, 2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light, then under nitrogen
- Solubility and stability of the test substance in the solvent/vehicle: soluble in DMSO
Method
- Target gene:
- S. typhimurium: histidine dependence
E. coli: tryptophan locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 5.00, 15.0, 50.0, 150, 500, 1500, and 5000 ug/plate
No precipitate was observed, some toxicity was noted at 500 ug/plate and above. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility of the test substance and compatibility with target cells
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
- Cell density at seeding (if applicable): 2.0 - 5.2 x 10^9 cells per milliliter
- Fixation time (start of exposure up to fixation or harvest of cells): 12 hrs
DURATION
- Exposure duration: 48-72 hrs
SELECTION AGENT (mutation assays): BBL selective agar
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: all
DETERMINATION OF CYTOTOXICITY
- Method:relative growth
- Any supplementary information relevant to cytotoxicity: A dose level was considered toxic if there was at least a 50% reduction in mean number of revertants per plate and a dose-dependent drop in the revertant count, and moderate to significant reduction in the background lawn. - Rationale for test conditions:
- In the initial assay, dose levels of 1.50, 5.00, 15.0, 50.0, 150, 500, 1500, and 5000 ug/plate were evaluated. Toxicity was observed beginning at 500 ug/plate. No precipitation was observed, thus the maximum dose for the confirmatory assay was 5000 ug/plate.
- Evaluation criteria:
- All S. typhimurium strains must demonstrate presence of rfa mutations and deletion in the uvrB gene. S. typhimuirum strains TA98 and TA100 must demonstrate presence of the pKM101 plasmid R-factor. E. coli culture must demonstrate deletion in the uvrA gene.
Mean number of spontaneous revertants: 10-50 (TA98), 80-240 (TA100), 5-45 (TA1535), 3-21 (TA1537), 10-60 (WP2 uvrA)
Tester strain culture titers must be >= 0.3 x 10^9 cells/mL.
Postitive controls must exhibit at a 3-fold increase in the number of revertants.
A minimum of 4 non-toxic dose levels. - Statistics:
- Mean, standard deviation
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxicity was observed starting at 500 ug/plate.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: None
RANGE-FINDING/SCREENING STUDIES: In the initial assay, dose levels of 1.50, 5.00, 15.0, 50.0, 150, 500, 1500, and 5000 ug/plate were evaluated. Toxicity was observed beginning at 500 ug/plate. No precipitation was observed.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: see table below
- Negative (solvent/vehicle) historical control data: see table below
Any other information on results incl. tables
Historical Control Data (2015 Revertants per Plate)
Strain | TA98 | TA98 | TA100 | TA100 | TA1535 | TA1535 | TA1537 | TA1537 | WP2 uvrA | WP2 uvrA |
Control | Negative | Positive | Negative | Positive | Negative | Positive | Negative | Positive | Negative | Positive |
Mean (no S9) | 16 | 190 | 90 | 697 | 13 | 624 | 7 | 392 | 25 | 336 |
Standard Deviation (no S9) | 5 | 191 | 12 | 172 | 5 | 196 | 3 | 292 | 8 | 112 |
Minimum (no S9) | 6 | 42 | 62 | 239 | 2 | 50 | 1 | 24 | 7 | 89 |
Maximum (no S9) | 43 | 2468 | 233 | 1767 | 35 | 2509 | 20 | 2887 | 73 | 1026 |
95% Confidence Limit (no S9) | 6 -26 | 66 -114 | 3 -23 | 1 -13 | 9 -41 | |||||
Mean (S9) | 23 | 329 | 98 | 671 | 13 | 137 | 9 | 73 | 28 | 352 |
Standard Deviation (S9) | 7 | 176 | 15 | 284 | 5 | 110 | 3 | 53 | 8 | 117 |
Minimum (S9) | 5 | 51 | 63 | 138 | 3 | 24 | 2 | 19 | 10 | 78 |
Maximum (S9) | 53 | 1786 | 15 7 | 2692 | 33 | 1060 | 23 | 574 | 96 | 1409 |
95% Confidence Limit (S9) | 9 -37 | 68 -128 | 3 -23 | 3 -15 | 12 -44 |
Applicant's summary and conclusion
- Conclusions:
- Not mutagenic either in the presence or absence of S9.
- Executive summary:
The mutagenicity of ethyl decadienoate was tested in an OECD Guideline 471 Ames test. The mutagenicity was tested both in the presence and absence of S9 using DMSO as a solvent. Doses of 5.00, 15.0, 50.0, 150, 500, 1500, and 5000 ug/plate were tested. Toxicity was seen at doses of 500 ug/plate or higher. The test substance was not mutagenic either in the presence or absence of S9.
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