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EC number: 235-922-4 | CAS number: 13048-34-5
- 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:
- 23 April 2013 - 17 June 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
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
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,10-decanediyl diacrylate
- EC Number:
- 235-922-4
- EC Name:
- 1,10-decanediyl diacrylate
- Cas Number:
- 13048-34-5
- Molecular formula:
- C16H26O4
- IUPAC Name:
- 10-(prop-2-enoyloxy)decyl prop-2-enoate
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- not applicable.
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix
- Test concentrations with justification for top dose:
- With a treatment volume of 1% (v/v) in culture medium, the dose-levels used for treatments, were as follows:
. 0.16, 0.31, 0.63, 1.25, 2.5, 5, 10 and 20 µg/mL in the first experiment without S9 mix,
. 0.31, 0.63, 1.25, 2.5, 5, 10, 20 and 40 µg/mL in the second experiment without S9 mix,
. 0.63, 1.25, 2.5, 5, 10, 20, 40 and 80 µg/mL in both experiments with S9 mix. - Vehicle / solvent:
- - Vehicle used: dimethylsulfoxide (DMSO), batch No. K42474850 145.
- Justification for choice according to solubility assays performed, the highest recommended dose-level of 5000 µg/plate was achievable using a test item solution of 100 mg/mL under a treatment volume of 50 µL/plate.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, 9-aminoacridine, 2-nitrofluorene, mitomycin C (-S9 mix); 2-anthramine, benzo(a)pyrene (+S9 mix)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 to 72 hours.
DETERMINATION OF CYTOTOXICITY
- Method: decrease in number of revertant colonies and/or thinning of the bacterial lawn - Evaluation criteria:
- A test item is considered to have shown a mutagneic activity if:
- a reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the mean number of revertants compared with the vehicle controls is observed, at any dose-level,
- and/or a reproducible dose-response relationship is evidenced.
In all case, biological relevance (such as reproducibility and reference to historical data) are taken into consideration when evaluating the results. - Statistics:
- no
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- with S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True 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:
- with S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- with S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True 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
- Remarks:
- with S9 only
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The number of revertants for the vehicle and positive controls met the acceptance criteria. Also, there were six analysable dose-levels for each strain and test condition. The study was therefore considered to be valid.
Since the test item was found to be poorly soluble in the preliminary test, the selection of the highest dose-level to be used in the main experiments was based on the level of emulsion, according to the criteria specified in the international guidelines.
Experiments without S9 mix
A moderate emulsion was observed in the Petri plates in all strains when scoring the revertants at dose-levels superior or equal to 625 µg/plate (first experiment), superior or equal to 1250 µg/plate (second experiment, depending on the strain, and third experiment) and
superior or equal to 2500 µg/plate (second experiment, depending on the strain).
No noteworthy toxicity was noted in the five tested strains, either with or without S9 mix.
In the first experiment, an increase in the number of revertant was observed at 5000 µg/plate in the TA 1537 strain. This increase exceeded the positive threshold of 3-fold the vehicle control value. The corresponding value obtained for the mean number of revertants was above the maximum value observed in historical data, but heterogeneity was noted between the corresponding individual revertant colony counts. Moreover, this effect was not reproduced either in the second or in the third experiments, performed in the same experimental conditions. Consequently, this effect was not considered to be biologically relevant.
In the first experiment, a slight increase in the number of revertants was noted at 5000 µg/plate in the TA 98 strain. This increase did not exceed the positive threshold (2-fold the vehicle control value) and no similar effect was noted in the second experiment. Consequently, this increase did not meet the criteria for a positive response.
Experiments with S9 mix
A moderate emulsion was observed in the Petri plates in all strains when scoring the revertants at dose-levels superior or equal to 1250 µg/plate in the first and second experiments.
Decreases in the number of revertants (cytotoxicity) were noted in the first experiment in the TA 1537 strain at dose-levels superior or equal to 2500 µg/plate.
A moderate toxicity (thinning of the bacterial lawn) was observed at 5000 µg/plate in the TA 98 strain, and at dose-levels superior or equal to 1250 µg/plate in the TA 1535 and TA 1537 strains.
A strong toxicity (decrease in the number of revertants and thinning of the bacterial lawn) was noted in the TA 98 strain at 1250 and 2500 µg/plate.
The test item did not induce any noteworthy increase in the number of revertants, in any of the five tested strains.
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of this study, 1,10-decanediol diacrylate did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium either in the presence or in the absence of a rat liver metabolizing system.
- Executive summary:
In a reverse mutation assay in bacteria, performed according to the OECD Guideline No. 471 and in compliance with GLP, Five strains of bacteria Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) were exposed to six dose-levels of the test item (three plates/dose-level) in three independent experiments, with and/or without a metabolic activation system, the S9 mix, prepared from a liver post-mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
All experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the pre-incubation method (60 minutes, 37°C). After 48 to 72 hours of incubation at, the revertant colonies were scored.
The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn. The test item was dissolved in dimethylsulfoxide (DMSO).
The number of revertants for the vehicle and positive controls met the acceptance criteria. Also, there were six analysable dose-levels for each strain and test condition. The study was therefore considered to be valid.
Since the test item was found to be poorly soluble in the preliminary test, the selection of the highest dose-level to be used in the main experiments was based on the level of emulsion, according to the criteria specified in the international guidelines.
In the first experiment, the treatment-levels were 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate for the five strains, both with and without S9 mix.
In the second experiment, the treatment-levels were:
. 92.59, 277.8, 833.3, 2500, 3750 and 5000 µg/plate for the TA 1535, TA 1537 and TA 98 strains, without S9 mix,
. 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate for the TA 100 and TA 102 strains without S9 mix, and for the five strains with S9 mix.
In the third experiment, the treatment-levels were 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate for the TA 1537 strain without S9 mix.
Experiments without S9 mix
A moderate emulsion was observed in the Petri plates in all strains when scoring the revertants at dose-levels superior or equal to 625 µg/plate (first experiment), superior or equal to 1250 µg/plate (second experiment, depending on the strain, and third experiment) and
superior or equal to 2500 µg/plate (second experiment, depending on the strain).
No noteworthy toxicity was noted in the five tested strains, either with or without S9 mix.
In the first experiment, an increase in the number of revertant was observed at 5000 µg/plate in the TA 1537 strain. This increase exceeded the positive threshold of 3-fold the vehicle control value. The corresponding value obtained for the mean number of revertants was above the maximum value observed in historical data, but heterogeneity was noted between the corresponding individual revertant colony counts. Moreover, this effect was not reproduced either in the second or in the third experiments, performed in the same experimental conditions. Consequently, this effect was not considered to be biologically relevant.
In the first experiment, a slight increase in the number of revertants was noted at 5000 µg/plate in the TA 98 strain. This increase did not exceed the positive threshold (2-fold the vehicle control value) and no similar effect was noted in the second experiment. Consequently, this increase did not meet the criteria for a positive response.
Experiments with S9 mix
A moderate emulsion was observed in the Petri plates in all strains when scoring the revertants at dose-levels superior or equal to 1250 µg/plate in the first and second experiments.
Decreases in the number of revertants (cytotoxicity) were noted in the first experiment in the TA 1537 strain at dose-levels superior or equal to 2500 µg/plate.
A moderate toxicity (thinning of the bacterial lawn) was observed at 5000 µg/plate in the TA 98 strain, and at dose-levels superior or equal to 1250 µg/plate in the TA 1535 and TA 1537 strains.
A strong toxicity (decrease in the number of revertants and thinning of the bacterial lawn) was noted in the TA 98 strain at 1250 and 2500 µg/plate.
The test item did not induce any noteworthy increase in the number of revertants, in any of the five tested strains.
Under the experimental conditions of this study, 1,10-decanediol diacrylate did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium either in the presence or in the absence of a rat liver metabolizing system.
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