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EC number: 928-726-1 | CAS number: 1179913-28-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction product of oxiran-2-ylmethyl 2,2,3,5-tetramethylhexanoate with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)
- Molecular formula:
- Not applicable (UVCB constituent)
- IUPAC Name:
- Reaction product of oxiran-2-ylmethyl 2,2,3,5-tetramethylhexanoate with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)
- Reference substance name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:2)
- Molecular formula:
- Not applicable (UVCB constituent)
- IUPAC Name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:2)
- Reference substance name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)
- Reference substance name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:3)
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:3)
- Reference substance name:
- High Mw components based on linseed oil fatty acids
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- High Mw components based on linseed oil fatty acids
- Reference substance name:
- Sum of unassigned components
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Sum of unassigned components
- Test material form:
- liquid
- Details on test material:
- UVCB
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch number 210162718
- Expiration date of the lot/batch: 16-12-2017
- Purity: 100% (UVCB)
- Purity test date: Not reported
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle: Stability in dimethyl sulfoxide (DMSO) - 96 h, solubility in DMSO >1 g/L
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: None
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Dilution of the test material in the vehicle: The test substance was dissolved in DMSO to produce a stock solution of 50 g/L and from this stock, serial dilutions of the working solutions were prepared in DMSO to result in nominal concentrations of 5000, 1500, 500, 150 and 50 μg/plate.
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 5000, 1500, 500, 150 and 50 μg/plate for plate incorporation experiment
5000, 2500, 1250, 625 and 313 μg/plate for pre-incubation experiment - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: DMSO does not have any effect on the viability of the bacterial strains or the number of spontaneous revertants in the tested concentrations and the test substance is sufficiently soluble in the solvent at >1 g/L
Controls
- Untreated negative controls:
- yes
- Remarks:
- The solvent DMSO was used as the negative control
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-nitro-1,2-phenylene diamine, 2-amino anthracene
- Remarks:
- Sodium azide and 4-nitro-1,2-phenylene diamine were used without metabolic activation. Benzo(a)pyrene and 2-aminoanthracene were used in presence of metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Two experiments were conducted. A plate incorporation method was used for the first experiment, followed by the second experiment (pre-incubation method).
FIRST EXPERIMENT (plate incorporation menthod)
DURATION
- Preincubation period: Not reported
- Exposure duration: 48 h
NUMBER OF REPLICATES USED: Per strain and dose, 3 plates with and 3 plates without S9 mix were used.
METHOD OF APPLICATION
The following solutions/suspensions were gently vortexed in a test tube and poured onto the selective agar plates:
1. 100 μL test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control)
2. 500 μL S9 mix (for test with metabolic activation) or phosphate buffer (for test without metabolic activation)
3. 100 μL suspension of the bacterial strains
4. 2000 μL overlay agar on the top
The plates were closed and left to solidify for a few minutes, then inverted and placed in the dark incubator at 37±1°C.
SECOND EXPERIMENT (pre-incubation menthod)
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATES USED: Per strain and dose, 3 plates with and 3 plates without S9 mix were used.
METHOD OF APPLICATION
The following materials were gently vortexed in a test tube and incubated at 37±1°C for 20 min:
1. 100 μL test substance suspension at each dose level, solvent (negative control) or reference
mutagen solution (positive control)
2. 500 μL S9 mix (for test with metabolic activation) or phosphate buffer (for test without metabolic activation).
3. 100 μL suspension of the bacterial strains
After pre-incubation, 2000 μL overlay agar was added to the top, the tube was gently vortexed and the mixture was poured onto the selective agar plate.
The plates were closed and left to solidify for a few minutes, then inverted and placed in the dark incubator at 37±1 °C.
TOXICITY CONTROL
Performed in experiment 1 only, analogous to the titre control with the maximum dose of test substance with and without S9 on maximal-soft agar, 2 replicates with and without metabolic activation, incubation for 48 h at 37±1°C.
POSITIVE CONTROL
For all the positive control substances, 3 replicates were prepared. The stock solutions of the positive control substances were diluted to effect an application volume of 0.1 mL/plate, incubation for 48 h at 37 ±1°C. - Evaluation criteria:
- A test substance is considered to have mutagenic potential, if a reproducible increase of revertant colonies per plate exceeding an increase factor of 2 in at least one strain can be observed. A concentration-related increase over the range tested is also taken as a sign of mutagenic activity.
- Statistics:
- Microsoft Excel® spreadsheet was used to calculate mean values and standard deviations of each treatment concentration, solvent control and positive control.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 97, 98, 100, 102, 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: in both pre-incubation and plate incorporation experiments
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, the test substance was considered to be non-mutagenic to the Salmonella typhimurium test strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation.
- Executive summary:
An in vitro bacterial reverse mutation study was conducted to determine the mutagenic potential of the test substance according to OECD Guideline 471 and EU Method B.13/14, in compliance with GLP. Two experiments were performed.In the first experiment, five concentrations of the test substance, dissolved in DMSO (ranging from 50 to 5000 µg/plate) were used. Five strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 (genetically manipulated) and TA1535) were exposed to the test substance both in the presence and in the absence of a Aroclor induced rat liver S9-mix metabolic activation system for 48 h, using theplate incorporation method.None of the concentrations caused a significant increase in the number of revertant colonies in the tested strains. The test substance showed no precipitates on the plates in all tested concentrations. To verify the results of the first experiment, a second experiment was performed, using 5 concentrations of the test substance (ranging from313to 5000 µg/plate) and a modification in study performance (i.e., using the pre-incubation method). The test substance did not show mutagenic effects in the second experiment, either. The test substance also showed no precipitates on the plates in all tested concentrations. Further, in both the experiments, no signs of toxicity towards the bacteria could be observed. The sterility control and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were also in the normal range. All positive controls showed mutagenic effects with and without metabolic activation. The study was therefore considered valid.Therefore, the test substance was considered to be non-mutagenic under the conditions of the reverse mutation assay (Andres, 2016).
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