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EC number: 273-601-0 | CAS number: 68990-47-6
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine
- EC Number:
- 273-601-0
- EC Name:
- Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine
- Cas Number:
- 68990-47-6
- Molecular formula:
- The substance is a UVCB substance. One of the most likely and the smallest molecule arising from the reaction process is assumed to be: C18H33O. C18H31O. 2C4H12N3 . C4H2O2
- IUPAC Name:
- Reaction product of 2,5-Furandione with reaction products of tall-oil fatty acids, diethylenetriamine, triethylenetetramine and tetraethylenepentamine
- Details on test material:
- Name: Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine
CAS No.: 68990-47-6
Batch no.: TEE3316/22
Physical state at RT: solid
Colour: dark
Purity: Date of analysis 11 February 2010
97% (w/w)
Storage Conditions: at room temperature, protected from light
Solubility in Water: very low
Safety Precautions: Routine hygienic procedures will be sufficient to assure personnel health and safety.
Constituent 1
Method
- Target gene:
- V79 cells
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- The V79 (ATCC, CCL-93) cells are stored over liquid nitrogen (vapour phase) in the cell bank of BSL BIOSERVICE, as large stock cultures allowing the repeated use of the same cell culture batch in experiments. Routine checking for mycoplasma infections was carried out before freezing.
For the experiment, thawed cultures were set up in 75 cm2 cell culture plastic flasks at 37 oC in a 5% carbon dioxide atmosphere (95% air). 5 x 105 cells per flask were seeded in 15 mL of MEM (minimum essential medium) supplemented with 10% FCS (foetal calf serum) and subcultures were made every 3 - 4 days.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- Experiment I:
with and without metabolic activation: 1000, 2500 and 5000 μg/mL
Experiment II:
with metabolic activation: 3000, 4000 and 5000 μg/mL
without metabolic activation: 250, 500 and 1000 μg/mL
Controls
- Untreated negative controls:
- yes
- Remarks:
- cell culture medium alone
- Negative solvent / vehicle controls:
- yes
- Remarks:
- cell culture medium alone
- Positive controls:
- yes
- Positive control substance:
- other: ethylmethanesulphonate without S9 and Cyclophosphamide with S9
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1 mg/ml in experiment II without S9, a relevant decrease of the relative mitotic index (<70%)was noted
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The selection of the concentrations used in experiment I and II was based on data from the solubility test and the pre-experiment.
In experiment I with and without metabolic activation 5000 μg/mL was selected as highest dose groups for the microscopic analysis of chromosomal aberrations. In experiment II without metabolic activation 1000 μg/mL and with metabolic activation
5000 μg/mL were selected as highest dose groups for the microscopic analysis of chromosomal aberrations.
The following concentrations were evaluated for microscopic analysis:
Experiment I:
with and without metabolic activation:
1000, 2500 and 5000 μg/mL
Experiment II:
with metabolic activation: 3000, 4000 and 5000 μg/mL
without metabolic activation: 250, 500 and 1000 μg/mL
Precipitation:
The test item was suspended in cell culture medium. Precipitate of the test item was noted in all dose groups evaluated in experiment I and II.
Toxicity:
In experiment I with and without metabolic activation, no biologically relevant decrease of the relative mitotic index (decrease below 70% rel. mitotic index) was noted at any concentration. The cell density was not decreased.
In experiment II without metabolic activation, a biologically relevant decrease of the relative mitotic index (decrease below 70% rel. mitotic index) was noted at 1000 μg/mL (47% at 1000 μg/mL. The cell density was not decreased. With metabolic activation, no biologically relevant decrease of the relative mitotic index (decrease below 70% rel. mitotic index) was noted at the concentrations evaluated. No decrease of the cell density was noted up to the highest dose evaluated.
Clastogenicity:
In experiment I without metabolic activation the aberration rate of the negative control (1.5%) and all the dose group tested with the test item (1.5% (1000 μg/mL), 0.5% (2500 μg/mL) and 2.5% (5000 μg/mL)) were within the historical control data of the
testing facility (0.0% – 4.0%. With metabolic activation, the aberration rates of the negative control (2.0%) and all dose groups treated with the test item 3.0% (1000 μg/mL), 2.0% (2500 μg/mL) and 2.0% (5000 μg/mL) were within the historical
control data of the testing facility (0.0% – 4.0%, Table 10). The number of aberrant cells found in the dose groups treated with the test item did not show a biologically relevant increase compared to the corresponding negative control. In addition, no doseresponse
relationship was observed.
In experiment II without metabolic activation the aberration rate of the negative control (2.0 %) and all dose groups treated with the test item (0.5 % (250, 500 and 1000 μg/mL)) were within the historical control data of the testing facility (0.0% –4.0%. With metabolic activation the aberration rates of the negative control (2.0%) and all dose groups treated with the test item (1.5% (3000 μg/mL), 2.5% (4000 μg/mL) and 3.5 (5000 μg/mL)) were within the historical control data of the
testing facility (0.0% – 4.0%. The number of aberrant cells found in the dose groups treated with the test item did not show a biologically relevant increase compared to the corresponding negative control. In addition, no dose-response relationship was
observed.
Polyploid cells:
No biologically relevant increase in the frequencies of polyploid cells was found after treatment with the test item.
EMS (400 and 600 μg/mL) and CPA (0.83 μg/mL) were used as positive controls and induced distinct and biologically relevant increases in cells with structural chromosomal aberrations.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine is considered to be non-clastogenic.
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