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EC number: 243-296-9 | CAS number: 19780-11-1
- 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: other: clastogenicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2011-05-19 to 2011-07-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Dihydro-3-(tripropenyl)furan-2,5-dione
- EC Number:
- 295-556-6
- EC Name:
- Dihydro-3-(tripropenyl)furan-2,5-dione
- Cas Number:
- 92077-08-2
- IUPAC Name:
- 92077-08-2
- Test material form:
- other: liquid
- Details on test material:
- Name: Tripropenyl succinic anhydride
Product: Genopur ASA
CAS No.: 92077-08-2
Batch No.: ESD0010823
Chemical Name: dihydro-3-(tripropenyl)furan-2,5-dione
Molecular Weight: 220 g/mol (calculated based on the given chemical structure)
pH: 1-2
Physical State at RT: liquid
Density: 1.01 g/cm3 (20°C, DIN 51757)
Colour: yellow to brown
Expiry Date: 01.12.2012
Storage Conditions: at room temperature
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 of Wistar phenobarbital and ß-naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-experiment:
with and without metabolic activation: 0.02, 0.039, 0.078, 0.16, 0.31, 0.63, 1.25, 2.5, 5 and 10 mM
Experiment I:
without metabolic activation: 2, 3 and 4 mM
with metabolic activation: 8, 9 and 10 mM
Experiment II:
without metabolic activation: 0.5, 1 and 2 mM
with metabolic activation: 8.5, 9.5 and 10 mM - Vehicle / solvent:
- -Vehicle (s)/solvent(s) used: cell culture medium
-Justification for choice of solvent/vehicle: Due to the nature of the test item it was suspended in cell culture medium (MEM) followed by ultrasonic for 10 minutes. The solvent was compatible with the survival of the cells and the S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 400 and 600 µg/mL
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
Migrated to IUCLID6: 0.83 µg/mL
- Details on test system and experimental conditions:
- TREATMENT TIME:
4 hours (Experiment I with and without metabolic activation, experiment II with metabolic activation)
20 hours (Experiment II without metabolic activation)
FIXATION INTERVAL: 20 hours (Experiment I and II with and without metabolic activation)
NUMBER OF REPLICATIONS: 2 independent experiments
NUMBER OF CELLS SEEDED: 1 x 10^4 - 5 x 10^4 cells
NUMBER OF CULTURES: two cultures per concentration
NUMBER OF CELLS SCORED: 200 cells per concentration (100 cells per culture)
DETERMINATION OF CYTOTOXICITY: Mitotic index, cell density - Evaluation criteria:
- There are several criteria for determining a positive result:
- a clear and dose-related increase in the number of cells with aberrations,
- a biologically relevant response for at least one of the dose groups, which is higher than the laboratory negative control range (0.0% - 4.0% aberrant cells (with and without metabolic activation)). - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
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
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Results of chromosome analysis
Without metabolic activation
Cytotoxicity | Chromatid aberrations | Isochromatid aberrations | rel. Mitotic index (%) | rel. Cell density (%) | Poly-ploidy | mean % aberrant cells | ||||||||
gaps | breaks | inter-changes | other | gaps | breaks | inter-changes | other | incl. Gaps | excl. Gaps | |||||
Experiment I | ||||||||||||||
negative control | - | 5 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 100 | 100 | 2 | 3.5 | 1.5 |
2 mM | no | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 78 | 87 | 1 | 1.5 | 0.5 |
3 mM | yes | 5 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 52 | 70 | 2 | 3.0 | 1.0 |
4 mM | yes | 7 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 34 | 66 | 2 | 4.0 | 1.5 |
5 mM | yes | - | - | - | - | - | - | - | - | 4 | 52 | - | - | - |
EMS (600 µg/mL) | - | 17 | 18 | 2 | 2 | 1 | 0 | 1 | 5 | 95 | 93 | 3 | 15.5 | 11.5 |
Experiment II | ||||||||||||||
negative control | - | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 100 | 2 | 2.0 | 0.5 |
0.5 mM | no | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 97 | 112 | 1 | 0.5 | 0.0 |
1.0 mM | no | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 95 | 97 | 1 | 1.5 | 1.0 |
2.0 mM | yes | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 50 | 91 | 0 | 2.0 | 1.0 |
3.0 mM | yes | - | - | - | - | - | - | - | - | 21 | 63 | - | - | - |
EMS (400 µg/mL) | - | 8 | 13 | 4 | 0 | 0 | 0 | 0 | 3 | 44 | 87 | 1 | 12.0 | 8.5 |
Table 2: Results of chromosome analysis
With metabolic activation
Cytotoxicity | Chromatid aberrations | Isochromatid aberrations | rel. Mitotic index (%) | rel. Cell density (%) | Poly-ploidy | mean % aberrant cells | ||||||||
gaps | breaks | inter-changes | other | gaps | breaks | inter-changes | other | incl. Gaps | excl. Gaps | |||||
Experiment I | ||||||||||||||
negative control | - | 3 | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 100 | 100 | 0 | 4.5 | 2.5 |
8 mM | no | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 82 | 94 | 1 | 2.0 | 0.0 |
9 mM | no | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 80 | 86 | 2 | 2.0 | 1.0 |
10 mM | yes | 3 | 4 | 2 | 0 | 0 | 0 | 0 | 0 | 56 | 94 | 5 | 4.5 | 3.0 |
CPA (0.83 µg/mL) | - | 5 | 10 | 8 | 3 | 2 | 1 | 3 | 0 | 103 | 90 | 2 | 12.5 | 11.0 |
Experiment II | ||||||||||||||
negative control | - | 3 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 100 | 100 | 0 | 3.0 | 1.5 |
8.5 mM | no | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 90 | 73 | 0 | 2.0 | 0.5 |
9.5 mM | no | 4 | 3 | 0 | 1 | 0 | 0 | 0 | 1 | 99 | 82 | 0 | 4.0 | 2.5 |
10.0 mM | no | 3 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 76 | 85 | 2 | 3.0 | 1.5 |
CPA (0.83 µg/mL) | - | 5 | 12 | 7 | 0 | 0 | 1 | 1 | 1 | 94 | 81 | 2 | 11.5 | 9.5 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
During the described in vitro chromosomal aberration test and under the experimental conditions reported, the test item, which is a category member (Tripropenyl succinic anhydride (TSA)), did not induce structural chromosomal aberrations in the V79 Chinese hamster cell line. Therefore, the test item Tripropenyl succinic anhydride is considered to be non-clastogenic. Data can be read-across among members of the C8-12 Alkenyl Succinic Anhydrides Category, based on common functional groups, similar break-down products and potency patterns among carbon-chain length. This is adequate to fulfill the information requirements, to be the basis for classification and labelling decisions, and for risk assessment. - Executive summary:
To investigate the potential of Tripropenyl succinic anhydride to induce structural chromosome aberrations in Chinese hamster V79 cells, an in vitro chromosome aberration assay was carried out.
The chromosomes were prepared 20 h after start of treatment with the test item. The treatment interval was 4 h with and without metabolic activation in experiment I. In experiment II, the treatment interval was 4 h with and 20 h without metabolic activation. Duplicate cultures were treated at each concentration. 100 metaphases per culture were scored for structural chromosomal aberrations.
Due to the nature of the test item it was suspended in cell culture medium (MEM) followed by ultrasonic for 10 minutes.
The following concentrations were evaluated for the microscopic analysis of chromosomal aberrations:
Experiment I:
without metabolic activation: 2, 3 and 4 mM
with metabolic activation: 8, 9 and 10 mM
Experiment II:
without metabolic activation: 0.5, 1 and 2 mM
with metabolic activation: 8.5, 9.5 and 10 mM
Precipitation of the test item was observed at concentrations of 3 mM and above (with and without metabolic activation). In the presence of S9 mix, less toxicity of the test item, compared to the experiment without metabolic activation, was found. Consequently, in the experiments with metabolic activation precipitation was noted at all concentrations evaluated.
In experiment I without metabolic activation toxic effects of the test item were observed at concentrations of 3 mM and higher, with metabolic activation at the highest concentration of 10 mM.
In experiment II without metabolic activation, toxic effects of the test item were observed at concentrations of 2 mM and higher. With metabolic activation no toxic effects of the test item were noted.
In the experiments I and II no biologically relevant increase of the aberration rates was noted after treatment with the test item with and without metabolic activation. The aberration rates of all dose groups evaluated were within the historical control data of the negative control.
In both experiments with and without metabolic activation no biologically relevant increase in the frequencies of polyploid cells was found after treatment with the test item as compared to the controls.
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.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OPPTS 870.5375; OECD 473 for in vitro cytogenetic mutagenicity data.
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