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EC number: 416-250-2 | CAS number: 84632-59-7
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study with well-characterizsed material
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 416-250-2
- EC Name:
- -
- Cas Number:
- 84632-59-7
- Molecular formula:
- C26 H28 N2 O2
- IUPAC Name:
- 3,6-bis(4-tert-butylphenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione
- Details on test material:
- Description Yellow solid (powder)
purity: 99.3%
Test substance storage: At room temperature in the dark
Stability under storage conditions: Stable
Expiry date: 14 December 2021
Constituent 1
Method
- Target gene:
- hpprt
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 25 - 800 µg/ml (4h, without S9)
2.5 - 80 µg/ml (all other incubations) - Vehicle / solvent:
- culture medium
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: Two days (experiment I and experiment II with S9 mix) or three days (experiment II without S9 mix) after sub-cultivation stock cultures
- Exposure duration: 4h or 24h
- Expression time (cells in growth medium): 7 -9 days
- Selection time (if incubation with a selection agent): 8 days
- Fixation time (start of exposure up to fixation or harvest of cells): 19 days
SELECTION AGENT (mutation assays): 6-thioguanine
NUMBER OF REPLICATIONS: Population doubling time 12 - 14h
NUMBER OF CELLS EVALUATED: not applicable
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency
OTHER: The stained colonies with more than 50 cells were counted. In doubt the colony size was checked with a preparation microscope. - Evaluation criteria:
- A test item is classified as positive if it induces either a concentration-related increase of the mutant frequency or a reproducible and positive response at one of the test points.
A test item is classified as mutagenic if it reproducibly induces a mutation frequency that is three times above the spontaneous mutation frequency at least at one of the concentrations in the experiment. - Statistics:
- A linear regression (least squares) was performed to assess a possible dose dependent increase of mutant frequencies. The number of mutant colonies obtained for the groups treated with the test item were compared to the solvent control groups. A trend is judged as significant whenever the p-value (probability value) is below 0.05.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Osmolarity: 316 mOsm (at 4 mg/mL)
pH: 7.28
Precipitation occurred at doses of 20 microgramms/ml and above. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
relative | relative | relative | mutant | relative | relative | relative | mutant | ||||||
conc. | P | S9 | cloning | cell | cloning | colonies/ | induction | cloning | cell | cloning | colonies/ | induction | |
µg/mL | mix | efficiency I | density | efficiency II | 106cells | factor | efficiency I | density | efficiency II | 106cells | factor | ||
% | % | % | % | % | % | ||||||||
Column | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 |
Experiment I / 4 h treatment | culture I | culture II | |||||||||||
Solvent control with medium | - | 100.0 | 100.0 | 100.0 | 33.1 | 1.0 | 100.0 | 100.0 | 100.0 | 16.6 | 1.0 | ||
Positive control (EMS) | 150.0 | - | 71.3 | 88.1 | 118.3 | 210.0 | 6.3 | 72.1 | 92.3 | 90.5 | 219.0 | 13.2 | |
Test item | 25.0 | P | - | 84.7 | 108.6 | 101.2 | 43.6 | 1.3 | 99.1 | 93.3 | 95.2 | 16.5 | 1.0 |
Test item | 50.0 | P | - | 80.7 | 103.5 | 96.6 | 28.1 | 0.8 | 96.3 | 96.0 | 102.5 | 35.2 | 2.1 |
Test item | 100.0 | P | - | 85.7 | 82.1 | 105.9 | 32.0 | 1.0 | 97.6 | 79.6 | 105.0 | 39.7 | 2.4 |
Test item | 200.0 | P | - | 82.0 | 92.3 | 125.1 | 32.2 | 1.0 | 95.7 | 81.2 | 97.9 | 22.2 | 1.3 |
Test item | 400.0 | P | - | 91.2 | 91.4 | 94.2 | 13.6 | 0.4 | 88.8 | 97.0 | 98.9 | 33.6 | 2.0 |
Test item | 800.0 | P | - | 90.9 | culture was not continued# | 81.0 | culture was not continued# | ||||||
Solvent control with medium | + | 100.0 | 100.0 | 100.0 | 34.9 | 1.0 | 100.0 | 100.0 | 100.0 | 20.1 | 1.0 | ||
Positive control (DMBA) | 1.1 | + | 78.1 | 101.6 | 80.3 | 487.9 | 14.0 | 65.2 | 62.3 | 97.8 | 305.9 | 15.2 | |
Test item | 2.5 | + | 88.8 | 127.9 | 132.2 | 12.0 | 0.3 | 108.5 | 53.8 | 87.0 | 19.2 | 1.0 | |
Test item | 5.0 | + | 81.6 | 109.0 | 137.4 | 17.0 | 0.5 | 100.5 | 99.5 | 84.6 | 20.8 | 1.0 | |
Test item | 10.0 | + | 84.4 | 122.6 | 91.2 | 17.3 | 0.5 | 108.5 | 81.7 | 76.6 | 27.3 | 1.4 | |
Test item | 20.0 | P | + | 88.5 | 171.1 | 116.1 | 10.5 | 0.3 | 101.8 | 60.3 | 87.8 | 26.2 | 1.3 |
Test item | 40.0 | P | + | 87.5 | 118.0 | 101.9 | 17.4 | 0.5 | 102.8 | 60.8 | 72.0 | 32.6 | 1.6 |
Test item | 80.0 | P | + | 84.8 | culture was not continued# | 103.2 | culture was not continued# | ||||||
Experiment II / 24 h treatment | culture I | culture II | |||||||||||
Solvent control with medium | - | 100.0 | 100.0 | 100.0 | 14.8 | 1.0 | 100.0 | 100.0 | 100.0 | 12.7 | 1.0 | ||
Positive control (EMS) | 150.0 | - | 115.8 | 81.0 | 99.5 | 455.0 | 30.8 | 117.8 | 73.8 | 110.2 | 759.2 | 59.7 | |
Test item | 2.5 | - | 119.0 | 98.0 | 97.6 | 22.0 | 1.5 | 115.4 | 93.6 | 100.3 | 15.0 | 1.2 | |
Test item | 5.0 | - | 130.2 | 85.7 | 99.0 | 14.4 | 1.0 | 110.9 | 86.0 | 102.7 | 15.8 | 1.2 | |
Test item | 10.0 | - | 119.4 | 89.2 | 96.0 | 9.8 | 0.7 | 119.1 | 103.6 | 102.4 | 18.2 | 1.4 | |
Test item | 20.0 | P | - | 127.3 | 86.8 | 96.5 | 10.6 | 0.7 | 125.1 | 97.2 | 104.4 | 17.5 | 1.4 |
Test item | 40.0 | P | - | 126.9 | 92.2 | 95.9 | 20.4 | 1.4 | 119.6 | 93.4 | 97.6 | 25.9 | 2.0 |
Test item | 80.0 | P | - | 123.1 | culture was not continued# | 126.6 | culture was not continued# | ||||||
Experiment II / 4 h treatment | |||||||||||||
Solvent control with medium | + | 100.0 | 100.0 | 100.0 | 8.9 | 1.0 | 100.0 | 100.0 | 100.0 | 11.0 | 1.0 | ||
Positive control (DMBA) | 1.1 | + | 38.1 | 77.2 | 94.4 | 736.6 | 82.5 | 46.6 | 66.6 | 99.2 | 619.3 | 56.1 | |
Test item | 2.5 | + | 97.3 | 104.5 | 93.8 | 10.7 | 1.2 | 103.2 | 93.7 | 98.3 | 11.6 | 1.1 | |
Test item | 5.0 | + | 100.7 | 97.7 | 95.6 | 15.3 | 1.7 | 95.6 | 101.8 | 100.2 | 22.4 | 2.0 | |
Test item | 10.0 | + | 93.0 | 87.2 | 98.6 | 13.0 | 1.5 | 90.9 | 93.3 | 97.7 | 14.8 | 1.3 | |
Test item | 20.0 | P | + | 95.9 | 102.0 | 96.0 | 20.7 | 2.3 | 99.5 | 100.4 | 98.8 | 25.0 | 2.3 |
Test item | 40.0 | P | + | 94.1 | 142.5 | 97.4 | 15.1 | 1.7 | 93.4 | 104.2 | 114.0 | 14.4 | 1.3 |
Test item | 80.0 | P | + | 94.4 | culture was not continued# | 100.6 | culture was not continued# |
P = Precipitation; #too many precipitates
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The substance did not cause gene mutations in mammalian cells in vitro. Test concentrations were limited by strong precipitation of in the culture medium.
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