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EC number: 413-920-6 | CAS number: 88949-33-1
- 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 gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted May 26, 1983
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 413-920-6
- EC Name:
- -
- Cas Number:
- 88949-33-1
- Molecular formula:
- C30 H20 N2 O2
- IUPAC Name:
- 3,6-bis({[1,1'-biphenyl]-4-yl})-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Substance type: Organic
- Physical state: Solid
- Lot/batch No.: Z-2281/1,2,4,5
- Expiration date of the lot/batch: April 01, 1997
- Storage condition of test material: at room temperature in the dark
Method
- Target gene:
- His: Salmonella; Trp: E. Coli
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9 mix
- Test concentrations with justification for top dose:
- 10; 100; 333.3; 1000; and 5000 µg/plate
- Vehicle / solvent:
- Dimethyl sulfoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see: "Details on test system and conditions"
- Details on test system and experimental conditions:
- POSITIVE CONTROLS:
Without metabolic activation (-S9-mix):
- TA1535, TA 100: sodium azide (SA), 10 µg
- TA1537, TA 98: 4-nitro-o-phenylene-diamine, 4-NOPD 50 µg
- WP2uvrA, WP2 : methylmethanesulfonate (MMS), 10 µl
With metabolic activation (+S9-mix):
- TA1537, : 2-aminoanthracene (2AA), 2.5 µg
- TA1535, TA 1537, TA98 and TA100: 2-aminoanthracene (2AA), 2 µg
- WP2uvrA and WP2: 2-aminoanthracene (2AA), 2 µg
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Incubation period: 48 hours. After this period revertant colonies (histidine independent for Salmonella typhimurium bacteria and tryptophan independent for Escherichia coli were counted.
- COLONY COUNTING:
- Exposure duration: The revertant colonies (histidine independent/ tryptophan independent) were counted automatically with a Protos model 50000 colony counter or manually, if less than 40 colonies per plate were present. Plates with sufficient test article precipitate to interfere with automated colony counting were counted manually.
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- A test article is considered as mutagenic if in the strains TA 100, WP2, and its uvrA derivate the number of reversions will be at least twice as high and in the strains TA 1535, TA 1537, and TA 98 it will be at least three times higher as compared to the spontaneous reversion rate.
Also, a dose-dependent increase in the number of revertants isregarded as an indication of possibly existing mutagenic potential of the test article regardless whether the highest dose induced the above described enhancement factors or not. - Statistics:
- No
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate without S9 mix in experiment I
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- PRECIPITATE: Not mentioned.
TOXICITY: Toxic effects evidenced by a reduction in revertant colony numbers occurred only in strain TA 1535 at 5000 µg/plate without S9 mix in experiment I. The plates incubated with the test article showed normal background growth up to 5000 µg/plate with and without metabolic activation in both independent experiments.
MUTAGENICITY: No increase in the number of revertants was observed upon treatment with the test substance under all conditions tested. All bacterial strains showed negative responses over the entire dose range, i.e. no dose-related, two-fold, increase in the number of revertants in two independently repeated experiments.
Any other information on results incl. tables
Table 1: Number of revertants in the control or after treatment with the test substance
First experiment (10 - 5000 µg/plate) | |||||
Strain | Metabolic activation system | mean revertants in Controls | maximum revertant factor | dose dependency | Assessment |
TA 1535 | no | 15 | 1.1 | no | negative |
yes | 15 | 1.2 | no | negative | |
TA 1537 | no | 6 | 1.1 | no | negative |
yes | 6 | 1.4 | no | negative | |
TA 98 | no | 20 | 1.2 | no | negative |
yes | 33 | 1.2 | no | negative | |
TA 100 | no | 78 | 0.9 | no | negative |
yes | 88 | 1.1 | no | negative | |
E. coli WP2 uvrA | no | 38 | 1.2 | no | negative |
yes | 41 | 1.1 | no | negative | |
E. coli WP2 | no | 30 | 1.6 | no | negative |
yes | 40 | 1.2 | no | negative | |
Second experiment (10 - 1000 µg/plate) | |||||
Strain | Metabolic activation system | mean revertants in Controls | maximum revertant factor | dose dependency | Assessment |
TA 1535 | no | 14 | 1.1 | no | negative |
yes | 15 | 1.2 | no | negative | |
TA 1537 | no | 11 | 1.2 | no | negative |
yes | 15 | 1.2 | no | negative | |
TA 98 | no | 24 | 1.2 | no | negative |
yes | 41 | 1.3 | no | negative | |
TA 100 | no | 90 | 1.1 | no | negative |
yes | 91 | 1.0 | no | negative | |
E. coli WP2 uvrA | no | 39 | 1.4 | no | negative |
yes | 47 | 1.1 | no | negative | |
E. coli WP2 | no | 57 | 1.1 | no | negative |
yes | 56 | 1.1 | no | negative |
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
- Executive summary:
In a GLP conform study according to OECD guideline 471, the potential of the test substance to induce gene mutations was investigated in two independent experiments using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA and WP2.
In both experiments, the test substance was tested up to a concentration of 5000 µg/plate in the absence and presence of S9-mix. The bacterial background lawn was not reduced at all concentrations tested and no decrease in the number of revertants was observed. The test substance did not induce a dose-related, two-fold, increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strains WP2uvrA and WP2, both in the absence and presence of S9-metabolic activation. These results were confirmed in two independent experiments. Based on the results of this study it is concluded that the test substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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