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EC number: 807-752-6 | CAS number: 1451734-05-6
- 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 gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
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
- Remarks:
- Department of Toxicology of BASF Aktiengesellschaft, D-67056 Ludwigshafen/Rhein, GER
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,3-Dihydro-1,3-dioxo-1H-perylo[3,4-cd]pyridine-8,9-dicarboxylic acid potassim salt (1:2)
- EC Number:
- 807-752-6
- Cas Number:
- 1451734-05-6
- Molecular formula:
- C24H9NO6K2
- IUPAC Name:
- 2,3-Dihydro-1,3-dioxo-1H-perylo[3,4-cd]pyridine-8,9-dicarboxylic acid potassim salt (1:2)
- Details on test material:
- It cannot be entirely excluded that the test material used was the mono potassium salt rather than the di potassium salt.
Constituent 1
- Specific details on test material used for the study:
- It cannot be entirely excluded that the test material used was the mono potassium salt rather than the di potassium salt. However, based on the very similar properties of these compounds, the toxicological data presented is considered valid and suitable to describe the toxicological property of the di potassium salt even if generated with the mono salt.
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- 0; 20; 100; 500; 2500 and 5000 µg/plate (SPT)
0; 4; 20; 100; 500 and 2500 µg/plate (PIT) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see "details in test system" for positive controls
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 minutes (only PIT)
- Incubation duration: 48-72 h at 37°C in the dark
NUMBER OF REPLICATIONS: triplicates
DETERMINATION OF CYTOTOXICITY
- Method: decrease in revertants, background growth, reduction in the titer
POSITIVE CONTROLS With S-9 MIX
- TA 1535, TA 100, TA 1537, TA 98: 2-amninoanthracene (2-AA), 2.5 µg/plate, dissolved in DMSO
- E. coli WP2 uvrA: 2-amninoanthracene (2-AA), 60 µg/plate, dissolved in DMS0
POSITIVE CONTROLS Without S-9 MIX
- TA 1535: TA 100: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), 5 µg/plate, dissolved in DMSO
- TA 98: 4-nitro-o-phenylendiamine (NOPD), 10 µg/plate, dissolved in DMSO
- TA 1537: 9-aminoacridine (AAC), 100 µg/plate, dissolved in DMSO
- E. coli WP2 uvrA: 4-nitroquinoline-N-oxide (4-NQO), 5 µg/plate, dissolved in DMSO - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met: A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if: The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Test substance precipitation was found from about 100 µg/plate onward.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A weak bacteriotoxic effect (slight decrease in the number of revertants and/or slight reduction in the titer) was observed depending on the strain and test conditions at doses ≥ 2,500 µg/plate.
Any other information on results incl. tables
EXPERIMENTAL RESULT
- Standard Plate Test
TA 1535 | TA 100 | TA 1537 | TA 98 | WP2uvrA | ||||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
solvent control | 18 | 18 | 107 | 137 | 11 | 13 | 22 | 32 | 32 | 38 |
20 | 16 | 18 | 97 | 133 | 9 | 10 | 24 | 29 | 34 | 37 |
100 | 16 | 16 | 121 | 129 | 7 | 11 | 24 | 30 | 26 | 30 |
500 | 13 | 17 | 120 | 142 | 7 | 7 | 23 | 30 | 25 | 28 |
2500 | 12 | 17 | 84 | 135 | 3 | 4 | 16 | 24 | 23 | 25 |
5000 | 8 | 7 | 87 | 104 | 4 | 3 | 10 | 16 | 23 | 31 |
positive control* | 894 | 195 | 659 | 1024 | 683 | 166 | 830 | 698 | 696 | 358 |
- Preincubation Test
TA 1535 | TA 100 | TA 1537 | TA 98 | WP2uvrA | ||||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
solvent control | 17 | 17 | 119 | 117 | 9 | 13 | 27 | 31 | 31 | 38 |
4 | 15 | 16 | 112 | 104 | 11 | 11 | 23 | 23 | 28 | 28 |
20 | 17 | 15 | 116 | 110 | 11 | 9 | 24 | 23 | 28 | 31 |
100 | 12 | 12 | 95 | 112 | 7 | 9 | 27 | 30 | 25 | 28 |
500 | 11 | 14 | 86 | 106 | 5 | 10 | 19 | 25 | 22 | 29 |
2500 | 11 | 9 | 96 | 110 | 5 | 8 | 17 | 24 | 19 | 27 |
positive control* | 741 | 115 | 974 | 677 | 477 | 94 | 693 | 628 | 527 | 225 |
*see above for details
Applicant's summary and conclusion
- Conclusions:
- According to the results of the present study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia ccli reverse mutation assay under the experimental conditions chosen here.
- Executive summary:
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains in a reverse mutation assay. The tester strains (TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA) were tested in a standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (Aroclor-induced rat liver S-9 mix). The dose range used was 20 - 5000 µg/plate in the standard plate test and 14 -2500 µg/ml in the preincubation test. Precipitation of the test substance was found from about 100 µg/plate onward. A weak bacteriotoxic effect was observed depending on the strain and test conditions from about 2500 µg/plate onward. An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolizing system. According to the results of the present study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia ccli reverse mutation assay under the experimental conditions chosen here.
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