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EC number: 216-125-0 | CAS number: 1503-48-6
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, compliant with OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21st July, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- dated May 30, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BSL Bioservice Scientific Laboratories GmbH, Planegg, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Quino[2,3-b]acridine-6,7,13,14(5H,12H)-tetrone
- EC Number:
- 216-125-0
- EC Name:
- Quino[2,3-b]acridine-6,7,13,14(5H,12H)-tetrone
- Cas Number:
- 1503-48-6
- Molecular formula:
- C20H10N2O4
- IUPAC Name:
- quino[2,3-b]acridine-6,7,13,14(5H,12H)-tetrone
- Details on test material:
- - Substance type: powder
- Physical state: yellow solid
- Analytical purity: 99.91%
- Purity test date: no given in report
- Lot/batch No.: 20487HH7
- Expiration date of the lot/batch: December 27, 2017
- Stability under test conditions: stable
- Storage condition of test material: room temperature, protected from light
Constituent 1
Method
- Target gene:
- his and trp operon
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:
- Mammalian microsome enzyme activation mixture (supplemented S9 fraction from liver of rats induced with phenobarbital and beta-naphthoflavone)
- Test concentrations with justification for top dose:
- 3.16, 10, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate
- Vehicle / solvent:
- The test item was suspended in DMSO and diluted prior to treatment. The solvent was compatible with the survival of the bacteria and the S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- A. dest.
- Positive controls:
- yes
- Positive control substance:
- other: Sodium azide (TA 100, TA 1535), 4-nitro-o-phenylene-diamine (4-NOPD; TA 98, TA 1537), Methyl methane sulfonate (MMS; E. coli)
- Remarks:
- without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (all strains)
- Remarks:
- with metabolic activation (rat liver)
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA; TA 1535, TA 1537, E. coli), Congo Red (TA 98, TA100)
- Remarks:
- with metabolic activation (hamster liver)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) (experiment I); preincubation (experiment II)
DURATION
- Preincubation period: 30 minutes at 30°C
- Exposure duration: at least 48 hours at 37°C
NUMBER OF REPLICATIONS: three plates
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- Evaluation of Cytotoxicity
Cytotoxicity can be detected by a clearing or rather diminution of them background lawn or a reduction in the number of revertants down to a mutation factor of approximately < 0.5 in relation to the solvent control.
Evaluation of Mutagenicity
The Mutation Factor is calculated by dividing the mean value of the revertant counts through the mean values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and E. coli WP2 uvrA the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher
as compared to the reversion rate of the solvent control.
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system.
A test is considered acceptable if for each strain:
-the bacteria demonstrate their typical responses to ampicillin (TA 98, TA 100)
- the control plates without S9 mix are within the following ranges (mean values of the spontaneous reversion frequency are within the historical control data range (TA98: 16-46, TA 100: 77-174, TA 1535: 5 -29, TA 1537: 5 -28, E. coli WP2 uvrA: 36-81)
- corresponding background growth on both negative control aod test plates is observed.
- the positive controls show a distinct enhancement of revertant rates over the control plate - Statistics:
- According to the 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:
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation of the test item was observed in all tester strains used in experiment I and II (with and without metabolic activation).
No toxic effects ofthe test item were noted in any ofthe five tester strainsused up to the highest dose group evaluated with and without metabolic
activation in experiment I and II.' - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Tables are provided in the attached document.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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