Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 232-318-2 | CAS number: 8003-22-3 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 47000.
- 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: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenic Screening of Marker Grenade Dyes by the Salmonella Reversion Assay, L5178Y/TK+/- Mouse Lymphoma Assay, and In Vivo Sister Chromatid Exchange Analysis in Mice
- Author:
- Martha M. Moore, James W. Allen, Larry Claxton, Carolyn Doerr, Carolyn Gwaltney, John S. Dutcher, Michael Kohan, B. Kay Lawrence, Ruth Templeton, and Barbara Westbrook-Collins
- Year:
- 1 988
- Bibliographic source:
- Environmental and Molecular Mutagenesis 12:219-233 (1988)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Data is from Journal with permission
- Principles of method if other than guideline:
- Mouse lymphoma assay was performed to evaluate the mutagenic potential for the test compound C.I. Solvent Yellow No. 33
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 1,3-isobenzofurandione, reaction products with methylquinoline and quinoline
- EC Number:
- 232-318-2
- EC Name:
- 1,3-isobenzofurandione, reaction products with methylquinoline and quinoline
- Cas Number:
- 8003-22-3
- Molecular formula:
- C18H11NO2
- IUPAC Name:
- 2-(quinolin-2-yl)-2,3-dihydro-1H-indene-1,3-dione
- Test material form:
- other: Solid
- Details on test material:
- - Name of test material (as cited in study report): Solvent Yellow 33; 2-(2-Quinolyl)-1,3-indandione
- Molecular formula (if other than submission substance): C18H11NO2
- Molecular weight (if other than submission substance): 273.29
- Substance type: Organic
- Physical state: Solid
Purity :99.9% (for the purified dye); Not mentioned (Impure dye)
- Impurities (identity and concentrations): No data available
Constituent 1
Method
- Target gene:
- TK+/- locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Fischer’s Medium for Leukemic Cells of Mice supplemented with sodium pyruvate, pluronic, penicillin, streptomycin, and horse serum was used.
- Properly maintained: yes - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- not specified
- Test concentrations with justification for top dose:
- Impure dye: 0.0 (100µL DMSO), 0.0 (200µL DMSO), 2.0, 6.0, 12.0, 16.0, 20.0, 40 µg/ml
Purified dye: 0.0, 0.1, 0.5, 1.0, 2.5, 5.0, 10.0, 20.0, 30.0, 40.0, 50.0 µg/ml - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data available
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period:
- Exposure duration: 4 hrs
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): after 2 days
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays): TFT (1 µg/mL)
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays): Giemsa stain
NUMBER OF REPLICATIONS: Twice
NUMBER OF CELLS EVALUATED: 100 metaphase spreads
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
OTHER: chromatid breakage and rearrangement; After 9-11 days of incubation at 37"C, colonies were counted on an Artek model 880 automatic colony counter with settings that optimize colony counts, compared with hand counts, without producing a spurious background - Statistics:
- Survival was calculated according to the method of Clive and Spector
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: Cell line used
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
other: Positive (With and without metabolic activation system)
The test material C.I. Solvent Yellow No. 33 is positive to induce mutations in the L5178Y TK+/- mouse lymphoma assay. - Executive summary:
L5178Y TK+/- mouse lymphoma assay was performed to evaluate the mutagenic potential of the test compound C.I. Solvent Yellow No. 33. In addition, a > 99.9% pure sample of the yellow dye [2-(2‘-quinolyl)-l,3-indandione] with and without exogenous activation was also tested.
The impure dye was tested at concentrations of 0.0 (100µL DMSO), 0.0 (200µL DMSO), 2.0, 6.0, 12.0, 16.0, 20.0, 40 µg/ml and the purified dye at concentrations of 0.0, 0.1, 0.5, 1.0, 2.5, 5.0, 10.0, 20.0, 30.0, 40.0, 50.0 µg/ml
C.I. Solvent Yellow No. 33 induced mutation at the thymidine kinase locus in mouse lymphoma cells, produced both large- and small-colony trifluorothymidine-resistant mutants, and was clastogenic.
According to the publication, the test material is positive for mutation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.