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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 vivo
Administrative data
- Endpoint:
- genetic toxicity in vivo
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- In Vivo Sister Chromatid Exchange Assay was performed to evaluate the SCE frequencies and cell replication kinetics was analyzed in mouse bone marrow cells.
- GLP compliance:
- not specified
- Type of assay:
- sister chromatid exchange 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 :No data available
- Impurities (identity and concentrations): No data available
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: C57B1/6J mice
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Jackson Laboratory, Bar Harbor, ME
- Age at study initiation: 3-4 months old - Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: five per cage in a U.S. EPA animal facility in laminar-flow rooms
- Diet - ad libitum chow (noncertified Purina Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Humidity (%): 60-68% relative humidity
- Air changes (per hr): 15 cycles/hr of biocleaned air
- Photoperiod (hrs dark / hrs light): 12-hr light-dark cycle.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Higher volumes of DMSO were determined in preliminary experiments
to be toxic, as evidenced by animal death or inhibited marrow cell cycling
- Amount of vehicle (if gavage or dermal): 0.1mL - Details on exposure:
- No details available.
- Duration of treatment / exposure:
- Duration of exposure: 23 hrs
- Frequency of treatment:
- Once
- Post exposure period:
- 3-4 hrs
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5, 15, 25, 35mg/kg
Basis:
no data
- No. of animals per sex per dose:
- 4/sex/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Route of administration: Intraperitoneal
- Doses / concentrations: 30 mg/Kg
Examinations
- Tissues and cell types examined:
- Marrow cells, second division metaphase cells
- Details of tissue and slide preparation:
- Details of tissue and slide preparation
DETAILS OF SLIDE PREPARATION: Marrow cells were harvested and processed through hypotonic (0.075 M KCl) and fixative (3:1 methano1:glacial acetic acid) steps, and slides were prepared in accordance with standard cytogenetic methodology. Chromatid differential staining was achieved with the fluorescence-plus-Giemsa (FPG) technique.
METHOD OF ANALYSIS: For each mouse, SCE frequencies were analyzed in 30 randomly selected, well-differentiated second-division metaphase cells that contained the diploid ±2 chromosomal complement.
Cell replication kinetics were also assessed in 200 marrow cell/animal, revealing frequencies of first- (M1), second- (M2), and third- (M3) division stain patterns. A replicative index (RI) was calculated for each animal with the formula RI = (1 X M1) + (2 X M2) + (3 x M3) - Evaluation criteria:
- Bone-marrow-cell SCE frequencies and cell kinetics were analyzed. An increase in the SCE frequency was evaluated.
Additional studies were performed to determine
1) If the injected test dye was dispersing or remaining localized within the peritoneum and
2) If higher marrow cell SCE frequencies would result from giving injections over 3 consecutive days. - Statistics:
- No details
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- negative
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Slight evidence of sister chromatid exchange but not mentioned in details.
Any other information on results incl. tables
Genotoxicity:
Negative
Treatment |
No. of Animals |
SCE/cell Mean ± SD |
RI |
Negative Control |
4 |
4.0 ± 2.01 |
1.91 ± 0.10 |
Solvent Control |
4 |
4.5 ± 1.91 |
2.00 ± 0.14 |
Positive control |
4 |
52.4 ± 10.92 |
1.58 ± 0.27 |
5 mg/Kg |
4 |
4.5 ± 2.49 |
2.14 ± 0.13 |
15 mg/Kg |
3 |
4.0 ± 2.14 |
2.31 ± 0.20 |
25 mg/Kg |
3 |
3.2 ± 2.00 |
2.24 ± 0.22 |
35 mg/Kg |
4 |
3.3 ± 2.13 |
2.54 ± 0.27 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The given dye C.I. Solvent Yellow 33 failed to increase the SCE frequencies and hence if negative for gene mutation in vivo. - Executive summary:
In Vivo Sister Chromatid Exchange Analysis was performed using Male C57B1/6J mice bobe marrow cells. SCE induction was determined by administering the test chemical as a single i.p. injection (≤ 0.2 ml volume) over a 3-4 point dose range, four mice per dose.
The dye injections were given 1/2 hr after BrdUrd tablet implantation. Negative control animals received no injections or were injected with only the solvent. Positive control mice were injected with 30 mg/kg cyclophosphamide.
Approximately 23 hr later, all control mice were injected i.p. with 0.6 mg/kg of colchicine to collect metaphases. Treated mice were injected with colchicine after an additional 3-4 hr because preliminary chemical injection trials had indicated that cell-cycle delays were occurring. Two hours after colchicine injection, animals were sacrificed by cervical dislocation, marrow cells were harvested and processed through hypotonic (0.075 M KCl) and fixative (3:1 methanol: glacial acetic acid) steps, and slides were prepared in accordance with standard cytogenetic methodology.
SCE levels were not significantly different from control levels and higherRIsprobably were a reflection of later cell harvest times. The dye-treated animals generally showed no greater SCE frequencies or cytotoxicity than controls.
Dye coloration or evidence of dye crystals was not apparent in the peritoneum of animals dissected at the time of marrow cell harvest. There were also no crystals of dye evident in peritoneal cell pellets examined under a microscope. The percentage of cells represented by macrophages also was comparable between negative control and treated mice (83-84%). No traces of the dyes were observed in the marrow cell preparations.
The i.p. injected dyes are distributed to marrow cells and are inactive for SCE induction and hence is negative for gene mutation in vivo.
According to the CLP regulation, the given test substance is negative for gene mutation.
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