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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 254-959-7 | CAS number: 40530-60-7
- 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: other: clastogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-07-07 to 2014-09-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Refer chapter 13 for detailed read across justification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]ethyl phenyl carbonate
- EC Number:
- 248-882-8
- EC Name:
- 2-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]ethyl phenyl carbonate
- Cas Number:
- 28173-59-3
- Molecular formula:
- C23H17NO7
- IUPAC Name:
- 2-[(1-amino-4-hydroxy-9,10-dioxo-9,10-dihydroanthracen-2-yl)oxy]ethyl phenyl carbonate
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 of Wistar phenobarbital and ß-naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-experiment:
with and without metabolic activation: 0.001, 0.0025, 0.005, 0.01, 0.025, 0.05, 0.075, 0.1, 0.125, 0.25 and 0.5 mM
The following concentrations were evaluated for the microscopic analysis of chromosomal aberrations:
Main Experiment:
without metabolic activation: 0.03, 0.04 and 0.05 mM
with metabolic activation: 0.03, 0.05 and 0.075 mM - Vehicle / solvent:
- -Vehicle (s)/solvent(s) used: DMSO and cell culture medium
-Justification for choice of solvent/vehicle: Based on the results of the solubility test dimethylsulfoxide (DMSO) was used as solvent (1% DMSO v/v final concentration). Different test item stock solutions were prepared and added to the samples. The solvent was compatible with the survival of the cells and the S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- cell culture medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation (900 µg/mL)
- Untreated negative controls:
- yes
- Remarks:
- cell culture medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation (1.11 µg/mL)
- Details on test system and experimental conditions:
- TREATMENT TIME:
4 hours (Experiment I with and without metabolic activation)
FIXATION INTERVAL: 20 hours (Experiment I with and without metabolic activation)
NUMBER OF REPLICATIONS: 1 experiment
NUMBER OF CELLS SEEDED: 1 x 10E4 - 5 x 10E4 cells
NUMBER OF CULTURES: two cultures per concentration
NUMBER OF CELLS SCORED: 200 cells per concentration (100 cells per culture),except for concentrations 0.05 and 0.075 mM (with metabolic activation) 400 cells were evaluated (200 cells per culture).
DETERMINATION OF CYTOTOXICITY: Mitotic index, cell count - Evaluation criteria:
- There are several criteria for determining a positive result:
- a clear and dose-related increase in the number of cells with aberrations,
- a biologically relevant response for at least one of the dose groups, which is higher than the laboratory negative control range (0.0 % - 4.0 % without and 0.0 % - 4.3 % with metabolic activation). - Statistics:
- A statistical evaluation was used as an aid for interpretation of the results. Statistical significance at the 5 % level (p <0.05) was evaluated by the Fischer´s exact test. The p value was used as a limit in judging for significance levels in comparison with the corresponding negative/solvent control.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
| Dose Group | Concentration [mM] | Relative Mitotic Index [%] | Relative Cell Count [%] | Mean % Aberrant Cells | Historical Laboratory Negative Control Range | Precipi-tationa | Statistical Signifi-canceb | |
incl. Gaps | excl. Gaps | ||||||||
without metabolic activation; 4 h treatment, 20 h preparation interval | C | 0 | 100 | 100 | 1.5 | 1.0 | 0.0 % - 4.0 % aberrant cells
| - | - |
S | 0 | 100 | 100 | 2.0 | 0.0 | - | - | ||
4 | 0.03 | 96 | 76 | 4.5 | 2.0 | - | - | ||
5 | 0.04 | 72 | 89 | 11.0 | 4.0 | + | + | ||
6 | 0.05 | 65 | 82 | 4.5 | 3.5 | + | + | ||
EMS | 900 μg/mL | 106 | 76 | 12.0 | 10.0 | - | + | ||
| |||||||||
with metabolic activation; 4 h treatment, 20 h preparation interval | C | 0 | 96 | 98 | 5.0 | 1.5 | 0.0 % - 4.3 % aberrant cells | - | - |
S | 0 | 100 | 100 | 4.0 | 3.5 | - | - | ||
4 | 0.03 | 71 | 92 | 7.0 | 2.0 | - | - | ||
6 | 0.05 | 62 | 90 | 9.5 | 5.5 | - | - | ||
7 | 0.075 | 71 | 98 | 9.0 | 5.3 | + | - | ||
CPA | 1.11 μg/mL | 113 | 98 | 18.0 | 15.0 | - | + |
The mitotic index was determined in 1000 cells per culture of each test group.
The cell count was determined by a cell counter per culture for each test group.
The relative values of the mitotic index and cell count are related to the solvent controls.
C: Negative Control (Culture Medium)
S: Solvent Control (DMSO)
EMS: Ethylmethanesulfonate
CPA: Cyclophosphamide
a: - without precipitation, + with precipitation
b: statistical significant increase compared to negative controls (Fisher’s exact test, p<0.05), + significant; - not significant
Applicant's summary and conclusion
- Conclusions:
- FAT 93504/B is considered to be clastogenic in this chromosome aberration test using V79 cells in the presence of metabolic activation.
- Executive summary:
The in vitro Mammalian Chromosome Aberration Test was carried out with FAT 93504/B according to OECD guideline 473 to assess its potential to induce structural chromosome aberrations in Chinese hamster V79 cells. Independent experiments were carried out with and without the addition of liver S9 mix from rats (exogenous metabolic activation). The metaphases were prepared at approximately 20 h after start of treatment with the test item. The treatment interval was 4 h without and with metabolic activation in the main experiment. Duplicate cultures were treated at each concentration. 100 metaphases per culture were scored for structural chromosomal aberrations. Based on the results of the solubility test dimethylsulfoxide (DMSO) was used as solvent (1 % DMSO v/v final concentration). Different test item stock solutions were prepared and added to the samples. The following concentrations were evaluated for the microscopic analysis of chromosomal aberrations:
Main Experiment:
without metabolic activation: 0.03, 0.04 and 0.05 mM
with metabolic activation: 0.03, 0.05 and 0.075 mM
In the pre-experiment, precipitation of the test item was detected without and with metabolic activation at concentrations of 0.05 and 0.075 mM with the unaided eye. In the main experiment, precipitation of the test item was observed without and with metabolic activation at concentrations of 0.04/0.05 and 0.075 mM, respectively. In the main experiment without metabolic activation, no cytotoxic effects of the test item were observed at all evaluated concentrations considering the relative cell count. However, the relative mitotic index was decreased and the highest concentration of 0.05 mM showed cytotoxic effects (rel. mitotic index below 70 %). With metabolic activation no cytotoxic effects of the test item were observed at all concentrations considering the relative cell count. The relative mitotic index of the dose groups evaluated was decreased (0.03 mM (71 %), 0.04 mM (62 %), 0.05 mM (71 %)) which indicates a slight cytotoxicity of the test item (rel. mitotic index below 70 %). In the main experiment without metabolic activation no biologically relevant increase of aberrant cells was determined at all evaluated concentrations compared to the solvent control. With metabolic activation increases of aberrant cells were observed at concentrations of 0.05 mM and 0.075 mM compared to the solvent control. These increases of aberrant cells were considered as biologically relevant. In all experiments vehicle controls gave frequencies of aberrations within the range expected for the V79 cell line. Both positive controls, EMS (900 μg/mL) and CPA (1.11 μg/mL) induced distinct and biologically relevant increase in the number of cells containing structural chromosomal aberrations. According to the results of the present study, the test substance did lead to a biologically relevant increase in the number of cells with chromosome aberrations after adding a metabolizing system (S9 mix). Furthermore, an increase in the number of polyploid cells was observed at the highest test item concentration of 0.075 mM (with metabolic activation). Thus, under the experimental conditions described, with regard to the data obtained in the in vitro Mammalian Chromosome Aberration Test, the test substance FAT 93504/B induced structural chromosome aberrations in the V79 Chinese hamster cell line in the presence of metabolic activation. The positive controls induced the appropriate responses.
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.