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EC number: 247-368-0 | CAS number: 25956-17-6
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Micronucleus assay study of the test chemical
- Author:
- Masamitsu Honma
- Year:
- 2 015
- Bibliographic source:
- Food and Chemical Toxicology 84 (2015)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- Determination of genotoxicity of the test chemical by Mammalian Erythrocyte Micronucleus test.
- GLP compliance:
- no
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- EC Number:
- 247-368-0
- EC Name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 25956-17-6
- Molecular formula:
- C18H16N2O8S2.2Na
- IUPAC Name:
- disodium 6-hydroxy-5-[(2-methoxy-3-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- IUPAC name: Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
Mol. formula: C18H14N2Na2O8S2
Molecular Weight: 496.4266 g/mol
InChI: 1S/C18H16N2O8S2.2Na/c1-10-7-14(16(28-2)9-17(10)30(25,26)27)19-20-18-13-5-4-12(29(22,23)24)8-11(13)3-6-15(18)21;;/h3-9,21H,1-2H3,(H,22,23,24)(H,25,26,27);;/q;2*+1/p-2/b20-19+;;
Smiles: c12c(cc(cc2)S(=O)(=O)[O-])ccc(c1/N=N/c1c(cc(c(c1)C)S(=O)(=O)[O-])OC)O.[Na+].[Na+]
Physical state: Solid particulate/powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: CD1 mice (Crlj:CD1)
- Details on species / strain selection:
- No data
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Japan
- Age at study initiation: 6 weeks
- Weight at study initiation: No data
- Assigned to test groups randomly: [no/yes, under following basis: ]
- Fasting period before study: No data
- Housing:No data
- Diet (e.g. ad libitum): CRF-1 pellet feed, Oriental Yeast
- Water (e.g. ad libitum): ad libitum
- Acclimation period:7 days before treatement
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: To:No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Vehicle(s)/solvent(s) used: 0.5% carboxymethylcellulose sodium
- Justification for choice of solvent/vehicle: The test chemical was soluble in 0.5% carboxymethylcellulose sodium - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:The test chemical was dissolved in 0.5% carboxymethylcellulose sodium solution prior to administration.
DIET PREPARATION
- Rate of preparation of diet (frequency):No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food:No data - Duration of treatment / exposure:
- 2 days
- Frequency of treatment:
- Daily with a 24 hr interval
- Post exposure period:
- No data
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 30 mice
6 mice per group - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- Tissue preparation:
Mice were sacrificed by cervical dislocation at 23-24 h after the final treatment.Femurs was removed and bone marrow cells were flushed from femurs into centrifuge tubes using calf serum. Cells were then resuspended in Dulbecco's phosphate-buffered saline and were centrifuged, and supernatants were then removed. These procedures were performed twice, and then cells were fixed in 10% neutral-buffered formalin solution. After exchanging the fixative twice by centrifugation, cells were re-suspended in formalin solution, and the cell suspension was filtered through a cell strainer.
Slide preparation:
Fixed cell suspensions were dropped onto cover slips and were immediately placed on acridine orange coated slides. Two thousand polychromatic erythrocytes (PCEs) per animal were analyzed using a fluorescent microscope with a 1000 lens, equipped with a blue excitation filter and a barrier filter, and numbers of micronucleated polychromatic erythrocytes (MNPCEs) were counted. To investigate the influence of the test substance on bone marrow cell proliferation, numbers of PCEs in a total of 500 erythrocytes were counted. - Evaluation criteria:
- No data
- Statistics:
- Frequencies of MNPCEs in treatment and positive control groups were compared with those in the negative control group using conditional binomial tests.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Remarks:
- 0.5% carboxymethylcellulose sodium
- Negative controls validity:
- valid
- Remarks:
- 0.5% CMC
- Positive controls validity:
- valid
- Remarks:
- Mitomycin C
- Remarks on result:
- other: No mortality observed
- Additional information on results:
- In micronucleus tests, no significant differences in MNPCEs were found between test chemical treatment groups and the negative control group. The frequency of PCEs, which offers an index of the influence of the test substance on bone marrow cells, did not differ between any of the treatment groups and the negative control group.The frequency of MNPCEs in the positive control group was increased (p ≤ 0.01) in comparison with that in the negative control group. No detahs, clinical signs and body weight changes were observed in control and tratment groups.
Any other information on results incl. tables
Table: The results of micronucleus test in bone marrow of CD1 mice after test chemical treatment.
Compound |
Dose(mg/kg) |
No. of animal |
% MNPCEa |
% PCE |
Control |
0 |
5 |
0.14±0.07 |
63.3±8.1 |
Test chemical |
500 |
5 |
0.20±0.04 |
61.8±5.1 |
|
1000 |
5 |
0.14±0.07 |
61.4±9.1 |
|
2000 |
5 |
0.17±0.14 |
62.9±5.0 |
MMC |
1 |
5 |
3.66±0.94** |
56.0±8.1 |
**:p < 0.01, significant difference from control (Kastenbaum and Bowman method, upper-trailed).
Control: negative control (0.5% Carboxymethylcellulose sodium, 10 ml/kg).
MMC: positive control (Mitomycin C, dose once a day, for 2 days, i.p., 1 days after administration).
aPolychromatic erythrocytes possessing one or more than one micronuclei (MNPCEs) were counted.
Applicant's summary and conclusion
- Conclusions:
- In a Mammalian Erythrocyte Micronucleus Test, the frequency of MNPCEs in the positive control group was increased (p ≤ 0.01) in comparison with that in the negative control group. Thus, the test chemical was considered to be not mutagenic in nature.
- Executive summary:
In a Mammalian Erythrocyte Micronucleus Test, the mutagenic nature of test chemical was evaluated in male CD1 mice (Crlj: CD1) mouse. The mice were dosed orally by gavage at a concentration of 500, 1000 and 2000 mg/kg bw. 0.5% carboxymethylcellulose sodium was used a vehicle and Mitomycin C was used as a positive control substance. 30 mice (6 mice /group) were dosed daily at an interval of 24 hrs for 2 days. Bone marrow cells were examined. The target tissues were treated to achieve cells, slide preparation of the cells was done and later the slide was used for electrophoresis. Frequencies of micro nucleated polychromatic erythrocytes (MNPCEs) in treatment and positive control groups were compared with those in the negative control group using conditional binomial tests.In micronucleus tests, no significant differences in MNPCEs were found between test chemical treatment groups and the negative control group. The frequency of PCEs, which offers an index of the influence of the test substance on bone marrow cells, did not differ between any of the treatment groups and the negative control group. The frequency of MNPCEs in the positive control group was increased (p ≤ 0.01) in comparison with that in the negative control group. No deaths, clinical signs and body weight changes were observed in control and treatment groups. Thus the test chemical was considered to be not mutagenic in nature.
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