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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 289-550-2 | CAS number: 89923-62-6
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
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:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate
- EC Number:
- 289-550-2
- EC Name:
- Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate
- Cas Number:
- 89923-62-6
- Molecular formula:
- C23H19N3O6S.Na
- IUPAC Name:
- sodium 1-amino-9,10-dioxo-4-[(3-propanamidophenyl)amino]-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- other: solid
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Name: FAT 20'242/B
Batch No.: FC-83/5T
Aggregate State at RT: Solid
Molecular Weight: 487.45
Purity: cf. Analytical Certificate in the sponsor file
Analysis: cf. Analytical Certificate in the sponsor file
Stability: Pure: stable for 24 months. In solvent: > 8 hours in H20, ethanol, acetone, DMSO and DMF
Storage: light protected
Expiration Date: March 1993
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- Large stocks of the V79 cell line are stored in liquid nitrogen in the cell bank of C C R allowing the repeated use of the same cell culture batch in experiments. Consequently, the parameters of the experiments remain similar because of the reproducible characteristics of the cells.
Thawed stock cultures are propagated at 37°C in 80 cm2 plastic flasks (GREINER, D-7440 Nürtingen, F.R.G.). Seeding is done with about 5 x 10s cells per flask in 15 ml of MEM medium supplemented with 10 % fetal calf serum (FCS; SEROMED, D-1000 Berlin). The cells are subcultured twice weekly. The cell cultures are incubated at 37°C and 4.5 % carbon dioxide atmosphere. - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomal fraction from the liver of old male Wistar rats.
- Test concentrations with justification for top dose:
- 1)Pre-experiment for toxicity:
without S9 mix:
7 h: 25; 50; 100; 150 µg/ml
18 h: 2.5; 10; 25; 50; 100; 150 µg/ml
28 h: 25; 50; 100; 150 µg/ml
with S9 mix:
7 h: 100; 200; 300; 400 µg/ml
18 h: 10; 50; 100; 200; 300; 400 µg/ml
28 h: 100; 200; 300; 400 µg/ml
2)Experiment:
Without S9 mix:
7 h: 50 µg/ml
18 h: 2.5; 25; 50 µg/ml
28 h: 150 µg/ml
With S9 mix:
7 h: 100 µg/ml
18 h: 10; 100; 200 µg/ml
28 h: 400 µg/ml - Vehicle / solvent:
- On the day of the experiment, the test article was dissolved in culture medium without fetal calf serum.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Concurrent solvent controls were performed.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- ethylmethanesulphonate
- Remarks:
- Ethylmethanesulfonate: without metabolic activation; Cyclophosphamide: With metabolic activation.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Plastic flask 25 cm3
NUMBER OF REPLICATIONS: 4 per dose
NUMBER OF CELLS EVALUATED: Determination of the mitotic index by scoring 1000 cells of each slide
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
Analysis of metaphase cells:
Evaluation of the slides were performed using NIKON microscopes with 100x oil immersion objectives. Breaks, fragments, deletions, exchanges and chromosomal disintegrations were recorded as structural chromosome aberrations. Gaps were recorded as well but not included in the calculation of the aberration rates. At least 100 well spread metaphases per slide were scored for cytogenetic damage on coded slides. Only metaphases with characteristic chromosome number of 22 ± 1 were included in the analysis. To describe a cytotoxic effect the mitotic index (% cells in mitosis) was determined. - Evaluation criteria:
- A test article is classified as mutagenic if it induces either a significant dose-related increase in the number of structural chromosomal aberrations or a significant and reproducible positive response for at least one of the test points.
A test article producing neither a significant dose-related increase in the number of structural chromosomal aberrations nor a significant and reproducible positive response at any one of the test points is considered non-mutagenic in this system.
This can be confirmed by means of the nonparametric Mann-Whitney test. However, both biological and statistical significance should be considered together. - Statistics:
- Statistical significance at the five per cent level (p < 0.05) was evaluated by means of the non-parametric Mann-Whitney test.
Solvent control versus fixation interval S9 mix p-value
Test group 50.0 µg 7 h - n.t.
" 100 µg 7 h + n.t.
" 2.5 µg 18 h - n.t.
" 25 µg 18 h - n.t.
" 50 µg 18 h - n.t.
" 10 µg 18 h + n.t.
" 100 µg 18 h + n.t.
" 200 µg 18 h + 0.0147*
" 150 µg 28 h - 0.0000*
" 400 µg 28 h + 0.0000*
n.t. = Not tested
* Aberration rate is statistically significant higher than the control rate.
Results and discussion
Test results
- 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:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- None
Any other information on results incl. tables
Dose Selection:
In the pre-experiment for 'toxicity the colony forming ability of the V79 cells was reduced to about 20% after treatment with 150.0 and 400.0 µg/ml*, respectively, in the absence and presence of S9 mix.
In the main experiment, in the absence of S9 mix at fixation intervals 7 and 18 h with concentrations higher than 50 µg/ml no metaphases could be found. At fixation interval 28 h cells after treatment with 150 µg/ml as maximum concentration were evaluated. In the presence of S9 mix after treatment with concentrations higher than 100 µg/ml (fixation interval 7 h) and 200 µg/ml (fixation interval 18 h) not enough scorable cells could be found. But at fixation interval 28 h. 400 µg/ml as maximum dose level could be evaluated for cytogenetic damage.
With the highest dose level applied in the absence and presence of S9 mix the mitotic index was clearly suppressed.
Applicant's summary and conclusion
- Conclusions:
- FAT 20242/B induced structural chromosome aberrations in the V79 Chinese Hamster cell line.
- Executive summary:
The test article FAT 20'242/B was assessed for its potential to induce structural chromosome aberrations in V79 cells of the Chinese Hamster in vitro in accordance with OECD Guideline 473.
Preparation of chromosomes was done 7 h (high dose), 18 h (low, medium and high dose), and 28 h (high dose) after start of treatment with the test article. The treatment interval was 4 h. In each experimental group, except the positive controls, four parallel cultures were used. Per culture 100 metaphases were scored for structural chromosomal aberrations. The following dose levels were evaluated:
without S9 mix: with S9 mix:
7 h
18 h
28 h
50.0 ug/ml 7 h: 100.0 ug/ml
2.5; 25.0; 50.0 ug/ml 18 h: 10.0; 100.0; 200.0 ug/ml
150.0 ug/ml 28 h: 400.0 ug/ml
The concentration range of the test article applied had been determined in a pre-experiment using the plating efficiency assay as indicator for toxicity response.
Treatment of the cells with 150.0 and 400.0 ug/ml, respectively, reduced clearly the plating efficiency of the V79 cells. Also the mitotic index was reduced after treatment with the highest concentrations at all fixation intervals in the presence and absence of S9 mix.
There were relevant enhancements of cells with structural aberrations after treatment with the highest dose levels at fixation intervals 18 and 28 h with and without metabolic activation by S9 mix.
Appropriate reference mutagens were used as positive controls and showed distinct increases of cells with structural chromosome aberrations.
CONCLUSION:
In conclusion, it can be stated that in the study described and under the experimental conditions reported, the test article induced structural chromosome aberrations as determined by the chromosomal aberration test in the V7 9 Chinese Hamster cell line. Therefore, FAT 20'242/B is considered to be clastogenic in this chromosomal aberration test.
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.