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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 429-240-8 | CAS number: 212652-59-0
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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
- Study period:
- Study initiation date - 01 December 1999; Experiment start date - 01 December 1999; Experiment completion date - 17 December 1999; Study completion date - 17 December 1999.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 92/69, L 383, Annexe V, B 12, dated December 29, 1992.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian bone marrow chromosome aberration test
Test material
- Reference substance name:
- -
- EC Number:
- 429-240-8
- EC Name:
- -
- Cas Number:
- 212652-59-0
- Molecular formula:
- Hill formula: C25 H22 F N8 Na3 O13 S4 CAS formula: C25 H25 F N8 O13 S4 · 3 Na
- IUPAC Name:
- trisodium 3-amino-4-[2-(4-{[4-({2-[2-(ethenesulfonyl)ethoxy]ethyl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}-2-sulfonatophenyl)diazen-1-yl]-5-hydroxynaphthalene-2,7-disulfonate
Constituent 1
- Specific details on test material used for the study:
- Identity: FAT 40574/B
Batch: WP 23/99
Purity: Approx. 75 %
Appearance: Solid, dark-red powder
Storage: At room temperature at about 20 °C
Expiration Date: 08 February 2006
Test animals
- Species:
- mouse
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: BRL, CH-4414 Füllinsdorf
Initial Age at Start of Acclimatization: 8 - 12 weeks
Acclimatization: minimum 5 days
Initial Body Weight at Start of Treatment: males mean value 34.3 g (SD ± 2.5 g); females mean value 27.8 g (SD ± 1.9 g)
Housing: single
Cage Type: Makrolon Type I, with wire mesh top (EHRET GmbH, D-79302 Emmendingen)
Bedding: granulated soft wood bedding (ALTROMIN, D-32791 Lage/Lippe)
Feed: Pelleted standard diet, ad libitum
Water: Tap water, ad libitum
Environment: Temperature 21 ± 3 °C; Relative humidity 25 - 54 %; Artificial light 6.00 a.m. - 6.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Deionised water
- Details on exposure:
- On the day of the experiment, the test item was formulated in deionised water. The vehicle was chosen to its non-toxicity for the animals. All animals received a single standard volume of 10 ml/kg body weight orally.
- Frequency of treatment:
- Once
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Vehicle - Group 1
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Remarks:
- Low dose group - Group 2
- Dose / conc.:
- 670 mg/kg bw/day (nominal)
- Remarks:
- Mid dose group - Group 3
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Remarks:
- High dose group - Group 4
- No. of animals per sex per dose:
- Male: 200 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 670 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 200 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 670 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide (CPA)
Examinations
- Tissues and cell types examined:
- The marrow of the femora;
Two types of erythrocytes were observed in the bone marrow smears: normochromatic (mature red blood cells about to pass into the blood stream) and polychromatic (immature red blood cells). - Details of tissue and slide preparation:
- Preparation of the Animals:
The animals were sacrificed by cervical dislocation. The femora were removed, the epiphyses were cut off and the marrow was flushed out with fetal calf serum, using a syringe. The cell suspension was centrifuged at 1500 rpm (390 x g) for 10 minutes and the supernatant was discarded. A small drop of the resuspended cell pellet was spread on a slide. The smear was air-dried and then stained with May-Grünwald (MERCK, D-64293 Darmstadt)/Giemsa (Gurr, BDH Limited Poole, Great Britain). Cover slips were mounted with EUKITT (KINDLER, D-79110 Freiburg). At least one slide was made from each bone marrow sample.
Analysis of Cells:
Evaluation of the slides was performed using NIKON microscopes with 100x oil immersion objectives. 2000 polychromatic erythrocytes (PCE) were analysed per animal for micronuclei. To describe a cytotoxic effect the ratio between polychromatic and normochromatic erythrocytes was determined in the same sample and expressed in normochromatic erythrocytes per 2000 the PCEs. The analysis was performed with coded slides. - Evaluation criteria:
- A test item is classified as mutagenic if it induces either a dose-related increase in the number of micronucleated polychromatic erythrocytes or a statistically significant positive response for at least one of the test points. A test item producing neither a dose-related increase in the number of micronucleated polychromatic erythrocytes nor a statistically significant positive response at any of the test points is considered non-mutagenic in this system.
- Statistics:
- Non-parametric Mann-Whitney test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Doses producing toxicity: In the pretest: 2000 mg/kg (reduction of spontaneous activity)
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Micronuclei in polychromatic erythrocytes (PCE) and relationship PCE/ total erythrocytes scoring 24 and 48 hours after treatment
Test group | Dose (mg/kg b.w) | Sampling time (h) | PCEs with micronuclei (%) | Range | PCE/NCE |
Vehicle | 0 | 24 | 0.105 | 1-5 | 2000/1610 |
Test article | 200 | 24 | 0.095 | 0-7 | 2000/1734 |
Test article | 670 | 24 | 0.055 | 0-3 | 2000/1750 |
Test article | 2000 | 24 | 0.040 | 0-4 | 2000/1860 |
Cyclo-phosphamide | 40 | 24 | 1.580 | 11 - 43 | 2000/2008 |
Test article | 2000 | 48 | 0.100 | 0-6 | 2000/1661 |
Applicant's summary and conclusion
- Conclusions:
- The test item did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the mouse.
- Executive summary:
This study was performed to investigate the potential of FAT 40'574/B to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the mouse. This study was conducted according to OECD test guideline 474 in a GLP-certified laboratory. The test item was formulated in deionised water. Deionised water was used as vehicle control. The volume administered orally was 10 ml/kg bw.. 24 h and 48 h after a single administration of the test item the bone marrow cells were collected for micronuclei analysis. Ten animals (5 males, 5 females) per test group were evaluated for the occurrence of micronuclei. 2000 polychromatic erythrocytes (PCEs) per animal were scored for micronuclei. To describe a cytotoxic effect due to the treatment with the test item the ratio between polychromatic and normochromatic erythrocytes (NCE) was determined in the same sample and reported as the number of NCEs per 2000 PCEs. The following dose levels of the test item were investigated:
24 h preparation interval: 200, 670, and 2000 mg/kg b.w..
48 h preparation interval: 2000 mg/kg b.w..
The highest dose (2000 mg/kg; maximum guideline-recommended dose) was estimated by a pre-experiment to be suitable. After treatment with the highest dose of the test item (2000 mg/kg b.w.) the number of NCEs was increased as compared to the mean value of NCEs of the vehicle control at preparation interval 24 hours thus indicating that FAT 40'574/B had cytotoxic effectiveness in the bone marrow. In comparison to the corresponding vehicle controls there was no enhancement in the frequency of the detected micronuclei at any preparation interval after administration of the test item and with any dose level used. 40 mg/kg b.w. cyclophosphamide was used as positive control which showed a substantial increase of induced micronucleus frequency. In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test item did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse. Therefore, FAT 40574/B is considered to be non-mutagenic in this micronucleus assay.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)