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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 251-257-2 | CAS number: 32846-21-2
- 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
- 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 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Sodium 6-amino-5[2-(2-chlorophenoxy)-5-chlorophenylazo]-4- hydroxy- naphthalene-2-sulphonate
- Cas Number:
- 103241-64-1
- Molecular formula:
- Hill formula: C22 H14 Cl2 N3 Na O5 S
- IUPAC Name:
- Sodium 6-amino-5[2-(2-chlorophenoxy)-5-chlorophenylazo]-4- hydroxy- naphthalene-2-sulphonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
- Specific details on test material used for the study:
- Name: FAT 20'070/C
Batch No.: UO-Vers. 1310/87
Aggregate State at RT: solid
Colour: dark brown
Stability: Pure: stable for 12 months. In vehicle: stable in DMSO and DMF for > 8 hours
Storage: room temperature / light protected
Expiration date: March 1992
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Housing: Single
Cage Type: Makrolon Type I, with wire mesh top (EBECO, D-4620 Castrop-Rauxel, F.R.G.)
Bedding :granulated soft wood bedding (ALTROMIN, D-4937 Lage/Lippe, F.R.G.)
Feed: pelleted standard diet (ALTROMIN, D-4937 Lage/Lippe, F.R.G.)
Water : tap water, ad libitum (Südhessische Gas- und Wasser AG, D-6100 Darmstadt)
Environment : temperature 21 +/- 3 °C; relative humidity not regulated; artificial light 6.00 a.m. - 6.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- The vehicle of the test article was used as negative control.
Name: Dimethylsulfoxide (DMSO)
Supplier: MERCK, D-6100 Darmstadt, F.R.G, - Details on exposure:
- Approximately 18 hours before treatment with the test article the animals received no food but water ad libitum. At the beginning of the treatment the animals were weighed and the individual volume to be administered was adjusted to the animal's body weight. The animals received the test article once. Twelve animals, six males and six females, were treated per dose group. Sampling of the bone marrow was done 24, 48 and 72 hours after treatment.
- Frequency of treatment:
- Once
- Post exposure period:
- 24, 48 and 72 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3000 mg/kg bw.
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Name: CPA; Cyclophosphamide
Supplier: SERVA, D-6900 Heidelberg, F.R.G.
Catalogue no.: 17681
Dissolved in: physiological saline
Dosing: 30 mg/kg b.w.
Route and Frequency of Administration: orally, singly
Volume Administered: 10 ml/kg b.w.
Examinations
- Tissues and cell types examined:
- Polychromatic erythrocytes (PCE) in the bone marrow
- 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 2.0 ml fetal calf serum, using a 5 ml syringe, into 1 ml fetal calf serum. The cell suspension was centrifuged at 1,000 rpm for 5 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/Giemsa. Cover slips were mounted with EUKITT (KINDLER,D-7800 Freiburg F.R.G.). At least one slide was made from eachbone marrow sample.
Analysis of Cells:
Evaluation of the slides was performed using NIKON microscopes with lOOx oil immersion objectives. 1,000 polychromatic erythrocytes (PCE) were analysed per animal for micronuclei. To describe a cytotoxic effect the ratio between polychromatic and normochromatic erythrocytes was determined in same sample and expressed in normochromatic erythrocytes per 1000 PCEs. The analysis was performed with coded slides. Five animals per sex and group were evaluated as described. The remaining animal of each test group was evaluated in case an animal had died in its test group spontaneously or due to gavage error. - Evaluation criteria:
- The frequencies of micronucleated PCEs in the groups treated with the test article are compared with their corresponding negative controls. This is achieved by means of the nonparametric Mann- Whitney test (6) .
Positive responses are those in which an increase of micronucleated PCEs can be confirmed statistically significant at the five per cent level (p < 0.05).
However, both biological and statistical significance should be considered together in the evaluation. - Statistics:
- Statistical significance at the five per cent level (p < 0.05) was evaluated by means of the non-parametric Mann-Whitney test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Test Group | Dose (mg/kg bw) | Time | PCEs with micronuclei | Range | PCE/NCE |
Solvent | 0 | 24 | 0.12% | 0-3 | 1000/600 |
Solvent | 0 | 48 | 0.05% | 0-2 | 1000/508 |
Solvent | 0 | 72 | 0.10% | 0-2 | 1000/547 |
CPA | 30 | 24 | 1.07% | 4-20 | 1000/693 |
Test Article | 3000 | 24 | 0.11% | 0-3 | 1000/522 |
Test Article | 3000 | 48 | 0.10% | 0-2 | 1000/551 |
Test Article | 3000 | 72 | 0.10% | 0-3 | 1000/399 |
Applicant's summary and conclusion
- Conclusions:
- FAT 20'070/C is considered to be not clastogenic in this micronucleus assay.
- Executive summary:
This study was performed to investigate the potential of FAT 20'070/C to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the mouse. This study was performed according to OECD test guideline 474. The test article was dissolved in DMSO which served as a negative control. The volume administered orally was 5 ml/kg bw. 24 h, 48 h and 72 h after a single application of the test article 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. 1000 polychromatic erythrocytes (PCE) per animal were scored for micronuclei. To describe a cytotoxic effect due to the treatment with the test article the ratio between polychromatic and normochromatic erythrocytes (NCE) was determined in the same sample and reported as the number of NCE per 1000 PCE. The following dose level of the test article was investigated: 24 h, 48 h, and 72 h preparation interval: 3000 mg/kg bw. In a pre-experiment this dose level was estimated to be the maximum attainable dose. The animals expressed toxic reactions. After treatment with the test article the ratio between PCEs and NCEs was not affected as compared to the corresponding negative controls thus indicating that FAT 20'070/C had no cytotoxic properties.
In comparison with the corresponding negative controls, there was no substantial enhancement in the frequency of the detected micronuclei at any preparation interval after application of the test article. An appropriate reference mutagen was used as positive control which showed a distinct increase of induced micronucleus frequency.
Hence, under the experimental conditions reported, the test article did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse. Therefore, FAT 20'070/C is considered to be not clastogenic 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.