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Diss Factsheets
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EC number: - | CAS number: -
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Details on test material:
- - Name of test material (as cited in study report): FAT 66'031/B
- Physical state: Yellow solid
- Analytical purity: 88.1%
- Lot/batch No.: BSG ex Pa 34/45
- Expiration date of the lot/batch: 1992
- Stability under test conditions: Pure test article reported to be stable for "years" and stability in water (vehicle) reported to be > 2 hours
- Storage condition of test material: At 4 ºC, protected from light
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Tierfarm Fullinsdorf
- Age at study initiation: at least 10 weeks
- Weight at study initiation: approx. 30 g
- Assigned to test groups randomly: yes
- Fasting period before study: 18 hours
- Housing: singly housed in Makrolon Type I cages with wire mesh top (EHRET GmbH, D-7830 Emmendingen)
- Diet: Pelleted standard diet (ALTROMIN, D-4937 Lage/Lippe)
- Water: tap water, ad libitum (Gemeindewerke, D-6101 RoBdorf)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 25 - 70
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: distilled water
- Duration of treatment / exposure:
- single adiministration
- Frequency of treatment:
- single administration
- Post exposure period:
- 24, 48 and 72 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 6/sex/group/time point
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide:
- Route of administration: single oral (gavage) dose
- Doses / concentrations: 30 mg/kg bw/day
Examinations
- Tissues and cell types examined:
- Polychromatic erythrocytes from femurs of all animals
- Details of tissue and slide preparation:
- TREATMENT AND SAMPLING TIMES:
The animals received the test article once. Sampling of the bone marrow was done at 24, 48 and 72h after treatment.
DETAILS OF SLIDE PREPARATION: 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 5 mL syringe. The cell suspension was centrifuged at 1500 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-Gruenwald (MERCK, D-6100 Darmstadt, F.R.G.)/Giemsa (Gurr, BDH Limited Poole, Great Britain). Cover slips were mounted with EUKITT (KINDLER, D-7800 Freiburg F.R.G.). At least one slide was made from each bone marrow sample.
METHOD OF ANALYSIS: 1000 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 the PCEs. The analysis was performed with coded slides. 5 animals/sex/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:
- A test article is classified as mutagenic if it induces a statistically significant increase in the number of micronucleated polychromatic erythrocytes in at least one of the test points.
A test article producing no statistically significant increase in the number of micronucleated polychromatic erythrocytes 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:
- nonparametric Mann-Whitney test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- One of the treated animals expressed slight toxic reactions (denoted as "reduction of spontaneous activity") up to 48 h after exposure.
Any other information on results incl. tables
Results:
Sampling time | Test group | Polychromatic erythrocytes | Normocytes / total amount polychromatic erythrocytes | Cells with micronuclei (%) |
Dose (mg/kg bw) | ||||
24 h | vehicle control | 10000 | 8291 | 0.06 |
5000 | 10000 | 9784 | 0.05 | |
CPA | 10000 | 8376 | 0.63 | |
25 h | vehicle control | 10000 | 8877 | 0.07 |
5000 | 10000 | 8941 | 0.06 | |
72 h | vehicle control | 10000 | 7685 | 0.06 |
5000 | 10000 | 8335 | 0.13 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
It can be stated that 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, the test substance 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.
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