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Diss Factsheets
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EC number: 632-619-2 | CAS number: 881685-58-1
- 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
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Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 15 May 2006 to 20 Jun 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1997
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 2000
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 632-619-2
- EC Number:
- 632-619-2
- Cas Number:
- 881685-58-1
- Molecular formula:
- C20 H23 F2 N3 O
- IUPAC Name:
- 632-619-2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HsdRCCHan
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 0.5 % w/v aqueous carboxymethylcellulose (CMC)
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Micronucleus Test
The test material was tested at the limit dose of 2000mg/kg. No significant increases in the incidence of micronucleated immature erythrocytes, compared to the vehicle control values, were seen in any treated rats at either of the sampling times investigated. The sensitivity of the test system was clearly demonstrated by the marked increases in the frequencies of micronucleated immature erythrocytes induced by the positive control substance, cyclophosphamide. The data from the study do not indicate any clastogenic activity of the test material in the rat bone marrow when tested up to 2000 mg/kg, the limit dose.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of test, the test material is not clastogenic in the rat bone marrow micronucleus test.
- Executive summary:
The test material has been evaluated for its ability to induce micronucleated immature erythrocytes in the bone marrow of HsdRCCHan: WIST rats in a study according to OECD TG 474 following GLP principles. A single oral dose was given to groups of male rats at a dose level of 2000 mg/kg. This dose level is the limit dose level of the assay. Bone marrow samples were taken 24 and 48 hours after dosing.
No significant increases in the incidence of micronucleated immature erythrocytes, over the vehicle control values, were seen at either of the sampling times investigated. Comparison of the percentage of immature erythrocytes showed no significant differences at either of the sampling times between the vehicle control animals and those treated with the test material. The test system positive control, cyclophosphamide, induced biologically meaningful increases in
micronucleated immature erythrocytes, compared to the vehicle control values, thus demonstrating the sensitivity of the test system to a known clastogen.
Under the conditions of test, the test material is not clastogenic in the rat bone marrow micronucleus test.
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