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Diss Factsheets
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EC number: 410-510-9 | CAS number: 86753-82-4
- 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
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V - method B.12
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
Constituent 1
Test animals
- Species:
- other: Mouse (C57BL/6JfBL 10/alpk)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- Corn oil
- No. of animals per sex per dose:
- Male: 3200 mg/kg; No. of animals: 5; Sacrifice time: 24 hoursMale: 5000 mg/kg; No. of animals: 5; Sacrifice time: 24 hoursMale: 5000 mg/kg; No. of animals: 5; Sacrifice time: 48 hoursMale: 5000 mg/kg; No. of animals: 5; Sacrifice time: 72 hoursFemale: 3200 mg/kg; No. of animals: 5; Sacrifice times: 24 hoursFemale: 5000 mg/kg; No. of animals: 5; Sacrifice times: 24 hoursFemale: 5000 mg/kg; No. of animals: 5; Sacrifice times: 48 hoursFemale: 5000 mg/kg; No. of animals: 5; Sacrifice times: 72 hours
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- reduced number of polychromatic erythrocytes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Observations:There was no observed increase in micronucleus formation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negativeUnder the conditions of the test, the substance is not clastogenic in the mouse bone marrow micronucleus test
- Executive summary:
The substance has been evaluated for its ability to induce micronucleated polychromatic erythrocytes in the bone marrow of C57BL/6JfBL10/Alpk mice. A single oral dose was given to groups of 5 male and 5 female mice at dose levels of 3200 and 5000 mg/kg, the higher dose being the limit dose for this assay. Bone marrow samples were taker 24 hours after dosing at 3200 mg/kg and 24, 48 and 72 hours after dosing at 500 mg/kg.
No statistically or biologically significant increase in the incidence of micronucleated polychromatic erythrocytes, over the vehicle control values, were seen at either dose level in males at any of the sampling times investigated. A small statistically significant increase was observed in females 48 hours after being dosed with the substance at 5000 mg/kg. This value is, however, within the concurrent vehicle control range and the statistical significance is considered to be due to a low female control value at 48 hour time point rather than to any effect of the substance. The increased observed is therefore considered to be of no biological significance. No such increase were observed at any other sampling time or dose level tested in the females.
The test system positive control, cyclophosohamide, induced statistically significant and biologically meaningful increase in mirconucleated polychromatic erythrocytes, compared to the vehicle control, thus demonstrating the sensitivity of the test system to a known clastogen.
Comparison of the percentage of polychromatic erythrocytes showed a statistically significant decrease, compared to the vehicle control value, in males 72 hours after being dosed at 5000 mg/kg. This indicates that the substance or one of its metabolites may have had a cytotoxic effect on the bone marrow resulting in a depression in the bone marrow proliferation.
It is therefore concluded that the substance, under the conditions of the test, is not clastogenic in mouce micronucleus 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.
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