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Diss Factsheets
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EC number: 457-470-9 | CAS number: 407-64-7
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study performed in accordance with the corresponding OECD-/EU-testing guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Method B.12 Mutagenicity (Micronucleus test) Regulation of Czech Ministry of Health No.251/1998 (identical with Method B.12 Commission Directive 84/449/EEC)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Details on test material:
- - Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BioTest s.r.o., Konárovice, Česká republika
- Weight at study initiation: males 160-197 g; females; 130-160 g
- Diet (e.g. ad libitum): Standard diet Peletisovaná NOAH (Racio Břecbv)
- Water (e.g. ad libitum): tap water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- distilled water
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
250 mg/kg
Basis:
nominal in water
5 males & 5 females
- Remarks:
- Doses / Concentrations:
750 mg/kg
Basis:
nominal in water
5 males & 5 females
- Remarks:
- Doses / Concentrations:
1500 mg/kg
Basis:
nominal in water
5 males & 5 females
- No. of animals per sex per dose:
- 5 animals per sex and dose group
- Control animals:
- yes
- Positive control(s):
- Cyclophosphamide was tested as positive control at a concentration of 25 mg/kg
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - Total number of animals: 50 rats
- Positive control: Cyclophosphamide (dose 25 mg/kg)
- Negative control: Water - aqua for injection
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The aqueous solution of the test item was found to be non mutagenic in this test - Executive summary:
The assay was performed 2001 in compliance with GLP and according to Method B.12 Mutagenicity (Micronucleus test) Regulation of Czech Ministry of Health No.251/1998 (identical with: Method B.12 of 84/449/EEC). The test was performed on male and female Wistar rats at concentrations of 250, 750 and 1500 mg/kg. The test item showed neither cytotoxicity nor mutagenic effects.
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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