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EC number: 280-489-7 | CAS number: 83567-04-8
- 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
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Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From November 12, 1999 to December 04, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- other: Mammalian Erythrocyte Micronucleus test
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- red powder
Constituent 1
- Specific details on test material used for the study:
- Purity: 52%
Suspension: in deionized water
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Origin: Harlan Winkelmann GmbH
Acclimatization: at least 5 days
Body weight (mean): 24.0 and 34.2 g (female and male)
Age: ca. 7 weeks
Temperature and relative humidity: 20+/-3°C and 50+/-20%, respectively
Lighting time: 12 h daily
Food: ssniff R/M-H (V 1534), ad libitum
Water: tap water, ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- deionized water
- Details on exposure:
- Twice at an interval of 24 h
Dose: 2000 mg/kg bw (based on a preliminary study)
Sacrifice: 24 h after administration - Duration of treatment / exposure:
- 24 h
- Frequency of treatment:
- Twice
- Post exposure period:
- 24 h
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- Remarks:
- volume: 10 mL/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Yes: Endoxan (cyclophosphamide), 50 mg/kg bw administered once orally
Examinations
- Tissues and cell types examined:
- Bone marrow from the femora
Erythrocytes - Details of tissue and slide preparation:
- A part of the suspension was smeared onto a cleaned slide and air-dried for about 12 h. The staining was performed as follows:
5 min in methanol, 5 min in May-Grünwald's solution, brief rinsing in distilled water, 10 min in Giemsa/buffer solution, rinsing in distilled water, drying and coating with Entellan - Evaluation criteria:
- Validity assessment and mutagenicity:
2000 polychromatic erythrocytes were counted for each animal. The number of cells with micronuclei was recorded, not the number of individual micronuclei. In addition, the ratio (proportion) of polychromatic erythrocytes to 200 total erythrocytes was determined. - Statistics:
- One-sided Wilcoxon test
(Both biological and statistical significances)
A substance is considered positive if there is a significant increase in the number of micronucleated polychromatic erythrocytes compared with the concurrent negative control group.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The number of polychromatic erythrocytes containing micronuclei was not increased. The ratio of polychromatic erythrocytes to total erythrocytes in both male and female animals remained unaffected by the treatment with the test substance and was not less than 20% of the control value.
Positive control (endoxan): induction of a marked statistically significant increase in the number of polychromatic cells with micronuclei. The ratio of polychromatic erythrocytes to total erythrocytes was not changed to a significant extent.
All animals survived after treatment. No signs of toxicity were observed. The following clinical signs were recorded: red colored urine and faeces.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance did not lead to a substantial increase of micronucleated polychromatic erythrocytes and was not mutagenic in the micronucleus test.
- Executive summary:
A study was conducted to determine the in vivo clastogenic potential of the substance according to OECD Guideline 474, EU Method B12 and US EPA OPPTS 870.5395, in compliance with GLP. Male and female NMRI mice received the test substance by oral gavage at a concentration of 0 (vehicle alone) or 2000 mg/ kg bw twice at an interval of 24 h. Positive control mice received cyclophosphamide at 50 mg/kg bw. Bone marrow erythrocytes from the femora were analysed. 2000 polychromatic erythrocytes were counted per animal for the presence of micronuclei. In addition, the ratio of polychromatic erythrocytes to 200 total erythrocytes was determined. As a result of the test substance exposure, the number of polychromatic erythrocytes containing micronuclei was not increased. The ratio of polychromatic erythrocytes to total erythrocytes in both male and female animals remained unaffected by the treatment with the test substance and was not less than 20% of the control value. The positive control group showed a statistically significant increase in the number of polychromatic cells with micronuclei. All animals survived the treatment and no signs of toxicity were observed. Under the study conditions, the substance did not lead to a substantial increase of micronucleated polychromatic erythrocytes and was not clastogenic in the micronucleus test (Stammberger, 1999).
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.
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