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EC number: 226-901-0 | CAS number: 5538-94-3
- 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 / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 September 1986 - 20 January 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Read-across
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Version / remarks:
- 1984
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1984
- GLP compliance:
- yes
- Type of assay:
- other: Micronucleus assay
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 7173-51-5
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch number: E06130085
Purity: 50.3%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CRL UK
- Assigned to test groups randomly: yes
- Fasting period before study: overnight prior to dosing
- Housing: plastic disposable cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Air changes (per hr): 30
- Photoperiod (hrs dark / hrs light): 12 hours artifical light/day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Sterile distilled water.
- Details on exposure:
- All animals in all groups were dosed by oral gavage with a standard volume of 20 ml/kg bw except that those receiving cyclophosphamide were dosed by IP injection.
- Duration of treatment / exposure:
- Single administration of dose.
- Frequency of treatment:
- Once.
- Post exposure period:
- 48 hours
Doses / concentrations
- Dose / conc.:
- 600 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 35/sex/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
40 mg/kg bw/day
Prepared in a solution in sterile 0.9% saline at a concentration of 2.0 mg/ml.
Examinations
- Tissues and cell types examined:
- Both femurs were dissected from the animals and the proximal epiphysis was remoaved and the marrow eluted.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: A preliminary toxicity test was conducted to evaluate the toxicity of the substance at various doses. The dose selcted for the main test was based on the lowest dose that did not result in any toxicity.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Sampling time (hrs) | Treatment | Doseage (mg/kg bw) | Incidence of aberrant cells (%) | |
Excluding gap damage | Including gap damage | |||
6 | Vehicle P0151 |
- 600 |
0 0 |
0 0 |
24 | Vehicle P0151 Cyclophosphamide |
- 600 40 |
0 0 5.6 |
0 0 5.6 |
48 | Vehicle P0151 |
- 600 |
0 0 |
0 0 |
Applicant's summary and conclusion
- Conclusions:
- The substance was found to be negative for chromosomal damage in rat bone marrow in the in vivo cytogenetic test when administered orally by gavage.
- Executive summary:
The substance was assessed for its potential to induce chromosomal damage in rats dosed by oral gavage at a dose of 600 mg/kg bw. The animals were observed for 48 hours for any signs of toxicity. Two hours prior to sacrifice the animals each received a dose of colchicine to arrest cells in the metaphase stage of cell division. At the end of the observation period the animals were terminated by cervical dislocation and the bone marrow from the femurs were removed for analysis. The substance was found to be negative for chromosomal damage in rat bone marrow in the in vivo cytogenetic test when administered orally by gavage.
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