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Diss Factsheets
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EC number: 485-300-3 | CAS number: -
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2009-04-23 till 2009-07-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.11 (Mutagenicity - In Vivo Mammalian Bone-Marrow Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5385 (In Vivo Mammalian Cytogenetics Tests: Bone Marrow Chromosomal Analysis)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- chromosome aberration assay
Test material
- Details on test material:
- Batch No.: FEB 279-810
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: minimum 7 weeks
- Weight at study initiation: the weight variation of animals should be minimal and not exceed ± 20% of the mean weight of each sex
- Assigned to test groups randomly: yes
- Housing: 5 animals of identical sex per cage
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to pH value of approximately 2.8 (drinking water, municipal residue control, micro -biologically controlled periodically)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): at least 10 x per hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Cottonseed Oil
- Duration of treatment / exposure:
- The exposition times were 24 h for all dose groups evaluated and 48 h for the additional negative control and highest dose group
- Frequency of treatment:
- The animals received the test item once.
- Post exposure period:
- 48 h
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
200 mg/kg bw
Basis:
- Remarks:
- Doses / Concentrations:
500 mg/kg bw
Basis:
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw.
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Positive control(s):
- Cyclophosphamide
- Route of administration: ip, single
- Doses / concentrations: 10 mL/kg bw
Examinations
- Tissues and cell types examined:
- bone marrow cells
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- 1000 mg/kg
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
RESULTS OF RANGE-FINDING STUDY:
One female and one male rat received a single dose of 2000 mg/kg bw ip and died within 26.5 hours for the female and 27.5 hours for the male after application of the test item. Three female and three male rats received a single dose of 1000 mg/kg bw ip and showed toxic symptoms as reduction of spontaneous activity, prone position, constricted abdomen and an abnorm pinna reflex, but survived 72 hours after the treatment. (Table 1). Due to the results obtained in the pre-experiment 1000 mg/kg was chosen as maximum tolerable dose (1 MTD) in the main experiment.
RESULTS OF DEFINITIVE STUDY:
For all dose groups, 100 metaphases per animal were scored for the incidence of structural chromosomal aberrations.
The negative controls (24 h and 48 h) evaluated were within the range of the historical control data (male: 0.0% - 5.1%, female: 0.0% - 3.7, Table 14). The mean values of aberrant cells observed for the negative control (24 h) were 0.6% for male and 0.2% for female rats. The mean values for the 48 h negative control were 0.4% for the male and 1.2% for the female rats.
The dose group treated with 1000 mg/kg bw (24 h treatment) showed mean values of 0.4% for male and 0.2% for female rats. The dose group treated with 500 mg/kg bw (24 h treatment) showed mean values of 0.6% for male and 1.2% for female rats. The dose group treated with 200 mg/kg bw (24 h treatment) showed mean values of 0.6% for both, the male and female rats. The mean values observed for the 1000 mg/kg bw (48 h treatment) were 0.6% as well for both, the male and female rats.
All mean values of aberrant cells noted after treatment with the test item were within the historical control data range of the negative control (Table 14). No biologically relevant increase of aberrant cells was found.
The nonparametric Mann-Whitney test was performed to verify the results. No statistically significant enhancement (p<0.05) of aberrant cells was noted at any dose group of the test item evaluated .
Cyclophosphamide (40 mg/kg bw) administered ip was used as positive control which induced a significant increase of induced aberrant cells frequency (percentage of aberrant cells was 54.4% for male and 44.8% for female rats). This demonstrates the validity of the assay.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The test item did not induce structural chromosomal damage in bone marrow cells of the rat.
Therefore, the test item is considered to be non-clastogenic in this Mammalian Bone Marrow Chromosome Aberration Test under the experimental conditions reported.
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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