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EC number: 279-087-4 | CAS number: 79135-87-8
- 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
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Remarks:
- source of read across
- Adequacy of study:
- key study
- Study period:
- From the 02nd February to the 23th March, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- adopted on 26th May, 1983
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian germ cell cytogenetic assay
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, FRG
- Age at study initiation: ca. 8 weeks
- Weight at study initiation: males 27 - 32 g; females 20 - 25 g
- Fasting period before study: withheld the night before dosing until 4 hours after administration.
- Diet: standard laboratory animal diet (RMH-B); certificate of analysis performed.
- Water: tap water; certificate of analysis performed.
- Accomodation: in groups of 5 per sex in polycarbonate cages.
- Acclimation: at least 6 days under laboratory conditions.
- Identification: by unique cage number and a mark on the tail.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3 °C
- Humidity: 40 - 70 %
- Air changes: 7.5 ACH
- Photoperiod: 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle: Milli-RO water.
- Concentration of test material in vehicle: 4000 mg/kg b.w., single dose.
- Amount of vehicle: 10 ml/kg b.w.
- Sampling time: 24, 48 and 72 hours. - Details on exposure:
- Single oral dose of 4000 mg/kg b.w.
- Duration of treatment / exposure:
- Bone marrow was sampled at 24, 48 and 72 hours after dosing for both treated and control animal groups. Groups A and B were dosed with 4000 and 2000 mg/kg b.w. substance respectively, and did not show any signs of reaction to the treatment.
Concentration higher than 4000 could not be assessed due to aggregation of test article in suspension.
Doses / concentrations
- Dose / conc.:
- 4 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 males and 5 females.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Yes, cyclophosphamide.
- Route of administration: oral gavage.
- Dose: single dose at 50 mg/kg b.w. dissolved in 0.9 % NaCl in Milli-RO water.
- Sampling time: 48 hours after treatment.
Examinations
- Tissues and cell types examined:
- Bone marrow and erythrocytes.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION
A pilot study was performed on 3 males and 3 females per each dose group (five).
DETAILS OF SLIDE PREPARATION
Both femurs were flushed with 2 ml of foetal calf serum. The cell suspension was collected and centrifuged at 1000 rmp for 5 minutes. A drop of the cell suspension was placed on a slide which was previously cleaned (24 hours immersed in a 1:1 mixture of 96 % ethanol/ether). The preparations were then air-dried and thereafter fixed for 5 min in 100 % methanol and air-dried overnight. Two slides were prepared per animal.
- Staining: stained for 3 minutes in undiluted May-Grunwald solution followed by 2 minutes in May Grunwald solution diluted 1:1 with Sorensen buffer pH 6.8. Thereafter slides were rinsed and stained for 25 minutes in 5 % (v/v) Giemsa solution in Sorensen buffer pH 6.8. The preparations were rinsed for 1 minute in running tap-water and blotted dry between filter paper.
METHOD OF ANALYSIS
Slides were scored at a magnification of 1000 x. The number of micronuclei was counted in 1000 polychromatic erythrocytes. The ratio polychromatic to normochromatic erythrocytes was determined by counting and differentiating the first 1000 erythrocytes at the same time. Averages and standard deviations were calculated. - Evaluation criteria:
- Test substance is considered negative if:
- None of the tested concentrations or sampling times showed a statistically significant (p < 0.05) increase in the incidence of micronuclei neither in the combined data for both sexes nor in the data for male or female groups alone.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei: no.
- Statistical evaluation: incidence of micronuclei in the control animals was found to be in the range of historical data of the performing laboratory. Positive control showed a statistical significant increase in the number of micronuclei.
Any other information on results incl. tables
Mean number of micronuclei
Sex | Group | Treatment | Dose [mg/kg b.w.] | Sampling time [h] | Micronuclei no. per 1000 polychromatic erythrocytes | Ratio polychromatic / normochromatic erythrocytes | ||
Mean | SD | Mean | SD | |||||
M | A | Vehicle | - | 24 | 0.0 | 0.0 | 1.50 | 0.27 |
B | Vehicle | - | 48 | 0.0 | 0.0 | 1.27 | 0.44 | |
C | Vehicle | - | 72 | 0.0 | 0.0 | 1.31 | 0.17 | |
D | Test item | 4000 | 24 | 0.0 | 0.0 | 1.46 | 0.89 | |
E | Test item | 4000 | 48 | 0.6 | 0.9 | 1.06 | 0.16 | |
F | Test item | 4000 | 72 | 0.0 | 0.0 | 1.64 | 0.45 | |
G | Positive control | 50 | 48 | 8.6 | 2.1 | 0.44 | 0.12 | |
F | A | Vehicle | - | 24 | 0.0 | 0.0 | 2.23 | 0.86 |
B | Vehicle | - | 48 | 0.4 | 0.9 | 1.94 | 1.45 | |
C | Vehicle | - | 72 | 0.0 | 0.0 | 1.38 | 0.40 | |
D | Test item | 4000 | 24 | 0.2 | 0.4 | 1.33 | 0.77 | |
E | Test item | 4000 | 48 | 0.2 | 0.4 | 1.39 | 0.41 | |
F | Test item | 4000 | 72 | 0.0 | 0.0 | 1.26 | 0.21 | |
G | Positive control | 50 | 48 | 8.0 | 0.7 | 0.40 | 0.11 |
Applicant's summary and conclusion
- Conclusions:
- The test substance can be considered as not mutagenic in the Mouse Micronucleus Test, under the experimental conditions of the test.
- Executive summary:
The substance was tested in the Micronucleus Test in mice, according to the method and procedures outlined into the OECD guideline 474. Three groups, each comprising 5 males and 5 females, received a single oral dose of 4000 mg/kg body weight. Bone marrow was sampled at 24, 48 and 72 hours after dosing. Corresponding vehicle treated groups served as negative controls. Bone marrow from a positive control group, treated with a single oral dose of cyclophosphamide (CP) at 50 mg/kg body weight, was harvested at 48 hours after dosing only. The test substance was found to respond negatively in the Micronucleus Test, whereas the positive control substance (CP) produced a statistically significant increase in the incidence of micronuclei in polychromatic erythrocytes.
Conclusion
The test substance can be considered as not mutagenic in the Mouse Micronucleus Test, under the experimental conditions of the test.
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