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EC number: 215-582-3 | CAS number: 1333-22-8
- 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 germ cell study: cytogenicity / chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- GLP compliance:
- no
- Type of assay:
- mammalian bone marrow chromosome aberration test
Test material
- Test material form:
- solid
- Details on test material:
- - Source: Glaxo Laboratories India Ltd, India.
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Departmental Animal House, University of Calcutta
- Age at study initiation: 8- 10 weeks
- Weight at study initiation: 20 - 25g
- Assigned to test groups randomly: not stated
- Fasting period before study: No
- Housing:Polycarbonate cages at no more than 8 animals per cage.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 15%
- Air changes (per hr): Not stated
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Isotonic saline
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test substance was prepared in isotonic saline prior to dosing. - Duration of treatment / exposure:
- A single dose of test substance was administered by intraperitoneal injection and animals were killed at 6, 12 or 24 hours by cervical dislocation.
- Frequency of treatment:
- One treatment
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw (total dose)
- Remarks:
- Control
- Dose / conc.:
- 1.1 mg/kg bw (total dose)
- Dose / conc.:
- 1.65 mg/kg bw (total dose)
- Dose / conc.:
- 2 mg/kg bw (total dose)
- Dose / conc.:
- 3.3 mg/kg bw (total dose)
- Dose / conc.:
- 6.6 mg/kg bw (total dose)
- No. of animals per sex per dose:
- Six males per dose at each time point.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C at 1.5 mg/kg bw administered by intraperitoneal injection. The animals were killed at 6 hours after dosing.
Examinations
- Tissues and cell types examined:
- Bone marrow of both femurs from each animal.
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION:
Each bone marrow sample was washed twice in fixative and slides were prepared by flame drying, coded and stained in diluted Giemsa.
METHOD OF ANALYSIS:
All the slides were observed under oil immersion lens. 50 metaphase plates from each of the 6 animals per dose were scored, the selection being based on uniform staining quality, lack of overlapping chromosomes and chromosome number (40 ± 2). Individual types of aberrations (i.e., chromatid vs. chromosome gaps, breaks and rearrangements) were recorded separately. Data were evaluated as the per cent aberrant metaphase cells (excluding gaps) and as the number of aberrations per cell (excluding gaps). All aberrations were considered equal regardless of the probable number of breakage events involved.
- Statistics:
- A 1-tailed trend test was used to determine if a treatment-related increase occurred. A 2-way ANOVA test followed by Duncan's multiple range test was carried out to observe the significant differences, if any, amongst the different concentrations and sampling times on the clastogenicity.
The level of significance was established at P = 0.05 for all analyses.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- positive
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
The following table summarises the results of the test:
Chromosomal Aberrations
Exposure (hours) | Mitomycin C 1.5 mg/kg bw (Positive Control) |
Test Substance Dose Level (mg/kg bw) | |||||
0 | 1.1 | 1.65 | 2 | 3.3 | 6.6 | ||
Chromosome Aberrations (excluding gaps) | |||||||
6 | 0.077 | 0.017 | 0.053 | 0.06 | 0.073 | 0.067 | 0.1 |
12 | --- | 0.017 | 0.023 | 0.040 | 0.037 | 0.05 | 0.087 |
24 | --- | 0.01 | 0.037 | 0.047 | 0.047 | 0.040 | 0.05 |
% damaged cells with at least 1 aberration |
|||||||
6 | 7.667 | 1.670 | 5.330 | 6.000 | 7.330 | 6,670 | 10.00 |
12 | --- | 1.670 | 2.330 | 4.000 | 3.670 | 5.000 | 8.670 |
24 | --- | 3.670 | 4.670 | 4.670 | 4.670 | 4.000 | 5.000 |
Note: table is reproduced from CLH Report for Tribasic Copper Sulphate
Applicant's summary and conclusion
- Conclusions:
- The test substance gave a positive response and was considered to be a moderately clastogenic agent in mice in vivo.
- Executive summary:
Introduction
The in vivo clastogenic effect of the test substance on the bone marrow chromosomes of mice was investigate using a method similar to OECD 475 Mammalian Bone Marrow Chromosome Aberration Test.
Method
The test substance dissolved in isotonic saline, was administered by intraperitoneal injection to Swiss albino male mice at dose levels of 1.1, 1.65, 2.0, 3.3 and 6.6 mg/kg. Groups of six mice were killed at 6, 12 and 24 h after treatment for each dose. Prior to sacrifice the mice were injected with 4 mg/kg colchicine to inhibit mitosis. A positive control group of mice was treated with 1.5 mg/kg mitomycin C (a positive control article) and then animals killed after 6 h. Bone marrow smears were prepared by standard methods and 50 metaphases from each of the six animals from each group were scored for aberrations, excluding gaps.
Results
Treatment with the test substance at results in chromosome aberrations at all concentrations with the degree of clastogenicity directly related to concentrations use and indirectly to period of exposure. The clastogenic effect was maximal at six hours after treatment compared to 12 and 24 hours indicating an early onset of clastogenesis.
Conclusion
The test substance gave a positive response and was considered to be a moderately clastogenic agent in mice in vivo.
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