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Diss Factsheets
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EC number: 938-868-6 | 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:
- genetic toxicity in vivo
- Remarks:
- Type of genotoxicity: other: chromosome and genome mutations
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The Scientific Committee on Occupational Exposure Limits (SCOEL) is is a committee of the European Commission.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Recommendation from the Scientific Committee on Occupational Exposure Limits for Copper and its inorganic compounds. SCOEL/SUM/171 March 2013
- Author:
- SCOEL
- Year:
- 2 013
- Bibliographic source:
- Scientific Committee on Occupational Exposure Limits; DRAFT for consultation March-September 2013. Employment, Social Affairs & Inclusion (EC); Ref. Ares(2013)340506 - 15/03/2013
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The evaluation is based on the results of in vivo studies in mice.
- GLP compliance:
- not specified
- Remarks:
- not applicable (it is a review)
- Type of assay:
- other: chromosome aberration assay and micronucleus tests
Test material
- Reference substance name:
- Copper
- EC Number:
- 231-159-6
- EC Name:
- Copper
- Cas Number:
- 7440-50-8
- IUPAC Name:
- copper(1+)
- Details on test material:
- - Copper
Constituent 1
Results and discussion
Test resultsopen allclose all
- Sex:
- not specified
- Genotoxicity:
- positive
- Remarks:
- chromosomal aberrations (chromatid type) and increase of chromosomal breaks at 1.1–6.6 mg Cu/kg bw in Albino mice
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Sex:
- not specified
- Genotoxicity:
- positive
- Remarks:
- chromosomal aberrations (chromatide gaps) in Swiss mice at 1.3–5 mg Cu/kg bw (i.p given as a single dose or in five daily doses; oral or s.c.); increase in micronuclei (i.p)
- Toxicity:
- yes
- Remarks:
- there were signs of cytotoxic effects at all doses.
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Sex:
- not specified
- Genotoxicity:
- positive
- Remarks:
- increased rate of micronuclei in BALB/c mice (twice i. p. at 14-hour intervals)
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Sex:
- male/female
- Genotoxicity:
- positive
- Remarks:
- micronuclei in bone marrow cells of CF1 mice gavaged for six consecutive days
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Sex:
- male
- Genotoxicity:
- positive
- Remarks:
- DNA single-strand breaks by the comet assay in leukocytes from Swiss albino mice (oral, 4.9 mg Cu/kg bw)
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Sex:
- male/female
- Genotoxicity:
- positive
- Remarks:
- DNA single-strand breaks, detected by the comet assay; induced in blood cells of Swiss Webster mice (oral)
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Sex:
- not specified
- Genotoxicity:
- negative
- Remarks:
- no increase in micronuclei in CBA mice exposed to single i.p. dose of 1.7–5.1 mg Cu/kg bw (copper sulphate pentahydrate)
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Single intraperitoneal injection of copper sulphate pentahydrate to Albino mice induced a significant and dose-related increase in chromosomal aberrations (chromatid type) at doses of 1.1–6.6 mg Cu/kg bw. There was also an increase of chromosomal breaks at the highest dose (Agarwal et al 1990).
A study by Bhunya and Pati (1987) reported an increase in chromosomal aberrations (chromatide gaps) in Swiss mice, which were intraperitoneally injected in single doses of 1.3–5 mg Cu/kg bw as copper sulphate, either given as a single dose or in five daily doses. Further studies were carried out with single doses of 5.1 mg Cu/kg bw by the oral or subcutaneous route. All exposures resulted in significant increases in chromosomal aberrations. In the mice dosed once intraperitoneally, the effect was dose-dependent. In parallel studies with the same strain of mice, these authors also reported a significant and dose-dependent increase in the incidence of micronuclei after two intraperitoneal injections (24 hours apart) of doses of 1.3–5 mg Cu/kg bw and day as copper sulphate. The authors used no positive controls and there were signs of cytotoxic effects at all doses.
A significant and dose-dependently increased rate of micronuclei was also reported in a study by Rusov et al (1997). These authors exposed BALB/c mice twice intraperitoneally at 14-hour intervals to copper acetate at doses of 0.3–13.0 mg Cu/kg bw. Male and female CF1 mice were gavaged for six consecutive days with CuSO4 (8.25 mg Cu/kg bw and day). This dose regimen induced micronuclei in bone marrow cells and was genotoxic when evaluated in the neutral and the alkaline version of the comet assay in whole blood (Prá et al 2008). Data on cytotoxic effects on bone marrow were not given. Saleha et al (2004) also detected DNA single-strand breaks by the comet assay in leukocytes from male Swiss albino mice administered orally up to 4.9 mg Cu/kg bw as copper sulphate. The trypan blue exclusion technique showed a cell viability ranging from 90–95 %. DNA single-strand breaks, detected by the comet assay (Franke et al 2006), were also induced in blood cells from male and female Swiss Webster mice after oral administration of copper sulphate (8.50 Cu mg/kg bw). In contrast to these findings, Tinwell and Ashby (1990) did not observe an increase in micronuclei following a single intraperitoneal injection of copper sulphate pentahydrate at doses of 1.7–5.1 mg Cu/kg bw to CBA mice.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): ambiguous
Copper sulphate (degree of hydratation is not specified) induced chromosomal aberrations, breaks and increase in micronuclei in mice of different strains, while inconsistent data are available on copper sulphate pentahydrate. - Executive summary:
Copper sulphate compounds (degree of hydratation is not specified) induced chromosomal aberrations, breaks and increase in micronuclei in mice of different strains. On contrary, copper sulphate pentahydrate induced an increase in chromosomal aberrations (chromatid type) and chromosomal breaks in Albino mice treated intraperitoneally, while no increase in micronuclei following a single intraperitoneal injection was observed in CBA mice.
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