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EC number: 215-572-9 | CAS number: 1332-65-6
- 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
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Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Already evaluated by the Competent Authority for Biocides.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- Deviations:
- no
- Principles of method if other than guideline:
- The study was not conducted in accordance with any internationally recognised guidelines. However, the methods employed in the study are comparable to OECD Guidelines 486 "Genetic Toxicology: DNA Damage and Repair/Unscheduled DNA Synthesis in Mammalian Cells in vivo".
See Other information on materials and methods.
METHODOLOGY Copper II sulphate pentahydrate was tested using an in vivo/in vitro assay for its ability to cause repairable DNA damage in cultured primary rat hepatocytes. Repair was measured as unscheduled DNA synthesis (UDS) by the uptake of radio-labelled thymidine assayed autoradiographically. The test method follows the techniques described by; Mirsalis, J.C. and Butterworth, B.E., 1980. Detection of unscheduled DNA synthesis in hepatocytes isolated from rats treated with genotoxic agents: An in vivo - in vitro assay for potential mutagens and carcinogens. Carcinogenesis, 1: 621 - 625. Ashby, J., Lefevre P.A., Burlinson, B. and Penman, M.G., 1985. An assessment of the in vivo rat hepatocyte DNA-repair assay. Mutation research, 156: 1-18. - GLP compliance:
- yes
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- Copper sulphate
- EC Number:
- 231-847-6
- EC Name:
- Copper sulphate
- Cas Number:
- 7758-98-7
- Molecular formula:
- CuSO4
- IUPAC Name:
- Copper(II) sulfate
- Reference substance name:
- Cu2+ as Copper Sulphate Pentahydrate
- IUPAC Name:
- Cu2+ as Copper Sulphate Pentahydrate
- Details on test material:
- Lot/batch number: A668269 350
Description: blue crystalline substance
Purity: 99-100.5 %
Stability: Stable at room temperature
Maximum tolerable dose: <2000 mg/kg
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Source: Charles River UK Ltd, Margate, UK
Sex: Male
Age/weight at study initiation: Test animals were 41-51 days old with a bodyweight range of 189-254 g.
Number of animals per group: 6 animals
Control animals: Yes
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Vehicle: purified water
Concentration in vehicle: Not reported
Total volume applied: 10 ml/kg
Positive controls were administered in corn oil or purified water (see Positive controls below). - Duration of treatment / exposure:
- Animals were sacrificed either 12-14 hours (experiment 1) or 2-4 hours (experiment 2) after dosing.
- Frequency of treatment:
- Number of applications: 1
Interval between applications: Not applicable - Post exposure period:
- Postexposure period: 12-14 hours for Experiment 1, 2-4 hours for Experiment 2
Doses / concentrations
- Remarks:
- Doses / Concentrations:
632.5 or 2000 mg/kg
Basis:
actual ingested
- Control animals:
- yes
- Positive control(s):
- Purified water was used as the negative control.
7.5 mg/ml 2-Acetamidofluorene (2-AAF) suspended in corn oil was the positive control for the 12-14 hour experiment.
1.0 mg/ml dimethylnitrosamine (DMN) dissolved in purified water was used as the positive control for the 2-4 hour experiment.
Both positive controls were dosed at 10 ml/kg giving achieved doses of 75 mg/kg and 10 mg/kg for the 12-14 and 2-4 hour experiments respectively.
See Table 1 for summary of administered doses.
Examinations
- Tissues and cell types examined:
- Hepatocytes from the liver.
- Details of tissue and slide preparation:
- Preparation of hepatocyte cultures:
After either 12-14 hours or 2-4 hours after dosing, animals were sacrificed and their livers perfused with collagenase to provide a primary culture of hepatocytes. Cultures were made from 5 animals in each group and were treated with [3H] thymidine. Six slides were prepared with fixed hepatocytes and of these, 3 were dipped in photographic emulsion to prepare autoradiograms. Slides were examined microscopically after development of the emulsion and staining, and the net grain count, the number of grains present in the nucleus minus the mean number of grains in 3 equivalent areas of cytoplasm, was determined for each of at least 2 of the 3 slides, each animals and dose group.
Number of animals: Cultures from 5 animals were taken.
Number of cells: 150,000 viable cells/ml
Time points: 12-14 hours in Experiment 1, 2-4 hours in Experiment 2. - Evaluation criteria:
- The net grain count, number of grains present in the nucleus minus the mean number of grains in 3 equivalent areas of cytoplasm were determined.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Clinical signs: Not reported.
Tissue examination: Treatment with copper II sulphate pentahydrate at doses up to 2000 mg/kg yielded group mean net grain counts of less than 0, producing group mean net grain counts over the 2 experiments in the range of -1.0 to -3.2, well below the value of 5 net grain counts required for a positive response. No more than 1.0% of the cells were seen in repair at any dose of test substance.
The data obtained indicate that oral treatment of male rats with 632.5 or 2000 mg/kg copper II sulphate pentahydrate did not result in increased unscheduled DNA synthesis in hepatocytes isolated approximately 12-14 or 2-4 hours after dosing.
The positive control chemicals (2-AAF and DMN) induced increases in the group mean net grain count of 5 or more (12.7 and 17.2 respectively), and 50% or more of the cells (90% and 99.6% respectively) had net grain counts of 5 or more. This result showed that the test system was sensitive to 2 known DNA damaging agents requiring metabolism for their action and that the experiment was valid.
The group mean net grain count for the vehicle-treated animals was less than 0 (-1.3 and -2.2 or Experiments 1 and 2 respectively).
For further information on results, please refer to Table 2a and Table 2b.
Genotoxic: No
Any other information on results incl. tables
Table 2a. Summary of Results.
Experiment 1: 12-14 hour sacrifice time.
Dose (mg/kg) |
Net Nuclear Grain Count |
Net Grain Count of Cells in Repair |
Percent of Cells in Repair (Net Grain Count ≥5) |
|||
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
0 water |
-1.3 |
0.6 |
0 |
- |
- |
- |
632.5 Copper II sulphate pentahydrate |
-1.3 |
0.3 |
10.2 |
6.4 |
0.6 |
0.9 |
2000 Copper II sulphate pentahydrate |
-1.0 |
0.3 |
5.5 |
0.9 |
1.0 |
1.0 |
75 2-AAF |
12.7 |
0.9 |
13.7 |
0.8 |
90.0 |
4.0 |
Table 2b. Summary of Results.
Experiment 2: 2-4 hour sacrifice time.
Dose (mg/kg) |
Net Nuclear Grain Count |
Net Grain Count of Cells in Repair |
Percent of Cells in Repair (Net Grain Count ≥5) |
|||
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
0 water |
-2.2 |
0.3 |
0 |
- |
- |
- |
632.5 Copper II sulphate pentahydrate |
-2.2 |
0.2 |
0 |
- |
- |
- |
2000 Copper II sulphate pentahydrate |
-3.2 |
0.5 |
0 |
- |
- |
- |
10 DMN |
17.2 |
2.8 |
17.3 |
2.9 |
99.6 |
0.9 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Treatment with 632.5 or 2000 mg/kg copper II sulphate pentahydrate did not produce a group mean net grain count greater than -1.0 nor were any more than 1.0% cells found in repair at either dose.
It was concluded that copper II sulphate pentahydrate has no genotoxic activity detectable in this test system under the
experimental conditions employed. - Executive summary:
Materials and Methods
Copper II sulphate pentahydrate was tested for its ability to induce unscheduled DNA synthesis (UDS) in the livers of orally dosed male rats using an in vivo/in vitro procedure. Groups of 6 male rats were treated once with copper sulphate at 632.5 or 2000 mg/kg by oral gavage at a dose volume of 10 ml/kg. For the negative control, a further 6 male rats received purified water as a negative control at the same dose volume. Positive control animals for the 12-14 hour experiment, 6 male rats were dosed orally with 75 mg/kg 2 -acetamidofluorene, suspended in corn oil. Dimethylmitrosamine, dissolved in purified water, was the positive control for the 2-4 hour experiment.
Approximately 12-14 hours (experiment 1) or 2-4 hours (experiment 2) after dose administration the animals were sacrificed and the livers perfused with collagenase to provide a primary culture of hepatocytes. The net grain count, number of grains present in the nucleus, minus the mean number of grains in 3 equivalent areas of cytoplasm were determined.
Results and Discussion
Negative control animals gave a group mean net grain of less than 0 with no cells in repair. Group mean net grain values were increased by both positive controls to more than 5 with more than 50% of cells found to be in repair. This was consistent with historical control data.
Treatment with 632.5 or 2000mg/kg copper sulphate pentahydrate (equivalent to 161 or 509 mg Cu/kg) did not produce a group mean net grain value greater than -1.0 nor were any more than 1.0% cells found in repair at either dose.
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