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Diss Factsheets
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EC number: 205-553-3 | CAS number: 142-71-2
- 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 somatic cell study: cytogenicity / erythrocyte micronucleus
- 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 Authorities for Biocides and Existing Substance Regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- Cited as Directive 2000/32/EC, B.12
- Deviations:
- yes
- Remarks:
- Following test termination, test animals were sacrificed and bone marrow extracted from both femurs of each test animal. However with one test animal (2338) only one femur was aspirated.
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
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: 338 mg/kg
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River, UK Ltd, Margate, UK
Age/weight at test initiation: Ages ranged from 35-42 days for both males and females. Bodyweight ranged from 24-30 g and 21-26 g for males and females respectively.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Vehicle used: Purified water.
Total volume applied: 20ml/kg. - Frequency of treatment:
- Two applications with an interval of 24 hours.
- Post exposure period:
- Test animals were sacrificed at either 24 or 48 hours following the second dose administration.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
447 mg/kg
Basis:
- No. of animals per sex per dose:
- Number of animals per group: 15 males and 15 females were treated with the test substance (this includes and additional 5 mice per sex to be used in the event of deaths among similarly dosed animals), 10 males and 10 females were treated with the negative control and 5 males and 5 females were treated with the positive control.
- Control animals:
- yes
- Positive control(s):
- Controls: Cyclophosphamide (CPA) was dissolved in purified water at 4 mg/ml to serve as a positive control, and administered at 80 mg/kg with a dose volume of 20 ml/kg. The positive control was administered as a single dose. The negative control was purified water administered twice at the same sampling points as the test substance.
Examinations
- Tissues and cell types examined:
- Erythrocytes in bone marrow.
- Evaluation criteria:
- Parameters analysed: polychromatic/normochromatic erythrocytes ratio.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- See additional information on results.
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Clinical signs: Not reported.
Tissue examination: Mice treated with copper II sulphate pentahydrate exhibited polychromatic/normochromatic erythrocytes (PCE/NCE) ratios which were decreased compared to concurrent vehicle controls at 24 hour sampling point. This is indicative of cellular toxicity and evidence of the test substance penetration into the bone marrow. Mice sampled at 48 hours after being treated with copper II sulphate pentahydrate exhibited ratios which were similar to those in the vehicle controls. The number of micronucleated PCE seen at both sampling times were similar to those seen in the controls and were not significantly different by x2 analysis.
The positive control induced a statistically significant increase in the frequency of micronucleated polychromatic erythrocytes.
See Table 1.
Any other information on results incl. tables
Table 1. Summary of Group Mean Data.
Treatment group (mg/kg x2) |
Sampling point (hours) |
Sex |
Mean ratio PCE/NCE |
Group mean frequency of micronucleated PCE (per 1000) |
|
Per sex |
Per treatment group |
||||
Vehicle control (purified water) |
24 |
Male |
1.07 |
0.40 |
0.35 |
Female |
1.20 |
0.30 |
|||
48 |
Male |
1.44 |
0.38 |
0.33 |
|
Female |
0.83 |
0.30 |
|||
447 (copper sulphate pentahydrate) |
24 |
Male |
0.70 |
0.60 |
0.50 |
Female |
0.84 |
0.40 |
|||
48 |
Male |
1.12 |
0.50 |
0.45 |
|
Female |
1.32 |
0.40 |
|||
Positive control (CPA – single dose only) |
24 |
Male |
0.52 |
26.87 |
28.07 |
Female |
0.48 |
29.27 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
It is concluded that copper II sulphate pentahydrate did not induce micronuclei in the polychromatic erthrocytes of the bone marrow of mice treated at 447 mg/kg/day, a dose at which limited mortality was observed. The test substance was therefore not genotoxic. - Executive summary:
Copper II sulphate pentahydrate was assayed in vivo in a mouse bone marrow micronucleus test at a single dose level of 447 mg/kg (113.76 mg Cu/kg) for two consecutive days to groups of 5 male and 5 female mice sacrificed 24 or 48 hours after the second administration. Both negative (purified water) and positive controls (cyclophosphamide) were included in the study. The study was conducted according to EEC Annex V test B12 guidelines and in compliance with GLP.
Mice treated with copper II sulphate pentahydrate exhibited frequencies of micronucleated polychromatic erthrocytes which were similar to vehicle controls at all sampling times. There were no instances of statistically significant increases in micronucleus frequency for any group receiving the test chemical at either sampling point.
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