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Diss Factsheets
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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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- 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:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- The method also addressed the following guidelines:
EC Directive 2000/32 Annex V Test B14
UKEMS Guidelines - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation 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
- Test material form:
- solid
- Details on test material:
- Lot/batch number: A668269 350
Description: Blue crystalline solid
Purity: 99.0 - 100.5%
Stability: Stable at room temperature
Constituent 1
Constituent 2
Method
- Target gene:
- See evaluation criteria.
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium Strains TA98, TA100, TA1535, TA1537, TA102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver (Sprague-Dawley male rat) post-mitochondrial fraction (S-9 mix)
- Test concentrations with justification for top dose:
- 1.6, 8, 40, 200, 1000 µg/plate and 50, 100, 200, 400, 800 µg/plate in mutation experiments 1 and 2, respectively.
- Vehicle / solvent:
- None.
- Details on test system and experimental conditions:
- Study type: Ames test.
Positive control: Details of the positive controls are in Table 1.
Negative control: Yes, tests carried out with purified water in quintuplicate both with and without metabolic activation.
Administration/Exposure; Application of test substance:
Concentrations: Following a range finding study, two experiments were carried out with concentrations of 1.6, 8, 40, 200 and 1000 µg/l in experiment one and 50, 100, 200, 400 and 800 µg/l in experiment two. The tests were carried out in triplicate.
Way of application: The test article was dissolved in sterile purified water.
Pre-incubation time: Only Experiment two included a pre-incubation step for the tests with metabolic activation. The test substance (or control substance), bacteria and S-9 mix were mixed together and incubated for 1 hour at 37 °C before the addition of 2.5 ml molten agar at 46 °C. Plating of these treatments then proceeded as for normal plate-incorporation procedure.
Examinations:
Number of cells evaluated: Colonies were counted electronically using a Seescan Colony Counter and the background lawn inspected for signs of toxicity. - Evaluation criteria:
- With the exception of strain TA102, these strains require biotin as well as histidine for growth. In strain TA102 the critical mutation in the histidine gene is located on a multicopy plasmid pAQ1. This strain is particularly sensitive to the activities of oxidative and cross-linking mutagens. The pKM101 plasmid derivatives (TA98, TA100 and TA102) have increased sensitivity to certain mutagens as the pKM101 codes for an error-prone DNA repair system.
- Statistics:
- The m-statistic was calculated to check that all the data were Poisson-distributed, and the Dunnett's test was used to compare the counts of each dose with the control. The presence or otherwise of a dose response was checked by linear regression analysis.
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium Strains TA98, TA100, TA1535, TA1537, TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- See additional information on results.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Evidence of genotoxicity: There was no evidence of genotoxicity observed in either Experiment 1 or Experiment 2 in the presence or absence of metabolic activation.
Cytotoxicity: Evidence of toxicity was observed in all Experiment 1 treatments of 1000 µg/plate. Some evidence of toxicity was also observed following strain TA102 treatments of 200 µg/plate in the presence of S-9 only. In Experiment 2, toxicity was observed following all treatments (with and without metabolic activation) of 800 µg/plate. Some treatments in the presence of S-9 at lower doses also produced evidence of toxicity. The higher degree of toxicity observed with Experiment 2 treatments of S-9 was attributed to the use of a pre-incubation step, which allowed an enhanced exposure of the bacteria to the test article. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It was concluded that copper II sulphate pentahydrate was unable to induce mutation in 5 strains of S. typhimurium, when tested at concentrations extending into the toxic range, in the absence and presence of a rat liver metabolic activation system (S-9 mix). - Executive summary:
Materials and Methods
Copper II sulphate pentahydrate was assayed for mutation in 5-histaidine requiring strains (TA98, TA100, TA1537 and TA102) of Salmonella typhimurium, both in the presence and absence of metabolic activation by Aroclor 1254 -induced rat liver post-mitochondrial fraction (S-9) in 2 separate experiments. Following a range finding study, two experiments were carried out with concentrations of 1.6, 8, 40, 200 and 1000 µg/l in experiment one and 50, 100, 200, 400 and 800 µg/l in experiment two. The tests were carried out in triplicate. Both positive and negative controls were included.
The study complied with the following guidelines and was conducted in accordance with GLP:
OECD Guidelines 471
EC Directive 2000/32 Annex V Test B14
UKEMS GuidelinesResults and discussion
None of the dose concentrations in any of the test strains in either the absence or presence of S-9 resulted in an increase in revertant numbers that were statistically significant at the 1% level when analysed using a Dunnett’s test. It was therefore concluded that copper II sulphate pentahydrate was unable to induce mutation in 5 strains ofS. typhimurium, when tested at concentrations extending to the toxic range, in both the absence and presence of rat liver metabolic activation system.
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