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EC number: 232-167-2 | CAS number: 7789-45-9
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- EU RISK ASSESSMENT - [COPPER, COPPER II SULPHATE PENTAHYDRATE, COPPER(I)OXIDE, COPPER(II)OXIDE, DICOPPER CHLORIDE TRIHYDROXIDE] CAS [7440-50-8, 7758-99-8, 1317-39-1, 1317–38–0, 1332-65-6] CHAPTER 4.1.2. HUMAN HEALTH - EFFECTS ASSESSMENT
- Author:
- RAPPORTEUR: ITALY
- Year:
- 2 007
- Bibliographic source:
- European Copper Institute
Materials and methods
Test material
- Reference substance name:
- Copper
- EC Number:
- 231-159-6
- EC Name:
- Copper
- Cas Number:
- 7440-50-8
- Molecular formula:
- Cu
- IUPAC Name:
- copper
1
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Results of a two-generation reproduction toxicity test in rats, conducted in accordance with Annex V and OECD guidelines, showed no treatment-related effects on reproductive parameters in either the parental generation or offspring associated with a diet containing copper sulphate. The NOAEL for reproductive toxicity in this study was 1500 ppm dietary copper sulphate pentahydrate (equivalent to 381 ppm copper), the highest concentration tested.
It is noted that the NOAEL of 250 ppm Cu for reduced spleen weight is consistent with the NOAEL for repeated dose toxicity reported by Hébert et al (1993) (see Section 4.1.2.6.1).
Additional useful data on fertility have been provided by a repeated exposure dietary study (Hébert 1993). This study showed that consumption of copper, as copper sulphate, at up to and including 68 mg Cu/kgBW/day in rats and 536 mg Cu/kgBW/day in mice for 13 weeks had no effect on male reproductive organ weights, spermatid or spematozoal measurements, oestrous cycle length or proportion of oestrous cycle spent in each stage. Effects on other reproductive parameters were not examined in this study.
Several animal studies have been published which have investigated developmental toxicity of copper compounds. Only one of these studies, conducted by Munley (2003a), conforms to recommended test methods (Annex V Test Guideline B.31; OECD Tets Guideline 414) and currently this provides the most reliable data on the developmental toxicity of copper. The findings of this study showed that developmental effects in rabbits, namely increased occurrence of a common skeletal abnormality, were only apparent at doses of copper hydroxide which caused maternal toxicity as indicated by initial weight loss and inappetance. There were no indications of fetal abnormalities associated with treatment at up to maternally toxic levels. The NOAEL for maternal toxicity and developmental effects in rabbits in this test was 6 mg Cu/kgBW/day. Effects on the fetus were considered to be secondary to maternal toxicity and thus not a specific effect of copper on reproduction. Maternal toxicity in this study was considered to be a local effect on the stomach resulting from gavage administration and consequently provides no basis for deriving a NOAEL for repeat-dosing toxicity.
Other studies investigating developmental effects in animals have significant deficiencies in methodology and/or reporting. In some of the studies which showed developmental effects, there was clear evidence of maternal toxicity; in other studies, maternal toxicity could not be ruled out. Consequently, these studies provide little useful information concerning the developmental effects of copper compounds which are relevant to human risk assessment.
Investigations of the effects of copper-containing IUDs on foetal development and other reproductive parameters in animals have failed to demonstrate any effects which could be associated with exposure to copper.
The available data concerning reproductive effects of copper in humans are sparse. Of the four human studies which have been reviewed here, two have major deficiencies which make the reliability of their findings uncertain. The remaining two studies, both drinking water studies, failed to demonstrate any association between copper levels in drinking water and adverse pregnancy outcome.
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