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EC number: 233-279-4 | CAS number: 10102-90-6
- 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
Endpoint summary
Administrative data
Description of key information
The pivotal repeated dose study was a 90-day study by the oral route with copper sulphate pentahydrate. In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound. The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed. The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats. This is the pivotal study and the NOAEL of 16.7 mg Cu/kg bw/day will be used in the risk characterisation.
The inhalation study LOEC is 0.2 mg cuprous oxide/m3, as (non-adverse) effects were seen at this dose. The study NOAEC is >= 2 mg/kg cuprous oxide/m3, the highest dose level tested and based on the lack of findings in the lung weight ratio.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
For further information please refer to read across justification in IUCLID section 13. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects at this concentration (NOAEL).
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 2 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- histopathology: non-neoplastic
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 2 000 ppm
- System:
- gastrointestinal tract
- Organ:
- kidney
- liver
- stomach
- Treatment related:
- yes
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 16.7 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- This study is considered to be a reliability 2 study as it has been conducted on an analogous substance and to a method similar to EU Method B.46 and under the conditions of GLP.
- System:
- gastrointestinal tract
- Organ:
- kidney
- liver
- stomach
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
For further information please refer to read across justification in IUCLID section 13. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- >= 2 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: The highest dose level tested and based on the lack of findings in the lung weight ratio.
- Dose descriptor:
- LOEC
- Effect level:
- 0.2 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Non-adverse effects were seen at this dose.
- Key result
- Critical effects observed:
- no
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 2 mg/m³
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The quality of the study is considered sufficient for assessment.
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
For further information please refer to read across justification in IUCLID section 13. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- >= 2 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: The highest dose level tested and based on the lack of findings in the lung weight ratio.
- Dose descriptor:
- LOEC
- Effect level:
- 0.2 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Non-adverse effects were seen at this dose.
- Key result
- Critical effects observed:
- no
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 2 mg/m³
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The quality of the study is considered sufficient for assessment.
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity
Read-across for the endpoint ‘repeated dose toxicity’ is justified on the following basis; CuPP is an inorganic ionic compound consisting of phosphate anions and copper cations. As phosphate is a natural component of bodily fluids and is not considered to be toxic the copper ion is considered to be the most relevant species for toxicological investigation.
Therefore, in order to minimise animal testing, the registrant has utilised available studies on copper sulphate and copper(I) oxide. This approach is supported by the fact that extensive investigations have shown that copper and copper compounds are considered equally or less bioavailable to a number of animal species when compared to copper sulphate, therefore the use of copper sulphate studies in determining the DNEL’s is justified on scientific grounds and will provide a worst-case for the risk assessment.
There are many studies in the public domain dealing with the repeat and chronic toxicity of copper compounds to several animal species. However, these studies did not meet the higher quality criteria (1 or 2) under the BPD quality criterion selection and will therefore not be used in the risk assessment and will not be described in this document. However, the VRAR, 2008 provides a full review of these studies and the discussion on the unsuitability/unacceptability of these studies, risk assessment. The studies summarised below have been identified as the pivotal studies in this Section
Non human information
The NTP study summarised above is considered to be the pivotal study for Cu2+ presented as copper sulphate pentahydrate and results in an NOAEL of 16.7 mg Cu /kg/bw/day in the rat. This study will be used in the subsequent calculation of the dermal DNEL.
A chronic study (>= 1 year) is not considered appropriate, as no serious or severe toxicity effects of particular concern were observed in the 90-day study for which the available evidence is adequate for toxicological evaluation and risk characterisation.
Repeated dose toxicity: dermal
This study is usually required when the dermal route of exposure is significant and the compound is known to be toxic by the dermal route and can penetrate through intact skin. The need to conduct this study with copper or copper compounds must therefore be considered not necessary as although the dermal route of exposure is the most significant route there is no evidence to indicate that copper or copper compounds can cause toxicity or indeed pass through intact skin at significant levels. Acute dermal toxicity studies showed no toxic effects up to and including the highest dose tested. In addition, CuPP does not induce a skin irritating effect facilitating penetration through the skin. Therefore an accurate and realistic determination of dermal toxicity can be derived from available sub-chronic oral exposure studies, permissible systemic copper levels and in vitro dermal penetration studies on copper and copper compounds.
Repeated dose: inhalation
A GLP-compliant 28 -day repeat-dose inhalation study was conducted in accordance with OECD Guideline 412, with the addition of a 13 -week recovery period and an evaluation of adaptation to test substance exposure (three intermediate time-points at week 0, week 1, and week 2). Further additional study endpoints were measurements of copper levels in lung tissue, lung lavage fluid, liver, brain, as well as wet/dry lung weight ratio and clinical chemistry and cytology of bronchoalveolar lavage fluid of all animals. The additional study endpoints were designed to aid in the interpretation of any test substance effects. The study resulted in the LOEL of 0.2 mg cuprous oxide/m3, as (non-adverse) effects were seen at this dose. The study NOAEL is >= 2 mg/kg cuprous oxide/m3, the highest dose level tested and based on the lack of findings in the lung weight ratio.
Justification for classification or non-classification
Specific target organ toxicity (CLP Regulation) – repeated exposure (STOT RE)
Summary and discussion of Specific target organ toxicity – repeated exposure
Chronic toxicity, oral:
The liver is the critical organ for copper. The high quality repeated dose study in rats (Hebert (1993) - rat ) is retained for assessing classification according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT-RE) –, oral. Classification criteria are not met since no severe adverse effects were observed at the guidance value, oral for a Category 1 classification of 10 mg/kg bw/day and at the guidance value for a Category 2 classification of 100 mg/kg bw/day. No classification required.
Subacute toxicity, inhalation:
No STOT classification is proposed from this study as none of the observed effects were considered severe enough to merit classification by the inhalation route.
Conclusions on classification and labelling
No classification as STOT-RE under regulation (EC) 1272/2008 (EU CLP) is proposed. No classification or SCLs are considered necessary.
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