Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-159-6 | CAS number: 7440-50-8
- 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
Several high quality criteria studies (reliability 1 or 2) on several copper compounds and copper are available from the VRAR (2008). Studies on coated copper flakes and CuO were retained.
The VRAR, 2008 provides additional lower quality studies as well as studies specific to other soluble copper compounds. If not pivotal to this copper REACH dossier, they are described in the copper VRAR (2008) but not further discussed in this CSR.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo for skin irritation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline 404 and EU method B.4 The test material has no batch number and no information on purity nor particle size distribution.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
At the start of the study the animals weighed 2.77 to 3.08 kg and were 12 to 16 weeks old. - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: distilled water
- Controls:
- no
- Amount / concentration applied:
- concentration in vehicle: 50% w/v
total volume applied: ca. 1ml - Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3: 2 females and 1 male
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant. no skin irritation was noted in this study
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant. no skin irritation was noted in this study
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant. no skin irritation was noted in this study
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant. no skin irritation was noted in this study
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant. no skin irritation was noted in this study
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant. no skin irritation was noted in this study
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material corresponds to the composition of “ copper coated flakes” .
A single 4hr, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation. - Executive summary:
The test material identity was not provided in details. Considering the information from the reports on the same material, the tested material falls in the composition category of "coated copper flakes", consistent with a biocidal product use (PBD notification was the reason for doing the test).
A single 4hr, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation.In this study, copper powder does not meet the criteria for classification for dermal irritation according to Annex VI of Commission Directive 2001/59/EC
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo for eye irritation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD Guideline 405 and EU Method B.5 The test material has no batch number and no information on purity nor particle size distribution.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
At the start of the study the animals weighed 2.0 to 3.5 kg and were 12 to 16 weeks old. - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL (approximately 72 mg).
- Duration of treatment / exposure:
- the test material was placed into the conjuctival sac of the right eye. The upper and lower lids were held together for ca. 1 second after treatment.
Apparently eyes were not rinsed. - Observation period (in vivo):
- Up to 14 days
- Number of animals or in vitro replicates:
- 3 per group (females)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72h
- Score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72h
- Score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72h
- Score:
- 1.7
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72h
- Score:
- 1.7
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72h
- Score:
- 1.7
- Reversibility:
- fully reversible within: 14 days
- Other effects:
- Clinical signs: copper-coloured staining of the eyelids and fur around the treated eye was noted in all animals during the study
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information however, not classified Criteria used for interpretation of results: EU
- Conclusions:
- Good quality study. The test material corresponds to the composition of “ coated copper flakes” . In this study the test material showed a slight potential to induce eye irritation. However, the material does not meet the criteria for classification for eye irritation according to Annex VI of Commission Directive 2001/59/EC
- Executive summary:
The test material corresponds to the composition of “coated copper flakes” . In this study the test material showed a slight potential to induce eye irritation. However, the material does not meet the criteria for classification for eye irritation according to Annex VI of Commission Directive 2001/59/EC
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
With regard to skin irritation, available animal data for copper (II) oxide and coated copper flakes do not require these substances to be classified as irritant. Considering the lower solubility and bioaccessability of copper powders compared to copper oxides and copper flakes, the data are read-across to (powders and massive forms) do not require classification for skin irritation.
With regard to eye irritation, available animal data for copper (II) oxide and coated copper powder indicated some slight eye irritation for the coated copper flakes but only the latter do require classification as irritant. Considering the lower solubility and bioaccessibility of copper powders compared to copper oxides and copper flakes, and the differences in shapes, no classification is proposed for copper powders.
Justification for selection of skin irritation / corrosion endpoint:
Several studies are used in WoE.
The studies, retained in weight of evidence approach, were evaluated by the competent authorities on existing substances and biocides
Justification for selection of eye irritation endpoint:
Several studies used in WoE.
The studies, retained in weight of evidence approach, were evaluated by competent authorities on existing substances and biocides.
Justification for classification or non-classification
Justification for classification/non classification:
RAC 2014 opinion on Sanders (2001d) for Coated copper flakes concludes on a mean scores per animal over the 24/48/72h time period are reported in the table below.
|
Cornealopacity |
Iritis |
Conjunctivalredness |
Conjunctivalchemosis |
Animal#1 Animal#2 Animal#3 |
0 1 2 |
0 0.67 1 |
1.67 1.67 2 |
0.67 1 1.67 |
The eye of animal#1 appeared normal on day7, the eyes of animals#2 and 3 on day14.By averaging the individual scores for all animals together,the dossier submitter arrived at mean scores of 1, 0.57, 1.8 and 1.13 for corneal opacity, iritis, conjunctivalredness and chemosis, respectively,and concluded that these were below the values requiring classification.
Coated copper flakes caused signs of irritation in the available eye irritation study. All effects were shown to be reversible within 21 days. Whereas the mean scores over 24-72 h were below the threshold values for classification for iritis, conjunctival redness and chemosis (≥1, ≥2 and ≥2, respectively), the mean score for corneal opacity over 24-72 h was at or above the threshold value for classification (≥1) in 2 of the 3 tested animals. The mean score over all three animals (1) was also at this threshold value. RAC therefore concludes that coated copper flakes fulfilled the criteria for classification and that it should therefore be classified as Eye Irrit. 2 – H319.
For copper (II) oxide, RAC 2014 concluded that there was no need for classification.
Copper powders differ from coated copper flakes on basis of their (bio availability) solubility pattern and their shapes (ie no blade-type edages) than coated copper flakes. No classification for copper powder is therefore proposed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.