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Diss Factsheets
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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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 406 and EU Method B.6 The test material has no batch number and no information on purity nor particle size distribution.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study was performed (ad assesed) before the 2016 change in the ECHA Guidance
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Source: sighting animals were received from David Hall Limited, Burton-on-trent, Staffordshire, UK. Main study animals were received from Harlan UK Ltd., Blackthorn, Bicester, Oxon, UK.
At the start of the main study the animals weighed 340 to 436g and were approximately eight to twelve weeks old.
6 sighting animals, 10 test animals and 5 control animals - Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction: 0.1 % w/w in arachis oil BP.
Topical induction: 50% w/w in arachis oil BP
Topical challenge: 50 and 25% w/w in arachis oil BP - Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction: 0.1 % w/w in arachis oil BP.
Topical induction: 50% w/w in arachis oil BP
Topical challenge: 50 and 25% w/w in arachis oil BP - No. of animals per dose:
- 10
- Details on study design:
- Day 0: intradermal induction
Day 7: topical induction
Day 21: topical challenge
scoring: 24 and 48h after challenge - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
- Positive control results:
- Non-concurrent positive control studies with 2 -mercaptobenzothiazole, showing 90 -100 % incidence of sensitisation, confirmed the sensitivity of this assay
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no skin reactions were noted at the challenge sites of the control group animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 % w/w. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no skin reactions were noted at the challenge sites of the control group animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no skin reactions were noted at the challenge sites of the control group animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0% w/w. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no skin reactions were noted at the challenge sites of the control group animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reactions were noted at the challenge sites of the test group animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin reactions were noted at the challenge sites of the test group animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reactions were noted at the challenge sites of the test group animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin reactions were noted at the challenge sites of the test group animals.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material corresponds to the composition of “coated copper flakes” . Under the conditions of this test, copper powder produced a 0% (0/10) sensitisation rate. The test material did not meet the criteria for classification as a sensitiser by skin contact according to labelling regulations outlined in Annex VI of Commission Directive 2001/59/EC
- 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).
Under the conditions of this test, the test material produced a 0% (0/10) sensitisation rate.
Copper powder did not meet the criteria for classification as a sensitiser by skin contact according to labelling regulations outlined in Annex VI of Commission Directive 2001/59/EC
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Available animal data on the skin sensitisation properties of copper (II) oxide and copper coated flakes have been considered against EU classification criteria as contained in Annex VI of Directive 67/548/. The available animal data do not meet the criteria requiring these substances to be classified for skin sensitisation. Considering the lower solubility and bioaccessability of copper powders compared to copper oxides and copper flakes, the data are read-across to copper (powders and massive forms) do not require classification for skin sensitisation.
With regard to sensitisation by inhalation, in the absence of relevant human or animal data, there is no basis for classification of copper substances covered by this Risk Assessment for respiratory sensitisation.
Migrated from Short 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). The data on coated copper flakes and copperoxide were retained for the CSR
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
Justification for selection of skin sensitisation endpoint:
Several studies used in WoE.
The studies, retained in weight of evidence approach, were already evaluated by competent authorities on existing substances and biocides
Justification for classification or non-classification
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.
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