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EC number: 215-270-7 | CAS number: 1317-39-1
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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:
- 1 988
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- These deviations are not considered to have influenced the outcome or the integrity of the study:The relative humidity in the experimental animal room was 50-85% (and not 30-70% as recommended), Full details on dressing were not provided.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Cuprous oxide [Copper (I) oxide]
- IUPAC Name:
- Cuprous oxide [Copper (I) oxide]
- Reference substance name:
- Dicopper oxide
- EC Number:
- 215-270-7
- EC Name:
- Dicopper oxide
- Cas Number:
- 1317-39-1
- Molecular formula:
- Cu2O
- IUPAC Name:
- copper (I) oxide
- Details on test material:
- Cuprous oxide [Copper (I) oxide]
Lot/batch number: Not specified
Specification: No information was provided on the specification of the sample used in this study.
Description: Orage-brown fine powder.
Purity: Not specified
Stability: Not specified.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Crl.:(WI)BR-Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River Wiga, 8741 Sultzfeld, Germany.
Age/weight at study initiation: At the start of the study males weighed 211.2 to 232.5 g and females weighed 222.6 to 258.7 g. The age of the animals was not reported.
Administration / exposure
- Type of coverage:
- other: Unclear if bandage used was occlusive or semi-occlusive
- Vehicle:
- water
- Remarks:
- (sterile water)
- Details on dermal exposure:
- TEST SITE
Area of exposure: An area of 8 x 5 cm.
Type of wrap if used: ‘Elasopast’ bandage
REMOVAL OF TEST SUBSTANCE
After a 24 h exposure period, the bandage and any excess test article was removed. The method for removal of the test material was not specified.
TEST MATERIAL
The test material was applied moistened at 2000 mg/kg bw. The total volume applied was not specified.
VEHICLE
Test material was moistened with 2-3 drops of ‘Ampuwa’ (sterile water). - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- One group of 5 males and 5 females.
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
- Statistics:
- No data.
Results and discussion
- Preliminary study:
- Dose range finding study: In a dose range finding study, 2 females rats were administered dermally 2000 mg/kg bw. No mortality or dermal findings were seen.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None.
- Clinical signs:
- other: There were no deaths, clinical signs of systemic toxicity, or dermal findings in this study.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- None.
Any other information on results incl. tables
Table 1 Acute dermal toxicity study - Summary of findings
Dose [mg/kg bw] |
Number dead/ number investigated |
Time of death (range) |
Observations |
|
2000 (Male) |
0/5 |
- |
There were no deaths, clinical signs of systemic toxicity, or dermal findings in this study. All animals gained weight during the study. No abnormalities were noted at necropsy. |
|
2000 (Female) |
0/5 |
- |
||
LD50> 2000 mg/kg bw (males and females) |
|
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 in the male and female rat was found to be greater than 2000 mg/kg bw.
Therefore, cuprous oxide did not meet the criteria for classification for acute dermal toxicity according to labelling regulations outlined in Annex VI
of Commission Directive 2001/59/EC. - Executive summary:
Materials and methods
This study was conducted according to GLP, and to OECD Test Guideline 402 'Acute Dermal Toxicity' (adopted 24 February 1987). Only minor deviations from test guideline occurred. These deviations are not considered to have influenced the outcome or the integrity of the study.
Cuprous oxide, moistened with sterile water, was applied to the shaven, intact dorsal skin of 5 male and 5 femaleCrl.:(WI)BR-Wistarrats at 2000 mg/kg bw under a ‘Elasoplast’ bandage. After a 24 h exposure period the dressing and any excess test article was removed.
At the start of the study males weighed 211.2 to 232.5 g and females weighed 222.6 to 258.7 g.
Animals were observed for overt signs of toxicity 1, 2, 3, 6 and 24/48 hours after test material application, and each day thereafter for 14 days. Dermal irritation was measured daily using a modified Draize scheme. Individual bodyweights were recorded on days 0, 7 and 14. Animals were killed and necropsied after a 14 day observation period.
Results and discussion
There were no deaths, clinical signs of systemic toxicity, or dermal findings in this study.
All animals gained weight during the study. No abnormalities were noted at necropsy. See also Table 1 for a summary of results.
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