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EC number: 243-815-9 | CAS number: 20427-59-2
- 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: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Copper dihydroxide
- EC Number:
- 243-815-9
- EC Name:
- Copper dihydroxide
- Cas Number:
- 20427-59-2
- Molecular formula:
- CuH4O2
- IUPAC Name:
- copper(2+) dihydroxide
- Details on test material:
- - Name of test material (as cited in study report):Copper hydroxide.
- Composition of test material, percentage of components: Not stated.
- Lot/batch No.: Not stated.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The rabbits were housed individually and acclimatised prior to dosing. Body weights were approximately 2 kg.
Administration / exposure
- Type of coverage:
- other: non-occlusive
- Vehicle:
- water
- Remarks:
- test material was moistened with deionised water prior to application.
- Details on dermal exposure:
- Doses were applied to an area of intact shaven skin (equivalent to approximately 10% of the body area) on each rabbit on Day 1. Males only were treated at 2700 mg/kg bw. The test substance was held in place with surgical gauze and surgical tape and the entire trunk of the animal was wrapped in a non-occlusive dressing. After 24 hours, the dressing was removed and residual test substance gently rinsed off with water.
- Duration of exposure:
- 24 hours.
- Doses:
- Dose levels were 2000, 2300 and 2700 mg/kg bw.
- No. of animals per sex per dose:
- Groups of five or 10 males and five females.
- Control animals:
- no
- Details on study design:
- Animals were observed frequently for treatment-related clinical signs on the treatment day and then daily for the 14 day post-dosing period. Animals were weighed prior to treatment and after 7 days (Day 8) and 14 days (Day 15). Decedents and animals surviving to 14 days were subject to gross necropsy.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 200 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 712 - 3 776
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was one male mortality at 2000 mg/kg bw and two male mortalities at 2300 mg/kg bw. The deaths occurred on Day 2 and Day 13. There were no female mortalities at 2000 mg/kg bw and no male mortalities at 2700 mg/kg bw. Refer to Table 1.
- Clinical signs:
- other: The clinical signs recorded included yellow fluid around the nose and mouth, and diarrhoea.
- Gross pathology:
- No abnormalities were recorded in males treated at 2700 mg/kg bw. Findings in surviving animals and those which died following treatment at lower doses included mottled lungs, pale kidneys, pale red mottled liver, foam/gas filled intestines, green mucoid material around the anus and red mottled adrenals.
- Other findings:
- None.
Any other information on results incl. tables
Table 1. Summary of Mortalities
Dose |
Males |
Females |
||
Mortality |
Time of death |
Mortality |
Time of death |
|
2000 |
1/10 |
Day 3 |
0/5 |
- |
2300 |
2/5 |
Day 2; Day 13 |
- |
- |
2700 |
0/5 |
- |
- |
- |
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 (calculated by Litchfield-Wilcoxon analysis) of copper hydroxide to the rabbit was 3200 mg/kg bw for males (with 95% confidence limits of 2712 to 3776 mg/kg bw) and greater than 2000 mg/kg bw for females.
Classification according to Directive 67/548/EEC: Not classified.
Classification according to CLP/GHS: Not classified. - Executive summary:
A GLP-compliant acute dermal toxicity study was conducted in accordance with US EPA 81-2 without deviation. Copper dihydroxide was moistened with deionised water prior to application. Groups of five or 10 male and five female New Zealand white rabbits weighing approximately 2 kg were used. The rabbits were housed individually and acclimatised prior to dosing. Dose levels of 2000, 2300 and 2700 mg/kg bw were applied to an area of intact shaven skin (equivalent to approximately 10% of the body area) on each rabbit on Day 1. Males only were treated at 2700 mg/kg bw. The test substance was held in place with surgical gauze and surgical tape and the entire trunk of the animal was wrapped in a non-occlusive dressing. After 24 hours, the dressing was removed and residual test substance gently rinsed off with water. Animals were observed frequently for treatment-related clinical signs on the treatment day and then daily for the 14‑day post-dosing period. Animals were weighed prior to treatment and after 7 days (Day 8) and 14 days (Day 15). Decedents and animals surviving to 14 days were subject to gross necropsy.
There was one male mortality at 2000 mg/kg bw and two male mortalities at 2300 mg/kg bw. The deaths occurred on Day 2 and Day 13. There were no female mortalities at 2000 mg/kg bw and no male mortalities at 2700 mg/kg bw. The clinical signs recorded included yellow fluid around the nose and mouth, and diarrhoea. Females and most surviving males treated at 2000 mg/kg bw gained weight during the study. Males treated at 2300 or 2700 mg/kg bw gained little weight or lost weight during the study. No abnormalities were recorded at necropsy in males treated at 2700 mg/kg bw. Findings in surviving animals and those which died following treatment at lower doses included mottled lungs, pale kidneys, pale red mottled liver, foam/gas filled intestines, green mucoid material around the anus and red mottled adrenals.
The acute dermal LD50 of copper dihydroxide to the rabbit was 3200 mg/kg bw for males (with 95% confidence limits of 2712 to 3776 mg/kg bw) and greater than 2000 mg/kg bw for females. Copper dihydroxide is not classified.
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