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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines. Restrictions: Study terminated before reversibility was demonstrated. This does not affect interpretation of the test results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guidelineopen allclose all
- 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
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: Copper hydroxide.
- Lot/batch No.: Not stated.
- Content of copper and content of copper hydroxide: Not stated.
- Storage condition of test material: The test substance was stored at ambient temperature in a dark place.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, 2740 Bremervorde, Neuendamm 88.
- Age at study initiation: Not stated.
- Weight at study initiation: 2.4 - 2.8 kg.
- Housing: Animals were kept separately in batteries.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: Not less than 7 days.
ENVIRONMENTAL CONDITIONS- Temperature (°C): 18°C +/- 2°C.
- Humidity (%): 50 - 85%.
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 grams.
- Duration of treatment / exposure:
- 4 seconds (3 animals) or unwashed (3 animals).
- Observation period (in vivo):
- 72 hours.
- Number of animals or in vitro replicates:
- Six.
- Details on study design:
- 0.1 grams of the test substance was was administered into the conjunctival sac of the left eye of each of six rabbits. The treated eyes of three animals were washed with water 4 seconds after dosing. The eyes of the three other animals remained unwashed. Animals were examined for signs of eye irritation after 1, 24, 48 and 72 hours. Irritation was scored according to Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animala
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Irritant / corrosive response data:
- Copper hydroxide caused iris lesions, conjunctival redness and chemosis in unwashed eyes (scores in the range 1 - 3) in all animals 1, 24, 48 and 72 hours after instillation. Copper hydroxide also caused corneal opacity 24 - 48 hours after instillation in two animals (score 1 or 2). Iris lesion, conjunctival redness and chemosis (but not corneal opacity) also occurred in the washed eyes but effects were less severe. Refer to Table 1 for a summary of individual and mean eye irritation scores.
- Other effects:
- None.
Any other information on results incl. tables
Table 1. Copper hydroxide: Summary of individual and mean eye irritation scores according to Draize.
Assessment time |
Scores according to Draize for animal number |
|||||
Unwashed |
Washed |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|
Cornea opacity |
||||||
1 hour |
0 |
0 |
0 |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
48 hours |
0 |
1 |
2 |
0 |
0 |
0 |
72 hours |
0 |
1 |
2 |
0 |
0 |
0 |
Mean score per animal |
0.0 |
0.7 |
1.3 |
0.0 |
0.0 |
0.0 |
Mean score for 3 animals |
0.7 |
0.0 |
||||
Iris lesion |
||||||
1 hour |
2 |
2 |
2 |
1 |
1 |
2 |
24 hours |
2 |
2 |
2 |
1 |
1 |
1 |
48 hours |
2 |
2 |
2 |
1 |
1 |
1 |
72 hours |
1 |
1 |
1 |
0 |
0 |
0 |
Mean score per animal |
1.7 |
1.7 |
1.7 |
0.7 |
0.7 |
0.7 |
Mean score for 3 animals |
1.7 |
0.7 |
||||
Conjunctival redness |
||||||
1 hour |
3 |
3 |
3 |
3 |
3 |
2 |
24 hours |
3 |
3 |
3 |
3 |
2 |
2 |
48 hours |
3 |
3 |
3 |
2 |
2 |
2 |
72 hours |
3 |
3 |
3 |
2 |
2 |
2 |
Mean score per animal |
3.0 |
3.0 |
3.0 |
2.3 |
2.0 |
2.0 |
Mean score for 3 animals |
3.0 |
2.1 |
||||
Conjunctival chemosis |
||||||
1 hour |
3 |
3 |
3 |
2 |
2 |
2 |
24 hours |
3 |
3 |
3 |
2 |
2 |
2 |
48 hours |
2 |
3 |
2 |
2 |
2 |
2 |
72 hours |
2 |
2 |
1 |
2 |
2 |
2 |
Mean score per animal |
2.3 |
2.7 |
2.0 |
2.0 |
2.0 |
2.0 |
Mean score for 3 animals |
2.3 |
2.0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean of the scores for Iris lesion in at least 2 out of 3 tested animals recorded at 24, 48 and 72 hours for unwashed eyes was > 1.5.
Classification according to Directive 67/548/EEC: Irritant (Xi). R41, Risk of serious damage to eyes.
Classification according to CLP/GHS: Eye Damage 1, H318: Causes serious eye damage. - Executive summary:
A GLP-compliant study was conducted in New Zealand White rabbits to determine the eye irritation potential of copper dihydroxide. The method followed the requirements of OECD Guideline 405, with the exception that the study was terminated before reversibility was demonstrated (this was not consideed to adversely affect the outcome). 0.1 grams of the test substance was was administered into the conjunctival sac of the left eye of each of six rabbits. The treated eyes of three animals were washed with water 4 seconds after dosing. The eyes of the three other animals remained unwashed. Animals were examined after 1, 24, 48 and 72 hours and irritation was scored according to Draize. The mean eye irritation scores recorded at 24, 48 and 72 hours for unwashed eyes in all three animals were 0.7 for corneal opacity (> 1.0 in one animal), 1.7 for iris lesion (> 1.5 in all three animals), 3.0 for conjunctival redness (> 2.0 in all three animals) and 2.3 for conjuntival chemosis (>= 2.0 in all three animals). In view of the iris lesion findings and lack of reversibility, copper dihydroxide is classified as Eye Damage Category 1, H318: Causes serious eye damage.
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