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EC number: 215-582-3 | CAS number: 1333-22-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental Phase: 18 February 2002 to 23 February 2002. Report issue: 13 June 2002.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tetracopper hexahydroxide sulphate
- EC Number:
- 215-582-3
- EC Name:
- Tetracopper hexahydroxide sulphate
- Cas Number:
- 1333-22-8
- Molecular formula:
- Cu4H6O10S
- IUPAC Name:
- tetracopper(2+) hexahydroxide sulfate
- Test material form:
- solid: bulk
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: Individually housed in suspended cages
- Diet & Water: Free access to mains drinking water and food (certified rabbit diet).
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 changes per h
- Photoperiod (hrs dark / hrs light): 12h continuous light (06:00 to 18:00) and 12h darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye by gently pulling the lower lid away from the eyeball.
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.
Initially, a single rabbit was treated. A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment using a numerical evaluation according to Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 120, 121, 122
- Time point:
- other: 1h
- Score:
- ca. 0
- Max. score:
- 80
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 120, 121, 122
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal: 120, 121, 122
- Time point:
- other: 1h
- Score:
- ca. 0
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- animal: 120, 121, 122
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 120
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 120
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 121
- Time point:
- other: 1 h
- Score:
- ca. 8
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 121
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 121
- Time point:
- other: 48/72h
- Score:
- ca. 0
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 122
- Time point:
- other: 1 h
- Score:
- ca. 8
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 122
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 20
- Irritation parameter:
- chemosis score
- Basis:
- animal: 120
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: 121
- Time point:
- other: 1 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 121
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: 122
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 122
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: 120
- Time point:
- other: 1h
- Score:
- ca. 0
- Max. score:
- 4
- Other effects:
- No corneal or iridial effects were noted during the study.
Any other information on results incl. tables
Results
Moderate conjunctival irritation was noted in two treated eyes with minimal conjunctival irritation in the remaining treated eye one hour after treatment. Minimal conjunctival redness was noted in one treated eye at the 24-hour observation.
Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced a maximum group mean score of 6. 7 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
- Executive summary:
Introduction
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following gudielines:
• OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987)
• Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)
Method
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used. Initially, a single rabbit was treated. A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The left eye remained untreated and was used for control purposes. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
Result
A single application of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.
Conclusion
The test material produced a maximum group mean score of 6.7 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
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