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EC number: 231-674-6 | CAS number: 7681-65-4
- 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
- Remarks:
- This study was conducted in light of a negative result in an Enucleated Rabbit Eye Test.
- 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:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Copper iodide
- EC Number:
- 231-674-6
- EC Name:
- Copper iodide
- Cas Number:
- 7681-65-4
- Molecular formula:
- CuI
- IUPAC Name:
- λ¹-copper(1+) iodide
- Details on test material:
- - Name of test material (as cited in study report): Copper iodide
- Analytical purity: 99.7%
- Lot/batch No.: 108701/2 REACH STANDARD 290911
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation: 2.24 or 2.48 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C.
- Humidity (%): 30 to 70%.
- Air changes (per hr): At least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 ml of the test item, weighing approximately 96 mg. - Observation period (in vivo):
- Up to 21 days.
- Number of animals or in vitro replicates:
- Two.
- Details on study design:
- Initially, a single animal was treated. A volume of 0.1 ml of the test item 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 lossof the test item, and then released. The left eye remained untreated and was used for control purposes. After consideration of the ocular responses produced in the first treated animal, a second animal was treated.
Immediately after administration of the test item, an assessment of the initial pain reaction was made according to the six point scale shown in Table 1 (attached). Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to Draize. Any other ocular effects were also noted. Additional observations were made on Days 7, 14 and 21 to assess the reversibility of the ocular effects. Any clinical signs of toxicity, if present, were also recorded. Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period.
Examination of the eyes 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
- Remarks:
- degree of opacity
- Basis:
- mean
- Remarks:
- (two animals)
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- area of cornea involved
- Basis:
- mean
- Remarks:
- (two animals)
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Remarks:
- (two animals)
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- Scattered or diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation were noted in one treated eye one hour after treatment and at the 24, 48 and 72-Hour observations. Moderate conjunctival irritation was noted in this treated eye at the 7-Day observation with minimal conjunctival irritation noted at the 14-Day observation. This treated eye appeared normal at the 21-Day observation. Scattered or diffuse corneal opacity was noted in the other treated eye one hour after treatment with translucent corneal opacity noted at the 24-Hour observation and all subsequent observations. Iridial inflammation was noted in this treated eye one hour after treatment and at the 24, 48, 72-Hour, 7 and 14-Day observations. Moderate conjunctival irritation was noted in this treated eye one hour after treatment with severe conjunctival irritation noted at the 24 and 48-Hour observations, moderate conjunctival irritation noted at the 72-Hour, 7 and 14-Day observations and minimal conjunctival irritation noted at the 21-Day observation. Areas of haemorrhage on the nictitating and upper conjunctival membranes were also noted in this treated eye at the 72-Hour and
7-Day observations. Vascularisation, approximately2 mm to 3 mm in size around approximately half of the outer edge of the cornea,was noted in this treated eye at the 7, 14 and 21-Day observations. The persistence of reactions in this treated eye at the 21-Day observation was considered to be indicative of irreversible ocular damage. - Other effects:
- Staining of the fur was noted around one treated eye at the 24-Hour observation.
Both animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
The persistence of reactions in the treated eye at the 21-Day observation was considered to be indicative of irreversible ocular damage.
See Table 2 (attached) for detailed occular irritation scores.
See Table 3 (attached) for individual bodyweights and bodyweight change.
See Table 4 (attached) for the results of the initial Rabbit Enucleated Eye Test. These and indicated that the test item was unlikely to cause severe ocular irritancy.
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:
- Copper iodide produced irreversible ocular damage and was considered to be corrosive to the rabbit eye (based on one rabbit only). The test item was classified as Irreversible effects on the eye (Category 1), H318: Causes serious eye damage.
- Executive summary:
A GLP-compliant study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. The method was designed to be compatible with OECD Guideline 405 and EU Method B5. A single application of the test item to the non-irrigated eye of two rabbits produced scattered or diffuse to translucent corneal opacity, iridial inflammation and moderate to severe conjunctival irritation. Other ocular effects noted in one treated eye were areas of haemorrhage on the nictitating and conjunctival membranes and vascularisation of the cornea. One treated eye appeared normal at the 21 -Day observation. The persistence of reactions in one treated eye at the 21 -Day observation was considered to be indicative of irreversible ocular damage.
The test item was considered to be corrosive to the rabbit eye. The test item was classified as Irreversible effects on the eye (Category 1). The Signal Word “Danger” and the Hazard Statement “H318: Causes serious eye damage” are therefore required.
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