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EC number: 235-113-6 | CAS number: 12069-69-1
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- 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 Substances Regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Copper(II) carbonate-copper(II) hydroxide (1:1)
- EC Number:
- 235-113-6
- EC Name:
- Copper(II) carbonate-copper(II) hydroxide (1:1)
- Cas Number:
- 12069-69-1
- Molecular formula:
- CuCO3.Cu(OH)2
- IUPAC Name:
- copper(II) carbonate, basic
- Details on test material:
- Lot/batch number - 26694/4/ROX
Description - Green powder
Purity - Not reported
Stability - Stable at room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source - David Percival Ltd, Moston, Sandbach, Cheshire, UK.
Sex - One male and two females
Age/weight at test initiation - At the start of the study the animals weighed 2.73-2.81 kg and were twelve to sixteen weeks old.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- The test substance was used as supplied with no additional preparation.
0.1 ml (91 mg) instilled per eye. - Duration of treatment / exposure:
- 72-hours
- Observation period (in vivo):
- 1 hour and 24, 48 and 72 hours following treatment.
Additional observations were made in two treated eyes on Days 7 and 14 - Number of animals or in vitro replicates:
- 3
- Details on study design:
- No details on removal/washing of treated eyes were given.
Opthalmic examinations for ocular damage/irritation were made approximately 1, 24, 48 and 72 hours after treatment.
Any other ocular effects were also noted. Additional observations were made in two treated eyes on Days 7 and 14 to assess the reversibility of the ocular effects.
SCORING: Draize scoring system and modified Kay and Calandra classification system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.88
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.22
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.22
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Reversability: One treated eye appeared normal at the 48-hour observation and two other treated eyes appeared normal at the 14-day observation.
- Other effects:
- Green residual test material around the eyelids of the treated eye was noted in two animals one hour after treatment. Diffuse or translucent corneal opacity was noted in two treated eyes at 24 and 48-hour observations with diffuse corneal opacity at the 72-hour and 7-day observations.
Vascularisation of the cornea was noted in two treated eyes at the 7-day observation. Iridial inflammation was noted in one treated eye one hour after treatment and in two treated eyes at the 24 and 48-hour observations. No other iridial effects were noted. Moderate conjunctival irritation were noted in all treated eyes one hour after treatment with minimal to moderate conjunctival irritation at the 24-hour observation. Moderate conjunctival
irritation was noted in two treated eyes at the 48-hour observation with minimal conjunctival irritation at the 72-hour observation. For further details please refer to Table 1.
Any other information on results incl. tables
Table 1 ACUTE EYE IRRITATION - SUMMARY OF RESULTS
|
CORNEA |
IRIS (Congestion) |
CONJUNCTIVA |
|||
(Degree of opacity) |
(Area of Opacity) |
Redness |
Chemosis |
Discharge |
||
Score (average of animals investigated) |
0-4 |
0-4 |
0-2 |
0-3 |
0-4 |
0-3 |
1 hour |
0 |
0 |
0.33 |
1.66 |
1.33 |
2 |
24 hour |
1 |
1 |
0.66 |
1.66 |
1.66 |
1.66 |
48 hour |
1 |
1 |
0.66 |
1.33 |
1.33 |
0.66 |
72 hour |
0.66 |
1 |
0 |
0.66 |
0.66 |
0 |
Average 24h, 48h and 72h |
0.88 |
1 |
0.44 |
1.22 |
1.22 |
0.77 |
Area effected |
Not reported |
Not reported |
Not reported |
Not reported |
Not reported |
Eyelids |
Maximum average score (including area affected, max 110) |
Not reported |
Not reported |
Not reported |
Not reported |
Not reported |
Not reported |
Reversibility |
Completely reversible |
Completely reversible |
Completely reversible |
Completely reversible |
Completely reversible |
Completely reversible |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 20.0 and was classified as a moderate irritant to the rabbit eye according to a modified
Kay and Calandra classification system. The test material did not meet the criteria for classification as an eye irritant according to EU labelling
regulations Commission Directive 93/21/EEC. - Executive summary:
Materials and methods
This study was conducted to assess the irritancy potential of copper carbonate to the eye of the New Zealand White rabbit.
Three New Zealand White rabbits (2 female, 1 male) were given a single dose of 0.1 ml copper carbonate (91 mg) applied directly into the conjunctival sac of the right eye. The left eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made 1, 24, 48 and 72 hours following treatment, according to the Draize scoring system and a modified version of the Kay and Calandra classification system. Any other ocular effects were also noted.
Additional observations were made in two treated eyes on days 7 and 14 to assess the reversibility of the ocular effects.
The study was conducted according to Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation/Corrosion), OECD Guidelines for the Testing of Chemicals No. 405 'Acute Eye Irritation/Corrosion' (adopted 24 February 1987) and EPA Health Effects Test Guidelines OPPTS 870.2400 Acute Eye Irritation, August 1998. The study was also conducted according to GLP.
No deviations from the test guidelines, or deficiencies in the method were reported.
Results and discussion
A single application of the test material to the non-irrigated eye of three rabbits produced diffuse or corneal opacity, iridial inflammation and moderate conjunctivae irritation. Vascularisation of the cornea was noted in two treated eyes at the 7-day observation. One treated eye appeared normal at the 48-hour observation and two treated eyes appeared normal at the 14-day observation.
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