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EC number: 701-287-1 | CAS number: -
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23 February 2010 to 01 June 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline was followed, but study was compliant to GLP; and there was adequate coherence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The principle of this evaluation is based on the measurement of two factors: the opacity and the permeability of the treated corneas. The changes in these parameters correspond to the damages induced to the tissues.
The method used is adapted from that described by Gautheron P. & al. (1992) Fundam. Appl. Toxicol. 18 442-449. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- dioxo-1,3-dioxa-2-chroma-4-baracyclobutane; dioxo-2,4-dioxa-3-cupra-1,5-dichromapentane; oxocopper
- EC Number:
- 701-287-1
- Molecular formula:
- CuO, CuCr2O4, BaCrO4
- IUPAC Name:
- dioxo-1,3-dioxa-2-chroma-4-baracyclobutane; dioxo-2,4-dioxa-3-cupra-1,5-dichromapentane; oxocopper
- Details on test material:
- - Name of test material (as cited in study report): Chromite de cuivre
- Substance type: multiconstituents
- Physical state: black powder
- Composition of test material, percentage of components: 34% of copper, 8.5% of baryum, 31% of chrome
- Purity test date: 11 January 2010
- Lot/batch No.: 09/0177
- Expiration date of the lot/batch: 17 August 2014
- Storage condition of test material: in darkness at room temperature
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 mg ± 75 mg of the test item was gently applied to the cornea, as uniformly as possible - Duration of treatment / exposure:
- 30 minutes (first experiment) and 10 minutes (second experiment)
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- Not applicable
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of each treatment period, the dosage form having adhered to the walls of the compartment was eliminated using a cotton bud (10-minute treatment) and/or a pipette of heated cMEM (32°C) (both 30- and 10-minute treatments).
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: Mean in vitro score = Corrected opacity + (15 x Corrected OD490nm)
- Run / experiment:
- Mean
- Value:
- 51.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- other: Mean in vitro score = Corrected opacity + (15 x Corrected OD490nm)
- Run / experiment:
- Mean
- Value:
- 42.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
For each experiment, the acceptance criteria were fulfilled:
- the individual corneal opacity values of negative controls were < 10 in both experiments,
- the individual OD490nm values of negative control corneas were < 0.100 in both experiments,
- the solution of fluoresceine (at 5 mg/mL in DPBS) diluted 1:1000 in cMEM had OD490nm values between 0.850 and 0.940 in both experiments,
- following the 30-minute treatment, the positive control mean in vitro scores was 124.1, thus demonstrating the sensitivity of the test system under the experimental conditions of this study.
No notable opaque spots or irregularities were observed on negative control corneas, either following the 30-minute treatment or following the 10-minute treatment.
Residual test item was observed on test item-treated corneas, following both the 30- and 10-minute treatments.
Following the 30-minute treatment, the mean in vitro score was 51.6. Then following the 10- minute treatment, the mean in vitro score was 42.8.
The test item is classified according the following table:
Mean in vitro score at the 30-minute treatment (X) |
|
Mean in vitro score at the 4-hour treatment (Z) or 10-minute treatment(Y) |
Class |
|
X ≤ 10 |
and |
Z ≤ 40 |
1 |
Slightly irritant |
40 < Z ≤ 100 |
2 |
Moderately irritant |
||
Z > 100 |
3 |
Irritant to severely irritant |
||
10 < X ≤ 25 |
and |
Y ≤ 10 |
2 |
Moderately irritant |
10 < Y ≤ 25 |
2 - 3 |
Moderately irritant to irritant |
||
Y > 25 |
3 |
Irritant to severely irritant |
||
25 < X ≤ 55 |
and |
Y ≤ 10 |
2 - 3 |
Moderately irritant to irritant |
Y > 10 |
3 |
Irritant to severely irritant |
Applicant's summary and conclusion
- Interpretation of results:
- other: irritant to severely irritant
- Remarks:
- Criteria used for interpretation of results: other: see table on page 15 of the report
- Conclusions:
- Under the experimental conditions of this study, according to both mean in vitro scores of the 30-minute and 10-minute treatments, the test item Chromite de cuivre tested in its original form is classified as irritant to severely irritant for the isolated calf cornea.
- Executive summary:
Method:
The corneas were obtained from the eyes of freshly slaughtered calves at the abattoir. They were mounted in the corneal holders with the endothelial side against the O-ring of the posterior half of the holder. Both compartments of the corneal holder were filled in excess with Minimal Essential Medium Eagle completed with 1% fetal calf serum plus penicillin/streptomycin (cMEM), then the
holders were preincubated for 1 hour at 32°C.
Three corneas were used for each treated series (test item, positive control and negative control).
Before the treatment, a first opacity measurement was performed using an opacitometer (determining the light transmission through the center of each mounted cornea).
For the treatment, the test item was used in its original form.
The test item was tested sequentially in two consecutive experiments.
As the mean in vitro score at the 30-minute treatment was > 10 but ≤ 55, the second experiment was undertaken using a 10-minute treatment.
At the completion of the treatment period, the test item was removed from the front opening of the anterior part of the holder and the epithelium was washed.
Following the 10- and 30-minute treatments, the corneas were incubated for 2 hours at 32°C. At the completion of the 2-hour incubation period, the second opacity measurement was performed.
After the second opacity measurement, the medium was removed from both compartments of each holder. The posterior compartment was refilled with cMEM at 32°C, while the anterior compartment received 1 mL of a 5 mg/mL fluoresceine solution in Dulbecco's Phosphate-Buffered Saline (DPBS). Then, the holders were incubated vertically for 90 minutes at 32°C.
At the end of the 90-minute incubation, the optical density of the solution from the posterior compartment of the holder was measured at 490 nm in order to determine the permeability of the cornea. Then the cornea was removed from the holder and observed for opaque spots and other irregularities.
Results:
For each experiment, the acceptance criteria were fulfilled and the study was therefore considered to be valid.
No notable opaque spots or irregularities were observed on negative control corneas, either following the 30-minute treatment or following the 10-minute treatment.
Residual test item was observed on test item-treated corneas, following both the 30- and 10-minute treatments.
Following the 30-minute treatment, the mean in vitro score was 51.6. Then following the 10- minute treatment, the mean in vitro score was 42.8.
Conclusion:
Under the experimental conditions of this study, according to both mean in vitro scores of the 30-minute and 10-minute treatments, the test item Chromite de cuivre tested in its original form is classified as irritant to severely irritant for the isolated calf cornea.
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