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EC number: 614-455-3 | CAS number: 68411-07-4
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 July 2010 to 21 october 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP; adequate coherence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD n° 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants
- Deviations:
- not applicable
- Principles of method if other than guideline:
- 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:
- Copper Lead Resorcylate Salicylate Complex
- EC Number:
- 614-455-3
- Cas Number:
- 68411-07-4
- Molecular formula:
- C7H5O4-, C7H5O3- Cu , Pb
- IUPAC Name:
- Copper Lead Resorcylate Salicylate Complex
- Details on test material:
- - Name of test material (as cited in study report): Lead-Cooper-Resorcylate-Salicylate (LC 12-15)
- Physical state: light pale green powder
- Composition of test material, percentage of components: 11.9% of copper, 35.7% of lead, 14.1% of resorcylate and 35.7% of salicylate
- Lot/batch No.: 09/201 (on the labeling), PRESE123/ (on the analytical certificate)
- Expiration date of the lot/batch: 04 November 2011
- Storage conditions of test material: at room temperature.
Constituent 1
Test animals / tissue source
- Species:
- other: isolated calf cornea
- Strain:
- other: bovine calf
- Details on test animals or tissues and environmental conditions:
- - Source: Origin: calf eyes were obtained from freshly slaughtered calves at the abattoir SOCAVIA, Cany Barville, France.
- Reason for choice: calf corneas are adapted for the evaluation of potential ocular irritants since they are part of the target organ.
- Transport from supplier to CIT: the eyes were transported to CIT at ambient temperature, immerged in buffered Hanks medium containing antibiotics (Hank’s Balanced Salts Solution (HBSS) plus penicillin/streptomycin).
- Preparation of the corneas: the corneas were prepared as quickly as possible after receipt. Each step was carried out avoiding to touch the corneas in order to not injure them
- Selection: upon arrival at CIT, all eyes were carefully examined macroscopically for defects (opacity, scratches, pigmentation, etc) and those exhibiting any defect were discarded. The too large eyes were also discarded in order to avoid the formation of folds at the assembly of corneas in the holder. The examination was performed under a lamp and using HBSS in order to maintain the corneas moistened and shiny. Each cornea was observed with attention, while making swivel the eye in order to see any less refringent areas under the light or any scratches.
- Preparation of the selected corneas: the tissue surrounding the eyeball was carefully pulled away and the cornea was dissected such that approximately 2 to 3 mm of sclera was present around the cornea. The isolated corneas were stored in HBSS until all corneas were dissected.
As the corneas were not used extemporaneously for a treatment, they were washed three times of 15 minutes each in HBSS plus penicillin/streptomycin (100 units/100 µg/mL final) at room temperature, then stored individually in 12 mL of M199 medium containing 5% dextran, plus penicillin/streptomycin, at +4°C for 24 hours maximum before use.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): as the dosage form was not able to be sampled by a pipette, an amount of 750 mg ± 75 mg of the test item was gently applied to the cornea, as uniformly as possible. - Duration of treatment / exposure:
- 30 minutes
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- Three corneas were used for each treated series (test item, positive control and negative control).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): as the dosage form was solid, the dosage form having adhered to the walls of the compartment was eliminated using a cotton bud. Then the compartment was filled with heated cMEM (32°C). The rinsing was repeated five times (i.e. until the dosage form is completely removed from the compartment). The efficiency of the rinsing was visually appreciated with the transparency of the medium of rinsing (despite the rinsing performed, residual test item was noted over corneas after treatment).
TOOL USED TO ASSESS SCORE: opacitometer, fluorescein, spectrophotometer
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 30 minutes
- Value:
- 62.7
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 30 min
- Value:
- 62.7
- Irritation parameter:
- other: mean corrected permeability value
- Run / experiment:
- 30 min
- Value:
- 0.004
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,
. the individual OD490 nm values of negative control corneas were < 0.100,
. the solution of fluoresceine (at 5 mg/mL in DPBS) diluted 1:1000 in cMEM had OD490 nm values between 0.850 and 0.940,
. following the 30-minute treatment, the positive control mean in vitro score was 90.3 thus demonstrating the sensitivity of the test system under the experimental conditions of this study.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: scoring table showed above (see section "any other information on materials and methods")
- Conclusions:
- Under the experimental conditions of this study, according to the mean in vitro scores of the 30 minute treatment, the test item Lead-Copper-Resorcylate-Salycilate (LC 12-15) 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 excesswith 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 first intended to be tested sequentially in two consecutive experiments, however, according to the results of the first experiment (mean in vitro score at the 30-minute treatment > 55), no second experiment was undertaken and the study was considered as complete.
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.
The corneas were incubated for 2 hours at. 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, 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
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.
Opacity, residual test item on corneas and fluoresceine fixation were observed on test item-treated corneas.
The mean in vitro score was 62.7.
Conclusion:
Under the experimental conditions of this study, according to the mean in vitro score of the 30‑minute treatment, the test item Lead-Copper-Resorcylate-Salycilate (LC 12-15) tested in its original form is classified as irritant to severely irritant for the isolated calf cornea.
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