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EC number: 263-064-0 | CAS number: 61789-51-3
- 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
- Remarks:
- other: validated "in vitro" test method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-08-10 to 2010-08-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for Testing of Chemicals 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants (September, 2009).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2009-03-30
Test material
- Reference substance name:
- Naphthenic acids, cobalt salts
- EC Number:
- 263-064-0
- EC Name:
- Naphthenic acids, cobalt salts
- Cas Number:
- 61789-51-3
- IUPAC Name:
- λ²-cobalt(2+) bis(3-(3-ethylcyclopentyl)propanoate)
- Details on test material:
- - Name of test material (as cited in study report): Cobalt naphthenate
- Physical state: blue, solid
- Storage condition of test material: At room temperature
Constituent 1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- Freshly isolated bovine eyes from at least nine month old donor cattle were collected from the abattoir. The donor cows were at least at the age of 9 month. Excess tissue was removed from the excised eyes. The isolated eyes were transported to the laboratory in Hank’s BSS supplemented with streptomycin / penicillin at ambient temperature. The corneae were isolated on the same day after delivery of the eyes, inserted in pre-cooled preservation medium composed of Medium 199 supplemented with L-glutamine, Na-bicarbonate and Taurine, and stored in the refrigerator at 2 – 8 °C until the following day. Shortly before use, Dextran was added to the medium.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- - Since the test item was of coarse-grained consistency, it was crushed and ground in a mortar with a pestle prior to the test.
Nevertheless, a 20 % (w/v) homogeneous suspension or solution in saline could not be produced. Therefore, the grained suspension in saline (0.9 (w/v) NaCl in deionsied water) was spread equally onto the corneae as demanded by the OECD guideline 437 for these cases.
- Amounts applied: 0.75 mL - Duration of treatment / exposure:
- - test item: 120 minutes (± 3 minutes)
- controls: 240 minutes (± 5 minutes) - Observation period (in vivo):
- measurement for opacity directly after incubation
- Number of animals or in vitro replicates:
- number of corneae: 3
- Details on study design:
- Fresh cMEM was placed in the posterior compartment, while the anterior compartment received the test item or negative or positive control at a volume of 0.75 mL each on the surface of the corneae and was incubated at 32 ± 1 °C in the water-bath in a horizontal position.
Due to its coarse-grained consistency, the test item was crushed and ground in a mortar with a pestle prior to the test. Since a 20 % (w/v) homogeneous suspension or solution in saline could not be produced. The suspension was grained. According to the OECD guideline 437 it was spread equally onto the corneae. The positive control was 10% (w/v) Benzalconium chloride. Saline was used as negative control item.
The incubation time lasted 120 minutes (± 3 minutes) for the test item and 240 minutes (± 5 minutes) for the controls.
After the test item or control items, respectively, were rinsed off from the application side with saline at least three times or until no visual evidence of the test item was observed. Fresh cMEM was replaced in both compartments and opacity was measured (t240). Also, each cornea was observed visually and pertinent observations were recorded (e.g. tissue peeling, residual test substance, non-uniform opacity pattern).
In the second step of the assay, permeability of the cornea possibly caused by the test item, was determined. Fresh complete medium was added to the posterior compartment and 1 mL of a Na-fluorescein solution, 0.5 % (w/v) dissolved in HBSS (Hank’s buffered salt solution), was placed in the anterior compartment. Corneae were incubated again in a horizontal position for an additional 90 minutes at 32 ± 1 °C in the water-bath. The optical density of an aliquot of the mixed complete medium from the posterior chamber was measured spectrophotometrically at 490 nm (OD490).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: in vitro score
- Basis:
- other: cornea 1
- Time point:
- other: 120 min
- Score:
- 1.14
- Irritation parameter:
- other: in vitro score
- Basis:
- other: cornea 2
- Time point:
- other: 120 min
- Score:
- 1.11
- Irritation parameter:
- other: in vitro score
- Basis:
- other: cornea 3
- Time point:
- other: 120 min
- Score:
- 1.07
- Irritation parameter:
- other: in vitro score
- Basis:
- mean
- Time point:
- other: 120 min
- Score:
- 1.11
- Irritant / corrosive response data:
- - With the negative control (0.9% NaCl solution) neither an increase of opacity nor permeability of the corneae could be observed. The mean in vitro score was calculated as 0.76.
- The positive control (10% (w/v) Benzalconium chloride) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as very severe eye irritant. The mean in vitro score was calculated as 163.40.
- The test item cobalt naphthenate did not cause any permeability or opacity of the corneae compared with the results of the negative control. The calculated mean in vitro score was 1.11 and therefore, the test item was classified as non eye irritant.
Any other information on results incl. tables
The following formula was used to determine the in vitro score of the negative control:
In vitro Score = opacity value + (15 x OD490value)
The following formula was used to determine the in vitro score of the positive control and the test item:
In vitro Score = (opacity value – opacity valuemean negative control) + (15 x corrected OD490value)
The in vitro score was calculated for each individual treatment and positive control cornea. The mean in vitro score value of each treated group was calculated from the individual in vitro score values.
Depending on the score obtained, the test item was classified into one of the following categories:
In vitro Irritation Score |
Proposed in vitro Irritation Scale |
0 - 3 |
Non eye irritant |
3.1 – 25 |
Mild eye irritant |
25.1 – 55 |
Moderate eye irritant |
≥ 55.1 |
Severe eye irritant EU (R41) or EPA/GHS (Category 1, H318) |
Applicant's summary and conclusion
- Interpretation of results:
- other: not severely eye irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test item cobalt naphthenate is not corrosive to the eye according to regulation (EC) No.: 1272/2008 and directive 67/548/EC.
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