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Diss Factsheets
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EC number: 941-064-8 | 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
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- Endpoint summary
- Stability
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- 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
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- Biotransformation and kinetics
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- 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
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- Additional toxicological data
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Remarks:
- other: validated "in vitro" test method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-06-09 to 2011-06-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2009-03-30
Test material
- Reference substance name:
- Neodecanoic acid, cobalt salt
- EC Number:
- 248-373-0
- EC Name:
- Neodecanoic acid, cobalt salt
- Cas Number:
- 27253-31-2
- IUPAC Name:
- Neodecanoic acid, cobalt salt
- Details on test material:
- - Name of test material (as cited in study report): Cobalt neodecanoate
- Storage: 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 9 month old donor cattle were collected from the abattoir. 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:
- other: saline and unchanged
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
Prior to the application the test item was tried to suspend in saline (20% (w/v)) by stirring heavily and additionally treating in an ultrasonic bath. Since the test item could not be suspended sufficiently, 0.75 mL of the insufficient suspension was placed directly onto the corneae. Additionally, the stamp of a syringe was dipped into the test item. A part of the amount sticking on the stamp was applied carefully to the corneae in a manner, that the corneae were covered by the test item evenly. - Duration of treatment / exposure:
- 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.
Prior to the application the test item was tried to suspend in saline (20% (w/v)) by stirring heavily and additionally treating in an ultrasonic bath. Since the test item could not be suspended sufficiently, 0.75 mL of the insufficient suspension was placed directly onto the corneae. Additionally, the stamp of a syringe was dipped into the test item. A part of the amount sticking on the stamp was applied carefully to the corneae in a manner, that the corneae were covered by the test item evenly. The positive control was 10% (w/v) Benzalkonium chloride in saline. Saline was used as negative control item.
The incubation time lasted 240 minutes (± 5 minutes).
After the test item or control items, respectively, were rinsed off from the application side with saline, fresh cMEM was added in both compartments and opacity was measured (t240).
In the second step of the assay, permeability of the cornea 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, 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 vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 0
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - With the negative control neither an increase of opacity nor permeability of the corneae could be observed (mean in vitro irritation score 2.86).
- The positive control showed clear opacity of the corneae (mean in vitro irritation score 305.30) corresponding to a classification as corrosive to the eye (CLP/EPA/GHS (class I)).
- Relative to the negative control, the test item cobalt neodecanoate did not cause an increase of the corneal opacity or permeability. The calculated mean in vitro irritation score was 0.00 and therefore the test item was classified as non eye irritant.
Any other information on results incl. tables
In vitro irritation score calculation:
The following formula was used to determine the in vitro irritation score of the negative control:
In vitro Irritation Score = opacity value + (15 x OD490value)
The following formula was used to determine the in vitro irritation score of the positive control and the test item:
In vitro Irritation Score = (opacity value – opacity valuemean negative control) + (15 x corrected OD490value)
The in vitro irritation score was calculated for each individual treatment and positive control cornea. The mean in vitro score irritation value of each treated group was calculated from the individual in vitro irritation 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:
- GHS criteria not met
- Conclusions:
- The test item cobalt neodecanoate is not corrosive to the eye according to regulation (EC) No.: 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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