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Diss Factsheets
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EC number: 248-374-6 | CAS number: 27253-32-3
- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2018-01-31
- Reliability:
- other: A reliability rating is not applicable. A pre-test on applicability of the test system (in accordance with OECD 437) was performed in an external laboratory with expertise in the respective GLP studies. Thus,results are assumed being reliable.
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- A pre-test on the applicability of the test system (in accordance with OECD 437) was conducted. Due to the physical form of the test items scheduled for the testing in the bovine corneal opacity and permeability assay, being pasty and sticky semi-liquid, a feasibility test was performed on a representative test substance (Bismuth (3+) neodecanoate) to assess whether the system is compatible with the substance manganese neodecanoate displaying similar properties.
The assay uses isolated corneas obtained as a by-product from animals freshly slaughtered at an abattoir, e.g. A. Moksel AG, Buchloe, Germany.
On the test day, fresh eyes are collected from the slaughterhouse and are transported in HBSS containing Pen/Strep on ice to the laboratories. Immediately after arrival of the eyes, cornea preparation is initiated.
The tissue surrounding the eyeball is carefully pulled away and the cornea is excised leaving a 2 to 3 mm rim of sclera. The corneas are mounted in corneal holders.
The chambers of the corneal holder are then filled with RPMI (without phenol red) containing 1% FBS and 2 mM L-glutamine (complete RPMI). The corneas are incubated for one hour at 32 ± 1 °C for equilibration. After the equilibration period, the medium is removed from both chambers and replaced with fresh complete RPMI. An initial measurement is performed on each of the corneas using the opacitometer. Afterwards the medium is removed from the anterior chamber and replaced with the test item or control. After incubation the test item or control substance is removed and the epithelium washed at least three times with MEM (containing phenol red). Once the medium is free of test substance, the cornea is finally be rinsed with complete RPMI (without phenol red). Second illuminance measurements are performed.
After the illuminance measurement medium is removed from both chambers of the holder. The posterior chamber is refilled with fresh complete RPMI and is incubated for 90 minutes at 32 ± 1 °C. Afterwards optical density is determined, using a spectrophotometer. - GLP compliance:
- no
Test material
- Reference substance name:
- Bismuth(3+) neodecanoate
- EC Number:
- 251-964-6
- EC Name:
- Bismuth(3+) neodecanoate
- Cas Number:
- 34364-26-6
- Molecular formula:
- C10H19O2.xBi
- IUPAC Name:
- bismuth neodecanoate
- Test material form:
- other: highly viscous, sticky
- Details on test material:
- - State of aggregation at room temperature: highly viscous, sticky, light yellow
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in a sealed container
OTHER SPECIFICS: The pre-test was conducted with a representative sample displaying pasty and sticky semi-liquid properties.
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: abattoir A. Moksel AG, Buchloe, Germany
- Storage, temperature and transport conditions of ocular tissue: fresh eyes were collected from the slaughterhouse and were transported in HBSS containing Pen/Strep on ice to the laboratories
- Time interval prior to initiating testing: immediately after arrival of the eyes.
Test system
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- not specified
- Duration of treatment / exposure:
- not specified
- Duration of post- treatment incubation (in vitro):
- not required, since only a pre-test on applicability was conducted
- Number of animals or in vitro replicates:
- 1 cornea was incubated with the test material (pre-test on applicability)
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
- tissue surrounding the eyeball was pulled away and the cornea was excised.
- isolated corneas were mounted in corneal holders
- the chambers of the corneal holder were then filled with pre-warmed RPMI (without phenol red) containing 1% FBS and 2 mM L-glutamine (complete RPMI).
- corneas were incubated for one hour at 32 ± 1 °C for equilibration in an incubator.SELECTION AND PREPARATION OF CORNEAS
QUALITY CHECK OF THE ISOLATED CORNEAS
- after the equilibration period, the medium was removed from both chambers and replaced with fresh complete RPMI.
- an initial illuminance measurement was performed on the cornea using the opacitometer.
APPLICATION DOSE AND EXPOSURE TIME
not specified
REMOVAL OF TEST SUBSTANCE/CONTROL SUBSTANCES
- epithelium was washed at least three times with MEM (containing phenol red).
- once the medium was free of test substance, the cornea was finally rinsed with complete RPMI (without phenol red).
METHODS FOR MEASURED ENDPOINTS
-the applicability of the test system was evaluated visually. In case the test material cannot be completely removed from the cornea without damaging the cornea, testing is considered technically not feasible.
Results and discussion
In vitro
Results
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Since the physical form of the manganese neodecanoate was identified as being intrinsically sticky, a pre-test was conducted in order to evaluate the feasibility of testing: A representative test item displaying similar properties (intrinsically sticky) was tested in a pre-test on one single tissue. The test material was examined for its suitability for the eye irritation testing using the BCOP assay. As the test material is highly sticky, it was not possible to remove the test material from the corneal chamber and to wash it off from the epithelium after incubation. Therefore, remaining test item would have an impact on subsequent opacity and permeability measurements. Due to the intrinsic properties (sticky) of the test item, testing was technically not feasible.
- Other effects / acceptance of results:
- Due to technical limitations, the study cannot be performed according to the guideline OECD439 and therefore the study is cancelled. Please refer to the field "Attached full study report".
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Since the physical form of the manganese neodecanoate was identified as being intrinsically sticky, a pre-test was conducted in order to evaluate the feasibility of testing: A representative test item displaying similar properties (intrinsically sticky) was tested in a pre-test on one single tissue.
Pre-test with one bovine cornea was performed with Bismuth neodecanoate. Due to the test items characteristics it was not possible to remove the substance from the corneal chamber and to wash it off from the epithelium after incubation. Therefore, remaining test item would have an impact on subsequent opacity and permeability measurements and BCOP-Assay is not feasible for this test substance.
The test item, manganese neodecanoate was examined by the respective study director. The study director did not recommend BCOP-Assay for classification of manganese neodecanoate due to the physical properties (sticky).
Sticky Substances will adhere to the cornea and it will not be possible to remove it without damaging the cornea. Due to these technical limitations the BCOP assay is not recommended for these substances and therefore the studies were cancelled because the studies cannot be performed according to the guideline OECD437.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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