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EC number: 807-888-6 | CAS number: 110621-40-4
- 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Aluminum magnesium sodium oxide (Al10.33Mg0.67Na1.67O17)
- EC Number:
- 807-888-6
- Cas Number:
- 110621-40-4
- Molecular formula:
- Al10.33Mg0.67Na1.67O17
- IUPAC Name:
- Aluminum magnesium sodium oxide (Al10.33Mg0.67Na1.67O17)
Constituent 1
- Specific details on test material used for the study:
- Name of test substance: ß''-Alumina (BASF)
Test-substance No.: 16/0110-1
Batch identification: 10978-52 H_K
CAS No.: 110619-69-7
Content: 90.8 % Sodium magnesium aluminium oxide (Na1.67Mg0.67Al10.33O17). Based on the XRD data, performed under non-GLP conditions, a content of approx. 82 g/100 g (90.8% from approx. 90%) of the crystalline fraction Na1.67Mg0.67Al10.33O17 can be calculated.
Identity: Confirmed
Homogeneity: The test substance was homogeneous by visual inspection.
Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility. The test facility is organizationally independent from the BASF SE sponsor division.
ADDITIONAL TEST-SUBSTANCE INFORMATION
pH-value: Ca. 10 (undiluted test substance, moistened with de-ionized water; determined in the lab prior to start of the GLP study. Ca. 12 (20% aqueous preparation; determined in the lab prior to start of the GLP study)
Physical state / color: Solid / white
Storage conditions: Room temperature, protect against humidity
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Isolated bovine cornea: The test system is the isolated bovine cornea. Bovine eyes are obtained as a by-product of freshly slaughtered cattle
(age of the animals: minimum 12 months, maximum 60 months).
Supplier: Schlachthof Mannheim, Schlachthofstr. 21, 68165 Mannheim, Germany
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 μL of the 20% (w/v) test-substance preparation
- Duration of treatment / exposure:
- 4 hours
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean
- Value:
- 244.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: permeability score
- Run / experiment:
- mean
- Value:
- 4.537
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 312.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Mean values for opacity, permeability and IVIS of the test substance, NC and PC
Test substanceidentification |
MeanOpacityValue |
MeanPermeabilityValue |
MeanIn VitroIrritancy Score |
16/0110-1 |
244.8 |
4.537 |
312.8 |
NC |
10.5 |
0.002 |
10.5 |
PC |
79.6 |
3.413 |
130.8 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the results for BCOP and applying the evaluation criteria, ß''-Alumina (BASF) causes ocular corrosion or severe irritation under the test conditions chosen.
- Executive summary:
The objective was to assess the eye irritating potential of ß''-Alumina (BASF). Using the currently available methods a single in vitro assay is not sufficient to cover the full range of eye irritating potential. Therefore, two in vitro assays were part of this in vitro eye irritation test strategy: The Bovine Corneal Opacity and Permeability Test (BCOP Test) and EpiOcular Eye Irritation Test.
BCOP
The potential of the test substance to cause ocular irritation or serious damage to the eyes was assessed by a single topical application of 750 μL of a 20% test-substance preparation to the epithelial surface of isolated bovine corneas. Three corneas were treated with the test-substance preparation for an exposure period of 4 hours.
In addition to the test substance a negative control (NC; de-ionized water) and a positive control (PC; 20% imidazole in de-ionized water) were applied to three corneas each. Corneal opacity was measured quantitatively as the amount of light transmitted through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance.
EpiOcular
The potential of ß''-Alumina (BASF) to cause ocular irritation was assessed by a single topical application of ca. 50 μL bulk volume (about 23 mg) of the undiluted test substance to a reconstructed three-dimensional human cornea model (EpiOcular™). Two EpiOcular™ tissues were incubated with the test substance for 6 hours followed by an 18-hours post-incubation period.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test-substance treated epidermal tissues is compared to that of negative control tissues. The ratio of the values indicates the relative tissue viability. The test substance is able to directly reduce MTT. Therefore, an additional MTT reduction control KC (freeze-killed control tissues) was introduced. The final mean viability of the test-substance treated tissues was 24.5%. Minimal test-substance residues remained on tissue 1 after the washing procedure. However, due to the unambiguous result, this did not impair the evaluation of the study.
Based on the results for BCOP and EpiOcular Test and applying the evaluation criteria, ß''-Alumina (BASF) causes ocular corrosion or severe irritation in the in vitro eye irritation test strategy under the test conditions chosen.
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