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EC number: 215-133-1 | CAS number: 1304-56-9
- 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:
- 2010-01-25 to 2010-02-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD 437 without deviations and fully GLP compliant.
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 437: Bovine opacity and permeability test method for identifying ocular corrosives and severe irritants (September 2009)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Beryllium oxide
- EC Number:
- 215-133-1
- EC Name:
- Beryllium oxide
- Cas Number:
- 1304-56-9
- Molecular formula:
- BeO
- IUPAC Name:
- oxoberyllium
- Details on test material:
- - Name of test material (as cited in study report): beryllium oxide powder
- Substance type: Powder
- Physical state: Solid
- Analytical purity: 99.9 %
- Lot/batch No.: UOX Lot-No 1846-B; Batch No. 0000690266
- Expiration date of the lot/batch: Not applicable
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature (range of 20 ± 5 °C, provided by Harlan Laboratories Ltd.), light protected
Constituent 1
Test system
- Vehicle:
- physiological saline
- Remarks:
- 0.9 % (w/v) NaCl
- Amount / concentration applied:
- Prior to the application the test item was suspended in saline (20% (w/v)). 0.75 mL of a 20 % (w/v) solution of the test item were applied to the isolated corneas
- Duration of treatment / exposure:
- The corneas were exposed to the test item for 4 hours.
- Details on study design:
- Corneas were treated with the test item solution. After 4 hour treatment at 32 ± 2 °C the opacity of the corneas was determined.After the test item or control items, respectively, were rinsed off from the application side by changing cMEM several times, fresh cMEM was replaced in both compartments and opacity was measured (t240).
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 further 90 minutes at 32 ± 2 °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).
Following to the opacity readings, the permeability endpoint was measured as an indication of the integrity of the epithelial cell sheets. After the final opacity measurement was performed, the complete medium was removed from the anterior compartment and replaced by 1 mL of a 0.5% (w/v) fluorescein solution in HBSS. Corneae were incubated again in a horizontal position for 90 minutes in a water-bath at 32 ± 2 °C. Complete medium from the posterior compartment was removed with a 5 mL-syringe, well mixed and the optical density at 490 nm (OD490) was determined with a spectrophotometer.
Results and discussion
In vivo
- 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 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 test item BeO Powder caused opacity of the corneae compared with the results of the negative control, while the permeability of the corneae did not change. The calculated mean in vitro score was 6.69 and therefore, the test item was classified as mild eye irritant.
Any other information on results incl. tables
In Vitro Score Calculation:
The following formula was used to determine the in vitro score of the negative control:
In vitro Score = opacity value + (15 x OD490 value)
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 value mean negative control) + (15 x corrected OD490 value)
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.
Table 2: Results after 240 Minutes Incubation Time
Test Group |
Opacity value = Difference (t240-t0) of Opacity* |
Permeability at 490 nm (OD490)* |
In vitro Score |
Meanin vitroScore |
Proposed in vitro Irritation Scale |
||
|
|
Mean |
|
Mean |
|
|
|
Negative Control |
0 |
-0.33 |
0.066 |
0.056 |
0.99 |
0.50 |
Non eye irritant |
Negative Control |
-1 |
0.052 |
-0.22 |
||||
Negative Control |
0 |
0.049 |
0.74 |
||||
Positive Control |
126.33* |
0.212* |
129.52 |
120.39 |
Very severe eye irritant |
||
Positive Control |
113.33* |
0.273* |
117.43 |
||||
Positive Control |
111.33* |
0.192* |
114.22 |
||||
BeO Powder |
16.33* |
-0.007* |
16.23 |
6.69 |
Mild eye irritant |
||
BeO Powder |
2.33* |
0.005* |
2.41 |
||||
BeO Powder |
1.33* |
0.006* |
1.43 |
*corrected values
Applicant's summary and conclusion
- Interpretation of results:
- other: mildly irritating
- Remarks:
- Criteria used for interpretation of results: other: according to OECD 437: Bovine opacity and permeability test method for identifying ocular corrosives and severe irritants (September 2009)
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item BeO powder is considered to be a mild eye irritant.
- Executive summary:
This in vitro study was performed to assess the corneal irritation and damage potential of BeO Powder by means of the BCOP assay using fresh bovine corneae. After a first opacity measurement of the fresh bovine corneae (t0), the 20 % (w/v) suspension in saline (0.9 % (w/v) NaCl in deionised water) of the test item BeO Powder, the positive, and the negative controls were applied to corneae and incubated for 240 minutes at 32 ± 2 °C.
The posterior chamber contained MEM medium supplemented with sodium bicarbonate and L-glutamine and 1 % fetal calf serum (FCS) (complete medium = cMEM). After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t240). After the opacity measurements permeability of the corneae was determined while application of 1 mL of a fluorescein solution for 90 minutes at 32 ± 2 °C in a horizontal position.
The liquid coming out was measured spectrophotometrically. With the negative control (0.9 % NaCl solution) neither an increase of opacity nor permeability of the corneae could be observed. 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 test item BeO Powder caused opacity of the corneae compared with the results of the negative control, while the permeability of the corneae did not change.
The calculated mean in vitro score was 6.69 and therefore, the test item was classified as mild eye irritant.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item BeO powder is considered to be a mild eye irritant.
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