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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-02-17 to 2010-02-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to EC 440/2008, B 46 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: EU method B.46: B.46. In vitro skin irritation: Reconstructed human epidermis model test
- Deviations:
- no
- 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
- Type of coverage:
- open
- Vehicle:
- water
- Controls:
- other: positive and negative control treatments were performed simultaneously.
- Amount / concentration applied:
- - Application amount: About 15 mg of the test item were applied to each tissue, wetted with 30 μL deionised water, and spread to match the tissue size.
- Duration of treatment / exposure:
- - Three tissues of the human skin model EpiSkin™ were treated with either the test item, the negative or the positive control for 15 minutes. The test item as well as the positive and negative controls were washed off the skin tissues after 15 minutes treatment.
- Observation period:
- After further incubation for about 42 hours the tissues were treated with the MTT solution for 3 hours following approx. 70 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.
- Number of animals:
- 3 tissue samples were equally treated with either the test item, negative or positive control.
- Details on study design:
- One experiment was performed. Three skin tissues were treated with each 15 mg of the pure test item. The tissues were esposed to the test item for 15 minutes. Afterwards the test item was washed off the tissues and they were incubated for further 42 hours.
Results and discussion
Any other information on results incl. tables
Table 1: Results after treatment with beryllium oxide powder
Dose group |
Treatment Interval |
Absorbance 570 nm |
Absorbance 570 nm |
Absorbance 570 nm |
Mean Absorbance of 3 Tissues |
Standard Deviation |
Rel. Absorbance [% of Negative Control]** |
Negative Control |
15 min |
1.0093 |
0.9923 |
0.9061 |
0.9692 |
5.7 |
100.0 |
Positive Control |
15 min |
0.1306 |
0.1778 |
0.1241 |
0.1441 |
3.0 |
14.9 |
BeO powder |
15 min |
0.9146 |
1.0956 |
0.9980 |
1.0027 |
9.3 |
103.5 |
* Mean
of three replicate wells after blank correction
** relative
absorbance [rounded values]: 100 x absorbance(test item)/absorbance
(negative control)
Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item BeO powder is non irritant to skin.
- Executive summary:
This in vitro study was performed to assess the irritation potential of BeO Powder by means of the Human Skin Model Test.
Three tissues of the human skin model EpiSkin™ were treated with either the test item, the negative or the positive control for 15 minutes. About 15 mg of the test item were applied to each tissue, wetted with 30 μL deionised water, and spread to match the tissue size.
15 μl of either the negative control (deionised water) or the positive control (5% sodium lauryl sulfate) were applied to each tissue.
After treatment with the negative control the absorbance values were well above the required acceptability criterion of mean OD ≥ 0.6 for the 15 minutes treatment interval thus showing the quality of the tissues.
Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 15 minutes treatment interval thus ensuring the validity of the test system.
After treatment with the test item BeO Powder the relative absorbance value was not decreased at all. Compared to the releative absorbance value of the negative control the value even increased to 103.5%. This value is well above the threshold for irritancy of ≤50 %. Therefore, the test item is not considered to possess an irritant potential.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item BeO Powder is non irritant to skin.
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