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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2010
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

Constituent 1
Chemical structure
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

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
Tissue 1*

Absorbance 570 nm
Tissue 2*

Absorbance 570 nm
Tissue 3*

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.