Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-06-08 to 2009-08-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: - Compliant to GLP - Compliant with OECD guideline 105

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): beryllium powder
- Substance type: metal
- Physical state: solid powder
- Analytical purity: 99.4 %
- Lot/batch No.: O-30H Grade/Blend# 051106
- Expiration date of the lot/batch: December 31, 2050
- Stability under test conditions: stable
- Storage condition of test material: Stored in a dry area

Results and discussion

Water solubility
Water solubility:
< 0.5 µg/L
Temp.:
20 °C
pH:
6.11
Details on results:
During pre-tests the water solubility of the test item at room temperature was estimated to be < 1 g/l by visual judgment and to be below 10 mg/l by a simplified flask test. Therefore, the column elution method was used for the performance of the main test.
During the main test six samples have been analyzed in the first run (0.53 ml/min) and six samples during the second run (0.26 ml/min), each with a sampling interval of one hour. Total elution time was 140.5 hours. The sample measurement was performed by AAS.
The measured results differ by less than 30 %. Therefore, the study is considered to be valid.

Any other information on results incl. tables

Table1       Results of the Water Solubility of Beryllium Metal Powder

Experiment No.

Flow rate

Sample No.

Concentration analyzed

Water solubility
calculated

pH

pH mean

 

[ml/h]

 

[µg/ml]

[µg/l]

 

 

1

32

1

0.00

 

-0.05

6.28

6.11

2

-0.07

 

6.06

3

0.00

-0.026

6.15

4

0.00

SD = ± 0.04

6.18

5

0.00

-Srel = 144.357 %

6.09

6

-0.07

 

6.05

2

16

7

-0.07

 

6.02

8

0.00

 

6.13

9

-0.07

-0.074

6.14

10

0.00

SD = ± 0.06

5.98

11

-0.15

-Srel = 87.313 %

6.10

12

-0.15

 

6.17

 

SD        =    Standard Deviation

SD rel.   =   Relative Standard Deviation

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
During this study the water solubility of beryllium metal powder at 20 °C and a pH value of 6.11 was determined using the column elution method and was found to be below the limit of quantification, which is < 0.5 μg/l.
Executive summary:

The determination of the water solubility of beryllium metal powder was performed according to the OECD guideline No. 105, “Water Solubility” (adopted July 27, 1995) and EC 440/2008, A.6 “Water Solubility” using the column elution method.

During pre-tests the water solubility of the test item at room temperature was estimated to be < 1 g/l by visual judgment and to be below 10 mg/l by a simplified flask test. Therefore, the column elution method was used for the performance of the main test. During the main test six samples have been analyzed in the first run (0.53 ml/min) and six samples during the second run (0.26 ml/min), each with a sampling interval of one hour. Total elution time was 140.5 hours. The sample measurement was performed by AAS. The water solubility of beryllium metal powder at 20 °C and a pH value of 6.11 was determined to be below the limit of quantification, which is 0.5 μg/l. The measured results differ by less than 30 %. Therefore, the study is considered to be valid. Details of the results are given in Table 1. The calibration curve fit was r² = 0.9995 (optimum 1.0000). This reflects the linearity of the AAS-system within the calibration range of 0.5 μg/l to 5.0 μg/l of the test item.