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Physical & Chemical properties

Water solubility

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Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
from 06 DEC 2005 to 15 JAN 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
and EU method A6 (water solubility) (in the report : EEC directive 92/69, A6)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method
Water solubility:
< 0.123 µg/L
Temp.:
20 °C
pH:
6.01 - 6.41
Details on results:
The measured results differ by less than 30%. Therefore, the study is considered to be valid.The water solubility was calculated including the content of the test item given in the certificate of analysis.

Table 1: Results of the water solubility of cerium dioxide

Experiment No.

Flow rate

(mL/h)

Sample No.

Concentration analysed (µg Cerium/L)

Mean (µg Cerium/L)

Water solubility calculated * (µg Test item/L)

Water solubility calculated (µg Test item/L)

pH

1

31

1.1

1.2

< 0.1

< 0.1

< 0.1

< 0.123

 

6.41

1

31

2.1

2.2

< 0.1

< 0.1

< 0.1

< 0.123

 

6.12

1

31

3.1

3.2

< 0.1

< 0.1

< 0.1

< 0.123

 

6.08

1

31

4.1

4.2

< 0.1

< 0.1

< 0.1

< 0.123

 

6.01

1

31

5.1

5.2

< 0.1

< 0.1

< 0.1

< 0.123

 

6.26

1

31

6.1

6.2

< 0.1

< 0.1

< 0.1

< 0.123

 

6.17

2

16

7.1

7.2

< 0.1

< 0.1

< 0.1

< 0.123

< 0.123 ± 0.0

6.34

2

16

8.1

8.2

< 0.1

< 0.1

< 0.1

< 0.123

 

6.21

2

16

9.1

9.2

< 0.1

< 0.1

< 0.1

< 0.123

 

6.20

2

16

10.1

10.2

< 0.1

< 0.1

< 0.1

< 0.123

 

6.30

2

16

11.1

11.2

< 0.1

< 0.1

< 0.1

< 0.123

 

6.35

2

16

12.1

12.2

< 0.1

< 0.1

< 0.1

< 0.123

 

6.15

SD = Standard deviation

* calculated with a content of cerium = 81.2455%

 

Conclusions:
The water solubility of cerium dioxide is < 0.123 µg/L at 20°C and therefore considered insoluble (< 0.1 mg/L).
Executive summary:

The determination of the water solubility of cerium dioxide was performed according to the EEC Directive 92/69, A.6 “Water Solubility” (1992) and the OECD guideline No. 105, “Water Solubility” (adopted July 27, 1995), using the column elution method.

During the pre-tests, the water solubility of the test item at room temperature was estimated to be < 10 mg/L by visual judgement. Therefore, the column elution method was used for the performance of the main test.

During the main test six samples have been analysed in the first run (0.52 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 94 hours.

The water solubility calculated on the basis of cerium content and purity of the test item is < 0.123 µg/L at 20°C .

The pH of the solution was between 6.01 and 6.41.

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2008-02-25 to 2009-11-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
certificate provided by Rheinlandpfalz
Type of method:
column elution method
Water solubility:
< 55 µg/L
Temp.:
20 °C
pH:
6.5
Details on results:
Limit of detection was calculated from the calibrated range to be 40.8 µg/L Zr, corresponding to 55 µg/L ZrO2. As none of the samples showed a signal at the voltage of the Zr-Alizarin-peak, concentration in the samples and therefore water solubility was considered to lie below LOD.
No observations arousing doubts concerning the accuracy of the results and the validity of the study were made.
Conclusions:
Interpretation of results: insoluble (< 0.1 mg/L)
The water solubility of the test item was found to be < 55 µg/L at a temperature of 20 +/- 0.5 degrees C and a pH of 6.5.
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Data in this peer-reviewed publication were taken from many sources, including both compilations and primary literature. Where conflicts were found, the value deemed most reliable was chosen for inclusion in the handbook. Reference sources were not provided for this parameter, nor were the experimental methods.
GLP compliance:
not specified
Remarks on result:
other: test substance is insoluble in water and is only slightly soluble in acid
Details on results:
It was reported that the test subsance is insoluble in water and is only slightly soluble in acid.
Conclusions:
Under the test conditions it was reported that the test substance is insoluble in water and only slightly soluble in acid.
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Data in this peer-reviewed publication were taken from many sources, including both compilations and primary literature. Where conflicts were found, the value deemed most reliable was chosen for inclusion in the handbook. Reference sources were not provided for this parameter, nor were the experimental methods.
GLP compliance:
no
Remarks on result:
other: test substance is practically insoluble in water; slightly soluble in HCl, HNO3.
Details on results:
Practically insoluble in water; slightly soluble in HCl, HNO3
Conclusions:
Under the test conditions it was reported that the test substance is practically insoluble in water; slightly soluble in HCl, HNO3.
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
The references mentioned in this endpoint study record only contain qualitative information, without numeric values for water solubility.
Qualifier:
no guideline available
Principles of method if other than guideline:
No data.
GLP compliance:
no
Remarks on result:
other: not soluble in water or organic solvents
Details on results:
not soluble in water or organic solvents
Conclusions:
Cerium oxide was not soluble in water or organic solvents.
Endpoint:
water solubility
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
Read across from water solubility data on the constituents cerium dioxide and zirconium dioxide which are used as supporting information for the reaction mass of cerium dioxide and zirconium dioxide. The read across justification document is attached to IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Remarks on result:
other: The water solubility data on CeO2 and ZrO2 support the conclusion that the reaction mass of CeO2 and ZrO2 is insoluble in water.
Remarks:
CeO2 and ZrO2 were determined to be insoluble in water.
Details on results:
An experimental study performed on cerium dioxide, scored as Klimisch 1 (Weissenfeld, 2007) indicates a water solubility of < 0.123 µg/L, and literature information, scored as Klimisch 4 (three sources), also available for cerium dioxide, indicates consistently this compound to be not soluble in water.
An experimental study performed on zirconium dioxide, scored as Klimisch 1 (Paulus, 2010) indicates a water solubility of < 55 µg/L, and literature information, scored as Klimisch 2 (two sources), also available for zirconium dioxide, indicates consistently this compound to be (practically) insoluble in water.
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 23-july-2007 to 18-july-2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method
Key result
Water solubility:
0.16 µg/L
Temp.:
20 °C
pH:
>= 6.76 - <= 6.95
Details on results:
The measured results differ by less than 30%. Therefore, the study is considered to be valid.

Table 1: Water solubility (Column-Elution-Method)

Experi-ment

No.

Flow rate

(mL/h)

Sample No.

Concentra-

tion analysed *

(µg Ce/L)

Water solubility calculated **

(µg Test item/L)

Water solubility calculated

(µg Test item/L)

Water solubility calculated

(µg Test item/L)

pH

1

31

1

2

3

4

5

6

0.062***

0.062***

0.062***

0.062***

0.062***

0.062***

0.139

0.139

0.139

0.139

0.139

0.139

0.139

0.16

SD = ± 0.03

Srel = ± 17.70%

6.90

6.89

6.95

6.82

6.76

6.81

2

16

7

8

9

10

11

12

0.067

0.071

0.074

0.101

0.076

0.088

0.150

0.159

0.166

0.226

0.170

0.197

0.178

SD = ± 0.03

Srel = ± 15.97%

6.78

6.93

6.76

6.79

6.86

6.95

SD = Standard deviation

* values measured by ICP / MS

** calculated with a content of cerium in the test item = 48.73%, a purity of the test item = 98.92% and a dilution factor of 1.08

*** the concentration has been analysed and found to be below LOQ (0.062 µg Ce/L) but above LOD (0.018 µg Ce/L)

Conclusions:
The water solubility of the test Item was found to be 0.16 µg/L (standard deviation ± 0.03 µg/L) at 20°C and therefore considered insoluble.
Executive summary:

The determination of the water solubility of the reaction mass of cerium dioxide and zirconium dioxide was performed according to the EEC Directive 92/69, A.6 Water Solubility (1992) and OECD guideline No. 105, Water Solubility (adopted July 27, 1995), using the column elution method.

During pre-tests the water solubility of the test item at room temperature was estimated to be < 9.47 mg/L by visual judgement. Therefore, the column elution method was used for the performance of the main test.

During the main test six samples have been analysed in the first run (0.52 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 143 hours.

The water solubility was calculated including the content of the test item given in the certificate of analysis.

The water solubility of the test item at 20°C was determined to be 0.16 µg/L (standard deviation ± 0.32 µg/L) using the column elution.

Description of key information

The water solubility of the reaction mass of cerium dioxide and zirconium dioxide was determined following the OECD 105 and EC A.6 test methods to be 0.16 µg/L at 20 °C (Weissenfeld, 2008). The study was performed on a representative nanoform of the reaction mass. The water solubility of any potential bulk form, should such form be placed on the market, can reasonably be expected to be even lower than that obtained for the representative nanoform.

Key value for chemical safety assessment

Water solubility:
0.16 µg/L
at the temperature of:
20 °C

Additional information

An experimental study performed on cerium dioxide, scored as Klimisch 1 (Weissenfeld, 2007), indicates a water solubility of < 0.123 µg/L, and literature information, scored as Klimisch 4 (three sources), also available for cerium dioxide, indicates consistently this compound to be not soluble in water.

An experimental study performed on zirconium dioxide, scored as Klimisch 1 (Paulus, 2010) indicates a water solubility of < 55 µg/L, and literature information, scored as Klimisch 2 (two sources), also available for zirconium dioxide, indicates consistently this compound to be (practically) insoluble in water.

Data on these constituents are used as supporting information in a read across analogue approach.