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Water solubility

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Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 April 2021 - May 2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes
Type of method:
flask method
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier): Imerys

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in the dark
Key result
Water solubility:
10.5 mg/L
Conc. based on:
element
Remarks:
Calcium
Incubation duration:
24 h
Temp.:
20 °C
pH:
10.2
Remarks on result:
other: Range: 10.5 to 48.4 mg/L at 20.0 ± 0.5 ºC
Key result
Water solubility:
4.7 mg/L
Conc. based on:
element
Remarks:
Silicon
Incubation duration:
24 h
Temp.:
20 °C
pH:
10.2
Remarks on result:
other: Range: 4.70 to 33.1 mg/L at 20.0 ± 0.5 ºC
Key result
Water solubility:
10.7 mg/L
Conc. based on:
element
Remarks:
Calcium
Incubation duration:
48 h
Temp.:
20 °C
pH:
9.6
Remarks on result:
other: Range: 10.5 to 48.4 mg/L at 20.0 ± 0.5 ºC
Key result
Water solubility:
5.17 mg/L
Conc. based on:
element
Remarks:
Silicon
Incubation duration:
48 h
Temp.:
20 °C
pH:
9.6
Remarks on result:
other: Range: 4.70 to 33.1 mg/L at 20.0 ± 0.5 ºC
Key result
Water solubility:
48.4 mg/L
Conc. based on:
element
Remarks:
Calcium
Incubation duration:
72 h
Temp.:
20 °C
pH:
8.5
Remarks on result:
other: Range: 10.5 to 48.4 mg/L at 20.0 ± 0.5 ºC
Key result
Water solubility:
33.1 mg/L
Conc. based on:
element
Remarks:
Silicon
Incubation duration:
72 h
Temp.:
20 °C
pH:
8.5
Remarks on result:
other: Range: 4.70 to 33.1 mg/L at 20.0 ± 0.5 ºC
Details on results:
Preliminary Test
The preliminary estimate of the water solubility at 20.0 ± 0.5 °C is shown in Table 2 below.

Definitive Test
The mean counts per second relating to the standard and sample solutions are shown in the
Table 3 below.
The concentration (mg/L) of test item in the sample solutions is shown in Table 4 below.

Table 2 Preliminary Results



















Concentration (mg/L)



Solution pH



Calcium



Silicon



28.0



11.7



10.4



Table 3 Counts Per Second









































































































Solution



Mean Counts per Second



Calcium



Silicon



Internal Standard



Matrix Blank



438.69



2458.41



28727.56



Standard 1.00 mg/L



10492.73



81901.27



29740.84



Standard 2.51 mg/L



25864.18



201543.83



29651.86



Standard 5.02 mg/L



50375.18



404143.70



29720.91



Standard 10.0 mg/L



92707.28



739154.23



28243.21



Standard 10.0 mg/L



90442.60



720630.05



27035.42



Standard 15.1 mg/L



127931.33



1026086.41



26563.14



Standard 20.1 mg/L



159899.18



1259745.08



24849.67



Matrix blank



404.02



2443.64



25837.71



Sample 1A



46579.16



169132.28



26057.00



Sample 1B



44064.21



167083.56



26048.19



Sample 2A



44228.87



178279.61



25425.08



Sample 2B



46331.05



182269.63



25750.96



Sample 3A



197974.19



1069064.05



25445.05



Sample 3B



191535.11



1045135.00



24662.64



Table 4 Results





































Sample Number



Time Shaken at ~ 30oC (hours)



Concentration (mg/L)



Solution pH



Calcium



Silicon



1



24



10.5



4.70



10.2



2



48



10.7



5.17



9.6



3



72



48.4



33.1



8.5



 


 

Conclusions:
The water solubility of the test item has been determined to be over the ranges of 10.5 to 48.4 mg/L for calcium and 4.70 to 33.1 mg/L for silicon in solution at 20.0 ± 0.5 °C.
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Testing was conducted between 10 March 2010 and 26 March 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Water solubility:
3.7 mg/L
Temp.:
20 °C
pH:
3

The counts per second relating to the standard and sample solutions are shown in table 2.

Table 2:

Solution

Counts per second

Matrix blank

4.005 x 105

Standard 1.0 x 10-2mg/L

4.181 x 105

Standard 5.0 x 10-2mg/L

4.395 x 105

Standard 0.10 mg/L

4.955 x 105

Standard 0.10 mg/L

4.900 x 105

Standard 0.50 mg/L

8.659 x 105

Standard 1.00 mg/L

1.368 x 106

Sample 1A

1.082 x 106

Sample 1B

1.115 x 106

Sample 2A

1.850 x 106

Sample 2B

1.790 x 106

Sample 3A

1.383 x 106

Sample 3B

1.370 x 106

The concentration (g/L) of test material in the sample solutions is shown in table 3:

 

Table 3:

Sample number

Time shaken at ~30°C (hours)

Time equilibrated at 20°C (hours)

Concentration (g/L)

Solution pH

1

24

24

1.91 x 10-3

3.0

2

48

24

3.87 x 10-3

3.1

3

72

24

2.66 x 10-3

3.0

 

Discussion:

The preliminary test was considered unnecessary in this instance as the test material was anticipated to be essentially insoluble in water.

 

The linearity of the detector response with respect to the concentration was assessed over the concentration range of 0 to 0.400 mg/L. This was satisfactory with a correlation coefficient of 0.999 being obtained.  

 

The results for samples 1 to 3 were somewhat variable and indicated no trend. However, a review of the chemical formula of the test material indicated that the above solutions would be essentially stable towards degradation, etc. Consequently, the variability in the results was considered to be due to non-uniformity of the test material as opposed to any issues with the test.

 

The highest result determined (sample) 2 has been given as a limit value for environmental assessment purposes.

Conclusions:
The water solubility of the test material has been determined to be less than or equal to 3.7 mg/L of solution at 20.0± 0.5°C. The test material has been determined to be essentially insoluble in water.
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, non GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
no
Type of method:
flask method
Key result
Water solubility:
11 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
7
Details on results:
Solubility increased with time, but did not exceed 15 %.
Conclusions:
Slightly soluble (0.1-100 mg/L)

Description of key information

The water solubility of the test material has been determined to be 10.5 and 10.7 mg/L for calcium and 4.70 and 5.17 mg/L for silicon. These represent the 24 and 48 hour shaking times.


 The test material has been determined to be essentially poorly soluble in water.  

Key value for chemical safety assessment

Additional information

Results are based on a key study performed to GLP and OECD guideline 105 (Fox 2021)