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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

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding):
- Preliminary purification step (if any):
- Final concentration of a dissolved solid, stock liquid or gel:
- Final preparation of a solid (e.g. stock crystals ground to fine powder using a mortar and pestle):

FORM AS APPLIED IN THE TEST (if different from that of starting material)
- Specify the relevant form characteristics if different from those in the starting material, such as state of aggregation, shape of particles or particle size distribution:
Key result
Water solubility:
3.8 mg/L
Conc. based on:
element
Remarks:
silicon
Incubation duration:
24 h
Temp.:
20 °C
pH:
8.5
Key result
Water solubility:
10.4 mg/L
Conc. based on:
element
Remarks:
calcium
Incubation duration:
24 h
Temp.:
20 °C
pH:
8.5
Key result
Water solubility:
4.2 mg/L
Conc. based on:
element
Remarks:
silicon
Incubation duration:
48 h
Temp.:
20 °C
pH:
9.6
Key result
Water solubility:
9.8 mg/L
Conc. based on:
element
Remarks:
calcium
Incubation duration:
48 h
Temp.:
20 °C
pH:
9.6
Details on results:
The pH of the samples increased with 8.5 and 9.6. That of the preliminary sample was 10.4. It was not clear whether pH was having an effect on the solubility or why the pH increased with shaking time. The loading rate was four times more for the preliminary test than for the main test. If a higher loading rate causes a higher pH then that may increase the solubility. Therefore, loading rate would be critical as to what solubility is achieved. If shaking time increases pH then this would affect the solubility result also.
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 10.4 and 9.8 mg/L for calcium and 3.8 and 4.2 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)