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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 August 2017 to 20 September 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2014
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method
Key result
Water solubility:
2.45 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
>= 7.9 - <= 8
Details on results:
- Preliminary Test: The content of test material dissolved in the water sample was 2.24 mg/L.

- Main Study: The results for the samples taken at a flow rate of 12 and 24 mL/h are given in Table 1. The coefficient of variation (CV) (n = 10 at a flow rate of 24 mL/h and n=6 at a flow rate of 12 mL/h) was ≤ 30 % at both flow rates. It demonstrated that the system was equilibrated at all flow rates. The concentrations of last four measurements of the 12 mL/h test were clearly above the rest of the aliquots (approximately one order of magnitude). This effect was not observed for the m/z 118 for Sn and m/z 182 for W (see paragraph 8.1.1). Therefore, they were not considered for the determination of the Mean Concentration. The maximum difference (MD) on the mean values of the samples at both flow rates was also ≤ 30 %. Based on this, the water solubility of the test material is given as the mean value of these measurements. The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates. Small responses in the samples from the blank column were observed. Responses were similar to the responses in the analytical blanks.

Table 1: Main study - water solubility of the test material

Flow rate

[mL/h]

Sample no.

Concentration analysed

pH

Individual
[mg/L]

Mean1
[mg/L]

CV
[%]

Mean2
[mg/L]

MD
[%]

 

24

1

2.11

2.18

3.7

2.45

22

8.0

2

2.07

3

2.29

4

2.27

5

2.28

6

2.18

7

2.23

8

2.13

9

2.11

10

2.14

12

1

2.63

2.73

4.2

 

 

7.9

2

2.63

3

2.70

4

2.68

5

2.81

6

2.92

7

6.663

8

22.53

9

33.33

10

35.53

1    Mean of the concentrations obtained at one flow rate.

2    Mean of the concentrations obtained at both flow rates.

3     Values not used for calculation of the mean concentration since not in the same order of magnitude as the first six measured concentrations.

Conclusions:
Under the conditions of this study, the water solubility of the test material at 20 °C was 2.45 mg/L. The pH of the aqueous samples was 7.9 and 8.0.
Executive summary:

The water solubility of the test material was investigated in accordance with the standardised guidelines OECD 105, EU Method A.6. and OPPTS 830.7840, under GLP conditions.

The column elution method was applied for the determination of the water solubility ofthe test material in the main study as the content of test material dissolved in the water sample was 2.24 mg/L, in the preliminary test.

The coefficient of variation (CV) (n = 10 at a flow rate of 24 mL/h and n=6 at a flow rate of 12 mL/h) was≤ 30 % at both flow rates. It demonstrated that the system was equilibrated at all flow rates. The concentrations of last four measurements of the 12 mL/h test were clearly above the rest of the aliquots (approximately one order of magnitude). This effect was not observed for the m/z 118 for Sn and m/z 182 for W. Therefore, they were not considered for the determination of the Mean Concentration. The maximum difference (MD) on the mean values of the samples at both flow rates was also≤ 30 %. Based on this, the water solubility of the test material is given as the mean value of these measurements. The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates. Small responses in the samples from the blank column were observed. Responses were similar to the responses in the analytical blanks.

Under the conditions of this study, the water solubility of the test material at 20 °C was 2.45 mg/L. The pH of the aqueous samples was 7.9 and 8.0.

Description of key information

Under the conditions of this study, the water solubility of the test material at 20 °C was 2.45 mg/L. The pH of the aqueous samples was 7.9 and 8.0.

Key value for chemical safety assessment

Water solubility:
2.45 mg/L
at the temperature of:
20 °C

Additional information

The water solubility of the test material was investigated in accordance with the standardised guidelines OECD 105, EU Method A.6. and OPPTS 830.7840, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The column elution method was applied for the determination of the water solubility ofthe test material in the main study as the content of test material dissolved in the water sample was 2.24 mg/L, in the preliminary test.

The coefficient of variation (CV) (n = 10 at a flow rate of 24 mL/h and n=6 at a flow rate of 12 mL/h) was≤ 30 % at both flow rates. It demonstrated that the system was equilibrated at all flow rates. The concentrations of last four measurements of the 12 mL/h test were clearly above the rest of the aliquots (approximately one order of magnitude). This effect was not observed for the m/z 118 for Sn and m/z 182 for W. Therefore, they were not considered for the determination of the Mean Concentration. The maximum difference (MD) on the mean values of the samples at both flow rates was also≤ 30 %. Based on this, the water solubility of the test material is given as the mean value of these measurements. The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates. Small responses in the samples from the blank column were observed. Responses were similar to the responses in the analytical blanks.

Under the conditions of this study, the water solubility of the test material at 20 °C was 2.45 mg/L. The pH of the aqueous samples was 7.9 and 8.0.