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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:
from 23 May 2018 to 06 August 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to other study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2016
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
1998
Deviations:
not specified
GLP compliance:
yes
Type of method:
flask method
Water solubility:
0.001 g/L
Incubation duration:
>= 48 - <= 72 h
Temp.:
20 °C
pH:
8.4
Remarks on result:
other: Result in the study report
Key result
Water solubility:
0.002 g/L
Incubation duration:
>= 24 - <= 48 h
Temp.:
20 °C
pH:
>= 8.4 - <= 8.5
Remarks on result:
other: Applicant's result. See "Overall remarks"
Details on results:
- In the study report the water solubility was calculated as the mean value of the 48- and 72-hour measurements (maximum difference <15%) because the 24-hour measurement was higher than the 48- and 72- hour measurements (maximum difference > 15%).
- A small response at the retention time of the test item was detected in the pretreated sample from the blank water mixture. The maximum contribution to the lowest sample (i.e. 72-hour measurement) was 0.021% and was considered negligible.

Table: water solubility results (Flask method)

Stirring time
[hours]

Analyzed concentration
[g/L]

pH

 

 

 

24

0.00152

8.5

 

 

 

48

0.00145

8.4

 

 

 

72

0.00128

8.4

 

 

 

Conclusions:
The water solubility of the substance at 20°C was determined to be 0.0015 g/L.
Executive summary:

The slow-stirring-flask method based on EC A.6, OECD 105 and OPPTS 830.7840 was performed. The study was performed directly at the test temperature of 20°C. Quantification was performed by UPLC-MS/MS. The pH of the aqueous samples was 8.4-8.5. The concentration analyzed after 24 h, 48 h and 72 h was 0.00152 g/L, 0.00145 g/L and 0.00128 g/L, respectively. Considering the continuous decrease in analyzed concentrations in time, it cannot be concluded that saturation equilibrium was reached after 72 hours. As degradation was observed in the hydrolysis study, it is assumed that both dissolving of substance and degradation of dissolved substance occurred in each of the flasks. The mean of the 24 h and 48 h measurements was therefore used as key result. The water solubility of the substance at 20°C was determined to be 0.0015 g/L.

Description of key information

Water solubility at 20°C: 0.0015 g/L (EC A.6, OECD 105 and OPPTS 830.7840: slow-stirring-flask method)

Key value for chemical safety assessment

Water solubility:
0.002 g/L
at the temperature of:
20 °C

Additional information

The pH of the aqueous samples was 8.4-8.5.