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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-06-12 to 2017-06-16
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
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
Principles of method if other than guideline:
The solubility of the test item is below 0.01 g/L, so the column elution method should be applied according to the guideline. However, column elution method is not feasible with this test item, because coating of the support material is not possible due to the low solubility of the test item in any solvent. Therefore, the flask method was applied.
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
0.95 mg/L
Conc. based on:
act. ingr.
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
3.3
Details on results:
The emasured concentrations were contant within +/- 15% and thus within the range required by the guidelines.

Table 1: Results of the determination of the test item concentrations

Sampling time   Measured concentration of the test item [mg/L] Measured pH
Test vessels Mean with the 95% confidence intervals
After 24 hours

0.87

0.86

1.01

 0.91 ± 0.21

3.38

3.37

3.37
After 48 hours

1.04

0.87

0.89

  0.94 ± 0.22

3.35

3.35

3.35  
 After 72 hours

1.01

0.96

1.00

  0.9 ± 0.07

3.31

3.32

3.32
Solubility of the test item (mg/L) 0.95 ± 0.06 -    
RSD%  8 -
Ultra-pure water    < LOQ 5.49
Conclusions:
The water solubility of the test item was assessed according to OECD Guideline 105, EU Method A.6 and US EPA OPPTS 830.7840 under GLP conditions. The water solubility of the test item was determined to be 0.95 +/- 0.06 (95% confidence interval) at 20 °C +/- 1 °C using the shake-flask method.
Executive summary:

The water solubility of the test item was assessed according to OECD Guideline 105, EU Method A.6 and US EPA OPPTS 830.7840 under GLP conditions. The solubility of the test item is below 10-2 g/L, so the column elution method should be applied according to the guideline. However, column elution method is not feasible with this test item, because coating of the support material is not possible due to the low solubility of the test item in any solvent. Therefore, the shake-flask method was applied. In result, the water solubility of the test item was determined to be 0.95 +/- 0.06 (95% confidence interval) at 20 °C +/- 1 °C.

Description of key information

The water solubility of the substance was determined to be 0.95 ± 0.06 mg/L (95% confidence interval)  at 20 °C ± 1 °C using the shake-flask method for the performance.

Key value for chemical safety assessment

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

Additional information

The water solubility of the test item was assessed according to OECD Guideline 105, EU Method A.6 and US EPA OPPTS 830.7840 under GLP conditions. The shake-flask method was applied. The water solubility of the test item was determined to be 0.95 +/- 0.06 (95% confidence interval) at 20 °C +/- 1 °C.