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Physical & Chemical properties

Water solubility

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Administrative data

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2016-01-27 to 2016-03-15
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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Noack Laboratorien GmbH, Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany
Type of method:
flask method
Key result
Water solubility:
742 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
5.6 g/L
Incubation duration:
72 h
Temp.:
20 °C
pH:
6.2
Details on results:
Preliminary Test (non GLP)
The determined solubility in double distilled water was in the range of 0.56 - 1.12 g/L For the application dose for the definitive study, 5.6 g/L, as ca. the fivefold of the maximum solubility result, was used.
  
Method Validation 
The method showed acceptable results for linearity, accuracy, precision and specificity according to SANCO 3029/99 rev.4 (2000) and fulfilled all requirements.
 
Check of the pH-Value 
The pH-values were determined with the remaining test item mixtures in the original test vessels, which were kept constant at 20 ± 0.5 °C.

Test temperature [°C]

 

Preincubation time [h]

Replicate

 

Measured pH

 

Mean value

20

24

1

6.171

6.2

2

6.001

48

1

6.332

2

6.184

72

1

6.025

2

6.374

Control

6.504

 

 

Water Solubility Results at 20 °C

 

Preincubation time [h]

Replicate

Test item [mg/L]

Concentration

mean

24

1

744

 

2

749

 

48

1

742

 

2

750

 

72

1

728

 

2

738

 

Mean (24 - 72 h)

 

 

742

Deviation [%] (24 - 72 h)

 

 

1.9

 

Conclusions:
The water solubility of the test item was determined to be 742 mg/L at 20 ± 0.2 °C.
Executive summary:

A study was conducted according to OECD Guideline 105 for Testing of Chemicals (1995) and Council Regulation (EC) No. 260/2014, Method A.6. The solubility of the test item was determined using the flask method at 20 ± 0.5 °C with pre-incubation at 30 ± 0.5 °C. The analytical method (HPLC-DAD, external standard) for the determination of the test item was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity. The water solubility of the test item was determined to be: 742 mg/L (20 °C, pH 6.2).

Description of key information

The water solubility of the test item was determined to be 742 mg/L at 20 ± 0.2 °C.

Key value for chemical safety assessment

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

Additional information

A study was conducted according to OECD Guideline 105 for Testing of Chemicals (1995) and Council Regulation (EC) No. 260/2014, Method A.6. The solubility of the test item was determined using the flask method at 20 ± 0.5 °C with pre-incubation at 30 ± 0.5 °C. The analytical method (HPLC-DAD, external standard) for the determination of the test item was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity. The water solubility of the test item was determined to be: 742 mg/L (20 °C, pH 6.2).