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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:
09 Oct 2015 - 10 Nov 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2014
GLP compliance:
yes (incl. certificate)
Remarks:
Staatliches Gewerbeaufsichtsamt Hildeshelm
Type of method:
flask method
Key result
Water solubility:
1 655 mg/L
Conc. based on:
test mat.
Incubation duration:
24 - 72 h
Temp.:
20 °C
pH:
5.2

Results

 

Preliminary Test (non GLP)

The determined solubility was in the range of 0.149 - 0.238 g/L. For the application dose of the first definitive study, 1.2 g/L, as an approx, fivefold of the solubility result, was used. As the test item was dissolved during this first test, the definitive test was repeated with a tenfold of the first application dose (12 g/L).

 

Main test

 

Water solubility results at 20 °C

Pre-incubation time

Replicate No.

Concentration1) (g/L)

Mean

24 h

1

1767

1740

2

1714

48 h

1

1548

1634

2

1721

72 h

1

1618

1590

2

1562

Mean (24 – 72 h)

SD

1655

Deviation (%) (24 – 72)2)

CV (%)

9.5

 

1) Mean value of double injections, dilution factor of 40 and weighing factor taken into account

2) Calculated according to the formula:

Deviation [%] = 100 x (max value - min value) / min value

SD Standard deviation

CV Coefficient of variation

 

No significant signal was determined for the control sample.

Validity Criteria

The study was performed based on OECD Guideline 105 for Testing of Chemicals (1995) and Council Regulation (EC) No. 260/2014, Method A.6. The validity criteria were fulfilled:

 

-       The concentration measured did not differ by more than 15 %.

-       Temperatures were kept constant within ± 0.5 °C.

 

Conclusions

The solubility of the test item was determined to be 1655 mg/L (pH 5.2) at 20 ± 0.5 °C.

Conclusions:
A water solubility value of 1655 mg/L (at 20 °C, pH 5.2) was determined for the test substance according to E.U. Method A.6.
Executive summary:

The water solubility of test item was determined according to OECD guideline 105 (1995) and Council Regulation (EC) No. 260/2014, Method A.6 under GLP. The solubility of the test item was determined using the flask method at 20 ± 0.5 °C with preincubation at 30 ± 0.5 °C over 72 hours. The concentrations were analyzed via HPLC-DAD and the water solubility of test item was determined to be 1655 mg/L (at 20°C and pH 5.2).

Description of key information

Water solubility: 1655 mg/L at 20 °C, pH = 5.2 (EU Method A.6., flask method)

Key value for chemical safety assessment

Water solubility:
1 655 mg/L
at the temperature of:
20 °C

Additional information

The water solubility of test item was determined according to OECD guideline 105 (1995) and Council Regulation (EC) No. 260/2014, Method A.6 under GLP. The solubility of the test item was determined using the flask method at 20 ± 0.5 °C with preincubation at 30 ± 0.5 °C over 72 hours. The concentrations were analyzed via HPLC-DAD and the water solubility of test item was determined to be 1655 mg/L (at 20°C and pH 5.2).