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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:
08 to 12 August 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Remarks:
Staatliches Gewerbeaufsichtsamt Hildeshelm
Type of method:
flask method
Key result
Water solubility:
28.2 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
6.6

Results

 

Preliminary Test (non GLP)

The determined solubility in double distilled water was in the range of 31.0 - 40.9 mg/L. For the application dose for the definitive study, approx. 0.409 g/L was used (approximately five times the maximum solubility result).

 

Main test

The results of the sampling are reported in the table below. No significant signals were obtained for the control sample.

 

Water Solubility Results at 20 °C

Preincubation time

Replicate

No.

Concentration [1] (mg/L)

Mean (mg/L)

24 h

1

26.63 [2]

24.93 [2]

2

23.23 [2]

48 h

1

26.5

27.7

2

28.8

72 h

1

30.1

28.8

2

27.5

Mean (48 - 72 h)

 

 

28.2

Deviation [%] (48 - 72 h) [3]

 

 

4.1

[1] Mean value of two injections, dilution factor of 2 and exact weight of the standard taken into account

[2] Not taken into account; according to the guideline, a deviation < 15% for the samples with the two longest preincubation times (48 and 72 h) is sufficient

[3] Calculated according to the formula:

 

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

 

SD Standard deviation

CV Coefficient of variation

 

 

Validity Criteria

The validity criteria were fulfilled:

- The concentration measured for the two longest incubation times did not differ by more than 15%.

- Temperatures were kept constant within ± 0.5 °C.

 

 

Conclusions

The solubility of the test item was determined at 20 ± 0.5 °C to be 28.2 mg/L (pH 6.6).

Conclusions:
A water solubility value of 28.2 mg/L (at 20 °C, pH 6.6) was determined for the test substance according to OECD guideline 105.
Executive summary:

The water solubility of the test item was determined according to OECD testing guideline 105 using flask method and GLP. The concentrations were measured via HPLC-DAD and the water solubility of test item was determined to be 28.2 mg/L at 20 °C.

Description of key information

Water solubility: 28.2 mg/L at 20 °C, pH 6.6 (E.U. Method A.6, flask method)

Key value for chemical safety assessment

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

Additional information

The water solubility of the test item was determined according to OECD-testing guideline 105 using flask method and GLP. The concentrations were measured via HPLC-DAD and the water solubility of test item was determined to be 28.2 mg/L at 20 °C.