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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:
05 to 12 September 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)
Type of method:
flask method
Key result
Water solubility:
2.81 g/L
Temp.:
20 °C
pH:
6.6

Results

 

Preliminary Test

The determined solubility in double distilled water was in the range of 210 - 525 mg/L. For the application dose for the definitive study, approx. 3 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. Undissolved test item was observed in all samples before sample preparation.

 

Water Solubility Results at 20 °C for the test item

Preincubation time

Replicate No.

Concentration [1] (g/L)

Mean (g/L)

24 h

1

2.76

2.79

2

2.81

48 h

1

2.84

2.81

2

2.78

72 h

1

2.78

2.83

2

2.89

Mean (24 - 72 h)

 

 

2.81

Deviation [%] (24 - 72 h) [2]

 

 

1.7

[1] Mean value of two injections, dilution factor of 40 and exact weight of the standard taken into account

[2] Calculated according to the formula: Deviation [%] = 100 x (max value - min value) / min value

 

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 2.81 g/L (pH 6.6).

Conclusions:
A water solubility value of 2.81 g/L (at 20 °C, pH 6.6) was determined for the test substance according to E.U. Method A.6.
Executive summary:

The water solubility of the test item was determined according to OECD guideline 105 (1995) and GLP. Based on the result of a preliminary test, the definitive test was dertmined using the flask method at 20 ± 0.5 °C with pre-incubation at 30 ± 0.5 °C. The concentration was analyzed via HPLC method with diode array detection (DAD). The water solubility of the test item was determined to be 2.81 g/L at 20 °C and pH6.6.

Description of key information

Water solubility: 2.81 g/L at 20 °C, pH 6.6 (E.U. Method A.6, flask method)

Key value for chemical safety assessment

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

Additional information

The water solubility of the test item was determined according to OECD guideline 105 (1995) and GLP. Based on the result of a preliminary test, the definitive test was dertmined using the flask method at 20 ± 0.5 °C with pre-incubation at 30 ± 0.5 °C. The concentration was analyzed via HPLC method with diode array detection (DAD). The water solubility of the test item was determined to be 2.81 g/L at 20 °C and pH6.6.