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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:
2016-02-08 to 2016-02-15
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)
Version / remarks:
2014
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
29.6 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
94.2 mg/L
Incubation duration:
> 24 - <= 72 h
Temp.:
20 °C
pH:
6.3
Remarks on result:
other: overall mean
Details on results:
The concentration measured did not differ for more than 15 % and temperatures were kept constant within ± 0.5 °C. Thus, all validity criteria were fulfilled.
No Tyndall-effect was observed in all replicates at all time points (24h, 48h, 72h).

pH-value of the Test Mixture

Test temperature [°C]

Preincubation time [h]

Replicate

Measured pH

Mean value (without control)

20

24

1

6.362

6.3

2

6.386

48

1

6.314

2

6.226

72

1

6.542

2

6.128

Control

6.584

 

Water Solubility Results at 20 °C

Preincubation time

Replicate No.

Concentration [mg/L]

Mean [mg/L]

24 h

1

29.6

30.0

2

30.4

48 h

1

28.6

29.1

2

29.6

72 h

1

28.4

29.7

2

31.1

Mean (24-72 h)

 

29.6

Deviation [%] (24-72 h)

3.1

Conclusions:
The water solubility of the test substance was determined to be 29.6 mg/L at 20 °C.
Executive summary:

The water solubility was determined in a GLP study according to OECD guideline 105 (1995) and Council Regulation (EC) No 260/2014, Method A.6. The solubility of the test item in double distilled water was determined employing the flask method at 20 ± 0.5 °C with preincubation at 30 ± 0.5 °C for 72, 48 and 24 h. The analytical method (HPLC-DAD) 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 substance was determined to be 29.6 mg/L at 20 °C.

Description of key information

The water solubility of the test substance was determined to be 29.6 mg/L at 20 °C.

 

Key value for chemical safety assessment

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

Additional information

The water solubility was determined in a GLP study according to OECD guideline 105 (1995) and Council Regulation (EC) No 260/2014, Method A.6. The solubility of the test item in double distilled water was determined employing the flask method at 20 ± 0.5 °C with preincubation at 30 ± 0.5 °C for 72, 48 and 24 h. The analytical method (HPLC-DAD) 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 substance was determined to be 29.6 mg/L at 20 °C.