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Physical & Chemical properties

Water solubility

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Link to relevant study record(s)

Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Principles of method if other than guideline:
To determine the water solubility of the test item, two different methods can be used according to OECD Guideline 105, EC Guideline A.6 and OPPTS Guideline 830.7840:
− The column elution method for solubility < 10-2 g/L.
− The shake flask method for solubility ≥ 10-2 g/L.
In a preliminary test, the water solubility of the test item was found to be > 10-2 g/L (approximately 345 g/L). Therefore the flask method was chosen for the determination of the water solubility.
For the main test, a quantity of the test item necessary for saturation is dissolved in demineralized water. The vessels are stoppered and stirred on a magnetic stirrer for 24 h, 48 h and 72 h at 30 °C in a temperature controlled water bath. Following this procedure, the temperature is reduced to 20 °C and is kept in the temperature controlled water bath for another 24 h. After phase separation by filtration with a disposable syringe filter and/or centrifugation, the concentration of the test item in the aqueous test solutions is determined by HPLC-analysis with UV-detection.
GLP compliance:
yes
Type of method:
flask method
Specific details on test material used for the study:
Sample number: 2835
Date of receipt: 2016-06-20
Expiry date: 2018-06-17
Water solubility:
240 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
69 other: g / 100 mL
Incubation duration:
24 h
Temp.:
20 °C
pH:
7.5
Remarks on result:
other: Mean value
Water solubility:
254 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
69 other: g / 100 mL
Incubation duration:
24 h
Temp.:
20 °C
pH:
7.5
Water solubility:
234 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
69.1 other: g / 100 mL
Incubation duration:
24 h
Temp.:
20 °C
pH:
7.5
Water solubility:
233 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
68.1 other: g / 100 mL
Incubation duration:
24 h
Temp.:
20 °C
pH:
7.5
Details on results:
The relative standard deviation between the single determinations is < 15 %. The validity criteria have therefore been met.
Conclusions:
The water solubility of Bayscript Gelbkomponente in demineralized water at 20 °C is determined to be 240 g/L according to OECD guideline 105.
Executive summary:

The water solubility of the test item Bayscript Gelbkomponente in demineralized water was determined with the shake flask method at 20 °C according to OECD 105 and OPPTS 830.7840.

The concentration of the test item in the aqueous test solutions was determined by HPLC analysis with UV detection.

Results:

 Water solubility test at 20 °C  Flask A [g/L]  Flask B [g/L]  Flask C [g/L]  Mean value
 Concentration of Bayscript Gelbkomponente  254  234  233  240 g/L
 pH-value  7.5  7.5  7.5  -

The relative standard deviation between the single determinations is < 15 %.

The validity criteria have therefore been met.

Water solubility of Bayscript Gelbkomponente at 20 °C: 240 g/L

Description of key information

The water solubility of the test item Bayscript Gelbkomponente in demineralized water was determined with the shake flask method at 20 °C according to OECD 105 and OPPTS 830.7840.

The concentration of the test item in the aqueous test solutions was determined by HPLC analysis with UV detection.

Results:

 Water solubility test at 20 °C  Flask A [g/L]  Flask B [g/L]  Flask C [g/L]  Mean value
 Concentration of Bayscript Gelbkomponente  254  234  233  240 g/L
 pH-value  7.5  7.5  7.5  -

The relative standard deviation between the single determinations is < 15 %.

The validity criteria have therefore been met.

Water solubility of Bayscript Gelbkomponente at 20 °C: 240 g/L

Key value for chemical safety assessment

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

Additional information