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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:
December from 03 to 08, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Reason / purpose for cross-reference:
reference to other study
Remarks:
validation of analytical method
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
adopted July 27, 1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
March 1998
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Water solubility:
2.36 g/L
Conc. based on:
test mat.
Incubation duration:
24 - 72 h
Temp.:
20 °C
pH:
ca. 9.4
Details on results:
The water solubility of test item was determined to be 2.36 ± 0.26 g/l (95 % confidence interval) at 20 ± 1 °C and pH ca. 9.4, using the shake-flask method for the performance.
The measured concentrations are constant within ± 15 % and thus within the range required by the guidelines.

PRELIMINARY TEST
The water solubility of the test item was estimated to be ~2.5 g/l in a preliminary test and therefore the shake-flask method was used in the main test.

Sampling time  Test vessels Mean with the 95 % confidence intervals (g/l) Measured pH
After 24h 2.31 2.40 ± 0.30 9.45
2.34 9.44
2.53 9.45
After 48h 2.25 2.25 ± 0.29 9.45
2.13 9.41
2.37 9.37
After 72h 2.42 2.45 ± 0.07 9.45
2.47 9.45
2.47 9.44

Solubility of the test item (g/l)

 2.36 ± 0.26 -

RSD%

 4 -

pH of ultra-pure water

 - 6.98-6.99
Conclusions:
2.36 g/l at 20 °C and pH ca 9.4
Executive summary:

The water solubility of the test item was determined in accordante with the method and procedures outlined into the OECD guideline 105.

A preliminary test for solubilitywas carried out for the decision whether the column elution method or the flask method has to be used for the performance of the main test. The water solubility of the test item was estimated to be ~2.5 g/l in a preliminary test and therefore the shake-flask method was used in the main test..

The concentration in the clear aqueous phase was determined by HPLC-UV validate method. The pH of each sample was recorded.

The water solubility of test item was determined to be 2.36 ± 0.26 g/l (95 % confidence interval)  at 20 ± 1 °C and pH ca. 9.4, using the shake-flask method for the performance.  

The measured concentrations are constant within ± 15 % and thus within the range required by the guidelines.

Conclusion

Water solubility: 2.36 g/l at 20 °C and pH ca 9.4

Description of key information

2.36 g/l at 20 °C and pH ca 9.4

Key value for chemical safety assessment

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

Additional information

OECD 105 - Flask method