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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:
29 June 2017 - 07 November 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
July 27, 1995
Deviations:
yes
Remarks:
The max difference between the results 24, 48 and 72 h stirred samples was not always ≤ 15%. The sample item was still turbid after centrifugation and filtration. None of the deviations were considered to have impacted the overall integrity of the study.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
March 19, 2014
Deviations:
yes
Remarks:
The max difference between the results 24, 48 and 72 h stirred samples was not always ≤ 15%. The sample item was still turbid after centrifugation and filtration. None of the deviations were considered to have impacted the overall integrity of the study.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
March 1998
Deviations:
yes
Remarks:
The max difference between the results 24, 48 and 72 h stirred samples was not always ≤ 15%. The sample item was still turbid after centrifugation and filtration. None of the deviations were considered to have impacted the overall integrity of the study.
GLP compliance:
yes
Type of method:
flask method
Key result
Water solubility:
< 100 mg/L
Conc. based on:
test mat. (total fraction)
Loading of aqueous phase:
100 mg/L
Incubation duration:
ca. 72 h
Temp.:
20 °C
pH:
ca. 6.4
Key result
Water solubility:
> 3 000 mg/L
Conc. based on:
other: The two main peaks
Loading of aqueous phase:
3 000 mg/L
Incubation duration:
ca. 72 h
Temp.:
20 °C
pH:
ca. 5.4
Conclusions:
The water solutibility of the test item was determined according to EC.A6, OECD Guideline No 105, EPA OPPTS 830.7840 and GLP principles.
The test was performed at 20°C by the flask method, the water solubility quantitification was based on the two major peaks in the chromatograms.
The solubility of the complete test item was <100 mg/L but maximum solubility for the two major peaks was not reached yet at a loading rate of 3000 mg/L
Executive summary:

The water solutibility of the test item was determined according to EC.A6, OECD Guideline No 105, EPA OPPTS 830.7840 and GLP principles.

The test was performed at 20°C by the flask method, and stirring the test item for 24, 48 and 72h.

A linear relationship between the nominal concentration and the mean results of the analysed concentration after two-times centrifugation and one filtration step based on peak 1 and peak 2 was observed. It proved that the maximum water solubility for peak 1 and peak 2 was not reached at nominal test item concentration of 3000 mg/L. Whereas, water solubility of the complete test item is <100 mg/L based on visual observation.

The pH of the aqueous samples was between 5.4 to 6.4.

Description of key information

The objective of the study was the determination of the water solubility of the test item.

The study was performed according to EC.A6, OECD Guideline No 105, EPA OPPTS 830.7840 and GLP principles, at at 20°C by the flask method, stirring the test items for 24, 48 and 72 h

For the highest loading concentrations, the centrifugation method was not found to be sufficient to remove all undissolved test item. Therefore all centrifuged samples were also filtered to remove any undissolved material

The water solubility quantitification was based on the two major peaks in the chromatograms.

The solubility of the complete test item was  <100 mg/L but maximum solubility for the two major peaks was not reached yet at a loading rate of 3000 mg/L

Key value for chemical safety assessment

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

Additional information

The solubility of the complete test item was  <100 mg/L but maximum solubility for the two major peaks was not reached yet at a loading rate of 3000 mg/L