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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
Study period:
Experimental start date: 30th January Experimental completion date: 16th May 2007 Study completion date: 12th June 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: - Study generated according to generally valid and/or internationally accepted testing guidelines - Performed according to GLP - Test parameters based on specific testing guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
92/69/EEC, A6 (Column Elution Method)
Deviations:
yes
Remarks:
First Amendment to Study Plan: Concerning: Schedule Alteration: New experimental completion date Reason for the alteration: Delay in study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
First Amendment to Study Plan: Concerning: Schedule Alteration: New experimental completion date Reason for the alteration: Delay in study
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method
Water solubility:
< 0.096 mg/L
Temp.:
20 °C
pH:
ca. 6.9
Details on results:
WATER SOLUBILITY:
During the preliminary test the water solubility of FP-100 at room temperature was estimated by a simplified flask method to be lower than the smallest calibration point of 0.379 µg/mI. Therefore, the column elution method was used for the performance of the main test.

During the main test six samples have been analysed in the first run (0.52 mI/min) and six samples during the second run (0.26 mI/min), each with a sampling interval of one hour. Total elution time was 93 hours. The sample measurement was performed by HPLC.
The measured results differ by less than 30 %. Therefore, the study is considered to be valid.

The r2 fit was 0.9994 (optimum 1.0000). This reflects the linearity of the HPLC-system within the calibration range of 0.09615 to 32.05 mg/I of the test item.

In conclusion, the water solubility of FP-100 at 20°C was determined to be below the smallest point of calibration, which is
<0.096 mg/l using the column elution method.
The water solubility was not corrected for the purity of the test item.
Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility of FP-100 at 20°C was determined to be below the smallest point of calibration, which is <0.096 mg/I using the column elution method.
Executive summary:

Not provided

Description of key information

During this study the water solubility and the partition coefficient of FP-100 were determined. The water solubility of FP-100 at 20°C was determined to be below the smallest point of calibration, which is <0.096 mg/I using the column elution method.

Key value for chemical safety assessment

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

Additional information

During the preliminary test the water solubility of FP-100 at room temperature was estimated by a simplified flask method to be lower than the smallest calibration point of 0.379 µg/mI. Therefore, the column elution method was used for the performance of the main test.

 

During the main test six samples have been analysed in the first run (0.52 mI/min) and six samples during the second run (0.26 mI/min), each with a sampling interval of one hour. Total elution time was 93 hours. The sample measurement was performed by HPLC.

The measured results differ by less than 30 %. Therefore, the study is considered to be valid.

 

The r2fit was 0.9994 (optimum 1.0000). This reflects the linearity of the HPLC-system within the calibration range of 0.09615 to 32.05 mg/I of the test item.

 

In conclusion, the water solubility of FP-100 at 20°C was determined to be below the smallest point of calibration, which is

<0.096 mg/l using the column elution method.

The water solubility was not corrected for the purity of the test item.