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Physical & Chemical properties

Water solubility

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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 January 2012- 25 April 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and EC guidelines and according to the principles of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
(2008)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
(1995)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
(1998)
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Paz-E
Substance type: mono-constituent
Physical state: white powder
Expiration date of the lot/batch: 25 November 2012
Storage condition of test material: At room temperature protected from light in desiccator (sample is hygroscopic)
Stability under test conditions: Stable

Results and discussion

Water solubilityopen allclose all
Water solubility:
43.6 µg/L
Temp.:
20 °C
pH:
7.5
Remarks on result:
other: Flowrate 24 ml/h. Mean of 10 samples. CV=24%.
Water solubility:
40.5 µg/L
Temp.:
20 °C
pH:
7.6
Remarks on result:
other: Flowrate 12 ml/h. Mean of 10 samples. CV=11%
Details on results:
The coefficient of variation (n = 10) was ≤ 30% at both flow rates. It demonstrated that the system was equilibrated at all flow rates.

The maximum difference on the mean values of the samples at both flow rates was also ≤ 30%. Based on this, the water solubility of the test substance is given as the mean value of these measurements (42.0 µg/L).

Any other information on results incl. tables

In the chromatogram of the samples from the blank column, a small response was observed at the retention time of the test substance. The concentration was < 0.667 µg/l (i.e. lowest calibration solution multiplied by the dilution factor). This concentration was considered negligible.

The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates.

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility of Paz-E at 20°C and pH 7.5-7.6 is 42.0 µg/L.