Registration Dossier
Registration Dossier
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EC number: 938-153-9 | CAS number: -
Water solubility
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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- (1995)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- column elution method
Test material
- Reference substance name:
- Paz-E
- IUPAC Name:
- Paz-E
- 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
Constituent 1
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
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.
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