Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 January 2008 - 14 May 2008
- 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 GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- yes
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- yes
- Principles of method if other than guideline:
- During the water solubility test, the maximum difference between the measurements of the last two sampling points was more 20% while it should be within 15%.
Evaluation: The test substance is a fine powder and it proved difficult to remove undissolved matter through centrifugation. This was the best possible result to achieve.
The study integrity was not adversely affected by the deviations. - GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Details on test material:
- - Name of test material (as cited in study report): S-500
- Physical state: yellow powder
- Lot/batch No.: MF1456-2345
- Expiration date of the lot/batch: 18 August 2011
- Storage condition of test material: At room temperature in the dark
- Stability under storage conditions: Stable
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- 0.001 g/L
- Temp.:
- 19.6 °C
- pH:
- 5.37
- Details on results:
- The maximum difference (MD) of the concentrations determined in the 24, 48 and 72 hour test samples was > 15%. The spread in data can be explained by the nature of the test substance, which is a fine powder that was finely dispersed in the water phase and therefore difficult to remove by centrifugation. As the maximum difference > 15%, then according to the guidelines, the water solubility of the test substance was given as the mean value of the 48- and 72-hour measurements.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The flask method was chosen for the determination of the water solubility of S-500. The water solubility of the test substance at 19.6°C ± 0.5°C was 0.71 x 10^-3 g/l. The pH of the aqueous samples after 72 hours stirring was 5.37.
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