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:
- 10 February 2009 - 08 May 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This 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:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- other: visual observation
Test material
- Details on test material:
- - Name of test material (as cited in study report): Custom Red #2
- Substance type: violet powder
- Physical state: solid
- Purity test date: no data
- Lot/batch No.: C50APR0805D
- Expiration date of the lot/batch: 08 January 2011
- Stability under storage conditions: stable
- Storage condition of test material: at room temperature in the dark
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- < 1 mg/L
- Temp.:
- 20 °C
- pH:
- 6.7
- Details on results:
- Preliminary test: No response of the test substance was observed in the chromatogram of the water sample. Based on the response of the lowest calibration solution (i.e. < 1 mg/l) and the dilution factor of the sample it demonstrated that the water solubility of the test substance is < 2 mg/l. To demonstrate that the water solubility of the test substance is < 1 mg/l a visual test at 1 mg/l was carried out.
Main study - visual test: After the stirring period, undissolved test substance was observed in the test sample. From this, it was concluded that the water solubility of the test substance at 19.8°C +/- 0.6°C is < 1 mg/l. The pH of the aqueous sample was 6.7. The pH of the aqueous sample was determined 56 days after the test. Undissolved test substance particles were observed. The sample had a pH similar to water. It indicated that no test substance was dissolved in the aqueous sample. The result was therefore accepted.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
From visual observation it was concluded that the water solubility of the test substance at 19.8°C +/- 0.6°C is < 1 mg/l. The pH of the aqueous sample was 6.7.
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