Registration Dossier
Registration Dossier
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EC number: 934-405-7 | CAS number: -
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- flask method
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:040802#
Results and discussion
Water solubility
- Key result
- Water solubility:
- 831 g/L
- Conc. based on:
- test mat.
- Incubation duration:
- 48 h
- Temp.:
- 20 °C
- pH:
- 6.84
- Remarks on result:
- completely miscible
- Details on results:
- In the case of the X330 sample number 1, this sample failed to crystallise after 24 hours at 20°C, despite being more concentrated than the other samples that did show signs of crystallisation. It is proposed that a degree of super saturation could have occurred.
Any other information on results incl. tables
| Sample number | Weight of X330 sample (g) | Weight of water added (g) |
| 1 | 5.005 | 3.009 |
| 2 | 4.998 | 4.017 |
| 3 | 5.011 | 5.030 |
| 4 | 5.004 | 6.022 |
Applicant's summary and conclusion
- Conclusions:
- X330 is fully miscible to water.
Its water solubility was visually estimated at 831 g/L (Water Used : HPLC Water; pH of water : 6.84) - Executive summary:
X330 was tested according to the EU method A.6, following the flask method. The solubility of the test item was assessed by visual estimation to a value of 831 g/l. X330 is therefore considered as fully miscible to water.
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