Registration Dossier
Registration Dossier
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EC number: 700-590-6 | CAS number: -
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to guideline. Restriction due to variablity of results obtained.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Details on test material:
- - Lot/batch No.: CM71217681
- Storage condition of test material: room temperature in the dark
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- <= 0.138 mg/L
- Temp.:
- 20 °C
- pH:
- >= 5.5 - <= 5.9
- Details on results:
- Results obtained for replicate analyses were variable ranging from ≤ 0.0869 mg/L to ≤ 0.138 mg/L. It was considered more appropriate to report a limit value for the test. This limit value was determined from the sample replicate containing the highest concentration of test material which was ≤ 0.138 mg/L.
Sample recovery from the HPLC column ranged between 82.8 % - 91 % with a mean % recovery of 86.6%
Any other information on results incl. tables
Table 2: Results of Water Solubility Test by Shake Flask Method
Flask |
Shake Time (hours) |
Equilibration Time (hours) |
Concentration (mg/L) |
pH |
1 |
24 |
24 |
≤ 0.138 |
5.5 |
2 |
48 |
24 |
≤ 0.112 |
5.9 |
3 |
72 |
24 |
≤ 0.0869 |
5.7 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility of the test substance is ≤ 0.138 mg/L at 20 deg. C - Executive summary:
The water solubility of the test substance was determined by the shake flask method according to the EU method A.6 guideline.
An HPLC method using an Evaporative Light Scattering detector was used for quantitation of water soluble components.
The water solubility of the test material was determined to be ≤ 0.138 mg/L at 20 deg. C.
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