Registration Dossier
Registration Dossier
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EC number: 608-209-4 | CAS number: 284461-73-0
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- flask method
- Water solubility:
- < 0.1 mg/L
- Temp.:
- 20 °C
- pH:
- 5.5 - 5.9
- Remarks on result:
- other: mean value of three determinations
- Water solubility:
- < 0.1 mg/L
- Temp.:
- 20 °C
- pH:
- 5.9
- Remarks on result:
- other: Initial weight: 0.62 mg
- Water solubility:
- < 0.1 mg/L
- Temp.:
- 20 °C
- pH:
- 5.7
- Remarks on result:
- other: Initial weight: 0.48 mg
- Water solubility:
- < 0.1 mg/L
- Temp.:
- 20 °C
- pH:
- 5.5
- Remarks on result:
- other: Initial weight: 0.68 mg
- Details on results:
- Result of the preliminary test: 0.5 mg/L
- Conclusions:
- Interpretation of results : insoluble (< 0.1 mg/L)
The test item can be considered as insoluble with a water solubility of lower than 0.1 mg/l at 20 °C. The pH value was determined to be in the pH-range 5.5 - 5.9. - Executive summary:
The water solubility of the test item was determined to be lower than 0.1 mg/l at 20 °C in the pH-range 5.5 - 5.9 according to the EU method A.6.
The result for the water solubility is below the LOD (0.1 mg/L) of the used analytical HPLC method. To prove the accuracy of the analytical method, one complete test solution was analyzed. The recovery for the applied test substance was 91 %.
Reference
The product consists of very fine crystals. Finest insoluble particles, not separable by centrifugation, are the probable cause for the higher value in the preliminary test, compared to the main test. The used excess in the main test was much lower than the excess used for the preliminary test (main test: about 0.6 mg/200ml, preliminary test: 510mg/50ml). The result for the water solubility is below the LOD (0.1 mg/L) of the used analytical HPLC method. To prove the accuracy of the analytical method, one complete test solution was analyzed. The recovery for the applied test substance was 91 %.
Description of key information
The test item can be considered as insoluble with a water solubility of lower than 0.1 mg/L at 20 °C. The pH value was determined to be in the pH-range of 5.5 to 5.9.
Key value for chemical safety assessment
- Water solubility:
- 0.1 mg/L
- at the temperature of:
- 20 °C
Additional information
"Should read: < 0.1 mg/l"
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