Registration Dossier
Registration Dossier
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EC number: 234-764-3 | CAS number: 12032-20-1
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:
- 14 November 2016 - 6 March 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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:
- column elution method
- Key result
- Water solubility:
- 4.2 mg/L
- Conc. based on:
- element (dissolved fraction)
- Remarks:
- Lu
- Temp.:
- 20 °C
- pH:
- 6
- Remarks on result:
- other: mean at flow rates of 12.5 mL/h and 25 mL/h
- Key result
- Water solubility:
- 4.8 mg/L
- Conc. based on:
- test mat. (dissolved fraction)
- Remarks:
- result calculated based on measured Lu concentrations
- Temp.:
- 20 °C
- pH:
- 6
- Remarks on result:
- other: mean at flow rates of 12.5 mL/h and 25 mL/h
- Details on results:
- Result of test 1: 4.351 mg Lu/L and 4.960 mg Lu2O3/L (at 25 mL/h and pH 6.0)
Result of test 2: 4.315 mg Lu/L and 4.919 mg Lu2O3/L (at 25 mL/h and pH 5.5)
Result of test 3: 3.858 mg Lu/L and 4.398 mg Lu2O3/L (at 12.5 mL/h and pH 6.0) - Conclusions:
- The water solubility of the test substance at pH 6 an 20°C was determined to be 4.8 mg Lu2O3/L and was calculated from the mean measured lutetium content in water which was 4.2 mg Lu/L.
Reference
Results were validated by:
- Linearity validation: The analysis showed a good linearity of the method (r > 0.99).
- Accuracy validation: Results in dilution mixture showed a good accuracy which indicates acceptable data (recoveries ranged between 75 and 125%).
- Repeatability validation: The results indicated a good precision of the data.
- Specificity: The intensity (CPS) of blank samples measured was negligible or similar to solvent intensity.
- Limit of quantification: 30 ng/mL (1.5 mg/L in the sample).
- Limit of detection: 10 ng/mL.
Description of key information
The water solubility of the test substance was determined according to OECD guideline 105 and the EC A.6 method (column elution method) in a GLP study (Jean-Baptiste, 2017) and was found to be 4.8 mg/L at pH 6 and 20°C expressed as lutetium oxide in water and 4.2 mg/L at pH 6 and 20°C expressed as lutetium content in water. Results of this study can be considered reliable without restriction and therefore assigned Klimisch 1.
Key value for chemical safety assessment
- Water solubility:
- 4.8 mg/L
- at the temperature of:
- 20 °C
Additional information
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