Registration Dossier
Registration Dossier
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EC number: 600-558-0 | CAS number: 104358-16-9
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:
- 21 MAR 2007 - 10 JUL 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- Guideline 67/548/EEC Annex V
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- 1995
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- column elution method
- Water solubility:
- < 0.03 mg/L
- Conc. based on:
- test mat.
- Temp.:
- 20 °C
- pH:
- 6.4
- Conclusions:
- The water solubility of the test item at a temperature of 20°C is < 0.03 mg/L (without correction for the purity).
- Executive summary:
The water solubility of the test item was tested according to EU Method A.6 (consolidated version of Guideline 67/548/EEC Annex V) and OECD Guideline 105 in a GLP study at 20 °C. The water solubility at this temperature is below 0.03 mg/L.
Reference
Preliminary Visual Estimation of the Water Solubility
The solubility of the test item in water is below 11.0 mg/L (without correction of the purity). Therefore the water solubility had to be determined by the column elution method.
Column elution method
The coating check was successful.
According to the guideline, the data of the fractions 1 to 5 were not taken into account for the following evaluation. The values for the water solubility were calculated from fractions 8 to 27 for column 1, from the fractions 34 to 53 for column 2, from the fractions 34 to 53 for column 3.
All other fractions were discarded.
Result column 1: Evaluation of the fractions 8 to 27: The water solubility was found to be: < 0.03 mg/L (without correction of the purity)
Result column 2: Evaluation of the fractions 34 to 53: The water solubility was found to be: < 0.03 mg/L (without correction of the purity)
Result column 3: Evaluation of the fractions 34 to 53: The blank concentration was found to be < 0.03 mg/L.
Recoveries of the 'recheck samples' range from 97.4 % to 98.1 %, indicating a good accuracy of the analytical method for these measurements.
Description of key information
The water solubility of the test item was tested according to EU Method A.6 (consolidated version of Guideline 67/548/EEC Annex V) and OECD Guideline 105 in a GLP study at 20 °C. The water solubility at this temperature is below 0.03 mg/L.
Key value for chemical safety assessment
Additional information
Determined value for water solubility is below the above mentioned value, because the content of test item was below the detection limit of gas chromatography. This does not affect the chemical safety assessment because the water solubility is in any case very low.
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