Registration Dossier
Registration Dossier
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EC number: 236-039-7 | CAS number: 13114-72-2
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:
- 21.04.-29.04.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Key result
- Water solubility:
- 234.8 mg/L
- Conc. based on:
- test mat.
- Temp.:
- 20 °C
- pH:
- 6.05
- Conclusions:
- The water solubility of the test substance Akardit is 234,8 mg/L.Stadard uncertainty of determination was estimated to 1.6 mg/L.Standard uncertainty equals to one standard deviation.testing was performed at temperature of 20°C
- Executive summary:
Water solubility test was performed for the test substance, Akardit. Flask method was used.
Test was performed according to the Method A.6., Water Solubility, Council Regulation (EC) No.440/2008, Published in O.J. L 142, 2008(part1.4.2.Flask method).
The concentration of the test substance in the aqueous solution was determined by HPLC.
Testing was performed at the temperature of 20°C.
The water solubility of the test substance Akardit established by the flask method is 234.8 mg/L.Standarduncertainty of determination was estimated to 1.6 mg/L.
Reference
Table No.1: Results of determination of test substance solubility in water by flask method
Day | pH of saturated solution | 1stdilution (mg/L) | 2nddilution (mg/L) | Average (mg/L) |
1st | 6.01 | 236.2 | 234.0 | 235.1 |
2nd | 6.04 | 233.6 | 232.4 | 233.0 |
3rd | 6.11 | 235.9 | 236.5 | 236.2 |
Overall Mean | 234.8 | |||
Standard deviation | 1.6 | |||
Relative standard deviation (%) | 0.7 | |||
Criteria of quality
Repeatability of the Flask method should be less than 15%.
The values of solubility obtained from measurements should fall within a range of 199.6 mg/L – 270.0 mg/L of test substance.
The range of results was from 232.4 mg/L to 236.5 mg/L, yielding an overall mean of 234.8 mg/L of test substance.
The determination of water solubility fulfils the criterion of quality.
Description of key information
Water solubility test was performed for the test substance, Akardit. Flask method was used. Test was performed according to the Method A.6., Water Solubility, Council Regulation (EC) No.440/2008, Published in O.J. L 142, 2008 (part 1.4.2. Flask method). Only one study is available.
GLP study.
Klimish score 1.
The water solubility of the test substance Akardit is 234,8 mg/L. The test substance Akardit is in water moderately soluble.
Key value for chemical safety assessment
- Water solubility:
- 234.8 mg/L
- at the temperature of:
- 20 °C
Additional information
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