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EC number: 700-146-1 | CAS number: 1141487-54-8
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:
- 2010-09-14 to 2010-10-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- , 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- , 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- , signed 2010-10-20
- Type of method:
- flask method
- Key result
- Water solubility:
- 18 mg/L
- Temp.:
- 20
- pH:
- 7.4
- Remarks on result:
- other: Deviation: 1.8 %
- Water solubility:
- 17.1 mg/L
- Temp.:
- 30
- pH:
- 7.9
- Remarks on result:
- other: Deviation: 12.2 %
- Details on results:
- TYNDALL-EFFECT
The Tyndall-effect was checked after 24, 48 and 72 h for each temperature. No particles could be observed.
ANALYTICAL METHOD VALIDATION RESULTS
- Linearity:
The analytical system gave linear response in the range of 2 – 50 μg/L (n = 7) of the standard. Linearity expressed as (r) correlation coefficient was determined to be > 0.992.
- Accuracy and Precision
Limit of Quantification (LOQ): 4 mg/L.
Recovery Rates of Fortified Samples (n = 5):
Mean recovery rate 103 % at mean calc. concentration of 4.1 mg/L (1xLOQ); SD: 0.173; RSD: 4.22 %
Mean recovery rates 104 % at mean calc. concentration of 20.8 mg/L (5xLOQ); SD: 0.679; RSD: 3.26 %
- Specificity:
Response of blank values of respective test medium control samples was lower than 30 % of LOQ. The identity of the test was confirmed by using four specific ions in GC-MS analyses.
VALIDITY CRITERIA
The concentration measured in at least the two last test vessels did not differ for more than 15 %. - Conclusions:
- According to Regulation (EC) No 440/2008 Method A.6 and OECD Guideline 105, the water solubility of the test item was determined to be 18 mg/L (20 °C, pH 7.4). The solubility of the test item was determined at test temperatures of 20 and 30 °C and showed no significant temperature dependency.
Reference
Description of key information
The water solubility of the test substance is 18 mg/L ± 0.2 mg/L at 20°C/pH 7.4.
Key value for chemical safety assessment
- Water solubility:
- 18 mg/L
- at the temperature of:
- 20 °C
Additional information
The water solubility of the test item was performed in accordance with the OECD 105 test guideline under GLP. Based on preliminary results (water solubility > 10 mg/L at 20°C) the flask method was applied. The test item was analytically verified using GC-MS.
The solubility of the test item was determined at test temperatures of 30 and 20 ± 0.5 °C. The water solubility of the test item showed no significant temperature dependency and varied from 18.0 mg/L at 20 °C to 17.1 mg/L at 30 °C. The pH values of the test solutions were in the range of 7.4 and 7.9.
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