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Physical & Chemical properties

Water solubility

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Administrative data

Link to relevant study record(s)

Reference
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.

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.