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EC number: 260-486-7 | CAS number: 56973-85-4
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:
- 17 March to 18 April 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to an internationally recognized method, and under GLP. No deviation was reported. Test substance is adequately specified with purity. Therefore full validation applies.
- 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)
- Remarks:
- UK GLP compliance programme (inspected on 05 July 2016 / signed on 28 October 2016)
- Type of method:
- flask method
- Key result
- Water solubility:
- 0.056 g/L
- Conc. based on:
- test mat.
- Loading of aqueous phase:
- 5 g/L
- Incubation duration:
- 72 h
- Temp.:
- 20 °C
- pH:
- >= 5.8 - <= 5.9
- Executive summary:
The water solubility of the test substance was measured under GLP according to OECD 105 / EU A6 guidelines, flask method. Three measurements were performed after 24, 48 and 72 h incubation at 20°C, with duplicate analysis by HPLC-UV. Equilibrium was found to be reached from 24 h, and the overall mean result was retained.
Mean concentration: 5.62 x 10-2 g/L at 20.0 ± 0.5 ºC
Range: 4.07 x 10-2 to 6.51 x 10-2 g/L
Relative Standard Deviation: 13.8 % (S.D.7.7 x 10-3 g/L)
The water solubility of the test item has been determined to be 56.2 mg/L of solution at 20.0°C, pH of saturated solution ca 5.9.
Reference
Preliminary Test
The preliminary estimate of water solubility was approximately 5 x 10-2 g/L (50 mg/L) at 20 °C.
Main Test
Table 4.8/2: Concentration (g/L) of test item in the sample solutions
Sample number
|
Time shaken at ~ 30 ºC (hours) |
Time equilibrated at 20 ºC (hours) |
Concentration (g/L)
|
Mean Concentration (g/L) |
Solution pH
|
1A |
24 |
24.25 |
5.75 x 10-2 |
4.91 x 10-2 (49.1 mg/L) |
5.9 |
1B |
24 |
24.25 |
4.07 x 10-2 |
||
2A |
48 |
24.25 |
6.51 x 10-2 |
6.45 x 10-2 (64.5mg/L) |
5.8 |
2B |
48 |
24.25 |
6.39 x 10-2 |
||
3A |
72 |
24.0 |
5.80 x 10-2 |
5.50 x 10-2 (55.0 mg/L) |
5.9 |
3B |
72 |
24.0 |
5.20 x 10-2 |
Mean concentration: 5.62 x 10-2 g/L at 20.0 ± 0.5 ºC
Range: 4.07 x 10-2 to 6.51 x 10-2 g/L
Relative Standard Deviation: 13.8 % (S.D.7.7 x 10-3 g/L)
Description of key information
Slightly soluble, with equilibrium reached at 24h.
pH of saturated solution: ca 5.9
Key value for chemical safety assessment
- Water solubility:
- 56.2 mg/L
- at the temperature of:
- 20 °C
Additional information
A fully reliable experimental study, conducted according to a recognized OECD/EC method and under GLP, is available. It is considered as a key study. The result is retained as key data for purpose of CSA.
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