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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
in between 2010/03/09 - 2010/05/07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
Preliminary test was not performed according to guideline
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Water solubility:
80.8 mg/L
Temp.:
20 °C
pH:
> 6.9 - < 7.2
Remarks on result:
other: 20 °C ± 0.5 °C

The preliminary estimate of water solubility was approximately 8.0 x 10-2 g/L. The results from the definitive study are shown in Table 3.

Table 3: Results from the definitive study

Sample No.

Time Shaken at ~ 30 °C [h]

Time Equilibrated at 20 °C [h]

Concentration [g/L]

Solution pH

1

72

24

7.74 x 10-2

6.9

2

48

24

8.05 x 10-2

7.0

3

24

24

8.42 x 10-2

7.2

Testing was also carried out using a loading rate of approximately 0.10 g test item plus 100 mL glass double-distilled water. However, at this much higher loading rate, the samples could not be cleaned-up fully. Consequently, as the preliminary and definitive test samples were all noted to contain undissolved test item prior to clean-up, the results and conclusion are considered to be valid.

The spectrophotometric analytical methodology used was based on a method supplied by the Sponsor.

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)

Description of key information

80.8 mg/L at 20 °C ± 0.5 °C, pH 6.9-7.2 (Walker, J.A., Croda Europe Ltd., 2010)

Key value for chemical safety assessment

Water solubility:
80.8 mg/L
at the temperature of:
20 °C

Additional information