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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 Jul - 15 Jul 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Flask method gave result below method limit; column elution method gave result above its upper applicability limit. Results were discussed with the regulatory authority and the water solubility obtained in the column elution method is reported as the final result.
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
adopted in 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
Type of method:
column elution method
Specific details on test material used for the study:
Storage: room temperature (20 ± 5 °C), keep away from light
Water solubility:
11.29 mg/L
Temp.:
20 °C
pH:
ca. 5.5

Results
Measurements for both flow rates were included in the mean calculation, since the differences between the measured concentrations are < 30%.

Table 8 – Results

Flow rate

Mean concentration [mg/L]

Standard deviation

Total mean [mg/L]

Total standard deviation [mg/L]

24.82

11.509

0.227

11.290

0.336

12.41

11.071

0.285

 

Mean at the plateau was 11.290 ± 0.256 mg/L.

Discussion
Good reproducibility and validity was seen within each of the two experiments performed. However, there was bad correspondence between the experiments: the flask method gave a value below its lower applicability limit and the column elution method gave a value above its lower applicability limit. Therefore, consultation with the regulatory authority (BAuA, Bundesanstalt für Arbeitsschutz und Arbeitsmedizin – REACH helpdesk) was taken. Following authority recommendations, both experiments are reported, but the value from the column elution method should be used for further evaluation.

The lower value in the flask method may have been due to insufficient contact between test item and water, as the test item is extremely sticky and does not easily disperse. Thus, solubility of the test item is stated as 11.290 ± 0.336 mg/L, measured with the column elution method.

Description of key information

11.29 ± 0.336 mg/L at 20 °C and pH 5.5 (OECD 105, Column elution method)

Key value for chemical safety assessment

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

Additional information

Following discussion with the regulatory auhtority unit BAuA Dortmund due to contradictory results obtained between the experiments performed (flask method and column elution method), the result reported as key is a mean of all 14 fractions of the column elution method.