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Diss Factsheets

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:
20 August 2012 to 11 September 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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)
Type of method:
flask method
Water solubility:
< 0 g/L
Temp.:
20 °C
pH:
>= 6.7 - <= 7
Remarks on result:
other: Based on total dissolved aluminium
Key result
Water solubility:
< 0 g/L
Temp.:
20 °C
pH:
>= 6.7 - <= 7
Remarks on result:
other: Based on test item concentration
Details on results:
No quantifiable concentration of aluminium was detected in any sample solution using a common loading rate of nominally 2.0 g/L and saturation periods of 24, 48 and 72 hours. Also no quantifiable concentration of aluminium was detected at a loading rate of nominally 20 g/L and a saturation period of 72 hours.

The quantification limit value reported originated from the concentration of the lowest calibration standard solution (0.010 mg/L as aluminium), corrected firstly for the sample dilution factor (1.25) to give total dissolved aluminium concentration (<1.25 x 10-5 g/L) and finally for the correction factor originating from the theoretical aluminium content of the substance (12.100), to give the overall result of a substance concentration of less than <1.50 x 10-4 g/L of solution at 20.0 ± 0.5°C.
Conclusions:
The water solubility of the substance as a 50% w.w. concentration in pharmaceutical white oil has been determined to be less than 0.0000125 g/L of solution at 20.0 ± 0.5°C, as total dissolved aluminium. This was equivalent to a substance concentration of less than 0.000150 g/L of solution at 20.0 ± 0.5°C.
Executive summary:

The water solubility of the substance as a 50% w.w. concentration in pharmaceutical white oil has been determined to be less than 0.00015 g/L of solution at 20.0 ± 0.5°C. The water solubility of test item was determined in a GLP-compliant, analysis study (Harlan 2013) following OECD guideline 105. The study is considered reliable and relevant for use for this endpoint.

Description of key information

The water solubility of the substance as a 50% w.w. concentration in pharmaceutical white oil has been determined to be less than 0.00015 g/L of solution at 20.0 ± 0.5°C.

Key value for chemical safety assessment

Water solubility:
0 g/L
at the temperature of:
20 °C

Additional information

The water solubility of test item was determined in a GLP-compliant, analysis study (Harlan 2013) following OECD guideline 105.