Registration Dossier

Physical & Chemical properties

Water solubility

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
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)
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
column elution method
Key result
Water solubility:
1.19 µg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
ca. 7
Remarks on result:
other: mean value of two determinations
Details on results:
The mean value determined with column 1 was 1.82 μg/L and the value determined with column 2 was 0.56 μg/L. For this reason, a mean value (1.19 μg/L) from these two values is used as a basis for assessing the chemical safety assessment.

The report stated all result being in the range below <3µg/L. Scrutinizing the raw data yielded measureable concentrations in the range 0.54 to 1.9 µg/L.

       Column 1 (12 mL/h) Column 2 (24 ml L/h)       
Fraction no.   pH value  Concentration  Fraction no.  pH value  Concentration
    [β] = g/L      [β] = g/L
11  7.3  < 3  1  6.4   < 3
12 7.4  < 3  2  6.3   < 3
13  7.1   < 3  3  6.5    < 3
14 7.3     < 3  4 6.6    < 3
15  7.0   < 3  5 6.7    < 3  
16 7.2    < 3    6 6.7    < 3
17  7.5    < 3  7 6.5    < 3
18 6.7   < 3  8 6.5    < 3
19  7.4   < 3  9 6.6     < 3
20 6.8    < 3    10 6.6     < 3
Conclusions:
The water solubility determined by the column elution method at 20 °C was lower than 3 μg/L.
Executive summary:

The water solubility was determined using the method (OECD Guideline 105, EC Guideline A.6). The water solubility of the test item, given by the sponsor, was lower than 10 mg/L. Therefore, the column elution method was chosen for the determination of the water solubility. For the main test the test item was eluted with water from a micro-column which is charged with silica gel, previously coated with an excess of the test item. At 20 °C twenty fractions were collected at a flow rate of 12 mL/h (column 1) and ten fractions at a flow rate of 24 mL/h (column 2). For each fraction 10 mL were collected. After dilution with acetonitrile the concentration of Solvent Green 28 in the solutions was determined by HPLC-analysis. The water solubility determined by the column elution method at 20 °C was lower than 3 μg/L. The mean values determined with both columns were 1.82 μg/L and 0.56 μg/L. For this reason, a mean value (1.19 μg/L) from these two values is used as a basis for assessing the chemical safety assessment.

Description of key information

The water solubility determined by the column elution method at 20 °C was lower than 3 μg/L.

Key value for chemical safety assessment

Water solubility:
1.2 µg/L
at the temperature of:
20 °C

Additional information

The mean value determined with column 1 was 1.82 μg/L and the value determined with column 2 was 0.56 μg/L. For this reason, a mean value (1.19 μg/L) from these two values is used as a basis for assessing the chemical safety assessment.