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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:
27.06.2016 - 01.07.2016
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
Key result
Water solubility:
6.45 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
50 g/L
Incubation duration:
72 h
Temp.:
20 °C
pH:
6
Remarks on result:
other: Mean of 2 replicate measurements
Details on results:
The method validation showed acceptable results for all parameters addressed. The test results are therefore considered valid.

The details of the results are:

pre-incubation time (h) replicate concentration (g/L) mean concentration (g/L)
24 1 6.54 6.5
2 6.45
48 1 6.52 6.49
2 6.46
72 1 6.37 6.38
2 6.38

The mean water solubility over 24 -72h is 6.45 with deviation 1.9 %

Conclusions:
The water solubility was determined to be 6.45 g/L (20°C, pH 6.0).
Executive summary:

In the current study the water solubility of the test item was determined according to OECD guideline 105 and Council Regulation (EC) No. 260/2014, Method A.6.

The solubility of the test item was determined using the flask method at 20 ± 0.5 °C with pre-incubation at 30 ± 0.5 °C. The analytical method (HPLC-DAD, external standard) was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity. The water solubility was determined to be 6.45 g/L (20°C, pH 6.0).

Description of key information

The water solubility was determined to be 6.45 g/L (20°C, pH 6.0).

Key value for chemical safety assessment

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

Additional information

There is one study available assessing the water solubility of the test item according to OECD guideline 105 and Council Regulation (EC) No. 260/2014, Method A.6. The solubility of the test item was determined using the flask method at 20 ± 0.5 °C with pre-incubation at 30 ± 0.5 °C. The water solubility was 6.45 g/L (20°C, pH 6.0).