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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:
11 Feb 2019 to 09 Jan 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
July 27, 1995
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
March 04, 2016
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
March 1998
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method
Specific details on test material used for the study:
Identification: Esacure 3644
Physical Description: Light yellow solid
Purity/Composition: UVCB
Storage Conditions: At room temperature protected from light
Key result
Water solubility:
5.5 µg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
7.4
Details on results:
Preliminary Test
The content of test item dissolved in the water sample was 2.36 µg/L.

Main Study
The results for the samples taken at a flow rate set to 12 and 24 mL/h are given in Table 6.
The coefficient of variation (CV) (n = 10) was ≤ 30% at both flow rates. It demonstrated that the system was equilibrated at all flow rates.
The maximum difference (MD) on the mean values of the samples at both flow rates was also ≤ 30%. Based on this, the water solubility of the test item is given as the mean value of these measurements.
The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates.
Small responses at the retention time of the test item were detected in the chromatograms of the pretreated samples from the blank column eluted at 24 mL/h. They were considered to derive from carry-over in the analytical system since similar responses were found in the analytical blanks. The maximum contribution to the samples was 3.2% which was considered acceptable.
Responses at the retention time of the test item were also detected in the chromatograms of the pretreated samples from the blank column eluted at 12 mL/h. The maximum contribution to the samples was 27%. No explanation was found for this. Since the results from the blank column eluted at 24 mL/h showed a much lower response and since concentrations measured for the test samples were comparable at both flow rates, it was considered that the response in chromatograms of the samples eluted at 12 mL/h has no significant effect on the results of the test samples.
Conclusions:
The column elution method was applied for the determination of the water solubility of Esacure 3644.
The water solubility of the test item at 20 °C was 5.50 µg/L.
The pH of the aqueous samples was 7.4.
Executive summary:

The water solubility of the test item at 20 °C was 5.50 µg/L.

Description of key information

Study conducted to recognised testing guidelines with GLP certification

Key value for chemical safety assessment

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

Additional information