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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13-09-2019 to 22-11-2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. All relevant validity criteria were met.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
inspected: August 2018 ; signature: November 2018
Type of method:
flask method
Water solubility:
0.457 mg/L
Conc. based on:
test mat.
Incubation duration:
24 h
Temp.:
30 °C
pH:
6.9
Remarks on result:
other: Determination of 1 (shaken 24 hours at 30 ºC): Equilibrated at 20°C 24 hours
Water solubility:
0.518 mg/L
Conc. based on:
test mat.
Incubation duration:
48 h
Temp.:
30 °C
pH:
5.8
Remarks on result:
other: Determination of 2 (shaken 48 hours at 30 ºC): Equilibrated at 20°C 24 hours
Water solubility:
0.479 mg/L
Conc. based on:
test mat.
Incubation duration:
72 h
Temp.:
30 °C
pH:
6.6
Remarks on result:
other: Determination of 3 (shaken 72 hours at 30 ºC): Equilibrated at 20°C 24 hours
Water solubility:
17 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
7
Remarks on result:
other: Mean concentration 1/2/3:17.0 mg/L at 20.0 ± 0.5°C

The preliminary estimate of the water solubility at 20.0 ± 0.5 °C was 0.864 mg/L and pH 5.9.

Conclusions:
Interpretation of results: slightly soluble (0.1-100 mg/L)
The substance water solubility was determined to be 0.0485 mg/L of solution at 20.0 ± 0.5 °C.
Executive summary:

The water solubility of the test item was determined using the flask method according to EU Method A.6 and OECD TG 102 under GLP. In the definitive test, mixtures of test item and purified water were added to three separate flasks. The flasks were shaken at approximately 30°C for 24, 48 and 72 hours, respectively. Followed by static equilibration with occasional swirling at 20°C for a period of 24 hours. The pH of each solution was also measured. The water solubility of the test item was determined using GC-FID. The mean water solubility was 0.485 mg/L of solution at 20.0 ± 0.5 °C and pH 6.4.

Description of key information

Water Solubility: 0.485 mg/L at 20 ± 0.5 °C and pH 6.4, EU Method A.6 – flask method, 2020

Key value for chemical safety assessment

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

Additional information

Key study : EU Method A.6, 2020 : The water solubility of the test item was determined using the flask method according to EU Method A.6 and OECD TG 102 under GLP. In the definitive test, mixtures of test item and purified water were added to three separate flasks. The flasks were shaken at approximately 30°C for 24, 48 and 72 hours, respectively. Followed by static equilibration with occasional swirling at 20°C for a period of 24 hours. The pH of each solution was also measured. The water solubility of the test item was determined using GC-FID. The mean water solubility was 0.485 mg/L of solution at 20.0 ± 0.5 °C and pH 6.4.