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Physical & Chemical properties

Water solubility

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Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method
Key result
Water solubility:
0.02 mg/L
Conc. based on:
test mat.
Incubation duration:
44.5 h
Temp.:
20 °C
pH:
8.5

A preliminary test for solubility was carried out as a range finding test prior to performance of the flask method or the column elution method. Based on the pretest results, the solubility of P5367 in water was determined using the column elution method to prepare a saturated solution. The temperature during the column elution method varied between 20.0°C and 20.5°C. A solid phase extraction method was used to concentrate the resulting solutions. Analyses were performed using High Performance Liquid Chromatography (HPLC). The water solubility was calculated to be 2.0 x 10 E-5 g/1.

Conclusions:
The water solubility was determined to be approx. 0.02 mg/L at 20°C and pH 8.5.
Executive summary:

The study was performed 1987 as GLP-test following EU-testing method A.6. A preliminary test for solubility was carried out as a range finding test prior to performance of the flask method or the column elution method. Based on the pretest results, the solubility of P5367 in water was determined using the column elution method to prepare a saturated solution. The temperature during the column elution method varied between 20.0°C and 20.5°C. A solid phase extraction method was used to concentrate the resulting solutions. Analyses were performed using High Performance Liquid Chromatography (HPLC). The solubility of P5367 in water was found to be 2.0 x 10 Exp.-5 g/l at 20°C and a pH-value of 8.5. A separate study conducted by another lab gave a result of 0.025 mg/l at 20°C.

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Key result
Water solubility:
0.025 mg/L
Incubation duration:
48 h
Temp.:
20 °C
pH:
ca. 5.8
Conclusions:
The water solubility was determined to be approx. 0.025 mg/L at 20°C and pH 5.8.
Executive summary:

The study was performed as GLP-test following EU-testing method A.6 using the flask method. The solubility of P5367 in water was found to be 2.5 x 10 Exp.-5 g/l at 20°C and a pH-value of approx. 5.8.

Description of key information

The water solubility was measured at two different test laboratories. In both labs, the studies were both performed under GLP and in accordance with EU-testing method A.6, showing almost similar results. The value of 0.02 mg/L (20°C) of the key study was used for the safety assessment.

Key value for chemical safety assessment

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

Additional information

Reference: GLP-report