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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:
03 June 2016 to 08 June 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:
column elution method
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source: Provided by sposor
- Lot/batch No.of test material: 150701
- Expiration date of the lot/batch: 14 July 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: - Storage conditions: Controlled room temperature (15-25 ºC, below 70 RH%), protected from humidity, under inert gas.
Water solubility:
< 0.02 µg/L
Conc. based on:
test mat.
Incubation duration:
< 117 h
Temp.:
20 °C
pH:
>= 4.95 - <= 5.03
Remarks on result:
other: LOQ tested
Details on results:
The test material was not detectable during the study. Therefore the water solubility is determined to be < 0.02 μg/mL (LOQ) at 20 °C ± 1 °C using the column elution method for the performance of the main test.
Conclusions:
Under the conditions of the study, the test material was not detectable during the study. Therefore the water solubility is determined to be < 0.02 μg/mL (LOQ) at 20 °C ± 1 °C using the column elution method.
Executive summary:

The water solubility of the test material was determined using the column elution method in a GLP study conducted in accordance with the standardised guidelines OECD 105 and EU method A.6.

The column elution method was used to investigate the water solubi.lity of the test material at 20 ± 1 °C. 200 mg of test material was dissolved in 100 mL acetone, and this solution was added to approximately 40-50 g of inert support material (glass beads). The solvent was completely evaporated using a rotary evaporator. The dry support material was poured into the micro-column, filled with water. The system was then equilibrated for two hours. Then the flow through the column was started at a rate of 25 mL/h. The first five bed volume water was discarded to remove water-soluble impurities. After 68, 74, 92, 96 and 117 hours circulation, 0.4 mL samples were taken and injected directly. A second run was performed in a similar manner at about 12.5 mL/h flow rate. After 68, 74, 92, 96 and 117 hours circulation 0.4 mL water samples were taken and injected directly. pH of all samples was determined.

Under the conditions of the study, the test material was not detectable during the study. Therefore the water solubility is determined to be < 0.02 μg/mL (LOQ) at 20 °C ± 1 °C using the column elution method.

Description of key information

Under the conditions of the study, the test material was not detectable during the study. Therefore the water solubility is determined to be < 0.02 μg/mL (LOQ) at 20 °C ± 1 °C using the column elution method.

Key value for chemical safety assessment

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

Additional information

The water solubility of the test material was determined using the column elution method in a GLP study conducted in accordance with the standardised guidelines OECD 105 and EU method A.6. The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

The column elution method was used to investigate the water solubi.lity of the test material at 20 ± 1 °C. 200 mg of test material was dissolved in 100 mL acetone, and this solution was added to approximately 40-50 g of inert support material (glass beads). The solvent was completely evaporated using a rotary evaporator. The dry support material was poured into the micro-column, filled with water. The system was then equilibrated for two hours. Then the flow through the column was started at a rate of 25 mL/h. The first five bed volume water was discarded to remove water-soluble impurities. After 68, 74, 92, 96 and 117 hours circulation, 0.4 mL samples were taken and injected directly. A second run was performed in a similar manner at about 12.5 mL/h flow rate. After 68, 74, 92, 96 and 117 hours circulation 0.4 mL water samples were taken and injected directly. pH of all samples was determined.

Under the conditions of the study, the test material was not detectable during the study. Therefore the water solubility is determined to be < 0.02 μg/mL (LOQ) at 20 °C ± 1 °C using the column elution method.