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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:
2016-09-16 to 2016-09-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
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:
51.6 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
6.9

The method showed acceptable results for linearity, accuracy, precision and specificity according to SANCO 3029/99 rev.4 (2000).

The recovery rate of the fortified samples ranged from 87 to 102 %, demonstrating a good accuracy.

The LOQ was determined to be 20 mg/L and LOD = 0.01 µg/L .

The temperature at pre-incubation ranged from 29.98 to 30.08°C, yielding a mean of 30.04 +/- 0.01°C.

The temperature at thermostatisation phase ranged from 20.03 to 20.18°C, yielding a mean of 20.06 +/- 0.03°C.

The pH values were determined with the remaining test item mixtures in the original vessels, which were kept constant at 20 +/- 0.5°C, and ranged from 6.709 to 7.151, yielding a mean of 6.9.

No Tyndall effect was observed.

Water solubility results:

Preincubation time

Replicate

Concentration

Mean

24h

1

50.9

50.7

2

50.5

48h

1

49.7

51.1

2

52.5

72h

1

51.5

53.0

2

54.6

Mean (24-72h)

51.6

Deviation (%)

(24-72h)

4.6

Conclusions:
The water solubility of the test item was found to be 51.6 mg/L at 20°C and pH 6.9.
Executive summary:

The water solubility of the test item was determined according to OECD 105, flask method. Samples of 1 g/L were pre-incubated at 30°C for 24, 48 and 72h. After pre-incubation, the samples were brought to 20°C, centrifuged and the concentration determined by GC-MS. The mean water solubility was found to be 51.6 °C at 20°C, pH 6.9.

The validity criteria were met.

Description of key information

For this endpoint, the water solubility of the test item was assessed according to OECD 105, flask method. The samples were pre-incubated for 24, 48 and 72h. The mean water solubility is 51.6 mg/L at pH 6.9 and 20°C.

Key value for chemical safety assessment

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

Additional information