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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:
from 2017-10-23 to 2017-10-28
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
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
2.31 g/L
Conc. based on:
test mat.
Incubation duration:
72 h
Temp.:
20 °C
pH:
>= 6.79 - <= 6.84

Preliminary test

The water solubility of the test item was estimated to be 2.35 g/L in a preliminary test and therefore the shake-flask method was used in the main test.

Main test

The calibration solutions were prepared in 0.5 - 20 μg/mL range. The calibration samples were analysed by HPLC-UV method with three replicate injections from each. The concentrations of the test item were calculated with the help of the calibration equation. Measured concentrations of the test item are summarised in Table 1. The repeatability of the determination was < 15% and thus within the range required by the guidelines.

Table 1: Results of the determination of water solubility of the test item

Sampling time

Measured concentration of

test item (g/L)

Measured pH
Test vessels Mean
After 24h 2.34 2.30 6.83
2.29 6.84
2.28 6.83
After 48h 2.31 2.30 6.81
2.31 6.81
2.27 6.84
After 72h 2.31 2.34 6.79
2.38 6.79
2.33 6.79

Solubility of the test item (g/L):

  2.31 ± 0.06 -
RSD%:   1.0 -
Conclusions:
The water solubility of the test item was determined to be 2.31 ± 0.06 g/L (95% confidence interval) at 20 ± 0.5 °C.
Executive summary:

A study was conducted according to OECD TG 105, Regulation (EC) No. 440/2008 method A.6 and OPPTS 830.7840 in order to determine the water solubility of the test item. In the preliminary test the water solubility was 2.35 g/L and therefore the shake-flask method was used in the main test. The calibration solutions were prepared in 0.5 - 20 μg/mL range. The calibration samples were analysed by HPLC-UV method with three replicate injections from each. The concentrations of the test item were calculated with the help of the calibration equation. The mean water solublity was determined to be 2.31 ± 0.06 g/L (95% confidence interval) at 20 ± 0.5 °C.

Description of key information

The water solubility of the test item was determined to be 2.31 ± 0.06 g/L (95% confidence interval) at 20 ± 0.5 °C.

Key value for chemical safety assessment

Water solubility:
2.31 g/L
at the temperature of:
20 °C

Additional information

A study was conducted according to OECD TG 105, Regulation (EC) No. 440/2008 method A.6 and OPPTS 830.7840 in order to determine the water solubility of the test item (reference 4.8-1). In the preliminary test the water solubility was 2.35 g/L and therefore the shake-flask method was used in the main test. The calibration solutions were prepared in 0.5 - 20 μg/mL range. The calibration samples were analysed by HPLC-UV method with three replicate injections from each. The concentrations of the test item were calculated with the help of the calibration equation. The mean water solublity was determined to be 2.31 ± 0.06 g/L (95% confidence interval) at 20 ± 0.5 °C.