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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:
07 March 2018 to 02 May 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to other 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)
Version / remarks:
2016
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method
Key result
Water solubility:
< 0.08 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
>= 6.3 - <= 6.4
Details on results:
PRELIMINARY TEST
The content of test material dissolved in the water sample was 0.000340 mg/L.

MAIN STUDY
The results for the samples taken at a flow rate set to 6, 12 and 24 mL/h are given in Table 1.
The coefficient of variation (CV) (n = 10) was ≤ 30 % at all flow rates. It demonstrated that the system was equilibrated at all flow rates.
The maximum difference (MD) on the mean values of the samples at flow rates 24 and 12 mL/h was > 30 %. The MD on the mean values of the samples at flow rates 6 and 24 mL/h was ≤ 30 %. Since most of the concentrations measured were extrapolated below the calibration curve, the water solubility of the test material is given as lower than the lowest calibration solution while taking a dilution factor of 2 into account (i.e. < 0.08 mg/L).
The turbidity of the eluates was < 0.2 NTU, with the exception of the test material containing column eluate at a flow rate of 12 mL/h. Since the measured concentration was < 0.08 mg/L it had no impact on the results. No undissolved particles were detected in the eluates of 6 and 24 mL/h.
No test material was detected in the samples from the blank column, with the exception of the blanks at 6 mL/h, which had no impact on the results.

Table 1: Main study - water solubility of the test material

Flow rate

(mL/h)

Concentration analysed

pH

Mean (mg/L)*#

CV (%)

Mean (mg/L) †#

MD (%)

24

0.057

11

0.052

18

6.3

12

0.084

7.4

 

 

6.4

6

0.047

4.5

 

 

6.3

 * Mean of the concentrations obtained at one flow rate.

# Water solubility is seen as <0.08 mg/L

Mean of the concentrations obtained at the flow rate of 24 and 6 mL/h.

Conclusions:
Under the conditions of the study the water solubility of the test material was determined to be < 0.08 mg/L at 20 °C.
Executive summary:

The water soloubility of the test material was investigated in a study which was conducted in accordance with the standardised guidelines OECD 105, EU Method A.6 and EPA OPPTS 830.7840, under GLP conditions, following the column elution method.

Under the conditions of the study the water solubility of the test material was determined to be < 0.08 mg/L at 20 °C.

Description of key information

Under the conditions of the study the water solubility of the test material was determined to be < 0.08 mg/L at 20°C.

Key value for chemical safety assessment

Additional information

The water soloubility of the test material was investigated in a study which was conducted in accordance with the standardised guidelines OECD 105, EU Method A.6 and EPA OPPTS 830.7840, under GLP conditions, following the column elution method. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

Under the conditions of the study the water solubility of the test material was determined to be < 0.08 mg/L at 20°C.