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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:
19 APR 2000 - 15 JUN 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
guideline 92/69/EEC
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method
Water solubility:
< 0.005 mg/L
Conc. based on:
test mat. (total fraction)
Temp.:
20 °C
pH:
6.89

VISUAL ESTIMATION

Even in a total volume of 1000 mL undissolved particles could be observed. Thus the water solubility of the test substance is less than 10 mg/L.

COLUMN-ELUTION METHOD

The coating check was successful

According to the guideline, the data of the fractions 1 to 5 were not taken into account for the following evaluation. The following values for the water solubility were calculated from the fractions 6 to 15 for both columns. Fraction 16 and all following fractions were discarded without determination of any parameter.

Result run 1 : Evaluation of the fractions 6 to 15. The water solubility was found to be less than 0.0054 mg/L for all fractions. Average water solubility: < 0.0054 mg/L.

Result run 2: Evaluation of the fractions 6 to 15. The water solubility was found to be less than 0.0052 mg/L for all fractions. Average water solubility: < 0.0052 mg/L.

The water solubility (ws) of the test substance at a temperature of 20 °C was determined as follows (average over both runs):

ws < 0.0053 mg/L

SD = 0.0002 mg/L

RSD = 3%

Conclusions:
The water solubility (ws) was found to be:
ws < 0.0053 mg/l
SD = 0.0002 mg/l
RSD = 3%
Executive summary:

The water solubility (ws) of the test substance has been determined according to the "column-elution" method following guideline 92/69/EEC, appendix A.6, according to GLP at a temperature of 20 °C.

It was found to be:

ws < 0.0053 mg/L

SD = 0.0002 mg/L

RSD = 3%

Description of key information

The water solubility (ws) of the test substance has been determined according to the "column-elution" method following guideline 92/69/EEC, appendix A.6, according to GLP, at a temperature of 20 °C.

It was found to be:

ws < 0.0053 mg/L

SD = 0.0002 mg/L

RSD = 3%

Key value for chemical safety assessment

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

Additional information

Determined value for water solubility is below the above mentioned value, because HPLC peak area is below a calculated value based on the minimum visible peak are. This does not affect the chemical safety assessment because the water solubility is in any case very low.