Polyamide wax

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviation from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

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

Water solubility:

< 0.012 mg/L

Temp.:

20 °C

Remarks on result:

other: Peak 1. pH was 4.2 and 6.0 for the two different flow rates.

Water solubility:

< 0.03 mg/L

Temp.:

20 °C

Remarks on result:

other: Peak 2. pH was 4.2 and 6.0 for the two different flow rates.

Water solubility:

< 0.1 mg/L

Temp.:

20 °C

Remarks on result:

other: Peak 3. pH was 4.2 and 6.0 for the two different flow rates.

Preliminary test:

The concentration of EA-3098 in the aqueous phases after two and three successive centrigugation steps was for peak 1 <1.0 x 10 ^-5 g/l, peak 2 <4.0 x 10^-5 g/l and for peak 3 <1.o x 10^-4 g/l, respectively. From this it could be concluded that the water solubility of EA-3098 is <10 mg/l. Therefore, the column elution method was chosen for the determination of the water solubility of EA-3098. The pH of the aqueous phase after 2 centrifugation steps was 9.5.

Main study (column elution method):

Analysis confirmed the presence of test substance on the loaded carrier material before filling the column.

The eluates did not contain undissolved particles. In the eluates from the blank column a small peak was detected for peak 1. The concentration was calculated using the RF-factor and was <Limit of Detection (LOD).

The results are summarised in Tables 1, 2 and 3.

Table 1: Results of column elution method for peak 1

Actual flow rate (ml/h)	Sample no.	Concentration analysed (mg/l)	pH
24	1-10	<LOD*	4.2
12	1-10	<LOD*	6.0

* LOD = 0.012 mg/l (all samples contained a small test substance peak, which was smaller than the limit of detection).

Table 2: Results of column elution method for peak 2

Actual flow rate (ml/h)	Sample no.	Concentration analysed (mg/l)	pH
24	1-10	<LOD*	4.2
12	1-10	<LOD*	6.0

*LOD = 0.03 mg/l

Table 3: Results of column elution method for peak 3

Actual flow rate (ml/h)	Sample no.	Concentration analysed (mg/l)	pH
24	1-10	<LOD*	4.2
12	1-10	<LOD*	6.0

*LOD = 0.1 mg/l

Conclusions:

Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
Since EA-3098 is a mixture of components, quantitative analysis was based on the three largest peaks in the chromatogramn of EA-3098.

The water solubility of EA-3098 at 20.4 ± 0.5°C is < 1. 2x 10-5 g/l based on peak 1, < 3.0 x 10-5 g/l based on peak 2 and < 1.0 x 10-4 g/l based on peak 3, using the column elution method.
The pH was measured to be 4.2 and 6.0.

Executive summary:

The column elution method was used to determine the water solubility of EA-3098 and was based on the following guidelines:

OECD Guideline no. 105: "Water Solubility" and EEC Directive 62/69/EEC Method A.6 "Water solubility".

Since EA-3098 is a mixture of components, quantitative analysis was based on the three largest peaks in the chromatogramn of EA-3098.

The water solubility of EA-3098 at 20.4 ± 0.5°C is < 1.2 x 10^-5 g/l based on peak 1, < 3.0 x 10^-5 g/l based on peak 2 and < 1.0 x 10^-4 g/l based on peak 3, using the column elution method.

The pH was measured to be 4.2 and 6.0.

.

Description of key information

Since EA-3098 is a mixture of components, quantitative analysis was based on the three largest peaks in the chromatogramn of EA-3098.

The water solubility of EA-3098 at 20.4 ± 0.5°C is < 1.2 x 10-5 g/l based on peak 1, < 3.0 x 10-5 g/l based on peak 2 and < 1.0 x 10-4 g/l based on peak 3, using the column elution method.

Key value for chemical safety assessment

Water solubility:

0.1 mg/L

at the temperature of:

20.4 °C

Additional information

The column elution method was used to determine the water solubility of EA-3098 and was based on the following guidelines:

OECD Guideline no. 105: "Water Solubility" and EEC Directive 62/69/EEC Method A.6 "Water solubility".

Since EA-3098 is a mixture of components, quantitative analysis was based on the three largest peaks in the chromatogramn of EA-3098.

The water solubility of EA-3098 at 20.4 ± 0.5°C is < 1.2 x 10^-5g/l based on peak 1, < 3.0 x 10^-5g/l based on peak 2 and < 1.0 x 10^-4g/l based on peak 3, using the column elution method.

The pH was measured to be 4.2 and 6.0.