Fatty acids, tall-oil, compds. with ethanolamine

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 June 2016 to 17 July 2016

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

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Key result

Water solubility:

< 0.052 g/L

Conc. based on:

test mat.

Loading of aqueous phase:

0.1 g/L

Incubation duration:

>= 24 - <= 72 h

Temp.:

20 °C

pH:

>= 8.7 - <= 8.8

Details on results:

PRELIMINARY TEST
- Preliminary estimates of water solubility at 20.0 ± 0.5 °C are shown in Table 13 (below).

MAIN TEST
- Typical chromatography is presented in Appendix 1 (attached).
- The mean total peak areas relating to the standard and sample solutions are shown in Table 14 (below).
- The calibration curve from which sample concentrations were interpolated is shown in Figure 8 (attached).
- The concentration (g/L) of test item in the sample solutions at 20.0 ± 0.5 °C are shown in Table 15 (below).

Table 13 – Results of preliminary test

Loading rate (g/L)	Concentration (g/L) LCMS analysis	Concentration (g/L) Total Organic Carbon	Solution pH
0.1	< 5.38 x 10^-2	< 5.26 x 10^-2	8.8
1	< 0.360	< 0.347	9.7

Table 14 – Main test mean total peak areas

Solution	Mean total peak area
Standard 1.03 mg/L	2.301 x 10^6
Standard 2.58 mg/L	3.532 x 10^6
Standard 5.16 mg/L	6.805 x 10^6
Standard 7.74 mg/L	8.904 x 10^6
Standard 10.1 mg/L	1.349 x 10^7
Standard 10.3 mg/L	1.186 x 10^7
Standard 15.5 mg/L	1.878 x 10^7
Standard 20.6 mg/L	2.454 x 10^7
Blank	None detected
Sample 1A	1.108 x 10^7
Sample 1B	1.195 x 10^7
Sample 2A	1.511 x 10^7
Sample 2B	1.612 x 10^7
Sample 3A	1.111 x 10^7
Sample 3B	1.081 x 10^7

Table 15 – Main test results

Sample number	Time shaken at approximately 30 °C (hours)	Time equilibrated at 20 °C (hours)	Concentration of test item (g/L)	Solution pH
1	24	24	3.73 x 10^-2	8.7
2	48	24	5.16 x 10^-2	8.8
3	72	24	3.54 x 10^-2	8.7

Conclusions:

Water solubility of the test item was determined to be < 5.16 x 10E-02 g/L at 20.0 ± 0.5 °C based on a nominal loading rate of 0.1 g/L. It was observed that the water solubility of the test material was loading rate dependent due to its ability to disperse in water.

Executive summary:

GUIDELINE

The determination was carried out using the flask method and was designed to be compatible with OCED 105 (27 July 1995) and Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 (30 May 2008).

RESULTS

Water solubility of the test item was determined to be < 5.16 x 10E-02 g/L at 20.0 ± 0.5 °C based on a nominal loading rate of 0.1 g/L. It was observed that the water solubility of the test material was loading rate dependent due to its ability to disperse in water.

Description of key information

Water solubility of the test item was determined to be < 5.16 x 10E-02 g/L at 20.0 ± 0.5 °C based on a nominal loading rate of 0.1 g/L. It was observed that the water solubility of the test material was loading rate dependent due to its ability to disperse in water (OECD 105 and EU Method A.6).

Additional information

The determination was carried out using the flask method and was designed to be compatible with OCED 105 (27 July 1995) and Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 (30 May 2008).