N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 12 February and 30 March 2012.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

GLP compliance:

yes

Type of method:

flask method

Remarks:

Using the flask method, designed to be compatible with Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.

Water solubility:

> 612 g/L

Temp.:

20 °C

pH:

>= 0.3 - <= 9.4

Remarks on result:

other: The water solubility of the test item has been determined to be greater than 612 g/L of solution at 20.0 ± 0.5 °C, the solubility showed loading rate dependence.

Results in Preliminary test

The analysed result from the preliminary estimate of water solubility was 541 g/L at 20 °C.

The results of the visual solubilities are shown in the following table.

Table 3.15

 

Mass of Test Item  (g)	Quantity of water  (mL or g)	Concentration  (mg/L or % w/w)	Observations
0.1014	100 mL	1.01 x 10³ mg/L	Colourless solution with some particles suspended
0.1052	10 mL	1.05 x 10⁴ mg/L	Colourless solution with some particles suspended
0.5037	10 mL	5.04 x 10⁴ mg/L	Colourless solution with some particles suspended
0.5068	2.0292 g	20.0 % w/w	Some particles in suspension
0.5070	1.5310 g	24.9 % w/w	Clear colourless solution. Only a few particles in suspension
1.0917	1.0157 g	51.8 % w/w	White cloudy solution
1.5056	0.5069 g	74.8 % w/w	White paste
1.8052	0.2268 g	88.8 % w/w	Test item appearance hardly changed

 

Overall result: Solubility is less than 1.01 x 10³

The mean peak areas relating to the standard and sample solutions are shown in the following table:

Table 3.16

Solution	Mean Peak Area
Standard at 502 mg/L	1.88 x 10⁸
Standard at 505 mg/L	1.88 x 10⁸
Matrix blank	none detected
Sample 1A	2.27 x 10⁸
Sample 1B	2.31 x 10⁸
Sample 2A	2.26 x 10⁸
Sample 2B	2.29 x 10⁸
Sample 3A	2.30 x 10⁸
Sample 3B	2.31 x 10⁸

 

The concentration (g/L) of test item in the sample solutions is shown in the following table:

Table 3.17

 

Sample Number	Time Shaken at ~ 30 °C (hours)	Time Equilibrated at 20 °C (hours)	Concentration (g/L)	Solution pH
1	24 ¼	24	612	9.40
2	48 ¼	24	608	9.37
3	72 ¼	24	615	9.35

 

Mean concentration: 612 g/L at 20.0 ± 0.5 °C Range: 608 to 615 g/L 

 

Validation

The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 101 to 1.01 x 10³ mg/L. This was satisfactory with a correlation coefficient of 1.000 being obtained.

Conclusions:

The test substance is very soluble (> 10000 mg/L). The water solubility of the test item has been determined to be greater than 612 g/L of solution at 20.0 ± 0.5 °C, the solubility showed loading rate dependence.

Executive summary:

The determination was carried out using the flask method, designed to be compatible with Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.

By this method, the water solubility of the test item has been determined to be greater than 612 g/L of solution at 20.0 ± 0.5 °C, and the solubility showed loading rate dependence.

Description of key information

The water solubility of the test item has been determined to be greater than 612 g/L of solution at 20.0 ± 0.5 °C, and the solubility showed loading rate dependence.

Key value for chemical safety assessment

Water solubility:

612 g/L

at the temperature of:

20 °C