Urea, polymer with ethanedial

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 7, 2012 - August 16, 2012

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

Remarks on result:

other: The test item probably is miscible with water in any rate.

Details on results:

The test item was miscible with distilled water in a ratio of 1:1 (1kg in 1 L of water), giving at 20 ºC 556.5 g/L of solution which was 257.1 g of dry substance/L and a TOC value of 94.5 g/L. It was concluded that the test item probably is miscible with water in any rate.

Table 1. Results of the preliminary test

Result	0.1g in x ml of distilled water
Miscibility (+/-)	+
Approximate miscibility, [g/L]	> 1000

Table 2. TOC and pH values of some test item homogenous, transparent water solutions before the solid phase formation.

NOPCOTE 1661 content, as weighed (i.e. the loading) g/L of water	0	2	3	4	10	1000	1280
Measured TOC after 10 min shaking, g/L of solution		0.39	0.56	0.73	1.81	94.50	129.28
Final pH	5.6	5.04	4.91	4.36	4.03	3.30	3.11
Form after 50 days from dissolving	+	+	+	+	+	+	+

Where:

TOC – Total Organic Carbon,

(+) complete miscibility, transparent

Conclusions:

It was concluded that the test item probably is miscible with water in any rate.

Executive summary:

The determination of test item solubility in water using shake flask method was carried out according to the OECD 105 Guideline and EEC A.6 Method (Shake flask method). It was technically infeasible to obtain the analytical standards of the solid components for HPLC analysis and therefore, a non-discriminating method (TOC) was used in order to quantify the total amount of material solubilised. The preliminary test revealed that the water solubility was greater than 1000 g of test item in one liter of water. Afterwards, six water solutions of various of test item content (as weighed 46.2% water solution i.e. the loading) were prepared and the pH and the TOC values of these homogenous, transparent solutions (stable solution for one day for a concentration of 1000 mg/l) were measured. The test item was miscible with distilled water in a ratio of 1:1 (1kg in 1 L of water), giving at 20 ºC 556.5 g/L of solution which was 257.1 g of dry substance/L and a TOC value of 94.5 g/L. It was concluded that the test item probably is miscible with water in any rate.

Description of key information

Key study: Test method OECD 105. GLP study. It was concluded that the test item probably is miscible with water in any rate.

Key value for chemical safety assessment

Water solubility:

94.5 g/L

at the temperature of:

20 °C

Additional information

Key study: The determination of test item solubility in water using shake flask method was carried out according to the OECD 105 Guideline and EEC A.6 Method (Shake flask method). It was technically infeasible to obtain the analytical standards of the solid components for HPLC analysis and therefore, a non-discriminating method (TOC) was used in order to quantify the total amount of material solubilised. The test item was miscible with distilled water in a ratio of 1:1 (1kg in 1 L of water), giving at 20 ºC 556.5 g/L of solution which was 257.1 g of dry substance/L and a TOC value of 94.5 g/L. It was concluded that the test item probably is miscible with water in any rate.