Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21.09.2009-24.04.2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

yes

Remarks:

For the preliminary test at pH > 6, 1 g of the test item was weighed instead of 0.1g. With a quantity of 0.1g, it was impossible to achieve the test item reaction.

GLP compliance:

yes (incl. QA statement)

Remarks:

Ministere de l'Economie, des Finances et de l'Emploi, Paris, France

Type of method:

flask method

Specific details on test material used for the study:

Name of the test material (as cited in the study report): sodium lauroyl amino-acids
Test item: LCE08118
Lot / batch: 820000006

Water solubility:

278 g/L

Temp.:

25 °C

pH:

ca. 6.2

Remarks on result:

other: The test item contains 28.3 % of dry material, the solubility of the test item, based on the dry material content is 79 g (dry material)/L in deionized water (pH 6.2) at 25 °C

The final test is performed with purified water ( pH 6.2)-flask method.

An amount of 2.75 g of the test item, corresponding to approximately 2 times the amount estimated

during the preliminary tests, is mixed with 5.0 mL of water (3 separate test solutions are prepared).

The test solutions are then incubated at 30 °C. One tube is withdrawn after 24 hours, 48 hours and 72 hours and equilibrated at the test

temperature 25°C for 24 hours. After this equilibration time, an aliquot of the test solution is taken and diluted with water and the

amount of test item is determined through HPLC analysis .

Results are summarised in the table below :

Solvent: Purified water (pH 6.2)

Presaturation time	Solubility (g/L)
24 hours	315.6
48 hours	186.1
72 hours	331.0

Average solubility (g/L) 277.6

Between 24 hours and 48 hours presaturation time, the solubility of the test item is decreasing. After

72 hours presaturation time, the measured solubility has increased again. This may be due to a lack of

homogeneity of the test solution.

Conclusions:

Interpretation of results (migrated information): very soluble (> 10000 mg/L)
The water solubility of the test item, TRADE NAME PROTEOL OAT PF, Chemical name: sodium lauroyl amino-acids, in water is :
278 g/L in deionized water (pH 6.2) at 25 °C

Executive summary:

The measurement of the water solubility according to OECD Guideline 105 of the sodium lauroyl amino-acids, in water is :

278 g/L in deionized water (pH 6.2) at 25 °C.

The test item produced, supplied and used, contains 28.3 % of dry material, the solubility of the test item, based on the dry

material content is 79 g (dry material)/L in deionized water (pH 6.2) at 25 °C

Description of key information

Test material: the liquid marketed product "Proteol OAT" which contains 28.3 % of the solid substance "Glutens, hydrozylates, reaction products with lauroyl chloride, sodium salts".

temperature: 25°C

solubility in water: 278 g/L in deionized water (pH 6.2)

Key value for chemical safety assessment

Water solubility:

278 g/L

at the temperature of:

25 °C

Additional information

The test item contains 28.3 % of dry material, the solubility of the test item, based on the dry

material content is 79 g (dry material)/L in deionized water (pH 6.2) at 25 °C