Peptones, soybean

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018-11-07 to 2018-11-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

GLP compliance:

no

Type of method:

flask method

Key result

Water solubility:

> 1 012 g/L

Conc. based on:

test mat.

Incubation duration:

72 h

Temp.:

20 °C

pH:

7

The preliminary test at room temperature showed, that the water solubility of the test item was between >1012.3 g/L.

Preliminary test for the water solubility

Amount of test item [mg]	Total volume of added water [mL]	Ultrasonic bath [min]	Remark
107.8	0.1	--	not dissolved
	0.6	1	dissolved
506.1	0.5	8	dissolved

For the determination of water solubilities of >1012 g/L, the flask method is recommended. The substance is a UVCB substance which consists of Polypeptide, Peptide and Protein. It was technically not possible to develop a suitable analytical method to determine the individual constituents. In addition, it was concluded that the substance is highly miscible with water as the water solubility was estimated to be above 1012 g/L. Thus, no main test could be performed.

 

Conclusions:

The substance was found to be completely miscible in water. The water solubility of the test item was determined to be above 1012 g/L.

Executive summary:

The water solubility was determined according to OECD 105 and Regulation (EC) No 440/2008 method A.6 using the shake flask.In a stepwise procedure, increasing volumes of water were added at room temperature to approximately 0.1 g of the test item in a 100 mL glass-stoppered measuring cylinder. After each addition of an amount of water, the mixture was stirred or treated in an ultrasonic bath and visually checked for any undissolved parts of the test item. The preliminary test at room temperature showed, that the water solubility of the test item was between >1012.3 g/L. It was technically not possible to establish a suitable analytical method for this UVCB substance. In addition, it was concluded that it was scientifically not necessary as the test item is highly miscible with water and above 1000 g/L the term water solubility will be not applicable.

Description of key information

The substance was found to be completely miscible in water. The water solubility of the test item was determined to be above 1012 g/L.

Key value for chemical safety assessment

Water solubility:

1 012.3 g/L

at the temperature of:

20 °C

Additional information

The water solubility was determined according to OECD 105 and Regulation (EC) No 440/2008 method A.6 using the shake flask (reference 4.8 -1). In a stepwise procedure, increasing volumes of water were added at room temperature to approximately 0.1 g of the test item in a 100 mL glass-stoppered measuring cylinder. After each addition of an amount of water, the mixture was stirred or treated in an ultrasonic bath and visually checked for any undissolved parts of the test item. The preliminary test at room temperature showed, that the water solubility of the test item was between >1012.3 g/L. It was technically not possible to establish a suitable analytical method for this UVCB substance. In addition, it was concluded that it was scientifically not necessary as the test item is highly miscible with water and above 1000 g/L the term water solubility will be not applicable.