Sodium 5-oxo-1-palmitoyl-L-prolinate

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19.07.2010-23.07.2010

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

Type of method:

flask method

Specific details on test material used for the study:

Test item: LCA10002
Batch n°: 1005700024
Chemical name: Palmitoyl Proline

The specimen was shipped at room temperature on behalf of Mr Olivier DENNY from DEFITRACES.
It was treated according to the ANADAG procedure PG 0204 for receipt, identification and storage.
The characteristics of the transport, of the receipt and of the storage in ANADAG facilities were all registered and are summarised in the following table.
Temperature during the transportation: RT = room temperature
Transportation date: 19.03.10
Date of receipt at the test facility: 22.03.10
Amount received: 50g
Condition of specimen upon receipt: Ok
Storage temperature: RT

The maximum temperature was daily recorded and was below 30 °C during the storage period
The test item was stored away from moisture and direct light.
The sample was submitted to the test as received.

Key result

Water solubility:

ca. 0.037 g/L

Conc. based on:

test mat.

Temp.:

25 °C

pH:

>= 5.6 - <= 5.9

The final test is performed with purified water ( pH 5.6 to 5.9)

An amount of the test item, corresponding to approximately the amount estimated during the preliminary tests, is mixed with water (3 separate test solutions are prepared). The mixture is submitted to ultrasonication to ease solubilisation.

The test solutions are then incubated at 30 °C. One tube is withdrawn after 24 hours, 48 hours and 72 hours and equilibrated at the test temperature 25°C for 24 hours.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 :

Presaturation time	Solubility (g/L)
24 hours	0.0376
48 hours	0.0358
72 hours	0.0380
Average solubility	0.037

Standard deviation of the mean of the 3 value: 0.0012 (RSD 3%)

Saturation of the aqueous solution is obtained after 24 hours presaturation time, (less than 15% relative standard deviation for the 3 measured values of solubility). The solubility is calculated as the mean of the 3 values obtaines with the 3 presaturation periods.

Conclusions:

The solubility of the test item is:
0.037 g/L in deionized water (pH 5.6-5.9) at 25°C

Executive summary:

The solubility of the test item is:

0.037 g/L in deionized water (pH 5.6-5.9) at 25°C

Description of key information

The solubility of the test item is:

0.037 g/L in deionized water (pH 5.6-5.9) at 25°C

Key value for chemical safety assessment

Water solubility:

0.037 g/L

at the temperature of:

25 °C