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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21/09/2009-20/05/2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Test material form:
solid
Details on test material:
Test ITEM : LCE08115 (SEPIFEEL ONE)
Batch N° : 826900020
The test item consist in a mix of palmitoyl proline, magnesium palmitoyl glutamate and sodium palmitoyl sarcosinate (CAS N°59441-32-6, CAS N°57539-47-6, CAS N°4028-10-8).

The specimen was shipped at room temperature on behalf of Mr Olivier DENNY from DEFITRACES
It was treated according to the ANADIAG procedure PG 0204 for receipt, identification and storage.
The characteristics of the transport, of the receipt and of the storage in ANADIAG facilities were all registered and are summarised in the following table.
Table of shipment and storage:
Sample n°: LCE08115 Batch N° 826900020
Anadiag n°: 1480/A
Temperature during the transportation: Room temperature
Transportation date: 11.09.09
Date of receipt at the test facility: 14.09.09
Amount received: 90g
Condition of specimen upon receipt: Ok
Storage temperature: Room temperature

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.
Specific details on test material used for the study:
Test ITEM : LCE08115 (SEPIFEEL ONE)
Batch N° : 826900020
The test item consist in a mix of palmitoyl proline, magnesium palmitoyl glutamate and sodium palmitoyl sarcosinate (CAS N°59441-32-6, CAS N°57539-47-6, CAS N°4028-10-8).

The specimen was shipped at room temperature on behalf of Mr Olivier DENNY from DEFITRACES.
It was treated according to the ANADIAG procedure PG 0204 for receipt, identification and storage.
The characteristics of the transport, of the receipt and of the storage in ANADIAG facilities were all registered and are summarised in the following table.

Anadiag n°: 1480/A
Temperature during the transportation: Room temperature
Transportation date: 11.09.09
Date of receipt: 14.09.09
Amount received: 90 g
Condition of specimen upon receipt: OK
Storage temperature: Room temperature


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

Results and discussion

Water solubility
Key result
Water solubility:
ca. 0.214 g/L
Conc. based on:
test mat.
Incubation duration:
>= 24 - <= 72 h
Temp.:
25 °C
pH:
ca. 5.9

Any other information on results incl. tables

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

An amount of 100 mg of the test item, corresponding approximately to the amount estimated during the preliminary tests, is mixed with 20 mL of water (3 separate test solutions are prepared). The mixture is submitted to ultrasonication to ease solubilisation. The test solutions are then incubated at 25 °C. One tube is withdrawn after 24 hours, 48 hours and 72 hours. After this time equilibration, 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 5.9)   

 Solubility (g/L) after 24 hours presaturation  0.2045
 Solubility (g/L) after 48 hours presaturation   0.2002
 Solubility (g/L) after 72 hours presaturation 0.2359 
Average solubility (g/L)  0.2140

Applicant's summary and conclusion

Conclusions:
The solubility of the test item in water is :
2.140 E-01 g/L in deionized water (pH 5.9) at 25 °C
The pH of the solution has no significant effect on the solubility.
Executive summary:

The solubility of the test item in water is :

2.140 E-01 g/L in deionized water (pH 5.9) at 25 °C

The pH of the solution has no significant effect on the solubility.