Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Start of experiment: 25 January 2010 End of experiment: 29 January 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies which did not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Principles of method if other than guideline:
The guideline specifies that the test item in excess should be added to water however the physical properties of Pellicer do not permit this. The study method therefore deviates from the guideline but is considered scientifically valid
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 13th to the 22nd of October 2008 (GLP certificate is valid for 2 years)
Type of method:
flask method

Test material

Constituent 1
Reference substance name:
Pellicer
IUPAC Name:
Pellicer
Details on test material:
Name: Pellicer
Lot No.: 01-09-17
Chemical name: L-Lysine,N2,N6-bis[N-(1-oxododecyl)-L-α(or γ)-glutamyl]-, sodium salt (1;?)
Appearance: White powder
Storage condition: Room temperature (15-25 °C), in the dark and protected from humidity (with desiccant)
Manufacture date: 17 January 2009
Expiry Date: 17 January 2011
Safety precautions: Routine safety and hygienic procedures sufficient to ensure personnel health and safety

Results and discussion

Water solubility
Water solubility:
> 200 g/L
Temp.:
23 °C
pH:
7.1 - 7.12
Details on results:
Results of the visual estimation:
Applying five minutes solution time water solubility of Pellicer was between 230 and 286 g/l using visual observation.

Any other information on results incl. tables

pH of the samples varied in the range of 7.10 – 7.12. The test mixtures were clean, homogeneous solutions without any undissolved part. Samples were analysed with the above HPLC method. Solubility of Pellicer proved to be more than 200 g/l.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): moderately soluble (100-1000 mg/L)
Considering the concentrations measured by HPLC, and also based on the visual estimation, water solubility of Pellicer is higher than 200 g/l at 20 °C.
Executive summary:

The water solubility has been determined using EU method A6 and OECD guideline 105. The water solubility has been determined to be > 200 g/l at 20 deg C.