Registration Dossier

Administrative data

Endpoint:
relative density
Remarks:
Other density types indicated (migrated information): density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4th August 2009
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:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method A.3 (Relative Density)
Qualifier:
according to guideline
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 13th to the 22nd of October
Type of method:
pycnometer 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

Densityopen allclose all
Type:
density
Density:
1 205 kg/m³
Remarks on result:
other: average of 5 readings
Type:
relative density
Density:
1.205

Any other information on results incl. tables

A fully automatic determination of the density was carried out with the help of MINIDENS Density Meter. The measured value was 1205 ± 4.97 kg/m3. The relative density (D420) is 1.205.

Applicant's summary and conclusion

Conclusions:
A fully automatic determination of the density was carried out with the help of MINIDENS Density Meter. The measured value was 1205 ± 4.97 kg/m3.
The relative density (D420) is 1.205.
Executive summary:

The density was carried out using EU Method A3 and OECD Guideline 109. The relative density was determined to be 1.205.