Registration Dossier

Administrative data

Endpoint:
boiling point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20th November 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:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method A.2 (Boiling Temperature)
Qualifier:
according to guideline
Guideline:
OECD Guideline 103 (Boiling point/boiling range)
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 13th to the 22nd of October 2008
Type of method:
other: Capillary 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

Boiling point
Atm. press.:
>= 98.5 - <= 98.7 kPa
Decomposition:
yes
Remarks:
started to decompose at 244°C
Decomp. temp.:
244 °C

Any other information on results incl. tables

In the melting point test (Study Code: 09/019-344AN) Pellicer started to decompose (darkened) at a temperature of 244°C.

The boiling point test was carried out at 98.5 and 98.7 kPa atmospheric pressure. Using a linear heating rate of 0.5 °C/min, Pellicer decomposed before the process of boiling could be observed.

This study was started at 239 °C using a linear heating rate of 0.5 °C/min. At 270 °C liquid phase appeared in the sample, adhered to the capillary walls. No further observation was made up to 400°C.

Applicant's summary and conclusion

Conclusions:
In the melting point test (Study Code: 09/019-344AN) Pellicer started to decompose (darkened) at a temperature of 244°C. At 270 °C liquid phase appeared in the sample, adhered to the capillary walls. No further observation was made up to 400°C.
Executive summary:

The test item is assessed visually for any possible changes in its appearance, consistency and colour. The initial temperature of boiling or other effects observed is registered with the corresponding heating temperature.

Result: In the melting point test (Study Code: 09/019-344AN) Pellicer started to decompose (darkened) at a temperature of 244°C. At 270 °C liquid phase appeared in the sample, adhered to the capillary walls. No further observation was made up to 400°C.