Registration Dossier

Administrative data

Endpoint:
relative self-ignition temperature (solids)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between the 12th of August 2009 and 7th October 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 guideline
Qualifier:
according to guideline
Guideline:
EU Method A.16 (Relative Self-Ignition Temperature for Solids)
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 13th to the 22nd of October 2008 (GLP certificate is valid for 2 years)

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

Relative self-ignition temperature (solids)
Relative self-ignition temperature:
389 °C
Remarks on result:
other:

Any other information on results incl. tables

The relative self-ignition temperature of Pellicer was 389 °C.

Applicant's summary and conclusion

Conclusions:
The relative self-ignition temperature of Pellicer was 389 °C.
Executive summary:

The relative self-ignition temperature of Pellicer was 389 °C, this was determined using EU method A16.