Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 January 2009 to 07 February 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 do 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:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of inspection: 19 August 2008; Date of signature: 04 March 2009
Type of method:
other: Differential Scanning Calorimetry (DSC)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification : H-CB sodium salt
Description : blue solid
Purity : 94.8%
Lot number : MB-2
Date received : 04 December 2008
Storage conditions : room temperature in the dark

Results and discussion

Melting / freezing point
Decomposition:
yes
Decomp. temp.:
ca. 588 K
Remarks on result:
other: As the test material decomposed, no value for the melting temperature could be determined.

Any other information on results incl. tables

Please see attachment 1 for tables and graphs.

Preliminary testing taken to 400 Deg C had shown a distinct exotherm with a black residue. This confirmed the test material decomposed prior to melting.

As a result of the low rate of enthalpy change during decomposition, the onset temperature can only be approximated.

Similar thermographic profiles were obtained using air and nitrogen atmospheres; this indicates that the observed decomposition in both determinations is probably thermal and not oxidative.

Applicant's summary and conclusion

Conclusions:
The test material has been determined to decompose from approximately 588 +/- 0.5 K. As the test material decomposed, no value for the melting temperature could be determined.
Executive summary:

Decomposition from approximately 588 +/- 0.5 K. As the test material decomposed, no value for melting temperature could be determined, by differential scanning calorimetry, using ASTM E537 -86, Method A1 Melting/Freezing Temperature of Commission Regulation (EC) No 440/2008 of 30 May 2008.