Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted between 26 October 2009 and 19 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 do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Version / remarks:
EXAMPLE:
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of inspection: 19-08-2008 Date of Signature: 04-09-2009
Type of method:
other: EXAMPLE: Differential scanning calorimetry (DSC)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification: DMH
Description: white crystalline solid
Batch number: N5439431
Date received: 24 February 2006
Storage conditions: room temperature in the dark

Results and discussion

Melting / freezing point
Melting / freezing pt.:
449 K
Remarks on result:
other: air (static)

Any other information on results incl. tables

Results

Thermograms and thermographic data for Determinations 1 and 2 are shown in Figure 4.1. and Figure 4.2. and in the following tables respectively.

Figure 4.1  Thermogram – Determination 1 (Please see attached Fig 4.1 & 4.2 Thermogram – Determination)

Table 4.2           Thermographic Data – Determination 1

Thermal Event

Interpretation

Temperature

ºC

K

Endotherm

Melting Temperature

176.10

449

 


Figure4.2 

 Thermogram – Determination 2 (Please see attached Fig 4.1 & 4.2 Thermogram – Determination)

Table4.3           Thermographic Data – Determination 2

Thermal Event

Interpretation

Temperature

ºC

K

Endotherm

Melting Temperature

176.14

449

 

Mean melting temperature: 449 ± 0.5 K

Applicant's summary and conclusion

Conclusions:
The melting/freezing temperature of the test material has been determined to be 449 ± 0.5 K.
Executive summary:

Method

The determination was carried out by differential scanning calorimetry (DSC) using the procedure specified in ASTM E537-86, Method A1 Melting/Freezing Temperature of Commission Regulation (EC) No 440/2008 of 30 May 2008.

Conclusion

The melting/freezing temperature of the test material has been determined to be 449 ± 0.5 K.