Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 23 January 2009 and 27 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 the 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.1 (Melting / Freezing Temperature)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of GLP inspection: 19/08/2008 Date of Signature on GLP certificate: 04/03/2009
Type of method:
other: Differential Scanning Calorimetry, using ASTM E537-86

Test material

Constituent 1
Details on test material:

- Name of test material (as cited in study report): Eldew APS-307
- Substance type: Organic UVCB
- Physical state: Pale yellow waxy solid
- Analytical purity: 100%
- Lot/batch No.: 809114
- Stability under test conditions: stable
- Storage condition of test material: Room temperature, in the dark

Results and discussion

Melting / freezing point
Melting / freezing pt.:
304 - 321 K

Any other information on results incl. tables

Thermographic data for Determinations 1, 2 and 3 are shown in the following tables respectively:

Table 4.2:       Thermographic Data - Determination 1

 

Thermal Event

 

 

Interpretation

 

 

                 Temperature

                    oC

              K

 

Onset of endotherm

 

 

Onset of melting temperature range

 

32.05

305

   Endset of endotherm

 Endset of melting temperature range

47.69

321

Table 4.3:       Thermographic Data - Determination 2

 

Thermal Event

 

 

Interpretation

 

 

                 Temperature

                    oC

              K

 

Onset of endotherm

 

 

Onset of melting temperature range

 

31.06

304

   Endset of endotherm

 Endset of melting temperature range

46.94

320

Table 4.4:       Thermographic Data - Determination 3

 

Thermal Event

 

 

Interpretation

 

 

                 Temperature

                    oC

              K

 

Onset of endotherm

 

 

Onset of melting temperature range

 

30.58

304

   Endset of endotherm

 Endset of melting temperature range

47.05

320

Overall melting temperature range: 304 to 321 ± 1 K

Please see Attachment 1 for Thermogram data.

Applicant's summary and conclusion

Conclusions:
The melting temperature range of the test material has been determined to be 304 to 321 ± 1 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 Council Regulation (EC) No 440/2008 of 30 May 2008.

Conclusion: The melting temperature range of the test material has been determined to be 304 to 321 ± 1 K