Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Version / remarks:
Méthode A1 - Directive 92/69/CEE Analyse thermique différentielle DSC
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
2003-03-27
Type of method:
thermal analysis
Remarks:
Differential Scannin Calorimetry method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Identification: SEPIWHITE MSH
- Identification of the flask: Validity date: 24/05/2005
- Batch: 02 144 00005 - Expiry date: May 24, 2005
- Supplier: SEPPIC - Appearance: whitish powder
- Packaging: 2 plastic bags
- Quantity received: 2 x 1 L
- Date of the reception: October 10, 2003
- Storage: in darkness at room
- Identification number for the study: 03-089

Results and discussion

Melting / freezing point
Melting / freezing pt.:
ca. 78.9 °C

Applicant's summary and conclusion

Conclusions:
Mean melting point of the test item: 79.2 +/- 0.9°C (done on four assay)
Executive summary:

MELTING POINT AND BOILING POINT (DSC METHOD)

In compliance with Commission Directive 92/69/EEC A1 and A2 methods (1992) OECD Guidelines No. 102 and No. 103 (1995)

AMENDMENTS

No amendment to the study plan was requested.

DEVIATIONS

The following deviation was recorded: - At the moment of the test the standard operating procedure approval was in progress. Therefore the test was supervised by the study director. This deviation was not considered to have affected the quality or the interpretation of the results obtained.

RESULTS

Mean melting point of the test item: 79.2 +/- 0.9°C (done on four assay)