Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-09-29 to 2007-04-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD Guideline 102 (Melting point/Melting range) and EU Method A.1 (Melting / Freezing Temperature) without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Deviations:
no
Remarks:
The testing facility indicated that there were no deviations from the protocol.
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
Remarks:
The testing facility indicated that there were no deviations from the protocol.
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
Department of Health of the Government of the United Kingdom
Type of method:
capillary method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): VRT-753136 hcl
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: no data
- Physical state: white powder
- Analytical purity: 99.4% w/w by High Performance Liquid Chromatography (HPLC)
- Impurities (identity and concentrations): individual unknown components were detected at 0.03 area%; isopropanol (residual solvent) at 300 ppm
- Composition of test material, percentage of components: not applicable
- Isomers composition: not applicable
- Purity test date: 2006-05-25
- Lot/batch No.: 25515
- Expiration date of the lot/batch: May 2008
- Stability under test conditions: no data
- Storage condition of test material: at room temperature
- Other: no data

Results and discussion

Melting / freezing point
Melting / freezing pt.:
> 170 °C
Decomposition:
yes
Decomp. temp.:
ca. 170 °C

Any other information on results incl. tables

In the duplicate definitive determinations, the samples were observed to darken from approximately 170 deg C. At this temperature, the samples changed from a white to an off-white powder, with browning at the surface. These observations were indicative of decomposition. When taken beyond this temperature in the initial estimation, the sample formed a brown melt at approximately 210 deg C.

Applicant's summary and conclusion

Conclusions:
The melting point could not be determined because the test substance decomposed at temperatures above 170 deg C before melting.
Executive summary:

Not applicable