Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The determination was carried out by differential scanning calorimetry, using a procedure designed to be compatible with Method A.1 Melting/Freezing Temperature of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 102 of the OECD Guidelines for Testing of Chemicals, 27 July 1995 and Method 830.7200 of the OPPTS Guidelines, March 1998.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Principles of method if other than guideline:
The temperature accuracy of the DSC was checked prior to testing with indium and zinc. These were within defined tolerances and the DSC was therefore considered acceptable for use.
GLP compliance:
yes (incl. certificate)
Type of method:
differential scanning calorimetry

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
White powder
Specific details on test material used for the study:
Batch Number : 18113833
Aliquots of test item were placed in crucibles and were subjected to a thermal programs (see table below).
The appearance of the samples was recorded before and after the test, their weight change were recorded after the test.

Results and discussion

Melting / freezing pointopen allclose all
Key result
Melting / freezing pt.:
ca. 216.16 °C
Key result
Melting / freezing pt.:
ca. 216.04 °C

Any other information on results incl. tables

The thermograms and thermographic data for determinations 1 and 2 are shown in the following figures and in the following table.

Mean melting temperature: 216 ± 0.5 °C (489 ± 0.5 K)

 Thermal Event

Interpretation 

 Determination 1 (Temperature)

  Determination 2 (Temperature)

 Endotherm extrapolated onset temperature  Melting Point  216.16 °C (489.3 K)  216.04  °C (489.2 K)
 Weight Loss    7.9%  10.9%

The temperature program range selected was based on endotherm temperatures observed during preliminary evaluations carried out using a temperature program of ambient to 400 °C at 20 °C/min (see boiling temperature). Although discoloration of the test item residue was observed on completion of each determination at 250 °C, the thermograms showed the beginning of decomposition above the temperature of 230 °C, suggesting that the test item melted without significant decomposition.

Applicant's summary and conclusion

Conclusions:
The temperature program range selected was based on endotherm temperatures observed during preliminary evaluations carried out using a temperature program of ambient to 400 °C at 20 °C/min (see boiling temperature section 4.2). Although discoloration of the test item residue was observed on completion of each determination at 250 °C, the thermograms showed the beginning of decomposition above the temperature of 230 °C, suggesting that the test item melted without significant decomposition.
Executive summary:

The melting point of the test Mephtamin HCL has been determined to be 216 ± 0.5 °C (489 ± 0.5 K).