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Melting point / freezing point

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Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Qualifier:
according to guideline
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
GLP compliance:
no
Other quality assurance:
other: ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Remarks:
also A2LA
Type of method:
differential scanning calorimetry
Key result
Melting / freezing pt.:
79.6 °C
Atm. press.:
101.3 kPa
Decomposition:
no
Key result
Melting / freezing pt.:
107.5 °C
Atm. press.:
101.3 kPa
Decomposition:
no
Key result
Melting / freezing pt.:
128.4 °C
Atm. press.:
101.3 kPa
Decomposition:
no
Conclusions:
Pentamid KH displayed no freezing point evident for the sample on cooling. A possible glass transition was evident on heating. The average onset of the transition was at 37.3°C. Three average melting points were found at 79.6°C, 107.5°C, and 128.5°C.
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2014 August - 2017 May
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Experimental methods using nationally accepted methods.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Principles of method if other than guideline:
Melting: Capillary method with liquid bath or block.- Principle of test: Capillary method
- Short description of test conditions: Sample was loaded into a capillary tube and heated to a plateau temperature ~10 degrees below the expected melting point in a Stuart SMP20 melting point apparatus. Temperature was increased by a constant rate until the sample began to melt. Record the range at which the sample melted. Benzoic acid was used as a standard.
- Parameters analysed / observed: Temperature, physical state of substance.
GLP compliance:
no
Type of method:
capillary method
Key result
Melting / freezing pt.:
>= 120 - <= 133 °C
Atm. press.:
101.3 kPa
Decomposition:
no
Remarks on result:
other: no data on decomposition
Remarks:
not noted to decompose

 Date  Batch Number

Melting Point (°C)

 19/08/2014  43040  124
12/05/2015   44673  128
 04/08/2015  45219  128.4
 09/05/2016  46679  129.1
 09/05/2016  46680  126.3
 09/05/2016  46681  133
 14/11/2017  47652  120
 18/05/2017  48654  126.1
  18/05/2017 48655   129.6
  18/05/2017 48656   130
  18/05/2017 48657   130

     

Conclusions:
Various samples of the commercial test substance was observed to melt over the range of 120 to 133 °C at approximately 101.3 kPa.

Description of key information

No melting/freezing point observed in a DSC study

Key value for chemical safety assessment

Additional information

There was no freezing point evident for the sample on cooling. A possible glass transition was evident on heating.