Registration Dossier

Administrative data

Endpoint:
boiling point
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is a solid which decomposes before boiling
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 14, 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to
Guideline:
other: Method AB46-1215
Version / remarks:
“Determination of melting point, boiling point and enthalpy using Differential Scanning Calorimetry”
Qualifier:
equivalent or similar to
Guideline:
other: ASTM E 537 – 07
Version / remarks:
“The thermal Stability Of Chemicals By Differential Scanning Calorimetry”
GLP compliance:
not specified
Type of method:
differential scanning calorimetry
Remarks:
on a Mettler DSC 1
Specific details on test material used for the study:
Batch no.: Solvent free version of batch 1439581
Appearance; solid
Key result
Decomposition:
yes
Decomp. temp.:
250 °C
Sublimation:
no
Remarks on result:
other: atm. press.:- assumed to be standard atmosphere

Several phase transitions were detected for the test substance (solvent free). The first one at -10°C was likely a phase transition. The second peak at 170°C did not correspond to melting as judged by looking at the sample in the oven. The third major peak, at 250°C, was likely decomposition as the sample in oven at that temperature was turned completely black. The sample appeared not to have a distinct melting temperature as judged by DSC.

Conclusions:
Under the study conditions, several phase transitions were detected for the test substance (solvent free). The first one at -10°C was likely a phase transition. The second peak at 170°C did not correspond to melting as judged by looking at the sample in the oven. The third major peak, at 250°C, was likely decomposition as the sample in oven at that temperature was turned completely black. The sample appeared not to have a distinct melting temperature (DSC).
Executive summary:

A study was conducted to determine the melting point and boiling point of the test substance, Oleyl TMAC, according to Method AB46-1215 and similar to ASTM E 537 – 07. The analysis was performed using the Differential Scanning Calorimetry on a Mettler DSC 1 under nitrogen atmosphere (20 mL/min). 14 mg of solid sample was placed in a 40 μL aluminium cup. The following temperature programming was used: -30-400ºC with a rate of 5 ºC/min. Under the study conditions, several phase transitions were detected for the test substance (solvent free). The first one at -10°C was likely a phase transition. The second peak at 170°C did not correspond to melting as judged by looking at the sample in the oven. The third major peak, at 250°C, was likely decomposition as the sample in oven at that temperature was turned completely black. The sample appeared not to have a distinct melting temperature as judged by DSC (Andersson, 2016).

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion