(2S)-5-methoxy-N-propyl-1,2,3,4-tetrahydronaphthalen-2-amine hydrochloride (1:1)

Boiling point

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 for cross-reference:

data waiving: supporting information

Reference

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 September 2017 - 20 October 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)

Version / remarks:

2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

Version / remarks:

1995

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 830.7200 (Melting Point / Melting Range)

Version / remarks:

1998

Deviations:

no

GLP compliance:

yes

Type of method:

differential scanning calorimetry

Key result

Melting / freezing pt.:

275.9 °C

Remarks on result:

other: Decomposition started during melting.

TGA EXPERIMENT (PRELIMINARY TEST)

Starting at 275°C, the weight of the sample decreased significantly. At 309°C, the sample weight had decreased by 25%.

After the experiment, a brown/black molten residue remained in the sample container. The change of the colour indicated reaction and/or decomposition of the test item.

DSC EXPERIMENT 1

An endothermic peak directly followed by an exothermic effect was observed between 250°C and 309°C. The extrapolated onset temperature of the endothermic peak was 275.948°C. The endothermic effect was most likely caused by melting of the test item. The exothermic effect was ascribed to reaction and/or decomposition of the test item. After the experiment, a yellow/green molten residue remained in the sample container. The change of the colour indicated reaction and/or decomposition of the test item. Based on this visual observation, it was concluded that the test item had molten and that the change of the colour demonstrated reaction and/or decomposition of the test item.

DSC EXPERIMENT 2

In order to investigate the melting peak, in Experiment 2 heating was stopped directly after the melting peak. The extrapolated onset temperature was 275.897°C. After the experiment, a white molten residue remained in the sample container. It demonstrated that melting and most likely reaction and/or decomposition were the reasons for the endothermic effect.

DSC EXPERIMENT 3

In order to investigate reaction and/or decomposition during melting, a lower heating rate of 5°C/minute was used in the Experiment 3. The extrapolated onset temperature was 274.566°C. Based on the shape of the observed effects it was concluded that reaction and/or decomposition occurred during and after melting of the test item. Since a lower heating rate was applied, the extrapolated onset temperature was not used for calculation of the melting temperature. After the experiment, a yellow/green molten residue remained in the sample container.

DATA HANDLING

The melting temperature was determined as the mean extrapolated onset temperature of Experiment 1 and Experiment 2.

Conclusions:

The melting temperature of the substance was determined to be 275.9°C.

Executive summary:

Differential Scanning Calorimetry (DSC) experiments were performed in a GLP study according to EC A.1, OECD 102 and OPPTS 830.7200.

The melting temperature of the substance was determined in duplicate obtaining a mean value of 275.9°C.

Reaction and/or decomposition of the substance started during melting.