Registration Dossier
Registration Dossier
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EC number: 284-656-5 | CAS number: 84961-66-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Nicotiana tabacum, Solanaceae.
Melting point / freezing point
Administrative data
Link to relevant study record(s)
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Testing was conducted between 6 August 2018 and 8 August 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study was conducted according to an internationally recognised method, and under GLP. The test substance is adequately characterised. Therefore full validation applies.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 102 (Melting point / Melting Range)
- Version / remarks:
- 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.1 (Melting / Freezing Temperature)
- Version / remarks:
- 2008
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 4,5 and 6 July 2016/ Signed on 10 January 2017
- Type of method:
- differential scanning calorimetry
- Key result
- Melting / freezing pt.:
- >= -3.4 - <= 51.2 °C
- Conclusions:
- The melting range of the substance was determined as – 3.4°C to 51.2°C.
- Executive summary:
The study was performed in order to determine the melting point of test item according to OECD 102, resp. EU A.1 guideline, using the DSC method.
3 trials were performed.A glass transition followed by a crystallization (exothermic peak without mass variation) is observed before the melting.
The melting range of the substance was determined as – 3.4°C to 51.2°C (mean of trials 1 and 3) and may correspond to the melting of two different crystalline phases.
Reference
Results
All the raw data (calibration, pre-test and main tests) is in the experimental report.
Pre-study
Mass taken: 11.11 mg
Heating rate: 10°C/min
Melting range was observed between 0.8 °C (onset temperature of the first melting peak) and 52.1°C (top of the last melting peak).
Main tests:
-Test 1:
Mass taken: 11.98 mg
A glass transition was observed near -72.9°C and was followed by an exothermic peak at -25.5°C (onset temperature) that seems to be a crystallization as no mass variation was observed. Then a melting range was detectedon the thermogram from -3.3°C (onset temperature of the first endothermic peak) to 51.4°C (peak temperature of the second endothermic peak).These peaks may correspond to the melting of two different crystalline phases.
-Test 2:
Mass taken: 10.87 mg
A glass transition was observed near -75.8°C and was followed by an exothermic peak at -26.8°C (onset temperature) that seems to be a crystallization as no mass variation was observed. Then a melting range was detected on the thermogram from -3.7°C (onset temperature of the first endothermic peak) to 51.0°C (peak temperature of the second endothermic peak). These peaks may correspond to the melting of two different crystalline phases.
-Test 3:
Mass taken: 12.37 mg
A glass transition was observed near -75.1°C and was followed by an exothermic peak at -26.4°C (onset temperature) that seems to be a crystallization as no mass variation was observed. Then a melting range was detected on the thermogram from -3.6°C (onset temperature of the first endothermic peak) to 51.0°C (peak temperature of the second endothermic peak). These peaks may correspond to the melting of two different crystalline phases.
Apparatus check:
-Temperature:
Reference substance: Indium
Expected melting point: 156.6 +/- 0.5°C
Obtained melting point: 156.5°C
-Sensitivity
Reference substance: Indium
Expected enthalpy: 28.6 +/- 2.9 J/g
Obtained enthalpy: 29.75 J/g
Conclusion
A glass transition followed by a crystallization (exothermic peak without mass variation) is observed before the melting.
The melting range of the substance was determined as – 3.4°C to 51.2°C (mean oftrials 1 and 3) and may correspond to the melting of two different crystalline phases.
Description of key information
A glass transition followed by a crystallization (exothermic peak without mass variation) is observed before the melting.
The melting range of the substance was determined as – 3.4°C to 51.2°C (mean of trials 1 and 3) and may correspond to the melting of two different crystalline phases.
Key value for chemical safety assessment
Additional information
A fully reliable experimental study conducted according to OECD 102/ EU A1 guideline is available.
It is considered as a key study.
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