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Physical & Chemical properties

Melting point / freezing point

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Link to relevant study record(s)

Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13-09-2019 to 22-11-2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. All relevant validity criteria were met.
Qualifier:
according to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
other: ISO 3016
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
inspected: August 2018 ; signature: November 2018
Type of method:
pour point
Melting / freezing pt.:
267 K
Atm. press.:
1 atm
Decomposition:
no
Sublimation:
no
Remarks on result:
other: -6 °C (pour point temperature); mean (n=2) ; on the basis that the stationary point was 264 K and/or the pour point was -6 °C (or 267 K) and therefore the freezing/melting point by definition must be > -20 °C (or > 253 K).

Measured temperatures were converted from °C to K using T = t + 273.15

T = temperature (K)

t = temperature (°C)

 

Definitive test:

Overall result; mean (n=2) : -6 ± 3 °C (267 ± 3 K) ; the test item substance showed no change in appearance although was determined to become increasingly viscous during cooling. Applicant assessment indicates: freezing/melting temperature by definition must be > -20 °C (or > 253 K) ; on the basis that the stationary point was 264 K and/or the pour point was -6 °C (or 267 K). Since the test item was observed to "pour" (or flow) at temperatures above -6 ± 3 °C (or 267 ± 3 K) it therefore would be considered “solid” at below -6°C and a "liquid" at -6°C to ambient (25°C) temperatures under definitions under Regulation (EC) 1272/2008 as amended.

Conclusions:
The pour point of the test item has been determined to be less than 267 K or -6°C. Applicant assessment indicates: Since the test item was observed to "pour" (or flow) at temperatures above -6 ± 3 °C (or 267 ± 3 K) it therefore would be considered “solid” at below -6°C and a "liquid" at -6°C to ambient (25°C) temperatures under definitions under Regulation (EC) 1272/2008 as amended.
Executive summary:

The pour point of the test item was determined using EU Method A.1 and/or equivalent to ISO 3016 under GLP. The test was initially performed using differential scanning calorimetry. However, due to the test item not having a definitive freezing point (scanned to below -20 °C), the thermograms did not show a definitive thermal event that could be attributed to a phase change in the test item. Even so, as it was observed that the test item became more viscous at colder temperatures, it was decided to conduct the pour point determination method. The pour point of the test item has been determined to be less than 267 K or -6°C in duplicate. Applicant assessment indicates: Since the test item was observed to "pour" (or flow) at temperatures above -6 ± 3 °C (or 267 ± 3 K) it therefore would be considered “solid” at below -6°C and a "liquid" at -6°C to ambient (25°C) temperatures under definitions under Regulation (EC) 1272/2008 as amended.

Description of key information

Pour point: -6 ± 3 °C (or 267 ± 3 K) at 1 atmosphere, EU Method A.1 - pour point method, 2020

Key value for chemical safety assessment

Additional information

Key study : EU Method A.1, 2020 : The pour point of the test item was determined using EU Method A.1 and/or equivalent to ISO 3016 under GLP. The test was initially performed using differential scanning calorimetry. However, due to the test item not having a definitive freezing point (scanned to below -20 °C), the thermograms did not show a definitive thermal event that could be attributed to a phase change in the test item. Even so, as it was observed that the test item became more viscous at colder temperatures, it was decided to conduct the pour point determination method. The pour point of the test item has been determined to be less than 267 K or -6°C in duplicate. Applicant assessment indicates: Since the test item was observed to "pour" (or flow) at temperatures above -6 ± 3 °C (or 267 ± 3 K) it therefore would be considered “solid” at below -6°C and a "liquid" at -6°C to ambient (25°C) temperatures under definitions under Regulation (EC) 1272/2008 as amended.