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Melting point / freezing point

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Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19-21 March 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. 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 15 and 16 November 2017/ Signed on 15 May 2018
Type of method:
method to determine freezing temperature
Key result
Melting / freezing pt.:
< -20 °C
Decomposition:
no
Remarks on result:
other: Pressure not specified but assumed to be ambient

After evaluation the following values were recorded:

Table:          Values Pre-Test

Room

Temperature

4.6°C

-18.9°C

-20.1°C

-80°C

Dark yellow, low viscous liquid

Still liquid

Still liquid, just a bit more viscous and slower flowable

Still liquid, just a bit more viscous and slower flowable

Solid, like ice

 

The Pre-Test at -20.1°C has been done in an extra Pre-test.

 

After performance of the pre-test, the sponsor was consulted. As according to REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, Annex VII, dated 18. December 2006 (last amended by Commission Regulation (EU) 2016/2235 of 12 December 2016), the determination of the melting / freezing point does not need to be conducted below a lower limit of - 20 °C; therefore no main test was performed.

Conclusions:
In a pre-test, the test item was still unfrozen and liquid at – 20 °C.
At -80 °C the test item was frozen. According to REGULATION (EC) No 1907/2006 OF THE EUROPEAN PAR-LIAMENT AND OF THE COUNCIL, Annex VII, dated 18. December 2006 (last amended by Commission Reg-ulation (EU) 2016/2235 of 12 December 2016), the determination of the melting- / freezing point does not need to be conducted below a lower limit of - 20 °C.
Therefore, no additional test was conducted and the freezing / melting point is stated as: < - 20 °C (< 253.15 K).
Executive summary:

This study was performed in order to determine the freezing point or the melting range of the test item according OECD 102 resp. EU A.1.

In a pre-test, the test item was still unfrozen and liquid at – 20 °C.

At -80 °C the test item was frozen. According to REGULATION (EC) No 1907/2006 OF THE EUROPEAN PAR-LIAMENT AND OF THE COUNCIL, Annex VII, dated 18. December 2006 (last amended by Commission Reg-ulation (EU) 2016/2235 of 12 December 2016), the determination of the melting- / freezing point does not need to be conducted below a lower limit of - 20 °C.

Therefore, no additional test was conducted and the freezing / melting point is stated as: < - 20 °C (< 253.15 K).

Description of key information

In a pre-test, the test item was still unfrozen and liquid at – 20 °C.

At -80 °C the test item was frozen. According to REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, Annex VII, dated 18. December 2006 (last amended by Commission Regulation (EU) 2016/2235 of 12 December 2016), the determination of the melting- / freezing point does not need to be conducted below a lower limit of - 20 °C.

Therefore, no additional test was conducted and the freezing / melting point is stated as: < - 20 °C (< 253.15 K).

Key value for chemical safety assessment

Melting / freezing point at 101 325 Pa:
-20 °C

Additional information

A fully reliable experimental study, conducted according to OECD 102/ EU A1 guideline is available.

It is considered as a key study, and the result is retained as key data.