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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:
From 14 to 15th November 2016
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 substance is considered to be 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
GLP compliance:
yes (incl. QA statement)
Remarks:
GLP compliance programme (inspected on 13 and 14 October 2014 / signed on 8 April 2015)
Type of method:
method to determine freezing temperature
Key result
Melting / freezing pt.:
< -20 °C

Performance of the Study

Pre-Test

The test item was filled into glass vessels and stored at a nominal temperature of - 80,– 20 and 5 °C.

Table 4.2/1.-Values Pre-Test

Room Temperature

2.8 °C

-21.1 °C

-80 °C

Paste like, cream or wax

Like a paste, harder than at room temperature but not frozen

Harder than at 2.8 °C but not frozen

solid (hard)

 After storage for 24h, the test item was still not solid at – 20°C. This was proved with a thin wire placed on the surface which sank into the test item.

Therefore the test item was considered as still not solid at – 20°C.

According to Regulation (EC) No 1907/2006 of the European parliament and of the council, Annex VII, dated 18. December 2006, column 2 of section 7.2, 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 conducted and the melting point is stated as: < - 20 °C (< 253.15 K).

 

No observations were made which might cause doubts on the validity of the study outcome. Therefore, the result of the study is considered valid.

Conclusions:
The freezing point of test item was stated as < - 20 °C (< 253.15 K). No further testing is required.
Executive summary:

The freezing point of the test substance was determined under GLP according to OECD 102 / EU A1 guideline.

The test item was still like a paste, harder than at room temperature and at 2.8°C but not frozen during cooling down to -21.1°C .

According to Regulation (EC) No 1907/2006 (REACH) annex VII, column 2 of section 7.2, 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 point is stated as < - 20°C (< 253.15 K).

Description of key information

The freezing point of the test item was determined to be < -20°C (<253.15 K). No further testing required.

Key value for chemical safety assessment

Additional information

A reliable GLP experimental study, conducted according to a recognized OECD/EC guidelines is available.

It is considered as a key study.

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