Registration Dossier

Diss Factsheets

Physical & Chemical properties

Melting point / freezing point

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 09 to 10 August 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
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection 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
Decomposition:
no

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

3.4 °C

-20.0 °C

-80 °C

liquid

liquid

liquid

solid

 

After storage for one day at – 20 °C, the test item was still liquid and no main test was performed.

Conclusions:
The freezing point of test item was stated as < - 20 °C (< 253.15 K).
Executive summary:

The freezing point of the test item was determined under GLP according to EU Method A.1 and OECD 102.

 

In a pre-test, the test item was still liquid at - 20 °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 is stated as: < - 20 °C (< 253.15 K)

Key value for chemical safety assessment

Additional information

A fully reliable experimental study, conducted according to a recognized OECD/EC method and under GLP, is available. It is considered as a key study.

After storage for one day at – 20 °C, the test item was still liquid.According to 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, the result is expressed as a limit value and cannot be retained as key data for purpose of CSA.