Concrete of Rosa Damascena (Rosaceae) obtained from fresh flowers by extraction with an apolar solvent

Melting point / freezing point

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 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.

Additional information

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

It is considered as a key study.