Phytosteryl Macadamiate

Melting point / freezing point

Administrative data

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-09-26 - 2001-01-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The GLP-study was performed according to an internationally accepted guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

thermal analysis

Test material

Test material information

Constituent 1

Test material form:

other: solid

Details on test material:

Purity: 100%

Results and discussion

Melting / freezing point

Melting / freezing pt.:

ca. 37 - <= 51 °C

Atm. press.:

1 013 hPa

Decomposition:

no

Sublimation:

no

Any other information on results incl. tables

	Heating range (°C)	Heating rate (K/min)	Melting range (°C)	Melting range(K)
Preliminary test	25 - 400	20	38.5 - 54.2	311.7 - 327.4
1^stmain study	25-70	2	33.3 -46.1	306.5 - 319.3
2^ndmain study	25- 150	10	36.5 - 52.0	309.7 -325.2
3^rdmain * study	25 - 150	10	38.4 -52.0	311.6 -325.2
Mean of melting range:			37 - 51	310-324

Applicant's summary and conclusion

Conclusions:

The melting range of YOFCO MAS was determined using the thermal analysis (DSC) to be between ~ 37 °C and 51 °C.

Executive summary:

The determination of the melting point/melting range of the test item was performed according to the EEC Directive 92/69, A.1 "Melting/Freezing temperature", December 1992 and to the OECD Guideline No. 102:" Melting point/melting range", adopted July 27, 1995.

In the DSC measurements the first endothermic heat effect was observed starting at 27 °C. A second heat was observed with an onset point at 38 °C. A third endothermic heat effect was detected at about 325 °C. After the experiment, the sample had lost about 48 % of its mass and the remaining test item was oily and colored brown.

In order to determine the melting more precisely, further DSC-runs were recorded between 25 °C and 70 °C or 150 °C, respectively. The heating rate was adjusted to 2 K/min or 10 K/min, respectively. In the first main test run, the first endothermic heat effect was detected at 26 °C, which was followed by a second endothermic heat effect with an onset point at 38 °C. Further runs shows the same thermal process. A first endothermic heat effect was with an onset point at about 27 °C was followed by a second endothermic heat effect with an onset point of about 38 °C. After all tests the test item was melted.

To indicate the origin of the endothermic effects a capillary test was performed. This test indicates the beginning of the melting at about 38 °C. At this temperature the test item was colored white and starts to liquefy. At 44 °C the test item is opalescent and at 46 °C YOFCO MAS was flowable. At 55 °C the test item was completely clear and highly fluid. This indicates, that the first endothermic heat effect starting at about 28 °C in the DSC runs are not due to the melting of the YOFCO MAS. This heat effect might be caused by a change in crystalline structure, but further evaluation is beyond of the scope of the study.

The melting range of YOFCO MAS was determined using the thermal analysis (DSC) to be between ~ 37 °C and 51 °C.