Registration Dossier

Administrative data

Endpoint:
boiling point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was conduced between November 07, 2008 and February 26, 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No amendment to the study plan was requested. No incident, which could have affected the quality or the interpretation of the results obtained, was observed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EC A2 method (2008) and OECD Guideline No 103 (1995)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of signature: May 26, 2008. Date of inspection: January 29, 2008
Type of method:
differential scanning calorimetry

Test material

Constituent 1
Reference substance name:
acetalization product between glucose and C14 alcohol
EC Number:
923-418-3
IUPAC Name:
acetalization product between glucose and C14 alcohol
Details on test material:
Name of test material (as cited in study report) : LCE08121; Batch: T82925
Storage: in darkness at room temperature.
Appearance: white pellets.

Results and discussion

Boiling point
Boiling pt.:
>= 283.9 - <= 286.9 °C
Atm. press.:
ca. 99.3 kPa

Any other information on results incl. tables

Four assays were performed during the test, the temperature values obtained for the corrected boiling point varied between 283.9 and 286.9 °C (uncorrected values).

Two assays were contained between the range for the boiling point. Only these two assays are presented.

Assay No. 3

Atmospheric pressure 99.3 kPa

Crucible used Aluminium, 100 μL, with lid

Mass of test item 10.3 mg

Ramp Heating phase: From 150 to 400 °C at 10 °C/min

Cooling phase: From 400 to 20 °C at 50 °C/min

Observed boiling point 285.3 °C

Corrected boiling point 286.2 °C

Remark: At the beginning of the test, the white pellets were ground. At the end of the test, the crucible was empty and blackened.

Assay No. 4

Atmospheric pressure 99.3 kPa

Crucible used aluminium, 100 μL, with lid

Mass of test item 10.0 mg

Ramp Heating phase: From 150 to 400 °C at 10 °C/min

Cooling phase: From 400 to 20 °C at 50 °C/min

Observed boiling point 285.0 °C

Corrected boiling point 285.9 °C

Applicant's summary and conclusion

Conclusions:
The mean corrected boiling point of the test item was: 286.1 ± 0.5 °C.
Executive summary:

Introduction

The boiling point of the test material has been determined in compliance with Commission Directive 92/69/EEC, Commission Regulation (EC) No. 440/2008 EC A2 method (2008) and OECD Guideline No 103 (1995).

The study was conduced between November 07, 2008 and February 26, 2009.

Method

The boiling point was determined by differential scanning calorimetry method (DSC).

The test item sample and reference material are both maintained at the temperature predetermined by the program even during a thermal event in the sample. The amount of energy which has to be supplied to the sample to maintain zero temperature differential between the test item sample and the reference material is the experimental parameter displayed as the ordinate of the thermal analysis curve. The rate of energy absorption by the sample is proportional to the specific heat of the sample.

Procedure

An aliquot of test item was placed into a crucible. The lid was fitted and the crucible was placed in the DSC analyzer. The boiling point is calculated automatically by the Setsoft program by integration of the curves obtained: “Heat flow as a function of the temperature”. The boiling temperature is corrected to the standard pressure (101.325 kPa).

Four assays were performed during the test.

Conclusion

The mean corrected boiling point of the test item was: 286.1 ± 0.5 °C.