Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts

Boiling point

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

boiling point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Nov. 2008-16 April 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline number 103 and GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 103 (Boiling point/boiling range)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.2 (Boiling Temperature)

Deviations:

no

Principles of method if other than guideline:

The objective of the test is to determine at which temperature the vapour pressure of the liquid is equal to 101.325 kPa, the normal atmospheric pressure (boiling), heating it under nitrogen and at the atmospheric pressure using the Differential Scanning Calorimetry method (DSC method).

Apparatus : Analyser DSC 131 The analyzer is connected to a computer using the Setsoft 2000 program
Balance
Barometer

Setting of the parameters : The following parameters were selected:
- Gas used (Ventilation)
- Nitrogen (Yes)

Experimental procedure :An aliquot of test item was placed into a crucible. The lid was fitted and the crucible was placed in the DSC analyzer.

Atmospheric pressure 98.5 kPa
Crucible used Aluminium, 100 μL, with lid
Mass of test item 10.6 mg(Assay 1); 8.6mg (Assay 2)
Ramp Isotherm at 20°C during 5 minutes, 10°C/ min from 20 to 250°C
Programmation: Isotherm at 20 °C during 5 minutes; Heating phase from 20 to 250 °C at 10 °C/min

GLP compliance:

yes (incl. QA statement)

Type of method:

differential scanning calorimetry

Specific details on test material used for the study:

TEST ITEM
Identification PROTEOL OAT
Identification of the flask LCE08118; 500 g
Batch number 0820000006
Expiry date Not provided
Supplier SEPPIC
Appearance Clear yellow limpid viscous liquid
Packaging 1 White plastic flask with blue stopper
Quantity received 1 x 500 g
Date of the reception November 18, 2008
Storage In darkness at room temperature
Expiry date: 18.July 2011

REFERENCE ITEM
Identification 1,2 Propanediol 99%
Last validation of the test December 05, 2007
Periodicity of validation (in months) 12
Results 187.0 ± 0.5 °C
Conformity Yes

Boiling pt.:

108.6 °C

Atm. press.:

98.5 kPa

Decomposition:

no

Remarks on result:

other: mean corrected boiling point of the test item

Four assays were performed during the test, the temperature values obtained for the correted boiling point varied between 107.9 and 113.4 °C.

The mean value for the boiling point is explained as the mean of at least two assays for which the boiling point value was in the range of the estimated accuracy of the method: +/- 0.5°C up to 326.9°C and +/- 2°C above 326.9°C.

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

Conclusions:

The mean corrected boiling point of the substance Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts was: 108.6 ± 0.5 °C

Executive summary:

In compliance with Commission Directive 92/69/EC, Commission Regulation (EC) No. 440/2008 EC A2 method (2008) and OECD Guideline No 103 (1995)

RESULTS

The mean corrected boiling point of the substance Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts was: 108.6 ± 0.5 °C

Reference 2

Endpoint:

boiling point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January-March 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: experimental study which follows standard guidelines

Qualifier:

according to guideline

Guideline:

OECD Guideline 103 (Boiling point/boiling range)

GLP compliance:

no

Type of method:

differential scanning calorimetry

Specific details on test material used for the study:

Name of the test material (as cited in the study report): PROTEOL OAT
Lot / batch: LR10746 et LR10761 et LR10768

Boiling pt.:

106 °C

Atm. press.:

1 atm

Decomposition:

no

Conclusions:

The mean boiling point of the substance Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts was (on 2 assays on 3 batches): 106°C (+/-3°C).

Executive summary:

The mean boiling point of the substance Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts was (on 2 assays on 3 batches): 106°C (+/- 3°C).

Reference 3

Endpoint:

boiling point

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

key study

Study period:

10 Sept.2009-6 Nov. 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP STUDY, OECD GUIDELINE

Qualifier:

according to guideline

Guideline:

other: OECD104 resp.EU A.4

Deviations:

no

Principles of method if other than guideline:

As no data was acquired using the effusion method, only the performance of the static method is described in this final report.
Preparations:
The test system was evacuated and checked for leaks. Then, vacuum was relieved and 20mL of test item were filled into the test vessel. The vacuum pump was started and the head space of the test vessel was evacuated. Strong foaming was observed: therefore, vacuum has to be built up slowly. After evacuation, the pump was turned off.
Measurements:
The test vessel was set into the water bath, and after a while, when no more variation of the manometer display was observed, the pressure in the head space was measured and recorded at the same time as the temperature of the water bath for the first measurement. The water bath was turned on for a short time, and after equilibrium had been reached, the temperature and the corresponding pressure of the head space were noted. In this manner, seven pairs of temperature and pressure were measured. After the heating phase, a cooling-down phase with again seven pairs of corresponding vapour pressures and temperatures were measured.
Calculation:
From the measured values, a plot of the log P (in log Pa) against 1/T (in 1/K) is plotted.
The regression curve with its slope B, its intercept A and its correlation r are calculated.
log P = B*1/T+A
From these parameters, the vapour pressures at 20.0°C and at 25.0°C were calculated.

GLP compliance:

yes (incl. QA statement)

Type of method:

other: calculation acording equation obtained by static method

Specific details on test material used for the study:

Identification PROTEOL OAT
Identification of the flask LCE08118; 500 g
Batch number 0820000006
Expiry date Not provided
Supplier SEPPIC
Appearance Clear yellow limpid viscous liquid
Packaging 1 White plastic flask with blue stopper
Quantity received 1 x 500 g
Date of the reception November 18, 2008
Storage In darkness at room temperature
Expiry date: 18.July 2011

Boiling pt.:

ca. 115.14 °C

Atm. press.:

1 atm

Decomposition:

no

Conclusions:

The boiling point of the substance Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts was calculated: 115.14°C

Executive summary:

The boiling point of the substance Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts was calculated: 115.14°C

Description of key information

material: the liquid marketed product "Proteol OAT" which contains ca. 27.5% of the solid substance "Glutens, hydrozylates, reaction products with lauroyl chloride, sodium salts"

method: differential scanning calorimeter (DSC)

pressure: 101.3 kPa

boiling point: between 103 and 109°C at 101.3 kPa.

Key value for chemical safety assessment

Boiling point at 101 325 Pa:

106 °C