4-O-α-D-glucopyranosyl-D-glucitol

Vapour pressure

Link to relevant study record(s)

Reference

Endpoint:

vapour pressure

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 27 February 2018 to 26 April 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

Version / remarks:

version 2009

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Version / remarks:

version 2006

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

effusion method: Knudsen cell

Specific details on test material used for the study:

Identification : MALTITOL
CAS No. : 585-88-6
EC No. : 209-567-0
Batch ELEL7
Appearance White powder

Key result

Test no.:

#1

Temp.:

85 °C

Vapour pressure:

< 0.001 Pa

Key result

Test no.:

#2

Temp.:

100 °C

Vapour pressure:

< 0.001 Pa

Key result

Test no.:

#3

Temp.:

120 °C

Vapour pressure:

< 0.001 Pa

Key result

Test no.:

#4

Temp.:

130 °C

Vapour pressure:

< 0.001 Pa

Remarks on result:

other: the tested sample melt

 

Assay No.	Testtemperature t(°C)	Mass of test item (mg)	Knudsen effusioncell aperture size (μm)	Takeninto accountor not
1	85	10.78	279.9	No
2	100			No
3	120			No
4	130			no

 

No reliable loss of mass was recorded during the assays. The temperature was not increased above 130 °C to prevent a beginning of melting of the test item and therefore a wrong value of vapour pressure. The limit of the apparatus in pressure is 10-3 Pa, the vapour pressure of the test item was considered to be lower than 10-3 Pa at 130 °C and as a consequence largely lower than 10-3 Pa at 20 °C.

Conclusions:

The vapor pressure of maltitol is lower than 0.001 Pa at 20°C

Executive summary:

The vapor pressure of Maltitol was determined according to the EU Method A.4 and OECD 104 and in compliance with the GLP.

The vapor pressure was measured using the dynamic effusion method with a micro-balance. The linear part of the raw experimental data of the measurements for at least 3 temperatures was used for calculation of the vapour pressure using the Knudsen equation. As the logarithm of the vapour pressure of a pure substance is a linear function of the inverse of the temperature, these vapour pressure values at different temperatures were used to plot a linear extrapolation of the vapour pressure.

No reliable loss of mass was recorded during the assays. The temperature was not increased above 130 °C to prevent a beginning of melting of the test item and therefore a wrong value of vapour pressure.

The limit of the apparatus in pressure is 10-3 Pa, the vapour pressure of Maltitol was considered to be lower than 10-3 Pa at 130 °C and as a consequence largely lower than 10-3 Pa at 20 °C.

The vapor pressure study is classified as acceptable, and satisfies the guideline requirements of the EU method A.4 and OECD 104.

Description of key information

The vapor pressure of maltitol is lower than 0.001 Pa at 20°C

Key value for chemical safety assessment

Vapour pressure:

0.001 Pa

at the temperature of:

20 °C

Additional information

The vapor pressure of Maltitol was determined according to the EU Method A.4 and OECD 104 and in compliance with the GLP.

The vapor pressure was measured using the dynamic effusion method with a micro-balance. The linear part of the raw experimental data of the measurements for at least 3 temperatures was used for calculation of the vapour pressure using the Knudsen equation. As the logarithm of the vapour pressure of a pure substance is a linear function of the inverse of the temperature, these vapour pressure values at different temperatures were used to plot a linear extrapolation of the vapour pressure.

No reliable loss of mass was recorded during the assays. The temperature was not increased above 130 °C to prevent a beginning of melting of the test item and therefore a wrong value of vapour pressure.

The limit of the apparatus in pressure is 10-3 Pa, the vapour pressure of Maltitol was considered to be lower than 10-3 Pa at 130 °C and as a consequence largely lower than 10-3 Pa at 20 °C.