Fatty acids, C10-12, esters with polylactic acid, sodium salts

Vapour pressure

Link to relevant study record(s)

Reference

Endpoint:

vapour pressure

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23.01.2012-12.02.2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was perfomred in fully compliance with GLP requirements, no deviations were observed.

Qualifier:

according to guideline

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Version / remarks:

EU Methods A.4 (Vapour Pressure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

effusion method: by loss of weight or by trapping vaporisate

Temp.:

ca. 25 °C

Vapour pressure:

ca. 0.003 Pa

Temp.:

ca. 20 °C

Vapour pressure:

ca. 0.002 Pa

Transition / decomposition:

no

Conclusions:

Vapour pressure at 20°C: 1.84 * 10-3 Pa and at 25°C: 2.85* 10-3 Pa

Executive summary:

The vapour pressure of the test item dermosoft® decalact was determined at 5 different temperatures (30, 45, 60, 75, 90 °C) following EU A.4 using the effusion method (weight loss). The first two days at 30°C were not evaluated because the test item bubbled over. The measurements at 90 °C showed no reproducible weight loss due to the decrease of the vapour pressure within the replicate measurements. Therefore, experiment 5 was not included in the evaluation as well. Because of a power breakdown the measurements on 05. Feb. were not considered for the calculation of the result. All measured values of the four evaluated experiments show good reproducibility, giving relative standard deviations of less than 26%, and good correlation. A vapour pressure lower than 1 Pa was to be expected. Therefore, the result is plausible. As the test item is an UVCB and due to the decrease of the vapour pressure within the replicate measurements at 90 °C it can be considered that the measured values represents the vapour pressure of the components with the highest vapour pressure. The result of the test can be considered valid.

Description of key information

Vapour pressure: 1.84E-03 Pa  was determined at 5 different temperatures (effusion method: weight loss, OECD 104)

Key value for chemical safety assessment

Vapour pressure:

0.002 Pa

at the temperature of:

20 °C

Additional information

For the test item dermosoft decalact the following vapour pressures at 20 °C and at 25 °C were calculated from the regression equation. Vapour pressure at 20 °C: 1.84E-03 Pa and at 25 °C: 2.85E-03 Pa . The linear regression of log p vs. 1/T gave a correlation coefficient r of - 0.998 showing good repeatability and precision. Therefore the determination is considered as valid.