Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
other:
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 9th to 25th, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 104 (Vapour Pressure Curve)
Qualifier:
according to
Guideline:
EU Method A.4 (Vapour Pressure)
Principles of method if other than guideline:
Source of correction constants: E.D. Cater, Ch.2A, Physicochemical Measurements in Metal Research, Part 1, R.A. Rapp, Ed., John Wiley, New York, 1970
GLP compliance:
yes (incl. certificate)
Type of method:
effusion method: Knudsen cell
Temp.:
20 °C
Vapour pressure:
0.374 Pa
Temp.:
25 °C
Vapour pressure:
0.619 Pa

Vapour pressure of positive control at 30 °C: 1.80x10-1 Pa

Criteria for the vapour pressure of the positive control at 30 °C: 1.44x10-1 ± 0.1 Pa

The vapour pressure met the validity criteria. Therefore the study can be considered as valid.

For the test item, the following vapour pressures at 20 °C and at 25 °C were calculated from the regression equation:

Vapour pressure at 20 °C: 3.71 x10-1 Pa

Vapour pressure at 25 °C: 6.19x10-1 Pa.

Conclusions:
Vapour pressure: 0.374 Pa (at 20 °C), 0.619 Pa (at 25 °C)
Executive summary:

The vapour pressure of the test item was determined at four different temperatures (30, 45, 60 and 75 °C) according to the OECD Guideline 104 resp. EU A.4 using the effusion method (weight loss). Three temperatures could be evaluated as they showed reproducible weight loss. For these temperatures, 1/T was plotted against log (p). Experiment 4 (nominal temperature 75 °C) showed no reproducible weight loss, because the cells were empty. All evaluated experiments showed good reproducibility, giving relative standard deviations of less than 12 % (limit value from the guideline 30 %) and good correlation. Therefore, the result of the test can be considered valid.

Vapour pressure at 20 °C: 3.74 x10 -01Pa

Vapour pressure at 25 °C: 6.19 x 10-01Pa

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion