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:
from May 2nd to 4th, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 104 (Vapour Pressure Curve)
Version / remarks:
Adopted 23. March 2006
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.:
135 °C
Vapour pressure:
0.018 Pa

Experiment 1-9 (nominal temperature 30-150 °C) showed no reproducible and relevant weight loss. No experiments could be evaluated as they showed no relevant and reproducible weight loss. Therefore, the highest vapour pressure, derived from all measurements, is stated as limit value.

Vapour pressure at 135 °C: 1.85* 10-02Pa

Conclusions:
Vapour pressure at 135 °C: 1.85* 10^-02 Pa
Executive summary:

The vapour pressure of the test item was determined at nine different temperatures (30, 45, 60, 75, 90, 105, 120, 135 and 150 °C) according to OECD 104 resp. EU A.4 using the effusion method (weight loss).

Experiment 1-9 (nominal temperature 30-150 °C) showed no reproducible and relevant weight loss. No experiments could be evaluated as they showed no relevant and reproducible weight loss. Therefore, the highest vapour pressure, derived from all measurements, is stated as limit value.

Vapour pressure at 135 °C: 0.0185 Pa

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion