4-oxovaleric acid

Acute Toxicity: inhalation

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 for cross-reference:

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

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Qualifier:

according to guideline

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. QA statement)

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