Hexadecyl hydrogen maleate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

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

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

vapour pressure

Type of information:

experimental study

Adequacy of study:

key study

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)

GLP compliance:

no

Type of method:

effusion method: Knudsen cell

Temp.:

90 °C

Vapour pressure:

0.573 Pa

Observations

At 30 °C: At the second measurement of experiment 1, all cells were slightly contaminated. Therefore, the cells were meticulously cleaned and weighed. This weight was used as initial weight for the subsequent measurements. To avoid bias, this measurement was not used for calculations.

At 45 °C: At the first measurement of experiment 2, all cells were slightly contaminated. Therefore, the cells were meticulously cleaned and weighed. This weight was used as initial weight for the subsequent measurements. To avoid bias, this measurement was not used for calculations.

* At 120 °C: At the third measurement all cells were nearly empty. Therefore, the study was finished.

Vapour pressure was examined at seven different temperatures. No temperatures could be evaluated as they showed no reproducible or relevant weight loss. Due to the low reproducibility and the resulting high RSD it is not possible to plot a graph with log p vs. 1/T. Therefore, it is not possible to extrapolate the vapour pressure at a temperature of 20 and 25 °C. As a calculation on base of the measured weight losses is not possible, the highest vapour pressure, derived from all measurements, is stated as limit value: Vapour pressure at 90 °C: 5.73 *10-1 Pa.

vapour pressure (positive control) at 30 °C: 1.29*10-1 Pa

The vapour pressure of the positive control met the validity criteria. Therefore, the study can be considered as valid.

Conclusions:

0.573 Pa, at 90 °C

Executive summary:

The vapour pressure of the substance was evaluated according to the OECD 104 and EU Method A.4 by means of Effusion method: Knudsen cell. First, the determination was performed at 30 °C. Then, further determinations were made at 45, 60, 75, 90, 105 and 120 °C. A positive control was tested in the same manner.

As a calculation on base of the measured weight losses is not possible, the highest vapour pressure, derived from all measurements, is stated as limit value. Vapour pressure at 90 °C: 5.73 *10-1 Pa.

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

particle size distribution (granulometry)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is marketed or used in a non solid or granular form

Reason / purpose for cross-reference:

data waiving: supporting information