Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
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
Justification for type of information:
According to REACH Annex VIII, 8.5.2. Column 2, (acute toxicity by inhalation), testing by the inhalation route is appropriate if exposure of humans via inhalation is 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.

The test item is of limited volatility with a vapour pressure of 3.9 Pa at 25ºC and predicted negative explosive and oxidising properties. The test item also has been shown to have a particle size distribution of 0.165% of particles less than 100μm in diameter . In consequence inhalation basesed on minimal vapour pressure and large particle size is not expected to be a significant route of exposure.

The potential for exposure of humans to aerosols, particles or droplets of an inhalable size is therefore considered unlikely based on the physico-chemical properties of the substance and that the substance is used under appropriate conditions of use at industrial use sites.

An inhalation study has therefore not been conducted.

In addition, based on the minimal systemic effects seen in an acute oral toxicity study and the absence of systemic toxicity effects in an acute dermal toxicity study, it can be anticipated that an acute inhalation study would not be expected to show evidence of significant systemic toxicity.

Data source

Materials and methods

Results and discussion

Clinical signs:
other:

Applicant's summary and conclusion