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:
JUSTIFICATION FOR DATA WAIVING
The vapour pressure was estimated to be 3.2E-19 Pa at 25°C. From this it can be concluded that the vapour pressure of the test substance is too low to have any relevant effect on humans via the inhalation exposure route.

Approximately 10% of the substance is not inhalable due to its large particle size (>100µm).

The remainder of the substance falls within the inhalable range (>10µm) and could be a concern for acute toxicity, however in-vivo acute toxicity tests via dermal and oral administration show no acute toxic effects and therefore testing via inhalation is considered to be unnecessary.

No significant amount of test substance is in the respirable range (<10µm) and therefore there is no concern for chronic toxicity for inhalation exposure.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion