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 (EC) No 1907/2006, Annex VIII, 8.5, column 2, at least one other route for substances other than gases shall be tested for acute toxicity in addition to the oral route. As the oral and dermal route have already been addressed, there is no need for further acute inhalation toxicity testing. Furthermore, due to the very low vapour pressure (1.1e-8 hPa) of the substance, exposure of humans via inhalation of vapours is unlikely. Although the test material is composed of relatively small particle sizes, the planned use of the substance at industrial sites is strictrly controlled and prevents exposure of humans to test material dusts.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion