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 the substance is classified as corrosive to the skin
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
REACH guidance Annex VIII column 2, indicates that in principle no inhalation studies are needed when vp is low or exposure to aerosols, particles or droplets of an inhalable size does not occur. Etheramine C10i-Acetate is a fluid with a boiling point of 340°C. Etheramine C10i has a vapour pressure of 0.72 Pa at 20°C and for the acetate salt it can be expected to be much lower. The use is limited to industrial manufacture and formulation and does not result in the forming of aerosols, particles or droplets of an inhalable size. Exposure to humans via the inhalation route will be unlikely to occur. The substance is classified as corrosive and no acute toxicity testing should normally be conducted. Symptoms of local respiratory irritation are expected, which should limit the systemic uptake of amounts needed for systemic toxicity considering the relatively low acute oral toxicity.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion