Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 shall be tested for acute toxicity in addition to the oral route. However, due to the estimated very low vapour pressure (1.39e-4 Pa) of the substance, exposure of humans via inhalation of vapours is unlikely. No adverse effects have been observed (i) in an acute oral toxicity study at a limit dose of 2000 mg/kg bw and (ii) in a combined repeated dose up to the highest dose tested. Therefore, although the test material is a solid powder and exposure to dusts are possible, no adverse effects are expected and no additional study on acute inhalation toxicity was performed.

Data source

Materials and methods

Results and discussion

Clinical signs:
other:

Applicant's summary and conclusion