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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
exposure considerations
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
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 has a very low vapour pressure of 2.0 x 10-11 Pa at 25ºC and predicted negative explosive and oxidising properties. The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 0.42% and the test item is considered to be essentially non-inhalable . Based on the vapour pressure and large particle size, inhalation 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.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion