Registration Dossier

Toxicological information

Acute Toxicity: inhalation

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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 substance is supplied in the EU in two forms - coarse powder or flakes. The average Mass Median Aerodynamic Diameter (MMAD) of a representative sample of the coarse grade was 339.301 μm, whilst the average MMAD of the flake grade was 572.394 μm. As the MMAD is > 100 μm, exposure via the inhalation route is unlikely and hence testing by the inhalation route is not considered to be appropriate, in accordance with REGULATION (EC) No 1907/2006 Annex VIII, Section 8.5.2, Column 2.

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Materials and methods

Results and discussion

Applicant's summary and conclusion