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
According to REACH Annex VIII, 8.5.2. Column 2, 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 substance is not considered to be volatile taking into account the vapour pressure of the substance (0.000077 Pa at 25°C.) It is considered that the substance has low potential to become airborne from the preparations in which the substance is used based on the substances physico-chemical properties. The potential for exposure of humans to aerosols, particles or droplets of an inhalable size is considered unlikely based on the vapour pressure and industrial use patterns of the substance. Therefore, inhalation is not considered to be a significant route of exposure and a study not conducted via this route.

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Applicant's summary and conclusion