Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
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:
In accordance with column 2 of REACH Annex VIII, the acute toxicity by inhalation study (required in section 8.5.2) 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. Based upon the low vapour pressure of 1.8 x 10-5 Pa the substance is not considered as volatile, also taking into account the boiling point and flash point. Inhalation of the substance is deemed unlikely and 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 (i.e. adequate measures, such as LEV, are in place to prevent exposure) Therefore, inhalation is not considered to be a significant route of exposure and a study not conducted via this route. In addition, based on the absence of systemic toxicity effects in an acute oral toxicity study and dermal toxicity study, it can be anticipated that an acute inhalation study would not be expected to show evidence of significant systemic toxicity.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion