Registration Dossier

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:
In accordance with column 2 of REACH Annex VIII (§8.5), the acute toxicity by inhalation does not need to be conducted since the acute toxicity study is already provided for both the oral and the dermal route. Moreover, the substance has a low vapor pressure (< 1E-9 Pa for the major constituent, and < 10 Pa for the second one at ambiant temperature) and, therefore, the potential for the generation of an inhalable form is low.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion