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:
According to Column 2 of Annex VIII of the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) 1902/2006 regulation, inhalation study does not need to be conducted if exposure of humans via inhalation is unlikely taking into account the vapour pressure (<0.01 Pa at 20ºC is considered the cut off) and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size (including the use of respiratory protective equipment where necessary). The vapour pressure of of Methylenebis (dibutyldithiocarbamate) is <1.3E-08 Pa at 20 ºC and there is no predicated inhalation exposure, therefore, this endpoint is waived.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion