Registration Dossier

Diss Factsheets

Administrative data

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:
The test substance has a low vapour pressure 0.00073 pa at 20°C and is manufactured and sold as a 50% paste with 25% diethylene glycol and 25% water. Due to the combination of the low acute oral toxicity, the low vapour pressure and the lack of potential for inhalation exposure due to its physical form as a paste it is considered not justified from an animal well-fare perspective to perform any additional acute dose toxicity studies. Therefore acute inhalation testing has not been performed, the study is waived as not scientifically justified.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion