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:
The substance has shown low acute toxicity by the oral and dermal routes both being greater than 2000mg/kg bodyweight. It is an amber-coloured liquid with low volatility < 0.1 PSI (<6.89 hPa) less than the lower limit of the method, so inhalation of vapour is not anticipated. Inhalation of respirable aerosols is not expected in its intended uses, even if these were inhaled, they would be unlikely to reach the lungs but could only cause local irritation in the upper respiratory tract. 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