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 Regulation (EC) No 1907/2006 (REACH) testing of acute inhalation toxicity can be omitted 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. Vaporisation needs not to be considered due to the substance’s very low vapour pressure of 2.266E-05 at 25°C, thus exposure to inhalable aerolsols is not expected. The median particle size (D50) of L-Asparagine was determined to be 251.4 µm and according to ECHA information requirements Chapter R.7c: Endpoint specific guidance this value is above the threshold size for inhalable particles (100 µm). Generation of inhalable particles such as dust is therefore not to be expected. The most likely route of human exposure for consumers is the oral route. Results of laboratory animal studies show a low acute toxicity after oral exposure. Therefore the acute intrinsic toxic activity of L-Asparagine is considered to be low. The occurrence of a systemic toxicity relevant to humans after inhalation is unlikely and therefore the conduct of an acute inhalation toxicity study is unjustified.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion