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:
JUSTIFICATION FOR DATA WAIVING
According to Annex VIII, section 8.5.2, column 2 of Regulation No. 1907/2006, testing by the inhalation route is appropriate if exposure of humans via inhalation is likely. The vapour pressure of 4-aminobenzoyl-b-alanine was found to be extremely low (9.70E-05 Pa at 20°C) and in a granulometry study the DV50 of 4-aminobenzoyl-b-alanine was 258 µm. Therefore, 4-aminobenzoyl-b-alanine is not considered to be of concern for inhalation due to its extremely low volatility and that its particle size is outside the inhalable range. Inhalation exposure during use of 4-aminobenzoyl-b-alanine as an intermediate is also unlikely due to the risk mitigation measures in place in the pharmaceutical facility and that all processes are performed in accordance with Good Manufacturing Practices. Therefore, the performance of an acute inhalation study on 4-aminobenzoyl-b-alanine is considered scientifically unjustified.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion