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 measured vapour pressure data on the freeze-dried β-Alanine, N-(2-carboxyethyl)-N-[3-[(2-carboxyethyl)amino]propyl]-, N-C12-18-alkyl derivs., trisodium salt CAS No 2136366-30-2 was very low at 2.6 Pa at 20°C. This value is low and also considered to be a worst case compared to the vapour pressure for the aqueous solutions of the substance which are used and put on the market. Taking together the low acute oral toxicity of this substance and the low vapour pressure of the aqueous technical product in combination with the low potential for aerosol formation, it is not considered justified from an animal well-fare perspective to perform any additional acute dose toxicity studies.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion