Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Remarks:
Waiving
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
β-Alanine, N-(2-carboxyethyl)-N-[3-[(2-carboxyethyl)amino]propyl]-, N-C12-18-alkyl derivs., trisodium salt manufactured as a ca. 30% solution in water. 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. Inhalation due to aerosol formation is not an expected route of exposure for the product as it is handed. As ECHA guidelines allows the calculation of inhalation DNELs from the oral repeat dose NOAEL where it assumes 50% absorption orally and 100% by inhalation, this conservative approach should ensure a sufficiently conservative DNEL to be calculated to protect against any incidental exposure to aerosols containing β-Alanine, N-(2-carboxyethyl)-N-[3-[(2-carboxyethyl)amino]propyl]-, N-C12-18-alkyl derivs., trisodium salt. It is therefore not scientifically justified to conduct and additional inhalation repeat exposure study in animals.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion