Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
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 is being tested in an oral OECD422 study and the ECHA guidelines allow the calculation of a dermal DNEL based on the oral NOAEL. It assumes the same absorption dermally and orally, when it is most likely that dermal absorption will be less than oral due to its high water solubility. Therefore calculating the Dermal DNELS based on the Oral NOAEL is a conservative approach, that will ensure adequate protect form dermal exposure. Therefore it is not scientifically justified to do an additional repeat dose dermal study in animals.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion