Registration Dossier

Administrative data

short-term repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
Benzenesulfonic acid, mono-C10-13-alkyl derivs., compds. with N1,N1-dimethyl-1,3-propanediamine is being tested in an oral OECD442 study and the ECHA guidelines allow the calculation of a dermal DNEL based on the oral NOAEL. It assumed the same absorption dermally and orally, when it is most likely that dermal absorption will be less than oral. 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