Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Benzenesulfonic acid, mono-C10-13-alkyl derivs., compds. with N1,N1-dimethyl-1,3-propanediamine is manufactured in 2-ethylhexanol as a 60% solution. Inhalation is not an expected route of exposure for the product as it is handed as a liquid and Benzenesulfonic acid, mono-C10-13-alkyl derivs., compds. with N1,N1-dimethyl-1,3-propanediamine is not volatile. 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 incident exposure to aerosols containing Benzenesulfonic acid, mono-C10-13-alkyl derivs., compds. with N1,N1-dimethyl-1,3-propanediamine.. 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