Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the available information indicates that the substance should be classified for respiratory sensitisation or corrosivity
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VII, an in vivo skin sensitisation study does not need to be conducted if the available information indicates that the substance should be classified for skin corrosivity.
Profiling in QSAR Toolbox (v.4.1) indicate that 3-((C9-11-iso,C10-rich)alkyloxy)propan-1-amine is not expected to bind to protein. Some QSARs for sensitisation indicate a concern, but exploration of structures upon which the prediction is based show little resemblance to alkyletheramine. Furthermore, its use is limited to industrial and professional users where its severe corrosive properties will provide for sufficient protection to exposure.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion