Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no valid human data available on sensitization for either the octadecylamines, nor for any other alkylamines considered a chemical category within this chemical safety assessment. Testing in animals with octadecylamines were not performed on animal welfare grounds because read-across from closely related primary alkylamines is possible. Animal data exist on C12 -18 -(even numbered)-alkylamines from a GLP-compliant Magnusson and Kligman maximisation test which demonstrated absence of a significant skin sensitizing potential, as well as from a non-GLP M+K maximisation test with hydrogenated tallow alkylamines which resulted also in an negative outcome. From both studies no significant skin sensitization potential of alkylamines is deducible. These data can be used also in the assessment of tallow alkylamines by applying read-across principles. Additionally, since all alkylamines exhibite strong dermal irritative / corrosive properties, dermal exposure has to be limited anyway.


Migrated from Short description of key information:
No data are available for octadecylamines with regard to skin sensitization. However, data from the closely related primary alkylamines C12-18-(even numberd)-alkylamines and from hydrogenated tallow alkylamines can be used based on read-across principles. In a GLP-compliant skin sensitization study according to OECD TG 406 (Magnusson and Kligman guinea pig-maximization test), 10 female guinea pigs and 5 control animals were treated with C12-18-(even numbered)-alkylamines (Genamin CC 100 D) using cotton seed oil as a vehicle. Based on the results of a pretest, a test concentration of 0.1 % was used for intradermal induction, followed by a 1 % concentration at epidermal induction. Challenge was performed using a 0.5 % substance concentration. After challenge treatment, 2 out of 10 animals showed a grade 1 erythema at the 24 hour reading. As no unequivocal result was obtained after this first challenge, no second challenge tretatment was performed. From the results of this study, no indication of significant skin sensitizing properties exist. Likewise negative results were also obtained with hydrogenated tallow alkylamines.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Based on negative skin sensitization data available for primary alkylamines as well as from all other available data, a respiratory sensitization potential of octadecylamines is not to be expected. 

Justification for classification or non-classification

Octadecylamines were not tested for skin sensitization for animal welfare reasons because read-across is possible. Maximization tests according to Magnusson and Kligman with two closely related primary alkylamines have not revealed significant skin sensitizing properties.Additionally, octadecylamines exhibite strong dermal irritative properties. Based hereupon, any potential dermal exposure has to be limited anyway.