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 (Z)-octadec-9 -enylamines, nor for any other alkylamines considered a chemical category within this chemical safety assessment. Testing in animals with (Z)-octadec-9 -enylamines was not performed on animal welfare grounds due to the corrosive nature of this material. However, animal data exist on C12 -18 -(even numberd)-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. 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 (Z)-octadec-9-enylamines with regard to skin sensitization. However, data from the closely related primary alkylamines C12-18-(even numbered)-alkylamines and from hydogenated 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 (Z)-octadec-9 -enylamines is not to be expected.Due to the corrosive nature of (Z)-octadec-9 -enylamines additional testing is not warranted.

Justification for classification or non-classification

(Z)-octadec-9 -enylamines was not tested for skin sensitization for animal welfare reasons. However, maximization tests according to Magnusson and Kligman with two closely related primary alkylamines have not revealed significant skin sensitizing properties. Additionally (Z)-octadec-9 -enylamines, like most of the primary alkylamines which are considered a chemical category, is corrosive to skin and classified as R34 - causes burns. Based hereupon, any potential dermal exposure has to be limited anyway.