Registration Dossier
Registration Dossier
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EC number: 701-068-0 | CAS number: 2156592-58-2
Endpoint summary
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 C12 -18 -(even numbered)-alkylamines, nor for any other of the primary alkylamines considered a chemical category within this chemical safety assessment. 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 primary alkylamines is deducible. Additionally, since all primary alkylamines exhibite strong dermal irritative / corrosive properties, dermal exposure has to be limited anyway.
Migrated from Short description of key information:
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.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on negative skin sensitization data available for C12 -18 -(even numbered)-alkylamines as well as for other primary alkylamines, a respiratory sensitization potential of hydrogenated tallow alkylamines is not to be expected. Due to the corrosive nature of C12-18-(even numbered)-alkylamines additional testing is not warranted.
Justification for classification or non-classification
C12 -18 -(even numbered)-alkylamines does not fulfill the requirements for classification as skin and/or respiratory sensitizer. A maximization test according to Magnusson and Kligman has not revealed significant skin sensitizing properties. Additionally C12 -18 -(even numbered)-alkylamines, like most of the alkylamines considered a chemical category, is corrosive to skin and classified as R35 - causes severe burns. Based hereupon, any potential dermal exposure has to be limited anyway.
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