Registration Dossier
Registration Dossier
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EC number: 292-550-5 | CAS number: 90640-32-7
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 octadecylamines, nor for any other alkylamines considered a chemical category within this chemical safety assessment. Animal data exist on hydrogenated tallow alkylamines from a Magnusson and Kligman maximisation according to OECD TG 405 test which demonstrated absence of a significant skin sensitizing potential, as well as from a GLP compliant M+K maximisation test with C12 -18 -(even numbered)-alkylamines, which resulted also in an negative outcome. From both studies no significant skin sensitization potential of primary alkylamines is deducible. These data can be used in the assessment of hydrogenated tallow alkylamines, as well as for primary alkylamines in general. 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:
Data for hydrogenated tallow alkylamines with regard to skin sensitization are available. Additionally, also data from the closely related primary alkylamines C12-18-(even numberd)-alkylamines are existing. In a 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 hydrogenated tallow alkylamines (Amin HBG) as aqueous dilutions. A test concentration of 1% was used for intradermal induction, followed by a 5% concentration at epidermal induction. Challenge was performed using a 0.5% substance concentration. From the results of this study, no indication of significant skin sensitizing properties exist. Likewise negative results were also obtained with C12-18-(even numbered)-alkylamines.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on negative skin sensitization data available for hydrogenated tallow alkylamines as well as for other primary alkylamines, a respiratory sensitization potential of hydrogenated tallow alkylamines is not to be expected.
Justification for classification or non-classification
Hydrogenated tallow alkylamines were tested for skin sensitization in a Maximization tests according to Magnusson and Kligman. Based on the results of this study, significant skin sensitizing properties have not been identified. Likewise, negative data regarding potential skin sensitization were also revealed with C12 -18 -(even numbered)-alkylamines. Based hereupon, classification of hydrogenated tallow alkylamines is not warranted.
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