C16-18-(even numbered, C18-unsaturated)-alkylamines acetates

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

No human data are available with regard to the endpoint skin sensitization. However, the skin sensitization potential of the close structural analogue compound C16 -18 -(even numbered)-alkylamines acetates was investigated in a guideline conform maximization test in male guinea pigs according to Magnusson and Kligman. 10 test and 5 control animals were used. Based on the results of sighting tests, 0.5% (w/v) for the intradermal induction, 3% (w/v) for the topical sensitization as well as 0.5% (w/v) for the dermal challenge phase were selected as concentrations of the test material. As vehicle for the dermal treatments vaseline was used. Under the conditions of this test, C16 -18 -(even numbered)-alyklamine actetats produced a 10% (1/10) sensitization rate and was classified as a non-sensitizer to guinea pigs. In addition, animal data also exist on the structural and functional similar 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. From both studies no significant skin sensitization potential of C16 -18 -(even numbered, C18 -unsaturated) -alkylamines acetates is deducible. Additionally, since the registration substance is considered to exhibite strong dermal irritative / corrosive properties, dermal exposure has to be limited.

Migrated from Short description of key information:
No human data are available with regard to the endpoint skin sensitization. The registration substance is considered to be corrosive to skin and thus testing is not considered justified based on animal welfare grounds. However, a guideline conform maximization test according to Magnusson and Kligman (OECD TG 406) in guinea pigs with the close structural analogue substance C16-18-(even numbered)- alkylamines acetates showed no evidence for skin sensitising properties. In addition, testing with the structural and functional similar C12-18-(even numbered)-alkylamines in a GLP compliant Magnusson and Kligman maximisation test also revealed no indications of a skin sensitization potential. Based hereupon, the registration substance is not considered to be a skin sensitizer.

Justification for selection of skin sensitisation endpoint:
Data on this endpoint is not available for the registration substance. However, analogous fatty amine acetetates as well as primary fatty amines revealed no skin sensitizing potential when tested according to OECD TG 406. In addition, from analogous primary fatty amines, the registration substance is considered to be corrosive to skin. Thus, testing for skin sensitization is scientifically not justified because of animal welfare reasons. This consideration is in line with REACH regulation (EC) 1907/2006 (Annex VIII, point 8.3, column 2).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

The registration substance is considered to be corrosive to skin and thus testing is not warranted. Based on data from structural and functional closely related C12-18-(even numbered)-alkylamines which are devoid of skin sensitizing potential, a respiratory sensitization potential of C16-18 -(even numbered)-alkylaamines acetates is not to be expected.