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 valid in vivo data for the assessment of the skin sensitising potential of N,N-dimethyldecanamide.

A test with a mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide (with traces of N,N-dimethyldodecanamide and N,N-dimethylhexanamide) for skin sensitisation was done using an adaptation of the method of Ritz and Buehler* (Stepan 1990, J.J Kreuzmann).The test substance was used as 5% w/v formulation in 80% ethanol/20% distilled water for induction and as 2.5% formulation in acetone for challenge and epicutanueous occlusive applied to 20 guinea pig. There were no grades of 1 produced in the test or control animals. The incidence of grade + responses in the test group (14 of 20) was compared to that of the naive control group (7 of 10). The incidence and severity of these responses in the test group were essentially comparable to those produced by the naive control group indicating that sensitization had not been induced. Therefore the mixture was classified as not sensitising!

Due to the fact that a high amount in the mixture was N,N-dimethyldecanamide and the rest of the mixture are homologues with a lower and higher molecular weight which can be assumed to have an similar toxicological behaviour it is concluded by the applicant that also pure N,N-dimethyldecanamide has no sensitising potential.

* Study according to Buehler protocol which satisfies the criteria of toxic control act (40 CFR) and the OECD Guideline, GLP.

Key study assignment:

As there is only one study available with suitable reliability and relevance this study is used as key study.

 


Migrated from Short description of key information:
Guinea Pig (Buehler): Mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide; not sensitising

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
no information available

Justification for classification or non-classification

Skin sensitisation:

Skin sensitisation was observed in a skin sensitisation guinea pig study (buehler protocol; mixture of dimethylamides): The scores obtained from the study led to no classification for skin sensitisation according to GHS (Regulation (EU) 1272/2008) and also to no classification according to EU-criteria DSD (67/548/EEC). This classification was also supposed for the pure N,N-dimethyldecanamide as a large portion of the mixture was N,N-dimethyldecanamide (see discussion).

Respiratory sensitisation:

There are no data available to classify N,N-dimethyldecanamide as a sensitizer to respiratory system.

Labelling skin/respiratory sensitisation:

GHS: no classification

DSD: no classification