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 experimental results for N,N-dimethylbutylamine itself known to exist.

However, several structurally related primary, secondary and tertiary alkylamines with saturated, short-chain ligands, were all tested negative in various screening tests (e.g. ear mouse swelling test) and guideline tests (guinea pig maximisation test, local lymph node assay). Evidence is as follows:

Saturated primary aliphatic amines:cyclohexylamine, hexylamine, n-octylamine, isopropylamine, 2-aminobutane) failed to produce an allergic response in screening test (e.g. mouse-ear swelling test) (Bingham et al. 2000). Also, N-Butylamine is reported to have been negative in a study of the potential of skin sensitisation (no primary source cited; Greim et al. 1998). No evidence of positive sensitization results was obtained I animal studies for isopropylamine, butylamine, octylamine, propylamine, 3-methoxy-, or 1-amino-2-propanol (OECD; 2011; primary references in the SIAR (at present not available) and in Iuclid Dossiers).

 

Saturated secondary aliphatic amines:diethylamine was negative in a mouse ear swelling test (Virginia Chemicals, 1987)

 

Saturated tertiary aliphatic amines:dimethylethylamine was negative in a guinea pig maximization test (similar to OECD 406). dimethylcyclohexylamine was negative in a guinea pig maximization test (similar to OECD 406), and in a mouse local lymph node assay (OECD 429) (OECD, 2012).

Based on the above it is anticipated that saturated primary, secondary, and tertiary aliphatic amines including N,N-dimethylamine generally lack a skin sensitizing potential. The N-atom of substances bears a free electron pair, i.e. the substances are strong bases. The free bases are corrosive to the skin,and according to REACH (Annexes VII and VIII, section 8.1, column 2) in-vivo skin sensitisation testing is not allowed. Skin protection is required to protect against skin corrosion and irritation, and this will also protect against sensitization in the unlikely case that the substance should possess a weak sensitization potential.

 


Migrated from Short description of key information:
N,N-dimethylbutylamine is not considered to be a skin sensitizer. It is, however, corrosive to the skin. Skin protection is therefore required.

Justification for selection of skin sensitisation endpoint:
REACH does not allow in-vivo testing of skin corrosives such as N,N-dimethylbutylamine (DMBA). No data are known to exist for this substance. Several other saturated, short chained primary, secondary, and tertiary aliphatic amines were all tested negative in-vivo. These substances are closely related and Read Across therefore suggests that N,N-dimethylbutylamine is also not a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
Aliphatic amines are irritating or corrosive, but there is no indication that any saturated primary, secondary or tertiary aliphatic amine does possess a sensitising potential. It is therefore unlikely that N,N-dimethylbutylamine does have a sensitising potential. An animal test is not proposed.

Justification for classification or non-classification

No classification proposed.