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:

No skin sensitisation reactions were observed when 0.5 and 25% structurally similar amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) was tested in two guinea pig maximisation studies conducted according to OECD guideline 406.


Migrated from Short description of key information:
Two available in vivo skin sensitisation studies suggest that the structurally similar amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) is not a skin sensitiser. Based on read-across, approach described at the beginning of Chapter 5, amides, C12-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl) is not expected to be skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Although no information is currently available, amides, C12-18 (even numbered) and C18 -unsatd., N, N-bis(hydroxyethyl) is not expected to be a respiratory sensitiser based on the available toxicological data.


Migrated from Short description of key information:
Although no information is currently available, amides, C12-18(even numbered) and C18 -unsatd., N, N-bis(hydroxyethyl) is not expected to be a respiratory sensitiser based on the available toxicological data.

Justification for classification or non-classification

Amides, C12-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl) is not expected to be a skin sensitiser based on the availablein vivoskin sensitisation tests conducted on the structurally similar substance: amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl). The substance does not meet the requirements for classification for skin sensitisation according to EC (67/548/EEC) and CLP criteria (EC 1272/2008).