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:

A group of 20 test animals was treated with 0.4 mL of amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) as a 30 % w/v solution in distilled water for an exposure period of 6 hours weekly for 3 induction exposures according toOECD guideline 406. Test (20) and control (10) animals were challenged with the test substance as a 30 % w/v solution in distilled water. At primary challenge, no positive responses were observed in the test and control animals. Under the test conditions,amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl)is not a sensitizer (Vinegar MB, 1978).


Migrated from Short description of key information:
The available in vivo skin sensitisation studies suggest that amides, C12-18 (even numbered) and C18-unsatd., N-hydroxyethyl is not a skin sensitiser, based on read-across from a structurally similar substance.

Justification for selection of skin sensitisation endpoint:
Sufficient data is available on read-across substance.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Amides, C12-18 (even numbered) and C18-unsatd., N-hydroxyethyl is not expected to be a skin sensitiser based on the available in vivo skin sensitisation tests conducted on a structurally similar substance.Therefore no classification is required for this endpoint according to EC (67/548/EEC) and CLP (EC 1272/2008) criteria.