Registration Dossier

Diss Factsheets

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 is no structural alert or mechanism causing skin sensitisation that would indicate a sensitisation potential for formamide in a validated QSAR model, the OECD Toolbox. Negative findings in Guinea pigs and rats support this. Negative results exist for related substances (acetamid, N, N-dimethyl formamide) identified by the QSAR model.

Formamide is therefore not considered to be a skin sensitizer. This endpoint may therefore be waived in accordance with Annex XI, No. 1.3


Migrated from Short description of key information:
There is no structural alert or mechanism causing skin sensitisation that would indicate a sensitisation potential for formamide in a validated QSAR model, the OECD Toolbox. Negative findings in Guinea pigs and rats support this. Negative results exist for related substances (acetamid, N, N-dimethyl formamide) identified by the QSAR model.

Justification for classification or non-classification

Skin sensitisation: no classification because formamide is not considered to be a skin sensitizer, based on the results obtained in a valid QSAR model, and negative results reported from supporting Guinea pig studies.