Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

3 mutagenicity studies are available for formaldehyde, reaction products with ethylendiamine: an Ames test, a Mouse Limphoma assay and a Chromosom Aberration test. The Amest test resulted inconclusive, while the other two studies resulted positive with and without metabolic activation.

Justification for selection of genetic toxicity endpoint

Two of the 3 studies available were positive, while 1 study was inconclusive.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

Basing on the results of the 3 in vitro mutagenicity studies, formaldehyde, reaction products with ethylendiamine resulted probably positive for mutagenicity, but no final conclusion can be formulated. The final classification would be confirmed by a in vivo mutagenicity study, therefore at present, no final classification can be assigned.