Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.