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Key value for chemical safety assessment

Additional information

The in vitro results on genotoxicity revealed evidence for mutagenic activity of EUF independent on a metabolic activation.

In a comet assay in mammalian cells, the test item induced a positive reaction in L5178Y/TK+/-mouse lymphoma cells (induction of DNA-protein cross links).

An in vitro gene mutation study in mammalian cells (induction of gene mutation in mouse Lymphoma L5178Y/TK+/- cells) according to OECD 476 also revealed positive effects.

It is considered that the genotoxicity of EUF is related to the hydrolysis product formaldehyde. The DNA-protein cross-linking activity of formaldehyde is a possible mechanism as shown in the positive comet assay with EUF. No evidence for genotoxicity has been detected in studies reported for ethylene glycol or urea respectively.

EUF was tested in an in-vivo genotoxicity test, in the mouse bone marrow micronucleus test (OECD guideline 474). The test substance did not induce a significant increase in the number of micronuclei at a dose level up to 2000 mg/kg bw.

Due to the fact that the positive outcome of in vitro mutagenicity tests with EUF are most likely related to the hydrolysis product formaldehyde, it is proposed to waive further mutagenicity testing, because formaldehyde has been extensively tested in various genotoxicity studies.

 


Short description of key information:
The two available in vitro test with EUF (Comet assay - DNA damage) and the gene mutation study (induction of gene mutation in mouse Lymphoma L5178Y/TK+/- cells) revealed positve results.
The in vivo micronucleustest had a negative outcome.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

EUF is considered positive due to the content (release) of formaldehyde. The new legal harmonised classification of formaldehyde (Index No 605-001-00-5) is Carc. 1B and Muta. 2.