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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No evidence for the induction of reverse mutation was seen in the Salmonella typhimurium / Escherichia coli reverse mutation assay in the standard plate test and in the preincubation test with and without the addition of the S-9 mix metabolizing system obtained from rat liver. No evidence of mutation was seen in a mouse lymphoma assay (L5178Y) in the absence of metabolic activation. A slight increase in mutation frequency was seen in one experiment in the presence of metabolic activation but this was not replicated in another experiment and the mutation frequency was within the historical control range and did not exceed the GEF. This finding was therefore considered to be without toxicological significance. 2-ethylaminoethanol did not induce any statistically significant increases in the frequency of cells with chromosome aberrations in either the absence or presence of a liver enzyme metabolising system in either of two separate experiments. 2-ethylaminoethanol was considered to be non-clastogenic to human lymphocytes in vitro. The battery of in vitro mutagenicity studies all gave negative results for induction of genotoxicity and consequently no classification is required for 2 -ethylaminoethanol and no in vivo mutagenicity investigations are required.

Justification for selection of genetic toxicity endpoint
A weight of evidence approach is used for this endpoint

Short description of key information:
An Ames test (bacterial mutation), a mouse lymphoma assay (mammalian cell forward mutation) and a study of chromosomal aberration are available. All studies are modern, guideline- and GLP-compliant.

The results of the Ames test indicate 2-ethylethanolamine is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay.

2 -ethylaminoethanol did not induce any toxicologically significant increases in the mutant frequency at the TK +/- locus in L5178Y cells and is therefore considered to be non-mutagenic under the conditions of the test

2-ethylaminoethanol did not induce any statistically significant increases in the frequency of cells with chromosome aberrations in either the absence or presence of a liver enzyme metabolising system in either of two separate experiments. 2-ethylaminoethanol was considered to be non-clastogenic to human lymphocytes in vitro.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No classification is proposed for genetic toxicity, based on the negative results from the available studies.