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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Regarding the in vitro data, gene mutation tests with prokaryotes and mammalian cells and chromosome aberration tests with mammalian cells are available, all performed in accordance with or to a method similar to OECD guidelines and under GLP.

Four Ames test were available. The study of Pharmakon Europe (1994e) is selected as key study as most details were reported for this study. In that study ETBE was not mutagenic in Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA98, TA 100 both in the absence and presence of S9 fraction. Additional strains (TA97(a) and TA102) were tested in some of the other studies and ETBE was also negative in these strains.

An in vitro HGPRT assay and an in vitro chromosomal aberration test both with in Chinese Hamster Ovary cells (Bushy Run Research Center (1995a/1995b) and performed according to methods similar to OECD guideline 476 and 473, respectively, were also negative.

In addition, extensive in vivo micronucleus data are available for ETBE which has been tested in the rat following repeat i.p. injection (Japan Bioassay Research Center, 2007a), repeat oral gavage (Japan Bioassay Research Center, 2007b), sub-chronic oral (drinking water) administration (Japan Bioassay Research Center, 2007c) and sub-chronic inhalation exposure (Japan Bioassay Research Center, 2007d). Data are also available for the mouse, obtained following single oral gavage administration (Bushy Run Research Center, 1995c) and sub-acute inhalation exposure (Institut Pasteur de Lille, 1992c). All investigations were Guideline- and GLP compliant. All returned negative results.

Short description of key information:
ETBE was negative in gene mutation tests in vitro (in prokaryotes and HGPRT with mammalian cells), in a chromosomal aberration test in vitro and in six in vivo micronucleus tests.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available negative data, ETBE is concluded to be non-mutagenic. In accordance to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for mutagenicity.