Ethyl vinyl ether

Endpoint summary

Additional information

EVE gave negative results in the standard plate test on S. typhimurium TA1535, TA100, TA1537, and TA98 both in the absence and in the presence of a metabolic activation system at concentrations up to 5000 µg/plate and saturated atmosphere (additional petri dishes with EVE) during the 4 -hrs exposure period at 37°C in desiccators to account for the high volatiliy of the test material (BASF 1993; Guideline study). EVE was not tested in S. typhimurium TA102 or in E. coli WP2uvrA, however, oxidizing or cross linking activity of the test substance is not expected.

In the HPRT assay (BASF 1998; Guideline study) conducted with Chinese hamster V79 cells with concentrations up to and including 720 µg/mL (ca. 10 mM; max. concentration recommended in current Guidelines), EVE did not induce an increase in the mutant frequency both with and without metabolic activation (exposure also in sealed culture flasks).

In a cytogenetic study (BASF 1998) according to current guidelines V79 cells were exposed in sealed petri dishes with and without metabolic activation for 4 h to up to 720 µg/mL (10 mM, recommended max. concentration) and harvested 18 and 28 hrs after start of exposure. In a 2nd trial without metabolic activation cells were exposed for 18 (sealed dishes) or 28 h (un-sealed) immediately followed by preparation. No cytotoxic effects were seen and no clastogenic or aneugenic activity.

Short description of key information:
In in vitro assays no gene mutagenic activity was detected in bacteria and mammalian cells.
No clastogenic or aneugenic effects were found in an in vitro chromosome aberration assay.
Data on genotoxicity in vivo are not available.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Classification is not warranted according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.