Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Genotoxicity:

2 -Phenoxyethanol was tested for genotoxic potential in an adequate battery of in vitro and in vivo tests with various end points.

In vitro: 2-Phenoxyethanol was not a point mutagen in studies on bacteria at concentrations up to 5000 µg/plate with and without metabolic activation (BASF AG, 2002; Sasol, 1994; Nipa Laboratories, 1982). Further tests on point mutations on the HGPRT locus in eukaryotic cells yielded also negative results (BASF AG, 2002, The Dow Chemical Company, 1987).
In vitro testing on chromosome-damaging effects in Chinese hamster cell cultures indicated no effects with and without metabolic activation (BASF AG, 2002; Unilever, 1985).

The available data indicate that 2 -phenoxyethanol was neither an in vitro cell mutagen nor a clastogen.

In vivo: The in vivo assays also showed no mutagenic effects with 2-phenoxyethanol treatment.
No chromosome-damaging effects were observed and testing on DNA damage in vivo via the UDS test in Wistar rat also failed to show mutagenic effects. (BASF, 2002, Nipa Laboratories, 1982; BASF AG, 2002; The Dow Chemical Company, 1988)

The available data indicate that 2-phenoxyethanol was not an in vivo cell mutagen or clastogen.

Overall, 2-phenoxyethanol is unlikely to pose a genotoxic hazard to man.


Short description of key information:
The available data indicate that 2-phenoxyethanol is not genotoxic.
In vitro: Negative in the Ames test, negative results in mammalian chromosomal aberration and gene mutation tests.
In vivo: Negative in chromosomal aberration, micronucleus and unscheduled DNA synthesis assays.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available data are conclusive but not sufficient for classification.