Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The genetic toxicity of the Reaction mass of 2-ethylpropane-1,3-diol(DMP) and 5-ethyl-1,3-dioxane-5-methanol(CTF) and propylidynetrimethanol(TMP) is adequately charecterised using a combination of studies on the substance and its components.

A negative Ames test is reported for Polyol TD (May, 2010). Negative results are reported for the components CTF and DMP in studies of clastogenicity in CHO cells in vitro (Murie, 2010); negative results are also reported for the components CTF and DMP in mouse lymphoma assays (Riach, 2010). All studies are modern and compliant with GLP and the appropriate guidelines and involved testing up to the respective limit concentrations.

The available studies therefore adequately demonstrate the absence of genotoxicity of the Reaction mass of 2-ethylpropane-1,3-diol(DMP) and 5-ethyl-1,3-dioxane-5-methanol(CTF) and propylidynetrimethanol(TMP)

: read-across is proposed from the DMP to the other component, TMP. No further studies are therefore required.


Short description of key information:
A negative Ames test is available for Polyol TD. Negative studies of clastogenicity and mutagenicity in mammalian cells are reported for the components CTF and DMP; read-across is proposed from DMP to the additional component TMP.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

There was no evidence that Polyol TD is mutagenic in a bacterial reverse mutation assay. Both CTF and DMP were considered to be non-clastogenic and non-mutagenic in mammalian cells. No classification for genetic toxicity for the Reaction mass of 2-ethylpropane-1,3-diol(DMP) and 5-ethyl-1,3-dioxane-5-methanol(CTF) and propylidynetrimethanol(TMP)

is therefore proposed under the Directive 67/548/EEC or Regulation (EC) No 1272/2008.