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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Genetic toxicity in vitro

Description of key information

In the bacterial genemutation test, there was a weak positive response in TA 100 and TA 1535 at highest concentrations only, without S-9. The study was repeated three times (only with TA100 and TA 1535 in two repeats) and both marginal positive and negative results were seen.

The mouse lymphoma (TK) assay resulted in slight,but significant, positive without S-9 at high concentrations only.

In-vivo UDS study also negative

This result implies low concentrations of potential genotoxic substance as impurity or metabolite

Note that key metabolite acetaldehyde presents as a positive genotoxic substance in the absence of S-9, and this result implies traces of acetaldehyde are present, but in the presence of enzyme metabolism, this is negated to form acetates and non-hazardous further metabolites.

Additional information

Justification for classification or non-classification