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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitizing potential of Ethyl difluoroacetate was assessed using the radioactive Murine Local Lymph Node Assay (BASF AG, 2008). Groups of 5 female CBA/J mice each were treated with the undiluted test substance and with 30% and 10% w/w preparations of the test substance in propylene glycol or with the vehicle alone. The study used 3 test groups and 1 control group.

No signs of systemic toxicity were noticed in the test animals. When applied as 10% and 30% preparations in propylene glycol or undiluted, the test substance did not induce a biologically relevant response (stimulation index (SI) 1.5) in the auricular lymph node cell counts. The increase of 3H-thymidine incorporation into the cells was not biologically relevant (increase above the cut off stimulation index of 3) at these concentrations. In addition no relevant change in lymph node weights was observed. The test substance at all concentrations did not cause increases in ear weights indicating ear skin irritation.

Migrated from Short description of key information:
-Skin sensitization: BASF AG, 2008, LLNA-mouse: not sensitizing
- Respiratory sensitization: no data

Justification for classification or non-classification

Regarding the results of the LLNA (BASF AG, 2008), it is concluded that Ethyl difluoroacetate is not to be classified as skin sensitizing.

According to 67/547/EEC Annex I and EC/1272/2008 Annex VI Ethyl difluoroacetate is also not classified.