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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based on in vivo mouse female LLNA. Not sensitising. OECD 429; Key study;

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The dermal sensitization potential of the test substance was evaluated in mice using the local lymph node assay (LLNA). The highest concentration tested, 26.7% active ingredient, was chosen based on its pH in the vehicle (pH~3), the lowest limit appropriate in this study.  Stimulation indices (SIs) of less than 3.0 were observed at all concentrations tested, 5, 25, 50, and 75% (1.78, 8.90, 17.8, 26.7% active ingredient). Statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at the 25, 50, and 75% test concentrations. Stimulation indices (SIs) of less than 3.0 were observed at all test concentrations of the test substance. Therefore, the EC3 value (the estimated concentration required to induce a threshold positive response, i.e., SI = 3) for the test substance under the conditions of this study was not calculable. The test substance did not produce a dermal sensitization response in mice.

Justification for classification or non-classification

There was no evidence of dermal sensitisation in a mouse local lymph node assay. The substance does not need to be classified for skin sensitisation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.