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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitisation (OECD 442B): skin sensitising

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The skin sensitising potential of the test substance was investigated in a Local Lymh Node Assay (LLNA) performed according to OECD Guideline 442B and in compliance with GLP (2017).

Treatment of CBA/N mice with the test substance revealed stimulation indices of 1.03, 1.01, 2.17, 3.06 and 3.09 at test substance concentrations of 1, 10, 25, 50 and 100% (w/v) in acetone/olive oil (4:1 v/v), respectively. The EC1.6 value was calculated to be 16.7%.

In conclusion, based on the available data the test substance is considered to be a weak skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation meets the criteria for classification as Skin Sens 1B (H317) according to Regulation (EC) 1272/2008.