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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
adverse effect observed (sensitising)
Additional information:

Following a preliminary screening test a concentration of 50% w/w was selected as the highest dose investigated in the main test.

three groups, each of 4 animals, were treated with 50 ul (25 ul per ear) of the test item as a solution in acetone/olive oil 4:1 at concentrations of 50%, 25% or 10% w/w.

A furhter group of four animals was treated with acetone/olive oil 4:1 alone.

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:

Concentration 10% w/w in acetone/olive oil 4:1: SI 9.42, Result positive

Concentration 25% w/w in acetone/olive oil 4:1: SI 14.78, Result positive

Concentration 50% w/w in acetone/olive oil 4:1: SI 12.98, Result positive

The test item was considered to be a sensitiser under the conditions of the test.


Migrated from Short description of key information:
The Local Lymph node Assay in the mouse was performed following the OECD Guidelines no. 429 "Skin sensitisation: Local Lymph node Assay" (adopted 22 July 2010) and the Method B.42 Skin Sensitisation (LLNA) of Commission Regulation (EC) no.440/2008.

Justification for selection of skin sensitisation endpoint:
The study was performed in compliance with the principles of the Good Laboratory Practice (GLP).
Experimental data: November 2011

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification