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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 test item was assessed for its possible contact allergenic potential in a local lymph node assay (OECD TG 429). For this purpose the test item was applied to the dorsal surface of the ears of female mice (4 per group) at concentrations of 5, 10, and 20% (w/v) in dimethyl sulphoxide for three consecutive days.The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 2.2, 1.5, and 0.8 were determined with the test item at concentrations of 5, 10, and 20%, respectively. The test item was not a skin sensitiser in this assay.

Two cases of allergic contact dermatitis caused by the submission substance and diagnosed by a medical specialist have been reported by an occupational physician. As no further information were provided these information have been judged not to be reliable (RL4). Based on the findings of the guideline study the submission substance has not to be classified as skin sensitiser.

Migrated from Short description of key information:
Not sensitising in a local lymph node assay in concentrations up to 20% (w/v).

Justification for classification or non-classification

Due to the negative findings in a local lymph node assay the test item has not to be classified as skin sensitiser according to Regulation (EC) No 1272/2008.