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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In a local lymph node assay with mice, mean stimulation indices (SI) of 3.0, 7.9 and 3.9 were attained in the 10%, 25% and 50% dose groups*, respectively. These represented a positive sensitisation response, although a dose related increase was only evident at 10% and 25% and not at 50%. The lower response in the 50% dose group than in the 25% group may have been related to the finding of hard ears seen in all animals of the 50% group which could have impaired skin penetration in this group.

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* Expressed as percentage of water- and minor impurity-free test substance in the vehicle (w/w).


Migrated from Short description of key information:
Group Mean Stimulation Index (SI) in Local lymph node assay in the mouse:
1.0, 3.0, 7.9 and 3.9 at test substance concentrations of 0 % (vehicle control), 10 %, 25 %, and 50 %, respectively.
Classification:
"irritant (Xi)" and "may cause sensitisation by skin contact (R43)" [DIRECTIVE 67/548/EEC] and
“Category 1” (Warning: May cause an allergic skin reaction)" [REGULATION (EC) 1272/2008].

Justification for classification or non-classification

In a local lymph node assay with mice, the stimulation index (SI) threshold of ≥ 3.0, indicating a positive sensitisation response, was attained in all treated groups. Therefore, according to EU classification rules the test substance was classified as "irritant (Xi)" and "May cause sensitisation by skin contact (R43)” [DIRECTIVE 67/548/EEC] and as “Category 1” (Warning: May cause an allergic skin reaction) [REGULATION (EC) 1272/2008].