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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

A pre-GLP study (Upman, 1973) found no evidence that the test substance produced skin hypersensitivity in guinea pigs. However, under the conditions of the experiment, the formulation appears to produce primary skin irritation. More reliable GLP studies (Grundler, 1981 and Allen, 1998) have shown the substance to be a sensitiser in contact with guinea pig skin. A local lymph node assay conducted to GLP standards in the mouse (Sanders, 2004) also showed the test substance to be a sensitiser.

Migrated from Short description of key information:
Sensitising to guinea pig skin (OECD 406)

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No data

Justification for classification or non-classification

Two GLP studies have shown that it is appropriate to classify the test substance as R43: may cause sensitisation

by skin contact under the criteria of Directive 67/548/EEC and Skin sensitizer Category 1 under GHS as

reflected by Regulation (EC) 1272/2008. Following the second amendment of the CLP Regulation as published

in Commission Regulation (EU) No 286/2011, the results from the local lymph node assay with MXDA can be

used to classify the substance into sub-category 1B, as the EC3 value is greater than 2% for this substance (the

stimulation index was 1.63 with a test concentration of 2.5% and 5.21 with a concentration of 5%).