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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Sensitisation was assessed using the Magnusson and Kligmann sensitisation assay. During the induction phase of the study, no irritation reactions were noted in both control and test groups. After the challenge exposure none of the 10 test group showed positive skin reaction.


On the basis of the results, the substance cannot be considered to be a skin sensitiser.

Migrated from Short description of key information:
Summary of skin sensitisation

Respiratory sensitisation

Endpoint conclusion
Additional information:

Disperse dyes are not known to be potential respiratory sensitisers, based on history of use. Respiratory sensitisation is therefore not considered to be applicable for this type of substance.

Migrated from Short description of key information:
Not assessed.

Justification for classification or non-classification

The above study has been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for sensitisation effects is therefore required.