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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 analogue substace was tested for sensitising properties following EU Method B6, GPMT (NONS dossier, 1988).

Guinea Pig were topycally and intradermally induced and then challenged at a concentration of the topic exposure at 10% of the test substance. Under the experimental conditions at the 10% dose the results at challenge time is 0% of skin positive reactions.

Based on the read across considerations the same resutls apply to Reactive Orange 12:1.

Migrated from Short description of key information:
GPMT, 10% epicutaneous, not skin sensitizing

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

A substance is classified as skin sensitizer cat 2 for Guine Pig Maximisation test

when >0.1 to <1% intradermal induction the positive skin reactions are>30 to <60% or

                             at >1% intradermal, the positive skin reactions are >30%

Based on the results of the GPMT the substance is not classified as skin sensitizer.