Registration Dossier

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.