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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Non skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No data on the substance in itself was available, thus a read across approach was used. Similar Substance 01 was used a read across substance as detailed in section 13.

Similar Substance 01 was tested for skin sensitisation according to OECD guideline 442b. A preliminary test was run to select appropriate doses. Upon a first phase showing evident toxicity, concentrations were lowered to 0.5, 0.25, 0.1, 0.05 % w/w. As no irritation was seen at 0.5 % w/w, main test was run using concentrations of 0.5, 0.25 and 0.1 % w/w in acetone:olive oil (4:1).

No mortality nor clinical signs were noted at all dose levels; stimulation indices were below the threshold value of 1.6.

Positive control results were valid.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to OECD Guideline 442b, substances that result in SI ≥ 1.6 at one or more test concentrations are considered to be positive for skin sensitisation.

No test concentrations showed a SI above the threshold value. Therefore, relying on a read across approach, no classification applied to Acid Orange 116 according to the CLP Regulation (EC 1272/2008).