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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).