Registration Dossier
Registration Dossier
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EC number: 273-386-3 | CAS number: 68959-00-2
Endpoint summary
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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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