Registration Dossier
Registration Dossier
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EC number: 274-407-9 | CAS number: 70210-10-5
Endpoint summary
Administrative data
Description of key information
Not sensitising in guinea pig maximisation test.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data on skin sensitising potential of Disperse Orange 080 was available, thus a read-across approach with Similar Substance 01 was used. The 2 substances are structural analogues. Details on the read across are reported in section 13.
Skin sensitisation was tested on guinea pigs in maximisation test by intradermal and dermal exposure. No skin reactions were seen in control and treatment group 24 and 48 hours after dermal challenge.
Moreover, no symptoms of systemic toxicity were seen in the animals and no mortality occurred.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), classification is applied in case of at least 30 % positive responses upon 1 % intradermal induction dose.
Since in the guinea pig maximisation test (adjuvant type), no positive responses in treated animals were found upon 1 % intradermal induction dose, Similar Substance 01 could not be assigned to a sensitising category and the result is considered as negative. Consequently, test substance is not classified in the CLP Regulation (EC 1272/2008).
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