Registration Dossier
Registration Dossier
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EC number: 276-012-7 | CAS number: 71786-55-5
Endpoint summary
Administrative data
Description of key information
Skin sensitising
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The purpose of the study was to obtain information on the potential of the test substance to induce delayed contact hypersensitivity (skin sensitisation) in the guinea pig after intradermal and epidermal exposure.
After identification of the slightly irritating and the non-irritating test substance concentrations in the primary irritation experiments, a main study was performed with selected test substance concentrations. The experimental animals were intradermally injected with a 5% concentration in physiological saline and epidermally exposed with a 50% concentration in vaseline, while the control animal were similarly treated, but with the vehicles only.
Immediately after the epidermal exposure, the skin irritation was scored. Two weeks after the epidermal application all animals were challenged with test substance concentrations of 25%, 10%, 5% and the vehicle. The challenge reactions were assessed 24 and 48 hours after bandage removal.
The epidermal exposure of test substance in the induction phase resulted in slight erythema in fifteen of the twenty animals. The epidermal exposure of test substance in the challenge phase resulted in thirteen positive sensitisation reactions in response to the 5% test substance concentrations.
No simptoms of systemic toxicity were observed in the animals duringn the study. No mortality occurred during the study.
Under the conditions used in this study, test substance resulted in a sensitisation rate of 65 per cent.
According to CLP (CE) n. 1272/2008 criteria the test substance is classified in category 1b.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Under the conditions used in this study, test substance resulted in a sensitisation rate of 65 %.
According to CLP (CE) n. 1272/2008 criteria the test substance is classified in category 1b.
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