Registration Dossier
Registration Dossier
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EC number: 201-353-5 | CAS number: 81-48-1
Endpoint summary
Administrative data
Description of key information
Several LLNA were available. In the key study, three groups each of five female mice were treated with different concentrations of the test item by topical application at the dorsum of each ear once daily each on three consecutive days. A control group of five mice was treated with the vehicle only. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (³H-methyl thymidine; ³HTdR). Stimulation Indices of 2.1, 2.6, and 3.5 were determined with the test item at concentrations of 5, 10, and 25% in DMF. A dose response was observed. The EC3 value calculated was 16.7 %.
In further LLNAs Macrolex violet B was found to be a skin sensitizer. Since only a single concentration was analysed an EC3 value could not be derived.
Additionally, a Guinea Pig Maximisation Test acccording Magnusson and Kligman was conducted. Under the experimental conditions employed, 20% and 15% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a Guinea Pig Maximisation Test according Magnusson and Kligman 20% and 15% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. A classification is therefore not justified in this test.
Several LLNA were available. In the key study, Stimulation Indices (SI) of 2.1, 2.6, and 3.5 were determined with the test item at concentrations of 5, 10, and 25% in DMF. A dose response was observed. The EC3 value calculated was 16.7 %. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Category 1B (indication of skin sensitising potential) is justified in this test.
Overall, based on all available data the registrant proposed a classification as Category 1B (indication of skin sensitising potential).
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