Registration Dossier
Registration Dossier
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EC number: 700-737-4 | CAS number: 1220100-43-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A local lymph node assay study based on internationally accepted guidelines was carried out to determine if the test article would induce a hypersensitivity response in mice as measured by the proliferation of lymphocytes in the draining lymph nodes.
A test material is considered to have skin sensitizing activity if, at one or more concentrations, it induces a 3 -fold or greater increase in proliferative activity relative to the concurrent vehicle treated control. Thus, a stimulation index above 3.0 is regarded as a positive response. Treatment with the test substance at a concentration of 50% (w/v) did result in stimulation indices greater than 3.0. Therefore, the test substance is considered to have skin sensitizing activity. The EC3 was calculated to be 29.7%.
Migrated from Short description of key information:
A test material is considered to have skin sensitizing activity if, at one or more concentrations, it induces a 3-fold or greater increase in proliferative activity relative to the concurrent vehicle treated control. Thus, a stimulation index above 3.0 is regarded as a positive response. Treatment with the test substance at a concentration of 50% (w/v) did result in stimulation indices greater than 3.0. Therefore, the test substance is considered to have skin sensitizing activity.
Justification for classification or non-classification
The test substance skin-sensitisation test data does meet classification criteria under EU Directive 67/548/EEC for skin sensitisation.
The test substance skin-sensitisation test data does meet classification criteria under Regulation (EC) No 1272/2008 for skin sensitisation
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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