Registration Dossier
Registration Dossier
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EC number: 942-732-1 | CAS number: -
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:
The in vivo skin sensitisation of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 429. A Local Lymph Node Assay (LLNA) was performed to assess the skin sensitization potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100% w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 μL (25 μL per ear) of the test item as a suspension in propylene glycol at concentrations of 100%, 50% or 25% w/w. A further group of four animals was treated with propylene glycol alone. The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group provided positive results for the 100% concentration tested. The test item was classified as sensitising, classification 1B, according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Migrated from Short description of key information:
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group provided positive results for the 100% concentration tested. The test item was classified as sensitising, classification 1B, according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Justification for selection of skin sensitisation endpoint:
Study was conducted on the registered substance according to OECD Testing Guideline 429.
Justification for classification or non-classification
The skin sensitisation study was conducted on the registered substance according to OECD Testing Guideline 429. The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group provided positive results for the 100% concentration tested. The test item was classified as sensitising, classification 1B, according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
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