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EC number: 212-133-3
CAS number: 764-99-8
The test item is not sensitising.
Test articel formulation and dosing:
The test article formed a homogenous mixture in the verhicle, AOO. No difficulties were experienced with the application of the test article to the ears or with the retention of test article by the ear surface.
Body weight changes were normal.
Mortality and systemic observations:
All animals survived the in-life phase of the study and appeared normal.
25 % test item: 1.8 (+/- 0.9)
50 % test item: 1.5 (+/- 0.8)
100 % test item: 2.4 (+/- 1.2)
For the assessment of the skin sensitising potential of the test item a Local Lymph Node Assay was performed with CBA mice according to OECD 429 (GLP guideline study; MB Research Laboratories 2007). Topical application of the test item at 25% and 50% resulted in stimulation indices of less than 3 compared to the vehicle control group. Topical application of the test item at 100% resulted in a stimulation index of less than 3 compared to the naive control group. Therefore, the test item is not a dermal sensitizer in the Local Lymph Node Assay.
Classification is not warranted according to
the criteria of EU Directive 67/548/EEC and EU Classification, Labelling
and Packaging of Substances and Mixtures (CLP) Regulation (EC) No
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