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EC number: 212-133-3
CAS number: 764-99-8
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.
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
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
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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