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EC number: 216-630-6
CAS number: 1631-25-0
The skin sensitisation potential of IMILEX-C
(1-cyclohexyl-1H-pyrrole-2,5-dione; CAS 1631-25-0) following dermal
exposure in mice was performed as a Local Lymph Node Assay. The study
was performed in vivo with vertebrate animals as no full regulatory in
vitro alternative was available.
In the main assay, twenty-four female CBA/CaOlaHsd mice were allocated
to six groups of four animals each for the test item concentration doses
(formulated in 1% Pluronic) of 2.5% (w/v), 1% (w/v), 0.5% (w/v) and 0.25
% (w/v). The negative control group received the vehicle (1% Pluronic)
only, and the positive control group received 25 % (w/v) HCA (dissolved
in 1% Pluronic). The test item solutions were applied on the dorsal
surface of ears of experimental animals (25 μL/ear) for three
consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5
No mortality or systemic clinical signs were observed during the main
study. No test item precipitate was observed on the ears of the
experimental animals. There were no indications of any irritancy at the
site of application. No treatment related effects were observed on the
mean body weight changes in the main study. The stimulation index values
were 47.1, 51.8, 37.3 and 21.8 at concentrations of 2.5% (w/v), 1%
(w/v), 0.5% (w/v) and 0.25% (w/v), respectively.
The result of the positive control substance α-Hexylcinnamaldehyde (HCA)
dissolved in the same vehicle was used to demonstrate the appropriate
performance of the assay. A lymphoproliferative response in line with
historical positive control data was noted for the positive control
chemical, this result confirmed the validity of the assay.
Under the conditions of the present assay, IMILEX-C, tested in a
suitable vehicle, was shown to have a sensitisation potential
(sensitizer) in the Local Lymph Node Assay. The extrapolated EC3 value
of IMILEX-C is 0.1% (w/v). The following classification/labelling is
triggered: Regulation (EC) No 1272/2008 (CLP) / GHS (rev. 6) 2015:
Category 1 (sub-category 1A).
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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