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EC number: -
CAS number: -
Skin sensitising potential of the test
There were no deaths on the study. No signs
of systemic toxicity were noted in the test or control animals during
Body weight change of the test animals
between Day 1 and Day 6 was comparable to that observed in the
corresponding control group animals over the same period.
A study was
performed to assess the skin sensitisation potential of the test
substance in the CBA/Ca strain mouse following topical application to
the dorsal surface of the ear. The
method was designed to meet the requirements of the following guidelines:
preliminary screening test in which no clinical signs of toxicity were
noted at a concentration of 100%, 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 either undiluted (100% v/v), or as a
solution in acetone/olive oil 4:1 at concentrations of 50% or 25% v/v.
A further group of four animals was treated with acetone/olive oil 4:1
The Stimulation Index expressed as the mean
radioactive incorporation for each treatment group divided by the mean
radioactive incorporation of the vehicle control group are as follows:
item was considered to be a sensitiser under the conditions of the test.
The test substance produced a significant
sensitisation response at all dose levels tested with a Stimulation
Index of 11.8 at 25% v/v (lowest concentration tested) and 15.6
at 100% (v/v). The EC3 was calculated to be < 0.052%. It
therefore meets the requirements for classification as a Category 1A
skin sensitiser according to Regulation (EC) No 1272/2008 based on the
Guidance to Regulation (EC) No 1272/2008 on classification, labelling
and packaging (CLP) of substances and mixtures Version 5.0, July 2017.
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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