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EC number: 442-300-8
CAS number: -
The test item has a skin sensitizing
potential as shown in animal studies.
A guinea pig maximization study according to
OECD guideline 406 was performed to evaluate the sensitization potential
of the test substance. The test was conducted with 30 female
Dunkin-Hartley guinea pigs (20 animals as test group, and 10 animals as
control group). During the induction procedure the test group was
exposed to 1% test substance via intradermal injections and 100% test
substance via topical application. The control group was exposed to
vehicle only during this procedure. All animals were challenged with 25%
and 50% test item and vehicle, respectively. When challenged with 50%
test substance, 9/10 (90%) positive responses were noted in the test
groups after 24 h and 10/10 (100%) positive response after 48 hours.
Following treatment with 25% test substance, 9/10 animals showed
erythema reactions at both 24 and 48 hour time points. Control animals
did not show any reactions. In conclusion, the test material produced a
100% (10/10) sensitization rate and was classified as an strong
sensitizer to guinea pig skin under the conditions of this study.
Labelling, and Packaging Regulation (EC) No 1272/2008
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. The epicutaneous
sensitisation study indicates a potential for skin sensitisation.
As a result the substance is considered to be classified as skin
sensitizer category 1A (H317: "May cause an allergic skin reaction")
under Regulation (EC) No 1272/2008, as amended for the eighth time in
Regulation (EU) No 2016/218.
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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