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EC number: 447-920-2
CAS number: 897393-42-9
van Huygevoort (2003) performed a skin sensitisation test according to
OECD Guideline 408, EPA OPPTS guideline 870.2600 and a Japanese Test
Guideline based on the method described by Magnusson and Kligman. In
this K1 study, the test substance was observed not to be sensitising in
male/female Dunkin-Hartley guinea pigs.
van Huygevoort (2003) assessed contact hypersensitivity of the test
substance in the Albino Guinea Pig (Maximisation Test). The study was
carried out based on the guidelines described in EC Commission Directive
96/54/EC, Part B.6, "Skin sensitisation", OECD No. 406, "Skin
sensitisation", EPA OPPTS 870.2600 " Skin sensitisation" and JMAFF:
Japanese Test Guidelines and based on the method described by Magnusson
and Kligman, "Allergic Contact Dermatitis in the Guinea Pig -
Identification of Contact Allergens".
Test concentrations selected for the main study were based on the
results of a preliminary study.
In the main study, ten experimental animals were intradermally injected
with a 0.1% concentration and epidermally exposed to a 2% concentration.
Five control animals were similarly treated, but with vehicle alone
(corn oil). Two weeks after the epidermal application all animals were
challenged with a 1% test substance concentration and the vehicle. No
skin reactions were evident after the challenge exposure in the
experimental and control animals. There was no evidence that the
substance had caused skin hypersensitivity in the guinea pig, since no
responses were observed in the experimental animals in the challenge
phase. This result indicates a sensitisation rate of 0 per cent.
Based on the available test results and according to the CLP Regulation,
the substance needs not to be classified as a skin sensitiser.
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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